Makers of Trasylol Failed to Tell the Truth to the FDA
Our drug safety system relies heavily on pharmaceutical companies that market the drugs for information about their benefits and risks. These big pharma companies conduct the pre-market research and independent resources to study marketed drugs are limited.
But can public safety still depend on pharmaceutical companies to report the bad, as well as the good, data on their products?
Recently, the FDA learned that Bayer A.G. failed to tell the agency about research suggesting that Trasylol, a widely used drug in heart surgery, might increase the risk of death or stroke. FDA found out from an independent researcher.
Such concerns have led to calls for the pharmaceutical industry to list all their clinical trials on a public Web site. Providers often don't know which of several drugs for a condition is best or more cost-effective because head-to-head trials have never been done.
Why would a drug company put its product against a competitor unless it was sure it would win? Too few independent studies are available. The Institute of Medicine has called for a public-private partnership to spur research.
When a drug wins FDA approval, the pharma company heavily promotes and markets the drug to physicians and consumers. Drug companies ply doctors with free samples, lunches, and posh trips compliments of a drug company plus lucrative consultant arrangements that may entail little work for big money. Big pharma sponsor medical school lectures and research which lead to distorting doctors' treatment decisions. (Source JSOnline)
