Behind the Paxil Scandals

In 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. This was aided by Paul Leber, director of the FDAs 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).