Jury Trials In 2008 Expected To Expose SSRI Maker's Dirty Secrets
The blockbuster sales figures for the new generation of selective serotonin reuptake inhibitor antidepressants (SSRI's), which have resulted from their promotion for so many unapproved uses, represents the most profitable off-label marketing coup in the history of modern medicine. Sales total about $21 billion a year, according to IMS Health.
However, in the end these drugs will probably also hold the title for the most lawsuits filed against drug companies for overstating their benefits while concealing their serious side effects from as far back as 20 years ago.
The SSRI's include Prozac by Eli Lilly; Paxil marketed by GlaxoSmithKline, Zoloft by Pfizer, and Celexa and Lexapro from Forest Laboratories. Cymbalta by Eli Lilly and Effexor by Wyeth are often called SSRI's, but they are actually serotonin norepinephrine reuptake inhibitors (SNRI's). Wellbutrin sold by Glaxo is an inhibitor of the neuronal uptake of norepinephrine and dopamine. Several of these antidepressants now have generic counterparts.
In 2008, at least a dozen jury trials are scheduled all over the country for Paxil suicide-related cases, all of which allege that Glaxo failed to warn consumers and doctors about the known risk of suicide associated with the drug. Many of these cases will be tried by Baum, Hedlund, Aristei & Goldman, the national law firm with the longest track record of handling SSRI cases.
Going into the trials, Baum Hedlund will be armed with the largest collection of internal GSK documents, depositions of GSK employees and experts, as well as the fruits of the firm's investigation of antidepressants and their makers for the past decade and a half.
During litigation, virtually every Paxil-related document obtained by Baum Hedlund was stamped "confidential" by Glaxo and sealed under a court order. However, through a series of legal challenges, the firm was able to unseal many of the documents, in part, by forcing Glaxo to admit that they did not contain trade secrets and should never have been sealed to begin with.
Off-label Promotion and Prescribing Drive Profits
The FDA approves drugs for uses that have been tested for safety and efficacy and includes those uses on the drug's label. The term off-label means prescribing a drug for a use that has not been tested and proven safe and effective or for a different patient group, or at a different dose, or for a longer duration, or in combination with other drugs.
While doctors may legally prescribe a drug for an unapproved use, it is illegal for drug makers to promote off-label prescribing. Over the past 20 years, SSRI's have been prescribed off-label to children as young as infants, the elderly and pregnant women, and for off-label uses that include insomnia, anxiety, shyness, grief, menstrual discomfort, pain, bed wetting, ADHD, dementia, impotence and restless leg syndrome, to name just a few.
To gain FDA approval to legally sell SSRI's to kids, all the drug companies would have to do is provide two clinical studies showing that the drugs work better than a placebo in depressed children, and they can conduct 100 trials to achieve the necessary results. But after 20 years on the market, they still have not been able to give the FDA two positive studies to prove these drugs work with children, with the exception of Prozac.
Critics are quick to point out that this is certainly not for lack of trying because there have been dozens of pediatric trials conducted that show the drugs work no better than a placebo. How Prozac gained approval remains a mystery in light of the thousands of adverse events that were already recorded among children.
A study conducted at the University of Georgia and published in the June 2006 Journal of Clinical Psychiatry reviewed prescribing records for 107,000 Medicaid recipients on drugs that act on the central nervous system and found that 75% of SSRI patients received the drugs off-label and most of the time without their knowledge.
In April 2004, the CDC reported in the Journal of Women's Health that antidepressants were the top drugs prescribed to women in doctors' offices and outpatient departments, ahead of estrogens and progestins, antiarthritics and drugs for acid/peptic disorders.
According to another report by the CDC, during 2005, antidepressants were the most prescribed drugs overall in visits to doctors and hospitals and were even prescribed more often than drugs used to treat high blood pressure, cholesterol, diabetes and headaches.
Chemical Imbalance - Selling Sickness in the Absence of Efficacy
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