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

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

Suicide Prevention Drug Pushing Racket – Part II

Evelyn Pringle August 21, 2009

A recent study in the April 2009, Pharmacoepidemiology and Drug Safety journal found no change in the suicide rate in teens as a result of the regulatory ban in the UK on the use of SSRI antidepressants with children under 18, which did result in a drastic reduction in SSRI use among kids.

“Anti-depressant use in under 18 year olds halved after the warnings,” Pulse Today reported on April 24, 2009.

The research team from the University of Bristol concluded that “there was no evidence of an overall effect on suicides of regulatory action to restrict prescribing of SSRIs to young people.”

Lead researcher, Dr Benedict Wheeler, told Pulse: “We found no clear evidence of a beneficial effect on population suicide rates. However, and equally importantly, we did not find evidence of an adverse effect on suicide rates either.”

“This is important, because many mental health workers and researchers have been concerned that reduced antidepressant prescribing to children might inadvertently lead to an increase in suicides,” he said.

Athough “the rate of suicide among 15 to 19 year olds fluctuated to varying degrees in the 22 countries analysed between 1990 and 2006, there was ‘no consistent change’ in the rate of suicide after the restrictions came into place in 2003,” Pulse reported.

A year and a half ago, Medscape reported that a study found the drop in SSRI prescribing in the UK did not lead to a spike in youth suicides on February 21, 2008. The study, also led by Dr Wheeler, was published online February 14, 2008, in the BJM. The researchers set out to evaluate the impact of changing patterns of antidepressant use on suicide or self-harm in young people in the UK, following 2003 regulatory action.

“These data for England do not indicate that reductions in antidepressant use have led to an increase in suicidal behavior,” the group wrote.

“The findings are important, in that reduced access to antidepressants in young people in the United Kingdom following regulatory intervention appears not to have had an adverse impact on suicide deaths or hospital admissions for deliberate self-harm,” Dr Wheeler told Medscape.

Continuing adherence to regulatory guidance on prescribing antidepressants to young people is supported by this evidence, he added.

In a related time trend study also published online February 14, 2008 in the BMJ, Lucy Biddle, PhD, and colleagues at the University of Bristol reported that the rate of death by suicide in young men in England and Wales was the lowest it had been in 30 years.

To investigate overall suicide trends, the researchers reviewed data from 1968 to 2005 for men and women aged 15 to 34, and found suicide rates in young men aged 15 to 24 and 25 to 34, peaked in 1990 and 1998, respectively, and then showed a steady decline. In 2005, suicide rates for men in these age groups were the lowest they had been since the mid-1970s.

The researchers reported that suicide rates in young women were also at the lowest level they had been in many years and they did not find any temporal correlation between the changes in antidepressant prescribing rates and changes in suicide rates.

On February 15, 2008, a researcher in both studies, Professor David Gunnell, noted in a BBC News report that concerns about the dangers of reducing antidepressant use in children, who might therefore be at an increased risk of committing suicide, had been raised by US research.

“There’s been a greater fall in antidepressant prescribing in the UK but we have seen none of the potentially alarming upturn in suicides,” he said.

In the Medscape report, Dr Wheeler pointed out that his findings differed from those of Robert Gibbons and colleagues, who reported in the September 2007, “American Journal of Psychiatry,” that mortality rates for suicides in 5- to 19-year-olds in the US increased in 2004, following regulatory action.

In a Newsweek article titled “Trouble in a ‘Black Box’”, Gibbons went so far as to say: “I think the FDA has made a very serious mistake. It should lift its black-box warning because all it’s doing is killing kids.”

“You may induce two suicides by treatment, but by stopping treatment you’re going to lose dozens to hundreds of kids. You’re losing more than you’re saving. That’s the calculus,” said Dr Robert Valuck, of the University of Colorado Heath Sciences Center, in the Newsweek article.

In the Medscape report, Dr Wheeler noted that “critiques” of the Gibbons study in “Letters to the Editor” in the Journal, suggested that the US situation might not actually differ that much from the study findings in UK.

In fact, in one such letter, the respected British Columbia researcher, Jon Jureidini, said the Gibbons study “incorrectly analyzed the relationship between U.S. selective serotonin reuptake inhibitor (SSRI) prescription rates and suicide rates among children.”

The Gibbons study claimed there was a correlation between a 22% decrease in SSRI prescriptions and a 14% increase in youth suicide rates between 2003 and 2004, after warnings were issued by the FDA.

“As it turns out,” Dr Jureidini wrote, “preliminary figures are now available from the Centers for Disease Control (CDC), which show that fewer people under age 25 committed suicide in 2005 (when prescribing did decrease) than in 2004.”

“In the year in which suicide rates rose sharply,” he said, “there was no significant drop in SSRI prescribing.”

When broken down into separate age groups, government statistics for 2005, show the number of suicides was lower for all young people in the US, on the website of the National Center for Injury and Prevention and Control.

For children aged 5 to 14, there were only 270 in 2005, compared to 285 suicides in 2004. In the age group of 15 to 24, the number of suicides dropped to 4,139 in 2005, from 4,316 in 2004.

The statistics show that overall, when children are combined in the age group of one through eighteen, suicides fell from 1,471 in 2004, down to 1,408 in 2005. In 2006, the latest year posted, there were only 1,296 suicides in this age group.

On July 24, 2008, Pharmalot’s Ed Silverman reported on data from the Agency for Healthcare Research and Quality that showed antidepressant prescriptions rose in 2005. “The increase amounted to roughly 10 percent, and that occurred in a year in which new and controversial Black Box warnings were added to the labeling,” he wrote.

A survey of doctor and hospital visits in 2005, by the CDC, found the most commonly prescribed drugs were antidepressants, with 48% of the prescriptions written by primary care physicians.

Yet, as recently as January 30, 2009, in a Medscape Continuing Medical Education seminar, sponsored by Lexapro and Celexa maker, Forest Labs, Robert Gibbons was still saying: “we have seen in 2004 and 2005, the years for which CDC [Centers for Disease Control] has available data on youth suicide rates, the largest increases in youth suicide rates in history since they initially were monitored,” in citing his own discredited study.

“There have been significant decreases in the prescriptions overall of antidepressants to children and adolescents,” Gibbons said “And that has spilled over to the young adult and middle-aged adult range as well.”

The disclosure section for the seminar shows Gibbons has served as an expert witness for Zoloft maker, Pfizer, and Wyeth Pharmaceuticals, maker of the antidepressants, Effexor and Pristiq.

Gibbons is a Professor of Biostatistics and Psychiatry and Director of the Center for Health Statistics at the University of Illinois at Chicago College of Medicine, according to his bio on the Department of Psychiatry’s webpage.

In 2007, the American Foundation for Suicide Prevention, and Paxil maker, GlaxoSmithKline, donated between $10,000 and $24,000, to UIC College of Medicine, according to the Spring 2008 “UIC Medicine,” newsletter. Zoloft peddler, Pfizer, donated between $50,000 and $99,000.

A co-author on the Gibbons study was Dr John Mann, a former president of the AFSP, and a professor of psychiatry at Columbia University.

Columbia University’s 2007 Annual Report shows donations of between $100,000 and $499,000 from the AFSP, GlaxoSmithKline, Pfizer Incorporated and Pfizer International. The Pfizer Foundation gave $1 million or more.

The report also shows gifts of between $50,000 to $99,999 from Wyeth, the GlaxoSmithKline Foundation, Eli Lilly and Company, and the Eli Lilly Foundation.
Mann has served as a paid expert witness for antidepressant makers Pfizer and Glaxo. He testified in the only Paxil suicide-homicide case ever to make it to a jury.

During his testimony, Houston attorney, Andy Vickery, brought out the fact that Mann had received more than $30 million in research funding from drug companies over the previous decade.

Mann admitted during cross-examination that he had written in three articles that there was possibly a small, subpopulation of patients vulnerable to suicide or violence under the drug, Vickery told Lawyers Weekly.

On June 6, 2001, the jury ruled against the drug maker and found that Paxil “can cause some people to become homicidal and/or suicidal,” and awarded the plaintiffs over $6 million.

In nearly all the studies and papers published over the years that claim SSRIs work with children and do not cause suicide, the same academic quacks appear as investigators and co-authors. The list of names includes, but is not limited to, Joseph Biederman, David Brent, Jeffrey Bridge, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, Anne Libby, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, Karen Wagner and Robert Valuck.

Many of the same names also appear on the ever-growing list of so-called “Key Opinion Leaders,” who have been exposed in an investigation by the US Senate Finance Committee, under the leadership of Senator Charles Grassley, as not disclosing Big Pharma money, which thus far includes, Harvard’s Biederman, Thomas Spencer and Timothy Wilens; Nemeroff and Zachary Stowe from Emory; Melissa DelBello at the University of Cincinnati; Stanford University’s Alan Schatzberg, president of the American Psychiatric Association; Keller at Brown University; Wagner and Rush from the University of Texas; and Goodwin, the former host of a radio show called “Infinite Minds.”

Graham Emslie’s earnings from antidepressant makers were highlighted in the media last year due to his role in the “Texas Children’s Medication Algorithm Project.” Emslie was chairman of the panel that issued guidelines in 1998, instructing doctors to prescribe SSRIs off-label to children for depression.

On August 18, 2008, the Dallas Morning News ran the headline: “Conflict of interest fears halt children’s mental health project.”

“A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News reported.

Emslie “has made at least $130,000 in drug company speakers fees and consulting contracts since 2002,” the paper noted, citing University disclosure forms. Co-authors on guidelines of the “Texas Children’s Medication Algorithm Project,” include Karen Wagner, John Rush and Neil Ryan.

The SEC filings for Cypress Bioscience provide a good source for estimating the amount of money these “KOLs” are pulling in per year, from each separate company.
Keller and Nemeroff have served on the board of directors, the scientific advisory board, and as consultants for Cypress. Under their 2004 consulting agreements, the firm was required to pay $50,000 per year for services rendered up to and including “two days per fiscal quarter.” In addition, Cypress could request additional services at a rate of $5,000 per day.

Nemeroff was paid $19,000 for additional services in 2003, and Keller made an extra $18,000. For serving on the scientific advisory board, Nemeroff was paid $19,000 and Keller earned $18,000, in 2003. As members of the board of directors in 2002, they each received $24,000.

A July 25, 2002, bio for Keller in the agenda for a Cypress annual meeting, shows he was also a consultant to, “Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories.”

The bio also reports that Keller served on the scientific advisory boards of, “Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst.”

Suicide Victims on Antidepressants

In the first seven months of 2008, the “Evansville Courier & Press,” reported a near record number of 23 suicides in Vanderburgh County, Indiana. On August 11, 2008, the County’s chief deputy coroner, and a member of the local suicide prevention coalition, told the Courier that in the results of a preliminary investigation “one element” stood out: “In a majority of the cases investigated, the victim was on antidepressant medication. And none of the victims were in counseling.”

A study in the August, 2006, Archives of General Psychiatry, found children aged 6 to 18, who took antidepressants in an inpatient setting, were 52% more likely to attempt suicide in the 60 days following discharge than children who were not taking the drugs.

This study analyzed data from the national Medicaid Analytic Extract Files, including information from all 50 states, and determined that children who filled prescriptions for antidepressants after an inpatient stay were over 15 times more likely to die by suicide than kids who were not taking antidepressants.

On May 25, 2007, MedPage Today reported a study that found young suicide victims were significantly more likely to have SSRIs in their bloodstream than were young homicide or accident victims.

“In an analysis of ‘unnatural’ deaths recorded by the Virginia Medical Examiner’s Office for 1987 through 2003,” MedPage wrote, “Antony Fernandez, MD, and colleagues, found that selective serotonin reuptake inhibitors or the serotonin-norepinephrine reuptake inhibitor venlafaxine appeared significantly more often in post-mortem toxicology of suicides than of accident or murder victims.”

Studies show the SSRIs were passed out like candy to children during this time period. According to FDA estimates, in 2003, eleven million antidepressant prescriptions were written for under 19-year-olds, representing a 27% increase in 3 years.

Dr Thomas Moore, with the Drug Safety Research group, conducted a study of antidepressant use with kids during the 4-period of 1998 to 2001, and found the use of SSRIs with children doubled, and in 90% of the cases the drugs were prescribed off-label for uses not approved by the FDA.

For example, among boys 6 to 12-years-old, 52% of the prescriptions were written for attention deficit or conduct disorders, and typically, Dr Moore says, in combination with an antipsychotic or a stimulant.

There is “no scientific evidence that says that combination therapy is effective in these disorders and I know of no evidence that it is safe either,” he advises.

The study found that 17% of the children were taking drugs that were ineffective in clinical trials, and 42% were taking two or more antidepressant drugs. “So, what we are seeing is when drugs are ineffective, rather than abandoning them or trying alternatives, doctors increase the dose or combine the drugs in ways, the safety of which we are not aware,” Dr Moore warns.

Wyeth’s Effexor me-too drug, Pristiq, was approved for adults with depression in May 2008. By the end of 2008, the FDA’s adverse event reporting system showed 17 death reports for which Pristiq was listed as the primary suspect, including twelve completed suicides. Another 31 reports turned up with a search for “Suicidal Ideation.”

On July 17, 2009, a press release issued by “Wichita Family Examiner.com,” announced a “Child and Adolescent Depression Study in Wichita.” The Clinical Research Institute in Wichita, Kansas, is “looking for children from 7 to 12 years of age that are suffering with depression to participate in the trial of Pristiq,” the press release states.

“Pristiq is a FDA approved antidepressant,” the announcement states, without informing parents that the drug is not FDA approved for use by children under 18.
“Participants are compensated for their time up to $750,” according to the press release.

Suicides Skyrocket Among Young Men and Women in the Military

On July 23, 2009, the “Air Force Times,” reported that the US Senate has ordered “an independent study to determine whether an increase in military suicides could be the result of sending troops into combat while they are taking antidepressants or sleeping pills.”

Senator Benjamin Cardin (D-Md), who pushed for the study, said he does not know whether there is a link, but he believes prescription drug use, especially when it is not closely supervised by medical personnel, needs a closer look, the Times noted.

“One thing we should all be concerned about is that there are more and more of our soldiers who are using prescription antidepressant drugs … and we are not clear as to whether they are under appropriate medical supervision,” Cardin told the Times.

“Surveys … have shown that as many as 12 percent of those who are serving in Iraq and 17 percent of those who are serving in Afghanistan are using some form of prescribed antidepressant or sleeping pills,” he said. “That would equal 20,000 of our service members.”

“Death by suicide is at record levels in the armed services,” according to Dr Peter Breggin, one of the top experts on psychiatric drugs in the US.

“Simultaneously,” he says, “the use of antidepressant drugs is also at record levels.”

“The army confirms that since 2002 the number of suicide attempts has increased six-fold,” he notes. “And more than 128 soldiers killed themselves last year.”

The FDA requires antidepressant makers to list the following adverse effects on the labels of their drugs: “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity … and mania.”

“We are giving our troops drugs that provide a prescription for uncontrolled, disinhibited violence, including agitation, irritability, impulsivity, hostility, and aggressiveness,” Dr Breggin points out.

“During Vietnam, a mere 1% our troops were taking prescribed psychiatric drugs,” he reports. “By contrast, in the past year one-third of marines in combat zones were taking psychiatric drugs.”

“Instead of shortening tours of duty, instead of temporarily removing stressed-out soldiers from combat zones, and instead of providing counseling–the new army policy is to drug the troops,” he notes.

In his latest book, “Medication Madness,” Dr Breggin describes dozens of cases in which peace-loving citizens became suicidal, violent and psychotic from taking antidepressants.

As of July 19, 2009, on the website, “SSRI Stories – Antidepressant Nightmares,” (http://www.ssristories.com), there were over 3,200 news stories, mainly criminal in nature, that have appeared in the media (newspapers, TV, scientific journals), or were part of testimony at FDA hearings on SSRIs in either 1991, 2004 or 2006, in which antidepressants are mentioned.

“Even these 3200+ documented stories only represent the tip of an iceberg since most stories do not make it into the media,” the website points out.
Drugs Drugs and More Drugs

From 1996 to 2006, prescriptions for psychiatric drugs in the US increased by 73% among adults and 50% with children, according to a study in the May/June 2009 issue of the journal “Health Affairs.”

Another study in the same issue, found spending for mental health care grew more than 30% over the same 10-year period, with almost all of the increase due to psychiatric drug costs.

According to the latest statistics from the Agency for Healthcare Research and Quality, the number of people treated for mental disorders increased from 19 million to 36 million between 1996 and 2006. “The overall treatment costs for mental disorders rose from $35 billion (in 2006 dollars) to nearly $58 billion, making it the costliest medical condition between 1996 and 2006,” Medical News Today reported on August 5, 2009.

The “National Survey on Drug Use and Health,” published by the Federal Substance Abuse and Mental Health Services Administration, in December, 2008, reported that in 2007, 10.9 percent of adults aged 18 or older, or an estimated 24.3 million persons, had experienced serious psychological distress in the past year, and 44.6% had received mental health services in the past year.

Of those adults who received services, 87% were given prescription medication, and 34.6% received drugs only. In contrast, only 10.7% received outpatient treatment alone with no medication.

The successful peddling of the new generation of psychiatric drugs, evidenced in the ten year period above, was accomplished through a suicide prevention racket. However, in 1996 there were 30,903 suicides in the US, and in 2006, there were 33,292, according to the National Center for Injury Prevention and Control.

Written for Natural News

Filed under: 2009, AFSP, antipsychotics, drugging children, front groups, KOL, Mann, military, Natural News, SSRIs, suicide, TMAP, veterans

SSRI Pushers Under Fire

January 2, 2009 Evelyn Pringle

Throughout the 1990′s, most doctors who attended conferences, medical seminars and other events were not aware that the so-called “key opinion leaders” encouraging them to prescribe the new generation of antidepressants for everything under the sun, including to children as young as infants, were nothing more than highly paid drug pushers for Big Pharma.

For years, the research that showed SSRI antidepressants (selective serotonin reuptake inhibitors) were dangerous and practically useless was kept hidden, while the studies published and presented to potential prescribers painted a glowing picture of success. These days, a person would be hard pressed to find someone who does not have a family member or friend labeled mentally ill and taking drugs like Prozac, Paxil, Zoloft, Lexapro and Celexa, or their chemical cousins Effexor, Cymbalta and Wellbutrin.

About once a year, a new round of headlines about all the money made by the SSRI pushers comes and goes; but nothing really ever seemed to stick, until now.

The Senate Finance Committee, with the ranking Republican, Senator Charles Grassley, leading the charge, is investigating GlaxoSmithKline regarding new revelations in a report filed in litigation showing that the company manipulated the numbers on adverse events related to suicidality in clinical trials back in 1989, to make it appear that Paxil did not increase the risk of patients experiencing suicidal behavior when, in fact, trial subjects on Paxil were eight times more likely to attempt or commit suicide than patients taking placebos.

Quite a few of the top pushers are also under investigation by the Committee due to revelations that millions of dollars has changed hands between the SSRI makers and the academics who signed off on some of the most fraudulently reported research in the history of modern medicine. A full list of names is easy to compile by scanning the literature on SSRI studies conducted on children. The same names appear repeatedly.

In alphabetical order, the Fortune 500 team of pushers, at a minimum, includes Drs Joseph Biederman, David Brent, Jeffrey Bridge, Daniel Casey, David Dunner, Graham Emslie, Daniel Geller, Robert Gibbons, Frederick Goodwin, Martin Keller, Andrew Leon, John Mann, John March, Charles Nemeroff, John Rush, Neal Ryan, David Shaffer, and Karen Wagner.

Truth Buried in Litigation Graveyard

On February 6, 2007, the world famous historian on psycho-pharmacology, Dr David Healy, published a commentary entitled, “Why you should never trust new wonder drugs,” in the UK’s Daily Mail stating:

“Ten years ago, I sat faced with boxes and boxes that contained a dirty secret. Inside were thousands of confidential internal company documents about Prozac.”

“The secret they revealed was that public statements about the safety of the drug were a lie; that the company knew Prozac was responsible for a raised risk of suicide and was only slightly more effective than a placebo.”

Several years later, Dr Healy recounts, he was faced with the secrets of Paxil. “No one outside the two companies, and few within them,” he writes, “knew what those boxes contained; I saw them because I was an expert witness in a court case.”

“Documents prised out of companies by American court cases,” he says, “have become the main way we have of discovering the truth about some of our best-selling drugs.”

“The scientific literature, the very place doctors would look for a warning,” he writes, “contained barely a hint of problems.”

“What’s more, no one seems likely ever to have to answer for what appears to be fraud,” he points out.

“In other organizations when evidence of disregard for public safety emerges, heads roll,” Dr Healy said. “But there have been no resignations following these drug disasters – barely a flicker of embarrassment.”

The UK’s medicines “watchdog,” the British Medicines and Healthcare Products Regulatory Agency, he reports, “has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue.”

“And no one in Britain,” he points out, “has any means of finding out why their husband or child might have died.”

Seven years before Dr Healy wrote this commentary, in a Prozac case for which he served as an expert witness, the plaintiff’s legal team learned that Eli Lilly had withheld evidence in a jury trial when the May 7, 2007 Boston Globe reported that Lilly had agreed to pay $20 million for the rights to a patent on a new version of Prozac that would reduce “akathisia,” the very side effect long believed to increase the risk of suicidal behavior, three months before the trial began.

While testifying under oath, Lilly researcher, Gary Tollefson, had told the jury, “there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence.”

When in fact, the wording in the patent for the new formula stated “fluoxetine (Prozac) produces a state of inner restlessness (akathisia), which is one of its more significant side effects,” and the “adverse effects which are decreased by administering the R(-) isomer of fluoxetine include but are not limited to headaches, nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts and self mutilation.”

Patients who lived to talk about a failed suicide attempt have described the SSRI-induced akathisia, as being so unbearable that their only option for relief seemed to be death.

America’s Most Wanted

Dr Daniel Casey was a major player in the SSRI drug-push and useful in many ways to the companies promoting the drugs. He was the chairman of the very first FDA advisory committee that met in 1991, to decide whether a warning about the increased risk of suicide should be added to the label of Prozac, the first SSRI approved in the US, and voted it down. He was also the chairman of the advisory panel that voted to approve Zoloft for Pfizer later that same year.

Bob Sorenson was a sales representative for Pfizer for 21 years. He moved to Oregon shortly before Zoloft was approved. During the first week at his new location, Pfizer’s chief of marketing at the time told him he needed to start calling on a doctor by the name of Dr Daniel Casey at the V.A. in Portland because he was very important to the company.

Dr Casey worked at the V.A., but never treated patients for depression, Mr Sorenson says. “His expertise [was] psychotropic drugs and experimentation.”

The chief of marketing said he was interested in finding out what Dr Casey thought of the company’s new drug, Zoloft. The company tried to call on him that day, but Dr Casey was not in. Mr Sorenson called on him later in the week and learned that Dr Casey was the lead investigator on Zoloft, which was up for approval by the FDA advisory committee Dr Casey chaired.

“He said I shouldn’t be there, but I did ask how it looks for the drug and he said very well,” Mr Sorenson recalls.

Dr Casey ended up making a ton of money from Zoloft. “He told me personally one time that he made enough from Pfizer in one year to purchase two cars,” Mr Sorenson reports.

Dr Casey became a member of Pfizer’s Advisory Board for Zoloft, which meant “all expense paid trips,” including honorariums, to anywhere Pfizer wanted him to advise, at any location in the world, Mr Sorenson explains.

“Many speakers were sought out that would only give lectures that put Zoloft in a positive light,” he notes, “there was no room for a balanced lecture.”

“Dr Casey later became one of the most sought after speakers for the Pfizer promotion of Zoloft,” he says, “the reps loved him because of his positioning of Zoloft.”

Mr Sorenson was often told to take information to speakers, “including Dr Casey, to have them add the information to their lectures,” he reports. “I look back at it now and see how wrong it was,” he states.

“As far as the suicide issue,” Mr Sorenson says, “the standard company line was that parents and doctors should be monitoring these kids because after being on Zoloft they finally feel good enough that they can carry out their suicide tendencies.”

“Another tactic was to blame Paxil and Effexor,” he recalls, “it was those drugs that caused suicidal tendencies, not Zoloft.”

“Finally,” he notes, “the statement was made that if they didn’t take Zoloft, they probably would have committed suicide anyway.”

Sales reps would practice and rehearse these statements at sales meetings to be able to respond to concerns or objections raised by Doctors about Zoloft’s relationship to suicidality, he says. “There would be contests as to who could detail the drug the best with objections,” he recalls.

Pfizer was able to get rid of employees and still keep them quiet, he says, by offering severance packages of up to a year’s salary, while forcing them to sign a confidentiality agreement, in which they promised not to sue, or speak adversely about Pfizer, as part of the deal.

Many people were so surprised at being terminated that they felt forced to sign because Pfizer kept the pressure on, he explains. They feared they wouldn’t find another job before financial problems set in, but regretted signing the agreement later, he says.

Mr Sorenson did not sign an agreement when he was fired. His young son had developed cancer, but Pfizer expected him to continue to attend out-of-town meetings and refused to believe that his son was terminally ill, he recalls. After 20 years with the company, Mr Sorenson was let go when he insisted that he needed to remain near his dying son and distraught wife. The Sorenson’s son passed away on April 1, 2005.

Going rate for Legal Drug Pushers

SEC filings for Cypress Bioscience provide a good source for estimating how much money legal drug pushers can make each year, from each company, because the names of several appear in these filings. According to its website, “Cypress Bioscience is committed to developing and commercializing pharmaceutical products and personalized medicine laboratory services that allow physicians to serve unmet medical needs.”

Drs Martin Keller and Charles Nemeroff, two of the most prolific depression-mongers, have served on the company’s board of directors, on its scientific advisory board and as consultants for this company. Under their 2004 Consulting Agreements, Cypress was required to pay them $50,000 per year for services rendered up to and including “two days per fiscal quarter.” In addition, the company could request additional services at a rate of $5,000 per day.

During 2003, Dr Nemeroff was paid $19,000 for additional services under his agreement, and Dr Keller was paid an extra $18,000. But they were only making $2,000 per day that year. As members of the Psychopharmacology Advisory Board, Dr Nemeroff earned $19,000 and Dr Keller $18,000 in 2003.

For their service as directors of the company in 2002, they each received $24,000. They were also offered stock options regularly. Cypress is only company. A bio on Dr Keller in a July 25, 2002 agenda for an annual meeting states that he is also a consultant to, “Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, Janssen, Merck, Inc, Organon, Otsuka Pharmacia/Upjohn, Pharmastar, Pfizer, Inc. and Wyeth-Ayerst Laboratories.”

It also shows he serves on the scientific advisory boards of, “Bristol-Myers Squibb, Cephalon, Cyberonics, Inc., Eli Lilly, Forest Laboratories, Merck, Inc, Mitsubishi, Organon, Pfizer, Sepracor, Scirex, SmithKline Beecham, Somerse, Vela Pharmaceuticals and Wyeth-Ayerst.”

Dr David Dunner and a few more of the usual suspects appear in the Cypress SEC filings as advisory board members as well.

Dr Nemeroff’s role in the prostitution of research is legendary. In April 2004, Shannon Brownlee, author of, “Overtreated,” wrote an article in the Washington Monthly entitled, “Doctors Without Borders,” after he was caught failing to disclose his financial ties to the companies whose treatments he promoted in a paper in Nature Neuroscience, and noted:

“With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest.

“A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst–indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness.

“He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers’ bureaus, delivering talks–for a fee–to other physicians on behalf of the companies’ products.”

Dr Nemeroff stood to “reap as much as $1 million in stock” from just one company that manufactured one of the products in his Nature Neuroscience paper,” she noted.

“But the drug industry’s most powerful means of boosting the bottom line is funding research,” Ms Brownlee writes, “which allows companies to control, or at least influence, a great deal of what gets published in the medical journals, effectively turning supposedly objective science into a marketing tool.”

She notes how companies are able to routinely delay or prevent the publication of data and specifically how the majority of studies which found antidepressants to be no better than placebos, “never saw print in medical journals.”

In conclusion, she states, “I’m struck more than anything by the apparent lack of shame among clinicians when it comes to this issue.”

Two years later, on July 19, 2006, the Wall Street Journal reported that the journal, Neuropsychopharmacology, published by the American College of Neuropsychopharmacology (ACNP), planned to publish a correction of a favorable review of a new depression treatment device because it failed to list the ties of the eight academic authors to the device maker, Cyberonics, including lead author Dr Nemeroff, the editor of Neuropsychopharmacology at that time. The FDA had approved the VNS device in July 2005 over the objections of “more than 20″ FDA scientists, Bloomberg reported a day earlier on July 18, 2006.

“This is about as classic an example as you’ll ever find of conflict of interest and manipulation by thought leaders who are beholden to corporations,” Dr Bernard Carroll, a member of the ACNP, told Bloomberg. “This article is a piece of a slick, skillfully coordinated PR campaign directed by the corporation,” he said.

Ten days before the Wall Street Journal article, Cyberonics had sponsored a little noticed symposium on treatment-resistant depression at the annual Collegium Internationale Neuro-Psychopharmacologicum Meeting. The main presenters at the July 9, 2006 event were Drs Nemeroff, Dunner, and Keller (the lead author of the infamous Paxil “Study 329″ on adolescents).

“In recent years, new treatment modalities have emerged, among them, the only FDA-approved treatment option specifically designed for this patient population, VNS Therapy,” Dr Dunner stated in a press release for the event.

Dr Dunner was one of the authors vouching for the new device in the Neuropsychopharmacology paper. However, a “stamp of approval” from this guy should be taken with a grain of salt. Back in March 1995, he also vouched for Paxil as lead author of a study titled, “Reduction of suicidal thoughts with paroxetine in comparison with reference antidepressants and placebo,” in the journal of European Neuropsychopharmacology. However, he later admitted that he never reviewed any of the actual data from that study.

Dr Nemeroff apparently learned nothing from the public embarrassment of the previous scandals. Last week, he was forced to step down as Chair of Emory’s psychiatry department. According to a December 23, 2008 posting by Ed Silverman, on the popular blog, Pharmalot:

“Under pressure from a US Senate Finance Committee investigation, renowned psychiatrist Charles Nemeroff is giving up the post he held for 17 years and must follow new restrictions on his outside activities, according to an Emory University statement.”

“Emory’s own investigation found Nemeroff received more than $800,000 from Glaxo, which paid Nemeroff more than any other drugmaker, but he never reported the fees. There were more than 250 speaking engagements between 2000 and 2006.”

“Moreover, Emory will not submit any National Institutes of Health grant or other sponsored grant or contract requests in which Nemeroff is listed as an investigator or has any other role for a period of at least two years,” Pharmalot reports.

All total, Dr Nemeroff earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to the Senator.

Dr Keller’s disclosure records are under investigation as well He also appears center stage in a new book by former Boston Globe reporter, Alison Bass, called, “Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial.” The book contains a treasure trove of insider revelations with specifics on Dr Keller’s endless conflicts of interest, along with other academics on the take. However, Ms Bass first broke the Keller story back on October 4, 1999, in the Globe, when she reported that he was forced to forfeit “hundreds of thousands of dollars” in state grant money in 1998.

She explained how in the same year that Dr Keller authored a review article in “Biological Psychiatry,” and concluded that the newer antidepressants Zoloft, Bristol-Meyer’s Serzone, and Wyeth’s Effexor were more effective, he received $77,400 in personal income and $1.2 million in research funding from Bristol-Myers, as well as $8,785 in personal income from Wyeth.

In “Side Effects,” she notes that Dr Keller did not report any income to the IRS from Glaxo for 1998, but says he did receive money from the Paxil maker, and also earned $62,500 from Celexa maker Forest Labs that year.

Dr 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 in 1998, and received $218,000 in personal income and more than $3 million in research funding from Pfizer the same year, Ms Bass reports.

The “colleagues,” referred to include the all-time champion of child drugging, Dr Joseph Biederman, the main promoter of the bogus epidemic of childhood bipolar disorder. He too is under investigation for taking $1.6 million from drug companies between 2000 and 2007, and only disclosing a fraction of that amount to Harvard. On December 30, 2008, Harvard’s teaching hospital, Massachusetts General announced that Dr Biederman was no longer participating in several industry-funded trials and had agreed to “not to participate in any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements.”

In most of the SSRI trials conducted on children, “colleagues,” will also include Dr Graham Emslie of Prozac fame, and the Zoloft Czar, Dr Karen Wagner, both from the University of Texas.

Back in April 2004, the British Medical Journal published a paper by a research team led by Dr Jon Jureidini, head of the department of psychological medicine at Women’s and Children’s Hospital in Australia, after a review of the clinical trial data on the safety and efficacy of antidepressant use with children. The review included the published trials, along with some unpublished data made public by the Committee on Safety of Medicines in the UK.

The Australian team was extremely critical of the published papers on the major trials of Prozac, Paxil and Zoloft, with Emslie, Wagner and Keller listed as lead authors. “In discussing their own data,” the team wrote, “the authors of all of the four larger studies have exaggerated the benefits, downplayed the harms, or both.”

“It is vital,” they wrote, “that authors, reviewers, and editors ensure that published interpretations of data are more reasonable and balanced than is the case in the industry-dominated literature on childhood antidepressants.”

Seven months later, the New York Times ran a report by Barry Meier on November 29, 2004, throwing another spotlight on the trail of corruption within the SSRI research factories, and zeroed in on Dr Wagner. He noted that, from 1998 to 2001, she was one of several researchers participating in more than a dozen industry-funded pediatric trials of antidepressants and other drugs, and that some of the results were published, but many were not.

In her Zoloft study, Dr Wagner acknowledged that she had received “research support” from several drug makers including Pfizer, which paid $80,000 to the center in connection with the test, Mr Meier reports. But she did not state that she received “sizable payments” from Pfizer for work related to the study, he says.

The same month that patients were first recruited for the Zoloft trial, in a financial filing with the school in December 1992, Dr Wagner reported that she received more than $10,000 from Pfizer, with no further details. A lawyer for the school told Meier that Dr Wagner said Pfizer had paid her $20,500 during the course of the Zoloft trial. But records for payments she received in speaking and consulting fees could not be located.

In September, Dr Wagner’s name was added to the Senator Grassley’s investigative roster, along with Dr John Rush. Between 2000 and 2005, Glaxo alone paid Dr Wagner $160,404, but only $600 was disclosed to the University, according to the Senator. She was also paid over $11,000 in 2002, by Eli Lilly, and that money was not disclosed either. Lilly paid Dr Rush $17,802 in 2001, but he only reported $3,000, Senator Grassley said.

Dr Emslie’s financial trail to the drug makers gained media attention last summer due to his prominent role in the “Texas Children’s Medication Algorithm Project,” and the creation of a drug formularies for children. He was chairman of the panel that wrote guidelines instructing doctors to prescribe SSRIs off-label to kids for depression in 1998. On August 18, 2008, the Dallas Morning News ran the headline: “Conflict of interest fears halt children’s mental health project.”

“A state mental health plan naming the preferred psychiatric drugs for children has been quietly put on hold over fears drug companies may have given researchers consulting contracts, speakers fees or other perks to help get their products on the list,” the News reported. University disclosure forms indicate that Dr Emslie “has made at least $130,000 in drug company speakers fees and consulting contracts since 2002,” the paper noted.

In discussing the investigation of Dr Wagner on the Senate floor, Dr Grassley pointed out that she was a co-author on Paxil Study 329. In 2001, when the study was published, Glaxo “reported paying her $18,255,” he said. “Study 329 was cited in a New York case where GlaxoSmithKline was charged with ‘repeated and persistent fraud,’” the Senator added.

Dr Emslie was also a co-author on the Paxil study and a check of the full list for 329, reveals that 5 of the co-authors appear with Dr Emslie on the guidelines for the “Children’s Medication Algorithm Project,” including Karen Wagner, Boris Birmaher, Barbara Geller, Neil Ryan and Michael Strober. Dr Rush’s name is also on the Texas guidelines but he moved to Singapore last August.

Filed under: 2009, Baum, Birth Defects, Glaxo, KOL, Mann, Paxil, SSRIs, suicide, TMAP

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