Behind the Paxil Scandals




I

n
June 2004 New York State Attorney General Eliot Spitzer brought
suit against Glaxo, alleging that it had engaged in repeated and
persistent fraud with respect to Paxil (a $3.1 billion grossing
drug in 2003). Spitzer had evidence that the giant pharmaceutical
corporation Glaxo had suppressed the results of studies on children
and adolescents that showed Paxil to be ineffective and to increase
the risk of suicidal thinking and behavior. When he first announced
the suit, Spitzer stated, “By concealing critically important
scientific studies on Paxil, GlaxoSmithKline impaired doctors’
ability to make the appropriate prescribing decision for their patients
and may have jeopardized their health and safety.” Spitzer
had an internal Glaxo memo from 1998 stating that the company intended
to “manage the dissemination of the data in order to minimize
any potential negative commercial impact.” 


In
a quick settlement with Spitzer in August 2004, Glaxo agreed to
pay a $2.5 million fine and disclose all clinical trial study data.
Though Spitzer had smoking-gun evidence that Glaxo had concealed
scientific studies that jeopardized the health and safety of children,
Glaxo executives faced no criminal charges. 


While
Eliot Spitzer, a rising star in the Democratic Party, achieved a
tough-on-corporations headline, Glaxo was quietly pleased with the
outcome. Wall Street investors saw the $2.5 million fine and the
rest of the deal as a slap on the wrist, a gentle one at that. Immediately
after the settlement was announced, Glaxo shares rose a half point
in morning trading. 


At
the same time Glaxo was managing the impact of Eliot Spitzer on
Wall Street, it also had a problem with Ricky Williams and Main
Street. In July 2004, Miami Dolphins star running back Ricky Williams
stunned Glaxo when, in announcing his early retirement from football,
he declared that he had found marijuana to be 10 times more helpful
than Paxil.” Williams, along with former Pittsburgh Steeler
quarterback Terry Brad- shaw, had been a Glaxo celebrity spokesperson,
sponsored by Glaxo to tour the U.S. for the purpose of erasing the
stigma of psychiatric treatment. 


The
Eliot Spitzer and Ricky Williams stories received a great deal of
coverage from the mainstream media, which, in contrast, gave scant
attention to another story: does Paxil become safe after we’ve
turned 18? 


In
July 2003 the European Agency for the Evaluation of Medicinal Products,
which licenses drugs for use in the European Union, recommended
that Paxil should be prescribed with extra caution to those between
18 and 29. The EU regulatory agency stated that Paxil could result
in an increased risk of “suicide-related behavior in young
adults” and required doctors to warn all patients under 30
of the suicide risk posed by Paxil (known as Seroxat in Europe). 


A
Wyoming jury in 2001 had ordered Glaxo to pay $6.4 million to relatives
of Donald Schell, aged 60, who had been taking Paxil for just 48
hours when he shot and killed his wife, his daughter, his granddaughter,
and himself. Glaxo lost the case because its internal documents
showed it was aware that a small number of people could become agitated
or violent from Paxil. Glaxo was seen as liable because, despite
this knowledge, its Paxil packaging did not include a warning about
suicide. 


The
sad story goes beyond Paxil and Glaxo to other antidepressants,
other giant pharmaceutical corporations, the FDA, and psychiatry. 


In
December 2003 the British Medicines and Healthcare Products Regulatory
Agency (the British FDA equivalent) told physicians that depressed
patients under 18 should not be prescribed Zoloft, Lexapro, Celexa,
Luvox, Effexor, Serzone, Remeron, and Paxil. The MHPRA concluded
the lack of these antidepressants’ safety—including the
risk of suicidal behavior and hostility—far outweighed any
evidence of effectiveness. What was the FDA’s response? 


An
epidemiologist at the FDA, Dr. Andrew Mosholder, its leading expert
on the safety and effectiveness of antidepressants, agreed with
the British, but senior officials at the FDA gagged him. Mosholder
concluded there is a statistically significant risk of serious suicidal
behavior among children taking these antidepressants. Children given
the drugs were 1.89 times more likely to become suicidal than those
given placebos. However, FDA bosses did not allow Mosholder to testify
at the FDA advisory meeting about antidepressants and suicidal behavior
in children held in February 2004. Finally, in September 2004—because
of an onslaught of public pressure—the FDA convened another
advisory panel. This panel recommended warning labels on these antidepressants
but did not, unlike the British, ban drugs for children that science
is now describing as dangerous and ineffective. 


In
October 2004 the FDA carried out the advisory panel’s recommendations
by ordering that all antidepressants’ packaging display a black-box
warning (the most serious warning) of increased risk of suicidal
thoughts and behaviors in children. However, by the end of 2004,
black-box warnings were not yet on antidepressants. Robert Temple,
director of FDA’s Office of Medical Policy, stated in late
December, “I’m sympathetic to the idea that you don’t
want to let a lot of time go by. But [when] we ask the companies
to modify labeling that they own…the right to disagree [over
the wording] is reasonable.” 


The
FDA, especially in the area of antidepressants, has long been seen
by much of the scientific community as compromised by drug company
influence and it is decreasingly recognized as a serious regulatory
agency. In a 1991 FDA “blue ribbon” panel investigating
the association between Prozac-type antidepressants and violence,
five of the nine FDA panel doctors had ties to pharmaceutical corporations.
The panel voted not to require these antidepressants to display
a violence warning label. T

his








was aided
by Paul Leber,


d


irector
of the FDA





s
Division of Neuropharma- cological Drug Products, who in the late
1990s left the FDA to direct a consulting firm that specializes
in advising pharmaceutical companies that are attempting to gain
FDA approval for new psychiatric drugs. The revolving door of employment
between the FDA and Big Pharma resembles other governmental-industrial
arrangements where regulatory favors routinely result in future
industry income. In 2001

The Lancet

, Great Britain’s
respected medical journal, described the FDA as a “servant
of industry.” 


Before
approving a drug, the FDA does no research on that drug. Instead,
the FDA evaluates studies handed to them by the pharmaceutical company
that created the drug. Despite repeated evidence of untrustworthiness
and outright fraud, the FDA continues to trust Big Pharma data. 


Psychiatrists
and other prescribing physicians, who should know the deficiencies
of the FDA drug approval process, are these days taking cover, saying
that these antidepressants were FDA approved. However, psychiatry’s
textbooks have for over a decade told them that antidepressants
have not proven to be better than a placebo for children and adolescents.
Psychiatrists know that unhappy kids with no history of self-harm
have become suicidal after taking antidepressants. No mental health
professional should be shocked at parent Tom Woodward’s testimony
at the September 2004 FDA hearing: “Julie never harmed herself
in her 17 years—the only variable was 7 days of Zoloft. We
are certain that Zoloft killed our daughter….  Julie began
experiencing akathisia [an intense agitation] almost immediately
after taking the first pill.”

 


U.S.
psychiatry is awash with Big Pharma money. Psychiatric journals
are replete with drug company advertising, and the American Psychiatric
Association’s annual convention has so many lavish drug company
booths that it appears more like a drug-selling bazaar than a scientific
conference. 


The
U.S. has more people incarcerated in prisons and jails than any
other industrialized nation as a result of drug laws severely punishing
those who are selling drugs to others who, for the most part, are
well aware of the dangers. At the same time, pharmaceutical corporations
receive tiny fines for fraudulently selling dangerous drugs to unaware
parents of troubled children. Big Pharma executives, far from doing
jail time, are not even sweating out criminal charges.



 





Bruce E. Levine,
a psychologist, is author of



Commonsense Rebellion: Taking
Back Your Life from Drugs, Shrinks, Corporations, and a World Gone
Crazy

(Continuum, 2003).