The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Zoloft Fails to Outperform Placebo: Class Action

In the studies submitted to the FDA for approving Zoloft (a drug that has killed numerous families, babies, mothers, children), the drug maker covered up the fact that Zoloft failed to outperform placebo, according to a new consumer fraud lawsuit filed by the firms Baum, Hedlund Aristei & Goldman and Pendley Baudin & Coffin.

Many of you already know about the Irving Kirsch reports which examined the combined total of all antidepressant studies including those which were never submitted to the FDA. What you may not be aware of, is the level of manipulation required to achieve the appearance of the effect that Zoloft was as good as or better than placebo in the faked studies that were submitted. If you know of all the horrible effects (aka “side effects”) of antidepressants, you may be wondering, “Where is the supposed benefit if it is all negative, deadly stuff that we are dealing with?”

The answer is, there are no benefits compared with a placebo. According to Attorney Michael Baum of Baum, Hedlund, Aristei & Goldman, the alleged benefits were “achieved” in studies by “unblinding” which means that study researchers know who is on the drug versus who is on the placebo. When the defective unblinded subjects were removed from the study, analyses showed that Zoloft failed to outperform placebo.

This is a travesty and something that one would hope could be caught by the FDA before this drug was ever approved.

The class action is for patients who were prescribed Zoloft for depression.

For more information, see the press release here: http://www.baumhedlundlaw.com/consumer-class-actions/zoloft-placebo-efficacy-class-action.php.

Filed under: antidepressants, Baum, Baum Hedlund, SSRIs, Zoloft

Glaxo Fights Against Public Paxil Trials

Evelyn Pringle April 8, 2008

Government attorneys appointed by the Bush Administration have been supporting GlaxoSmithKline in a number of courts across the country in an effort to convince the courts that lawsuits filed by victims of Paxil-induced injuries should be dismissed before ever making it to a jury.

In fact, the Administration has spent a massive amount of tax dollars filing amicus briefs on behalf of just about every drug maker involved in litigation in an attempt to get the lawsuits filed by private citizens thrown out of court.

The government claims that, once a drug and the warnings on its label are approved by the FDA, claims alleging injuries caused by a company’s failure to warn about a risk not listed on the label are preempted.

The Bush Administration says preemption applies even when a company (1) continues to sell a drug when a risk is known; (2) fails to warn when new risks are discovered; (3) fails to send letters notifying prescribing doctors of a known risk, and (4) fails to disclose a known risk to the FDA during the approval process, or anytime for that matter. In essence, if the FDA doesn’t make the companies warn, they’re off the hook.

If the Administration is successful in obtaining immunity for these drug companies, taxpayers will be left to pay not only the costs of medical care for all persons injured by drugs but also the life-long care for persons disabled by a product.

If Americans realized what was happening, there is no way they would approve of their tax dollars being spent to help the richest industry on the planet deprive fellow citizens of their right to a jury trial.

The typical brief against a plaintiff is filed by an army of government attorneys and will include an Assistant Attorney General, a Deputy Assistant Attorney General, a United States Attorney, an Assistant United States Attorney, two Appellate Attorneys from the Department of Justice, the FDA’s Chief Counsel, and the Deputy Chief Counsel, Associate Chief Counsel, and General Counsel for the Department of Health and Human Services.

Glaxo takes things one step further by submitting government amicus briefs that were filed in other cases (not just Paxil cases) and re-files them in virtually every one of the cases filed against the company in order to bolster its preemption arguments.

In O’Neal v GlaxoSmithKline, a case involving the suicide of a 13-year-old Sacramento, California boy, Benjamin Bratt, Glaxo recently used the Bush Administration’s preemption policy to argue that the child’s family should not be allowed to sue Glaxo for failing to warn about the suicide risk.

Benjamin committed suicide on February 14, 1997 by hanging himself. His parents, Terri O’Neal and Barry Bratt, filed a lawsuit alleging that, despite knowledge of suicide risks associated with Paxil prior to 1997, Glaxo concealed the information, failed to warn doctors, the medical community, and the public and all the while the company promoted the drug as safe and effective for children.

In the lawsuit, the Bratt Family alleged that Glaxo should have warned Benjamin’s doctor about the suicide risk both through the label and through other means, such as promotion, advertising, and “Dear Doctor” letters.

On January 30, 2008, federal judge, Frank Damrell, in the US District Court, Eastern District of California, dismissed the case and ruled that all of the family’s claims were preempted. The Bratt family has asked the court to reconsider the ruling. They believe the judge committed error in essentially holding that a drug that is not safe for adults is nonetheless safe for children until proven otherwise.

The family argues that adult clinical trials conducted by Glaxo as far back as 1989 showed an 8 times increased risk of suicidal behavior for Paxil users compared to patients receiving a placebo, but that Glaxo manipulated the data to obscure the risk, and then published the false data in medical journals and articles throughout the 1990’s.

In his ruling, Judge Damrell held that, even if GSK had clinical trial data prior to 1997 that showed an increased risk of suicidality in adults, that data was not sufficient to prove the risk extended to children using Paxil.

The Court held that, because the first clinical trial of Paxil with children did not conclude until 1998, Glaxo could not have known about the suicide risks with kids before that date.

During the January 18, 2008 oral argument on the preemption motion, Judge Damrell himself pointed out that a finding of an increased risk of suicidality in adults would logically apply to children. He specifically stated:

“As a practical matter, if I see there was an association of suicide ideation with anybody and enough of it, the last person I want to see using it is a child. That may not be scientific, but I’m just talking as a grandfather and human being.”

However, in his order, Judge Damrell seems to say the exact opposite:

“That later clinical studies ultimately led to a clear signal of pediatric suicidality, and that these studies arguably reflected the initial data in 1989 and 1991 of similar associations among adults, simply does not provide ‘reasonable evidence’ of the association of pediatric suicidality in February 1997.”

“It is difficult to reconcile Judge Damrell’s statements during oral argument with his ruling,” says senior trial attorney, Ron Goldman of Baum, Hedlund, Aristei & Goldman, the law firm representing the Bratt family.

Baum Hedlund has roughly 30 lawsuits on file involving Paxil-induced suicides and suicide attempts. Over the past 18 years, the firm has handled more than 3,000 cases involving antidepressants, including Glaxo’s Paxil, Eli Lilly’s Prozac and Pfizer’s Zoloft.

The first study Glaxo conducted on children was called Study 329. The study was started in 1994, three years prior to Benjamin’s suicide, and was completed in 1998, nine months after his suicide.

Judge Damrell bought Glaxo’s argument that, because Study 329 wasn’t completed until after Ben Bratt’s death, the company could not have warned of a risk in children prior to that. But, during the four years the study was ongoing, Glaxo received numerous reports of suicidal behavior occurring in children taking Paxil.

Coupled with the risk evident from the adult clinical trials since 1989, the Bratt family argues that Glaxo could have and should have warned of the risk for all people taking the drug long before Benjamin ingested Paxil.

Coincidentally, when the study 329 was finally published, the authors stated that, “The adverse-effect profile of paroxetine in this adolescent population was concordant with that reported in studies of adult patients with depression.”

The Bratt family argues that, the question of whether reasonable evidence of an association existed between Paxil and suicidality in any population at the time of Benjamin’s death is one for the jury.

The question of what Glaxo knew and when Glaxo knew it is also a question for the jury. Glaxo’s attempt to continue the parade down this rabbit trail is simply an attempt to divert attention away from the core issue here. The decisive question in a preemption context for the Court to determine is, “was GSK ever prohibited by the FDA from issuing a warning” thus creating a direct and positive conflict. The answer is unequivocally “NO.”

Judge Damrell also held that, if Glaxo had warned about a suicide risk for kids prior to 1997, such a warning would have been subject to a misbranding action by the FDA.

According to Mr Goldman, “Under no circumstances, given the regulatory scheme, can a drug be considered ‘misbranded’ if the science supports a truthful warning of the risk of suicidality.”

“Under the law,” he says, “it is a drug manufacturer’s duty to warn of risks known or reasonably scientifically knowable.”

“A drug company that fails or refuses to conduct necessary analyses in a scientifically acceptable manner,” he states, “shirks its legal, not to mention ethical and moral, duty to the medical profession and the public.”

According to the US Supreme Court, preemption applies (1) where it is impossible for a private party to comply with both federal and state law; and (2) where the state law stands as an obstacle to the accomplishment and execution of the full purposes and objective of Congress.

“When carefully analyzed, there is absolutely no evidence showing that it would have been ‘impossible’ for Glaxo to warn of this very serious risk, an absolute requirement in cases where conflict preemption is raised,” Mr Goldman contends.

“To the contrary,” he says, “such a warning is in perfect harmony with the FDA regulations and the overarching purpose of the FDA: to promote health and safety in prescription drugs.”

In their brief filed in opposition to summary judgment, the Bratt Family stated: “GSK would like to convince this Court that it is merely a ‘puppet’ when it comes to labeling its multi-billion dollar blockbuster drug, Paxil.”

“According to GSK,” the brief notes, “it is hapless and at the mercy of the FDA when it comes to the content of Paxil’s label.”

Glaxo claims it needed the FDA’s prior approval to issue a warning. However, the attorneys in the Paxil cases point out that Glaxo itself changed the label and sent out a Dear Doctor letter warning about the suicide risk in May 2006, with no prior approval from the FDA. The FDA never objected to the letter or the strengthened warning label.

The FDA, in its amicus briefs, has asserted twisted logic in these cases because the FDA cannot force a company to add a warning to a label. On March 1, 2005, the FDA’s deputy director for the Office of New Drugs, Dr Sandra Kweder, testified at a hearing before the Senate Committee on Health, Education, Labor and Pensions, that the FDA does not have the authority to require a specific label change and that the agency has to negotiate with the companies about how things should be worded, placement, those kinds of things.

During oral argument in SSRI suicide cases, industry attorneys claim that the reevaluation of the suicide risk of all the pediatric studies on SSRIs occurred after Glaxo “voluntarily” offered up the studies to the FDA.

For instance, on December 10, 2007, during oral argument in a case in a federal court in Philadelphia, a Pfizer attorney, Malcolm Wheeler was asked by the court: “What was the tipping point then for the change in position with respect to adolescents and then later extending that to young adults up to age 24?”

Mr Wheeler replied: “The tipping point was because GlaxoSmithKline voluntarily went forward and informed the FDA of some study results and said here are these results.”

“And what the FDA did as a result of that,” he told the court, “was to conduct a new analysis, pooling the data from nine different drugs, not just SSRIs, but nine different antidepressants, to say when we pool all the data from these various antidepressants, does it indicate any signal that suggests that we ought to do something other than what we’ve done in the past?”

However, that is a gross misrepresentation of what actually happened. The truth is, according to FDA documents obtained in litigation, that the European Medicines Agency (EMEA) contacted the FDA in mid-2003 to alert officials about the hidden suicide risk in the pediatric Paxil studies.

According to a June 2, 2003, FDA email written by Dr Russell Katz to Dr Andrew Mosholder, the FDA was notified in May 2003, that suicide events were hidden under the term “emotional lability.” Dr Katz’s email states:

“We have recently become aware of a presumed association between Paxil and suicidality in pediatric patients. We received a call from the EMEA a little over a week ago.

A Dr. Raines told us that the company (GSK) had submitted data that demonstrated that use of Paxil in kids was associated with increased suicidality compared to placebo, and that the company proposed labeling changes.

“I believe she also said that it was in the news, and it was a big issue. Tom and I told her that the company had not informed us of any of this, and we agreed to look into it.”

Dr Katz told Dr Mosholder that the FDA had asked Glaxo to elaborate on the events listed under the term emotional lability and further stated:

“We received this partial response, and almost all of these events related to suicidality. The bottom line is that when data from the controlled trials in depression, OCD, and Social Anxiety are pooled, for “possible suicide related” events occurring during treatment or within 4 days after discontinuation, the rate is 0.14/patient-year on drug, and 0.05/patient-year on placebo, p=0.02.”

“We have some problems with the methodology they used to capture cases, but this is the major finding, and it has us worried,” he wrote.

“We are planning to look at the NDAs for other SSRIs to see whether or not similar events are being hidden by various inappropriate coding maneuvers, but we’d also like to compare the drugs in other meaningful ways if we can,” Dr Katz informed Dr Mosholder.

A report by Harvard psychiatrist, Dr Joseph Glenmullen, retained by Baum Hedlund as an expert witness in the Bratt case shows that Glaxo knew as early as 1989 that patients who received Paxil in clinical trials showed an 8-fold increased risk of suicidality compared to patients who received placebos. Dr Glenmullen’s report was initially filed under seal, however, on January 30, 2008, the majority of the report was unsealed.

In the report, Dr Glenmullen also notes that, when Glaxo coded suicidal behavior in its computerized database, most of the suicides and suicide attempts were coded as “emotional lability,” which he says is “a technical term for rapid mood swings, for example from crying to laughing.”

Another claim consistently made by both the Bush Administration attorneys and the attorneys for the SSRI makers, is that the FDA’s failure to make the companies issue warnings somehow means the FDA considered and rejected offers by the companies to add warnings about the suicidality risk.

However, Dr Katz specifically notes in his email that Glaxo never offered to add a warning to the label in the US, even after the FDA became aware of the increased suicide risk and discussed the issue with Glaxo.

“The sponsor has not proposed labeling changes and makes a feeble attempt to dismiss the finding,” he told Dr Mosholder in the email.

In the first SSRI case where preemption was raised (the company lost the argument), Motus v Pfizer, the judge wisely observed that, “although the FDA did not require Pfizer to include suicide-related warnings in Zoloft’s label, FDA has not prohibited Pfizer from doing so” and the “FDA never stated that it would be impermissible to include additional warnings.” Likewise, because Glaxo never sought to add a suicide warning, it is not possible that the FDA considered and a suicide warning.

On June 10, 2003, the UK’s Medicines and Healthcare Products Regulatory Agency issued the warning: “It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks.”

In the June 11, 2003 New York Times, Gardiner Harris reported that Alan Metz, the vice president for clinical development at Glaxo, said the company was not warning American doctors against using the drug with depressed children in the US.

Dr Metz acknowledged that Paxil was not approved for treating children in the US but that many doctors prescribed the drug for children anyway. Mr Harris pointed out that Glaxo had applied for approval from the FDA to sell Paxil to children with obsessive compulsive disorder and the application was pending at that time.

On June 20, 2003, the Times reported that the FDA’s reanalysis found that the risk of suicidal thoughts and suicide attempts was 3 times greater among children using Paxil, mostly teenagers, than among children given placebos.

On August 12, 2003, the Times ran a commentary by Richard Friedman, a psychiatrist and director of the psychopharmacology clinic at Weill Medical College of Cornell University, which stated in part:

“What is disturbing about the recent report is that the purported link between Paxil and suicidal thinking comes from an unpublished study sponsored by Paxil’s manufacturer, GlaxoSmithKline.”

“In fact, GlaxoSmithKline has published only one of its nine studies of Paxil in children and adolescents to date,” he reported.

In its preemption motion, Glaxo offered nothing to support the claim that the FDA had considered, much less rejected, a proposal to add a warning about the increased suicide risk for kids. In fact, the studies in question were not submitted to the FDA until 2002, when Glaxo sought approval for new uses of Paxil, meaning it would have been impossible for the FDA to have considered whether a warning was appropriate based on a risk known only to Glaxo.

To support their argument that the FDA had never rejected a Glaxo proposed warning, the Bratt family brief states: “None of the GSK employees in the past 14 years who have, or had, responsibility for communicating with the FDA regarding Paxil could point to any specific, proposed suicide or suicidality language that was rejected by the FDA.

In his report, Dr Glenmullen explains how Glaxo successfully avoided having to include a warning on the label when it obtained FDA approval for Paxil in 1992:

“GlaxoSmithKline’s ‘bad’ Paxil data made it look as if patients randomized to Paxil were no more likely to become seriously suicidal when, in fact, the correct data shows patients on Paxil were eight times more likely to commit or attempt suicide.”

“One again,” he states, “GlaxoSmithKline’s ‘bad’ Paxil numbers carried the day: The FDA approved Paxil on December 29, 1992 with no warning to doctors or patients of the significant increased risk of suicidal behavior.”

The FDA’s Dr David Graham, most famous for exposing the risks associated with Vioxx, says the government’s attempts to immunize drug companies must not succeed. In an August 30, 2005 interview with Manette Loudon, the lead investigator for Dr Gary Null, (author of numerous books including “7 Steps To Overcoming Anxiety and Depression”), Dr Graham was asked about his views on attempts to pass tort reform.

“I think it’s dangerous and wrong,” he stated. “We already have an FDA that’s been neutralized by industry and sees industry as its client.”

Dr Graham said the agency is not going to protect the average citizen from the consequences of unsafe drugs, so the only alternative is the legal system. “That’s the only way we have of getting companies to change their behavior,” he said and, “tort reform would remove that threat as well.”

“It’s basically giving companies immunity because now the people who are injured by the drugs can’t recover damages that might actually mean something to industry,” he advised.

“I mean $250,000 for damages; they blow that in one ad campaign,” he stated. “To them, that’s nothing.”

“But a lawsuit for multiple millions of dollars has more of an impact,” he added.

“Now, is that optimal?” he said. “No.”

“But the fact is that since we have a regulatory agency that doesn’t regulate and we have a public health agency that doesn’t protect the public, we have thousands of people who are being injured by products that the FDA knows are unsafe,” he told Ms Loudon.

He pointed out that the FDA knew there was a big problem with Vioxx in mid 2000, and did nothing about it. If the FDA is not going to exercise control over companies, he said, there has to be a system in place “that reins companies in.”

In addition to the agency’s failure to protect the public against Vioxx, Dr Graham also discussed the FDA’s attempts to conceal the increased suicide risks that were found in the reevaluation of the pediatric SSRI studies in early 2004. “The FDA had suppressed a report written by a colleague of mine in drug safety and had prevented him from presenting this information in an advisory committee meeting,” he explained.

“That information leaked to the media,” Dr Graham continued, “embarrassing the FDA because it had been caught suppressing very important information – that most of the antidepressants don’t work for treating children.”

He told Ms Loudon that someone in his supervisory chain at the FDA even initiated a criminal investigation to identify the person who had leaked the information to the media.

With the SSRIs, he says, the FDA should have insisted on a signed informed consent form, that said three things: (1) these are the antidepressants available and only Prozac has been shown to work for children; (2) all the other drugs are no better than placebos; and (3) all these drugs appear to have the ability to increase the risk of suicidal behavior.

As a parent, he stated, if I saw that in writing and the doctor was going to write the prescription for some drug other than Prozac, I could say, “Doc, why are you putting my child on a drug that doesn’t work in kids.”

According to Dr Graham, the FDA did not want patients to have that information, so it refused to require signed informed consent. And, the companies didn’t want parents to have that information because all of a sudden the lucrative “off-label” use of the drugs would have dried up.

Dr Graham also explained that, if the FDA pulls a drug off the market due to safety issues, it not only hurts the marketing of the drug, but also calls into question why it was approved in the first place.

“Therefore,” he said, “you get this culture of cover-up, this culture of suppression, this culture of denial, and this culture that demonstrates above all else that industry is the client and not the American people.”

Most Americans do not realize that a preemption decision on whether to throw out a lawsuit largely hinges on the judge assigned to the case. Attorneys James Beck and Mark Herrmann run the “Drug and Device Law” blog and they post their personal views on topics that arise in the defense of pharmaceutical company product liability litigation.

On May 17, 2007, they posted a piece called, “Picking Spots In Preemption Cases.” The bloggers lamented that “two adverse preemption decisions over the last couple of weeks [ ] have us scratching our heads.”

The opinions referred to were Barnhill v Teva Pharmaceuticals, No 06-0282, (SD Ala Apr 24, 2007), and Kelly v Wyeth, 2007 WL 1302589 (Mass Super Apr 12, 2007).

In their blog, Mr Beck and Mr Herrmann discuss the importance of filing preemption motions with judges who are already known to be unsympathetic to private plaintiffs who sue drug companies.

“With respect to Kelly,” they state, “the most salient point for us is why a preemption motion was brought at all in a state trial court in Massachusetts – a known pro-plaintiff jurisdiction.”

“There’s certainly no history of success with preemption motions in prescription medical product cases in Massachusetts,” they point out.

“Part of preemption strategy is choosing the jurisdictions in which such motions would have a reasonable likelihood of success,” they explain.

“In plain English, you gotta pick your spots,” the attorneys advise.

“If defendants go running helter skelter into courts filing preemption motions no matter how hostile the jurisdiction – well, the result is going to be decisions like Kelly,” they warn.

“That doesn’t do the filing defendant any good,” they state. “Nor does it do anyone else defending prescription drug cases any good.”

On the other hand, in the September 2007 paper, “The Truth about Torts: Using Agency Preemption to Undercut Consumer Health and Safety,” legal scholars, William Funk, Sidney Shapiro, David Vladeck and Karen Sokol, of the Center for Progressive Reform, discuss the importance of jury trials, and the tort system in general.

“It is less susceptible to disproportionate influence by large companies and trade associations than the federal regulatory system,” they note and explain:

“When agencies respond to such influence by failing to regulate, or by adopting inappropriately weak regulations, the tort system becomes the primary legal vehicle for consumers to obtain protection from dangerous products and services.”

“Because tort decisions are made by juries, and because plaintiffs’ lawyers have the necessary skill and incentives to seek appropriate levels of protection for consumers and patients, the civil justice system puts individual consumers on the same footing as large corporations,” according to the paper.

“Unlike the regulatory system,” the authors explain, “the civil justice system makes it possible for members of the general public to be directly involved in governing.”

“This is a crucial distinction,” they note, “since individuals normally lack the same incentives as politically appointed government officials to resolve regulatory problems in favor of regulated entities.”

They also note that, “although corporate interests expend significant resources in an attempt to populate the judiciary with industry-friendly judges in states where judges are elected, there is simply no way to ‘capture’ all the judges throughout the country’s numerous state and federal, trial and appellate courts.”

“Moreover, even where judges are elected, citizens serving on juries are responsible for making decisions about liability,” the paper concludes.

(Written as part of the SSRI Antidepressant Litigation Monthly Round-Up, Sponsored by Baum, Hedlund, Aristei & Goldmans’ Pharmaceutical Antidepressant Litigation Department)

Filed under: 2008, Baum, Fraud, Glaxo, Graham, Paxil, Preemption, suicide

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

CDC Leads SSRI Disinformation Media Blitz

Evelyn Pringle July 20, 2007

In a June 27, 2007 press release that made headlines all over the world the US Centers for Disease Control announced that birth defects associated with the use of antidepressants by pregnant women are rare. As proof for this claim, the CDC cited two new studies published in the New England Journal of Medicine.

Over the following 2 weeks hundreds of stories magically appeared in newspapers with headlines splashed all over the internet and “medical experts” appeared live on all the major television networks to tout the new studies as major health “news” in a well-coordinated media blitz clearly aimed at promoting the sale of selective serotonin reuptake inhibitor antidepressants (SSRIs) to pregnant women.

The well-coordinated blitz downplayed all the serious birth defects that have been reported in numerous studies over the past several years and all the warnings issued by the FDA over the past several years about the fetal harm known to be associated with the drugs.

The antidepressants included in the NEJM studies included Paxil by GlaxoSmithKline, Zoloft marketed by Pfizer; Prozac sold by Eli Lilly; Celexa and Lexapro by Forest Laboratories, Effexor marketed by Wyeth, Luvox by Solvay, and the generic makers of these drugs include Barr Pharmaceuticals, Ranbaxy Labs and Genpharm.

The public needs to know that the CDC study was funded in part by GlaxoSmithKline, the maker of Paxil, which carries the strongest FDA warnings about birth defects developing in infants exposed to the drug in the womb.

Experts point out that the hundreds of headlines failed to disclose the best kept secret about SSRIs – that the drugs do not work. “When tested in head-to-head competition it would take more space than a newspaper article will permit to explain how hard the researchers have to “work” to “prove” that these antidepressants work at all,” says SSRI expert, Dr Grace Jackson, author of “Rethinking Psychiatric Drugs: A Guide for Informed Consent.”

A fact also not mentioned in the headlines is that the studies were limited to women who took the drugs during the first trimester of pregnancy and the research consisted of mostly phone conversations that took place years ago with women who relied on their own memories without reviewing any medical records or actual pharmacy prescription data.

Most importantly, experts say, the researchers diluted the FDA warning about studies that found babies exposed to SSRIs after the 20th week of pregnancy, have a 6-fold increased risk of developing persistent pulmonary hypertension, a life-threatening lung disorder.

On July 19, 2006, the agency issued a Public Health Advisory and said, “the FDA has asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN.”

The Advisory warned that: “Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies” and “Babies with PPHN can be very sick and may die.”

On October 16, 2006, the first PPHN related lawsuit was filed against Glaxo on behalf of the family of an infant born with the disorder after exposure to Paxil in the womb, by Attorney Karen Barth Menzies, a partner in the Baum Hedlund law firm and the leader of the firm’s Antidepressant Litigation Department.

According to Ms Menzies, “FDA regulations require Glaxo to issue stronger warnings whenever there is reasonable evidence of an association between a serious risk and Paxil.”

She points out that research indicated the risk of PPHN in a study published more than 10 years ago on October 3, 1996, in the New England Journal of Medicine, lead by Dr Christina Chambers of the Department of Pediatrics at the University of California-San Diego.

“FDA regulations specifically state that a causal link need not be proven and allow Glaxo to issue a new warning without prior FDA approval,” Ms Menzies notes.

She reports that infants born with PPHN often require mechanical assistance to breath but 10% to 20% of infants do not survive even when they receive treatment.

The PPHN babies that do survive often experience developmental delays, brain abnormalities and hearing loss, experts say.

The headlines about the NEJM studies in the media were also misleading because the researchers did find that Zoloft and Paxil were associated with “significant increases” in specific birth defects, and stated the “current study suggests that specific SSRIs may increase the risk of specific birth defects, and further studies will need sufficient power to pursue these important clinical questions.”

Heart birth defects in infants exposed to Paxil were found to occur 3 times more often and heart defects were 2 times higher in newborns exposed to Zoloft. The CDC researchers reported that by using an “embryologically based classification” of heart defects, “we found a doubling of the risk of septal defects” associated with Zoloft use, and “a tripling of the risk of right ventricular outflow tract obstruction defects” associated with Paxil.

The studies also found a nearly 6-fold rise in the risk of clubfoot in children of women who used Paxil and reported other birth defects including (1) anencephaly, (2) craniosynostosis; and (3) omphalocele.

Anencephaly, a neural tube defect where much of the brain does not develop, was found to be 2.4 times higher, and omphalocele, a condition in which the infant’s intestine or other abdominal organs protrude from the navel was 2.8 times more prevalent overall and 6.4 times higher with Paxil.

Craniosynostosis, an abnormality in which connections of the skull bones close prematurely, was found to be 2.5 times greater, and the neural tube defect, spina bifida, a condition where the spinal column does not completely close in the first month of pregnancy, was also noted.

Experts warn that far more infants will be born with birth defects in the coming years as a result of tens of thousands of infants being exposed to SSRIs in the womb every year.

In addition to birth defects, many other serious adverse events have been found to be associated with SSRIs over the past decade. Studies have shown the drugs to be linked to suicidality, violent and homicidal behavior, abnormal gastrointestinal and uterine bleeding, fertility problems, sexual dysfunction, a decrease in bone density, and a severe withdrawal syndrome in patients and infants born to mothers taking the drugs.

The risk associated with depression in pregnancy is suicidality. But one of the world’s leading authorities on SSRIs, Dr Peter Breggin, reports that SSRIs are known to increase the risks of suicide. “In fact,” he says, “the new FDA labels for antidepressants specifically warn about SSRI-induced suicidality in youth and in young adults, the very group most likely to become pregnant.”

“The SSRIs not only threaten to cause the death of the mother through suicide but the death of the child through lethal birth defects as well,” Dr Breggin advises.

As a direct result of the industry’s control over the mainstream media, the public is never properly warned about serious risks found to be associated with a drug because if the story gets told at all, it will only be in the news for a day or two, and then “medical experts” will suddenly show up on “news” programs for 2 or 3 days in a row to present what amounts to an infomercial to discount the risks reported in the study.

The industry’s control of the media began back in the late 1990s when the ban on direct-to-consumer advertising was lifted. Since then, the industry has invested so much money in advertising that all the media companies in the US are now dependent on drug money.

Due to this control, the industry paid shills are now dispatched on a regular basis to disseminate false information about the risks and benefits of a drug using the public airwaves even when an advertisement that contained the same bogus information would result in the sanction of a drug company for presenting false and misleading information to the public.

Drug companies basically bribe the medial journals to print their studies because the editors know the company will purchase thousands of copies for distribution to prescribing doctors, with full knowledge that most doctors will never read the whole study, but will remember the misleading headline because it was published in the “reputable” medical journal.

And Big Pharma funnels money to researchers in a variety of ways. Dr Marcia Angell, a nationally recognized authority on medical ethics and a former editor of the New England Journal of Medicine, had this to say in a the NEJM in 2000, about the financial ties between the industry and researchers:

“The ties between clinical researchers and industry include not only grant supports, but also a host of other financial arrangements.

“Researchers also serve as consultants to companies whose products they are studying, join advisory boards and speakers bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings”

After a rigged study is planted in a medical journal, the next step in the marketing scam is to provide a favorable report on the findings, also ghost-written by the drug maker or a PR firm, in a press release that is sent out to all the major news outlets which guarantees that headlines about the results will appear all over the world.

From there, the company uses the media to plant feature stories to reinforce the headline of the press release and in many cases, the news articles will quote the information verbatim from the drug maker’s press release.

In the final act, the media provides the company with a platform for the “medical experts” to reach consumers to tout the new study on all the major networks in “news” segments which in turn sends patients running to their doctors with news of the miraculous new findings and demanding a prescription for the drug.

In the book, “Trust Us We’re Experts,” by Sheldon Rampton and John Stauber, the authors document the many techniques used by PR firms hired to pump out propaganda through the press and refer to the mainstream media as the “disinfotainment industry.”

They report that the psychiatric manipulation industry is enormous and pays out about $10 billion a year to propaganda experts and that about 40% of all stories in the media are planted by PR firms.

Because most news stories on radio and TV are nothing more than a rehashing of stories published in newspapers, the book notes, the news Americans receive every day amounts to nothing but propaganda.

The success of the media backed campaign to sell SSRIs to pregnant women by discounting the years of studies showing serious harm to the fetus is clear evidence that “disinfotainment industry” is still paying high dividends to all shareholders in the US.

Filed under: 2007, Baum, Birth Defects, Breggin, CDC, KOL, Paxil, PPHN, SSRIs

FDA Advisory Committee Schedules Hearing on SSRIs and Suicide

Evelyn Pringle December 5, 2006

The FDA’s Psychopharmacologic Drugs Advisory Committee will hold a public hearing on December 13, 2006, to review the adult selective serotonin reuptake inhibitor (SSRI) studies on the increased risk of suicide associated with the antidepressants.

The panel is expected to vote on whether the risk of suicidality in adults should be included in a Black Box warning on all SSRI labels, including Paxil, Prozac, Zoloft, Lexapro, and Celexa.

The fact is, the FDA has known about the increased suicide risk associated with SSRIs for over 15 years as evidenced at a September 20, 1991, hearing, at which FDA official Dr Robert Temple stated:

“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.”

Yet here it is nearing the end of 2006, and the FDA is still refusing to provide a logical answer to explain why people who were not depressed before taking SSRIs would all of a sudden commit suicide after taking the drugs.

Top experts from all over the US and abroad will be testifying at the hearing and for many it will be a repeat performance. For instance, Baum Hedlund attorney, Karen Barth-Menzies, will be testifying again. She has been battling SSRI makers for over a decade and as a result, she has obtained internal company documents that show the SSRI makers were fully aware of the increased suicide risks associated with SSRIs but instead of warning the public, they continued to promote SSRIs as safe and effective with children and adults.

“Through our Paxil litigation,” Ms Menzies says, “we obtained documents that show a seriously troubling mentality of profit over safety and a callous disregard for the welfare of children.”

“That’s about as reprehensible as you can get,” Ms Menzies says.

“The manufacturers of the SSRIs,” she states, “have continuously and adamantly denied even the possibility of a causal connection between the SSRIs and suicide, and, instead, have blamed the victim and the ‘disease.'”

“This is notwithstanding clear evidence,” Ms Menzies says, “very early on in the clinical trials of these drugs that they can cause these problems.”

“We have documents,” she notes, “obtained through discovery in our litigation showing that there was an awareness of the problem as far back as the late 1970s, long before the first SSRI, Prozac, was approved for marketing in this country.”

Over the past 10 years, in addition to representing thousands of clients in SSRI lawsuits, Ms Menzies has been a tireless advocate working to increase public awareness about the host of health risks now known to be associated with SSRIs.

After listening to her testimony before the FDA Advisory Committee in 2004, a California state Senator invited Ms Menzies to work on legislation designed to inform California healthcare providers and parents about the increased risk of suicidality in children and adolescents taking SSRIs.

She also testified at a hearing in August 2004, before the California State Senate and called for better patient informed consent on the risks associated with SSRIs.

Ms Menzies has given presentations at medical conferences in the US and other countries to warn healthcare professionals about the dangers of SSRIs.

In fact, she gave one presentation that directly addressed the FDA’s mishandling of the SSRI matter titled, “Federal Preemption – How the U.S. Food & Drug Administration Has Become an Advocate for the Drug Industry Against the Consumers It Has a Duty to Protect” – SSRIs and Collisions Between Medical, Legal and Regulatory Worlds, at the 29th International Congress On Law and Mental Health, in Paris, France, on July 2-8, 2005.

Another one of the world’s most highly respected experts on SSRIs, Dr David Healy, a professor at the Department of Psychological Medicine, at Cardiff University in North Wales, will be traveling from the UK to testify. His appearance will also be a repeat performance.

Dr Healy states that he will testify about the manipulation of the scientific data on SSRIs. “We have here,” he says, “the greatest divide in medicine between the raw data on an issue on the one side and the published accounts purporting to represent those data on the other.”

“The divide,” he says, “it is important to note, only came to light as a result of the efforts of journalists and lawyers.”

“No clinician or scientist had a hand in questioning the validity of the ‘science’,” he points out.

The most famous fraudulent study involving SSRIs is GlaxoSmithKline’s study 329, involving Paxil. The study stated that Paxil was safe, well-tolerated and effective in children, but noted that some children became emotionally “labile” while taking the drug.

“In the published version of 329,” Dr Healy points out, “suicidality vanishes under a carpet of emotional lability.”

Few readers of this paper, academic or lay, he says, would have realized what lay behind this term as it appeared in the paper. “The question of what was happening to children,” Dr Healy says, “deemed to have become emotionally labile, was picked up by journalists and lawyers rather than scientists or regulators.”

As a result of Glaxo’s application for a license for the use of Paxil to treat children with nervous disorders, he explains, the raw data from clinical trials were lodged with a number of national regulators.

“Within a fortnight of seeing the raw data in May 2003,” Dr Healy says, “after the events lying behind the term emotional lability had been clarified, the regulators in the UK issued a warning against the use of Paxil for minors.”

A few weeks later, he notes, Glaxo wrote to all doctors warning that Paxil was linked to suicidality and that withdrawal from the drug was also linked to an apparent doubling of the rate of suicidality.

“This reassessment of the data does not however represent a triumph of scientific method,” Dr Healy says, “it indicates rather a crisis triggered by media concerns.”

The final nail in the coffin as far as selling SSRIs to kids in the UK, came in December 2003, when British regulators issued a position statement that said none of the SSRIs had demonstrated efficacy in treating depression in children.

By far the most damning revelations about what SSRI makers knew about the link between SSRIs and suicide came when the British Medical Journal received internal company documents from an anonymous source that left no doubt that Eli Lilly knew about the suicide risks with Prozac years before the drug was FDA approved.

After receiving the documents, the BMJ sent them to officials at the FDA, and to US Congressman, Maurice Hinchey, who in turn sent them to psychiatrist, Dr Peter Breggin, a court-certified expert on SSRIs, and author of, “Talking Back to Prozac,” and “The Anti-Depressant Fact Book.”

After examining the documents, Dr Breggin confirmed their authenticity as those that he had evaluated in the early 1990s when he served as an expert witness in Prozac litigation and discussed when testifying during a trial in 1994.

Evidence of the hidden studies showing the suicide risk can be found in a May 1984 document presented at trial which states regarding Prozac: “During the treatment with the preparation 16 suicide attempts were made, 2 of these with success.”

“As patients with a risk of suicide were excluded from the studies,” the document says, “it is probable that this high proportion can be attributed to an action of the preparation.”

In fact, a March 29, 1985 document says that the rate of suicide with Prozac was 5.6 times higher than with the other medication imipramine and went on to state:

“The benefits vs. risks considerations for fluoxetine currently does not fall clearly in favor of the benefits. Therefore, it is of the greatest importance that it be determined whether there is a particular subgroup of patients who respond better to fluoxetine than to imipramine, so that the higher incidence of suicide attempts may be tolerable.”

On November 13, 1990, a memo from a Lilly employee in Germany, Claude Bouchy, to another Lilly employee, Leigh Thompson, regarding the adverse drug event reporting of suicide and Prozac written in response to Lilly’s request that he change the event “suicidal ideation” to “depression,” Mr Bouchy writes:

“Hans (Lilly employee) has medical problems with these directions and I have great concerns about it.

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

A second memo dated November 14, 1990, from Mr Bouchy to Leigh Thompson about adverse drug event reporting states: “I personally wonder whether we are really helping the credibility of an excellent ADE system by calling overdose what a physician reports as suicide attempt and by calling depression what a physician is reporting as suicide ideation.”

The documents also reveal how worried Lilly was about the commercial impact to the company if the truth about the Prozac-induced suicides got out. A February 7, 1990 Leigh Thompson Memo, says, “Anything that happens in the UK can threaten this drug in the US and worldwide. We are now expending enormous efforts fending off attacks because of (1) relationship to murder and (2) inducing suicidal ideation.”

On February 7, 1990, a Leigh Thompson memo also says, “I hope Patrick (a Lilly employee) realizes that Lilly can go down the tubes if we lose Prozac and just one event in the UK can cost us that.”

Dr Breggin says that after he testified in the trial in 1994, these documents seemed to just disappear, until they were handed over to the BMJ.

Filed under: 2006, Baum, Breggin, Eli Lilly, FDA, FDA hearing, Glaxo, Paxil, Prozac, SSRIs, Study 329, suicide

Glaxo Writing Checks Left and Right to Settle Paxil Legal Battles

Evelyn Pringle December 6, 2006

GlaxoSmithKline is no doubt looking forward to the New Year because the end of this one is becoming costlier by the month.

On November 1, 2006, the Associated Press reported that Glaxo had agreed to pay $63.8 million to settle a class action lawsuit with allegations that Glaxo promoted Paxil for use with children and adolescents while withholding negative information about the drug’s safety and effectiveness.

Members of the class include all US residents who bought Paxil for their children, and those people who have records of their purchase can reportedly get a full refund.

According to the Associated Press, Madison County, Illinois, Judge Ralph Mendelsohn, approved the settlement on October 6, 2006, and unsealed the agreement on October 27. The judge has scheduled a hearing for March 9, 2007 to determine whether the settlement is fair and whether the plaintiffs’ attorneys are entitled to the fee they are requesting.

Another similar class action antitrust case filed against Glaxo, on behalf of consumers and third party payers, who paid all or part of the purchase price of Paxil, was settled on April 22, 2005 for $65 million.

In that case, the plaintiff’s alleged that they were forced to pay too much for Paxil because Glaxo unlawfully maintained a monopoly and excluded competition by (1) conducting sham patent infringement litigation against generic Paxil makers which triggered automatic 30 month stays of generic competition; (2) made intentional misrepresentations to the Patent and Trademark Office; and (3) made intentional misrepresentations to the FDA which enabled Glaxo to exclude generic competition.

However, although Glaxo doled out $65 million, it refused to admit guilt. Paragraph 22 of the final Order in that case, dated April 22, 2005 states:

“Neither this Final Order and Judgment, the Settlement Agreement, nor any of its terms or the negotiations or papers related thereto shall constitute evidence or an admission by Defendant, that any acts of wrongdoing have been committed, and they shall not be deemed to create any inference that there is any liability therefore.”

What this says is that Glaxo maintains it did nothing wrong but it wrote out a check for $65 million just to get the natty little plaintiffs off its back and furthermore, the court says no inference of guilt should be drawn by the $65 million pay-off.

Fair enough, never mind the inference of guilt, but how much does this not-guilty penalty cost consumers in terms of increased drug prices?

In settling the latest Madison County class action, Glaxo also denies all the allegations, and says it will pay the $63 million to keep the cost of litigation down. However, there are indications that this case might not end as smoothly as Glaxo planned because plaintiff’s attorneys in competing class actions have filed objections to the settlement.

Jim Gottstein, an attorney who recently won a landmark case in the Alaska Supreme Court that does away with forced drugging with psychiatric medications in state institution, sees major problems with the way this latest Glaxo settlement went down.

“One of the abuses in class actions,” he says, “is defendants finding lawyers supposedly representing the class who are willing to push settlements that are unfairly favorable to the defendants, thus allowing them to limit their liability.”

“The amount and other aspects of this proposed settlement,” he notes, “raise questions about whether that has happened here.”

“It still seems like a small amount,” Mr Gottstein points out, “assuming far more than $63 million was spent on Paxil prescribed to people under 18.”

He also says the settlement may result in a large payment to the lawyers for what may not be very much work, and notes that the first time this case surfaced was when a settlement had already been secretly negotiated with the immediate effort to kill the other class actions that seemed to be proceeding along a forthright path.

These on-going legal proceedings against Glaxo seem like one never-ending vicious cycle. Glaxo overcharges consumers, then runs up legal costs for years denying the charges, and then in the end, pays millions to settle the charges but is allowed to deny guilt, and then ups the prices on its products to cover the penalty.

The latest 2 settlements are eerily similar to the fraud case Glaxo settled in the summer of 2004, in which New York State Attorney General, Eliot Spitzer, charged the company with hiding studies that “not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo.”

According to Mr Spitzer, the company had conducted at least 5 studies on the use of Paxil with children, but only published one, and even it revealed questionable results. Glaxo ended up paying more than $2 million to settle those charges and also had to agree to publish all of its clinical trials online.

How many get out of jail free cards does Glaxo get? In that case, Mr Spitzer estimated that by suppressing the studies showing that Paxil was not effective with children and that it may cause them to commit suicide, Glaxo made $55 million off prescriptions written for children in 2002 alone.

Glaxo was also recently busted for another overcharging racket across the globe. On November 9, 2006, the Comet reported that “BRITAIN’S largest drugs company is facing a bitter pill in the form of a bill from Whitehall that could be for over �1 billion.”

“An independent report on behalf of the Department of Health has revealed that GalxoSmithKline,” the Comet said, “may have over-charged the NHS by a staggering �280 million a year for at least five years.”

It seems Glaxo agreed to price cuts in talks with the British government in 1999, but the Pharmaceutical Price Regulation Scheme independent arbitration panel, set up by the Department of Health, has now determined that the company continued to bill the government the full price for 5 years after agreeing to the lower prices.

Less than 2 months earlier, on September 11, 2006, Glaxo announced that it has settled its tax dispute with the US Internal Revenue Service, in a statement to the London Stock Exchange. “This settlement resolves all the issues which were in dispute in this case,” the company said.

“Under the agreement,” Glaxo stated, “the final net cash cost to GSK will be approximately 3.1 billion dollars which covers federal, state and local taxes, interest and also the benefit of tax relief on the payments made.”

According to Glaxo, the settlement covered the dispute for the years between 1989 and 2000, which was set to go to trial in February 2007, and also covers the subsequent years of 2001 to 2005.

At the end of the statement, came the customary denial of wrongdoing. “GSK was confident of the strength of its position,” it stated, “but in view of the size of the potential financial exposure, as well as the continued level of resource being applied to the case, GSK concluded that it was in the best interests of its shareholders to reach this settlement, thereby removing the costs and uncertainty of future litigation.”

For its part, the IRS said that Glaxo will pay $3.4 billion all total, once interest is included, making it the largest single payment ever to resolve a US tax dispute.

In another potentially troublesome legal development, last month Glaxo was hit with the first of likely many more lawsuits to come, filed on behalf of an infant who was born with persistent pulmonary hypertension, a life-threatening lung disorder, following exposure to Paxil in the womb during his mother’s pregnancy.

Attorney, Karen Barth-Menzies, a partner at Baum Hedlund, a national law firm with offices in Los Angeles, Washington, DC and Philadelphia, is the lead attorney on the case, and says a study published in the New England Journal of Medicine, back on October 3, 1996, led by Dr Christina Chambers, of the Department of Pediatrics, at the University of California-San Diego, indicated an increased risk of the lung disorder in infants born to mothers who were prescribed SSRI antidepressants like Paxil.

As a follow-up, Dr Chambers and colleagues performed a study of women who gave birth between 1998 and 2003, published in the February 9, 2006, New England Journal of Medicine, that found mothers who took SSRIs in the second half of their pregnancies were 6 times more likely to give birth to babies with the lung disorder.

According to Jennifer Liakos, an associate attorney at Baum Hedlund in Los Angeles and a member of the firm’s Antidepressant Litigation Department involved in Paxil birth defect cases, between 10% to 20% of infants born with persistent pulmonary hypertension do not survive, even after they receive treatment.

Filed under: 2006, Baum, Birth Defects, drugging children, Glaxo, Paxil, PPHN, settlement, Spitzer, suicide

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