FDA not capable of policing it's own house?
Mar/26/2008 06:36 Filed in: Regulatory
Environment
Bringing a case to trial costs a lot of time and money, especially in a case as complicated as the Zyprexa case in Alaska. At stake was the credibility of Lilly which this author has worked for and although they have made some missteps is known as an ethical company. There was some damaging testimony from a physician who said that he believed there was a correlation between Zyprexa and diabetes. Whether Lilly "sat on that data" in order to safeguard Zyprexa sales is still up for debate but there can be no doubt that Zyprexa has helped a lot of people lead more normal lives and become less of a burden on caregivers and the medial economic system.
William Bigley, in another courtroom one floor below the states Zyprexa trial, had his own opinions on Zyprexa, and all the other drugs he has taken since 1980 to battle demons that only he can see. On this day, March 14, a state court judge would decide whether Mr. Bigley should be held for 30 days in a psychiatric hospital. Mr. Bigley, 55, told the judge that the drugs were “poison” and that he did not need them. “I’m fine,” he said. His words were sadly undercut by his regular pronouncements that he knows President Bush, owns a private jet and has seen flying saucers. Of all the facts at issue in the two courtrooms, one is beyond debate. Mr. Bigley is not fine.
Even so, Mr. Bigley’s hearing — which had an unexpected outcome — offered a textbook illustration of the agonizing choices faced by mentally ill patients as they consider taking Zyprexa and similar medicines, called antipsychotics. All antipsychotics have side effects, and Zyprexa’s are among the worst, according to the American Diabetes Association and independent scientists. In many patients, Zyprexa causes severe weight gain that can lead to diabetes, as well as sharply higher cholesterol and triglyceride levels in the blood. Those are all risk factors for heart disease, the leading killer in the United States.
Further, the documents introduced in Courtroom 403 show that for much of the last decade, Lilly executives played down those risks. Among themselves, in internal e-mail messages and memorandums, they shared worries that Zyprexa’s sales would fall if the drug was linked to weight gain or diabetes. Sales would fall? So then in this case the company put sales above patients health? When it comes to matters of patient health there can be no compromises..patients deserve the benefit of doubt when it comes to possible serious side effects. At a minimum physicians should have been advised to monitor patients on Zyprexa for weight gain and the problems that go along with it including diabetes.
The FDA is in a no win situation with past approvals of some drugs. If Lilly is to learn anything from this case it's that patients health comes first and transparency has to be immediate when possible serious side effects are starting to show up (for example pancreatitis with Byetta). Companies can no longer take months to "analyze the data" and amend the label so it has minimum impact on sales. They have to start showing that patients, customers come first not Wall Street analysts.
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