Controversy
Several studies have stimulated doubt about the effectiveness of
antidepressants. A 2002 study cited that the difference between antidepressants
and placebo is close to negligible.
The paper in question has been severely criticized by independent
researchers, however. One reason for this is that it deals almost
exclusively with the SSRI class of medication. In leveling criticism against the
efficacy of SSRIs, critics state, it is not the best paper, merely the most
widely known one. Also, other classes of antidepressants have demonstrated
superior efficacy, and it has been argued that this paper is "throwing the baby
out with the bathwater", while its thrust should in fact be leveled at the
serotonin hypothesis of depression.
Furthermore, not all patients necessarily respond to a given medication,
studies do not always address dosage versus drug-placebo differences for those
who do. Data submitted to the FDA can also underestimate how a drug will perform
in clinic practice, as studies sometimes are designed as much for marketing
purposes as they are to estimate the magnitude of a medication's effects.
Through a
Freedom of Information Act request, two psychologists obtained 47 studies
used by the FDA for approval of the six antidepressants prescribed most widely
between 1987-99. Overall, antidepressant pills worked 18% better than placebos,
a statistically significant difference, "but not meaningful for people in
clinical settings", says University of Connecticut psychologist Irving Kirsch.
He and co-author Thomas Moore released their findings in "Prevention and
Treatment", an e-journal of the American Psychological Association.20]
More than half of the 47 studies found that patients on antidepressants
improved no more than those on placebos, Kirsch says. "They should have told the
American public about this. The drugs have been touted as much more effective
than they are." He says studies finding no benefit have been mentioned only on
labeling for
Celexa, the most recently approved drug. The others included in his
evaluation:
Prozac,
Paxil,
Zoloft,
Effexor and
Serzone.
Dr Joseph Glenmullen, a Harvard psychiatrist, has written a book on the
subject for the layperson; see link below.
In 2005, anti-depressants became the most prescribed drug in the United
States, causing more debate over the issue. Some doctors believe this is a
positive sign that people are finally seeking help for their issues. Others
disagree, saying that this shows that people are becoming too dependent on
anti-depressants.
[21]
Lawsuits
In many cases SSRI drug manufacturers have withheld information from the FDA
and the public to play down the risks and adverse effects associated with SSRIs.
This had led to litigation against many of the pharmaceutical manufacturers of
SSRI anti-depressants in cases covering suicidality, SSRI withdrawal and birth
defects in neonates from nursing mothers on SSRIs.
In one of the only three cases to ever go to trial for SSRI indication in
suicide, li
Lilly was caught corrupting the judicial process by making a deal with the
plaintiff's attorney to throw the case, in part by not disclosing damaging
evidence to the jury. The case, known as the
Fentress Case involved a Kentucky man,
Joseph Wesbecker, on Prozac, who went to his workplace and opened fire with
an assault rifle killing 8 people (including Fentress), and injuring 12 others
before turning the gun on himself. The jury returned a 9-to-3 verdict in favor
of Lilly. The judge, in the end, took the matter to the Kentucky Supreme Court,
which found that "there was a serious lack of candor with the trial court and
there may have been deception, bad faith conduct, abuse of judicial process and,
perhaps even fraud." The judge later revoked the verdict and instead, recorded
the case as settled. The value of the secret settlement deal has never been
disclosed, but was reportedly "tremendous".
On December 22, 2006, a US court decided in Hoorman, et al. v. SmithKline
Beecham Corp. that individuals who purchased Paxil(R) or Paxil CR(TM) (paroxetine)
for a minor child may be eligible for benefits under a $63.8 million Proposed
Settlement. The lawsuit won the claim that pharmaceutical maker
GlaxoSmithKline (GSK) promoted Paxil(R) or Paxil CR(TM) for prescription to
children and adolescents while withholding and concealing material information
about the medication's safety and effectiveness for minors.
The lawsuit stemmed from a consumer advocate protest against Paroxetine
manufacturer GSK. Since the FDA approved paroxetine in 1992, approximately 5,000
U.S. citizens � and thousands more worldwide � have sued GSK. Most of these
people feel they were not sufficiently warned in advance of the drug's side
effects and addictive properties.
According to the
Paxil Protest website, hundreds more lawsuits have been filed against GSK.
The Paxil Protest website was launched
ugust 8,
005 to offer both
information about the protest and information on Paxil previously unavailable to
the public. Just three weeks after its launch, the site received more than a
quarter of a million hits.
The original Paxil Protest website is no longer available. It is understood
that the action to remove the site from the internet was undertaken as part of a
confidentiality agreement or 'agging
order' which the owner of the site entered into as part of a settlement of
his action against GlaxoSmithKline. (However, in March 2007, the website Seroxat
Secrets
[22]discovered that an archive of Paxil Protest site
[23]was still available on the internet via Archive.org) Gagging orders are
common in such cases and can extend to documents that defendants wish to remain
hidden from the public. However, in some cases, such documents can become public
at a later date, such as those made public by Peter Breggin in February 2006. A
press release from Dr. Breggin can be seen here:
[24]
In January 2007, according to the Seroxat Secrets website,
[25], the national group litigation in the
United Kingdom, on behalf of several hundred people who allege withdrawal
reactions through their use of the drug Seroxat, against GlaxoSmithKline plc,
moved a step closer to the High Court in
ondon, with
the confirmation that Public Funding had been reinstated following a decision by
the Public Interest Appeal Panel. The issue at the heart of this particular
action claims Seroxat is a defective drug in that it has a propensity to cause a
withdrawal reaction. Hugh James Solicitors confirm this news on their website
[26]
On
January 29, 007,
the BBC in the UK aired a fourth documentary in its 'Panorama'
[27] series about the controversial drug Seroxat. This programme, entitled
Secrets of the Drug Trials, focuses on three GSK paediatric clinical trials on
depressed children and adolescents. The documentary claims Seroxat could not be
proven to work for teenagers, and that one clinical trial indicated they were
six times more likely to become suicidal after taking it.
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