These comments are made for the purpose of discussion and should NOT be used as recommendations for or against therapies or other treatments. An individual patient is always advised to consult their own physician.
Side Effects
Question: How completely and accurately are drug “side-effects” i.e. effects other than those intended, identified. Who compiles such information, what incentives are there to report known (or suspected) adverse effects, and how efficiently is this information evaluated and communicated to patients and physicians?
Answer: Drug side-effects and their listing begins during the drug evaluation process of the FDA. The drug companies have forms that list the side-effects for each patient in controlled studies. The only incentive is the censure which would occur with a “cover-up”. However, the drug companies are not interested in producing drugs which have unacceptable side-effects. This is due to the legal process resulting in excess damages to patients and the inability to sell drugs that patients won’t take. Indeed, in the development process the companies are relatively eager to find problems. However, as the drug comes to production, things change. After release, the drug is reported on in two ways. The first is adverse drug reactions which are turned in by physicians or pharmacists. The second is ongoing surveillance studies required by the FDA to uncover unsuspected side-effects. Markedly severe side-effects are generally communicated rapidly, less severe side-effects are published yearly in the Physicians Desk Reference and with the drug information profile supplied with each prescription. Some of the major products can be found on the Drug Infonet web site.
