Recently, Dr. David Graham of the FDA's Center for Drug Evaluation and Research spoke at a roundtable on drug safety at the University of Michigan Medical Center in Ann Arbor. Dr. Graham stated that the FDA remains a "culture of denial" more focused on whether drugs are effective than whether those drugs are safe for patients.
This is all well and good, however, what constitutes a 'safe' drug? All drugs have side effects, some worse than others. If the drug is effective at treating a problem, who decides the level of side effects which constitute 'safe'? It's a typical cost/benefit problem. Does a patient incur the cost of the side effects for the benefit of treating a medical problem? If I'm given a drug to cure toenail fungus and the side effect is my arm will fall off, I'll probably choose to live with the toenail fungus. If, however, I'm given a drug which will likely kill my cancer, but might cause me to have a secondary cancer 10-20 years later, I'd be willing to take that drug, even though it is clearly not 'safe'.
The key thing is that evaluation of drug safety cannot be made by a government agency. It can only be made by the patient in consultation with their physician. It is certainly important for drug manufacturers to publish full details on their drugs so that consumers and physicians can make intelligent decisions, but the decision on whether a drug is 'safe' or not ultimately has to belong to the patient.
Dr. Graham likes to say that 60,000 people died from taking Vioxx due to cardiovascular problems. The danger in overly focusing on drug safety is that you will end up killing hundreds of thousands more people because key drugs aren't made available because some government agency determined that the drug wasn't safe enough. The problem is that deaths attributed to Vioxx are visible, the deaths attributable to drugs which aren't made available are not. I would prefer to know that there is a drug which might help my medical condition even if it had side effects, than to not know that a drug existed at all.
