Baum Hedlund Response to British Regulators' Ban on SSRIs For Children

Baum Hedlund

December 12, 2003
FOR IMMEDIATE RELEASE

Baum Hedlund, A Law Corporation
12100 Wilshire Blvd., Suite 950
Los Angeles, CA 90025

In Response to British Regulators' Ban on SSRIs For Children
Firm Representing Thousands of SSRI Victims Expresses Grave Concerns
Over Anticipated FDA Whitewash

Los Angeles, December 12, 2003 -- Following the United Kingdom's December 10, 2003 ban on all SSRIs (except Prozac) for children and adolescents under 18, Los Angeles-based law firm, Baum Hedlund, while applauding the UK regulator's actions, expressed its continued skepticism that the FDA is gearing up for a whitewash of the SSRI suicide issue in the United States. An FDA Advisory Committee meeting is scheduled to take place on February 2, 2004 to review the SSRI suicide issue related to children and adolescents in the U.S.

"There are so many reasons we have grave doubts about the legitimacy of the February 2, 2004 meeting," stated Baum Hedlund attorney Karen Barth Menzies, "it's hard to begin." For instance, according to an October 28, 2003 New York Times article, the FDA "plans to re-examine many of the clinical conclusions made during studies of the drugs." In essence, the FDA will be second-guessing the clinical judgment of the researchers who had first-hand contact with these patients and who, at the time, determined that the patient experienced a suicidal event and in some instances came to the conclusion that the SSRI caused the suicidal behavior.

According to world renowned psychopharmacologist, Dr. David Healy, of the University of Wales College of Medicine: "The principles of clinical trial randomization mean you cannot post hoc analyze to look for confounding factors."

"The FDA's planned methodology can only lead to one conclusion -- the suicidal behavior will be minimized and the whole issue will be swept under the carpet," said Barth Menzies. "What the FDA proposes is scientifically illegitimate and predestined to reach a favorable conclusion for the drug companies," she stated. "The FDA is not looking at all of the pediatric data to determine if some events were missed or not properly recorded. The suicidal events can only decrease, thus there can be but one conclusion and that is the drugs are not to blame" she concluded.

If that were not enough, the New York Times reports that the FDA intends to "determine whether those given antidepressants may have been, in aggregate, at greater risk of committing suicide than those given inert pills. If so, the larger number of suicidal events among those given antidepressants could be explained by their increased suicidal tendencies and not to the drugs." Barth Menzies stated: "The FDA is looking for ways to explain away the higher rates of suicide, not to legitimately examine the issue. The FDA's bias could not be more plain."

The FDA has not indicated whether it will be looking into the efficacy issues related to the SSRIs, however, this would be necessary in order to balance the benefits vs. risks. A pivotal part of the British government's review concerned the drugs' lack of efficacy. The question of whether these drugs are generally efficacious has been a public issue for many years. In fact, according to an internal memorandum written by former FDA official, Dr. Paul Leber, there was some concern within the FDA that the approval of Zoloft may "come under attack" because the FDA is not "as demanding as it ought to be in regard to its standards for establishing the efficacy of antidepressant drug products."

Dr. Leber went on to state: "I have considered the fact that the evidence marshaled to support [Zoloft's] efficacy as an antidepressant is not as consistent or robust as one might prefer it to be."

According to Leber, there were a number of studies that "found no difference between placebo and [Zoloft] treated subjects." Any conclusions the FDA reaches following the February 2 meeting should include the question of efficacy.

The FDA has refused to identify who will be sitting on the advisory committee panel. Without the identities, it is impossible for the public to determine whether and to what extent conflicts of interests exist among the panelists. In fact, the first panel formed to look at the SSRI suicide issue in the UK was disbanded because some members were too closely tied financially to the drug companies.

Another cause for skepticism is that the FDA, in the past year, has joined forces with drug manufacturers and against consumers in SSRI litigation. For instance, the FDA intervened in a Zoloft suicide case in favor of Pfizer, the maker of Zoloft, after the FDA's newly appointed Chief Counsel, Daniel Troy, received a personal telephone call from Pfizer's national counsel, Malcolm Wheeler, asking for help. Alarmingly, Baum Hedlund learned that Troy worked for Pfizer during the pendency of the case. The FDA also intervened this past year to prevent a United States District Court judge in California from forcing Paxil's manufacturer, GlaxoSmithKline, to stop airing television commercials that proclaimed Paxil to be "non-habit forming."

According to lead attorney, Karen Barth Menzies: "FDA has been violating its own mandate to act in the interests of the American consuming public by taking sides with the pharmaceutical companies it is supposed to police. The problem is not only the cover-up by the pharmaceutical industry, it is the FDA's lack of objectivity, which facilitates that cover-up. The consequences of this complicity has, in far too many instances, led to tragedy and death."

A former FDA scientist who reviewed drugs for approval between 1995 and 2000, Michael Elashoff:, has stated: "[I]t was pretty well understood that if you were advocating turning a drug down -- particularly if it was from a large pharmaceutical company -- that that wouldn't be good for your career." Elashoff told PBS's Frontline that he was marginalized within the agency after he voiced his concerns about a new flu drug called Relenza.

A study released on June 1, 2003, in the Journal of the American Academy of Child and Adolescent Psychiatry: "SSRIs have become the most rapidly increasing psychotropic used to treat children and adolescents in the United States."

"According to Laurence L. Greenhill, M.D., Director of Research Unit in Pediatric Psychopharmacology at New York Psychiatric Institute,
'SSRIs like paroxetine have become the most rapidly increasing psychotropic drugs used to treat U.S. children and adolescents.'"

See:
J Am Acad Child Adolesc Psychiatry. 2003 Jun;42(6):627-33

What do we know about drug safety in children and adolescents?

NAMI's website states: "[T]he number of prescriptions for popular drugs, such as Prozac, are rising each year, with '200,000 in the past year just for the top four new medications.'" See http://knox.nami.org/youth/fda.htm

According to a study by Herman Van Praag published recently in "World Journal of Biological Psychiatry" titled "A Stubborn Behaviour: the Failure of Antidepressants to Reduce Suicide Rates," despite the increased use of antidepressants "completed suicide has remained quite stable" and "suicide attempts even seem[] to have increased."

In addition, a recent study published by Harvard psychiatrists Wilens, Biederman et al. titled: "A Systematic Chart Review of the Nature of Psychiatric Adverse Events in Children and Adolescents Treated with Selective Serotonin Reuptake Inhibitors" found that 22% of children and adolescents receiving SSRIs experience psychiatric adverse events (PAEs, or "behavioral side effects" or "disturbances in mood").

Baum Hedlund has been litigating SSRI suicide cases for over a decade and currently represents thousands of SSRI victims, including dozens of families of children and adolescents who have committed suicide or attempted suicide. The class of antidepressants known as selective serotonin reuptake inhibitors (SSRI's) includes Zoloft, Paxil, Prozac, Effexor, Celexa, and Luvox.

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The Committee on the Safety of Medicines (CSM) and Medicines and Healthcare products Regulatory Agency (MHRA) announced on June 10, 2003, that "[n]ew data from clinical trials in children and adolescents ... do not demonstrate efficacy in depressive illness ... and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behavior in the [Paxil] group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with [Paxil] compared to placebo." (Emphasis added.)

According to the Chairman of the CSM, Professor G. Duff: "[Paxil] should not be used in children and adolescents under the age of 18 years to treat depressive illness." (Emphasis in original.) (Paxil is called "Seroxat" in the U.K.)

The first group impaneled was disbanded after revelations that some of the members had shareholdings in GSK and other SSRI-producing companies.

According to Daily Mail in London, GSK may have "suppressed a series of negative studies," but, GSK has denied claims that it was involved in a cover-up.

The independent panel is in the process of "examin[ing] urgently what implications, if any, these data have for the use of SSRIs in adults ..."

The FDA issued its own warning about the use of Paxil in children and adolescents on June 19, 2003, however, it has stated that it is still examining the issue. (The UK, on the other hand, made a definitive determination re children/ adolescents -- and stated that it is still examining the issue of all SSRIs and suicide in both children and adults.)

On August 7, 2003, the New York Times reported that of the 10 experts on the 1991 PDAC panel, seven now say that "the new information [about Paxil] would prompt them to reconsider that decision, if they were asked."

The New York Times stated: "While the regulators' warnings address only Paxil, many of the experts on the 1991 panel said all S.S.R.I.'s act similarly in the body, so concerns about one could apply to all."

According to Dr. Jeffrey Lieberman, a professor of psychiatry and pharmacology at the University of North Carolina and member of the 1991 panel: "In 1991, we said there wasn't sufficient evidence to support a link between these drugs and suicide. ... Now there is evidence, at least in children, and I wouldn't rule out that it's in adults, too."

On August 22, 2003, Wyeth, the maker of a similar drug, Effexor, issued similar warnings to doctors in the US:

Safety and effectiveness in pediatric patients (individuals below 18 years of age) have not been established. In pediatric clinical trials, there were increased reports of hostility and, especially in Major Depressive Disorder, suicide-related adverse events such as suicidal ideation and self-harm. (Emphasis in original.)

In the meantime, on August 27, 2003, Pfizer released (knowing full well of the investigation of all SSRIs and suicide in children and adults in the UK) a study conducted by Dr. Karen Dineen Wagner, which, according to the author demonstrates that Zoloft is effective and safe in children and adolescents.

This same doctor, Dr. Karen Dineen Wagner, conducted FOUR Paxil studies, apparently never published, which formed the basis, in part, of the UK's ban and FDA's warning re Paxil in children and adolescents.

An October 1, 2003 article in The Guardian, a British publication, pointed out that, like Zoloft, "Dr. Wagner and colleagues ... concluded that [Paxil] was effective and well-tolerated" in children and adolescents.

Dr. Wagner reportedly has now conceded, however: "I think it requires further investigation and looking at the entire database of these medications."

The answer: "For a small number of people, there may be an increase in suicidal thoughts and behaviour in the early stages of treatment with any antidepressant, including SSRIs. This is nothing to be ashamed of. If you experience thoughts or feelings of suicide or wanting to harm yourself you should talk to your doctor as soon as possible."

On October 27, 2003, the FDA issued a Public Health Advisory regarding SSRIs and suicidality in the pediatric population, stating that "preliminary data suggest an excess of such reports for patients assigned to several of these antidepressant drugs compared to those assigned to placebo." The FDA also announced that on February 2, 2004, the FDA will hold an advisory committee meeting, which will be open to the public, concerning the issue of SSRIs and suicidality in the pediatric population.

Despite the above Public Health Advisory and announcement that an advisory committee would be assembled to examine the issue, Dr. Thomas Laughren of the FDA told a New York Times reporter: "I think probably that we have backed off a little bit from the advisory issued in June, which recommended against using Paxil." (October 28, 2003, "FDA Intensely Reviews Depression Drugs.")

On November 13, 2003, PBS's Frontline aired an exposé about the failures of the FDA in assessing the dangers of pharmaceutical drug products and discussed the FDA's inappropriately cozy relationships with the pharmaceutical industry. Not only should the SSRI-producing companies and their drugs be investigated, but the FDA should be investigated as well.

On December 10, 2003, the MHRA announced that it has banned the use of all SSRIs (except Prozac) in children and adolescents.

According to the UK regulators: "The commonest reason for discontinuation of treatment [for Zoloft] was suicidal thoughts/self harm ..." In conclusion, the MHRA stated, with respect to Zoloft: "The data show a consistently higher incidence of suicidal thoughts and self harm in children and adolescents with depression treated with sertraline [Zoloft], which is in the region of twice the apparent placebo rate." It made similar findings related to other SSRIs (except Prozac) and stated that the risk/benefit balance was unfavorable for Zoloft, Effexor, Luvox, Celexa, and Lexapro.