More Legal Controversy Over Zyprexa
> 1/5/2007 10:53:05 AM

The recent $500 million dollar class action settlement on the part of drug manufacturer Eli Lilly makes necessary a reexamination of the industry's legal responsibility to its customers and the crucial relationships between the FDA, the manufacturers, and the doctors who ultimately prescribe the drugs they make. The company agreed to pay an average of $27,000 to the 18,000 plaintiffs involved in the suit, each of whom claimed to have been damaged by Lilly's top drug, the antipsychotic Zyprexa. This settlement only furthers recent controversy over the potential dangers of the medication, and some consumer advocacy groups wonder if the company properly tested the drug or accurately informed patients of its potential side-effects.

One ongoing issue raised by this development is the industry's allegedly inefficient practice of utilizing "underpowered" trials to get their drugs approved by the FDA. The sample groups in these trials are often so small that they do not provide a satisfactory overview of the effects certain drugs will have once released for use by the general public. Representatives from the Center for Bioethics and related groups write in a past issue of the Journal of the American Medical Association that the scientific validity of such studies is suspect and that their implementation needs to be curtailed. The clinical trials for Zyprexa, for example, involved only 3,100 volunteers, while more than 2 million patients worldwide take the drug. The authors of the essay argue that this practice also downplays the rights of those participating in the trials in question:

"The smaller the study is, the less it is of clinical value. To deny patients the opportunity to know the relative clinical value of a study that they're considering enrolling in is unethical because it prevents them from making a fully informed decision." The authors say that conducting underpowered trials is only justifiable in narrowly defined circumstances. For instance, it might be difficult for investigators to find enough patients with a rare disease to conduct an adequately powered study. In such cases, Halpern says underpowered trials may be acceptable as long as the investigators can document plans at the trial's outset to combine the results with those from similar trials conducted elsewhere. Such investigators must also tell potential research subjects that it is uncertain whether the trial will yield clinically important information.

Some industry watchdogs also allege that Lilly downplayed the potential side-effects of the drug -particularly the risk of weight gain and diabetes- and encouraged its prescription beyond the approved applications as treatment for schizophrenia and bipolar mania. The truth of these accusations is up for debate, and in 2003 the FDA issued an order requiring warning labels about the potential for Zyprexa to raise blood-sugar rates. The case also highlights the fact that careful, ongoing scrutiny should be paid to the results of an approved drug once it reaches the public. The practice of essentially ignoring the safety issues surrounding drugs once they've gained approval from the FDA clearly does not benefit the patients to whom the drug is prescribed. If significant problems arise, they should be addressed as soon as possible for the safety of the public. Attorneys representing Lilly argued that the company fulfilled this obligation by agreeing to place the warning label on the medication, and as a result the settlements were smaller than those in similar previous cases.

Attempts by critical parties to villify Eli Lilly and, by extension, the pharmaceutical industry, seem largely unfounded. The company obviously does not operate with the intent to injure its customers, and there is no doubt that the drug has been extremely helpful to hundreds of thousands of patients suffering from psychosis. A possible solution to the current problem may be attempting to limit the wave of ultimately frivolous legal filings on the behalf of plaintiffs due to unwanted side-effects. Though some have truly suffered due to lack of oversight on the part of the manufacturer, the lifestyle choices of medicated patients affect their health much more than general industry practices. Though such lawsuits eliminate only small portions of overall revenue, the companies on trial rightly believe that negative publicity surrounding isolated cases could lead to fear and hesitation among patients who could greatly benefit from the drugs in question. If pharmaceutical companies were not so overly concerned about potential litigation, perhaps they could establish a more efficient web of communication between themselves, the FDA, and the doctors who prescribe their drugs.

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