The only definite finding of the study was that patients taking the drug gained an average of 20 pounds, once again documenting a side effect that has been known for 15 years.
Experts say the rapid weight gain is the most worrisome side effect of Zyprexa because obesity leads to so many other serious health problems like diabetes, hypertension and heart disease.
Public health programs are throwing good money after bad paying for Zyprexa. A recent study published in the October 12, 2006, New England Journal of Medicine, funded by the National Institute of Mental Health, found atypical use with Alzheimer patients was no more effective than a placebo for most patients and put them at risk of serious side effects including confusion, sleepiness and Parkinson like symptoms.
According to the report, about a third of the roughly 2.5 million Medicare beneficiaries in nursing homes have taken atypicals, and their use accounts for an estimated $2 billion in annual sales, much of it paid by Medicare and Medicaid.
All that said, Lilly cannot claim to be unaware of the continued off-label sale of Zyprexa in the US, because it buys the detailed prescribing records for every doctor in the country and provides them to sales representatives so they can better direct the company's promotion efforts.
Lilly knows exactly which doctors are prescribing Zyprexa, in what dose, and how often, on any given day of the year and that places Lilly in the best position to contact doctors to tell them to halt the off-label prescribing but that obviously has not happened.
Allowing Lilly to keep documents that were produced in litigation hidden even after the cases were settled has done nothing to curb the off-labeling prescribing of Zyprexa either.
And, the fact that a judge would even entertain Lilly's demands to place the recently released documents back under seal has resulted in outrage voiced by health care professionals all over the US. The pubic health crisis created by Lilly's off-label sale of Zyprexa for 10 years without warning about the health risks is no small matter.
On November 16, 2005, USA Today interviewed FDA scientist, Dr David Graham, the man famous for blowing the whistle on the mishandling of the Vioxx disaster, who estimates that there are 62,000 deaths each year from the off-label use of atypical drugs.
The allegations made by the plaintiffs in the underlying litigation are all verified in the leaked documents. For instance, the California law firm, Hersh and Hersh, represented plaintiffs in the first settlement, who alleged that Lilly "fraudulently withheld relevant information from potential users of Zyprexa."
The lawsuits also alleged a failure to warn doctors and patients that Zyprexa carried potentially lethal risks from weight gain and diabetes, and one of the leaked documents dated 6 years ago, written by a panel of diabetes doctors hired by Lilly to assess the diabetes risk, warned Lilly back then that "unless we come clean on this, it could get much more serious than we might anticipate."
According to Leonard Roy Frank, in "Zyprexa: A Prescription for Diabetes, Disease and Early Death," in the August 2005, edition of Street Spirit, if Lilly had issued the warnings, "there undoubtedly would have been fewer cases of diabetes and fewer deaths from taking Zyprexa."
"But truthfulness is not one of Eli Lilly's strong suits when profits are at stake," Mr Franks says.
"Telling the truth," he points out, "would undoubtedly have cut into sales for its blockbuster drug (the fifth best-selling prescription drug in the world), which, in 2004, produced revenues of $4.4 billion, almost a third of the company's total revenues and more than a third of its profits."
This is not the first time that the judge's Zyprexa protective order has been criticized. In 2005, the Swedish Academy of Pharmaceutical Sciences journal ran an article titled, "Lilly is hiding negative information about Zyprexa," featuring an interview with Dr Curt Furberg, Professor of Public Health Sciences, at Wake Forest University.
Dr Furberg said that he had seen secret documents on Zyprexa in his capacity as an expert witness and stated that the most hazardous effects of Zyprexa were hidden from prescribing physicians and the public.
A big hurdle with the Zyprexa issue is Lilly's credibility over their continuous PR on how they are going to pay out $1.2 billion in damages.As long as they keep up this rhetoric and don't actually pay the issue won't go away.
Think about the need to 'put their money where their mouth is'.
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Daniel Haszard
by
Danny Haszard (2 articles, 0 quicklinks, 0 diaries, 52 comments)
on Monday, February 5, 2007 at 11:34:19 AM
1 comments
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