The Bitter Pill

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Lawmakers Catch Glaxo Hiding Paxil Suicide Risks – Again (Part I)

Evelyn Pringle February 12, 2008

GlaxoSmithKline recently received greetings from a Congressional Committee, asking the company to explain the findings in a report unsealed last month in a lawsuit which shows that Glaxo knew as early as 1989 that Paxil increased the risk of suicidal behavior in patients by more than 8-fold compared to patients who received a placebo.

In a February 6, 2008 letter, Senator Charles Grassley (R-Iowa), ranking member of the Senate Finance Committee, is asking Glaxo to explain why the American public was never adequately informed of this risk until May 2006 in a “Dear Healthcare Professional” letter which reported a “higher frequency of suicidal behavior” associated with Paxil as compared to placebo.

The report showing the 8-fold suicide risk, by Harvard instructor and psychiatrist Joseph Glenmullen, was unsealed on January 18, 2008, by a federal judge in a US District Court in Sacramento, California in the Paxil suicide case of O’Neal v SmithKline Beecham d/b/a GlaxoSmithKline, filed by the surviving family members of 13-year-old Benjamin Bratt.

Dr Glenmullen was retained as an expert in the case by the California-based Baum, Hedlund, Aristei & Goldman law firm.

On January 30, 2008, the court dismissed the lawsuit on the basis of the Bush Administration’s new preemption policy, largely unknown to most Americans, which says that once the FDA approves a drug and its label, citizens may not sue a company for failing to warn about a risk not listed on the label, even in cases like this where the plaintiff can prove that the company knew about the risk and intentionally concealed it.

SSRI’s are antidepressants known as selective serotonin reuptake inhibitors and include Paxil, Eli Lilly’s Prozac, Zoloft by Pfizer and Celexa and Lexapro marketed by Forest Labs. Wyeth’s Effexor, Lilly’s Cymbalta and Glaxo’s Wellbutrin are not considered SSRI’s, but they also carry a warning about an increased risk of suicidality in young people.

Two SSRI suicide cases are now awaiting a joint decision from the Third Circuit Court of Appeals for which oral arguments took place in December 2007.

In the case of Colacicco v Apotex, the US District Court for the Eastern District of Pennsylvania was the first to dismiss a failure-to-warn claim based on the new preemption policy, and in McNellis v Pfizer, the US District Court for the District of New Jersey found no preemption.

Also unbeknownst to most Americans, the Bush Administration is instructing judges to dismiss the lawsuits against the SSRI makers in amicus briefs filed by the government’s top attorneys, who also attend hearings when necessary to argue on behalf of the SSRI makers during oral arguments on motions to dismiss.

In fact, in regard to requiring a warning about suicide, during oral arguments in the Third Circuit, Bush Administration attorney Sharon Swingle told the court that the FDA “had again and again and again made an expert determination that the warning was not appropriate.”

She maintained that the claims were preempted because the SSRI makers were not allowed to add warnings to the label under any circumstances without prior approval from the FDA.

At one point, the court asked an attorney for an SSRI maker, “assume for the moment that you had reasonable evidence of an association between your product and a serious hazard or a serious possibility of an enhanced suicide risk.”

Under federal regulations, “what would be your obligation?”

The attorney stated, “our obligation would be to take that information to the FDA, advise the FDA of the information.”

“It then would be the FDA’s determination whether that represented a substantial relationship,” he told the court.

“So if you had evidence internally that there’s an enhanced risk of suicide, you would go to the FDA,” the court said, and asked, “And how long would that take?”

“I do not know the answer to that, your Honor,” the attorney said, and the court asked, “Could it take months?”

“I imagine it would depend on the seriousness –,” the attorney stated.

“But isn’t there a significant possibility that additional people then might have the same consequence that happened here with McNellis, or with Colacicco and McNellis’s father?” the court asked.

The attorney said, “on the basis of the information that was available we would take it per FDA directive to the FDA and they would make the determination whether the label should be changed.”

“Other people could then,” the court continued, “possibly have an enhanced risk of suicide and other people may commit suicide as a result of taking your product?”

“We would be bound by law to comply with the FDA, then to comply with its directives,” the attorney replied.

“Are they requiring that you go through them first rather than act on your own?” the court asked.

“That’s exactly correct, your Honor, because there is the bigger issue of the –” the attorney stated.

However, at the end of the hearing, Pennsylvania attorney Derek Braslow proved beyond any doubt that the claims made by the Bush Administration attorney and the attorneys for the drug makers were blatant lies, when he informed the court that Glaxo had “independently, strengthened their warning in May 2004 to warn about increased suicidality and worsening depression in everyone, not just children.”

“There was specifically in bold letters a new warning with respect to increased suicidality and worsening depression in May 2004,” he stated.

“Glaxo changed the label on their own without FDA approval,” Mr Braslow told the court.

Glaxo did it again in May 2006, he said, when they sent out a “Dear Healthcare Professional” letter and warned about the increased risk of suicidality and suicidal behaviors with Paxil in persons of all ages.

During oral arguments in the O’Neal case on January 21, 2008, Glaxo’s preemption argument was presented by King & Spalding attorney Mark Brown, who just happens to be a former Associate Chief Counsel for the FDA from the first Bush Administration.

The family intends to ask the court to reconsider the ruling in the O’Neal case, according to a statement by Baum Hedlund.

In his report, Dr Glenmullen sums up the inadequacy of the system, including the FDA, that allowed Glaxo to keep this vital information hidden from prescribing doctors and patients for nearly 2 decades and states, in part:

“One of the most sobering aspects of the story of Paxil-induced suicidality is that GlaxoSmithKline was not forthcoming with its data demonstrating the risk and regulatory agencies like the FDA did not take the initiative to get to the bottom of and expose the true risk.”

“Rather, the impetus came from attorneys and medical experts surprised by what they found in GlaxoSmithKline’s confidential documents, which only came to light through litigation.”

“The GlaxoSmithKline documents that have so-far made it into the public record have in turn been critical to educating patients, the public, and the media about the true risk. The media – particularly the BBC in England – played a crucial role in turning the tide in the history of Paxil-induced suicidality.”

According to Dr Glenmullen, “it was the diligent efforts of plaintiff’s attorneys that forced GlaxoSmithKline to divulge the inaccurate counting method to the FDA.”

Another leading expert on pharmacology, Dr Peter Breggin, warns that an 8-fold increased risk of suicidality in controlled clinical trials could mean 80-fold in actual practice. “We can’t determine exactly how much greater the risk will be in clinical practice but it will be astronomically greater,” he advises.

In actual practice, he explains, many patients are already suicidal when they start taking the drug, increasingly the likelihood that the drug can push them over the edge.

Despite the warnings to watch patients closely, Dr Breggin says, busy doctors do not monitor patients properly. He explains that they are almost never evaluated for suicidality and are often given multiple drugs at the same time, by doctors who know little about their adverse effects on the mind.

Glaxo is facing lawsuits from surviving family members of Paxil suicide victims all over the country and is attempting to use preemption to avoid public trials for good reason. The first case to go before a jury in Wyoming in 2001, involved a man who shot his wife, daughter and infant granddaughter before shooting himself after being on Paxil for just a matter of days.

The trial resulted in a verdict against Glaxo for $6.4 million after the jury weighed the expert testimony of famed pharmacologist Dr David Healy, who presented a summary of Glaxo’s hidden suicide data on Paxil, against the testimony of the industry-funded SSRI defender Dr John Mann, whose name appears on many of the studies issued over the years, some as late as 2007, that steadfastly proclaim that SSRI’s are not linked to suicide and should be prescribed to children.

In addition to Dr Healy’s revelations about hidden data showing that Glaxo was aware of the increased risk, Dr Mann’s credibility was likely weighed against the fact that he had received over $30 million in research funding from drug companies between the early 1990’s and the trial in 2001, which was brought out during his testimony by Houston attorney Andy Vickery.

Mr Vickery also established that, roughly 10 years and $30 million earlier, Dr Mann had published a paper stating that SSRI’s could increase suicidality in a small subset of patients.

In his report, Dr Glenmullen states that, since Glaxo had the original data in 1989 that showed a greater than eightfold increased risk, it should have warned doctors and patients about the risk “a decade-and-a-half ago when Paxil was first approved by the FDA.”

The report includes portions of an April 29, 1991 report, written by Glaxo psychiatrist Dr Geoffrey Dunbar, sent to the FDA in response to a specific request for information on suicidality in which Glaxo openly lies in stating: “analyses of our prospective, clinical trials for depression show that patients who were randomized to Paxil therapy were at no greater risk for suicidal ideation or behavior than were patients randomized to placebo or other active control therapies.”

Dr Glenmullen notes the importance of the date that this false data was submitted because the FDA had scheduled a hearing with a nine-member advisory panel for September 20, 1991, to discuss concerns raised a year earlier about the possibility of Prozac making patients suicidal. Paxil was not approved for use in the US until December 2002.

In his report, Dr Glenmullen points out that 5 of the 9 members on the advisory panel had conflicts of interest with drug makers and that 2 psychiatrists, Dr David Dunner of the University of Washington in Seattle and Dr Stuart Montgomery from England, had done research on Prozac for Eli Lilly, and later played crucial roles in Glaxo’s publishing of what he calls “bad” suicide numbers in the Paxil story.

Dr Glenmullen’s report includes portions of a September 19, 1991, memo distributed to over 20 senior staff the day before the hearing with a “Statement to be used to respond to inquiries re Paxil/Suicide,” which claims explicitly that during GlaxoSmithKline’s studies: “the incidence of suicide was lower among patients receiving Paxil than among those receiving placebo.”

This was the statement the company ordered employees to make, even though 5 patients on Paxil committed suicide while no patients in the placebo group did. In addition, Dr Glenmullen points out that, up to 1989, seriously suicidal patients were excluded from Glaxo’s studies, and therefore “anyone who became seriously suicidal during the studies only became so after being given Paxil or a placebo.”

Yet the actual numbers show that there were 40 suicide attempts in the clinical trials by patients taking Paxil compared to 1 suicide attempt in the placebo groups.

Despite the poor quality of the data available to the advisory committee, and despite the many conflicts of interest of its members, one third of the members still voted for a warning in 1991, Dr Glenmullen points out.

Three months later, in December 1991, Dr Dunner, together with Glaxo psychiatrist Dr Dunbar, presented Glaxo’s Paxil data with the “bad” numbers at a meeting of the American College of Neuropsychopharmacology (ACNP) in Puerto Rico.

During the presentation, the doctors told the ACNP: “Suicide and suicide attempts occurred less frequently with Paxil than with either placebo or active control,” according to the Glenmullen report.

The ACNP’s members are considered prominent academic psychiatrists who specialize in pharmacology, and the group has issued a number of position papers over the years which consistently denied a link between SSRI’s and suicidality.

Dr Mann led an ACNP task force which included Dr Fred Goodwin, Dr Charles O’Brien and Dr Robinson, which supposedly reviewed all the clinical trial data on SSRI’s and issued a consensus statement with the position that SSRI’s did not increase the risk of suicidal behavior, which was published in the journal Neuropsychopharmacology in 1993.

In March 1995, Dr Dunner, Dr Montgomery and Dr Dunbar published the paper, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo,” in the European journal Neuropsychopharmacology. This paper included a table with the “bad” numbers and claimed that other antidepressants were more likely to increase the risk of suicide than Paxil.

The paper specifically states: “Consistent reduction in suicides, attempted suicides, and suicidal thoughts, and protection against emergent suicidal thoughts suggest that Paxil has advantages in treating the potentially suicidal patients.”

On July 5, 1995, Glaxo’s marketing department issued a memo urging its sales force to use the Dunner-Dunbar paper to reassure doctors who were concerned over Paxil-related suicide that there was no need for concern.

The fact is, documents obtained in litigation prove that the FDA has known about the suicide risks of SSRI’s for roughly 23 years. Two years before Prozac was approved, in May 1985, the FDA’s chief investigator, Dr Richard Kapit, wrote: “Unlike traditional tricyclic antidepressants Fluoxetine’s profile of adverse side effects more closely resembles that of a stimulant drug than one that causes sedation.”

“It is Fluoxetine’s particular profile of adverse side-effects which may perhaps, in the future give rise to the greatest clinical liabilities in the use of this medication to treat depression,” he noted.

Dr Kapit’s review described data from 46 clinical trials with a total of 1,427 patients and under the section, “Catastrophic and Serious Events,” he listed 52 cases of “egregiously abnormal laboratory reports which were the reason for early termination,” and “additional adverse event reports not reported by the company were revealed on microfiche.”

“In most cases,” he wrote, “these adverse events involved the onset of an unreported psychotic episode.”

There were ten reports of psychotic episodes including 2 reports of completed suicides, 13 attempted suicides, 4 seizures, and 4 reports of movement disorders. In 1985, Dr Kapit recommended “labeling warning the physician that such signs and symptoms of depression may be exacerbated by this drug”.

When Prozac was approved, no such warning was issued.

Two weeks after the FDA advisory panel met in February 2004 to review the data on SSRI’s to determine whether they were linked to suicide, Dr Healy sent a report to Peter Pitts, Associate Commissioner for External Relations, at the FDA, in response to an invitation by Dr Robert Temple for a submission of the details of studies referred to in the course of a presentation at the meeting.

“A great number of the patient testimonies in the course of the Feb 2nd hearing were from individuals who became suicidal on an SSRI when their underlying disorder was Lyme Disease, migraine or a condition such as social phobia,” Dr Healy pointed out.

He also noted that this had been the case in the 1991 hearings, when it was framed by FDA’s Dr Temple as follows:

“The discussion we heard earlier showed that people who commit suicide are highly likely to have a diagnosis of depression, which means that somebody identified them as in a high-risk category. But there were still a significant number of people who committed suicide without having that sort of diagnosis and I guess I would like some advice or discussion on who those people were.”

“The anecdotes that one hears that are most evocative to me anyway are not the ones where people who have a 20-year history of suicidal ideation and then finally do it – that is not too surprising – it is where they assert that there has never been anything in their minds like that before and yet now they have suddenly become excessively concerned with suicide and may even do it.”

Dr Healy’s analysis submitted to the FDA included the data from the pediatric trials on suicidality and hostility, including some that were concealed for years. To distinguish the difference between suicide caused by SSRI’s verses suicide caused by the underlying depression, he separated the data on children who were treated for depression and children who were treated for obsessive compulsive disorder or social phobia.

The analysis found that SSRI’s can cause some children who are not depressed to become suicidal when taking the drugs for other conditions. From a pool of 931 depressed patients taking SSRI’s versus 811 depressed patients taking placebo, Dr Healy determined that there were 52 suicidal acts by patients on SSRI’s versus 18 in the placebo group.

In a pool of 638 patients taking SSRI’s for other disorders versus 562 patients taking a placebo, there were 10 suicidal acts in the SSRI group versus 1 in the placebo group.

When these data sets were combined, there were 62 episodes of suicidality in the 1,569 patients on SSRI’s versus only 19 episodes in the 1,373 patients on a placebo.

In his submission to the FDA, Dr Healy also explained that he had conducted his own trial on Zoloft in 2000 with 20 “healthy volunteers,” meaning they had no mental disorder when entering the trial, and two of the Zoloft patients became suicidal. This type of study provides the strongest evidence of drug-induced suicidality because it’s impossible for drug companies to claim that a patient became suicidal as a result of the underlying depression.

Seven years ago, during the Wyoming jury trial involving the tragic Paxil-induced murder-suicide, the man’s physician testified that he may not have prescribed Paxil if a warning regarding homicide and suicide had been added to the drug’s label.

In his report released last month, Dr Glenmullen offers the following heart-wrenching conclusion to the court: “It is my opinion to a reasonable degree of medical probability that if GlaxoSmithKline had provided a warning all these years, Benjamin Bratt would still be alive today.”

On April 24, 2004, the Lancet medical journal published an editorial entitled, “Depressing Research,” with the following comments that surely ring doubly true today for the Bratt family, as well as all the other families whose children committed suicide while on SSRI’s:

“It is hard to imagine the anguish experienced by the parents, relatives, and friends of a child who has taken his or her own life. That such an event could be precipitated by a supposedly beneficial drug is a catastrophe. The idea of that drug’s use being based on the selective reporting of favourable research should be unimaginable.”

Filed under: 2008, Baum, Braslow, Breggin, Colacicco, FDA, FDA hearing, Fraud, ghostwritten, Glaxo, KOL, Mann, Paxil, Preemption, SSRIs, Study 329, suicide, Vickery

Lawmakers Catch Glaxo Hiding Paxil Suicide Risks – Again (Part II)

Evelyn Pringle February 13, 2008

Apparently, GlaxoSmithKline is still trying to hide damaging information about Paxil, because 9 pages of a report released from under a court order last month, are not available to the public. However, Senator Charles Grassley has instructed Glaxo to provide him with the full report by February 14, 2008.

In the report, which is dated roughly 6 months ago on June 29, 2007, Harvard Professor, Dr Joseph Glenmullen reveals that Glaxo had clinical trial data since 1989 which showed that Paxil increases the risk of suicide by more than 8-fold compared to patients who received a placebo.

The report was submitted in O’Neal v Glaxo, a lawsuit filed in a California federal court by the surviving family members of Benjamin Bratt who committed suicide at age 13 while on Paxil. The family is represented by the California law firm of Baum, Hedlund, Aristei & Goldman.

On January 30, 2008, the judge dismissed the case on the basis of the new preemption policy of the Bush Administration, but the family intends to ask the court to reconsider the ruling, according to Baum Hedlund.

In his report, Dr Glenmullen also makes a plea for public disclosure of all information that remains sealed under court orders on the basis of Glaxo’s claim that the documents contain trade secrets and states:

“Given the importance of GlaxoSmithKline’s internal documents, it is unfortunate that so many of the documents cited in this report and the attached Appendix are still confidential.”

“Given the stakes for public health and safety, GlaxoSmithKline should not be permitted to claim the documents are proprietary trade secrets.”

“All the documents should be made part of the public record so the full story of Paxil-induced suicidality can be told and the additional necessary steps can be taken to fully protect patients and the public.”

Dr Glenmullen also mentions a companion report related to children and adolescents and a “Specific Causation Report” in the case of Benjamin Bratt, and Senator Grassley has instructed Glaxo to provide him with a copy of that report as well.

In what can only be viewed as an eerily prophetic comment, in a letter back on September 16, 2004, to the Secretary of Health and Human Services, and the acting FDA Commissioner at the time, Senator Grassley warned: “I intend to keep the FDA’s feet to the fire to insure that the American public is knowledgeable about the risks of SSRI’s.”

SSRI’s refer to antidepressants known as selective serotonin reuptake inhibitors that include Paxil, Eli Lilly’s Prozac, Zoloft by Pfizer and Celexa and Lexapro marketed by Forest Labs, along with their generic counterparts. Lilly’s Cymbalta, Wyeth’s Effexor and Glaxo’s Wellbutrin are often referred to as SSRI’s but they are slightly different chemically. However, the new antidepressants all carry the same warnings about the suicide risks.

Senator Grassley’s letter followed the vote by an FDA advisory committee for a black box warning about the increased risk of suicide with kids to be added to the drugs’ labels.

His angry tone, and not so subtle threat, was due to the fact that, during the advisory committee meeting, it became apparent that not only Glaxo, but all the SSRI makers, had concealed and misrepresented clinical trial data for years in the published medical literature which clearly indicated that there was an increased risk of suicidality with SSRI use.

In fact, as soon as Glaxo’s was asked about the hidden studies by regulators in the UK, Glaxo issued a “Dear Doctor” letter to physicians in England saying Paxil should not be prescribed to children because it “failed” to work any better than a placebo and frequently caused “hostility, agitation, emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts, and attempted suicides.)”

Glaxo did not issue any such warning to doctors in the US.

The paper that garnered the most wrath from pharmacology experts all over the world was published in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry on Paxil study 329, which was conducted from 1993 through to late 1995 or early 1996, according to a leading pharmacology expert, Dr David Healy.

Twenty academics, considered to be the tops in their field, signed off on the study. The main authors of paper on the study were later found to be in constant contact with Glaxo when the media began reporting that the data published was fraudulent, and include Dr Martin Keller, Dr Neil Ryan and Dr Karen Wagner.

In the paper, the authors write: “Of the 11 patients only headache (one patient) was considered to be related to the treatment,” and Paxil is “generally well tolerated and effective.”

However, when the actual study was analyzed in 2003, it showed suicidal acts by 5 out of 93 children on Paxil compared to no suicidal acts in the 89 children who received placebo.

On January 29, 2007, the BBC’s Panorama broadcast, “Secrets of the Drug Trials.” Attorney Karen Barth Menzies obtained many of the secret Paxil documents that were quoted during litigation, and she explained how Glaxo found ways “to blow up out of proportion the supposed benefits in Study 329 and downplayed the negative findings.”

Glaxo recruited the opinion leaders to put their names on the published 329 study, she said, because they were academics whom everybody looked up to, and the company knew that doctors would be far more likely to prescribe Paxil after listening to these doctors than they would be if approached by Glaxo salespersons.

One letter that was quoted, revealed that these so-called opinion leaders never even wrote a paper. The letter was from a ghost writer to Dr Keller, informing him that all the necessary materials were enclosed for him to submit the study to a journal for publication. The packet even included a cover letter, with instructions telling Dr Keller to: “please re-type on your letterhead. Revise if you wish.”

Dr Wagner, along with Dr Graham Emslie, was also responsible for publishing papers on studies that resulted in Prozac’s approval for children, and Dr Wagner and Dr Keller were also investigators on Zoloft studies and several of the unpublished Paxil studies.

In the October 4, 1999 Boston Globe, Alison Bass reported that in 1998, as a professor at Brown University, Dr Keller was forced to forfeit “hundreds of thousands of dollars” in state grant money and was paid more than $500,000 in consulting fees in 1998, most of it from companies whose drugs he touted in medical journals and at conferences.

In the report, Ms Bass pointed out that Keller was a valuable resource for the University, and had brought in about $14.4 million in research funding from drug companies and federal agencies since 1993.

According to the report, in 1998, the year Keller published 3 studies with colleagues in the Journal of the American Medical Association and the Journal of Clinical Psychiatry touting the efficacy of Zoloft, he received $218,000 in personal income and more than $3 million in research funding from Zoloft maker Pfizer.

Several ethicists contacted by the Globe said Keller’s unusually large consulting fees, a total of $556,000 in 1998 and $444,000 in 1997, constitute the most serious potential conflict they’ve heard of yet, Ms Bass noted.

Dr Wagner received an onslaught of criticism from experts all over the world when she misrepresented trial data in a paper on Zoloft, claiming it was safe and effective for use with children. On November 29, 2004, Barry Meier wrote, “Contracts Keep Drug Research Out of Reach,” in the New York Times, and reported that over the past decade, Dr Wagner from the University of Texas Medical Center in Galveston had led or worked on some 20 studies published in medical journals and had also “attracted a large number of industry-financed studies, including those aimed at testing whether antidepressants approved for use in adults were safe and effective in children and adolescents.”

In a financial filing with the university in December 1999, Mr Meier found the same month that a Zoloft trial began recruiting patients, Dr Wagner disclosed that she had received more than $10,000 from Pfizer but she did not provide details.

She also did not respond to written questions about the payments but a lawyer for the school, told Mr Meier that Dr Wagner had told him that Pfizer had paid her $20,500 during the course of the Zoloft trial.

Mr Meier also noted that academic researchers routinely receive speaking and consulting fees from companies whose products they test and at Galveston the financial threshold for such a review is $10,000. But the school lawyer, told Mr Meier that the center had been unable to locate records related to Pfizer’s payments to Dr Wagner.

Glaxo’s study 329 was successfully used to promote Paxil for children, and sales to kids skyrocketed to $55 million in 2002 alone. It also served as the smoking gun in a lawsuit filed against Glaxo by New York Attorney Elliot Spitzer, charging Glaxo with fraud for promoting the off-label use of Paxil to children while concealing and misrepresenting the data from 5 studies that showed the increased suicide risks and the fact that Paxil did not work with children. Glaxo settled out of court to shut that lawsuit down within 2 months.

In 2003, after reviewing the same fraudulent studies, the UK banned the use of Paxil with children, and the FDA scheduled an advisory committee meeting in February 2004 to review the data on all SSRI’s.

In response to the announcements by the regulatory agencies, the American College of Neuropsychopharmacology (ACNP), which designated a Task Force in the early 1990’s to review the SSRI trial data, and subsequently published an position paper saying SSRI’s were not linked to suicide, appointed a new Task Force in September 2003, to study the matter again.

This Task Force was made up of many of the same authors whose published papers were under attack for being fraudulent and included Dr John Mann, Dr Graham Emslie, Dr Karen Wagner, Dr Neal Ryan, Dr Andrew Leon, Dr Fredrick Goodwin, Dr David Shaffer, Dr Beardslee, Dr Jan Fawcett, Dr Herbert Meltzer and Dr Ross Baldessarini.

Two weeks before the advisory committee meeting, the Task Force issued a report, once again claiming SSRI’s did not cause suicide, and began making what many experts condemned as preemptive statements in the media to influence the advisory committee to vote against adding a warning about the risk of suicide to SSRI labels.

On January 21, 2007, WebMd’s headline on the internet stated: “Group Finds No Suicide-Antidepressant Link”.

“Our conclusion is that when you look at the SSRI’s as a group, there is evidence they are effective for treating depression in children and adolescents,” Dr Mann told WebMD.

“Instead of being a risk for suicidal behavior, they are potentially therapeutic,” he stated.

In fact, the $30-million Dr Mann, who admitted under oath in a jury trial that it was possible that he got over $30 million in research funding from drug companies over a 10-year period, said the group found strong evidence that SSRI’s help depressed kids and that suicide rates started going down when SSRI’s became available.

He claimed that a 14-year study showed a decline in suicide rates in kids. “Across 15 countries there has been a 33% decline in suicide rates amongst youths,” he told WebMD.

“Doctors must go on treating depression, and SSRI’s appear to be a reasonable choice,” he stated.

The FDA even allowed Task Force members Dr Andrew Leon and Dr Neil Ryan to participate as voting members of the February 2, 2004 advisory panel.

The day after a September 2004 advisory committee finally voted to add a black box warning to the SSRI labels, on September 14, 2004, Senator Grassley issued a press release stating that the FDA “needs to learn an important lesson from what’s developed this year on the matter of kids and antidepressants.”

“Transparency in government is the best policy,” he noted. “Parents and doctors should not be left in the dark, and especially when information that’s available could be a matter of life and death.”

“Given the scientific findings,” he added, “it’s obvious that the strongest label warning for this class of drugs is critically important for the health and safety of young Americans.”

“These measures are especially critical,” he said, “since I also understand from previously released studies and from the Advisory Committee’s own deliberations that only one of the nine antidepressant drugs has been proven to provide any benefit to children and adolescents.”

“In fact,” he pointed out, “in almost all cases, the FDA’s own data demonstrates that these drugs actually perform no better than do placebos.”

In a September 16, 2004, letter, Senator Grassley asked the FDA to “very quickly and fully consider” the recommendations for the black box and med guides, “before the lives of more children are needlessly lost because parents and others lack adequate, readily understandable information when they most need it.”

He also brought up the issue of informed consent and said he was curious about the FDA’s rationale for not requiring doctors to provide a clear, informed consent document that parents must read, understand and sign before accepting a prescription, as the FDA had done with the drug Lotronex, due to a 1 in 300 risk of ischemic colitis in patients.

In the case of antidepressants, Senator Grassley pointed out, “a suicide-related event involving Prozac (fluoxetine) is about 1 in 15 according to the TADS study, and about 1 in 30 for all SSRI’s, according to FDA’s own study.”

The letter said that the informed consent form should at least include the following points: (1) Only Prozac has been shown to be effective in treating depression in children and adolescents, and is the only drug approved for this; (2) All others have been shown to be no different than a placebo, and their use in the treatment of children and adolescents is not an approved use; (3) All antidepressants increase the risk of suicidality, and (4) The risk of a suicide event (planned or actually attempted) is one for every 15 to 30 children and adolescents taking the antidepressant.

Senator Grassley also asked what the FDA planned to do about educating doctors and the public about the risk-benefits of antidepressants, especially in children. Obviously, the short answer to that question more than three years later is, not a thing.

In fact, in the January 17, 2008, Wall Street Journal, David Armstrong and Keith Winstein reported that, “the effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.”

“As a result,” they wrote, “doctors and patients are getting a distorted view of how well blockbuster antidepressants like Wyeth’s Effexor and Pfizer Inc.’s Zoloft really work,” in discussing research led by Erick Turner, a psychiatrist at Oregon Health & Science University, published in a study in New England Journal of Medicine.

They also point out that sales of antidepressants total about $21 billion a year.

In all the studies, old and new, which promote the off-label sale of SSRI’s for children with claims that the drugs work and do not cause suicide, almost without fail, the same names appear as investigators and authors. A complete listing includes Dr John Mann, Dr Martin Keller, Dr Graham Emslie, Dr Frederick Goodwin, Dr Karen Wagner, Dr Neal Ryan, Dr Charles Nemeroff, Dr David Dunner, Dr Andrew Leon, Dr John March, Dr David Shaffer, Dr John Rush, Dr Mark Olfson and Dr Robert Gibbons.

This time around, in addition to going after Glaxo for concealing and misrepresenting the data that showed an 8-fold increased risk of suicide, somebody needs to take the bull by the horns and see to it that these industry-funded quacks get thrown in the slammer.

It’s also more than apparent that a few FDA officials belong there as well.

Filed under: 2008, Fraud, ghostwritten, Glaxo, KOL, Mann, Paxil, SSRIs, Study 329, suicide

4 Part Series Mothers Act Disease Mongering Campaign

Evelyn Pringle July 2009

Written for Natural News

The Mothers Act Disease Mongering Campaign – Part I

The Mothers Act represents the ultimate example of disease mongering at its worst because the eight-year attempt to pass this federal legislation has evolved into profiteering never before exhibited so conspicuously.

Disease mongering “is the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatments,” according to Ray Moyniahan and David Henry in the April 11, 2006 paper in PLoS Med, titled, “The Fight against Disease Mongering.”

“It is exemplified most explicitly by many pharmaceutical industry–funded disease-awareness campaigns—more often designed to sell drugs than to illuminate or to inform or educate about the prevention of illness or the maintenance of health,” the authors explain.

“Drug companies are by no means the only players in this drama,” they point out. “Through the work of investigative journalists, we have learned how informal alliances of pharmaceutical corporations, public relations companies, doctors’ groups, and patient advocates promote these ideas to the public and policymakers—often using mass media to push a certain view of a particular health problem.”

The Mothers Act campaign has operated under the guise of helping women suffering from postpartum depression and postpartum psychosis to develop a new industry, complete with specialties like, “reproductive psychiatry,” or “reproductive mental health,” with a plan to “screen” and “treat” women of childbearing years for a long list of “perinatal” mental disorders, to financially benefit psychiatric drug makers, as well as the treatment providers and “experts” in the new self-created field.

“Drug companies have been trying for years to get a better deal with pregnant women by saying they were under a lot more stress than people realize,” according to UK pharmacology expert, Dr David Healy, author the new book,”Mania: A Short History of Bipolar Disorder.”

This is now the easiest marketing for the drug makers, he says. In fact, “almost too easy because lots of people are cooperative.”

The Mothers Act has already passed in the House and Senator Robert Menendez (D-NJ), is the main sponsor of the bill in the Senate. In 2006, his home state of New Jersey became the first state in the nation to enact a law forcing all new mothers to submit to mandatory screening.

A June 24, 2009 report by the public interest advocacy group, “Common Cause,” lists Menedez as one of the top 20 recipients of healthcare industry campaign contributions in the Senate between 2000 and 2008. Since the year 2000, Menendez has received a total of $2,252,169, including $723,550 from Big Pharma.

On June 8, 2009, a headline on New Jersey.com, read: “E-mail: Drug lobbyist targeted Menendez to help with importation bill,” and reported that the subject line of the email said: “URGENT”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. “And McCain read it on the Senate floor – twice,” the article notes.

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

“We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said. “Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez’s office and ask him to take the lead?”

“Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion,” according to New Jersey.com.

Officially known as the “Melanie Blocker-Stokes Post Partum Depression Research and Care Act,” the bill is “named after Melanie Stokes, a woman who suffered emotional difficulties after giving birth and was subsequently prescribed a cocktail of intensely controversial psychiatric drugs including anti-psychotic, anti-anxiety, and anti-depressant drugs before being subjected to electroshock treatment,” according to a letter made available on the AbleChild, website for persons to sign and send to Senators, via the internet, encouraging them to vote against the Act.

“Melanie Stokes was in the mental health system, was prescribed drugs, was hospitalized, was subjected to the still barbaric practice of electroshock and only after receiving mental health “treatment” did she commit suicide,” it further explains.

“That is what the mental health industry did for a new mother named Melanie,” the letter points out.

The Mothers Act “quite simply is a feeder line for the psycho-pharmaceutical industry and will result in more mothers and infants being put at risk for being prescribed antidepressant and other dangerous psychiatric drugs,” the AbleChild letter warns.

Suicide Prevention Hoax

The disease mongering campaigns for the new generation of psychiatric drugs over the last 20 years were accomplished under the ruse of suicide prevention. However, in 1987, the year Prozac was approved, and kicked off the bogus epidemic of mental illness in this country, the number of suicides was 30,796, and in the latest year reported on the website of the National Center for Injury Prevention and Control, the number of suicides was 33,292 in 2006.

The suicide related adverse event reports submitted to the FDA’s MedWatch system are summarized on the “Adverse Psychiatric Drug Reaction” website. For a two-year period between January 2004 and December 2006, the top 20 list of most commonly reported adverse events for Prozac, included 187 suicides and 68 attempts. Zoloft had 154 suicides and 162 suicide attempts. Paxil’s top 20 list included 841 suicides, Celexa had 232 suicide reports, and Lexapro had 189 suicides, and 87 suicide attempts, reported to MedWatch.

Only between one and ten percent of adverse events ever get reported to the FDA’s system.

In May 2009, journalist, Philip Dawdy, reported on the popular Furious Seasons website, that Wyeth’s new Effexor me-too drug, Pristiq, approved in early 2008, had already generated 1,272 adverse event reports in MedWatch by the end of 2008.

“It’s discouraging that 17 of those reports involve completed suicides through the end of 2008,” Dawdy said. “There are also 48 reports of suicidal ideation.”

Symptoms Equal Side Effects

Purely for profit, patients are told to stay on antidepressants indefinitely to prevent a relapse of depression or anxiety disorders. It’s doubtful that patients realize that their sex lives could be ruined by taking the drugs or that the use of common pain relievers, vitamins and alcohol is dangerous or that their driving ability might be altered, for years on end.

The website Prozac.com lists depression symptoms as: depressed mood most of the day, nearly every day; lack of interest or pleasure in your usual activities and a lack of motivation; changes in appetite; sleep problems; anxiety or restlessness; feelings of guilt, worthlessness, and insecurity; difficulty concentrating and thinking clearly; fatigue or lack of energy; and thoughts of suicide.

Compare those “symptoms” to the severity and number of adverse events listed and described on the “Safety Information” page for Prozac, which includes the following statement:

“Patients on antidepressants and their families or caregivers should watch for worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.”

Under the heading, “What are possible side effects of PROZAC?” the website states:

“Some people experience side effects like nausea, difficulty sleeping, drowsiness, anxiety, nervousness, weakness, loss of appetite, tremors, dry mouth, sweating, decreased sex drive, impotence, or yawning.”

“PROZAC can cause changes in sexual desire or satisfaction,” it warns.

Sexual dysfunction, including lack of libido, orgasmic dysfunction and delayed ejaculation, are common side effects of using SSRIs, according to the May 2005 report, “The Marketing of Depression: The Prescribing of SSRI Antidepressants to Women,” by Dr Janet Currie.

“Since SSRIs are prescribed more often for women, women are more frequently affected by SSRI-induced sexual dysfunction,” she explains.

“Because SSRIs can also lead to a worsening of depression, paradoxical effects, emotional blunting or detachment, reduced emotional activity, memory loss and confusion, these effects, in conjunction with sexual dysfunction, can negatively affect intimate relationships,” she warns.

“There are concerns that not all sexual dysfunction may fully resolve after termination of treatment,” Currie also reports.

“Be sure to tell your doctor if you are taking PROZAC and are taking or plan to take non-steroidal anti-inflammatory drugs or aspirin since combined use of these drug products have been associated with an increased risk of bleeding,” the Prozac website advises.

“Also, tell your doctor if you are taking or plan to take any vitamins, herbal supplements or alcohol,” the warning says.

An October 2007 study by researches led by Dr Sonal Singh, published online in Alimentary Pharmacology & Therapeutics, reported that SSRIs may double the risk of bleeding in the upper digestive gastrointestinal tract including the esophagus, stomach or upper intestine.

The researchers also noted that when SSRIs are taken with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), such as prescription Celebrex or over-the-counter Aleve, the risk of bleeding was 6 times higher than in persons not on the drugs.

“Do not drive a car or operate dangerous machinery until you know what effects PROZAC may have on you,” the Prozac website instructs.

A December 2006 study in the, “Journal of Clinical Psychiatry,” reported that about seven out of every ten people who take antidepressants have impaired driving ability and that 16% of the people on the drugs have severe motor impairments.

A new May 2009 study, in the “American Journal of Psychiatry,” reports that long term use of antidepressants raises the risk of diabetes, especially in moderate to high doses. SSRIs increased the risk by 106% and tricyclic antidepressants increased the risk by 77%.

The precaution section on the labeling for Prozac states: “Hyponatremia may occur as a result of treatment.”

“Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls,” it explains.

“More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death,” the label warns.

Antidepressants lose patent profitability

Since the new generation of antidepressants lost their patent profitability, the treatment for all the “mood” and “anxiety” disorders women will be diagnosed with as a result of the Mothers Act disease mongering campaign, now includes not only antidepressants, but drugs used as “mood stabilizers,” such as the antipsychotics Zyprexa, Seroquel, Risperdal, Invega, Geodon and Abilify, and antiseizure medications including Lamictal, Depakote, Topamax, Trileptal, Neurontin, Gabitril and Lyrica, along with benzodiazepines like Xanax, Ativan, Valium and Klonopin, and sleeping pills such as Ambien or Lunesta.

In 2008, psychiatric drug makers had overall US sales of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs, and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.

“In 2008, 85 million prescriptions were filled for the top 20 benzodiazepines, an increase of 10 million over 2004, according to IMS Health, a health-care information company,” the Wall Street Journal reported on June 30, 2009.

“Worldwide revenue for Xanax rose to $350 million last year, up nearly 50 percent from 2003, according to pharmaceutical company Pfizer’s financial reports,” the Journal reported.

Xanax sold for $203 for 100 middle dose tablets, and Ativan cost $230 per hundred at DrugStore.com on July 13, 2009.

Benzodiazepines are often prescribed to manage anxiety, panic and sleep disorders, the Journal noted. “Health professionals and consumers are increasingly recognizing that taking the drugs for more than a few weeks can lead to physical dependence, often ending with a grueling withdrawal,” the article said.

Psychiatric drugs are now doled out in multiple drug cocktails to treat “co-occurring” mental illnesses such as “anxiety disorders” and “treatment resistant” depression, or the latest rage, “Adult ADHD.”

In an April 2008 report, the market research firm, Datamonitor, announced: “ADHD – Immature adult market continues to offer greatest commercial potential.”

“Estimated to be twice the size of the pediatric ADHD population,” the reports states, “the highly prevalent, yet largely untapped, adult ADHD population continues to represent an attractive niche to target.”

“The rising awareness of ADHD brought about by marketing campaigns for Adderall XR and Strattera has paved the way for the entry of additional adult ADHD drugs,” it notes.

“The US dominates the ADHD market with a 94% market share,” Datamonitor points out, demonstrating that the rest of the world has apparently not lost the ability to concentrate without the use of “legal speed.”

Last year, Adderall and Vyvanse maker, Shire, issued a press release on May 12, 2008, to announce a “Nationwide Adult ADHD Mobile Awareness Tour,” and launched a “13-city mobile screening initiative” for adults with ADHD.

“The screening initiative, known as the “RoADHD Trip,” is housed, transported and anchored by the RoADHD Trip Tractor Trailer which expands into a tented area housing eight self-screening stations,” Shire explained in the press release.

Shire claims that ADHD “affects approximately 4.4 percent of the U.S. adult population aged 18-44 according to the National Comorbidity Survey Replication, a nationally representative household survey.”

Dr David Stein, author of, “Unraveling the ADD/ADHD Fiasco,” warns that stimulant drugs are “near the top of the heap of potentially addictive drugs.”

There is no way of pinpointing which people are at risk of becoming addicted, he says, and “psychiatry has an extremely poor track record for treating addiction problems.”

Profitable Victims Spur Disease Mongering

When drugs are peddled through mental illness disease mongering campaigns, stories in the media seldom mention medication prices, much less the number of drugs commonly prescribed together to treat the various disorders; leaving the public unaware of the enormous profit motive behind the mass drugging of the victims.

A women diagnosed with ADHD and treatment resistant depression might end up taking Strattera, Cymbalta and Zyprexa, all sold by Eli Lilly. The recent prices of these drugs at a middle dose on DrugStore.com were $427 for 100 capsules of Strattera, $391 for 90 capsules of Cymbalta, and Zyprexa was $1,195 per ninety pills.

A year of these three drugs would bring in roughly $24,156, per patient, for Lilly and the pharmacy alone, not counting the prescribing doctors’ fees and the cost of any therapy sessions deemed necessary.

Bristol-Myers Squibb’s Abilify is now approved as an “Adjunctive Treatment of Major Depressive Disorder,” at a price of $1,230 for ninety capsules at DrugStore.com. The “Information for Patients,” section on the labeling states in part:

“Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.”

“A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs,” the Abilify labeling warns.

On April 29, 2009, Philip Dawdy’s headline on Furious Seasons, read: “10 Percent Of Depressed Patients Now Take Antipsychotics,” based on statements made during a conference call by executives of Bristol-Myers Squibb.

“Forget about Prozac Nation, this is Atypical Nation,” he said. “Antipsychotics are now the top revenue producing class of drugs, topping even statins.”

Zyprexa and Prozac are combined in Lilly’s Symbyax, recently approved for “treatment resistant” depression and the Abilify warnings are also on the labeling of this drug. The price of Symbyax was $1,564 for ninety 12-25mg capsules on DrugStore.com in May 2009, meaning each patient could bring in $18,768 per year for Lilly and the pharmacy alone.

A 2007 study titled, “Serious Adverse Drug Events Reported to the Food and Drug Administration,” between 1998-2005, by Thomas Moore, Michael Cohen, and Curt Furberg, in the Archives of Internal Medicine, found the number of fatal adverse event reports to the FDA had increased nearly 300%, from 1998 to 2005. The top 15 drugs with the most fatalities included the antipsychotics, Clozaril with 3,277 deaths, Risperdal with 1,093, and Zyprexa with 1,005. Paxil also made the top 15 list with 850 death reports.

In 2008, the FDA warned that anticonvulsants double the risk of suicidal behavior or ideation, with epilepsy treatment having the highest risk, ruling out psychiatric disorders, such as depression, as the underlying culprit.

The prices for anticonvulsants at a middle dose ran as high as $1,029 for 180 tablets of GlaxoSmithKline’s Lamictal, and $1,286 for 180 tablets of Johnson & Johnson’s Topamax, in May 2009.

Unconscionable Disease Mongers Target the Nursery

“The rights of the unborn to a safe and healthy birth are being taken away by this legislation,” says Mothers Act opponent Larry Bone.

“One third of pregnant women in the US already take psychiatric drugs at some point during their pregnancies and most are never warned of the known risks for themselves, their unborn and nursing babies, depriving them of their right to informed consent,” according to Dr Fred Baughman, author of the “ADHD Fraud,” and former director of the March of Dimes, Birth Defects Clinic of Western Michigan.
“Should the Act pass,” he warns, “it will guarantee that more mothers-to-be, their unborn still-developing babies, and more nursing mothers and their nursing infants, will join the ranks of the psychiatrically drugged.”

A young Texas mother, Amy Philo, is the leader of “Unite for Life,” a coalition of 53 groups fighting against the Mothers Act, which includes the Alliance for Human Research Protection, AbleChild, Citizens Commission on Human Rights, International Center for the Study of Psychiatry and Psychology; International Coalition For Drug Awareness; Law Project for Psychiatric Rights, Mindfreedom International, and the National Association for Rights Protection and Advocacy.

The coalition points out that there is no language in the bill that will ensure mothers are granted the most fundamental right of “informed consent,” meaning they will be told about all the risks of the proposed treatments and all the alternatives.

“If this bill was really for moms with PPD,” Amy says, “it would ensure express written informed consent and ensure that all medical testing and non-drug options are explored.”

“When the sponsors in the Senate refuse to add informed consent language and an examination of existing data on risks of existing treatments, then you know something is wrong,” she says. “Seriously wrong.”

The lack of an informed consent provision also concerns other experts in the field.

“In every case in which a doctor writes a prescription, the person receiving the drug must be fully and understandably provided a statement of the risks associated with treatment,” says Harrisburg, Pennsylvania psychiatrist, Dr Stefan Kruszewski, who serves as an expert in litigation on the harms of psychiatric drugs.

“This is never more serious than when two lives are potentially at risk, such as the pregnant or nursing mother and her infant,” he advises.

“The risks for a pregnant mom on antidepressants may include withdrawal, akathisia or rapid mood swings,” he warns. “For the fetus, the overwhelming worry is a withdrawal syndrome and congenital malformations, resulting in complications for both mother and child.”

Drugged Victims

In 2004, Amy was prescribed Zoloft, to “prevent” PPD, because she became extremely anxious and concerned after she witnessed her newborn son’s life-threatening choking incident, based on a recommendation of a home visiting nurse.

Without any explanation of alternative treatments, or warnings about side effects, the doctor told Amy that Zoloft would make her and her nursing infant happy, in a consultation lasting about two minutes.

Zoloft caused Amy to become homicidal and suicidal and she ended up locked in a mental ward away from her baby for two days. Rather than recognize the side effects of Zoloft, the “professionals” upped the dose and also tried to feed Amy Zyprexa, Celexa, Ambien, and Klonopin, which she refused to take because she was nursing.

Amy’s obsessive homicidal and suicidal thoughts persisted for five months, until she weaned herself off Zoloft against medical advice, and they disappeared and never returned. Her recently obtained medical records show she was labeled with obsessive-compulsive disorder and major depression. These stigmatizing labels will stay in her records forever with no explanation that Zoloft was the cause of any alleged mental disorder.

The family’s insurance was billed about $8,000 for the 2-day stay in the mental ward, and Amy and her husband were stuck with an $800 co-payment. Ninety 100mg tablets of Zoloft cost $318, at DrugStore.com on July 13, 2009. Of the drugs Amy refused to take, Celexa sold for $355 for 100 20mg tablets, Klonopin was $209 for 100 2mg tablets, and Ambien cost $173 for 30 10mg pills. As mentioned above, Zyprexa recently sold for $1,195 per ninety tablets.

Andrea Yates is another example of a women drugged into madness. On June 20, 2001, the Texas housewife and former nurse, filled a bathtub with water 3 inches from the top and methodically drowned her five children one by one. After she was done she called 911. When the policemen arrived she led them to the bodies.

“Contrary to the mantra that it is untreated mental illness that causes these tragic events, more often than not, we see these events occurring in individuals who are receiving mental health “treatment,” almost always in the form of psychotropic drugs,” warns attorney, Karen Barth Menzies, who has worked on cases involving drug-induced homicide and suicide, as well as SSRI birth defect litigation. 

“From everything I have read about the Yates case,” she says, “it is a tragic consequence of an incompetent, failing and corrupt mental health system.”

“Ms Yates was on a chemical soup of various medications and, therefore, it is difficult to point the finger at any one drug,” she explains. 

“But it seems clear that the drugs she was taking did nothing but exacerbate her condition,” she adds.

“I think the drug manufacturers who grossly oversell the benefits of their drugs and the doctors who pile on drug after drug, bear responsibility for the death of these children and deserve to be criminally charged as well,” Menzies states.



“What we have observed, particularly in criminal cases,” she says, “is that people taking these drugs will commit crimes they normally would never have committed due to a combination of side effects.”

“For over a decade, antidepressant manufacturers have monitored the criminal courts for suspects who became violent while taking an antidepressant — and they secretly help prosecutors fight against an SSRI-antidepressant defense,” Menzies reports. 


”The last thing drug companies want is for juries (and the public) to learn the truth – that these drugs can cause people to become violent and homicidal,” she advises. 

“Of course, the drug companies do not give the prosecutors the whole story,” she says. “To protect the reputation of their money-making drug, the companies hide the internal evidence of people in clinical trials who become violent and homicidal on their drug, but then fully-recovered once they were off.”

“These adverse reactions normally include an agitated state as well as a condition called “depersonalization” where the individual becomes disconnected from the reality of their actions, where everything seems unreal, as if they are watching a movie,” Menzies explains.

“Often times,” she notes, “there is a state of disinhibition, where normal inhibitions are no longer present, such as when people become intoxicated or are on street drugs.”

“Unfortunately,” she says, “the cost to bring a drug-induced violence (involuntary intoxication) defense is extraordinary, especially because the state is backed by drug company resources to fight this defense.”

“Not exactly a level playing field,” she says, “And the drug companies, as we’ve seen, will spare nothing when it comes to protecting the profits they make on these drugs!”

An April 20, 2009 press release by Senator Menendez claimed the Mothers Act legislation would increase federal efforts to combat postpartum depression by:

“Creating a grant program to public or nonprofit private entities to deliver or enhance outpatient, inpatient and home-based health and support services, including case management and comprehensive treatment services for individuals with or at risk for postpartum conditions.

“Activities may also include providing education about postpartum conditions to new mothers and their families, including symptoms, methods of coping with the illness, and treatment resources, in order to promote earlier diagnosis and treatment.”
As will be shown in the next parts of this series, the “public or nonprofit private entities” are already in place and the profiteers are waiting with their hands out for the tax dollars to start rolling into their bank accounts.

The Mothers Act Disease Mongering Campaign – Part II

The Mothers Act legislation specifically defines the term “postpartum conditions” as “postpartum depression” or “postpartum psychosis.” Use of the Act as an 8-year disease mongering campaign to further promote the new cottage industry of “reproductive psychiatry,” or “reproductive mental health,” comes from websites often run by people who will financially benefit from passage of the Act.

In 1992, the late journalist Lynn Payer wrote a book titled, “Disease Mongering,” and defined disease mongering as, “trying to convince essentially well people that they are sick, or slightly sick people that they are very ill.”

Tactics identified in the book currently used in the Mothers Act campaign include: (1) Framing the issues in a particular way, (2) Taking a normal function and implying that there’s something wrong with it and it should be treated, (3) Defining as large a proportion of the population as possible as suffering from the ‘disease’, (4) Selective use of statistics to exaggerate the benefits of treatment, and (5) Getting the right spin doctors.

“Since disease is such a fluid and political concept, the providers can essentially create their own demand by broadening the definitions of diseases in such a way as to include the greatest number of people, and by spinning out new diseases,” Payer explained in the book.

Although the mandatory screening language was removed from the Mothers Act last year, due to strong opposition, the words and actions by the bill’s supporters demonstrate that the screening dragnet was always the main component of this disease mongering campaign. The language in the previous bill stated in part: “To ensure that new mothers and their families are educated about postpartum depression, screened for symptoms, and provided with essential services.”

The main sponsor of the Act in the House was Illinois Democratic Congressman, Bobby Rush. On March 30, 2009, the Postpartum Support International website posted the headline: “Congressman Rush passes The Melanie Blocker Stokes MOTHERS Act in the U.S. House of Representatives.. now it’s on to the senate!!”

In a speech on the House floor that day, Rush made the following ridiculous disease mongering statement: “Madame Speaker, today, 60 to 80 percent of new mothers experience symptoms of postpartum depression while the more serious condition, postpartum psychosis, affects up to 20 percent of women who have recently given birth.”

He then took it a step further and told members of Congress: “Experts in the field of women’s health like Susan Stone, Chair of the President’s Advisory Council of Postpartum Support International, says that these statistics do not include mothers whose babies are stillborn, who miscarry, or who are vulnerable to these devastating disorders which raises those at risk into the millions.”

“Every 50 seconds a new mother will begin struggling with the effects of mental illness,” he added.

“After eight long years,” Rush said, “today marks an important step forward in the journey for Congress to fully recognize postpartum depression as a national women’s health priority.”

“H. R. 20 will finally put significant money and attention into research, screening, treatment and education for mothers suffering from this disease,” he reported.

In a 2005 paper in the Psychiatric Bulletin titled, “Psychiatry and the pharmaceutical industry: who pays the piper?,” a perspective from the Critical Psychiatry Network, the authors, Joanna Moncrieff, Steve Hopker, and Philip Thomas, point out that psychiatry is particularly vulnerable to the influence of the pharmaceutical industry for a number of reasons.

“There is no objective test for external validation of psychiatric disorders,” they explain. “This means the boundaries of ‘normality’ and disorder are easily manipulated to expand markets for drugs.”

“The adverse effects of drugs are downplayed, and alternative approaches to distress neglected,” they warn. “Patients and carers are led to believe that there are simple, drug-based solutions to their problems, leading to disillusion and disappointment when this turns out not to be so.”
Self-Promoted Experts

“Disease mongering turns healthy people into patients, wastes precious resources, and causes iatrogenic harm,” Ray Moyniahan and David Henry warn in the April 11, 2006 paper in PLoS Med, titled, “The Fight against Disease Mongering,” in words that certainly apply to the Mothers Act campaign.

“As an initial step toward combating disease mongering at a health policy level,” the authors “urge decision makers to promote a renovation in the way diseases are defined.”

“Continuing to leave these definitions to panels of self-interested specialists riddled with professional and commercial conflicts of interest is no longer viable,” they warn.

Susan Stone, the “expert” Bobby Rush referred to, runs PerinatalPro, a blatant profiteering website used to advertise her treatment and training services at a facility in New Jersey, which tells readers:

“Welcome to Perinatal Pro, the website presence of Blue Skye Consulting, LLC, posted by women’s reproductive mental health expert Susan Dowd Stone, MSW, LCSW, to help educate and inform women, families and health care providers about the often unexpected challenges of mood changes during pregnancy, the postpartum and throughout a woman’s reproductive life.”

Susan is not a psychiatrist nor a psychologist, she is a social worker and a past president of Postpartum Support International. Yet she maintains a private practice, “specializing in women’s reproductive mental health across the life cycle,” according to her bio.

The “Clinical Focus” of treatment advertised for Blue Skye with PerinatalPro includes: Perinatal Mood Disorders and Postpartum Depression; Perimenopause and menopause; Bereavement associated with child loss, stillbirth or miscarriage; Lifestyle changes and loss (divorce, remarriage, health issues); Depression associated with medical conditions; Disordered Eating and Body Dysmorphic Disorder; Trauma/PTSD; and Affective Disorders including depression and anxiety.

“We work with your physician, psychiatrist or other healthcare provider to ensure a continuum of care,” the website says.

A more likely explanation for this collaboration would be that a social worker is not qualified to diagnose patients with mental disorders and a doctor would have to sign off on the diagnosis in order to bill public and private insurance programs for treatment.

Susan would also need a doctor to prescribe drugs to her “patients.” In return, the doctor would profit from the fees paid for the brief office calls required to obtain the prescriptions.

The PerinatalPro site even has a link to schedule an appointment at Blue Skye, through an email address with Susan Stone’s name in the box. The joint is open for business on Monday through Friday beginning at 7 am and ending at 9 pm, “most evenings.”

Blue Skye “also provides licensed professionals who will come to your office, agency or Grand Rounds to facilitate groups or educational presentations on  mental health topics of interest to your staff,” the website advertises. “In addition, we work with EAP’s  to provide therapy on or off site to your clients.”

Susan posts a running list of groups that endorse the Mothers Act on her website and just about every Big Pharma funded pill pushing front group in the US is on it. The drug company dollar amounts funneled to these “non-profits” in recent years is broken down in my article, “Just Say No to the Mothers Act,” which can be found with a google search of the internet.

Amy Philo, the leader of “Unite For Life,” a movement of 53 groups against the Act, posted the estimated amount traceable to the main supporters on her website, based on the “Just Say No,” article, with a total of between $13,095,010 and $16,487,497. The wide estimate resulted from the fact that groups’ annual reports will often list the amounts given with wide margins.

For instance, the 2006 report for “Mental Health America,” shows the “non-profit” received over $1 million from Eli Lilly, Bristol-Myers Squibb, and Wyeth. Janssen and Pfizer gave between $500,000 and $1,000,000, and AstraZeneca and Forest Labs donated between $100,000 and $499,000. GlaxoSmithKline gave between $50,000 and $100,000.

Pfizer’s 2008 grant report shows a $20,000 grant to a Mental Health America group in Georgia to sponsor: “Project Healthy Moms: Education for Prevention/Treatment for Perinatal Depression Disorders.”

Big Pharma money is funneled to front groups to make sure the leaders of the “non-profits” are extremely well-paid. Mental Health America’s 2002 tax returns show the President, Michael Faenza, received compensation of $306,727, and another $35,275 to employee benefit plans and deferred compensation that year, for a 35 hour work week.

Lea Ann Browing-McNee, the Senior VP, received $122,007, and $14,353 in contributions to employee benefit plans and deferred compensation for 35 hours a week. The VP, Charles Ingoglia, was paid $121,673, and $15,907 to employee benefit plans and deferred compensation, for a 35 hour week.

In a May 29, 2009, blog on PerinatalPro Susan wrote: “I humbly announce that I will be honored by the Mental Health Association in New Jersey at an event on June 10th for advocacy and clinical work related to national ppd initiatives”.

The “Association” Susan refers to is actually a “Mental Health America” group.

In the same her blog, Susan mentions how the Mothers Act might help fund “inpatient maternal mental health” programs all across the US.

“Just this morning,” she wrote, “I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country.”

The PerinatalPro site also provides links to buy Susan’s book, co-authored with Alexis E Menken, titled: “Perinatal and Postpartum Mood Disorders Perspectives and Treatment Guide for the Health Care Practitioner,” listed for $54.00 on one site, with a product description including the following disease mongering comments:
“Statistics on the prevalence of perinatal mood disorders suggest that up to 20% of women experience diagnosable pregnancy related mood disorders.”

“Over the past three years, pregnancy related mood disorders have become the focus of health care advocates and legislators alike with subsequent reflection in nationwide media.”

“This increasing awareness has also resulted in recent legislative and healthcare initiatives to screen, assess, and treat such disorders,” the Amazon website states, using the “screen” word.

Karen Kleiman, another social worker transformed into a “medical expert,” runs a treatment facility called the “Postpartum Stress Center,” in Rosemont, Pennsylvania.

“The Postpartum Stress Center specializes in the diagnosis and treatment of prenatal and postpartum depression and anxiety disorders,” Kleiman’s site says.

“Referrals to The Postpartum Stress Center come from Psychiatrists, OBGYNs, Family Practitioners, Pediatricians, RNs, other therapists, Depression After Delivery, Midwifery groups, Women Centers, Breastfeeding support groups, and direct referrals from the mother or family members,” the site states.

As a social worker, like Susan Stone, Kleiman would also need a doctor to diagnose women with mental disorders before she could bill public and private insurance programs to “treat” them. And, she would need a doctor to prescribe the drugs.

Kleiman wrote a raving review of Susan’s book on the Amazon website, and as luck would have it, three books listed as “Frequently Bought Together” on Amazon, include Susan’s and two by Kleiman. The deal price for purchasing all three together is $95.65.

Kleiman sells seven books on her website that she either wrote or contributed to. Some can even be purchased with a direct payment through a paypal account, to bypass Amazon.

Kleiman conducts a workshop at her Center every three months titled: “Advanced Practice Development Workshop: Launching your private practice,” and uses her internet blogs to recruit paying participants.

In this four-hour training session, future “private practice” owners learn in part: “Which marketing strategies are most effective for this population of clients and the medical community”.

They also learn: “How to connect with the community at large and maximize the need and desire for your services”.

Participants receive a copy of the Center’s Guide to “Enhancing your PPD Private Practice: A checklist for successful practice”, as well.

The class is part of a two-day deal with another 6-hour workshop titled, “Fundamentals of PPD,” for a total of 10 hours at a cost of $750. The website says they try to keep the classes small (6 to 10), so that would mean Kleiman’s take would be between $6,000 and $7,500, or between $24,000 and $30,000 for 40 hours work in four seminars a year teaching people how to “Launch” their own private practice.

At $100 a crack, Blue Skye Consulting seems like it offers a better deal for half-day workshops for professionals “to help develop a specialty in perinatal mood disorders,” including two titled: “Identifying Perinatal Mood Disorders,” and “Treating Perinatal Mood Disorders.”

But then Susan Stone’s course may not teach people how to “Launch” their own private practice.

In a June 4, 2007, blog on the Center’s webite, Kleiman reported a new study that found 79% of doctors were unlikely to formally screen for postpartum depression and noted that the co-author of the study “reminds us that in addition to the Edinburgh (EPDS) Screening tool (most commonly used), healthcare practitioners can check for signs of PPD by a simple 2-question tool, developed by Whooley et al.”

Further elaborating on this pop quiz, Kleiman wrote: “It has been shown that these two questions may be as effective as longer instruments,” and listed the questions as: (1) “Over the past 2 weeks, have you felt down, depressed, or hopeless?”, and (2) “Over the past 2 weeks, have you felt little interest or pleasure in doing things?”

“A positive response to either question indicates a positive screen and should be followed by an comprehensive history and assessment to confirm the diagnosis of depression,” she wrote.

Under a heading: “Doctors take note” she stated: “We should not need state legislation to mandate what we know to be medically significant. Patients should be screened for postpartum depression. It is easy. It take 5 minutes. It can save lives.”

She followed up with a heading: “Clinicians take note,” and wrote: “Healthcare practitioners need this information. Take the time to get this information to the doctors you work with or want to market to. Arm yourself with screening tools and literature to substantiate this practice.”

How to Practice Medicine Without a License

Kleiman is listed as a postpartum depression “expert” on another propaganda pumping internet site called StorkNet, complete with her own bio page, where she posts advice for pregnant and nursing mothers to access over the internet and provides a live link to her treatment center.

In response to the question, “what are the best drugs for a breastfeeding mom with postpartum depression?”, Kleiman wrote in part: “Keep in mind that this information is based on MY practice and will vary considerably from doctor to doctor.”

“The SSRI antidepressants (Selective Serotonin Reuptake Inhibitors) we are most comfortable using based on the research we have are: Zoloft (Sertraline) and Paxil (Paroxetine). Other antidepressants (tricyclics) that are used are Pamelor (Nortriptyline) and Desipramine (Norpramin), although it seems that the SSRIs are preferable these days because they have fewer side effects and are easily tolerated.”

In answering questions on “How Long to Take Medication,” Kleiman said to think of antidepressants as a “Serotonin vitamin,” and cited a recommendation from the American Psychiatric Association for staying on antidepressants for 6 to 9 months after the woman is feeling better.

“That’s not 6-9 months after you start taking the pill, it’s after you start feeling better!” she wrote. “The reason they recommend that you remain on it that long is because studies show there is a high risk of relapse if you get off the meds too early. And if you relapse, the symptoms are often harder to treat.”

“For that reason,” she said, “I tell my patients to try to think of this as a Serotonin vitamin; just take it, don’t think about “why” you’re taking it, you need it, it’s helping, and you’ll worry about getting off of it later.”

In 2008, Zoloft maker, Pfizer, donated more than $700,000 to the “non-profit” American Psychiatric Association.

Eli Lilly, the maker of Cymbalta, Prozac, and Symbyax, a drug that combines Zyprexa and Prozac, gave the APA grants worth more than $600,000 in both the first and second quarters of 2008. In 2007, the group received over $400,000 from Lilly, and roughly $450,000 more was given to the American Psychiatric Foundation for the APA fellowship program.

“Antidepressants are one of the most efficient and effective treatments for PPD,” Kleiman boldly tells women reading her StorkNet advice.

In another blog Kleiman wrote: “Women who experience depression during pregnancy are at an increased risk for PPD.”

“Current research supports the use of antidepressants immediately after delivery to reduce the likelihood of PPD.”

“Many women and their doctors choose this option,” Kleiman said, “to start their medication right after the baby is born, and I mean right in the delivery room!”
Doesn’t sound like any alternative therapies are considered, or tried, by this “expert” before dosing nursing infants with psych drugs.

On May 30, 2007, Kleiman ran the headline, “SSRIs and Pregnancy: Encouraging Study,” and wrote the following paragraph in a blog on the Postpartum Stress Center website:

“As presented at a poster session at the 2007 American Psychiatric Association (APA) conference, “APA: SSRIs in Pregnancy Not Associated With Cardiac or Pulmonary Problems”–there is a prelimiary data which offers encouraging support for the use of SSRIs during pregnancy.”

“While a retrospective chart review isn’t the best methodology (it’s certainly the best bet for pregnancy),” Kleiman said, “this is very positive and evidence-based study with a large number of patients, supporting the safety of SSRIs in pregnancy.”

True Experts Weigh In

“If a woman has been informed that an SSRI will not harm the fetus, then she has been misinformed,” says Dr Grace Jackson, author of “Rethinking Psychiatric Drugs: A Guide to Informed Consent,” and the new book, “Drug Induced Dementia: A Perfect Crime.”

“Research in non-human animal species and epidemiological human studies suggest that SSRIs pose direct and indirect risks to the embryo and fetus,” she reports, “especially to the formation of the brain, heart, and craniofacial skeleton.”

“Because SSRIs pass through the placenta,” she explains, “they may exert toxic effects directly by inhibiting or accelerating the process of apoptosis (programmed cell death).”

“Alternatively, SSRIs may exert toxic effects indirectly by disrupting maternal levels of serotonin and other hormones (including prolactin, thyroid hormone, and glucose), all of which participate in the development of the unborn child,” Dr Jackson advises.

“For humans,” she states, “the long-term risks of prenatal or neonatal exposure to SSRIs remain uncharacterized.”

“However,” she says, “it should concern medical professionals that research in rodents has repeatedly and consistently revealed a link between early exposure to serotonin reuptake inhibitors and the emergence of potentially long-lasting decrements in learning, memory, and emotion (e.g., abnormal responses to fear-producing stimuli, diminished capacity for nurturance and attachment, and depression).”

Julie Edgington took Paxil for a couple of weeks before she learned she was pregnant. Despite stopping the drug in the first trimester, Julie’s son Manie was born with “Transposition of the Great Arteries,” a condition where the aorta and pulmonary arteries in the heart are switched.

At 8-days-old, Manie had to undergo a 12-hour open heart surgery. Because of the surgery, he has a leaky heart valve and has had to undergo several more medical procedures. Manie also must take drugs for high blood pressure.

For a long time, Julie did not know Paxil caused Manie’s heart defect. “The guilt I feel will never go away even though it was not my fault,” she states.

She has this warning for pregnant women. “If you think you are depressed now wait until your life is flipped upside down when your baby is born with a horrible birth defect like Manie.”

Shameless Self Promotion

On April 28, 2008, Kleiman posted a blog announcing that her new book would be out in September 2008, which began with the comment: “Shameless self-promotion alert! ;)”.

She also pasted an excerpt from the book’s forward in the blog, written by Dr Shari Lusskin. “There is a treasure trove of ‘clinical pearls’ in this eminently readable book which even the most experienced clinician will be able to use right away,” Lusskin told potential buyers of the book.

A glowing review of Susan Stone’s book by Lusskin appears on the Amazon website as well.

Lusskin is an adjunct Associate Professor of Psychiatry, Obstetrics, Gynecology, & Reproductive Sciences at Mt Sinai School of Medicine. Her specialty is “Psychopharmacology,” according to her bio on the New York University Langone Medical Center website.

She is also an advisory council member of Postpartum Support International and has her own website.

The “Pregnancy-related Mood Disorders,” section of Lusskin’s site warns that: “Panic Disorder, Generalized Anxiety Disorder, Obsessive Compulsive Disorder, and Eating Disorders may also develop or worsen during pregnancy and postpartum. Women with Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder are particularly vulnerable during pregnancy and postpartum.”

“Medications (pharmacotherapy) and psychotherapy (using interpersonal psychotherapy and cognitive-behavioral techniques) both play a role in the treatment of perinatal psychiatric disorders,” Lusskin advises on her site, with medications of course listed first.

A May 28, 2005 presentation brochure shows Lusskin is a paid speaker for the psychiatric drug makers, Glaxo, AstraZeneca, Pfizer and Wyeth.

Lusskin’s site explains that: “Reproductive Psychiatry is a specialty that helps women deal with psychiatric conditions that develop in relation to specific points in their reproductive life cycle, such as their menstrual cycle, pregnancy, and perimenopause.”

“Women with psychiatric disorders that develop in relation to their reproductive life cycle are an under-served population that can benefit from treatment which considers both psychiatric and gynecologic factors,” Lusskin’s site states.
“Dr. Lusskin is one of a small number of physicians in the United States who specialize in this relatively new field,” her website claims.

Victim of “Reproductive Psychiatry”

Bobby Fiddaman runs the popular website Seroxat Sufferers. Seroxat is sold as Paxil in the US. He recently forwarded a story sent to him by Kimberly S, a young mother who went to a doctor for problems with mood swings before her menstrual cycle, with permission to reveal the story.

In a nutshell, Kimberly was prescribed Paxil first, and ended up on Remeron, benzodiazapines, Ritalin, Zyprexa, Lithium and sleeping pills, before her 3-year nightmare that included two suicide attempts and two lengthily stays in mental institutions was over.

The suicide attempts occurred when she tried to go off Paxil, without any warning about the severe withdrawal syndrome that can lead people to become suicidal. After the second attempt, Kimberly was on life-support for 3 days and then transferred to a mental institution where nothing she said was taken seriously because of course by now she was considered too mentally ill to be believable. She explains this situation as follows:

“When you are suffering from any kind of mental illness you have no credibility. If you get angry you are mental. If you cry it’s because you are mental. If you complain it’s because you are mental and all of this will wind you up on more medication that creates a vicious cycle you have little chance of breaking free from.”

“A psychiatric diagnosis is a prison sentence at first which can easily become a death sentence,” she warns. “You might not die physically but your soul and who you are dies eventually if you don’t break free from it.”

Kimberly finally found a doctor who alerted her to the Paxil withdrawal syndrome and helped her taper off the drug. “Had he not I don’t know where I would be today,” she says. “Probably 7 feet under.”

However, Kimberly was on her own when she stopped taking the other drugs. “I was by myself and at home on the floor, in a pool of sweat and vomit, screaming at those fierce anxiety attacks and the debilitating memories of everything that had happened,” she recalls.

“There were many times I wanted to give up and go back on those drugs because it was hell getting off,” she says. “There were times I did not think I was strong enough and my poor kids had already endured enough.”

But Kimberly did not give up, and today she is living a drug free normal life with her children, back at work and healthy, she reports.

July 31, 2009

Natural News

The Mothers Act Disease Mongering Campaign – Part III

In an article titled, “Disorders Made To Order,” in the July 2002 issue of Mother Jones Magazine, Brendan Koerner described the “modus operandi” of marketing a disease rather than selling a drug, “typical of the post-Prozac era.”

“The strategy [companies] use-it’s almost mechanized by now,” said the late Dr Loren Mosher, a San Diego psychiatrist and former official at the National Institute of Mental Health, in the article.

“Typically, a corporate-sponsored “disease awareness” campaign focuses on a mild psychiatric condition with a large pool of potential sufferers,” Koerner noted.

“Prominent doctors are enlisted to publicly affirm the malady’s ubiquity,” he said. “Public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies.”

“Companies fund studies that prove the drug’s efficacy in treating the affliction, a necessary step in obtaining FDA approval for a new use, or ‘indication,'” he wrote.

“Finally, patient groups are recruited to serve as the “public face” for the condition, supplying quotes and compelling human stories for the media; many of the groups are heavily subsidized by drugmakers, and some operate directly out of the offices of drug companies’ P.R. firms,” Koerner explained.

The disease focused on in Koerner’s article was generalized anxiety disorder, or GAD. The PR firm credited with orchestrating the successful campaign of selling the disease and Paxil to treat it, was Cohn & Wolfe, working for GlaxoSmithKline.

As an ex-employee of Cohen & Wolfe, Katherine Stone serves well as one of the “public faces” for the Mothers Act disease mongering campaign, complete with her own website, Postpartum Progress.

“This is the most widely-read blog in the U.S. on depression & anxiety during pregnancy & postpartum,” Katherine announces on the first page of her site.

She serves on the board of directors of Postpartum Support Internation, as the public relations outreach chairwoman, and provides live links on Postpartum Progress to buy the books of all the “experts” profiting off their self-created industry of “reproductive psychiatry.”

In a July 11, 2008, posting titled, “Postpartum Depression By The Numbers,” Katherine states that, “more women will suffer from postpartum depression and related illnesses this year than the combined number of new cases for men and women of tuberculosis, leukemia, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease and epilepsy.”

Advice for Healthcare Professionals

On Postpartum Progress, the public face, Katherine, provides a link to a down-loadable copyrighted document titled, “Six Things Every Healthcare Professional Should Know About Pregnancy & Postpartum Depression & Anxiety.”

In point one, she states: “Postpartum depression is only one in a spectrum of perinatal mental illnesses. One size does not fit all.”

“Perinatal mood and anxiety disorders include antepartum depression and anxiety, postpartum depression, postpartum anxiety, postpartum OCD, postpartum psychosis and postpartum post-traumatic stress disorder,” Katherine informs “Healthcare Professionals”.

In point six, she uses the “screen” word and states: “It is important to screen because you can’t tell by looking.”

In point five, the public face tells the professionals: “The sooner your patient gets treatment the better,” and writes a whole paragraph filled with the following misleading and false disease mongering comments:

“Many recent studies show that both the physical and emotional health of untreated women and their children are negatively impacted over the long term. Babies whose mothers have untreated depression during pregnancy, for instance, are twice as likely to be born pre-term, twice as likely to go to the NICU and have a 50% higher risk of developmental delay. It is important to identify sufferers as early as possible to avoid such complications where possible.”

“Together,” she claims, “perinatal mood and anxiety disorders are the number one complication of childbirth.”

On another webpage, she provides answers to the question: “What are Perinatal Mood and Anxiety Disorders?” and shows how easy it is to pin a money-making diagnosis of PSTD on vulnerable and naive new mothers.

For “Postpartum Post-Traumatic Stress Disorder,” Katherine writes: “All you have to do to be at risk for getting postpartum PTSD is to have the perception of a traumatic childbirth — in other words, even if your doctors and nurses feel that everything went fairly normally, if it was upsetting and scary and unexpected to you that’s what counts.”

A March 2009, “Practice Guideline for the Treatment of Patients With Acute Stress Disorder and Posttraumatic Stress Disorder,” by David Benedek, MD, Matthew Friedman, MD, PhD, Douglas Zatzick, MD, and Robert Ursano, MD, reports that, “SSRIs are recommended as first-line medication treatment for PTSD.”

“Benzodiazepines may be useful in reducing anxiety and improving sleep,” the authors state. 

“In addition to being indicated in patients with comorbid psychotic disorders, second-generation antipsychotic medications … may be helpful in individual patients with PTSD,” it says. “Anticonvulsant medications … , α2-adrenergic agonists, and β-adrenergic blockers may also be helpful in treating specific symptom clusters in individual patients.”

Another Human Face

Another public face in the Mothers Act disease mongering campaign is Lauren Hale. Hale is the Postpartum Support International coordinator for Georgia. She also runs a website called “Sharing the Journey,” and in unison with all the others, writes blogs parroting the agreed upon talking points of the campaign.

“This Blog Supports the Mothers Act,” is prominently posted on her site. Hale also tells visitors: “A Girl’s Gotta Eat! Click the icon above to make a donation to support this hard-working blogger!”

Of course, Hale’s site also provides links to all the other sites that make up the internet chain of disease mongers, such as Postpartum Support International and Postpartum Progress, and the two treatment centers owned by social workers, Karen Kleiman and Susan Stone, recruiting potential customers through the websites “Postpartum Stress Center,” and “PerinatalPro.”

In fact, a quick count on Hale’s site shows links to a total of 10 different websites with “PPD,” in their names, and 11 more with “Postpartum Depression,” in their title.

On July 15, 2009, Hale described the legislation as follows: “The MOTHER’S Act as it reads in the current version would provide funds for a public awareness campaign, education campaign for caregivers, increase availability of treatment options and entities as well as require the current Secretary of Health & Human Services to conduct a study regarding the validity of screening for Postpartum Mood & Anxiety Disorders.”

This statement is a typical example of the disease mongering complained of because nowhere in the bill does it say a study will be conducted on the “validity of screening for Postpartum Mood & Anxiety Disorders.” The “conditions” are defined as “postpartum depression” and “postpartum psychosis” only.

Hale takes the campaign to a whole new level on her site in being the most prolific promoter of the notion that new dads also suffer from postpartum depression and need treatment. For instance, a link on her site takes readers to a pamphlet with a warning: “Don’t Forget about DAD!”

“Dads too can suffer from Paternal Postnatal Depression (PPND) and need to be on the lookout for signs and symptoms of this increasingly occurring disorder,” it states, and describes what to look for in the new disorder, as follows:

“Signs that Dad may be suffering from PPND may include change in appetite, loss of interest in hobbies and other activities, feeling down for more than two weeks, increased irritability and frustration, guilt or shame surrounding these feelings, inadequacy feelings related to fatherhood, and insomnia.”

“If these symptoms do not go away after two weeks, Dad should be seen by a medical professional,” the pamphlet advises.

Hale even includes a special section on her site for the “Postpartum Dads Project,” and also provides links to websites called “Postpartum Dads” and “Postpartum Men.”

On January 19, 2008, Katherine also featured a blog on Postpartum Progress to announce a, “New Resource for Men with PPD,” and provided a link to the website “PostpartumMen.”

“This site was expressly created for men who experience postpartum depression themselves,” Katherine said. “Recent research has indicated that men can experience postpartum depression, or PPND (paternal postnatal depression), too, and this population has been underserved until now.”

This is but one example of the way the Mothers Act gang works. Once an item is posted on one website, the others will pick it up and repost it to flood the internet.

All the sites put out blogs promoting screening tools. On September 2008, Postpartum Support International ran the news flash: “3 Questions Can Spot Possible Postpartum Depression.” 

A three-item anxiety sub-scale of the Edinburgh Postpartum Depression Scale turned out to be a better screening tool than the two other abbreviated versions which are almost the same as the commonly used Patient Health Questionnaire, PSI reported.
The same day, Katherine repeated the story with the headline: “Researchers Find 3-Question Screening Test Effective in ID’ing PPD.”

The StorkNet website wrote: “Postpartum Depression: Three Simple Questions to Ask Yourself,” for the same pop quiz. “A simple new 3-question test has proven very reliable at detecting postpartum depression,” it reported.

In a July 8, 2009, blog, Hale reported on the latest hot screening tool. “This morning I discovered an iPhone app which includes the Edinburgh Postpartum Depression Scale along with three other depression scales,” she wrote.

“Chances are many new moms either have an iPhone or know someone who does,” she said. “What’s really cool about this app is that it stores the last 30 entries so you can take the results straight to your doctor.”

“Speaking of doctors,” she continued, “if you’re a professional, you too can get this app for your iPhone as well so if you’re faced with a new mom who doesn’t seem to be doing very well, you can screen on the spot without having to hunt down a screening tool in your office.”

“Pretty cool, huh?” Hale wrote.

Undiagnosed Foot in Mouth Disease

As a “public face” in the campaign, Katherine regularly and dutifully discusses her bout with “postpartum obsessive-compulsive disorder,” which began with her first pregnancy in 2001, and has now apparently required eight years of treatment, including five antidepressants and two antipsychotics, according to her reporting on Postpartum Progress.

In a June 2004, Newsweek article, Katherine publicly discussed how she ended up getting treatment for OCD, and made sure to tell readers: “I’ve written my congressman and senators and asked them to pass the Melanie Blocker-Stokes act.”

“I took advantage of my company’s employee-assistance program and called the help line,” she said. “God blessed me that day. They put me in touch with a wonderful therapist who saw me immediately and recognized what was wrong.”

“As it turns out, I had postpartum obsessive-compulsive disorder,” Katherine stated.
In describing her treatment, she wrote, “in my case, that meant taking an antidepressant and going for weekly therapy sessions.”

“For a while I was convinced that I’d never be the same person again,” she noted. 

“But I did everything my doctor told me to do, and I’m now back to the old me,” Katherine told readers of Newsweek in June 2004.

On February 11, 2005, Katherine posted a “Letter to Bill O’Reilly,” on her website, which she sent in response to segment on PPD on his show.

“Unless I’m misunderstanding him,” she wrote in her blog, “he doesn’t want to seem to admit that this is a real illness that many women suffer.”

In the “Dear Bill” letter, Katherine wrote in part:

“I saw your segment last night on postpartum depression. I can understand your concern over making sure that true criminals don’t misuse mental illness defenses. I share that concern. But let me assure you, this is as real an illness as any other.”

“I am 35 years old, and am the former Director of Experiential Marketing at The Coca-Cola Company. I now run my own marketing consultancy. I tell you this so you’ll know I am a bright, successful young woman.”

“Sir, you have to understand that I am as competent as they come and a fairly accomplished young person,” Katherine told Bill.

“Before the birth of my son, I had never been treated for or experienced any mental illness,” she said. “Upon his birth, I spiraled into a darkness so horrific I thought I’d never be the same again,” and further described the OCD disorder in stating: “I couldn’t eat. I couldn’t sleep. I had uncontrollable thoughts of harming my son.” 

“I can’t explain to you why I thought of smothering my son with a burp cloth,” Katherine said. “I had never had such disturbing thoughts in all my life.”

“I felt like a defective human being who would be sent away forever never to see my loved ones again,” she wrote.

“In fact,” she said, “all I needed was a competent psychiatrist, some medication and some therapy,” in making treatment sound so simple.

“I am now perfectly fine,” Katherine informed Bill in 2005, giving the definite impression that she was cured, four years after the bout began in 2001.

In a webpage titled, “The Art of Psychiatric Medication,” originally published with a date of June 8, 2006, Katherine told readers:

“I’ve taken many medications, including Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, etc.”

“Throughout all of them I was on the road to recovery,” she said. “Some just worked better than others at treating my symptoms.”

A few months later, in a September 5, 2006 blog, Katherine was praising antidepressants again, and was seemly annoyed that Brooke Shields accepted an apology from Tom Cruise.

“So Tom Cruise has now apologized to Brooke Shields, and she accepted his apology,” Katherine wrote.

“Good for them both,” she added.

“I, on the other hand, have not forgiven Tom Cruise,” she said. 

“It hurt all of us when he dragged our illness into the spotlight and essentially made us feel awful for having taken medications that were prescribed to us by legitimate physicians in order to recover,” she stated, using the term, “legitimate physicians.”

“It’s okay with me that he doesn’t believe in antidepressants,” she wrote. “No problem.”

“But don’t judge me because I do believe in them,” Katherine said.

“Don’t make me look bad in the public eye because I had to take them,” she wrote, with the verb “had,” making it sound like she “used” to take antidepressants.

“They saved my life,” Katherine announced.

In a November 30, 2006 blog, she wrote: “I agree with the premise that every illness doesn’t require medication.” 

“But the truth is, no doctor or mental health industry or advertisement or any other such thing made me think or do anything,” she said, claiming she made the right choices about medications.

“I made the choices about being treated, working with my doctor, and I recovered,” Katherine wrote in late 2006, once again leaving the impression that she was cured with the past tense “recovered.”

On June 6, 2007, Katherine boldly told her readers, “I and thousands of other women like me are evidence that, when in postpartum crisis, antidepressants can save lives and restore families.”

“I used meds, and yes it took me several to find the one that worked for me, but once it did it was GREAT,” she wrote, without mentioning the names of the five she tried, and with the term “used meds” in past tense as if she was through with antidepressants.

“I’m proud of the choices I made,” Katherine once again claimed. 

“I wouldn’t change them for a second,” she proudly pronounced in mid-2007.

In April 2009, after all of the above comments, and after the reporting of her admissions in the Art of Medication article that she took two antipsychotics, and not one but five antidepressants, to treat a single diagnosis of postpartum OCD, Katherine removed the names of the drugs from the article and inserted the following paragraph:

“My psychiatrist gave me seven different medications, partially because he didn’t know what he was doing and partially because some of them didn’t work for me. 

“When I finally found a trained doctor, we developed a plan that worked, including one antidepressant and weekly therapy.”

In further explaining her supposedly erroneous comments in the Medication webpage, that remained on her site for women to read for nearly three years, on April 12, 2009, Katherine wrote: “What I also should have said, though, is that my first psychiatrist who put me on all those meds was horrible and untrained and a total nightmare.”

“It wasn’t until I left him and found someone who had specific experience in perinatal mood and anxiety disorders that I got a whole lot better,” she said, in reference to apparently firing a “male” doctor. 

Katherine then identified the new doctor as a female. “She and I talked in depth about the variety of treatments available to me,” Katherine said, “I chose to take medication and attend therapy weekly, and the speed limit on my road to recovery went from 35 to 70 mph.”

However, less than two years ago, on June 14, 2007, Katherine identified her doctor as a male, in a blog with the headline: “Upcoming Event in Asheville Features My Psychiatrist!” 

This announcement was for a seminar held for “prescribing clinicians,” titled, “Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment.”

“The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women’s Mental Health Program here in Atlanta and also my psychiatrist!!!!”, Katherine wrote in her blog.

“I have firsthand knowledge that Dr. Newport rocks,” she told readers. While it may be true that Newport “rocks,” as far as helping Katherine change her obsessive and compulsive thought processes, years of rocking with the good doctor has seemingly failed.

The story on Postpartum Progress is that: “In 2001 she suffered postpartum obsessive compulsive disorder after the birth of her first child.”

On April 17, 2009, Katherine wrote that she continues to take “meds” (plural) “for my OCD.” Other blogs mention Cymbalta and that she took antidepressants to “prevent” PPD during her second pregnancy. In a blog describing her treatment, she wrote: “I saw my fabulous psychiatrist at Emory every month (Hi Dr. Newport!).” 

A June 8, 2009, article titled, “Is Congress Ignoring Unintended Consequences?”, contains this statement: “Stone suffered from postpartum obsessive compulsive disorder after the birth of her son and was prescribed an anti-depressant that she said provided immeasurable support.” 

In this article, Katherine is a source plugging the Mothers Act. A google search, with the story’s headline in quotes, brings up 26 hits on the internet, and once again misleads women into believing that she only took a single antidepressant to recover from postpartum OCD.

Critics of disease mongering say the costs, duration, risks and benefits of treatment should be fully discussed when reporting on disorders and their treatments. Nowhere in the endless blogs written for Postpartum Progress, and reposted on other websites, over the past 5 years, is there any mention of the costs incurred by Katherine for all the “treatment” she received between 2001 and 2009, to “recover”.

In summary, the first doctor, who she now alleges was a flunky, was a male. Next, a second female doctor reportedly came on the scene, and then another male was listed in 2007. That’s three doctors, that we know of. Each prescribed drugs and Katherine merrily attended weekly therapy sessions for years on end, according to her own reporting.

The public deserves to know how much money is at stake for the pharmaceutical industry here. The price of Eli Lilly’s Cymbalta at a middle dose was $391 for ninety capsules on May 6, 2009, at DrugStore.com, meaning a years worth would run $4,692.

Of the other antidepressants Katherine was prescribed, Weyth’s Effexor cost $197 for 90 tablets, 30 tablets of GlaxoSmithKline’s 24-hour Wellbutrin was $202, and Luvox CR cost $135 for 90 pills, in December 2008 at DrugStore.com. One hundred tablets of 20mg Celexa sold for $355 in July, 2009.

For the two antipsychotics, in April 2009, Janssen’s Risperdal cost $716 per 90 tablets, and 100 tablets of AstraZeneca’s Seroquel cost $839. A year’s worth of Seroquel alone would add up to $10,068 on DrugStore.com. 

The latest shrink identified by Katherine, Jeffrey Newport, has received research support from Lilly, Glaxo, Janssen, and Wyeth, and has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to an August 2007 disclosure for a study in the American Journal of Psychiatry.

The disclosures do not reveal the amounts paid to Newport by each drug maker.

However, Newport is the associate director of Emory University’s Women’s Program, and recently revealed information on his boss, the director, Zachary Stowe, may shed some light on the potential earning power of Newport.

Stowe is the latest addition to a long list of psychiatric researchers under investigation by the US Senate Finance Committee for not disclosing the money they were paid by drug companies, while conducting federally funded studies on psych drugs.

Much of Stowe’s research specifically focused on the use of drugs with pregnant and nursing mothers and Newport is a co-author on many papers.

Senate records show Stowe received roughly a quarter of a million dollars from one drug maker, Glaxo, for giving mostly promotional talks on Paxil, in 2007 and 2008 alone. And like Newport above, Stowe is a paid speaker for numerous drug companies. 

As chairman of Emory’s psychiatry department, Dr Charles Nemeroff, was boss to both Newport and Stowe, until he was forced to give up his chair in 2008, after the Finance Committe found he failed to report at least $1.2 million of the $2.8 million he earned from drug makers between 2000 and 2007, including over $800,000 from the Paxil maker.

With links to its website, the Emory program has been promoted as the top women’s program in the US for years, by nearly all the major Mothers Act disease mongering sites.

The total amount a woman would have to spend on office calls for the prescribing physician and the therapy sessions attended by Katherine over a period of 8 years is impossible to estimate.

In the Art of Medication article, she told women that “expecting to get better in a week is unrealistic.”

“What you can expect is to get less sick over time until you get back to who you were before you got sick,” she said. “For some people that takes a couple of months, for some people longer.”

Some women might think that eight years of taking drugs and seeing mental health professionals is quite a bit longer than “a couple of months.”

Queen of the Depression Bloggers

Katherine’s website was selected as one of the top 10 depression blogs by PsychCentral in both 2007 and 2008, according to her website bio. 

The CEO and founder of the PsychCentral website is psychologist, John Grohol, an avid supporter of the Mothers Act. In fact, he often allows Katherine to repost entire articles, written for Postpartum Progress, on PsychCentral. 

However, a review of Grohol’s website reveals a few potential profit motives behind pumping up Katherine’s status and publicly listing her as “top 10″ depression blogger two years in a row, to draw women to his website. 

In fact, PsychCentral appears to be running a one-stop internet treatment center with 24 hour service online. For starters, Grohol’s provides a link for potential patients to: “Consult an online therapist.”

When clicking on the link, the webpage states: “Our certified personality and emotional disorder therapists can help.”

The good news is: “All sessions are private and start free.” However, in checking the “services” for the first three listed “experts,” the chat prices were listed as $1.50, $1.99 and $2.00 per minute, at the end of the description.

With a vivid imagination, it may be possible to form a deep therapeutic relationship by looking in eyes of the counselors in the pictures on Grohol’s website, while listening to voice on the phone, and blocking out the fact that every word is costing $2.00 per minute. 

Being the service sounds eerily similar to psychic hotlines, it may be safe to assume that the “therapy” will not be billable to insurance and public health care programs and a credit card might be required for each chat.

As a further service to potential patients visiting PsychCentral, Grohol posts ads for drug companies. The antipsychotic, Abilify, is prominently advertised with a statement saying, “Adding ABILIFY to your antidepressant may help,” along with a link to the drug’s website.

The Abilify site claims: “A clinical study showed that approximately two-thirds of those diagnosed with depression did not achieve adequate symptom relief after taking an antidepressant alone.”

“If you’re currently taking an antidepressant, it may not be providing you with adequate symptom relief,” the website advises. 

“Ask your healthcare professional if adding ABILIFY is right for you,” it tells readers. The cost of Abilify at DrugStore.com was $1,230 for ninety 10mg tablets in April, 2009.

Grohol’s site also features an ad for the antidepressant, Cymbalta, where people can: “Sign up for a free sample of Cymbalta with your doctor’s prescription,” and click on a link to “Get the Voucher Now!”

People reading the Cymbalta ad can even get instructions on: “What should I talk about with my healthcare provider?”

For the 66% of the people who click on the link for Abilify, and decide they do not “achieve adequate symptom relief,” with Cymbalta, at a cost of $391 a month, they can add Abilify to the mix for a total of only $1,621.

Disease mongering through “treatment resistant depression” is the latest rage. With Pharma funded front groups flooding the internet with the online depression screenings, combined with websites like Grohol’s posting free drug coupons, this marketing coup has turned into one of the most effective customer recruitment schemes for everyone involved.

However, before gulping down a grand a month worth of psych drugs for “treatment resistant depression,” or paying $2 a minute to chat about “personality or emotional disorders,” people may want to reconsider the diagnosis after reading comments posted over on the, “Carlat Psychiatry Blog,” on May 13, 2009, by Gina Pera, one of the top disease mongers for “legal speed freaks,” and hawker of a book on Adult ADHD.

“Maybe a sizeable majority of these “treatment resistance depression” and “personality disorders” populations are people with ADHD,” she wrote. “Especially in women.”

On July 15, 2009, Pera offered further advice about the Mothers Act on PsychCentral. “My only concern with the Mothers Act is that it is too narrowly focused on depression, specifically PPD,” she said.

“Conservatively,” she wrote, “10 million adults in the U.S. have ADHD, but only one tenth know that they do, and only a fraction of those are pursuing treatment.”

“Presumably, half of those 10 million are women. (And again, that is an extremely conservative estimate.),” Pera said.

“It would make more sense to me to screen new mothers for all mental illness, because if they go in looking for PPD or depression, well, you know what they say about a hammer and everything looking like a nail,” she continued. 

“Moreover, I would like to see new fathers screened as well,” she added.

The above advice from Pera, on the type of screening that should be implemented via the Mothers Act, for both mothers and fathers, comes from “an award-winning print journalist based in the San Francisco Bay area,” according to a bio on her website.

In a July 2, 2009, blog on her own site, Pera posted, “A quick note to let you know that yesterday Amazon reduced the price of my book, Is It You, Me, or Adult A.D.D.? Stopping the Roller Coaster When Someone You Love Has Attention Deficit Disorder — from $21.95 to $14.26.”

Self-Made Expert for Hire

Katherine is now listed on LinkedIn for hire, with an online summary that reads: “Talented, award-winning marketing and PR professional returning to the workforce after brief sabbatical as full-time mom.”

“Skills include experiential marketing concept development, brand positioning, marketing strategy, social networking, and public relations campaign development and execution,” she writes.

“Used break from full-time employment to become an expert at social media, creating most widely-read blog in the U.S. in her niche,” the summary states in obvious reference to Postpartum Progress.

Last year, Katherine was honing her skills by giving one-hour talks on, “Project Healthy Moms: What You Need To Know About Perinatal Mood Disorders,” paid for with a $20,000 grant from Zoloft-maker, Pfizer, funneled through the Georgia chapter of Mental Health America, a Big Pharma front group that receives millions of dollars from psych drug makers every year.

On her website, Katherine posts a live link to the Georgia group, for which she says, “this is my home chapter for MHA, so I’m biased!”

In March 2008, Lauren Hale teamed up for a seminar titled, “Managing Perinatal Depression: Reappraising the Risks,” with Katherine, and speaker Jeffrey Newport. Learning objectives were listed in part as: “Delineate the fetal/infant risk of exposure to maternal depression and review currently available antidepressants,” and “Propose a comprehensive treatment model for perinatal depression.”

“Katherine Stone and Lauren Hale discuss their experience with postpartum depression,” a summary for the event said. The seminar was sponsored by a treatment facility and the MHA Georgia group.

After the funneling of Pfizer money to Katherine was exposed, she claimed she did not get the whole twenty grand. But the amount she received averaged out to be roughly $350 per talk, which is not too shabby considering her “human face” role in the disease mongering campaign.

A petition for people who want to sign on to support the Mothers Act is provided on a website called, “GoPetition,” with a current “Public Signature List,” of 33 names.

The latest signature was added on July 13, 2009.

GoPetition says the petition was posted by “Heidi,” presumably referring to signature, Heidi Koss-Nobel, telling members of Congress to: “Please pass this important bill to protect thousands of families from the undiagnosed suffering of pregnancy and postpartum depression.”

However, some of the viewable comments posted along side the supporter’s signatures seem a bit odd. For example, the comment for the name, “BestSellersq,” reads: “This is the best viagra shop! The best price for viagra. Please visit it!”

Signature Mindy Brooks wrote: “This is insane! Where will it end?”

But on the other hand, supporter, Terri Buysse, states: “This act is essential to help protect our children and to support uncounted numbers of women who suffer from devastating illnesses after giving birth.”

And Sarah Masterson wrote: “As the PSI coordinator for Washington, DC, as a mother and an advocate for mothers, I would like to join my colleagues in urging our members of Congress to pass the MOTHERS Act.”

Katherine signed the petition but apparently decided not to post a comment.

The young mother heading an organization of over 50 groups against the Act, Amy Philo, provides a petition for people against the Act to sign on her “Unite for Life,” website, which is then sent to members of Congress. At last check, the petition had about 12,600 viewable signatures.
Natural News

The Mothers Act Disease Mongering Campaign – Part IV

The Mothers Act campaign has evolved into the most rabid gang of disease mongers seen in recent years, likely due to its 8-year existence.

In the 2002 paper titled, “Selling sickness: the pharmaceutical industry and disease mongering,” in the British Medical Journal, Ray Moynihan, Iona Heath, and David Henry, describe the mechanisms of the Mothers Act disease mongering campaign to a tee when explaining that:

“Within many disease categories informal alliances have emerged, comprising drug company staff, doctors, and consumer groups. Ostensibly engaged in raising public awareness about underdiagnosed and undertreated problems, these alliances tend to promote a view of their particular condition as widespread, serious, and treatable.”

“A key strategy of the alliances is to target the news media with stories designed to create fears about the condition or disease and draw attention to the latest treatment. Company sponsored advisory boards supply the “independent experts” for these stories, consumer groups provide the “victims,” and public relations companies provide media outlets with the positive spin about the latest “breakthrough” medication.”

The A Team

In review, the main leaders of the Mothers Act disease mongering campaign include Susan Dowd Stone and Karen Kleiman, two social workers who own treatment centers recruiting customers via their websites, PerinatalPro and Postpartum Stress Center, and who also sell books. The two most prominent “victims” or “human faces” in the campaign are Katherine Stone with the “Postpartum Progress,” website and Lauren Hale with a site called “Sharing the Journey.”

All the websites follow the lead of a group called, “Pospartum Support International,” and parrot the buzz words and phrases invented by the self-interested specialists and experts, such as “women’s reproductive mental health,” and “pregnancy related mood disorders,” and “reproductive psychiatry.”

Old Chemical Imbalance in the Brain Scam

On July 7, 2006, in discussing a press release for book in which: “Mothers share their challenges with sleep deprivation, anxiety, colicky and ill babies, and other issues that sent them into a downward spiral,” Katherine Stone wrote on Postpartum Progress:

“In my opinion, I consider chemical brain imbalances to be the source of sending us into a downward spiral, not colicky babies and sleep deprivation as the press release seems to infer. Those things just make the experience worse.”

Dr David Stein, a professor of psychology and criminal justice at Virginia State University, and author of, “Unraveling the ADD/ADHD Fiasco,” has taught psychopharmacology for 25 years. One of the greatest myths about mental disorders, is that they are caused by a chemical imbalance, he says.

“The myth is founded on some of the tricks that are pulled in so-called scientific research in psychology and psychiatry,” he explains.

“The manipulation of research has become one of the most powerful and most unethical marketing tools ever devised,” he says. “Not one study can be replicated at the testing labs of hospitals or by laboratories involved in clinical patient care.”

“Replication is a basic step for all sciences,” Dr Stein explains.

When a drug alleviates a certain condition, such as depression and anxiety, patients are told that the drug is correcting a chemical imbalance. “However, this type of logic is not permitted in true science,” Dr Stein reports.

To simplify the point, he provides the analogy of people drinking alcohol, which is a sedative drug, and experiencing relief from anxiety. “Can we say that alcohol clears up chemical imbalances that cause anxiety?”, he points out.

If so, Dr Stein says, “then the entire human race is running around with chemical imbalances.”

“This type of logic is not permitted within proper scientific circles,” he says. “Sadly, proper scientific circles are evaporating within psychiatry and psychology.”

Sad Daddies

As part of this overall disease mongering scheme, the Mothers Act campaign has now taken aim at new fathers. All the gals provide links to the “PostpartumMen,” website. And in return, PostpartumMen dedicates a whole webpage to promoting the Mothers Act, complete with a link that takes readers directly to the website of Susan Stone’s treatment center.

“PostpartumMen is a place for men with concerns about depression, anxiety or other problems with mood after the birth of a child,” according to its website.

Dr Will Courtenay runs the site. Courtenay is a Licensed Clinical Social Worker and has served on the clinical faculty in the Department of Psychiatry at Harvard Medical School, and the University of California, San Francisco, Medical School, according to his bio.

“Yes, men do get postpartum depression,” he writes on PostpartumMen.

“It’s a fact that most people – and even many health professionals – don’t know,” he claims.

“Depression, anxiety or other problems with mood can occur anytime during the first year of your child’s life,” he tells men.

“The truth is, depression, anxiety and other mood disorders are common,” he states. “In fact, they’re just as common – and just as real – as physical problems, like heart disease and diabetes.”

“It really pains me to see so many men suffering alone, in silence,” Courtenay says on PostpartumMen. “Especially since depression, anxiety and the other mental health problems that afflict us are treatable.”

For men, the newly coined disorder is called “paternal postpartum depression,” and referred to as “PPND.”

“Up to 1 in 4 new dads have PPND,” Courtenay tells readers on PostpartumMen. “In the United States alone, that amounts to 2,700 new fathers who become depressed every day.”

And as it turns out, Courtenay hosts a total of six websites for men, accessible with live links from PostpartumMen, including one for his “Men’s Health Consulting,” firm.

In advertising for this firm, he provides a webpage on, “Media Coverage of Dr. Will Courtenay,” and posts selective remarks and comments made regarding himself or PPND and men.

For instance, this description of himself was listed as coming from Newsweek: “An expert on why fathers can also become depressed after the birth of a child, and what couples can do about it. “

“Each day in the U.S., 1,000 new dads become depressed, and according to some studies that number is as high as 3,000,” was posted as coming from CNN.

According to the above, at 3,000 new dads per day, times 365 days year, a potential 1,095,000 new customers could be recruited each year for the “Reproductive Psychiatry” industry, via the PPND component of the disease mongering campaign alone.

On the Media Coverage page, Courtenay also provides a link to a May 14, 2008, Parent Map article titled, “Sad dads: postpartum depression in men,” in which he states: “Men need to know that this can happen to them, and that if it does happen to them, there are other people out there experiencing it, too.”

This article says Courtenay publishes a website about “postpartum depression among dads” called “www.saddaddy.com.” However, when clicking on the saddaddy link, PostpartumMen comes up today.

And surely by coincidence, Courtenay will soon have a new book for sale titled, “Sad Dads,” which he is currently writing, according to his bio on the consulting firm’s website.

“If you’d like to arrange an individual consultation with Dr. Courtenay, please call 415-346-6719,” the PostpartumMen website states.

And apparently postpartum depression in dads is catchy. “If you’re experiencing PPND, it increases the likelihood that your partner is also depressed,” Courtenay informs men on his website.

“It’s important that she get help for herself as well,” he kindly advises.

He then provides a link to a page with resources “specifically for women,” where Kleiman’s Postpartum Stress Center just happens to be listed as specializing “in the diagnosis and treatment of prenatal and postpartum depression and anxiety disorders,” along with a clickable link to the center’s website.

On the StorkNet website, where Kleiman dishes out disease mongering tidbits on a regular basis, she does her part to promote PPND by telling readers: “Yes, absolutely dads can get depressed after the birth of a baby. We just don’t hear a lot about it.”

“PPND is a very serious condition,” Courtenay states on PostpartumMen. “But it’s also a very treatable condition.”

“If left untreated,” he warns, “PPND can result in damaging, long-term consequences for yourself, your child, and your family as a whole.”

Men who think they might have it can click on a link and be screened right on the spot, for free no less.

“Do YOU have PPND? Complete the PPND Assessment and find out,” the website tell men.

In fact, Courtenay is running the “Dads’ Postpartum Depression Study,” on his website, “in collaboration with the Center for Men and Young Men at McLean Hospital, Harvard Medical School.”

“You are invited to participate in a research study conducted by Dr. Will Courtenay, an internationally recognized scholar in understanding men,” the website tells men.

“Upon completion, you will receive a score from an assessment for postpartum mood disorders,” the consent form states. “This will allow you to determine whether you might be suffering from anxiety or depression.”

Respected Researchers support the Mothers Act

No psychotropic drug is FDA approved as safe for use by pregnant and nursing mothers, meaning every prescription written to these women is off-label. The drug makers cannot legally push their drugs for unapproved uses to doctors or consumers so they simply hire a few highly paid quacks to do it.

Then these quacks will drag a “human face” along for drama when giving seminars or public interviews. For instance, on February 26, 2009, Katherine wrote a Postpartum Progress blog with the headline: “Interview Today on Postpartum Depression & Related Illnesses”.

“Getting ready to go do interview with CNN/Turner Private Networks for the CNN Accent Health Network that appears in doctors’ offices and reaches more than 140 million viewers each year,” she told readers.

“They will also be interviewing Dr. Zachary Stowe from the Emory Women’s Mental Health Program,” Katherine added, with a live link to Stowe’s Emory program.

Not mentioned is the recently revealed matter that Stowe, the director of the Emory Women’s Program, made a quarter million dollars from the Paxil maker alone in 2007 and 2008, and failed to disclose the majority of those earnings to Emory University.

The “National Institute of Mental Health said it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the Atlanta Journal-Constitution reported on June 11, 2009.

One of Stowe’s emails that turned up in litigation, dated September 19, 2003, shows his nicer side when demanding to be paid for promotional talks he never gave for Glaxo because they were apparently canceled due to lack of interest.

“I do not want to be a prick,” he said, “but given the time and frustration, I think she should arrange to pay me for both talks, as noted in my last email to her.”

On October 17, 2008, Katherine appeared at a “Perinatal Depression Conference,” in Chicago with another “prominent speaker,” Dr Lee Cohen, director of the Massachusetts General Hospital Center for Women’s Mental Health, and an Associate Professor of Psychiatry at Harvard Medical School, put on by the Jennifer Mudd Houghtaling Postpartum Depression Foundation.

Other featured speakers who have appeared at seminars sponsored or co-sponsored by the same Foundation include Zachary Stowe, and Dr Katherine Wisner, according to the Foundation’s website.

In February 2006, Cohen was the lead author on a paper titled, “Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment,” published in the “Journal of the American Medical Association,” for a study that claimed stopping antidepressants could greatly increase the risk of pregnant women relapsing into depression.

A few months after the study was published, the July 11, 2006, Wall Street Journal revealed the obvious motives of the “experts” who authored the paper in wanting pregnant women to stay on antidepressants.

The Journal reported that, “the study and resulting television and newspaper reports of the research failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants,” and “the authors failed to disclose more than 60 different financial relationships with drug companies.”

The Journal noted that Cohen was a longtime consultant to 3 antidepressant makers, a paid speaker for 7, and his research work was funded by 4 drug companies. Adele Viguera, associate director of the Mass General perinatal psychiatry program and professor at Harvard, also did not disclose a paid speaking relationship with Paxil maker GlaxoSmithKline.

Among the most significant absent disclosures found, were those of Dr Lori Altshuler, director of the Mood Disorders Research Program at UCLA, who was a speaker or consultant for at least five antidepressant makers. “Two of her colleagues — Vivien Burt and Victoria Hendrick — were also authors who didn’t report financial relationships they have with antidepressant makers,” the report said.

JAMA has required authors to list all financial interests since 1990, and publishes the disclosures. In an online editorial in July 2006, JAMA editor, Dr Catherine DeAngelis, announced her intention to enforce disclosure policies in part, by publicizing any author’s failure to follow the rules and specifically noted that 3 consecutive nondisclosures involved authors from Harvard, and included the Cohen study.

The financial ties of the authors to the drug makers was brought to the attention of JAMA by Dr Adam Urato, and a letter from Dr Urato was published in JAMA, stating that since the study dealt in part with the question of pregnant women stopping antidepressants, the readers should be aware of the potential for pro-drug bias.

In the case of SSRI use by pregnant women, the Journal noted that the industry-paid opinion leaders have become dominant authorities in the field, and explained that:

“They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors.”

Ironically, the only financial relationships disclosed were for Zachary Stowe and Jeffrey Newport of the Women’s Mental Health Program at Emory. However, nowhere was it revealed that Stowe might be raking in a quarter million dollars from each drug company, and Newport’s list of disclosures on financial ties to drug makers is every bit as long as Stowe’s.

In blogs on Postpartum Progress, Katherine Stone refers to Newport as her shrink.

Emory’s bio page for Newport shows he received an Eli Lilly Fellowship from the Society of Biological Psychiatry, an Eli Lilly Psychiatric Research Fellowship from the American Psychiatric Association, and a “Psychiatry Resident of the Year Award,” from Pfizer.

Newport also received a “Young Investigator Award,” from the National Alliance for Research on Schizophrenia and Depression (NARSAD). Eli Lilly’s 2007 grant reports shows a $15,000 donation to NARSAD in one quarter and second $15,000 grant in another. The 2008 grant report lists a $15,000 donation, two $5,000 grants, and another $100,000 donation to NARSAD.

In her book, “Perinatal and Postpartum Mood Disorders,” Susan Stone tells readers: “Respected university medical centers conducting research and offering education include Emory University School of Medicine (website address inserted) and Massachusetts General Hospital Center for Women’s Mental Health (website address inserted).”

On April 14, 2009, the Harvard’s website for the Mass General program posted a blog with the headline, “Postpartum Depression Legislation Still Needs Your Support,” with the message that “Susan Dowd Stone, fomer president of Postpartum Support International, has taken the lead in putting together a petition of those who support the MOTHERS Act,” and listed Susan’s email address to sign the petition.

The website for the Women’s program also includes a link to the “Screening for Mental Health,” website, where SMH is described as:

“SMH is a non-profit organization that provides screenings for depression, bipolar disorder, anxiety, post traumatic stress disorder, suicide intervention, alcohol problems and eating disorders. These programs are designed for community and mental health sites, employers, health care organizations, colleges/universities and high schools.”

Tax returns show drug companies have provided this “non-profit” with at least $4,985,925 up to 2008

Eli Lilly’s grant report for 2007, lists three grants of $24,250, $50,000 and $50,000 to SMH. In 2008, SMH received donations from Lilly worth $100,000.

And Speaking of Harvard

On September 27, 2007, the New York State Board for Professional Medical Conduct reported that Dr Jack Gorman, now the former president and psychiatrist-in-chief of Harvard University’s McLean Hospital, in charge of psychiatry at the other Harvard-affiliated hospitals in the Partners HealthCare system, was found guilty of negligence on more than one occasion for engaging in “inappropriate sexual contact with a patient.” A month later he surrendered his right to practice medicine in Massachusetts.

Gorman was instrumental in both selling the diseases, and promoting SSRIs to treat, Social Anxiety Disorder and General Anxiety Disorder, as well as “Compulsive Shopping Disorder,” in conjunction with Katherine Stone’s former employer, the Cohn & Wolfe public relations firm hired by Glaxo.

On June 9, 2008, with a headline, “Harvard doctors’ studies tainted,” the Pittsburgh Tribune-Review wrote: “Harvard Medical School doctors who helped pioneer the use of psychiatric drugs in children violated U.S. government and school rules by failing to properly disclose at least $3.2 million from drugmakers led by Johnson & Johnson and Eli Lilly & Co., a U.S. senator said.”

An investigation by the US Senate Finance Committee found Dr Joseph Biederman earned about $1.6 million from drug companies between 2000 and 2007, but failed to report about $1.4 million on forms filed with the school. Doctors, Thomas Spencer and Timothy Wilens, raked in a combined $2.6 million in the same time period.

Biederman, Spencer and Wilens are major proponents for the validity of the bogus “Adult ADHD” diagnosis, with claims that over 4% of the population in the US has it.

Moving right along, Dr Jeffrey Bostic, Assistant Clinical Professor of Psychiatry at Harvard Medical School, and the medical director of the Massachusetts Child Psychiatry Access Project at Massachusetts General, became the “star spokesman” for Forest Labs in the promotion of Celexa and Lexapro for unapproved uses with children from 1999 through 2006, according to a lawsuit filed in February 2009, by the US Department of Justice, charging the company with defrauding the government of millions of dollars by illegally marketing the drugs off-label for kids.

Between 2000 and 2006, “Forest paid Bostic over $750,000 in honoraria for his presentations on Celexa and Lexapro,” the complaint reports. Bostic gave more than 350 Forest-sponsored talks and presentations in 28 states, many of which addressed the pediatric use of Celexa and Lexapro.

On March 13, 2009, Bloomberg News reported that, “Harvard Medical School doctor Lee Simon, accused last year of plagiarizing a scientific article on immune disease, has resigned.”

On April 10, 2009, the Wall Street Journal health blog announced: “More news on the research-fabrication front.” Robert Fogel, “a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients, the Office of Research Integrity at HHS said,” the Journal noted.

Fogel “has been disciplined by the U.S. Department of Health and Human Services for falsifying as much as half of the data he used for a Harvard study on sleep apnea in morbidly obese patients,” the Harvard Crimson reported on April 9, 2009.

In March 2009, as part of the Senate Finance Committee investigation, Senator Charles Grassley asked Pfizer to provide details of its payments to roughly 150 faculty members at Harvard Medical School since January 2007.

Disease Mongering in the Media

In an April 11, 2006, paper in PLoS Medicine, Steven Woloshin and Lisa Schwartz of Dartmouth, point out that discussions “about disease mongering usually focus on the role of pharmaceutical companies—how they promote disease and their products through “disease awareness” campaigns and direct-to-consumer drug advertising, and by funding disease advocacy groups.”

“But diseases also get promoted in another way,” they note, “through the news media.”

“Unless journalists approach stories about new diseases skeptically and look out for disease mongering by the pharmaceutical industry, pharmaceutical consultants, and advocacy groups,” they warn, “journalists, too, may end up selling sickness.”

Journalists “should be very wary when confronted with a new or expanded disease affecting large numbers of people,” they said, in words certainly applicable to the Mothers Act disease mongering campaign.

“If a disease is common and very bothersome, it is hard to believe that no one would have noticed it before,” they aptly point out.

“Prevalence estimates are easy to exaggerate by broadening the definition of disease,” they advise.

“Journalists should also reflexively question whether more diagnosis is always a good thing,” they said. “Simply labeling people with disease has negative consequences.”

“Similarly, journalists should question the assumption that treatment always makes sense,” they state. “Medical treatments always involve trade-offs; people with mild symptoms have little to gain, and treatment may end up causing more harm than good.”

“Finally,” the authors note, “instead of extreme, unrepresentative anecdotes about miracle cures, journalists should help readers understand how well the treatment works (e.g., what is the chance that I will feel better if I take the medicine versus if I do not?) and what problems it might cause.”

“Sick people stand to benefit from treatment, but healthy people may only get hurt: they get labeled “sick,” may become anxious about their condition, and, if they are treated, may experience side effects that overwhelm any potential benefit,” they point out.

However, relaying any information in the media contrary to the propaganda pumped out by the rabid disease mongers running the Mothers Act campaign has proven to be easier said than done.

Time Magazine Blasted

In July, 2009, Time Magazine published a great article by Catherine Elton titled, “Postpartum Depression: Do All Moms Need Screening?”

Elton reported that “the Melanie Blocker-Stokes Postpartum Depression Research and Care Act, familiarly known as the Mothers Act, has passed the House and is headed for the Senate.”

“If it becomes law, it will mandate the funding of research, education and public-service announcements about postpartum depression (PPD) along with services for women who have it,” she explained.

In the article, Elton accurately reported the arguments put forth by people for and against the Act, and summarized the story of the Malanie Blocker-Stokes, the woman the bill is named after.

“The legislation has sparked surprisingly heated debate, dividing psychologists and spurring a war of petition drives aimed at either bolstering the bill or blocking its passage,” Elton pointed out.

“At the root of the dissent is the issue of screening,” she noted. “Does PPD screening identify cases of real depression or simply contribute to the potentially dangerous medicalization of motherhood?”

“Although the current version of the Mothers Act does not specifically include funding for PPD testing, an earlier one did (it was based on a New Jersey law that mandates universal PPD screening), and critics say the new act will naturally lead to greater use of screening if it passes,” she correctly reported

“Opponents of the bill contend that mental-health screens are notoriously prone to giving false positives — research suggests that as few as one-third of women flagged by a PPD screen actually have the condition — and say testing is a gambit by pharmaceutical companies to sell more drugs,” Elton accurately pointed out.

“But clinicians and researchers say screening is intended not as a diagnostic tool but as a way to identify patients who need further evaluation,” she said. “Studies suggest that PPD affects as many as 1 out of 7 mothers and that failing to treat it exposes women and their babies to unwarranted risk.”

“Postpartum depression is not a benign, uncommon thing. We screen all infants for [the genetic disorder] phenylketonuria, which is extremely rare. Why don’t we screen women for this?” asked University of Pittsburgh Medical Center psychiatrist Katherine Wisner, in the article.

“Why?” Elton wrote. “Because increased screening could lead to an increase in mothers being prescribed psychiatric medication unnecessarily.”

“That concern lies close to the heart of Amy Philo, 31, of Texas, who has become a leader of the anti–Mothers Act movement,” she reported.

“In 2004, shortly after her first son was born, he choked on his vomit and needed emergency treatment,” the article explained.

“Her son recovered, but after the incident, Philo became preoccupied with his safety and felt severe anxiety about protecting him — a common symptom of PPD.”

“After a one-minute conversation with my doctor,” Amy told Time, “he gave me Zoloft and said it would make me and my baby happy.”

“But Philo says she started having suicidal and homicidal thoughts, which got stronger when another doctor raised her dosage,” Elton wrote.

However, Amy explains that Zoloft caused problems that never existed, it did not “make them worse.”

The drug caused me to turn from “a worried mother after my son almost died in the ER, into a psychotic, homicidal, suicidal person,” she says, and it got worse when the dose was upped.

Eventually, Amy “weaned herself off the drug, and her violent feelings disappeared,” Time noted.

“What TIME failed to disclose is that Dr. Wisner is listed on the speakers bureau for Pfizer and Lilly, makers of the antidepressants, Zoloft and Prozac–drugs that carry Black Box label warnings about increased risks of suicide,” Vera Hassner Sharav, president of the Alliance for Human Research Protection, pointed out in a June 15, 2009, infomail to the group’s mailing list.

“Doctors who serve on pharmaceutical speaker’s bureaus give “promotional talks” on behalf of the company that pays them–the service they render for pay is to advertise drugs to other doctors–despite the confirmed evidence of these drugs serious hazards,” she explains.

Wisner is a main promoter of mandatory screening of new mothers for mental disorders. In a December 2006 editorial in the Journal of the American Medical Association, Wisner recommended “that the United States take steps to implement a universal screening program, in which all women are screened between two- and 12-weeks postpartum,” her University reported in a December 5, 2006, disease mongering press release titled, “JAMA Editorial Notes Childbearing Presents Unique Vulnerability for Psychiatric Illness, Making Effective Screening, Education and Treatment Essential.”

“Those presenting with symptoms of a psychiatric disorder should be treated immediately after diagnosis,” Dr Wisner said in the news release.

Five months before her editorial called for “universal screening,” Medical News Today ran the headline: “Commonly Used Anti-depressants Safe And Effective For Treating Postpartum Depression,” on August 5, 2006, for a study led by Wisner in the Journal of Clinical Psychopharmacology.

The Alliance for Human Research Protection is one of more than 50 advocacy groups in a coalition, organized by Amy Philo, that have come out against the Mothers Act. Other prominent members of the coalition include: AbleChild, the Citizens Commission on Human Rights, International Center for the Study of Psychiatry and Psychology; International Coalition For Drug Awareness; Law Project for Psychiatric Rights; and Mindfreedom International.

Amy Liked It

“Catherine Elton did a fantastic job of showing both sides in a fair light,” Amy wrote about the Time article in a blog on her website.

“She tells the truth about the treatment given to Melanie Stokes, about my experience with Zoloft, and about screening,” she pointed out.

“People who would otherwise never think twice if their doctor hands them a prescription for psych drugs will see this article and perhaps be saved because of it,” she noted.

“But this does not sit well with people who make a living marketing disorders to the public,” Amy wrote.

Plan of Attack

Likely unbeknownst to even Amy, a well-orchestrated plan of attack against Elton, Time Magazine, and Amy herself, was already well underway.

On July 12, 2009, Lauren Hale sprung into action on her website with the headline: “TIME Magazine misfires debate on MOTHER’S Act.”

Hale went so far as to give women specific instructions to make sure the Time article was not read, and wrote: “I am personally asking you to boycott – even asking if you can take the copy of TIME home from the doctor’s office in order to keep other moms from reading it!”

“And make sure you ASK – because just taking it would be stealing and that’s illegal,” she added.

“I happen to know that Ms. Elton did indeed interview fellow survivors who support the bill,” Hale informed readers of her website.

“One has to wonder then,” she said, “why did their stories not make it into the article? Was it length? Was it editing? Or was it intentional?”

“The only survivor story featured in this article is that of Amy Philo,” Hale wrote, “one of five recipients of an Outstanding Achievement for Mothers’ and Children’s Rights awards from the Citizens Commision on Human Rights or CCHR.”

“CCHR was founded in 1969 by none other than the Church of Scientology, well-known to oppose the entire psychiatric field,” she continued. On July 13, 2009, Amy responded to Hale in a blog on the Hale’s website with the following comments:

“Actually Lauren, I was one of five women to receive a group award called “Outstanding Achievement for Mothers’ and Children’s Rights.”

“The other women include two who lost children to antidepressants and ADHD medications, and two who were targeted by schools and CPS for refusing to allow their children to be drugged with antidepressants and ADHD meds.”

“I am by far the least of these women, but thanks for bringing up my award,” Amy said. “I was honored to be recognized by an amazing mental health watchdog group.”

“I am not a member of CCHR, but I have zero problem with their group,” she continued. “Their membership includes both Scientologists and non-Scientologists.”

“I think it’s hilarious that you choose to bring up Scientology,” Amy said. “Especially considering that many of your friends received awards from drug companies.”

On July 13, 2009, on Postpartum Progress, Katherine Stone ran the headline, “Time Magazine Skips the Facts about Postpartum Depression,” and wrote in part: “Time completely blew it.”

“The editors should really be ashamed of themselves for allowing an article on a topic that they clearly knew so little about to be published,” she stated.

Katherine concluded her blog by telling readers: “If you haven’t already written to them to express your displeasure, you should,” and conveniently provided a live link to send a letter to Time.

“If you’d like to send me your letter I will be happy to share it on Postpartum Progress,” she kindly told letter writers.

Katherine would in fact go on to post a total of 6 such letters (at last count), on PostPartum Progress over the next couple weeks.

On July 15, 2009, Hale reported on her website: “I fired off a letter to TIME over the weekend.”

“Katherine Stone has graciously published the full text over at her blog, Postpartum Progress,” she told readers, and “graciously” provided a link to her letter on Katherine’s site.

On July 15, 2009, Katherine also posted “A Mother’s Letter to Time Magazine,” from a women named Kim Rogers.

“For every Amy Philo, there are 100 women who support and understand the importance of the MOTHERS Act,” Kim wrote.”I was very disappointed to not even see one of them represented.”

On July 15, 2009, Medical News Today highlighted the discussion in the Time article with a report under the headline: “Bill Fuels Debate Over Universal Screening For Postpartum Depression.”

The next day, Hale posted a response on the Medical News website with a heading: “Over 50+ Women’s Advocates And Professionals Disappointed In TIME Article.”

“When the TIME article, “The Melancholy of Motherhood” was first published online, myself and several others immediately rallied to send TIME a letter to point out many of the article’s shortcomings,” she said.

“This letter, authored by none other than Katherine Stone of Postpartum Progress, advises TIME of several mistakes and oversights within the article,” she reported.

“All of us were deeply disheartened by the lack of information and one-sided presentation of this debate by TIME Magazine,” she continued.

“I am even further disappointed,” Hale said, “to read an even more lacking rehash of an already inaccurate article here at Medical News Today, a normally reliable resource.”

“I sincerely hope readers of this article will also choose to click the following URL to read our Open Letter to TIME in order to obtain further facts and information regarding the MOTHER’S Act and the TIME article,” she wrote, above a link to Postpartum Progress.

For starters, Katherine’s letter shows only 47 signatures. And of those, eleven women are listed with books to sell. Fifteen are hooked in with Postpartum Support International, as a past or current office holder, coordinator, or chairperson of affiliated groups, and many run websites or support groups

Only four names among the 47 signatures are listed as simply being a mother.

After Katherine posted the open letter to Time on Postpartum Progress, replies to it included one by a John Smith, who stated: “You know Time is abjectly derelict in its duty when it offers, as the “opposing side,” a person who seems to be an obvious Scientology sympathizer, Amy Philo.”

“Did they do no research at all? Do they not understand the importance of vetting sources?” Smith wrote.

“Do they not realize that mentally ill people don’t always have a grip on reality?” he stated, in an obvious dig against Amy, without mentioning that Amy was not mentally ill prior to taking Zoloft, after being screened by a home visiting nurse who told her take drugs to “prevent” PPD.

Internet Battle Breaks Out

On July 13, 2009, with a headline that read, “Motherhood is Not a Medical Disorder,” Dr Douglas Bremner discussed the Time article on a website called the “Drug and Health Safety News Blog.”

Bremner is a professor of psychiatry and radiology at Emory University, the director of the Emory Clinical Neuroscience Research Unit, and the director of Mental Health Research at the Atlanta VA Medical Center. He also wrote the not too Pharma friendly book titled, “Before You Take That Pill: Why the Drug Industry May Be Bad for Your Health.”

In discussing the Time article, Bremner pointed out that the Mother’s Act legislation was “initiated in response to the story of Melanie Blocker-Stokes, who leaped to her death from her hotel room in Chicago three months after the birth of her daughter.”

“Officially known as the Melanie Blocker-Stokes Post Partum Depression Research and Care Act, but referred to as the Mother’s Act, this legislation would require screening of all women post-partum for depression,” he wrote, and further explained:

“The problem with this is the attitude that being a mother is a risk factor for a psychiatric disorder. First of all, there is no evidence that women without a prior history of anxiety and depression have any increased risk of getting post partum depression. So to screen all moms as if giving birth is a risk factor for depression is ridiculous.”

“And whenever you start screening the general population,” he warned, “you get into problems with over-identification of people and an increase in the number of people that go on antidepressants.”

“I am opposed to mandatory screenings of the population, like Teenscreen, which are bonanzas for the pharmaceutical industry, but a major intrusion into the privacy and autonomy of American citizens,” Bremner said.

“In the case of Melanie Blocker-Stokes,” he wrote, “she had already been treated with multiple courses of psychotropic drugs and electro-convulsive therapy, so there is no reason to think that her life would have been saved by ‘screening'”.

On July 14, 2009, psychologist, John Grohol, took Bremner to task on the website, PsychCentral, with the headline: “Bremner’s False Claims about Postpartum Depression.”

“My BS alert goes off whenever someone tries to change the argument from a reasonable effort to help increase education and information about a stigmatized mental health issue, to hyperbole, suggesting that a piece of legislation is trying to turn motherhood into a psychiatric disorder,” Grohol reported.

“It goes off again,” he said, “when a professional makes an extraordinary claim like, ‘there is no evidence that women without a prior history of anxiety and depression have any increased risk of getting post partum [sic] depression.’”

“These are objective researchers calling for more screenings,” Grohol claimed. “Not politicians. And not people (or professionals) with a political agenda.”

The Mothers Act disease mongers will often initiate debates about topics like the Time article but then censor the comments of bloggers who try to post contrary views. When Bremner was blocked from responding to Grohol’s comments on PsychCentral, Bremner opened up the debate on his own site and stated: “Motherhood is STILL Not a Medical Disorder: Response to Critics.”

An all-out blogging war then erupted on the competing websites. On July 14, 2009, a guy named Frank Lee wrote on PsychCentral: “As far as I can tell, the ringleaders of the anti-Mothers Act movement are the anti-psychiatry, anti-medication, anti-the-brain-is-an-organ crowd.”

“Legitimate researchers and mental health experts may regard them as “Internet nutters,” in the words of one highly published psychiatrist,” he claimed. “Their views may sound so ridiculous to educated (and sane) people that they are dismissed outright.”

“But, unfortunately,” he noted, “they have a lot of time on their hands, and they gather force on the Internet and make their voices known — and LOUDLY.”

“The fact is,” Lee said, “a significant percentage of the American population has untreated mental disorders.”

“But many of them have been treated — and treated hamhandedly by ignorant physicians,” he added. ‘These former patients are angry — and LOUD.”

“Some, no doubt, blame their current disordered mental state on medication when in fact it is the natural progression of their disorder,” Lee said.

“Some are simply so selfish they will deprive others of the chance for medical care simply because treatment for theirs didn’t work out so well,” he wrote. “Selfish. Selfish. Selfish.”

“But that’s the way many mental disorders are — selfish,” Lee added.

“We need to recognize these people as the sick minds that they are,” he said, “or all progress is lost.”

“It’s a SCREENING, you wingnuts,” Lee announced.

“Learn to read,” he told the wingnuts. “And take your medication. And shut up.”

In writing on Bremner’s site, Gina Pera, who has a book to hawk on Adult ADHD, also basically claimed that statements and opinions about the Mothers Act, by Amy and people like her, should be ignored because these people are mentally ill.

“We cannot make public-policy decisions based on the stories of people who have been diagnosed with mental health disorders and treated for them,” she wrote.

“Sorry, but it’s true,” she added.

“Many mental health disorders limit objectivity,” Pera states, “so these people are just not the best judges of what has been done to them and why.”

“They can have their stories and they can share them,” she said. “But we can’t make policy on this kind of hearsay and paranoia.”

On PsychCentral, the mental health expert Pera further explained: “To those who contend that the mentally ill always know they are mentally ill, that flies entirely in the face of all that we know about anosognosia and the denial of illness.”

“Mental illness can — and often does — limit accurate perception of self and others,” she said. “It’s just a fact.”

In a July 15, 2009, post on PsychCentral, John Smith jumped on the bandwagon and wrote: “These bloggers who pander to the Scientology crowd (and their mentally ill ilk) are simply seeking the spotlight, in my opinion. Shameless self-promotion, at the expensive of accurate information.”

“They’re whipping up the hornets’ nest and taking no responsibility for their actions” he said. “Despicable.”

In a second blog posted immediately after the first, Smith said: “Check out Ms. Philo’s connection with the Scientology front’s ‘Natural News.'”

“As if it’s not obvious she’s mentally unstable,” he wrote.

“The idea that Time magazine would give her a platform is ridiculous, as if she represents the “other side” of the issue,” Smith said. “She sings straight from the Scientology songbook: off-key.”

After allowing all the attacks to be posted on his site about Amy, when Amy posted truthful information such as Katherine Stone being a paid speaker with money from Zoloft maker Pfizer, Grohol wrote a blog basically warning Amy to knock it off or she would not be allowed to post comments on his site.

“We don’t allow ad hominem or personal attacks here,” he said, “So I suggest that if you want to engage in such, you go elsewhere for your enjoyment.”

It was at this point that Evelyn Pringle (me) felt compelled to enter the debate and wrote: “This from a someone who has allowed people to posted snide remarks and inuendoes to discredit Amy, or anyone else with an opposing view, who has been diagnosed with a mental disorder, rightfully or wrongfully, all over the internet, including here.”

“These people verify everything I have warned about in my articles,” she said. “Once a woman is tagged with a mental illness diagnosis via the Mothers Act, she will lose all credibility for life.”

“In the Mothers Act disease mongering campaign we now have social workers, running treatment centers with websites, diagnosing mental disorders, with 2 and 3 question screening tools, and advising women on which drugs they recommend,” Pringle wrote on PsychCentral on July 16, 2009.

“It’s hard enough to accept that the nation’s mental health is gauged on disorders defined by a single 38,000 member psychiatric professional group,” she said, “delegating the treatment of mental illness to social workers, with a doctor signing off on the diagnosis for billing purposes, is not acceptable.”

Pringle’s comments were also soon blocked on Grohol’s website.

But on July 20, 2009, she wrote on Bremner’s website: “I think every blogger who brings up Scientology should identify their religious faith for the record.”

“As I’ve said many times, I am not a fan of any organized religion, and disagree with the practices of many, but I fail to see what religious beliefs have to do with opposing the Mothers Act legislation,” she wrote.

“For instance,” she said, “I always thought it was ridiculous that Catholics were not allowed to eat meat on Fridays (when I was young), get divorced, or use birth control (to name a few).”

“However, being my father was a firm believer in the Catholic religion, I never felt the need to belittle his faith,” she wrote. “I simply decided not to be a Catholic when I grew up.”

“Nor do I feel the need to preface peoples’ name with their religion in a low-ball attempt to win a debate,” Pringle said.

“I disagree with the beliefs of many other religions but who am I to say which one of the world’s millions of religions is correct,” she added.

“Trying to use Scientology as a smoke-screen is really getting old,” Pringle said. “Anyone who is a member of an organized religion should be required to identify that affiliation if they want to make Scientology an issue in this debate.”

On July 22, 2009, a blogger on Bremner’s site named Lisa wrote: “Dr. Bremner, just my opinion, but I suspect the reason you riled Dr. Grohol has to do with the fact that he can’t very well blame your opposition to the Mother’s Act on Scientology or Anti-psychiatry.”

“I wish the debate over this bill didn’t have to devolve into that,” she said. “It’s so tiring.”

Grohol’s Internet One-stop

As noted previously in this series, Grohol, the guy supporting “objective researchers calling for more screening,” is operating a profitable one-stop treatment center on the internet with PsychCentral, where people can get therapy from “live” online “experts” 24 hours a day, 7 days a week, as well as coupons for free samples of psychiatric drugs, with instructions on what to discuss during doctors appointments.

Grohol’s one-stop even provides links to quizzes for people to self-screen not only for depression, but for Adult ADHD, anxiety, OCD, PSTD, schizophrenia, bipolar disorder, and just about every other so-called mental disorder known to mankind.

One helpful link takes potential customers to the: “Do I Need Therapy? Quiz”.

A weekly chat with a PsychCentral therapist would cost a mom who screens positive for PPD roughly $120 per hour, billed at $2 per minute, or $6,240 a year.

The Abilify advertised on PsychCentral, to treat depression as an add-on with antidepressants, was recently priced at $1,230 on DrugStore.com. Add Cymbalta, one of the antidepressants Grohol promotes with another ad, complete with a voucher for a free sample, at a cost of $390 a month, and a woman is looking at a yearly tab of $19,440, bringing the combined drug and therapy total to $25,680.

And God forbid, if mom and dad both screen positive, the cost of treatment could double to $51,360. As a psychologist, Grohol can not write prescriptions, and neither can his online “therapists,” so this amount would not include the fees for office calls to the prescribing physician.

However, before heading over to Gohol’s one-stop, perhaps postpartum couples may want to see if a new car could pull them out of their funk. On the “Car Connection” website, the starting price for a brand new 2009 Kia Rio is only $11,495, and the 2009 Honda Fit is listed at $14,750, bringing the total cost to only $26,248 for two vehicles.

If the new cars don’t do the trick, the parents would still have $25,112 left over to spend on a half year of treatment at PsychCentral, based on the estimated costs for drugs and therapy found on the website.

Also, a quick search of the internet turned up a website called, “Live Psychic Readings,” supposedly featured on “Good Morning America,” that only charges $1 per minute, with a toll free number. And better yet, another site with the heading, “The Honest Psychics,” only charges a buck for 10 minutes.

Grohol also allowed Katherine to post a link on PsychCentral to a petition for people to sign in support of the Mothers Act, a process funded by the “Depression and Bipolar Support Alliance,” a Big Pharma front group that serves as a funnel of drug company money to finance disease mongering campaigns.

The DBSA’s 2007 annual report shows the group received between $150,000 and $499,000 from AstraZeneca, Pfizer and Wyeth, and between $10,000 and $149,000 from Abbott, Cyberonics, Forest, Glaxo, Organon, and Otsuka American Pharmaceuticals. DBSA also received $37,510 from Eli Lilly in 2007, and another $20,000 from Lilly in 2008.

Lilly’s first quarter grant report for 2009 shows a $5,000 donation to the DBSA. The Rhode Island chapter of the group also received $7,500 from Lilly in the first quarter of 2009.

Overpathologising Motherhood

In the title of a paper in the May, 2009, Journal of Affective Disorders, Stephen Matthey, of the University of Sydney Infant, Child & Adolescent Mental Health Service Research Unit in Australia, asks, “Are we overpathologising motherhood?”

The paper was critical of self-report screening measures such as the Edinburgh Depression Scale for overestimating the rate of psychiatric disorders in motherhood. “The properties of the Edinburgh Scale show that around 50% of women scoring high are not in fact depressed,” the paper’s abstract reports.

The paper was further critical of the high percentage of women being screened as ‘at-risk’. Classifying women to be ‘at-risk’ based upon “the presence of a single risk factor is questionable given that the majority of women with risks do not become depressed, and also the rate of women reported to have at least one risk (up to 88%) is so high as to negate the usefulness of this concept,” the abstract warns.

Matthey also questioned the use of the diagnostic criteria for depression in the DSM IV, such as weight loss, sleep problems and fatigue, which could easily be attributed to new parenthood rather than depression.

“Current estimates of the prevalence of perinatal distress, and of women with risks, are an overestimation of the true rates,” the abstract concludes.

“The clinical practice of using the presence of a single risk factor, or a single high score on a self-report mood scale, to form part of the assessment to determine whether or not to actively intervene may also overpathologise the situation,” Matthey warns.

“A more thorough understanding of these issues will improve our assessment procedures so that resources can be appropriately targeted to those women, and their families, who really need specialist mental health intervention,” he points out.

With the above paper in mind, consider the posting on Postpartum Progress by Katherine on July 29, 2009, of: “A Nurse/Mother’s Letter to Time Magazine: Alison Palmer.”

In the letter to the editors, Palmer described herself as, “a maternal-newborn clinical nurse specialist, coordinator of a Postpartum Emotional Support Program, and most importantly as a mother.”

It sounds like she works at the Maternity Center at Elliot Hospital in Manchester, New Hampshire, which “does about 2200 births per year,” according to the letter.

“Postpartum depression or other mood and anxiety disorders occur at least 20% of the time, and can occur anytime in the first year after birth,” Palmer claims in the letter.

“Our organization recently implemented an Inpatient Postpartum Depression Risk Assessment,” Palmer told the editors.

“An 11-item questionnaire is distributed to EVERY new mother who delivers, and screens them into a risk category for developing PPD,” she wrote.

“This screening tool identifies risk factors and does not indicate that a woman will definitely experience PPD,” she said.

“Just like someone who smokes, is obese, has high blood pressure and a family history of cardiac disease is at higher risk for a heart attack, these PPD risk factors simply indicate that one might be at a higher risk for the illness,” Palmer explained to Time editors.

“In our first month of screening, we had patients screen out as 46% low risk, 21% moderate risk, 30.5% high risk and 2.5% immediate risk,” she reported.

“More than HALF of all of the new mothers who delivered had some increased risk for PPD,” Palmer added.

“The “at-risk” moms view a PPD video, receive more in-depth PPD education, get follow up phone calls at home, are offered Visiting Nurse visits and are invited to attend weekly New Moms Groups and the Postpartum Depression Support Group,” she told Time.

After reading the above information, on July 29, 2009, Amy posted a blog to Nurse Palmer on Postpartum Progress and asked: “Did the program refer the low risk women for further evaluation? Is low-risk considered at risk?”

“In the risk assessment survey, the mother needs to answer “NO” to ALL 11 items in order to be scored as “LOW” risk,” Palmer wrote back to Amy, demonstrating that no mother will ever escape this dragnet.

“I always tell people there is no such thing as “NO RISK”, since simply giving birth puts a woman at risk due to the hormone and biological changes that occur,” she explained.

“Even answering “yes” to one item on the survey puts mom in a “moderate risk” category,” Palmer claimed.

“Women who score low risk still have routine PPD teaching done by the RNs,” she told Amy. “They just don’t have the follow up by VNA and phone calls.”

“Interesting,” Amy wrote back to Palmer. “I myself was told I needed drugs because of my high risk for PPD.”

“I was later told by a pediatrician, lactation consultant and OBGYN that perhaps I should consider staying on drugs permanently even during pregnancy or not having any more kids because of my high risk of having PPD again after the birth of any subsequent children,” she explained further.

“I had no problems at all after the birth of Toby,” Amy said. “I am thankful I did not listen to them.”

Nurse Palmer compares the use of “risk factors” to diagnose women with mental disorders to the use of risk factors for other diseases. In June 2005, the Seattle Times published a series of reports including one titled, “Suddenly Sick,” by Susan Kelleher and Duff Wilson, with the byline: “The hidden big business behind your doctor’s diagnosis,” and discussed the successful trick of using “risk factors” in past drug marketing campaigns.

“You are suddenly sick,” the authors wrote, “simply because the definitions of disease have changed.” And behind those changes, the Times found, were “the companies that make all those newly prescribed pills.”

The authors noted that “Dartmouth Medical School researchers estimate that during the 1990s, tens of millions more Americans were classified as having hypertension, high cholesterol, diabetes or obesity simply because the definitions of those diseases were changed.”

“The medical profession’s term for these people is ‘the worried well,'” the authors said. “They are otherwise healthy people who have risk factors, such as high blood pressure or high cholesterol, but may never suffer a heart attack or stroke.”

“Every time the boundary of a disease is expanded — the hypertension threshold is lowered by 10 blood-pressure points, the guideline for obesity is lowered by 5 pounds,” they pointed out, “the market for drugs expands by millions of consumers and billions of dollars.” The results, they wrote:

“Skyrocketing sales of prescription drugs. Soaring health-care costs. Escalating patient anxiety. Worst of all, millions of people taking drugs that may carry a greater risk than the underlying condition. The treatment, in fact, may make them sick or even kill them.”

“Pharmaceutical firms have commandeered the process by which diseases are defined,” the Times found. “Many decision makers at the World Health Organization, the U.S. National Institutes of Health and some of America’s most prestigious medical societies take money from the drug companies and then promote the industry’s agenda,” the authors reported.

“Treatment guidelines established by international and national health organizations instruct physicians on diagnosis and treatment of disease and are meant to be scientifically pristine,” they said. But the Times found that for a broad spectrum of diseases, “the experts writing the treatment guidelines had drug-company ties ranging from research contracts to consultancies to stock ownership.”

Attack on Vogue Magazine Journalist

On April 29, 2009, Hale used her website to “refute” some of the top experts in the field, quoted by Alexis Jetter, in an article in the May issue of Vogue Magazine titled, “Pregnant Pause,” which warned that: “With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines.”

“What alarms doctors is the sheer number of pregnant women who use SSRI antidepressants – perhaps as many as 250,000 in the U.S. each year – when we still know so little about how the drugs effect babies,” Jetter reported.

The number of pregnant women on SSRIs has apparently skyrocked over the past three years. Back in 2006, the American Medical Association gave an estimate “that over 1% of pregnant women in the U.S., or more than 40,000, are taking antidepressants,” the Wall Street Journal reported in July 2006.

“SSRI usage dramatically increases the chances that a baby may be miscarried, born prematurely or too small, suffer erratic heartbeats, and have trouble breathing,” Jetter points out in Vogue.

In response to the article, Hale wrote a commentary titled, “Thoughts on exploring a “Pregnancy Pause,” and sent it to Vogue. “I methodically refuted and balanced the article’s bias against medicating with anti-depressants during pregnancy,” she wrote, when publishing the letter in full on her website.

On May 6, 2009, Katherine posted a link to Hale’s site with the headline, “Hale Responds to Vogue Piece on Antidepressants in Pregnancy,” and Kleiman provided a link on her treatment center website, telling readers: “Please take the time to read her very thoughtful and well-researched post.”

Upon reading the commentary, anyone with knowledge on this topic would have a hard time believing that the human face, Hale, did the “methodical refuting” all on her own.

In the Vogue article, Jetter explains that serotonin, “the neurotransmitter that helps regulate mood, also sends crucial developmental signals to the fetal heart, lung, and brain.”

“Some scientists think that SSRIs, which prevent the body’s natural absorption of serotonin, could be tampering with essential cell growth,” she reports.

“Never before in human history have we artificially changed the architecture of brain development,” said Feng Zhou, PhD, of the Indiana University School of Medicine, in the Vogue article.

“We always predicted that developmental exposure to these drugs would have some deleterious effects,” Jean Lauder, PhD, of the University of North Carolina School of Medicine, told Jetter. “But no one was listening back then.”

Jetter also cites warnings by Dr Adam Urato, the guy who alerted JAMA to the undisclosed financial conflicts of interest among the authors of the Cohen Relapse in Depression study, and assistant professor of Maternal-Fetal Medicine at Tufts University School of Medicine, stating:

“Women and their providers have been told that even mild depression or anxiety will hurt their baby …. And these antidepressants are portrayed almost like prenatal vitamins that will level out their mood and lead to a healthier baby.”

“But antidepressants have not been shown to decrease rates of miscarriage or birth defects or low birth weight. On the contrary, they’ve been show to increase those problems.”

“On top of that,” argues Urato, “only one voice is reaching the ears of most women’s health practitioners: that of a small coterie of influential doctors who he says underplay the dangers of antidepressants,” Jetter reported.

“Many of these physicians have accepted lucrative speaking fees and consulting contracts from drug companies,” she wrote. “And yet – sometimes without divulging those connections – these same doctors are shaping treatment guidelines.”

True to form, in her commentary, Hale referred to work by the industry shill Wisner. In fact, the Mothers Act disease mongers repeatedly tout papers by Wisner without disclosing her financial ties to the drug makers.

For instance, Hale’s headline for a March 28, 2009, blog read: “The Confusion of Ante-Partum Depression: To Medicate or Not?”

“Ante-Partum Depression” being another newly coined buzz term for depression during pregnancy, a disorder not listed in the DSM.

In her blog, Hale reported that: “A recent study by Dr. Katherine Wisner … found that continuous exposure to either SSRI or Depression during pregnancy results in pre-term delivery rates in excess of twenty percent while mothers with no exposure to either depression or SSRI over the course of their pregnancy experienced rates of pre-term delivery at six percent or lower.”

The actual study titled, “Major depression and antidepressant treatment: impact on pregnancy and neonatal outcomes,” was published in the March 2009, AJP. And the researchers in fact found women exposed to continuous treatment with SSRIs had an increased risk for preterm birth of 23%, and women with continuous depression but no SSRIs had a lower increased risk of 21%, compared to a 6% rate for women with no depression and no SSRIs.

However, women reading spinmaster Hale’s summary of the results were told “the pre-term delivery rates were the same with depression exclusive of SSRI treatment.”

“So what’s a pregnant depressed mama to do?”, Hale wrote on her website.

“I read,” she stated. “Voraciously.”

“The two biggest sources of help for me,” she said, “were Karen Kleiman’s What Am I Thinking? Having a Baby After Postpartum Depression and Kornstein/Clayton’s Women’s Mental Health.”

“Karen’s book allowed me to realize my emotions were right on target for a woman facing pregnancy (expected or not) after surviving a PMD episode while Women’s Mental Health laid out the risk factors in a no-nonsense manner,” she wrote.

“I was convinced to stay on medication,” Hales said, “after I read my risk for relapse went up by 50% if I discontinued my medication during pregnancy.”

“With my risk factor already 50% higher than women having never experienced a PMD, there was no way I was giving myself a 100% risk of traveling down that road,” she wrote.

Kleiman’s book sells for about $19 on Amazon and Women’s Mental Health is listed for $85.

In a May 12, 2009, Postpartum Progress blog, Katherine made sure to promote the continued use of SSRIs by pregnant women in posting a sentence from an editorial in the AJP titled, “Assessing Risk and Benefit: To Treat or Not to Treat Major Depression During Pregnancy With Antidepressant Medication,” by Dr Barbara Parry, which states:

“Thus, all things considered, on the basis of the findings from the methodologically sound and rigorous study of Wisner et al. and the evidence available from long-term studies, this author thinks that the risk of untreated major depression outweighs the risk of effects of SSRI treatment on neonatal outcomes.”

As part of the campaign against Vogue, Hale published in full a letter sent to Vogue from Arienne Einarson, without disclosing Einarson’s drug industry ties or controversies surrounding Einarson’s Canadian program.

In a blog on Hale’s site, Einarson said of the Vogue article: “I am the author of the largest study on paxil(no drug company funding) published in a premier psychiatry journal and they certainly did not contact me. I WONDER WHY NOT?”

First off, maybe Einarson wasn’t contacted because she is a nurse and not a doctor. She is the Assistant Director of Clinical Services of the Motherisk program at Toronto’s Hospital for Sick Children, also known as SickKids, and works under Motherisk Director, Dr Gideon Koren.

And maybe it was because her often co-author, Dr Koren, was involved in one the biggest academic research scandals in history a few years back when he sent vicious letters to discredit fellow researchers and denied doing so until DNA evidence from postage stamps proved he was lying, years later. In September 2003, the Canadian Association of University Teachers reported in the CAUT Bulletin:

“The Ontario College of Physicians and Surgeons has formally reprimanded University of Toronto professor of medicine Dr. Gideon Koren. He had written anonymous harassing letters about Dr. Nancy Olivieri and three colleagues during Olivieri’s dispute with the Hospital for Sick Children, the University of Toronto and Apotex Inc. He then had lied repeatedly to conceal his responsibility. The college also cited him for additional misconduct, in research.”

“In its decision, the discipline committee said it was “deeply troubled by this case” and “seriously considered administering a more severe penalty” than that proposed to it, as it wished “to express unequivocally its condemnation of Dr. Koren’s misconduct.”

“It defies belief that an individual of Dr. Koren’s professed character and integrity could author such vicious diatribes against his colleagues as he did in the ‘poison pen letters’,” the committee wrote in its decision.

The committee described Koren’s actions as “childish, vindictive and dishonest” and noted that “only when confronted with irrefutable scientific evidence of his guilt did he admit he was the perpetrator” of the letter campaign. The Teachers Association further explained in the Bulletin:

“The college’s finding of research misconduct was in relation to a study on a drug to treat a blood disorder in children that Koren and Olivieri had once collaborated on. Olivieri identified risks that the drug was ineffective and caused liver damage, and voiced her concerns despite legal warnings from its maker, Apotex. Koren differed and, contrary to accepted norms, published an article on the drug using data from other researchers, including Olivieri, without their knowledge or consent.”

“The penalty had been jointly proposed to the college discipline committee through prior agreement between counsel for Koren and counsel for the college,” the Bulletin reported.

“The discipline committee did not have before it the facts that Koren had violated additional university and international norms of conduct in this publication,” it pointed out.

“Koren had received hundreds of thousands of dollars in funding from Apotex after the company had terminated the drug trials in its efforts to prevent Olivieri from disclosing risks to patients, as well as the hundreds of thousands of dollars in funding he had received during the trials,” the newsletter reported, citing an journal article by the authors of “The Olivieri Report.”

It should be noted that Apotex went on to market a generic version of Paxil, or paroxetine. In September 2005, the FDA issued a warning about possible birth defects associated with Paxil when the drug is taken during the first trimester of pregnancy.
The warning was based on one study that found about a 2% risk of heart defects in babies born to mothers who took Paxil in early pregnancy, compared with a 1% risk in the general population, and a second study that found the risk of heart defects was 1.5% in babies whose mothers took Paxil in the first three months, compared with 1 percent in babies whose mothers took other antidepressants in the first trimester.

In October 2005, Einarson put out a paper titled, “The safety of psychotropic drug use during pregnancy: a review.”

“This article reviews the various classes of psychotropic drugs that are commonly used to treat psychiatric disorders–antidepressants, benzodiazepines, antipsychotics, antiepileptics, lithium and monoamine oxidase (MAO) inhibitors–in terms of their safety during pregnancy,” the abstract on PubMed states.

“A substantial number of women of childbearing age are prescribed psychotropic drugs, and because nearly 50% of pregnancies are unplanned, many women are still taking them upon becoming pregnant,” Einarson points out.

“Evidence-based information from epidemiologic studies indicates that most psychotropic drugs are relatively safe for use during pregnancy,” the abstract states. A November 2005 abstract for another Einarson paper on PubMed states:

“A number of pregnant women suffer from psychiatric disorders that require treatment with psychotropic drugs. A literature review suggests that these medications are relatively safe to use during pregnancy. Abrupt discontinuation of these drugs can have both physiological and psychological ramifications, which include unpleasant physical symptoms and re-emergence of the psychiatric condition. Therefore, it is not good practice to discontinue these medications abruptly upon diagnosis of pregnancy.”

Here’s Einarson and Koren back in November 2005, still available on the Motherisk website, answering questions under the tab for “Pregnancy & Breastfeeding” with a heading: “Counseling pregnant women who are treated with paroxetine”.
One webpage says: “Motherisk questions are prepared by the Motherisk Team at the Hospital for Sick Children in Toronto, Ont.” In a November 2005 Special Supplement, the question was phrased as:

“I have always reassured my patients that taking an SSRI in pregnancy would not increase their risk for having a child with a major malformation. However, I recently read the warning from Health Canada regarding the release of a study from GSK, stating that infants exposed to paroxetine may be at a higher risk of congenital malformations, specifically cardiovascular defects. Some of my pregnant patients who are taking paroxetine (Paxil) heard about this information in the media and called me to ask if they should stop taking it. What should I tell them?”

Their answer was:

“The new warning is based on small non peer review, unpublished studies. It ignored 2 published studies that failed to show such association, and no such association has been shown for SSRI’s as a class. The data suggested that even if there is a risk, it is small. The warning does not disclose the details of the cardiovascular malformations in these studies. Many cases of ventricular septal defect, the most common cardiac malformation, resolve spontaneously. Concerned mothers to be should know that beyond the first trimester a drug cannot cause cardiac malformation. Failure to treat depression during pregnancy can have significant negative ramifications for both mother and child, and it is the strongest predictor of postpartum depression.”

In December 2005, the FDA instructed GlaxoSmithKline to reclassify Paxil from a Category C to D for pregnant women. A Category D warning means studies in pregnant women have demonstrated a risk to the fetus.

An advisory to “Neuropsychiatric and other healthcare professionals,” specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised:

“Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it.”

A little over a year ago, a study in the April 2008 American Journal of Psychiatry, reported an “Evaluation of the Risk of Congenital Cardiovascular Defects Associated With Use of Paroxetine During Pregnancy,” with authors that included Einarson and Koren.

The conclusion for the abstract stated: “Paroxetine does not appear to be associated with an increased risk of cardiovascular defects following use in early pregnancy, as the incidence in more than 3,000 infants was well within the population incidence of approximately 1%.”

The Winter 2009 issue of the Canadian Journal of Clinical Pharmacology published a paper by Einarson titled, “Risks/safety of psychotropic medication use during pregnancy–Motherisk Update 2008.” The abstract contains the standard talking points, and states in part:

“Psychiatric disorders are relatively common among women of childbearing age, who may be prescribed psychotropic drugs. There remains a high level of anxiety regarding their safety among patients and healthcare providers alike, most likely because of the conflicting studies that have been published in the literature and warnings from government organizations.”

“The body of evidence in the literature to date suggests that psychotropic drugs as a group are relatively safe to take during pregnancy and women and their health care providers should not be unduly concerned if a woman requires treatment,” the abstract concludes.

Koren and Einarson routinely fail to list financial ties to drug makers in their papers. The following disclosure was published in the November 2008 American Journal of Psychiatry as a correction to an article for which no disclosures were made:

“Dr. Koren and Ms. Einarson have received research support from Janssen-Ortho and Wyeth. Dr. Koren has received research support from Apotex, Duchesnay, Novartis, and Pfizer. Ms. Einarson has received unrestricted research grants from GlaxoSmithKline for studying ondansetron in pregnancy and from Organon for studying mirtazapine in pregnancy. Dr. Einarson has received research support from Bristol-Myers Squibb, Eli Lilly, Janssen-Ortho, Lundbeck, Novo Nordisk, and Organon.”

When reposting Einarson’s letter on her website, Hale states, “Adrienne currently serves as Coordinator for the International Reproductive Psychiatry group at Motherisk in Toronto.”

At the start of the letter to Vogue, Einarson writes: “I am writing to you on behalf of an international group of individuals who are involved with reproductive mental health, as either clinicians, researchers and in some cases both.”

“We would like to voice our concerns regarding your recent piece entitled “Pregnant Pause,” which we felt, did not achieve a balanced perspective on this issue, which was surprising to us, coming as it did from such a highly esteemed publication as Vogue,” she states.

Einarson makes claims on behalf of this group without identifying a single member by name. If these “International” groups exist, there is remarkably little information about it on the internet. A google search a couple months ago for “International Reproductive Psychiatry Group” brought up 2 hits – both to the comments above. A search for “North American Reproductive Psychiatry Group” had 2 hits – both to references made by Einarson at various times.

In her letter to Vogue, Einarson wrote: “Another disturbing theme that came up several times in the article, is that physicians hand out antidepressants like candy, and physicians in our group were most offended by this statement as they are very careful about prescribing antidepressants and would not give them to someone who not does not require treatment.”

Here she is likely referring to Dr Urato’s warnings and statements such as: “What alarms doctors is the sheer number of pregnant women who use SSRI antidepressants – perhaps as many as 250,000 in the U.S. each year – when we still know so little about how the drugs effect babies,” as Jetter reported.

In conclusion in her letter to Vogue, Einarson refers to her “International” group again, and states: “Finally, and I am sure this was not your intention, several of our group members who are psychiatrists have reported that their pregnant patients have decided to stop taking their antidepressant since they read your article,” she claims.

She then gives what she calls “one example of the damage you may have caused by this highly biased and often inaccurate article.”

“After reading this article, a woman called her psychiatrist and informed her that she was not going to take her Prozac anymore,” she told Vogue, in what can only be considered good news.

Disease Mongers Wage War on TV Series

In a February 2, 2009, headline on Postpartum Progress Katherine gleefully announced: “ABC’s “Private Practice” to Feature PPD Storyline”.

ABC Television Network’s “Private Practice” will feature a storyline related to postpartum depression on its February 12 episode, the blog reported.

“After the show, viewers will be directed to ABC’s website to see a public service announcement on postpartum depression that will link to Postpartum Support International,” Katherine wrote. “We don’t know any details about the episode because it’s top secret. I’ll definitely be tuning in.”

On February 11, 2009, Postpartum Progress told readers to: “Get Your DVRs and Your TV Dinners Ready,” and Katherine wrote: “Don’t forget this Thursday night (tomorrow) is the episode of Private Practice on ABC featuring a perinatal mood and anxiety disorder, and a link after the show to a new PSA on ABC.com.”

However, on February 13, 2009, the tone suddenly soured with Katherine posting the headline: “ABC Television Should Be ASHAMED of “Private Practice” Postpartum Psychosis Treatment”.

“I’m horrified that I encouraged you to watch what I thought would be a responsible storyline about postpartum depression on the ABC network television show “Private Practice,” she wrote.

“Never again,” she said, “will I tell the readers of Postpartum Progress to watch something that I haven’t already seen myself and can’t fully endorse.”

“Sorry I waited to write about this until now,” she continued, “but I was so spitting mad late last night I couldn’t calm down enough to type,”

“Last night’s episode was promoted, both to the public and to the members of Postpartum Support International, as one about postpartum depression,” she said, “but — surprise, surprise — it immediately devolved into a show about postpartum psychosis and a mom attempting to kill her child by holding her down under the water in the bathtub.”

“Every time the media, whether entertainment or news, chooses to cover perinatal mood and anxiety disorders,” Katherine claimed, “the portrayal is always of some out-of-control woman committing or attempting to commit infanticide.”

Katherine obviously could not accept that the show was not meant to be a pitch for the new cottage industry of “Reproductive Psychiatry,” or an extension of the disease mongering campaign for all the other “illnesses” in the “perinatal mood and anxiety disorder spectrum.” The plot rightfully remained focused on the rare occurrence of “postpartum psychosis.”

“We have to stand up at some point and let the media know the way they treat perinatal mood and anxiety disorders, and mental illness in general, is unacceptable,” Katherine wrote, to incite readers.

“Just as I stopped going to Tom Cruise movies,” she said, “I will not watch “Private Practice” ever again.”

“In fact,” she said, “I may stop watching my favorite ABC show “Grey’s Anatomy” and switch over to NBC which has equally compelling shows in the 9pm EST time slot (“The Office” and “30 Rock”).”

“I ask you to please join me to PULL THE PLUG ON PRIVATE PRACTICE,” Katherine told readers.

“I also encourage you to write about this on your own blogs and use the tag ‘Pull the Plug on Private Practice'”, she advised all the other disease mongers.

Katherine then went on to list “some other bloggers’ takes on this,” and included excerpts from a blog by Susan Stone, posted on the website for her treatment center, with a headline that said: “ABC’s Private (Mal)Practice Fails to Present the Facts In a Botched Opportunity to Raise PPD Awareness.”

Katherine also provided a link to a blog by Hale with a title, “ABC’s Private Practice Misses the Mark.”

On February 13, 2009, tag-team member, Hale, chimed in with the headline: “More irresponsibility from ABC regarding PMD’s,” and told visitors to her website: “A quick visit to Katherine Stone’s blog this morning got my juices revving again. And Susan Dowd Stone was not happy about the display either.”

As if anybody gives a rat’s butt about whether the two Stone broads are happy or not.

“Katherine is calling for a boycott of the show and I have to wholeheartedly agree,” Hale wrote.

“Pull the Plug on Private Practice and their sham of attempting to represent the medical world,” she said. “How dare they drop the ball on such a sensitive topic!”

“No voice will have a louder effect than a sudden drop in viewership because that means decrease in advertising and then well, if a show isn’t profitable anymore…….,” she wrote.

“Spread the word – and stop watching,” Hale told readers.

On February 15, 2009, Katherine announced: “Warrior Moms Pull the Plug on ABC’s ‘Private Practice'”.

“I’m so happy to hear from those of you who are choosing to stop watching “Private Practice” (and a lot of you quitting “Grey’s” too) or to speak out against ABC’s irresponsible portrayal of perinatal mood and anxiety disorders like postpartum depression, postpartum anxiety and postpartum psychosis,” she wrote in the blog.

“And my original post is also over on PsychCentral (thank you Dr. John Grohol for allowing me a little real estate on your amazing site),” she reported.

In fact, Grohol allowed Katherine to repost her entire rant in full on the PsychCentral.

In a reply on Grohol’s site, an “anonymous” commentator, calling himself a shrink, wrote: “As a psychiatrist, although I did not see this show, I have seen how TV and movies portray mental health issues, and the consensus is the majority overtypifies symptoms and issues, as mainstream illness is not “exciting” enough to warrant a show to titilate/wow audiences.”

“My advice,” the shrink said, “although wary to give it, is ask NAMI to get involved if they see it as a viable issue. They have the manpower to mobilize people.”

NAMI of course being another Big Pharma front group that serves as funnel of drug company money to fund disease mongering campaigns, called the “National Alliance on Mental Illness.” NAMI is listed as a main supporter of the Mothers Act on Susan Stone’s Perinatal Pro site, and was recently forced to admit that 56% of its funding since 2005, came from the pharmaceutical industry.

The February 15, 2009, headline on Postpartum Progress read: “In Their Own Words: Why They’ll Never Watch ABC’s “Private Practice” Again.”

“I wanted to share with all of you some of the commentary I received, so that you can see the kind of impact media, whether news or entertainment, has on vulnerable women,” Katherine wrote.

On February 17, 2009, she posted a headline with instructions on: “How to Contact the Media About Responsible Mental Health Representation,” and provided a link “to contact ABC to share your feelings directly on the “Private Practice” episode,” complete with a clickable email address for Anne Sweeney, President, ABC Entertainment.

It’s worth mentioning that despite all the efforts to intimidate ABC by the disease monger above, a rerun of the same episode of Private Practice just aired a few weeks ago.

Pringle Ordered to Cease and Desist

Evelyn Pringle’s first in a series of articles on the Mothers Act was published on April 7, 2009, with the title, “Mother’s Act Fuels Multibillion Dollar Industry,” by Scoop Independent News, and several other internet dailies.

The same day, Pringle received an email from Susan Stone with orders to: “Immediately correct current and past falsehoods in all posts, articles, blogs, communications and other media content regarding me and my practice.”

“In addition you are warned to cease and desist from future false and libelous statements with regard to my practice, income, funding and resources,” Susan informed Pringle, and went on to misstate the comments and topics discussed in the article.

“As far as your comments about the legislation which are ridiculously inaccurate,” she said, “I wonder how you can intentionally mislead thousands of suffering women who need treatment.”

“It appears your anti pharma agenda has clouded your reason, your compassion and your ability to be truthful in journalism,” Susan told Pringle.

“A blind copy of this email is being sent to my attorney,” Susan wrote, clearly as an intimidation tactic meant to shut Pringle up due to a fear of being sued.

“You can blind copy anything you want to your attorney or to anybody else for that matter,” Pringle replied in email. “It’s a free country.”

“I plan to blind copy my reply to several people,” she told Susan.

“Nothing I reported is factually incorrect or false but I have no intention of wasting my time debating with you,” Pringle said. “The article will remain as is and I will try to remember to mention your intimidation tactic in my next Mother’s Act article.”

“As far your phony line about me misleading “thousands of suffering women,” save it for your future victims,” Pringle told Susan.

“Maybe you could have one of the Big Pharma front groups listed on your site as backing the Mother’s Act put out a press release warning members of Congress not to read my articles,” she advised Susan.

“From this day forward, I want you to cease and desist contacting me,” Pringle told her.

On April 7, 2009, on the website for her treatment center, Kleiman also swung into action with the headline: “Mother’s Act “Scoop”ed Again.”

“Those of you who know me, know that I try hard to resist the temptation to repond to any misinformed rant with respect to postpartum depression,” she stated.

“It’s really not worth my time to defend the work that we do,” she added. “But still …” Kleiman wrote, and went on to warn readers:

“To any of you who inadvertently found yourself reading a piece called “Mother’s Act Fuels Multibillion Dollar Industry” by Evelyn Pringle, please be advised.

Here’s the article’s opening tease line: “Motherhood has fallen prey to the psycho-pharmaceutical complex. If new legislation as the Mother’s Act becomes law, the drugging of infants through pregnant and nursing mothers will no doubt increase.”

“We should be flattered to have received attention from an excellent writer who spends a great deal of her time seeking media-soaked and provocative avenues for her unique perspective and right to free speech,” Kleiman wrote. “But when it gets personal, it reveals the flaw in this particular effort of hers.”

“I suspect that if Ms Pringle were to sit down with Katherine Stone, Susan Dowd-Stone or myself, she might actually understand this issue a bit better,” she continued. “If she could step down from her big Pharma platform for long enough to see the other side of this picture that is inundated with women in real life who are pleading for their lives, she might consider another angle to her protest.”

“Let’s not be distracted,” Kleiman said. “And let’s certainly hope that Ms Pringle never experiences the hardship of loving someone who suffers with a severe mental illness.”

Just like clockwork, the human face Hale showed up on Kleiman’s website and added the comment: “Couldn’t have said it better myself, Karen.”

On April 8, 200, Amy picked up on the postings and ran the headline: “Karen Kleiman Attacks Evelyn Pringle,” on her “Bitter Pill” website.

“Evelyn Pringle has angered the beast,” Amy said. “After months of ignoring victims who speak out against The MOTHERS Act and pretending that the pro-informed consent movement did not exist, it seems that the perinatal “experts” are gearing up for an online twist-a-thon.”

Pringle responded to Kleiman with the following comments in a blog on Kleiman’s website: “I am going to do everything in my power to derail this profiteering scheme, for one reason and one reason only, to protect the helpless, voiceless victims – the fetus and nursing infants.”

“I have been investigating and reporting on off-label drug marketing schemes set up with screening scams since 2004, and this is the most disgusting one I’ve covered because it is aimed straight at the nursery and most helpless victims in the world,” she wrote.

Queen of the Spin Masters

On April 6, 2009, Grohol allowed Katherine to publish an entire article, also posted on Postpartum Progress, on PsychCentral, with the truthful title for a change of, “MOTHERS Act To Drug America’s Moms for Fake Postpartum Depression.”

However, the article was actually an attack on the people and groups that have worked to expose the Mothers Act for what it is, and quite possibly Katherine’s most brazen disease mongering article to date.

“The emotional health of approximately 1 million American families each year depends on this,” she claimed in regard to the need to get the Mothers Act passed.

“Because honestly,” she wrote, “if we can’t get this one bill passed, how are we going to tackle the much bigger task of helping every single woman with a perinatal mood or anxiety disorder who needs help in this country?”

“There are some people who, for whatever reason,” Katherine said, “have decided to convince others that the singular purpose of the Melanie Blocker Stokes MOTHERS Act is to line the pockets of the pharmaceutical companies and drug our nation’s mothers.”

Katherine then posed the question: “Have these people not seen the research?”, and proceeded on with a rant of totally false and misleading statements about the medical problems occurring in women and infants resulting from the treatment or non-treatment of pregnant women for depression.

Do they not know, she said, that women with untreated depression during pregnancy are (1) twice as likely to have pre-eclampsia, (2) twice as likely to have a C-section, (3) twice as likely to have a preterm delivery, and (4) twice as likely to have their baby go to NICU?

A good place to start the debunking process is with the false claims about preeclampsia, because it leads to preterm birth and babies ending up in intensive care, if they live at all.

Preeclamsia is a disorder of pregnancy typically occurring after the 20th week of gestation. “It is characterized by sudden and dangerous spikes in blood pressure, protein in the urine, abnormal swelling of feet, face, and hands, upper abdominal pain, and nausea,” according to the Preeclampsia Foundation.

“The only known treatment is to deliver the baby,” the Foundation states. “Preeclampsia is the most common known cause of premature birth and responsible for half a million neonatal deaths worldwide.”

“Women taking antidepressants experienced significantly higher frequency of birth complications, including preeclampsia, gestational diabetes, and premature rupture of membranes, than women with depression who had not taken antidepressants during pregnancy,” according to a report on a study presented at the Annual Meeting of the American Academy of Child & Adolescent Psychiatry, by Psychiatric News on December 7, 2007.

A more recent study in the March, 2009, AJP, titled, “Selective Serotonin Reuptake Inhibitor Use and Risk of Gestational Hypertension,” assessed the effects of treating pregnant women with SSRIs on the risks of gestational hypertension and preeclampsia, compared to women who did not receive SSRIs during pregnancy or received SSRIs only in the first trimester of pregnancy.

The study found gestational hypertension “was present in 9.0% of the 5,532 women who were not treated with SSRIs and 19.1% of the 199 women who were treated with SSRIs.”

“Among women who received treatment, gestational hypertension was present in 13.1% of the 107 women who received treatment only during the first trimester and in 26.1% of the 92 women who continued treatment beyond the first trimester,” the research showed.

“The occurrence of preeclampsia was 2.4% among women who were not treated with SSRIs, 3.7% among women who were exposed to SSRIs only during the first trimester, and 15.2% among women who continued SSRI treatment beyond the first trimester,” according to the study.

Then there is the study by the drug company hack, Wisner, discussed above that found women exposed to continuous treatment with SSRIs had an increased risk for preterm birth of 23%, and women with continuous depression but no SSRIs, had a lower increased risk of 21%.

Voiceless victims

The warning section on the labeling for antidepressants contains the following statements on babies being born to women who use the drugs during pregnancy, listing features “consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome:”

Neonates exposed “late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. … Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.”

In some states, mothers who take street drugs are arrested for subjecting newborns to drug withdrawal, yet the antidepressant withdrawal syndrome is no less traumatic. The only wall separating culpability between the two drug ingesting mothers is that addicts are usually aware of the consequences of their use, while the naive mothers on legal drugs are seldom warned about the withdrawal effects they may cause.

An August, 2006 study in the Archives of General Psychiatry compared babies born to depressed mothers treated with SSRIs to those born to depressed mothers who were not treated, and found a significantly greater incidence of respiratory distress, 13.9% vs 7.8%, as well as longer hospital stays for infants exposed to SSRIs. The study also found birth weight and gestational age were significantly less in SSRI exposed infants.

“These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression,” lead researcher, Dr Tim Oberlander, told Reuters on August 25, 2006.

On August 13, 2009, Psychiatry Update carried the headline: “SSRI babies need monitoring,” for a report by Louise Wallace on a study in the Australian and New Zealand Journal of Psychiatry that found infants exposed to antidepressants in late pregnancy were at risk of discontinuation symptoms and more likely to suffer from jaundice and be admitted to special care nurseries.

“In more than 50 pregnant women who took part in the prospective study, newborns exposed to SSRI antidepressants had more symptoms including reflux, poor sleeping and feeding, crying, sneezing and tremor than those who were not exposed,” Wallace wrote.

The authors of the study, “suggested the length of hospital stay for mothers who are exposed to antidepressant medication in late pregnancy should be reviewed and that the length of stay should be measured in days rather than hours after giving birth,” Wallace reported.

“Symptoms such as tremor, irritability and jitteriness may be easily confused with convulsions, which may result in misdiagnosis and significant associated morbidity for the infant,” the authors said. “This suggests the need to clarify diagnostic criteria for the neonatal to improve identification and management.”

On July 19, 2006, the FDA issued a warning that: “A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRI’s) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy.”

Infants with PPHN require intensive care nurseries often with mechanical assistance to breath, and 10% to 20% do not survive even if they receive treatment. Those that do, may experience developmental delays, brain abnormalities and hearing loss.

PPHN normally occur in 1-2 live births per 1,000. Based on the estimate of 250,000 pregnant women taking antidepressants in the US, and a rate increase of 6-fold, the rate of babies born with PPHN would increase from between 250 and 500 per year, to between 1,500 and 3,000.

A number of jury trials are scheduled to begin in the US this fall involving families of infants born with heart birth defects as a result of women not being warned about the danger of taking Paxil while pregnant, with jury selection in the first case, at last check, scheduled to begin in Philadelphia on September 10, 2009.

More than 600 birth defect cases are currently pending against Paxil maker, GlaxoSmithKline, alone in the combined Multi-District Litigation in Pennsylvania.

Recruitment of Life-long customers

In the article on Grohol’s website, in reference to people fighting against the Mothers Act, Katherine asks: “Do they not know that women with untreated postpartum depression can go on to have chronic depression for the rest of their lives?”

No, but we do know that Katherine was diagnosed with what must be chronic and possibly life-long “postpartum OCD” in 2001, because she is still on antidepressants eight years later in 2009, and was still calling the drug company shill, Jeffrey Newport, her shrink in 2007.

But then much to the drug makers’ delight, many people are forced to take antidepressants for years. The author of the new book, “Drug-Induced Dementia: A Perfect Crime,” Dr Grace Jackson, explains that many patients find they can not stop. Not because they develop a craving, she says, “but because the withdrawal effects are severe and often misinterpreted by doctors as proof of a relapse into depression.”

In the book, “The Antidepressant Solution,” Dr Joseph Glenmullen calls this situation the “antidepressant catch 22,” because withdrawal symptoms like anxiety, depression, insomnia, and crying spells can mimic a patient’s original condition. “When this happens, patients are needlessly put back on the drugs, often for years and despite severe side effects,” he reports.

In July 2009, UK expert, Dr David Healy, author of the new book, “Mania: A Short History of Bipolar Disorder,” issued a “SSRI Withdrawal Guide,” available on Bob Fiddaman’s popular website, “Seroxat Sufferers Stand Up and Be Counted.”

“One of the biggest problems of SSRI dependence involves women who are on treatment and unable to stop who wish to become pregnant,” Dr Healy warns in the guide. “Getting off an SSRI at present seems more difficult for women than men, even with the incentive of wishing to become pregnant.”

Dr Jackson warns that almost all psychiatric drugs either sensitize the brain to other addictions, such as benzos cross-sensitizing to alcohol or stimulants cross-sensitizing to cocaine, or become addictive substances on their own.

For most patients, she says, the use of psychiatric medications fulfills four of the seven DSM criteria for dependence including: (1) tolerance; (2) withdrawal; (3) larger amounts consumed, or longer use than intended; and (4) continued use despite the fact that the treatments cause significant suffering and disability, such as impaired judgment when driving, insomnia, sexual dysfunction, or impulsivity.

This knowledge provides additional reasons to fight against the Mothers Act disease mongering campaign in order to prevent the forced drugging of more helpless and voiceless infants through pregnant and nursing mothers.

Filed under: 'ADHD', 2009, anticonvulsants, antipsychotics, ghostwritten, Glaxo, KOL, mothers act, Natural News, Paxil, PPD, PPHN, prices, Quacks, SSRIs, Stone

Paxil Birth Defect Litigation – First Trial A Bust For Glaxo

Evelyn Pringle February 18, 2010

GlaxoSmithKline has paid out close to $1 billion to resolve lawsuits involving Paxil since the drug came on the market in 1992, according to a December 14, 2009 Bloomberg report. But the billion dollars does not cover the more than 600 Paxil birth defect cases currently pending in multi-litigation in Pennsylvania.

Glaxo has settled about 10 birth defect cases, according to Sean Tracey, a Houston attorney who represented the family of a child victim in the first jury trial that decided in favor of the plaintiff on October 13, 2009, Bloomberg reports. The settlements in those lawsuits averaged about $4 million, people familiar with the cases told the new service.

First Trial A Bust for Glaxo

The first trial, in the case of Kilker v Glaxo, ended with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The jury awarded the family $2.5 million in compensatory damages.

After the trial, juror Joe Mellon told Bloomberg that Glaxo did not conduct adequate studies on Paxil. “There were a couple of what I thought were safety signals and what the plaintiffs presented as safety signals that they should have maybe looked into further,” he said.

On October 14, 2009, the American Lawyer reported that the plaintiff’s lead attorney, Sean Tracey, had quizzed the jurors about what swayed their decision. “They said the fact that GSK never adequately studied their own drug was a big deal,” Tracey said. “The animal testing they did showed that they had a potential problem, and they didn’t follow up with adequate studies on animals or humans.”

Glaxo’s lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.

Over 600 Trials To Go

A number of birth defect cases are set for trial in 2010. Andy Vickery, who practices at the Houston firm of Vickery, Waldner and Mallia, is handling several cases, with the Novak trial set to start first. The case is unique in that it involves an infant born with heart birth defects to Derek and Laura Novak on April 4, 2002, after Laura was prescribed Paxil during pregnancy for the off-label treatment of migraine headaches.

“Although one might worry that this would cause a jury to blame the prescribing doctor,” says Vickery, “in this case, we can show that GSK encouraged this use, by sending out over 1500 “medical information” letters touting the benefits of Paxil for migraine headaches, and by leaving “approved WLF reprint” articles with the prescribing doctors.”

Delaney Novak underwent open heart surgery on April 29, 2002, and again on February 21, 2003. Cardiac catheterization procedures were performed on December 4, 2002 and May 25, 2006. She will likely need repeated heart surgeries as she continues to grow.

In December 2005, the FDA reclassified Paxil from a pregnancy Category C drug to a Category D. Category D means studies in pregnant women have demonstrated a risk to the fetus. An advisory to healthcare professionals specifically stated that the “FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations,” and advised:

“Despite this categorization,” says Vickery, “in numerous lawsuits across the country, Glaxo has continued to deny that Paxil causes birth defects.”

“Hopefully that issue has now been laid to rest by the jury verdict in Philadelphia,” he notes.

Case of the Dead Rats

During opening statements in the first trial on September 15, 2009, Sean Tracey told the jury they were “going to see documents in this case that have never seen the light of day before.”

“You will see internal GlaxoSmith documents that the FDA hasn’t seen, that the United States Congress hasn’t seen, and that no jury has ever laid their eyes on before,” he said. “They have been under seal for over three years.”

Many of the sealed documents related to the Paxil studies conducted on rats and rabbits. The world-renowned expert from the UK, Dr David Healy, testified on behalf of the plaintiffs.

Paxil was originally owned by a Danish company called Ferrosan, and that company did the preliminary animal studies on rats and rabbits to look at teratogenicity around 1979 and 1980.

Healy explained that a teratogen is an agent that will cause birth defects and “it could be a drug or maybe a virus or maybe an illness.”

In addition to birth defects, he said, a teratogen can cause a fetus to be born dead or cause a miscarriage, which is death before birth.

The jury heard about studies 295, 296 and 297, with the most damning being study 295, in which three groups of pregnant rats were given Paxil at doses of 5, 15, and 50 milligrams. The pregnancy outcomes at birth, and 4 days beyond, were then compared to rats born to mothers who received no Paxil.

The rat pups born to mothers who did not receive Paxil were all born alive. Of the 415 pups born to mothers who were given Paxil, 47 were born dead.

In the group of rats exposed to 5 milligrams of Paxil, 65 percent were dead by day four. In the 15 milligram group, 92 percent had died by the fourth day. Of the pups exposed to 50 milligrams, 100 percent were dead by day 4.

Eighty-eight percent of the pups born to mothers who received no Paxil were still alive at day four.

Autopsies were not performed on all the rats to figure out why they died or whether they had birth defects, and specifically heart defects.

After Tracey described the study in his opening statement, in regard to the product information that Glaxo was providing in April 2005, during her opening statement, Glaxo attorney, Varner, told the jury, “GSK in its label reported on the animal studies, including the death of the rat pups that you have heard so much about this morning.”

“I would like you to note three things about the discussion in the product information about the animal studies,” she said.

“First, there were no birth defects in the study,” she told he jury. “That is, there were no malformations or difficulties, structural difficulties, with the animals.”

“Second,” she said, “the rat pups who died shortly after birth were dosed at something like ten times the normal dose.”

“And, third, the dosing occurred not in the first trimester, the dosing occurred in the third trimester and continued throughout lactation,” Varner told the jury.

“You will hear expert testimony that the death of the rat pups is believed to have been due to a lactation problem,” she said, “it was during the lactation period that these pups died.”

While Healy was testifying, Tracey read part of a summary on the study that directly contradicted Varner’s claims in stating: “Females were dosed for 14 days prior to pairing, throughout the pairing period, during gestation and for those females allowed to litter during lactation.”

He then asked Healy whether the female rats were exposed to Paxil for more than just the third trimester. “Yes, they were,” Healy said. “They were actually exposed throughout the pregnancy and for a period of time before the pregnancy and after.”

He also told the jury that there were three major malformations in the Paxil exposed group, and “there may well have been more.”

“The figures from the studies do give grounds for concern that there were, in fact more,” he said, “far more.”

The fact that the more Paxil they got the more they died, “indicates that the drug has played a part … in whatever the cause of death is,” Healy told the jury.

“It’s clearly the drug that has caused the death,” he said. “What we aren’t clear from here is just what actually happened. Why they died.”

In 1980, Glaxo had a doctor by the name of John Baldwin review the Ferrosan rat and rabbit studies. In a March 20, 1980 memo to the company, Baldwin discussed the studies and further dispelled Varner’s claim that the rats received 10 times the normal dose.

“At first the examination of individual litter data, et cetera, supports the possibility of embryo lethality then this observation at nonmaternally toxic dose levels which are only three to six times the proposed human dose could contraindicate the use of Paroxetine in pregnancy,” Baldwin wrote.

“That means that this appears to be grounds for concern from the work that Dr. Baldwin has reviewed,” Healy told the jury.

“That Paxil is a drug that if it comes on the market, may cause birth defects,” he said. “So that it would be classified with the drug like Accutane where the drug would have to come on the market contraindicated.”

Which “would mean in this case,” Healy said, “do not use the drug in women of childbearing years unless, for instance, they’re using some form of birth control.”

Another portion of Baldwin’s memo stated: “On the other hand, if the embryonic death is unrelated to treatment, we would have to repeat the study at higher dose levels to produce some maternal or embryonic/fetal effect. There remains the possibility of this compound could be teratogenic at higher dose levels.”

“This means that Dr. Baldwin is saying there is a real risk here from the data that we have that this drug may cause birth defects,” Healy told the jury. “We need to do more work to actually before it’s out, does the drug come with this risk or not.”

“He says we need to check and see if the company that has made this drug has conducted this extra research or are in the process of doing the extra research or not,” Healy said. “The implication being that if they haven’t done it, we should.”

In reviewing the documents for the case, Healy found nothing to show that Glaxo ever did the studies that Baldwin was talking about. “I know they did further studies, but I don’t think they did anything to address the issues that were raised by 295, 296, 297,” he said. “Or if they did, they kept it well hidden it would seem.”

Yet nine years after he wrote the memo, Baldwin published a 1989 paper on the reproductive toxicology of Paxil in a journal called, “Active Psychiatric Scandinavia,” and stated: “There appeared to be no selective effect on the embryo or any signs of teratogenicity.”

Baldwin “appears to be saying here that there is no evidence that the drug causes birth defects,” Healy told the jury. “That appears to me to be incompatible with the data that we reviewed earlier.”

Baldwin’s paper was published the same year the new drug application for Paxil was submitted to the FDA on November 10, 1989.

Incriminating Data Destroyed

During the trial, the jury saw an exhibit showing minutes from a teleconference for a Paxil project team meeting, at which Anne Bell and others were present, on March 26, 1998. Page eight of the minutes stated: “It has already been discovered that raw data from four of the original Ferrosan sponsored toxicology studies conducted at Huntingdon Life Sciences were destroyed by HLS in 1993.”

Healy told the jury that he had done studies for Glaxo and other major pharmaceutical companies and he still had the raw data 15 or 20 years later. “From my work on the serotonin system back in the early ’80s, almost 30 years ago,” he said, “I still have the raw data.”

“The idea that I would destroy the data is almost inconceivable,” Healy stated.

People may be concerned about a particular study and want to go back and look at the books, he said. “It’s a bit like auditing a major company like Enron.”

But it’s “even more important actually in science,” Healy told the jury. “People with a different point of view need to be able to say, look, show me the data.”

They may “even suspect that I didn’t do the study,” he said, “so a defense for me is to be able to say here are the notebooks, here are the clinical records.”

So you have to “be prepared to have all sorts of challenges,” he told the jury. “But for that to happen, the notebooks, the clinical records, the lab notebooks must be there.”

Healy testified that he did not believe the raw data from the original four Ferrosan studies had ever been located. “I believe there were efforts to try and find the microfilms, but they have not been found,” he said.

Healy explained that when studies are done, there are a set of procedures called “good laboratory practice,” or GLP.

“And it is hoped these days when a company brings a drug to the market,” he said, “that the animal work that they do and the human work they do will conform to good laboratory practice and good clinical practice.”

“And part of the requirements here of good laboratory practice is that the raw data is maintained,” he told the jury.

Later in Healy’s testimony, Tracey showed the jury that Study 295 itself, in regard to raw data, under “maintenance of records,” stated “this material will be stored,” and the “material will not be discarded or released from these laboratories without the sponsor’s prior consent.”

Initially, Paxil was FDA approved in 1992, with a Category B rating for pregnant women, meaning animal studies failed to demonstrate a risk to the fetus.

During the trial, it came out that the FDA employee who signed off on a Category B rating, a Dr Evoniuk, went on to work for Glaxo in the marketing department that sells Paxil.

A former FDA scientist, Doctor Suzanne Parisian, also testified as an expert for the plaintiffs. Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony.

Parisian testified that Doctor Sparenborg, a toxicologist at the FDA, raised a concern that there might be a problem with Paxil being a teratogen in 1995, when the pregnancy rating was changed from Category B to Category C.

When the company applied for approval of Paxil to treat Panic Disorder, Sparenborg suggested that the company “do a cross-fostering study to see if the adverse effect is occurring before the baby is born or after the baby is born,” she said.

“Cross-fostering is … taking rats from treated mothers and putting them with a control rat that didn’t receive the drug,” she explained to the jury. “So you are looking at whether the effect in the rat that could be produced in the pup was due to the mother herself or if it was something that was due to the rat before it was born.”

The FDA asked Glaxo to submit a protocol for the study, “for our concurrence,” before initiating it. But to her knowledge, Parisian said, Glaxo never submitted a protocol and never conducted a cross-fostering study.

She testified that such a study “would have helped to address where the negative effects were coming from.”

While Parisian was testifying, the jury was shown the label for Paxil as it appeared in early January 2005, when Lyam’s mother was prescribed Paxil as a Category C drug, with a discussion about the death of rat pups that implied the pups only died if the mothers received Paxil during the last trimester.

The label stated: “in rats there was an increase of pup deaths during the first four-day lactation when dosing occurred during the last trimester.”

Parisian told the jury that there were deaths in pups born to mothers exposed to Paxil in the first and second trimesters as well. This Paxil label “implies to a physician that the animal studies support that it is safe to give the drug to the woman in the first and second trimester; that you need to be concerned about it in the last trimester,” she testified.

The label is saying “there is no evidence of teratogenic effects,” she said, “that means that it’s safe for the first trimester. “

“If a physician were to read this, they would be more likely to prescribe it early in pregnancy,” she told the jury.

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com)

Filed under: 2010, Birth Defects, ghostwritten, Glaxo, Kilker, KOL, Paxil, Paxil birth defect litigation, SSRIs, Vickery

Ghostbusting in Paxil Birth Defect Litigation

Evelyn Pringle March 1, 2010

A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, “Glaxo Used Ghostwriting Program to Promote Paxil,” in reporting on a program called “CASPPER,” which allowed doctors to “take credit for medical journal articles mainly written by company consultants.”

“Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work,” the Associated Press said on August 19, 2009. “Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: “Paxil Product Management has budgeted for 50 articles for 2000.”

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo “negligently failed to warn” the doctor treating Lyam Kilker’s mother about Paxil’s risks and the drug was a “factual cause” of Lyam’s heart defects. The family was award $2.5 million.

Ghostwriting 101

The world-renowned neuropsychopharmacologist from the UK, Dr David Healy, testified as an expert witness for the plaintiffs in the Kilker trial.

While testifying, Healy explained the process of ghostwriting to the jury. He said ghostwriting probably began seriously in the 1980s. “It’s where an article appears under the name of usually a fairly distinguished person in the field,” he testified.

But it involves more than just the true author being concealed, he told the jury. “It’s a process where the ghostwriters work for companies who are very good at getting articles into the best journals in the field, like the New England Journal of Medicine, and recruiting some of the best known names in the field to be the apparent authors of the articles.”

“They may come from one of the big named universities like Princeton or whoever, but the actual fact the person who appears to be the author isn’t the true author,” he said. “If you were to read the article, you often don’t get any hints of who the true author of the article actually was.”

Ghostwriting impacts doctors in the real world trying to make decisions on whether to prescribe a drug in several ways, Healy told the jury. For instance, he said, if he was doing his own writing, he “would write an article on the drug, warts and all.”

“But if the article has been written by a ghostwriter working for one of the pharmaceutical companies,” he said, “the chances are the warts are somehow going to vanish.”

“The article will talk about the good aspects of the drug and will leave out the risky issues which are probably the most important things for the practicing doctor to know,” he explained.

If the ghost author comes from an extremely distinguished university, doctors reading the article will think it has to be right, he said. “The simple fact that the article is going to be apparently written by this big named person and appears in an extremely good journal means that most average doctors will think this has to be true,” he told the jury.

It’s not just the case of the doctor who reads the article being deceived, he said. “It’s the fact that the credibility of the institution is and the name is being used to sell the drug, as well.“

Healy came face-to-face with ghostwriting when one of the drug companies offered to ghostwrite his articles, he said. Since then, he has researched the ghostwriting process to assess how common it is.

The assessment found that “at least half, maybe more, of the articles that appear in major journals under the names of the best known people in the field, are ghostwritten when they have to do with pharmaceutical drugs,” he told the jury.

“If they have to do with the drugs that are being sold at the moment, the ones that are fashionable at the moment, then these articles are highly likely to be ghostwritten even when they appear in the very best journals,” Healy said.

Ghostwriting Up Close

While testifying, Healy told the jury that he was familiar with companies that Glaxo hired to ghostwrite literature and put other doctors’ names on it. “I think the leading firm in the field was one called STI,” he said. “This stands for Scientific Therapeutics Information.”

The jury was shown a July 28, 2003, document sent to the Glaxo product manager for Paxil, by Sally Laden, working for STI, which stated: “Thank you for offering me the chance to work with you to write two review articles.”

“This letter summarizes my fees for this project,” Laden wrote. “The safety paper is priced higher because of a greater number of named authors and the anticipated additional work involved in assessing the CR data in progress.”

For the development of the manuscript, and up to five drafts, the price quoted was $12,000. One of the topics for a manuscript was on the safety of antidepressants in breast-feeding.

“The first draft will be the first run through the material,” Healy told the jury. “She will have put the article together laying out the issues, laying out the references, structuring the paper up in the way that the journal she actually expects that this paper is going to go to will want the article structured.”

Draft 2 goes back to Glaxo again and the author, whoever is actually going to put their name on the paper. Then draft 3 goes back to Glaxo and the author for sign-off, and then there will be a final version that goes to the journal, Healy explained. Then draft 5 is revisions from journal reviewers, he said.

He noted that Laden said the safety paper is more expensive because there was going to be more authors. “I should emphasize that more authors here does not mean more authors writing the paper,” Healy told the jury. “It means more names appearing on the authorship line.”

“She has to recruit people and the people whose names are on the authorship line get paid for being authors,” he explained.

Sally Laden’s “name has appeared on a range of different articles that have been produced for GlaxoSmithKline, not just on the issue of giving drugs to women of childbearing years but across the board,” Healy said.

During Healy’s testimony, the family’s lead attorney from Houston, Sean Tracey, introduced the actual manuscript by STI. “This is an article that is going to go to a journal,” Healy said. “It has been authored by Ms. Laden, contrary to what appears there.”

The names Zachary Stowe and Jeffrey Newport appeared on the authorship line. Healy noted that Draft 4 stated: “Final article cover page to be removed.”

“The cover page will be removed,” he explained, “because the journal will treat the article quite differently if they think that the true author is not on the authorship line.”

Healy said the paper was an example of ghostwriting. “It is going to go to a journal called Psychopharmacology Bulletin,” he testified. “And in this particular issue of the journal where this paper later comes out, every paper in that issue of the journal has to do with Paxil.”

The jury was then shown the actual article that was published and it was the exact same article but without Laden’s name on it.

Healy testified that Stowe runs the women’s mental health program at Emory University and publishes on SSRIs and women’s health issues, with publications favorable to Paxil, and also gives seminars and talks for other doctors which outline “how it can be a good thing to treat women of childbearing years with Paxil.”

He was not allowed to tell the jury how much Glaxo had paid Stowe over the last year or two, which was revealed by an investigation led by Iowa Senator, Charles Grassley, as the ranking Republican on the US Senate Finance Committee. The amount Stowe got paid “is not public knowledge where you can show me a document that says it,” the judge said.

However, Stowe’s Glaxo earnings are most certainly public knowledge. A google search in December 2009, with the following three key words in quotes, “Stowe” “GSK” “paid,” brought up 15,800 hits.

On June 10, 2009, in reference to Stowe, the Wall Street Journal reported, “Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women.”

The National Institute of Mental Health said “it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the June 11, 2009 Atlanta Journal-Constitution reported.

The charts with dates for Stowe’s promotional talks reveal that many times he gave two talks for Glaxo on the same date and made five grand per day, in addition to payment for all traveling expenses. On one date, he billed $96 for meals alone.

For ready reference, the list of academics in the field of psychiatry identified by Grassley’s investigation thus far, as not fully disclosing money from drug companies, includes Joseph Biederman, Thomas Spencer and Timothy Wilens at Harvard, Charles Nemeroff and Zackery Stowe from Emory; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford; Martin Keller at Brown University; Karen Wagner and A John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, “Infinite Minds,” broadcast for years by National Pubic Radio, before it was thrown off the air.

The supplement to the Spring 2003, “Psychopharmacology Bulletin,” found online, sure enough shows the ghostwritten paper, “Clinical Management of Perinatal Depression: Focus on Paroxetine,” with the names Stowe and Newport, along with papers by Martin Kelly, Charles Nemeroff, Alan Schatzberg, Karen Wagner, and Kim Yonkers, for a total of fourteen Paxil papers altogether.

Under “Disclosure,” the article ghostwritten by Laden stated: “This work was supported by an unrestricted educational grant from GlaxoSmithKline. Doctor Stowe serves as scientific advisor for and receives research grants from Pfizer and GlaxoSmithKline. He also receives grant support from Wyeth.”

The disclosure that the work was supported with a grant from Glaxo would not tell a doctor reading the paper that it was actually written by somebody else, Healy said.

While testifying, Healy explained that an “unrestricted educational grant, if I were to receive one, it would assume that I am saying things that are relatively favorable to the pharmaceutical company who has given me the educational grant.”

“If I am saying things hostile to the drug,” he said, “I will not get an unrestricted educational grant, although the word “unrestricted” suggests that I should.”

Stowe’s undisclosed income above was from Glaxo alone. In August 2007, he was listed as an author on a study titled, “Atypical Antipsychotic Administration During Late Pregnancy,” in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth, has served on advisory boards for Glaxo, Wyeth, and Bristol-Myers Squibb, and has served on speaker’s bureaus and/or received honoraria from Glaxo, Lilly, Pfizer, and Wyeth.

The second author on the ghostwritten paper, Jeffrey Newport, is the associate director of Emory’s Women’s Program. Newport was also an author on the “Atypical Antipsychotic” study. He has received research support from Glaxo, Lilly, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for Glaxo, AstraZeneca, Lilly, Pfizer, and Wyeth, according to the disclosures.

The next person the jury heard about was Charles Nemeroff. He was also an author on the atypical study. Nemeroff was the Chief of Psychiatry at Emory, until he lost the position last year, Healy told the jury. “He’s possibly best known or was the best known psychiatrist in the United States.”

“He influenced an awful lot of heads of departments, professors of psychiatry, general people within the field of academic mental health, and through them and an awful lot of prescribing doctors here in the U.S. And, indeed, perhaps worldwide,” Healy testified.

A link to “Articles” on the Emory website in mid-2009, brought up roughly 90 studies and papers that include the co-author Nemeroff.

Healy said he believed Nemeroff was one of the founding members of the Paxil advisory board and he participated in continuing medical education seminars with talks on Paxil.

Nemeroff would have been “the key person in producing the kinds of talks with slides that would have been held for large audiences of doctors, and then those slides and talks would have been distributed out to different doctors in the field who hadn’t been at the major meetings as he gave his talk,” Healy told the jury.

During his testimony, Tracey showed Healy a document from a continuing medical education seminar titled, “Fertility, Mood and Motherhood,” and Healy said the material for the seminar was prepared by Glaxo for Nemeroff. It was again supported by unrestricted educational grant from Glaxo and Nemeroff “was reimbursed for his role in this,” Healy pointed out.

Healy was also not allowed to testify about Nemeroff’s fall from grace at Emory, how much he was paid by Glaxo, or his failure to disclose over a million dollars from drug companies.

Dr Bernard Carroll, a past chairman of the department of psychiatry at Duke University Medical Center, summarized the Nemeroff saga well on the Healthcare Renewal website on November 3, 2008, in writing: “The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds.”

During her cross examination of Healy, Glaxo’s lead attorney, Chilton Varner, presented an exhibit showing a continuing medical education presentation given by Nemeroff.

“Can you see that in this continuing medical education program Doctor Nemeroff says that paroxetine, sertraline, fluvoxamine, (are) not associated with increased risk of teratogenicity or other complications?” she asked Healy.

“Yes, I do,” he replied.

In small print, the disclosure for the presentation showed Nemeroff had received research grants and participated in the speakers bureau and consulted for Glaxo, Eli Lilly, Solvay and Pfizer.

During re-direct, Tracey asked Healy to tell the jury what the actual results of the study that Nemeroff was discussing in the presentation showed, and specifically when Paxil was looked at alone. The results “showed that there was a 1.8-fold increase in the odds ratio of a birth defects to the women who have been taking Paxil during pregnancy,” Healy testified.

“Overall, for this group of drugs there was an increase in risk,” he said, “but specifically for Paxil the risk was greatly increased.”

“And beyond that,” Healy stated, “what isn’t included here in the conclusions, overall there was a — on this group of drugs, there was a doubling of the rate of miscarriages on the drug compared with the rate of miscarriage for the women who are being compared who weren’t on the drug.”

“There was also an increased rate of women going on to voluntarily abortions on the drug,” he added.

One of the lead authors on the study was Gideon Koren. “Doctor, without giving any details,” Tracey asked Healy, “do you know whether Doctor Koren has ties to the pharmaceutical industry?”

“I know he has,” Healy said.

During his opening statement, Tracey told the jury that 1998 was a big year for Paxil because a study came out by a doctor named Gideon Koren, and a researcher named Kulin, that looked at Paxil and two other SSRIs.

The study compared women who took SSRIs, to women who didn’t take any SSRIs, and the number of birth defects in the two groups was the same. “So Doctor Koren concluded that SSRIs appear to be safe,” Tracey said.

“Within, literally within 24 hours,” he told the jury, “GSK’s marketing machine cranked up and they faxed this information to their entire sales force.”

And the sales force took this information and began to use it to sell to women, he noted. “What they didn’t tell anybody was this,” Tracey said. “That when you separated Paxil out from the other SSRIs, you saw that Paxil was causing birth defects, that there was an increased risk of birth defects in this study in these women when you looked at Paxil by itself.”

“That was not in the paper,” he said. “That information was not found out until two years ago.”

While testifying, Healy was barred from telling the jury about Koren’s involvement in one the biggest academic research scandals in history a few years back when he sent vicious anonymous letters to discredit fellow researchers and denied doing so until DNA evidence from postage stamps proved he was lying years later. In September 2003, the Canadian Association of University Teachers reported on the disciplining of Koren in the CAUT Bulletin as follows:

“The Ontario College of Physicians and Surgeons has formally reprimanded University of Toronto professor of medicine Dr. Gideon Koren. He had written anonymous harassing letters about Dr. Nancy Olivieri and three colleagues during Olivieri’s dispute with the Hospital for Sick Children, the University of Toronto and Apotex Inc. He then had lied repeatedly to conceal his responsibility. The college also cited him for additional misconduct, in research.”

The Teachers Association further explained in the Bulletin: “The college’s finding of research misconduct was in relation to a study on a drug to treat a blood disorder in children that Koren and Olivieri had once collaborated on. Olivieri identified risks that the drug was ineffective and caused liver damage, and voiced her concerns despite legal warnings from its maker, Apotex. Koren differed and, contrary to accepted norms, published an article on the drug using data from other researchers, including Olivieri, without their knowledge or consent.”

“Koren had received hundreds of thousands of dollars in funding from Apotex after the company had terminated the drug trials in its efforts to prevent Olivieri from disclosing risks to patients, as well as the hundreds of thousands of dollars in funding he had received during the trials,” the newsletter reported, citing an journal article by the authors of “The Olivieri Report.”

Apotex marketed a generic version of Paxil, or paroxetine.

The penalty had been jointly proposed to the discipline committee through prior agreement between Koren’s attorney and counsel for the college, the Bulletin noted. In its decision, the committee said it was “deeply troubled by this case” and “seriously considered administering a more severe penalty” than that proposed, as it wished “to express unequivocally its condemnation of Dr. Koren’s misconduct.”

Glaxo Money Still Flowing

In a December 14, 2009 report on Pharmalot, Ed Silverman noted that Glaxo had published a list of fees paid out to US healthcare professionals for speaking and consulting services for the three month period of April 1, 2009 to June 30, 2009. “By its own tally, Glaxo paid $14.6 million to approximately 3,700 US docs and other healthcare professionals,” he reported.

Although Glaxo paid out millions of dollars over the years to the doctors discussed in this article, not one of them was called to testify as an expert in the first birth defect trial.

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com)

Filed under: 2010, Birth Defects, CASPPER, front groups, ghostwritten, Glaxo, Kilker, KOL, Paxil, Paxil birth defect litigation, pregnant, SSRIs, Study 329, Vickery

Cold Case Files – Paxil Birth Defects Litigation

Evelyn Pringle March 2, 2010

Almost like an episode of the TV show, Cold Case Files, the first Paxil birth defect trial was dominated by a story about what happened to the rat pups that died around 1979 and1980, involved in a study in which Paxil was being tested on pregnant female rats.

The animal studies giving Paxil to rats and rabbits were conducted by a Danish company called Ferrosan before the drug maker, that later became part of GlaxoSmithKline, purchased the drug.

The family’s lead attorney in the case of Kilker v Glaxo, Sean Tracey from Houston, brought in the world-famous neuropsychopharmocology expert from Wales, Dr David Healy, to testify extensively about rat pup study 295.

In summary, Healy told the jury that all the rat pups born to mothers who received Paxil were dead four days after they were born, while eighty-eight percent of the pups not exposed to Paxil were still alive on day four.

In fact, of the 415 rat pups born to mothers who received Paxil, Healy testified that, “One in every ten or actually maybe more like possibly one in every eight or so were born dead.”

As far as he could make make out, all the rats were not autopsied, Healy said, so the question was why the pups died.

“It’s clearly the drug that has caused the death,” he told the jury.

“One of the possible reasons for their death is they’re born with birth defects that lead to them actually dying early in infant life,” he testified. “A responsible approach to data like this is to investigate it further and find out just what the cause is.”

Doctor Suzanne Parisian, a former FDA scientist, also served as an expert for the plaintiffs. She testified that the first safety signals that indicated Paxil could cause birth defects were seen in the animal studies conducted in 1979-1981 period, as well.

Parisian said the studies showed birth defects, embryos that died, and rat pups that did not survive.

Adam Peavy, of the Houston firm of Bailey, Perrin and Bailey, handled her testimony. While testifying, Peavy had Parisian review comments in a memo by a Doctor John Baldwin to Glaxo in 1980, discussing the Ferrosan studies, which stated: “There remains the possibility that this compound could be teratogenic at high-dose levels.”

“We need to ascertain whether Ferrosan have conducted or are conducting or intend to conduct a peri- and postnatal study and a neonatal acute toxicity study,” Baldwin wrote.

Based on her review the documents, Parisian told the jury, Glaxo never ascertained whether Ferrosan did the studies and Glaxo never conducted the studies.

As far as she knew, the company never told the FDA about Baldwin’s statements either, she said, but “they should have.”

On October 13, 2009, the jury in Philadelphia rendered a verdict against Glaxo and awarded the family $2.5 million. More than 600 Paxil birth defect cases are pending in the multi-litigation in Pennsylvania.

Paxil Worse Than Cocaine

In May 2009, a paper was published by a Doctor Sloot and the complete version of the study came out in September 2009. During closing arguments, Tracey told the jury, the “Sloot study is probably the single most problematic document in this case for them because it could have easily been done.”

“They would have known that the drug was a clear teratogen. It was more powerful than cocaine,” he said. “And it was more powerful a teratogen than even the control or as powerful as the control retinol that everybody in this courtroom, everybody that has testified, has said that drug is a teratogen.”

“And had GSK done the studies that Baldwin told them they should do, or a study like Sloot, any time before they started marketing,” he told the jury, “we wouldn’t be here.”

Retinol is an active ingredient in Accutane, a pregnancy Category X drug, meaning it is known to cause birth defects and is not to be used by pregnant women.

During his testimony, Healy was asked to tell the jury what the Sloot study was seeking to do.

“Schering-Plough had acquired a different European company called Organon who had a number of drugs which were serotonin reuptake inhibiting drugs,” he explained.

“One of the things that Schering-Plough wished to find out was could they bring any of these drugs to the market,” he said.

“What they then did was to do reproductive toxicology studies on these drugs that were new to them, plus on, I believe, all of the SSRI drugs that were on the market, plus a number of drugs which also inhibit serotonin reuptake, like cocaine, and they threw into the mix one or two more drugs, one that was known not to cause birth defects and one that was known to cause birth defects closely related to Accutane,” he told the jury.

They had a “particular system to look at the impact of all these drugs on the developing fetus to see were there any indicators of risk,” he said, using rat fetuses.

The study “found that Paxil, of all the SSRIs on the market now, was the most likely to cause birth defects and caused birth defects at the same rate as Accutane did,” Healy said.

He was asked how Paxil did in the study compared to cocaine in terms of potency.

“It was much more likely to cause birth defects than cocaine,” he said. “Cocaine in this particular system was much safer than Paxil.”

On September 21, 2009, the jury also heard testimony on the Sloot study from Doctor Shira Kramer, an epidemiologist. “Doctor Sloot’s paper demonstrated that Paxil was a clear teratogen,” she said, “that it was not just an effect of developmental or birth-weight related effect, that it was a direct teratogen, and that there was a spectrum of defects observed in rat embryos at low doses, establishing that it was a very potent teratogen, more teratogenic than cocaine and retinol, clear teratogens in their own right.”

Parisian told the jury that the Sloot study, conducted in 2009, could have been conducted in 1981 and it would have answered the question that Dr Baldwin was asking about embryotoxicity in 1980.

“If you use that type of a study, it specifically addresses embryotoxicity,” she told the jury.

Paxil Journey to Japan

Although Paxil was not approved in Japan until 2000, a couple years after it was approved in the US in 1992, Glaxo began looking into marketing the drug in Japan and meeting the requirements for approval by the Minister of Health and Welfare (MHW), the Japanese equivalent to the FDA.

“And the Japanese, they suspected, were not going to accept their dead rat pup studies,” Tracey told the jury in his opening statement on September 15, 2009.

“And so GSK began discussions internally,” he said. “Internally among themselves they said: What are we … going to do if Japan makes us do the studies to find out why the rat pups died?”

While Healy was testifying, Tracey introduced a February 9, 1994 memo to Glaxo employee Charlie Fake, and copied to others, from Jenny Greenhorn titled, “Paroxetine Japanese reprotox requirements,” and asked Healy to explain the meaning of “reprotox.”

Any “agency in the world has a requirement from the pharmaceutical companies to look at the reproductive toxicities of a drug,” Healy said. “This includes the impact of the drug on fertility, as well as the potential for the drug to cause birth defects.”

The first sentence of the memo stated, “we have reviewed the three plans for meeting the Japanese reprotox requirements for their regulatory implications elsewhere, should a valid, significant positive i.e., adverse, result be obtained.”

The next two sentences in the memo stated: “The conclusions reached within regulatory are summarized below.”

“It should be noted that there is little or no regulatory information in this area, and we know of no precedents, neither have we consulted with experts outside of the company due to sensitivity of the issue,” they wrote.

“These are, therefore, only our opinions of the likely consequences of positive findings in such studies,” they pointed out.

“What you want from this kind of study is that there is no harm to the fetus,” Healy explained to the jury.

“A positive outcome means there has been a harm,” he said. “So they’re here trying to plan if things go wrong, how do we handle it.”

Healy testified that, “regulatory implications elsewhere,” refers to the fact that the market in Japan is extremely small and the market in the US is huge. “They really have to work out if it is a worthwhile risk being asked to do particular studies which might cause a problem which we would then have to report back to the FDA,” he said.

“And the implications for the market here in the U.S. may mean that it’s just not worth our while trying to go to Japan at all,” Healy testified.

Indeed, throughout page one they discussed the “consequences” of positive findings in the plans for “such studies” if done for Japan. For instance, they stated at one point: “A change in the pregnancy category from B to C is a possibility.”

“This may have commercial implications as the other SSRIs have a B categorization,” they pointed out.

After reviewing the first page and explaining several statements to the jury, Healy was asked whether it appeared that anybody had considered the safety of Paxil. “It appears to me actually as a scientist that this is the opposite to what one would do,” he said, “if the point of view from the scientific end of things is we want to find out what happens.”

What “seems to be happening here is there is a much more business approach which is, well, we don’t really want to know what happens,” he said. “Because if we know, then there are commercial implications.”

For Plan II, they also discussed the “problem” and stated: “A positive finding in the Japanese style Segment II study would be more of a problem since in this case it is undoubtedly exposure during early pregnancy that is of concern for women.”

“A strengthening of the labeling might be likely, EG, women of childbearing potential should not take the drug unless they know they are not pregnant and are taking adequate contraceptive precautions,” they warned. “Worst case, but just possible, contraindication of women of childbearing potential.”

“What they’re saying here is that an awful lot of women clearly don’t know they’re actually pregnant until a few weeks into the pregnancy,” Healy had explained earlier, regarding what was meant by “contraindication” for women in childbearing years.

“Those early few weeks are the period when the harms may happen,“ he said. “And in the case of a drug like this where … there may be a risk of being hooked to the drugs so you cannot get off it if you think you may have become pregnant, then clearly this all becomes extremely risky as it goes on.”

And in this paragraph, they reiterated: “Again, a change in U.S. Pregnancy category from B to C is likely.”

“A positive in the Japanese Segment III would be less of a problem,” they wrote, “since it defines the critical period as the third trimester which authorities would feel more comfortable with.”

“However,” they warned, “they may insist on animal findings being added to the labeling with additional comments and this is certainly the case with the United States, Canada and Australia who have extensive product information.”

In the last paragraph for Plan III, they stated: “This is the same as Plan I, but the lower doses make findings much less likely.”

Again, “this looks like risk management,” Healy told the jury.

“What seems to be happening here,” he said, “is an effort to design a particular kind of experiment that would look like we have been doing things but we’re trying to control the risks, things that could go wrong.”

“So that people will say, well, yes, they have done the experiments, but it didn’t show a particular problem,” he told the jury.

Later in the memo, they stated: “Obviously, conducting no more studies and arguing the case with the MHW would have no regulatory implications elsewhere unless our arguments fail and the MHW requests us to do the type of study we wish to avoid.”

And then it went on to warn: “If they do request a study, there’s a potential problem in that they may direct/insist on our performing a study to their preferred design.”

“At least we are now in the position of being able to do the study we chose and then defending it,” they wrote, with an exclamation point.

After having Healy discuss what was meant by comments throughout the memo, Tracey asked: “Is there anything in this entire document you see, Dr. Healy, that appears as if there is a study being designed by this company to find out the truth about their drug in pregnancy?”

“No, there isn’t,” Healy replied.

While Parisian was testifying, the jury was shown an email dated March 30, 1994, with a discussion about the Japanese government asking for specific information about behavioral changes in babies exposed to Paxil and the protocols for a study that was being designed to respond.

The last sentence read to the jury stated: “Gwyn Morgan will be responsible for the review and the analysis of the protocols to ensure that a likelihood of any potential negative outcome is minimized.”

The goal of pharmacovigilance is not to minimize risk, “particularly when the Japanese government is concerned about the risk,” Parisian told the jury.

The purpose of doing pharmacovigilance and safety surveillance, in terms of toxicology, she said, “is to identify risks so that it can be addressed.”

“And in terms of pharmacovigilance, animal study feeds into the information you have about outcomes of infants,” she told the jury.

In 1997, Glaxo teratologist, Patrick Wier, conducted the rat study, with Segment one comparable to women in the first trimester of pregnancy, and Segments Two and Three comparable to women in the second and third trimesters.

Each “type of study in a rat is trying to simulate what would occur in a woman at those different stages,” Parisian explained to the jury.

Rats are only pregnant for about 22 days, or 7 to 8 days per trimester, she said.

Wier’s study was not designed to find out whether Paxil was a teratogen. It was a behavioral study, “which the ultimate goal was to keep pups alive so that you could look at changes in their behavior,” she pointed out.

“They designed the study to fail,” Tracey told the jury in his opening statement.

A 1997 document stated the doses “have been adjusted accordingly and the risk is now considered as minimal and acceptable,” he said in closing arguments.

But the study did have rats that died with birth defects. Specifically, a ventricular septal defect (VSD), was found in an edematous (swollen) rat; one of the same defects that Lyam Kilker was born with.

The conclusions in the report did not disclose whether the rat with VSD was born to a mother exposed to Paxil. “It was in the text and it was also in appendix 9,” Parisian said.

She testified that the 1980 Ferrosan study also had two edematous rats but they were not autopsied. There is “no information as to why those two rats were edematous,” she stated, “but the company listed them as major malformations.”

“They also had malformations in their rabbit studies,” Parisian reported.

Testimony Debunked

In closing arguments, Tracey pointed out that Patrick Wier had testified that he knew why the rats died because he did a study in 1997.

“Let’s see whether or not that’s true,” he told the jury.

He then reread a memo, gone over during the trial, from July 10, 1998, a year after Wier did his study, which stated in reference to Wier: “Have you worked with Patrick on the concern about the REPROTOX work having been conducted in the seventies? If no, please initiate discussions and set up plans for the MHW discussion. If yes, I would like to know how we intend to justify the validity of these studies and the arguments for rebutting why we should not repeat them.”

“I don’t know how I can take that out of context,” Tracey told the jury.

“If they knew the reason,” he asked, “why do they need to defend or justify the validity of the studies?”

“Why do they have to have an argument for not repeating them if they are fine and … everybody knows why the rats died?,” he pointed out.

He noted that Wier’s memo said, “all we really need is a plausible explanation in case the regulators ask us why the rats died.”

One thing is undisputed in this case, Tracey said. “They never did the test at the higher level with the rabbit to figure out whether or not this drug was a teratogen.”

“If what a drug company really wants to know is whether or not their drug is dangerous, they test it. They don’t avoid tests,” he told the jury in closing arguments.

“Because the negative result will cost us money is not a defense to not finding out the truth about your drug,” he pointed out.

Secret Reports

During her testimony, Parisian explained that once a drug is approved it is the manufacturer’s job to do pharmacovigilance.

The clinical trials done to get a new drug approved typically do not have women that are pregnant, she testified. Once a drug is marketed, the company will start getting data about mothers who are pregnant and their babies and it’s “the duty of the manufacturer to monitor that,” she said.

In the case of Paxil, the trials excluded both women who were pregnant and women who could become pregnant because the animal date suggested that there was a risk, she noted, citing a 1984 FDA letter.

While testifying, Peavy had Parisian review a 1997 internal Glaxo document titled, “Paroxetine: Pregnancy with Abnormal Outcomes,” discussing the reporting of birth defects in Japan.

The document stated in part: “There have been 17 reports of congenital abnormality reports to the MHW.”

It also stated: “The company should consider it important that this many cases have appeared.”

The document contained a table with a list of adverse event reports collected on birth defects and birth outcomes, based on an internal review of information received about pregnancies, that showed 32 reports of abnormal outcomes with congenital anomalies.

The company had information on a total of 635 pregnancies in general but only knew the outcomes for 315 infants. “So about half they don’t know what happened,” Parisian explained.

You don’t “know what has happened to those babies at all,” she stated.

Parisian testified that Glaxo internally had reports that looked at all birth defects known to the company, which she had reviewed prior to the trial.

One of the reports was titled, “Paroxetine in Pregnancy,” on adverse events and pregnancy outcomes.

This analysis had a cutoff date of May 1996, and would include the knowledge of the company on pregnancies from the date Paxil was approved in 1992, through May of 1996, Parisian said. The table in this report showed 36 cases of abnormal or congenital outcomes.

This report was never submitted to the FDA according to the testimony of Glaxo employees, Parisian said, but it should have been because it “is safety information.”

In 1998, Glaxo prepared another internal report titled, “Paroxetine and Reports of Congential Abnormalities,” with a cutoff date of November 1997, that showed 42 cases of congenital anomalies.

Parisian said this analysis was also never submitted to the FDA, as far as she knew, but under the rules it should have been.

Peavy then had Parisian review the draft version of the report, showing the same cutoff date and 42 congenital anomalies. On page 5, it stated: “The incidence rate of congenital abnormalities as observed in the data reported in this document is 13.3 percent.”

But the draft version contained the following statements that did not appear in the final report: “A figure much higher than that reported by birth-defect monitoring bodies. Taken at face value, this represents an alarming finding.”

Under FDA rules, drug companies are required to report alarming findings to the FDA, Parisian said. “They are also required to report any kind of safety analysis that they have done internally like this to address an issue about safety.”

In fact, Peavy produced a 1984 letter to the company from the FDA, which specifically stated that the agency wanted to be informed about any “alarming findings” in either human or animal studies.

The 13.3 percent incident rate of congenital abnormalities was between six and seven times the 2.5 percent overall birth defect rate you would expect to see for births in the US, Parisian told the jury. The CDC uses a 2.5 percent background rate.

A 13.3 percent rate “would be a type of signal that a manufacturer should address,” she testified.

Another exhibit reviewed for the jury showed the Japanese had received 27 reports of congenital abnormalities since December 1998 and they were requesting more information about safety, and included emails written by Glaxo employees, Ann Bell and Narita San.

An email written by Narita San stated in part: “This is unexpected number of reports, because only 50 cases were reported in the previous position paper. I think we have to take this abrupt increase of reports into consideration to the reply.”

Parisian explained that “the Japanese are saying that they have received 27 reports of congenital anomalies and they want an update on the prior information.”

In 2000, another internal report of the adverse events for pregnancy outcomes was completed by Doctor Stephen Hughes, Ms Easterbrook and Ms Caley, the worldwide clinical safety group, updating the report made in 1998, Parisian said.

The analysis, with a cutoff date of March 2000, showed Glaxo knew the outcome of 656 pregnancies, out of a total of 1,189 known Paxil pregnancy exposures. By then, there were 79 reports of congenital abnormalities, meaning 12 percent of pregnancies with known outcomes resulted in birth defects.

It was possible that some of the babies in the pregnancies with unknown outcomes also had birth defects, Parisian said. “They are unknown what they had.”

While testifying, Parisian was asked to explain the general rule of “underreporting.”

It is general “knowledge that adverse events that the FDA receives are underreported,” she said. “The FDA’s numbers range from 1 to 10 percent.”

So the FDA looks at the adverse event reports they receive as the tip of the iceberg, “maybe 10% of the reports that are actually out there,” she pointed out.

If talking about underreporting figures for 79 cases of congenital defects, she said, “that would be 1 percent maybe to 10 percent, which would be 7,900.”

“That would be babies that actually lived to getting born,” she told the jury. “That’s nothing to do with the miscarriages and what is not known.”

The reports discussed during her testimony, “were not your classic safety analysis,” Parisian explained. They were a “reporting or a tabulation of what information the company had.”

They were being prepared for the Japanese because the Japanese government wanted safety information on pregnancy outcomes and they were also concerned about “late pregnancy, what the behavior would be of the baby when the baby was born if the mother was taking Paxil,” she told the jury.

But under the rules, Glaxo was required to turn over any internal safety reviews, reports, and analysis to the FDA, Parisian told the jury, “particularly with pregnancy, which the FDA has been asking for information since the product was approved.”

None of the analyses were turned over to the FDA, according to the testimony of Glaxo employees, Parisian said.

Under cross-examination, Glaxo attorney, Joe O’Neil, asked Parisian to identify the FDA regulation she was referring to in stating the reports should have been submitted to the FDA. “I would specifically use (21 CFR) 314.81,” she said, “FDA talks about issues with children, information about children that they are to receive that information.”

“Also, as a postmarket study asked (for) by the Japanese which is the 2000 report,” she stated. “That would be under (21 CFR) 314.80.”

While cross-examining Parisian, O’Neil put up a power point slide listing the FDA approvals of Paxil and Paxil CR, the controlled release version, for additional indications between the initial approval for major depression disorder in 1992 through 2004, including panic disorder, obsessive compulsive disorder, general anxiety disorder, and PSTD.

Several times, Parisian noted that Paxil was not approved for use by pregnant women. O’Neil pointed out that for each new indication, FDA approved the label and Paxil was never contraindicated for use by pregnant women on the label.

Under redirect examination, Parisian testified that when Glaxo applied for approval of the new indications, the FDA was not given the internal analysis of birth defects available at the time or told about Dr Baldwin’s comments on the early animal studies.

Although the 2000 report with 79 cases of birth defects was supposedly done for the Japanese government, it was never given to the Japanese, Tracey told the jury in closing arguments. “It wasn’t given to the people it was prepared for,” he said.

And after the report in 2000, Glaxo stopped doing the pregnancy analysis, he said. “For the next five years we have nothing,” he told the jury. “We don’t have any reports. We don’t know how many birth defects are reported to them.”

FDA Stamped Paxil Label

Glaxo’s lead attorney in the Kilker trial was King & Spalding partner, Chilton Varner.

In her closing argument, Varner stated: “FDA repeatedly reviewed and approved the safety of Paxil, including the scientific data and the animal tests, 13 different times between 1992 and 2004.”

In his final summation, Tracy told the jury: “Ms. Varner has said time and time and time again the FDA rubber-stamped” the label.

“What we know is the FDA didn’t have all their information,” he said.

“The FDA didn’t know what they thought about the animal studies,” he stated. “The FDA didn’t know the analysis they had done.”

“And one thing you need to understand is to this day, the FDA still hasn’t seen these documents,” Tracey told the jury.

“To this day, only my experts have seen the internal GSK documents,” he said. “To this day, you are the only people outside of this courthouse that have laid eyes on these documents.”

“These documents were under seal until this trial began,” he pointed out.

(The Paxil Birth Defect Litigation Update Series is sponsored by the Houston law firm of Vickery, Waldner and Mallia at http://www.justiceseekers.com)

Filed under: 2010, Birth Defects, ghostwritten, Glaxo, Kilker, KOL, Paxil, Paxil birth defect litigation, SSRIs, Vickery

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