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Exerpts from an article by Martha Rosenberg who is a journalist living in Chicago. Article at: http://www.alternet.org/
A potentially deadly "off-label" drug manufactured by pharmaceutical giant AstraZeneca has been linked to the deaths of soldiers returning from war. Yet the FDA continues to approve it.
Sgt. Eric Layne’s death was not pretty. He had been taking a prescribed drug cocktail with the antidepressant Paxil, the mood stabilizer Klonopin, and AstraZeneca’s controversial antipsychotic drug Seroquel. A few months later, the Iraq war veteran was “suffering from incontinence, severe depression, [and] continuous headaches,” according to his widow, Janette Layne, at FDA hearings for new Seroquel approvals last year.
Sgt. Layne had just returned from a seven-week inpatient program at the VA Medical Center in Cincinnati, where he was being treated for post-traumatic stress disorder (PTSD). A video shot during that time, played by his wife at the FDA hearings, shows a dangerously sedated figure barely able to talk.
Soon he had tremors. “[H]is breathing was labored [and] he had developed sleep apnea,” said Janette Layne, who served in the National Guard during Operation Iraqi Freedom along with her husband. On the last day of his life, Eric stayed in the bathroom nearly all night battling acute urinary retention, she testified. He died while his family slept.
Sgt. Layne was not the first healthy veteran to die after being prescribed medical cocktails including Seroquel for PTSD. In the last two years, Pfc. Derek Johnson, 22, of Hurricane, W. Va.; Cpl. Andrew White, 23, of Cross Lanes, W.Va.; Cpl. Chad Oligschlaeger, 21, of Roundrock, Texas; Cpl. Nicholas Endicott, 24, of Pecks Mill, W.Va.; and Spc. Ken Jacobs, 21, of Walworth, N.Y. have all died suddenly while taking Seroquel cocktails.
Death certificates and other records collected by veteran family members suggest more than 100 similar deaths among Iraq and Afghanistan combat vets and other military personnel, many on PTSD cocktails with Seroquel and other antipsychotics, antidepressants, mood stabilizers, sleep inducers, and pain and seizure medications.
Since the 2008 publication of “The Battle Within,” the Denver Post’s exposé of a “pharmaco-battlefield” in Iraq, in which troops were found to be routinely propped up on antidepressants, the Department of Defense (DOD) has sought to curb the deployment of troops with mental health problems to combat zones. The DOD has also stepped up monitoring of soldiers who have been medicated, according to the Hartford Courant. Thirty-four percent of the 935 active-duty soldiers who made suicide attempts in 2007 were on psychoactive drugs.
Although it has not been approved for PTSD, Pentagon purchases of Seroquel nearly doubled between 2003 and 2007. Elspeth Ritchie, medical director of the Army’s Strategic Communications Office told the Denver Post the drug is “increasingly utilized as an adjunct for PTSD.”
The trial of Vietnam veteran Ted Baker, who claims Seroquel he was prescribed for PTSD caused diabetes, which began last month in New Jersey, is one of 26,000 lawsuits AstraZeneca faces. And last year, London-based AstraZeneca agreed to pay $520 million to settle suits pertaining to clinical trials and illegal Seroquel marketing.
Yet instead of reconsidering a drug linked to deaths and tainted by at least eight corruption scandals in 13 years—Seroquel was even prescribed to a 4-year-old Massachusetts girl, Rebecca Riley, before her death—the FDA continues to wave through new approved uses for Seroquel.
Seroquel (quetiapine) was first approved to treat schizophrenia in 1997. The FDA subsequently expanded its use, approving it for “acute manic episodes associated with Bipolar I Disorder” in 2004, “major depressive episodes associated with Bipolar Disorder” in 2006, and “maintenance treatment for Bipolar I Disorder” in 2009.
Last April, the FDA opened the door to prescribing Seroquel to people who have not even been diagnosed with schizophrenia or bipolar disorder, approving Seroquel as “an additional therapy in patients suffering from depression who do not respond adequately to their current medications.” Not that Seroquel needed a boost; its $4.9 billion in sales in 2009 signals usage far beyond the 1 percent of the population with schizophrenia and the 2.5 percent with bipolar disorder. North Carolina’s Medicaid spends $29.4 million per year on Seroquel—more than on any other drug, according to the Charlotte News and Observer.
Most recently, in December 2009, while the nation was watching the health reform bill, Seroquel was quietly approved for children between the ages of 10 and 17 who are diagnosed with bipolar mania and children between 13 and 17 with schizophrenia. The stealth decision was not announced by the FDA itself but by AstraZeneca and appears as a footnote on Seroquel’s FDA approval page, saying “Patient Population Altered.” Quite an alteration.
A search of the U.S. National Library of Medicine database yields 20 articles linking “Seroquel” and “sudden death,” 24 linking “Seroquel” and “QT prolongation” (a heart disturbance that can lead to death), 55 linking “Seroquel” and “toxicity,” and others linking Seroquel with the terms “cardiac arrest” and “death.”
A 2005 article in the Journal of Forensic Sciences says Seroquel was detected in 13 postmortem cases and the cause of death in three and states, “little information exists regarding therapeutic, toxic, and lethal concentrations.” A 2003 article in CNS Drugs reports: “Some patients have died while taking therapeutic doses” of atypical antipsychotics like Seroquel and that “toxicity may be increased by coingestion of other agents.”
“The second-generation antipsychotics were termed ‘atypical’ based on misconceptions of enhanced safety and efficacy,” Dr. Grace Jackson, a former Navy and Veterans Administration psychiatrist and author of “Drug-Induced Dementia and Rethinking Psychiatric Drugs,” said in an interview. “In 2002 and 2003, according to a VA study published in 2007, 20 to 30 percent of demented veterans died within the first 12 months of beginning treatment with an antipsychotic,” says Jackson.
“When you combine antipsychotics with antidepressants, benzodiazepines, and anti-epileptics—especially in Iraq/Afghanistan veterans who have likely sustained traumatic brain injuries—you have potential lethality from sleep apnea, endocrine anomalies, and opioid intoxication.”
Seroquel’s record of causing sudden cardiac death was even on the docket at last year’s FDA hearings, which Stan and Shirley White and Janette Layne attended. According to Dr. Wayne Ray, who testified before the FDA’s Psychopharmacologic Drugs Advisory Committee, one study involving 93,300 users of antipsychotic drugs, half of whom were on atypical antipsychotics, showed that such users were at double the risk of a “sudden, fatal, pulseless condition, or collapse … consistent with a ventricular tachyarrhythmia occurring in the absence of a known, non-cardiac cause.”
When committee members asked Dr. Ray how AstraZeneca’s own studies, presented earlier at the hearings, could show no risk—like the White-Layne VA Inspector General report—he said the drug company data was skewed by “Simpson’s paradox,” the same statistical manipulations that made Vioxx look safe.
But unwilling to let Seroquel’s approval prospects sink just because it’s dangerous, the FDA’s Marc Stone, a medical reviewer, donned his AstraZeneca hat at the hearing in a presentation rebutting Dr. Ray’s testimony. How can it be known if the death certificates in these cases were accurate, he asked, when “paramedics are more likely to identify some deaths as sudden cardiac deaths?
“Smoking as an important risk factor for sudden cardiac death is unlikely to appear in the Medicaid claims data used in this study,” Stone said of Dr. Ray’s findings. “How do we know smoking wasn’t a factor in the deaths or that antipsychotic users aren’t less likely to communicate symptoms of cardiac disease to medical personnel?” He also pointed out that “mental illness severe enough to require antipsychotic drugs … may also increase the chances of someone being homeless or living alone with little social contact,” apparently forgetting that the purpose of the FDA hearings was to approve Seroquel for non-mentally ill people with anxiety and depression.
In 2009, internal AstraZeneca(AZN_) reports and emails written by company officials show they knew a decade ago that their psychiatric drug Seroquel caused diabetes and major weight gain, plaintiffs' lawyers said Friday after releasing dozens of the previously sealed documents.
"They not only failed to warn about the risk of diabetes, but they marketed it as not having that risk," said Houston attorney Ed Blizzard, one of the lead attorneys representing roughly 15,000 plaintiffs suing the British drugmaker.
The plaintiffs claim Seroquel, approved for treating schizophrenia and bipolar disorder, caused diabetes, weight gain and related health problems, from kidney failure and heart attacks to amputations and damage to the pancreas, which makes insulin.
It's exceeded only by Lipitor, Nexium, Plavix, and Advair Diskus, its safety, effectiveness, clinical trials, and promotion records are highly checkered.
It would be hard to find a drug with a wider fraud footprint than Seroquel—at least one that’s still on the market. One of its first backers, Richard Borison, former chief of psychiatry at the Charlie Norwood VA Medical Center, lost his medical license, was fined $4.26 million, and was sentenced to 15 years in prison for a "pay-to-play" swindle involving Seroquel’s original clinical studies.
AstraZeneca’s U.S. medical director for Seroquel, Dr. Wayne MacFadden, had sexual affairs with two different women doing research on Seroquel: a study investigator at London’s Institute of Psychiatry and a Seroquel ghostwriter at the marketing firm Parexel. According to court documents, MacFadden even joked about the conflicts of interest with one paramour. Last year, the Chicago Tribune and ProPublica reported that Chicago psychiatrist Michael Reinstein, who wrote 41,000 prescriptions for Seroquel, received $500,000 from AstraZeneca. Meanwhile, a report in the Minneapolis Star Tribune discredited influential studies by AstraZeneca-funded Charles Schulz, M.D., chief of psychiatry at the University of Minnesota.
Seroquel was even promoted by the disgraced former chief of psychiatry at Emory University School of Medicine, Charles Nemeroff, who was accused by congressional investigators of failing to report $1 million in pharmacological income in AstraZeneca-funded continuing medical education courses. And until a Philadelphia Inquirer expose last year, Florida child psychiatrist Jorge Armenteros, a paid AstraZeneca speaker, was chairman of the FDA Psychopharmacologic Drugs Advisory Committee responsible for recommending Seroquel approvals.
“There is no cure for PTSD, especially in a magic pill,” says (Ret) Staff Sergeant Tom Vande Burgts in an interview. “Good old-fashioned talk therapy and support groups are tried and true … all the others are just quick fixes that add to the problem, not addressing the root of the problem.”