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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