There were also 20 deaths, including 12 suicides, in the Zyprexa group. "Shockingly, these deaths went unreported in the scientific literature," Mr Frank said, "The death cover-ups also took place in reporting trial results of several other atypicals during the 1990s."
In his book, Mad In America, Mr Whitaker, reported that one in every 145 subjects who entered the trials for Zyprexa, Risperdal, Seroquel, and Serdolect had died.
And the studies reported after Zyprexa was on the market contained no selling points either. In December 2000, the British Medical Journal published a review of 52 randomized trials comparing atypical antipsychotics with the older antipsychotics that concluded there was "no clear evidence that atypical antipsychotics are more effective or better tolerated than conventional antipsychotics."
To determine whether the new atypicals were worth their price, the National Institute of Mental Health conducted one of the largest and longest studies ever, the Clinical Antipsychotic Trials of Intervention Effectiveness, or CATIE. Four years and $44 million later, the results in September 2005, concluded: the new drugs "have no substantial advantage" over the old ones.
In 2002, P Murali Doraiswamy, the chief of biological psychiatry at Duke University, conducted a review of adverse events reported to the FDA by Zyprexa patients and found:
Of the 289 cases of diabetes linked to Zyprexa, 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 developed pancreatitis, or inflammation of the pancreas, which is life threatening. There were also 23 deaths, including a 15-year-old patient who died of necrotizing pancreatitis, according to the journal Pharmacotherapy, in July 2002.
Yet with this track record, by 2003, Zyprexa was Lilly's top selling drug with worldwide sales of over $4 billion. According to a May 2003 report in the New York Times, government programs paid for 70% of the Zyprexa sold in the US that year. California Medicaid alone spent over $500 million on Zyprexa, Risperdal, and Seroqual in 2003.
Apparently drug makers would have us believe that there is an epidemic of schizophrenia in the US. The mass marketing of these drugs is the same in states all across the country. In the past 5 years, prescription costs for Iowa Medicaid have increased 82.5%, and by class, antipsychotics reflect the largest increase for mental health drugs.
In 2005, while the average monthly cost for any first generation antipsychotic to Iowa Medicaid was only $36, a month's supply for one of the new antipsychotics cost between $100 - $1000, depending on dose, drug and formulation, according to the December 8, 2005 Mental Health Subcommittee Report to the Medical Assistance Pharmaceutical and Therapeutics Committee.
In fact, worldwide in 2005, antipsychotics were the fourth-highest-ranking class of drugs in sales, and two of the top ten selling drugs were antipsychotics.
And regardless of the thousands of lawsuits filed against Lilly claiming Zyprexa is being illegally promoted and sold for off-label uses, the drug is still selling like hot cakes. According to Lilly's 2006-second quarter earning report, its sales in the second quarter totaled $1.12 billion, a 2% increase over the second quarter of 2005. US sales fell 1% to $542.9 million due to a lower demand, the filing noted, but the lower sales were partially offset by higher prices.
However, Zyprexa's high sales days may soon be over, according to a July 7, 2006, press release by Decision Resources, Inc, a research and advisory firm on pharmaceutical and healthcare issues, that says the antipsychotic market will experience negative growth falling from $15 billion in 2006, to a little over $10 billion in 2015.
A new Pharmacor report titled, Antipsychotics: Analysis of Disease Markets and Emerging Agents, predicts the tumble will be due to generic erosion, reimbursement constraints, and the lack of ground-breaking emerging therapies.
The most severe threat to the market, the report says, is the risk of therapeutic substitution with generic risperidone, when the drug loses patent protection in 2008 in the US, in 2007 in Europe, and 2006 in Japan.
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