Will British Ban Spur FDA to Act?
By Kelly Patricia O Meara
Insight on the News - Features
Issue: 03/16/04

For several years a TV commercial has been running in the United States in which a small black circle with a sad face slowly, almost desperately, flops across a stark white screen while a narrator soothingly explains that depression doesn't have to be a part of everyday life. But with help from the antidepressant drug being advertised the sad face becomes a smile, happily floating across the screen to indicate how beautiful life can be with the aid of the mind-altering drug.

Microscopic writing at the bottom of the TV screen advises that depression "may be due to a chemical imbalance," a kind of assurance that the alleged mental disorder for which the drug is recommended is a product of a measurable physical malady confirmed by scientific evidence. Although "may" is the operative word, a "chemical imbalance" sounds scientific. Never mind, experts say, that there is nothing in the medical literature to establish what qualifies as a healthy "chemical balance," let alone what does not.

Critics of the use of mind-altering drugs for alleged mental disorders contend that it is precisely this kind of misinformation that has led tens of millions of people to rush to these new "feel-good" drugs which, in fact, have turned the mood in some of those taking them from down to deadly.

That may be why a recent decision by the British Committee on Safety of Medicines (CSM) may tilt the balance in the debate whether antidepressants hurt more than they help. The CSM is an arm of the Medicines and Healthcare Products Regulatory Agency, the United Kingdom's equivalent of the U.S. Food and Drug Administration (FDA).

The information the CSM provided is so damning that manufacturers of many of the most-widely prescribed antidepressants may find it necessary to add a disclaimer to their feel-good commercials saying that the drugs may cause violence and suicide in children younger than 18. And it is precisely this finding that led the United Kingdom effectively to ban or "contraindicate" the use of most antidepressants by children youn-ger than 18.

Last year, after concerns were raised about patients becoming suicidal while taking antidepressants, the CSM conducted a review of all available evidence provided by the respective pharmaceutical companies about their selective serotonin reuptake inhibitors (SSRIs). The CSM found the "risks of treating depressive illness in under 18s with certain SSRIs outweigh the benefits of treatment." The risk outweighs the benefit.

Of the seven antidepressants under review - Zoloft, Celexa, Lexapro, Luvox, Paxil, Effexor and Prozac - four (Zoloft, Celexa, Paxil and Effexor) were found to increase the rate of self-harm; two (Lexapro and Luvox) had no clinical trial data available in which to make a decision. Only Prozac, the mother of psychopharmacological intervention, was found to have a favorable risk/benefit ratio.

The CSM further revealed that despite the widespread use of SSRIs in children - an estimated 50,000 in Great Britain alone - only two of the seven antidepressants, Zoloft and Luvox, had been approved for use in children 18 years or younger who had been clinically (i.e., subjectively) diagnosed with obsessive-compulsive disorder (OCD). Whether the drug was effective could not be demonstrated for Zoloft, Celexa, Paxil and Effexor, and there were no data about the efficacy rate in Lexapro or Luvox, the mind-altering drug that one of the Columbine school shooters, Eric Harris, was taking at the time of his deadly assault.

Although the CSM report includes the seven major antidepressants on the market, two of them, Paxil and Effexor, were banned for children earlier in the year by the United Kingdom's regulating board. This same action was followed up in the United States when, in September, Connecticut's Department of Children and Families announced it would stop giving Effexor to children under the state's care because of the possible link to increased suicide risk. The FDA also took action in October of last year by putting out a public-health advisory "alerting physicians to reports of suicidal thinking (and suicide attempts) in clinical studies of various antidepressant drugs in pediatric patients with major depressive disorder."

Beyond the advisory, the FDA apparently is going one step further in its effort to ascertain whether there is a causal relationship between antidepressants and violence and self-harm. A special meeting has been scheduled for the first week in February in which members of the FDA's Advisory Committee, made up of experts from both its Psychopharmacologic Drugs Advisory Committee and its Pediatric subcommittee of the Anti-Infective Drugs Advisory Committee, will consider "optimal approaches to the analysis of data from these trials, and the results of analyses conducted to date, with regard to the question of what regulatory action my be needed pertinent to the clinical use of these products in pediatric patients." In other words, the FDA intends to reanalyze data that was analyzed by analysts who conducted the clinical trials for each of the SSRIs in question.

Karen Barth Menzies, an attorney with Baum and Hedlund, a Los Angeles law firm that represents alleged victims of SSRIs, tells Insight, "The only reason that the FDA is even looking at this issue is because they don't want to be seen as sitting back doing nothing. We are thrilled with what the U.K. has done and we believe that it only happened because they put together a panel that wasn't biased or had any pharmaceutical connections. But I think the FDA will try to whitewash the issue."

As Menzies sees it, "The FDA's planned methodology for the hearing is to go back and look at the number of suicide events that were recorded during the drug companies' clinical trials. These suicide events were recorded by the researchers at the time with the patients sitting in front of them. The researchers are treating them and seeing exactly how they are reacting. And it was during this evaluation that they recorded the suicide event as a suicide event and in some cases even noted that the suicide event was caused by the drug. Now what you have is the FDA bringing in an 'independent' panel to go back and look at those researchers' assessments, and they are going to determine whether the reported incident was really a suicide event. The only thing that can come from this panel's review of the data is that they get the same number or fewer incidents of suicide events which now will be based on the panel accepting that the researchers' evaluation was correct."

Another concern, Menzies says, "is that the FDA will not release the names of the experts who are going to sit on the panel. The 'independent' experts that will be sitting on the panel may or may not have financial ties and conflicts with the pharmaceutical companies, but the FDA says that it's part of the process that the committee members will be announced the morning of the hearing. If they really wanted to reassure everyone that there are no ethical concerns and conflicts of interest, why not just give us the names of the members who will sit on the committee before the hearing? Instead they hide under the bureaucratic cloak."

These concerns appear reasonable to critics who note that the United Kingdom was forced to set up an entirely new panel because of the conflicts of interest between members of the original panel and the pharmaceutical companies whose drugs were under consideration. Furthermore, many still remember the 1991 FDA hearing tasked with considering the reported link between suicide and Prozac and similar antidepressants and whether it was necessary for a warning to be included in the labeling. Five of the 10 committee members of the 1991 hearing either had active financial interests in Eli Lilly, the maker of Prozac, or with other pharmaceutical companies that manufactured similar drugs. These same five members voted that a warning was not necessary.

Andy Vickory of the Houston law firm of Vickory and Waldner has spent nearly a decade representing families who believe they have been harmed by SSRIs. He was the lead attorney in a landmark decision in the 2001 case of Donald Schell, a retired oil-rig worker who had taken Paxil for just two days when he shot and killed his wife, daughter and granddaughter before turning the gun on himself. The jury in the Schell case found that Paxil, made by GlaxoSmithKline, "can cause some individuals to commit suicide and/or homicide" and awarded the surviving family members $8 million in damages.

Vickory tells Insight, "I'm pleased with the decision in the U.K., but I don't see anything coming from the FDA. I think they're going to stall. I've devoted the last eight or 10 years of my life to this issue and no telling how many years of my life trying to make every effort to understand these issues so ordinary people can understand what's at stake. And now I've been told by the FDA that I'll get just three minutes before the committee. There's not a whole hell of a lot you can say in three minutes about such an important issue."

Although Vickory is hopeful about the United Kingdom's decision on the SSRIs, he is openly confused about the panel's decision on Prozac. "It is astonishing," says Vickory, "that the U.K. didn't ban Prozac. There was an article in the British Journal of Psychiatry about a large-scale study - some 2,770 or so patients - on SSRIs. And what they found was that fluoxetine [Prozac] has the highest risk of deliberate self-harm. The study shows that if you take Prozac you are 6.6 times more likely deliberately to harm yourself. So why in the face of that data the U.K. would ban all other SSRIs but not Prozac is astounding. The answer for public consumption is that none of the other drugs being considered by the U.K. even showed any efficacy. My response to the British would be, 'Okay, if that's your decision, since you know it also triggers suicide in some, at least make the manufacturer put a warning label on it.'"

Menzies agrees. "Why was Prozac excluded? If you ask those of us who have been litigating against Eli Lilly we think it is because they've been dealing with this issue a lot longer and they're a lot better at hiding evidence of a causal link between suicidality and Prozac. It was during the Forsyth trial [see sidebar] that we were able to get a complete timeline of evidence indicating that the company [Eli Lilly] knew about the link and what they did to hide it."

The case of Forsyth v. Eli Lilly was brought by the family of Bill Forsyth, who complained of suicidal thoughts after several days on Prozac, and then killed himself and his wife of 37 years (see "Misleading Medicine," April 30, 2001).

While there is no doubt that all of the above parties feel somewhat vindicated by the United Kingdom's decision effectively to ban all but one of the top SSRIs for children, there is one organization that also wonders when the FDA and other regulating bodies finally will address what it sees as the real problem. Bruce Weisman, president of the Citizens Commission on Human Rights, a California-based organization that investigates violations of human rights by mental-health practitioners, tells Insight, "Our concern has always been the diagnoses in the DSM [Diagnostic and Statistical Manual] of the American Psychiatric Association, a self-interested collection of subjective criteria. All the drugging of kids follows subjective and contrived diagnoses. You wouldn't have kids on these toxic chemicals if you didn't have some bogus diagnoses in the DSM and some psychiatrist labeling a child as having some nonexistent disease."

According to Weisman, "It's been more than a decade since we were first contacted by thousands and thousands of people who had been damaged by these drugs, and God knows how many tens of thousands of adverse-reaction reports have been reported to the FDA since then. Studies throughout peer-review literature as well as from the most prestigious universities in the world have made it clear that these drugs cause violent behavior."

"The U.K.," Weisman insists, "did the right thing, and now it is time for the FDA to step up to the plate. It's too late for thousands of kids who are dead who got slapped with these bogus labels and were drugged, but it's not too late for the FDA to do what it's supposed to do, which is protect people and the public health. But to get to the heart of the problem they've got to confront the diagnoses and look at the fact that there are 8 million kids on these drugs and here is the evidence of suicide and violence that is occurring. I'd turn the scientific telescope onto the DSM and find out how it is that psychiatrists can come to a committee and squabble over a diagnosis and then literally vote on a diagnosis for which they now can be reimbursed and the treatment for that diagnosis is drugs, which now have been banned for children because not only are they not effective but they actually cause harm."

The flaw in this FDA hearing, critics say, is that they already have approved drugs and only now are making the decision whether the drugs cause suicidal behavior in kids for diagnoses of diseases that do not exist.

It's difficult to know when or what the FDA's decision will be, especially in light of the fact it already has announced that no decisions will be made at the February hearing. Parents, in the meantime, may want to inquire of the FDA what evidence the United Kingdom had in order to make its landmark decision about the protection of its children that the U.S. drug-regulating body does not have. If it is the same pharmaceutical clinical-trial data, health professionals are asking, how long will the FDA keep America's youth at risk?

Kelly Patricia O'Meara is an investigative reporter for Insight.

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