The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

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

Attorney Subpoenas J&J AstraZeneca and Lilly for Hidden Antipsychotic Data – Part II

Evelyn Pringle September 10, 2007

Attorney Jim Gottstein is the director of the Law Project for Psychiatric Rights, a public interest law firm that has mounted a campaign against forced psychiatric drugging all over the country. He represents mostly indigent clients through his non-profit organization and is not involved in the lawsuits filed against the atypical makers by patients or their families.

In turning the secret Eli Lilly documents over to the press, Mr Gottstein’s goal was the same as Dr David Egilman’s, to alert the public about Lilly’s off-label marketing schemes aimed at getting doctors to prescribe Zyprexa to more patients who were unaware of the serious health risks associated with the drug.

Zyprexa was approved only for the treatment of adults with schizophrenia in 1996, and it wasn’t until several years later, that it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.

In a February 13, 2007, interview with the Anchorage Daily News, Mr Gottstein explained that the secret document showed the rate at which Zyprexa caused diabetes, massive weight gain and other metabolic problems and how Lilly trained sales staff to mislead doctors about the drug’s association with diabetes and illegally promoted Zyprexa for off-label use with children and the elderly.

As the playing field stands today, the average American alone would be lucky to find any law firm financially strong enough to take a drug giant like Lilly with its billions of dollars of power and a well that will never run dry in large part because the illegal off-label marketing of Zyprexa is ongoing and continues to earn billions of dollars each year.

However, a small group of patient advocates that included some of the most well-known psychiatric drug experts, journalists, and attorneys in the US went head to head with Lilly in the public battle in a US District Court in New York that dragged out over 2 months to lift an injunction that barred the public disclosure of information about the serious adverse effects of Zyprexa that Lilly had successfully kept hidden under a court order until the documents were leaked to the press in December 2006.

Lilly filed the motion for the injunction in attempt to get the documents back under seal and succeeded in muzzling just about every expert in the US involved in the fight to dismantle the mass-drugging schemes put in place by the pharmaceutical industry over the past 10 years including Dr Peter Breggin, Dr Grace Jackson, Dr David Cohen, and Dr Stefan Kruszewski, as well as the award winning journalist, Robert Whitaker, who wrote “Mad in America,” and revealed all the negative information that showed up in the clinical trials conducted on Zyprexa and the other atypicals.

The score looked bad for the home team early on when Lilly won the second round by getting the court to add the names of two of the world’s most powerful patient advocacy groups to the injunction, along with their internet web sites and leaders, including Vera Sharav, director of the Alliance for Human Research Protection, and Judy Chamberlin and David Oaks from the international organization MindFreedom, a coalition of about 100 advocacy groups in 13 different countries.

At the time, Mr Oaks said, “This appears to be about Eli Lilly using its billions of dollars to try to intimidate grassroots critics.”

The New York legal battle turned into an all out war when Ms Sharav and Dr Cohen brought in the high profile attorney, Alan Milstein, to file their own motion asking the judge to unseal the documents because they should have never been designated confidential to begin with.

“What is abundantly clear,” Mr Milstein told the judge in a hearing, “is that they are not trade secrets.”

“Lilly in no way fears dissemination of these documents to their competitors, to Merck or to Glaxo,” he said.

“What Lilly wants to prevent, is the public at large, the consumers of its products, from seeing these documents and learning the truth about the product that Lilly produces and the way it markets it,” Mr Milstein said in the hearing.

Alaskan Attorney, John McKay, stepped in to represent Mr Gottstien and his wife Terrie, and then attorney, Fred von Lohmann of the Electronic Frontier Foundation, widened the battlefield by filing a brief on behalf of John Doe, described as a citizen-journalist who wanted to publish the secret documents on web sites because they were “plainly related to a matter of overriding public concern.”

California attorney, Ted Chabasinski, jumped in the ring on behalf of Robert Whitaker, Judi Chamberlin, and David Oaks. “While the injunction purports to be an attempt to recover the documents,” he wrote in a letter to the judge, “it is clear that its real purpose is to intimidate Lilly’s critics, and the court should refuse to cooperate with this.”

Mr Chabasinski told the court that criminal charges should be filed against Lilly executives for illegally marketing Zyprexa for unapproved uses, with full knowledge that thousands of patients were being injured and killed. “If executives can go to prison for stealing their companies’ money,” he told the judge in a letter, “surely those who steal people’s lives deserve at least the same fate.”

Mr Chabasinski informed the court that the secret documents were evidence of Lilly executives’ “criminal behavior” and their “willingness to kill people for profit.” He also made it known that he was encouraging members of the public to contact state attorney generals and was directing private citizens to a list of current contact information for each state posted on the Mindfreedom web site.

And some citizens did just that. Richard Bleecker, whose nephew died unexpectedly of hyperglycemia due to Zyprexa, wrote to the New Jersey attorney general and stated: “In your capacity as New Jersey’s Attorney General, I ask that you launch an investigation into Eli Lilly’s violation of the public interest by its concealment of the risks of Zyprexa.”

“Despite the FDA restrictions on use and warning labels,” he wrote, “the drug continues to be vigorously promoted by Lilly and prescribed for patients in record numbers, including children.”

He pointed that the state itself had an interest in the matter “since government programs like Medicare and Medicaid purchase over 70% of the Zyprexa sold in the USA, taxpayers in our State as well as across the nation are footing most of the bill.”

“I appeal to you, to investigate Eli Lilly’s willingness to see patients suffer and die to enhance its profits,” Mr Bleeker wrote.

Over 10 states have now sued Lilly for Medicaid fraud over the off-label marketing of Zyprexa. And for good reason according to a report in the March 23, 2007, New York Times, that said Zyprexa costs more than $300 a month and is the single biggest drug expense for state Medicaid programs with spending of more than $1.3 billion in 2005.

During court hearings, several people restrained by the injunction testified about why the documents should be made public which resulted in media reports about what was in them before the legal battle even ended.

For instance, at a January 17, 2007, hearing, Mr Gottstein was asked, “at the time you subpoenaed Dr. Egilman, had you the impression that Eli Lilly had deliberately withheld from the public and from physicians adverse side effects of Zyprexa?”

And he answered: “Absolutely.”

He was then asked whether he feared there would be thousands more cases of harm to people from Zyprexa, while Lilly was settling cases out of court, and Mr Gottstein said yes, and that he wanted the documents released “to protect people from this drug.”

Mr Milstein told the judge that the documents were critically important to saving human lives and said, “this Court should in no way assist Lilly in keeping them from the public.”

At the same hearing, Lilly attorneys asked Ms Sharav why she was interested in the documents and she said because they documented the fact that Lilly knew in 2000, that Zyprexa caused diabetes, “from a group of doctors that they hired who told them you have to come clean.”

“And instead of warning doctors who are widely prescribing the drug, Eli Lilly set about in an aggressive marketing campaign to primary doctors,” she testified.

Ms Sharav told the court, “This is a safety issue,” and “to continue to conceal these facts” from the public “is not in the public interest.”

She said, “this is about the worst that I have seen.”

“It borders on indifference to human life,” she told the judge. “Eli Lilly knew that Zyprexa causes hypoglycemia, diabetes, cardiovascular damage and they set about both to market it unlawfully for off label uses to primary care physicians.”

She said Lilly taught primary care doctors to diagnose patients as bipolar if they experienced mania after taking antidepressants. “That is absolutely outrageous and that is one of the reasons that I felt that this should involve the Attorney General,” she testified.

Mr Sharav also objected to the off-label sale of Zyprexa to kids. “Little children are being exposed to horrific diseases that end their lives shorter,” she testified.

She said, “the reason the drug became a four and a half billion dollar seller in the United States is because they encouraged the prescription for children, for the elderly, for all sorts of reasons.”

“I consider that a major crime,” she told the judge and said she asked Mr Gottstein for 2 copies of the documents so that she could deliver one copy to the New York attorney general.

By the time of that hearing, Ms Sharav no doubt was aware that the crime was ongoing because in January 2006, USA Today reported that although the atypicals are not approved for any use with children, the prescription rate for children “is growing dramatically faster than the rate for adults,” quoting Robert Epstein, chief medical officer for Medco Health Solutions, pharmacy benefit managers.

In addition, an assessment by Christoph Correll, of the Child and Adolescent Psychiatric Clinics of North America, showed Zyprexa to be the worst of the atypicals for kids and listed the side effects of diabetes and weight gain with the drug as “severe.”

Technically, on February 13, 2007, Lilly scored a knock-out punch when the judge issued a permanent injunction prohibiting Mr Gottstein and Dr Egilman from further disseminating the documents and allowed Lilly to keep them sealed under a court order.

However, the judge also acknowledged in his written ruling that there was no way he could not enjoin the world by extending the injunction to the internet and by that time the worldwide web was flooded with all the damning information.

And Lilly would soon learn that the push to make the information public extended far beyond the courtroom. On February 23, 2007, a grass roots advocacy group issued a press release to rally support for Mr Gottstein for providing the documents to the media and to announce the “The Just Say “Know” to Prescription Drugs Campaign,” with a goal of getting one million people reevaluate the prescription drugs they were taking.

“If there is a case that dramatically highlights the need to stop blindly taking prescriptions drugs, this is it,” said Dr Greg Tefft, co-founder of the Campaign.

“We’re talking 20 million people potentially at risk and more being added daily,” he added.

The group set out to educate the public about off-label prescribing and what consumers must do to protect themselves against Zyprexa, or other drugs, when they are prescribed without warnings about side effects or unapproved uses.

“We are convinced that the way to solve this problem is to work the demand side of the market,” Dr Tefft said. “We are going directly to consumers and encouraging them to know what they are taking.”

Chairman of the Campaign, Dr Dominick Riccio, hosted a Zyprexa radio series and Dr Laurence Simon provided information to consumers about the drug and they set up an official web site for the Campaign is http://justsayknow.kpncradio.com

A month and a half later, on April 4, 2007, the ranking Republican on the Senate Committee on Finance, Senator Charles Grassley (R-Iowa), was knocking on Lilly’s door with a letter to the CEO saying, “I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.”

“I am aware of several pending products liability actions regarding Zyprexa,” he said, “and questions have been raised regarding safety information and marketing practices relating to that drug.”

Senator Grassley also wrote, “I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee,” referring to leaked documents and said, “please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available … pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.”

And in the end, it could be said that injunction or no injunction, the small group of warriors led by Mr Gottstein and Dr Egilman, who bravely banded together against the billion dollar giant helped make Lilly’s worst nightmare come true by fighting against the injunction and keeping the spotlight on the documents that the company fought so hard to keep hidden, not so much from the public, but from the stockholders.

According to legal experts, Lilly’s desperate filing for the injunction had nothing to do with the lawsuits filed by private plaintiffs because that litigation was the least of its worries being the company was settling the cases for peanuts with plaintiffs signing confidentiality agreements that would shut them up for life.

However, following the public disclosure of proof that Lilly had engaged in a 10-year illegal off-label marketing scheme while concealing the adverse effects of Zyprexa, the company was hit with the big Kahoona, when 4 class action lawsuits were filed in April 2007 on behalf of shareholders, alleging the fraud by Lilly and its top executives had cost them more than $30 billion, and the evidenced cited to support the allegations was the information from the secret documents that resulted in the battle over the injunction.

It remains to be seen whether these shareholder lawsuits will do anything to stop the drugging of kids in the US because as it stands right now the mass drugging campaign appears to be unstoppable. On September 5, 2007, Rob Waters reported that the number of antipsychotic prescriptions for children doubled to 4.4 million between 2003 and 2006, citing data provided to Bloomberg News by Wolters Kluwer NV, a drug-tracking firm.

Mr Waters also reported that the growth was most dramatic in the youngest children with 20,280 prescriptions written for kids aged 4 and younger, a five-fold increase over 2003, and with 5- to 9-year-olds, prescriptions increased almost six-fold to 710,937 in 2006.

Filed under: 2007, antipsychotics, drugging children, KOL, Zyprexa

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part I

Evelyn Pringle August 30, 2007

On August 21, 2007, the Associated Press reported that drug companies spend a lot of money on the members of Minnesota advisory panels who help select the drugs which are to be used by patients covered by Medicaid.

The news agency’s review of financial disclosure records in Minnesota found that a doctor and a pharmacist on the 8-member panel simultaneously received large checks from drug companies for speaking about their products.

According to the report, Minneapolis psychiatrist John Simon, appointed to the panel in 2004, earned $354,700 from drug makers that included Eli Lilly and AstraZeneca, from 2004 to 2006, in honoraria, speaker and consulting fees, as well as other payments ranging from $500 to $93,012.

The records also showed that Robert Straka, a University of Minnesota pharmacy professor, was paid $78,000 by drug companies while he served on the panel from 2000 to 2006. He told the Associated Press that he was paid for “educational talks” and that he routinely discloses his ties with drug companies and did so as a panel member, both verbally and in writing.

But according to information obtained with a public records request by the AP, there is no indication that Mr Straka made any such disclosures in meeting minutes dating back to February 2001, and other panel members and staff interviewed by the AP could not remember Mr Straka making any such disclosures either.

The Associated Press reported that roughly a third of the drugs on Minnesota’s preferred drug list were sold by companies which paid Mr Simon or Mr Straka, but the news agency could not track any link between the payments and their votes because the minutes from the advisory panel meetings did not record how the 8 members voted.

The top-selling drugs prescribed to Minnesota Medicaid patients for the years 2000 through 2006 included the atypical antipsychotic drugs Zyprexa, marketed by Eli Lilly; Seroquel, sold by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.

These drugs were originally FDA-approved for the limited use of treating adults with schizophrenia or the manic phase of bipolar disorder. However, the massive over-prescribing of this enormously expensive class of drugs for unapproved uses has caused many states to remove them from the Medicaid preferred drugs lists and requires doctors to obtain prior authorization before prescribing them to Medicaid patients.

In fact, roughly 10 states are now suing several atypical makers for Medicaid fraud to recoup the cost of purchasing the antipsychotics prescribed off-label to Medicaid patients and also to recover the money paid for medical care of the persons injured by the drugs.

The lawsuits allege that the drug makers illegally influenced doctors to prescribe the drugs off-label to patients of all ages, for conditions such as behavior and mood disorders, eating disorders, anxiety, post traumatic stress disorder, insomnia, PMS, dementia, and many other unapproved indications, and concealed the adverse effects associated with the drugs.

The atypical makers are also facing tens of thousands of lawsuits filed by patients, private insurance carriers and company shareholders for similar allegations.

According to Lilly’s August 6, 2007, SEC filing, since August 2006, Lilly has received civil investigative demands or subpoenas from a number of states. “Most of these requests are now part of a multistate investigative effort being coordinated by an executive committee of attorneys general,” the filing states.

“We are aware that approximately 30 states,” Lilly wrote, “are participating in this joint effort, and it is possible that additional states will join the investigation.”

The filing notes that the attorneys general are seeking a broad range of Zyprexa documents, “including documents relating to sales, marketing and promotional practices, and remuneration of health care providers.”

Presumably, that would also include the “remuneration” of Minnesota shrinks like Dr Simon. According to the August 27, 2007, Pioneer Press, since 2002, Dr Simon has received more than $570,000 from six drug makers, with most of the money coming from Eli Lilly, “whose antipsychotic drug Zyprexa is the most costly each year for Minnesota’s fee-for-service health program for the poor and disabled,” the article states.

In fact, Lilly’s disclosure records for 2004 show payments to Dr Simon totaling a whopping $91,854.95 in that one year, and he also received another couple grand from Seroquel maker AstraZeneca.

Dr Simon told the Pioneer Press that companies pay him to speak about their drugs at conferences and clinics or about the conditions that are treated with the drugs. “Most of the psychiatrists who are really good,” he said, “have ties to industry.”

Whether Dr Simon is a “really good” psychiatrist is certainly open to debate. In 1997, the state medical board made him complete a clinical training program and issued a report which said that Dr Simon, “frequently makes abrupt and drastic changes in type and dosage of medication which seem erratic, not well considered and poorly integrated with nonmedication strategies.”

The board also noted that Dr Simon prescribed addictive drugs to addicts and failed to stop giving medicines to patients when they were suffering severe drug side effects. He said in an interview with the Times that the board’s action was a learning experience and that drug makers continued to hire him to speak because he was respected by his peers.

For years, Dr Simon reportedly shared an office with another “really good” psychiatrist by the name of Dr Faruk Abuzzahab. On June 3, 2007, Gardiner Harris and Janet Roberts published a story in the New York Times with the headline: “After Sanctions, Doctors Get Drug Company Pay,” and stated:

A decade ago, the Minnesota Board of Medical Practice accused Dr. Faruk Abuzzahab of a “reckless, if not willful, disregard” for the welfare of 46 patients, 5 of whom died in his care or shortly afterward. The board suspended his license for seven months and restricted it for two years after that.

Over the past 20 years, this “really good” psychiatrist has repeatedly prescribed narcotics and other controlled substances to addicts and prescribed narcotics to pregnant women, one of whom delivered a baby prematurely that died, the board found.

The Times reports that separately, in 1979 and 1984, the FDA concluded that Dr Abuzzahab had violated the protocols of every study that the agency audited and that he reported inaccurate data to drug makers.

The FDA said he routinely oversaw 4 to 8 trials at the same time, moved patients from one study to another, gave experimental drugs to patients at their first consultation and once hospitalized a patient for the sole purpose of enrolling him in a study.

As recently as June 2006, the medical board criticized Dr Abuzzahab once again for writing prescriptions for narcotics and this time to patients he knew were using false names, according to the Times.

All that said, Dr Abuzzahab told the Times that he has helped study many popular psychiatric drugs, including Lilly’s Zyprexa and Prozac, Janssen’s Risperdal, AstraZeneca’s Seroquel, Glaxo’s Paxil and Pfizer’s Zoloft.

A review of the Minnesota disclosure records for 2004 show that the drug makers apparently thought it was beneficial to keep paying big bucks to Dr Abuzzahab. Glaxo paid him $1,000, Pfizer gave him $750, and Wyeth forked over $18,084, in that year alone.

In 2003, psychiatrist Dr Ronald Hardrict pleaded guilty to Medicaid fraud. But a little charge like fraud apparently did not effect this Minnesota psychiatrist’s earning power either. The very next year, disclosure records for 2004 show Risperdal maker Janssen paid him $10,000; Seroquel maker AstraZeneca gave $1,250; Abbott Labs paid him over $7500; Glaxo paid $1,500, and Wyeth forked over $8,846.

In reviewing the Minnesota disclosure records for 2004, the name Dr Dean Knudson kept popping up. A September 2004 Newsletter from the Ada Canyon Medical Education Consortium listed Dr Knudson as an associate professor of psychiatry at the University of Minnesota Medical School.

He must be a “really good” psychiatrist, too, because in 2004 alone, Lilly paid him close to $37,000; he earned nearly $2,750 from Pfizer; Seroquel maker AstraZeneca paid him $6,700; Janssen forked over $3750; Wyeth paid him $11,632, and he received $2,082 from Abbott. Lilly’s 2003 forms also show another $8,740 paid to Dr Knudson.

The newsletter showed that Dr Knudson was paid to give educational presentations on dementia. On October 18, 2005, the Associated Press reported a study that showed atypicals used to treat elderly patients with dementia raised their risk of death.

For the study, the researchers pooled the results of 15 studies on the atypicals Zyprexa, Risperdal, Seroquel and Abilify and among more than 5,000 dementia patients, those taking any of the four drugs faced a 54% increased risk of dying within 12 weeks of starting the drugs, compared to patients taking placebos.

Another name that jumps out in the 2004 disclosure records is Dr David Adson. According to the August 20, 2007, Pioneer Press, Dr Adson, of the University of Minnesota, also has a state advisory role as the clinical leader of a program funded by Lilly and provided free of charge to Minnesota, which notifies doctors when their prescriptions for psychiatric drugs are out of line with clinical standards.

Although the program is funded by Lilly, it is supposedly run by an independent company called Comprehensive NeuroScience, Inc. All totaled, 20 states have contracts with CNS to identify doctors “who are prescribing psychiatric drugs outside of recommended guidelines for safety and effectiveness,” according to the Press.

Critics say the program is actually a scam set up with state policy makers to make sure the expensive psychiatric drugs remain on the Medicaid covered drug lists instead of being placed on the lists that require prior authorization.

Ben Hansen, a member of the Michigan Department of Community Health Recipient Rights Advisory Committee, has been investigating the atypical makers’ involvement in the Medicaid programs in Michigan and other states and says that none of the states with CNS contracts require prior authorization for the atypical drugs.

Mr Hansen published some of the results of his investigation in the Spring 2007 Newsletter of the International Center for the Study of Psychiatry and Psychology. By using the FOIA, Mr Hansen says he has obtained nearly a thousand pages of documents which show that Medicaid is being “milked like a huge cash cow.”

According to Allen Jones, a former Medicaid fraud investigator, the long list of corporate sponsors for CNS includes: AstraZeneca, Janssen, Bristol-Myers, Pfizer, Lilly and Glaxo.

Back in 2002, Mr Jones found that Janssen was using CNS to funnel payments to state officials who controlled the Medicaid preferred drug lists in Pennsylvania to ensure that Risperdal would be on the list.

For his part, the leader of the Minnesota CNS program, Dr Adson, was paid $5,200 by AstraZeneca, Glaxo shows $331,947 going to him, and Pfizer gave him $1,000, in 2004 alone.

Also, in 2006, Dr Adson received $83,325 from AstraZeneca and roughly $6,100 from Bristol-Myers, according to a compilation of disclosure forms by the Pioneer Press and the watchdog group Public Citizen.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, KOL, MEDICAID, SSRIs, TMAP

Psychotropic Drug Makers Bankroll Prescribing Shrinks Part II

Evelyn Pringle September 2, 2007

Influence peddling in the field of psychiatry is out of control. An analysis of Minnesota disclosure records by the Pioneer Press and the consumer watchdog group Public Citizen shows that, between 2002 and 2006, 187 Minnesota doctors received payments from drug companies worth a grand total of $7.38 million.

No other field of medicine even comes close to that amount. The next highest specialty was neurology, with 99 doctors receiving $2.89 million, according to the analysis.

In psychiatry, drug makers underwrite decision makers at every level of care, according to a May 10, 2007, report by Gardiner Harris in the New York Times. “They pay doctors who prescribe and recommend drugs, teach about the underlying diseases, perform studies and write guidelines that other doctors often feel bound to follow,” Mr Harris states.

He determined that, between 2000 and 2005, payments to Minnesota psychiatrists increased more than six-fold. The Times also analyzed Minnesota Medicaid records, and the report provides details on how the financial relationships between doctors and drug makers have played a major role in the growing use of atypical antipsychotics with children.

The drugs include Zyprexa, marketed by Eli Lilly; Seroquel, by AstraZeneca; Risperdal, marketed by Johnson & Johnson subsidiary Janssen; Geodon, sold by Pfizer, and Abilify, from Bristol-Myers Squibb.

The drugs are the most powerful psychiatric drugs on the market and were FDA-approved only to treat adults with schizophrenia or adults in the manic phase of bipolar disorder.

Over the past three years, every atypical maker has come under fire for influencing doctors to prescribe the drugs off-label to children for uses never approved by the FDA, and they are all currently involved in litigation related to the illegal promotion and sales of the drugs.

A study at Columbia University on the use of antipsychotics with children found that only a small percentage of the kids on the drugs had psychotic disorders and that, most of the time, the drugs were prescribed to treat mood disorders, depression, anxiety and ADHD.

Mr Harris reports that the Minnesota psychiatrists who received the most money from the drug’s makers tended to prescribe them to kids the most often. On average, psychiatrists who received at least $5,000 between 2000 to 2005 appeared to have written 3 times as many prescriptions for kids as psychiatrists who received less or no money, the Times notes.

The rising Medicaid costs for atypicals also coincides with the rising payments to doctors. For instance, Minnesota Medicaid spent roughly $521,000 in 2000 on antipsychotics for children; but in 2005, the cost was more than $7 million, or a 14-fold increase.

In June 2007, Vermont officials revealed that disclosure records in that state showed payments to psychiatrists had more than doubled in one year, from an average of $20,835 in 2005, to an average $45,692 in 2005. There, too, antipsychotics were among the highest Medicaid drug expense.

The drug makers have shrinks in their pockets all over the country. However, only 3 states, Minnesota, Vermont and Maine, have laws that require companies to disclose their payments.

The media’s recent reporting that members of a Minnesota advisory panel who decide which drugs will be covered by the state’s Medicaid program are on the take, adds a new chapter to an old book. This same scam has been used in states all over the country since the late 1990’s, and if not for two relentless fraud investigators from Pennsylvania, the fact that the formulary committees are bought and paid for by the pharmaceutical industry might have remained a secret for all time.

The fact that drug makers were bribing state policy makers and members of advisory panels with the ultimate goal of capturing the lucrative Medicaid customer base to increase the sale of psychiatric drugs was first discovered several years ago by Allen Jones, while he was a federal fraud investigator in the Pennsylvania Office of Inspector General Bureau of Special Investigations, and Dr Stefan Kruszewski, a pediatric psychiatrist by trade, who was hired by the Pennsylvania Department of Public Welfare to review the quality of care provided to persons covered by state programs.

According to Mr Jones, “the pharmaceutical industry has systematically infiltrated the mental health service delivery system of this nation.”

“The situation uncovered in Minnesota,” he says, “will be exposed in every state that demonstrates the political will to force transparency through full disclosure of industry payments to decision makers.”

“Thinly veiled bribery of public officials by the pharmaceutical industry is a pervasive and deeply rooted problem,” he warns.

During his investigation in Pennsylvania, Mr Jones found a drug money trail to key policy officials who controlled the Medicaid preferred drug list in that state, which eventually led him to Texas and an elaborate scheme that involved influential psychiatrists, including many who served as professors at Texas universities, and state policy officials who developed the preferred drug list known as the “Texas Medication Algorithm Project (TMAP)”.

Mr Jones calls the Texas panel the “most transparent example” of industry influence, because all of the project directors had financial ties to the drug makers. It was put into effect, he says, by buying off doctors who were considered “opinion leaders” in the psychiatric field, along with state policy makers in positions of authority with control over the preferred drug lists.

For instance, Dr John Rush, from the University of Texas Southwestern Medical Center, served as the TMAP Project Co-Director with Dr Steven Shon, the Medical Director of the Texas Department of State Health Services.

Mr Jones determined that Dr Rush had received grants, research funding and served as a consultant and speaker for atypical makers Bristol-Myers, Janssen, Eli Lilly and Pfizer.

The director for the schizophrenia module was Dr Alexander Miller, of the University of Texas Health Science Center at San Antonio, who also served as a consultant, advisory board member and speaker for AstraZeneca, Bristol-Myers, Lilly, Janssen and Pfizer.

The director of the bipolar disorder module was Dr Patricia Suppes, from the University of Texas Southwestern Medical Center in Dallas, who also received grants and research funding and served as a consultant for AstraZeneca, Bristol-Myers, Janssen, Lilly and Pfizer.

Other University of Texas professors who participated in the development of TMAP included psychiatrist Dr Graham Emslie, who has received grants and research support and served as a consultant and member of speakers’ bureaus for atypical makers Bristol-Myers, Lilly and Pfizer.

Another professor, Dr Karen Dineen Wagner, was a member of the speakers’ bureaus for Janssen, Lilly and Pfizer, and a member of a scientific advisory board for Lilly, Janssen and Pfizer and received research funding from the same 3 atypical makers and Bristol-Myers.

Once the formulary was in place in Texas, the drug makers paid Dr Shon to travel around the country to convince policy makers in other states to use the TMAP model for their Medicaid approved list. Pennsylvania adopted the program and called it PennMap.

Mr Jones found that Janssen paid for Dr Shon to fly to Pennsylvania two times, and a document he obtained shows that the grant covering Dr Shon’s travel expenses was “to expand atypical usage.”

The New York Times reported that some payments were made through patient advocacy groups instead of directly to state officials. In 2002, Janssen gave the Olympia, WA, chapter of the National Alliance for the Mentally Ill a grant of $15,000 to fly Dr Shon and other Texas officials to speak to state legislators about the formulary, the Times found.

While reviewing the medical care provided to patients under state care in the summer of 2002, Dr Kruszewski immediately recognized that a mass drugging-for-profit scheme involving Medicaid patients, especially children, was taking place in Pennsylvania, and that several patients had died.

In one case, where the child fortunately survived, Dr Kruszewski found that the girl had been placed on 11 psychiatric drugs at the same time, including 5 antipsychotics, without ever being diagnosed with a psychiatric disorder. She exhibited impulsive behaviors and was mentally disabled, but there was nothing in the records to justify the use of all these drugs, he says.

According Dr Kruszewski, the atypicals are associated with an increased the risk of obesity which can lead to diabetes type II, hypertension, heart attacks and stroke. The weight of the girl who was on 11 drugs had ballooned from 106 pounds to 194, Dr Kruszewski found.

In reviewing patient records, he found a state-wide pattern where patients who were not mentally ill were placed on cocktails of 3 or more expensive psychiatric drugs at the same time and kept on the cocktails indefinitely and if patients experienced side effects from the original medications, more drugs were added to the mix.

The sheer greed evidenced by the mass drugging of patients on Medicaid all over the US, similar to that discovered by Dr Kruszewski in Pennsylvania, has forced state Medicaid programs to either put a stop to the drug maker’s encouragement of the rampant prescribing of atypicals or go broke.

For instance, Texas Medicaid was charged nearly $15 million for antipsychotics for foster children in 2004, according to the December 2006 Special Report, “Foster Children – Texas Health Care Claims Study.” In fact, Texas spent more money on antipsychotics for foster kids than any other class of drugs, and the report said, Zyprexa, Seroquel and Risperdal typically cost an average of $229 per prescription.

The report also pointed out that the drugs were not approved for children, and listed the health risks associated with the atypicals and stated, in part:

“These very powerful and expensive medications were prescribed despite a lack of studies demonstrating their safety and efficacy in children. There are questions regarding the long-term safety of these medications; documented serious side-effects include menstrual irregularities, gynecomastia, galactorrhea, possible pituitary tumors, hyperglycemia, type 2 diabetes and liver function abnormalities.”

In a May 10, 2006 Press Release, Comptroller Carole Keeton Strayhorn said she was “particularly concerned” about the use and side effects of the atypical antipsychotic drugs.

“A clear pattern of overmedication and potential misdiagnosis of foster children is evident,” she said and the “potential for Medicaid fraud and the possibility of long-term health problems in these children is alarming.”

A USA TODAY study of FDA data from 2000 to 2004 found 45 pediatric deaths in which atypicals were the primary suspect, with at least six related to diabetes and other causes ranged from heart and pulmonary problems to Zyprexa, choking and liver failure.

A 15-year-old boy died of an overdose, an 8-year-old boy died of cardiac arrest, a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin, and the youngest death was a 4-year-old boy whose symptoms suggested diabetes complications, who was also taking 10 other drugs.

A July 29, 2007, report by Robert Farley in the St Petersburg Times revealed that in the last 7 years, the cost to Florida tax payers for atypicals prescribed to children jumped nearly 500%, from $4.7 million to $27.5 million, and on average in 2006, it cost the state nearly $1,800 for each child on atypicals.

Mr Farley reported that last year, more than 18,000 kids on Medicaid were prescribed antipsychotics including 1,100 under the age of 6 and some as young as 3, even though guidelines from the Florida Agency for Health Care Administration say children younger than 6 should generally not be given psychotropic drugs and they should “only be considered under the most extraordinary of circumstances.”

According to Mr Jones, these new “miracle” drugs have proven to be no better than generics, and, “it is a statistical certainty that many lives have been lost and many others irreparably damaged.”

In September 2005, the New England Journal of Medicine, reported that although Zyprexa was the most expensive and most prescribed antipsychotic, it was the only atypical that worked slightly better than the 40-year-old generic drug, perphenazine, but the NEJM also noted that Zyprexa had more side effects. The cost for a 3 month supply of Zyprexa in September, 2005 at drugstore.com, was $1,500, while a 3 month supply of perphenazine was only $135.

And the atypical drugging for profit scheme is not limited to the Medicaid population. An analysis revealed in March 2006 by investment firm CIBC World Markets showed that in the previous 12 months, the top 20 drugs in managed care spending included Zyprexa with $2.6 billion, Seroquel at $2.5 billion, and Risperdal was $2.2 billion.

The corrupt psychiatrists in Minnesota and other states might want to think about what is happening to “professionals” who were involved in similar behavior in Pennsylvania and Texas.

In Pennsylvania, the state Ethics Commission determined that Pfizer operated its own “Advisory Boards,” comprised exclusively of formulary committee chairmen from various states who received honorariums and all-expense-paid trips from Pfizer at the same time they were evaluating Pfizer drugs for use in state mental health systems.

The Commission determined that Steven Fiorello, Director of the Pharmacy Services in the Office of Mental Health and Substance Abuse Services in Pennsylvania, and Chairman of the Formulary Committee, had used his office to obtain private pecuniary benefits for his participation in Pfizer’s advisory board meetings in New York when he received honoraria for his participation in the meetings, as well as for his presentations at conferences in Orlando, Florida and Dublin, Ireland.

Mr Jones found that Mr Fiorello traveled to Pfizer’s world headquarters in Manhattan 3 times to participate in advisory board meetings, with all expenses paid for by Pfizer, including lodging at Manhattan’s Millennium Hotel and he was paid an honorarium of $1,000 for attending each meeting.

The Commission also found a number of additional violations, including Mr Fiorello’s receipt of honoraria from other companies for whom he made presentations in connection with his public employment, and ordered Mr Fiorello to make restitution of $27,268.50 and referred the case to the Pennsylvania Attorney General’s Public Corruption Unit.

On November 21, 2006, Mr Fiorello was charged with two counts of conflicts of interest, one count of accepting honoraria and one count of failing to disclose income on annual Statements of Financial Interests. In a press release, Pennsylvania’s Attorney General stated: “As part of his responsibilities, Fiorello served on a committee that decided which drugs would be used for mental health treatment in all state hospitals – decisions which guided more than $9 million in annual drug purchases by the Commonwealth.”

He also noted that, “while Fiorello was helping to guide the purchase of various drugs by the Department of Public Welfare, he was also paid more than $12,000 by drug companies for appearances, speeches and presentations, as well as service on a drug company advisory board.”

Down in Texas, Dr Shon was fired last fall after the state’s attorney general found that Janssen had improperly influenced him to list Risperdal on the state formulary. An October 9, 2006, letter to Dr Shon from Dr Charles Bell, acting commissioner of the Texas Department of State Health Services, obtained by the Austin American-Statesman states: “It is my determination that your services are no longer required by the Department.”

“I am, therefore, terminating you as the Medical Director for Behavioral Health effective immediately,” Dr Bell wrote.

In addition, Texas is now closely monitoring the prescribing of psychiatric drugs to Medicaid patients, and several psychiatrists have been ordered to reimburse the state for the cost of the drugs they prescribed to foster children.

Texas and Pennsylvania have also recently filed Medicaid fraud lawsuits against the makers of Zyprexa, Risperdal and Seroquel, seeking to recoup the cost of the drugs prescribed to Medicaid patients, as well as the medical care for persons injured by the drugs.

Filed under: 'ADHD', 2007, anticonvulsants, antipsychotics, drugging children, Fraud, KOL, MEDICAID, SSRIs, TMAP

SSRI-Induced Akathisia’s Link To Suicide and Violence

Evelyn Pringle August 18, 2007

Medical experts have long known that the side effect associated with the class of antidepressants known as the selective serotonin reuptake inhibitors most likely to drive people to suicide or violence against others is “akathisia”.

Akathisia is but one in a long list of side effects that SSRI makers were able to keep hidden, as they settled thousands of lawsuits out of court, by obtaining court orders to seal documents produced in litigation. For instance, a 1984 Eli Lilly document showed akathisia occurred in at least 1% of patients long before Prozac was approved.

In a paper entitled, “Suicides and Homicides in Patients Taking Paxil, Prozac, and Zoloft: Why They Keep Happening – And Why They Will Continue,” Dr Jay Cohen points out that, as soon SSRI’s arrived on the market in the late 1980s, reports of sudden, unexpected suicides and homicides by patients taking the drugs began to come in.

The DSM-IV acknowledges the association of akathisia with suicidality and states: “Akathisia may be associated with dysphoria, irritability, aggression, or suicide attempts.”

According to Dr Cohen, SSRI’s can create a combination of side effects that reduce impulse control and cause severe agitation or restlessness that may become intolerable. He says, impulsive behavior coupled with impaired cognitive functioning can be dangerous.

A 1998 article on akathisia associated with Prozac and its link to suicidal ideation in the Journal of Psychopharmacology, by Roger Lane, who was working for Pfizer at the time, states in part:

“It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.

“Hamilton and Opler (1992) stated that the term ‘suicidal ideation’ to describe the apparent suicidality associated with akathisia was misleading, as the ‘suicidal ideation’ reported in patients receiving fluoxetine was a reaction to the side-effect of akathisia (i.e., unbearable discomfort and restlessness) and not true suicidal ideation as is typically described by depressed patients experiencing suicidal ideation.”

Dr Joseph Glenmullen, author of “Prozac Backlash” and “The Antidepressant Solution,” obtained a Lilly document dated November 13, 1990, from Claude Bouchy, a Lilly employee in Germany, to three executives at Lilly’s Indianapolis headquarters, complaining about directions to change the identification of events as they are reported to doctors from “suicide attempt” to “overdose” and “suicidal ideation” to “depression”.

“I do not think I could explain to the BGA, to a judge, to a reporter or even to my family,” Mr Bouchy wrote, “why we would do this especially on the sensitive issue of suicide and suicide ideation.”

Dr Glenmullen says akathisia makes people profoundly agitated, uncomfortable in their own skin and impulsive. It erodes judgment and can lower their threshold to become violent toward themselves or others, he states.

Dr Martin Teicher, an associate professor at Harvard Medical School and McLean Hospital researcher at the time, co-authored a paper with psychiatrist and psychopharmacologist Jonathan Cole on the link between Prozac and suicide back in 1990, which found that 3.5% of patients on Prozac either attempted or committed suicide due to severe agitation from akathisia.

In the paper, the authors discussed 6 cases of patients who became intensely preoccupied with suicide after taking Prozac. Dr Cole said, in an affidavit submitted in litigation on April 20, 2000, “Our purpose in writing this article was to alert the profession to an alarming, probable drug side effect which we had observed.”

“There was a very clear association,” he said, “not merely temporal, between the ingestion of Prozac and the patients’ suicidality.”

“I have also seen patients and reviewed cases,” Dr Cole stated, “where an SSRI unmistakably precipitated a driven preoccupation with suicide.”

“The SSRI drugs, as a class,” he advised, “clearly have the potential to cause, and in reasonable medical probability or certainty do cause, akathisia in some patients.”

“Although in 1997,” Dr Cole notes, “practicing physicians undoubtedly varied in their level of sophistication and knowledge about the phenomenon, the potential to cause akathisia and its potential, in turn, to trigger suicidal behavior.”

Additional evidence showing Lilly knew about the akathisia-induced suicide surfaced in an application for a patent for a second-generation Prozac pill which claimed that the new-and-improved Prozac would decrease the side effects of, “inner restlessness (akathisia), suicidal thoughts and self-mutilation.”

Besides the concealment of this adverse effect by the drug companies, another major problem in getting the word out, according to Vince Boehm, who tracks all studies and research published on SSRI’s, is that the FDA refuses to fully acknowledge the role of drug-induced akathisia in what he refers to as “this hideous equation.”

“Akathisia is up to 6 times more likely to trigger a suicide,” he states, “than any form of depression caused by life’s circumstances alone.”

“The minds inner turmoil is so intense that a person will do anything to escape it,” he says.

“The Brits, the Aussies, Canada, and the European Union,” he points out, “have all gone on record recognizing this phenomenon for all age groups.”

Judging by internal FDA documents which have surfaced in litigation, Mr Boehm appears to be correct. For instance, in a September 11, 1990, memo, FDA scientist Dr David Graham found that Lilly’s data on Prozac was insufficient to prove the drug was safe, stating: “Because of apparent large-scale underreporting, the firm’s analysis cannot be considered as proving that fluoxetine and violent behavior are unrelated.”

A more recent study in the September 2006 journal Public Library of Science (PLoS) has further verified the warnings made by many other experts, when it reported that, in addition to self-harm, SSRI’s cause some patients to become violent and homicidal.

Dr David Healy, described as “one of the three most eminent academic clinical psychiatrists in the UK,” professor David Menkes, from Cardiff University in Britain, and Andrew Herxheimer, from the Cochrane Centre, did the study to determine the risk of violent behavior in people taking SSRI’s.

As part of their investigation, the researchers reviewed all available clinical data on SSRI’s and summarized a series of “medico-legal” court cases involving patients who had became violent on SSRI’s.

One case discussed dated back to 2001, when Dr Healy testified at a wrongful death trial in Wyoming, after a 60-year-old man on Paxil shot and killed his wife, daughter and infant granddaughter before turning the gun on himself in 1998.

At trial, the jury returned a verdict for the man’s son-in-law after Dr Healy presented the jury with a summary of an unpublished company study that found incidents of serious aggression in 80 patients on Paxil, including 25 that involved homicide, and proved that the drug maker knew about the violence and suicide risks before the 1998 shootings.

Dr Healy points out a rechallenge study by Rothschild and Locke in McLean Hospital where the authors found Prozac-induced emergent suicidality associated with akathisia in several patients. In order to test whether suicidality was coincidental or associated with Prozac, they withdrew Prozac, then re-administered it, and in all three cases, the patients experienced the exact same effect. “All three patients developed severe akathisia during treatment with fluoxetine and stated that the development of the akathisia made them feel suicidal and that it had precipitated their prior suicide attempts.”

However, even more alarming, one set of patients who became suicidal on Prozac were described as follows: “[n]one had a history of significant suicidal behavior; all described their distress as an intense and novel somatic-emotional state; all reported an urge to pace that paralleled the intensity of the distress; all experienced suicidal thoughts at the peak of their restless agitation; and all experienced a remission of their agitation, restlessness, pacing urge, and suicidality after the fluoxetine was discontinued.”

Filed under: 2007, akathisia, Glaxo, KOL, Mann, Paxil, SSRIs, suicide, Teicher

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