Women's Health Activist January/February 2005: Prescription for Change
Just Say No to New Drugs
By Adriane Fugh-Berman, M.D.
A colleague of mine at the Food and Drug Administration (FDA) warns friends not to take certain drugs that were deemed unsafe by FDA scientists, but were approved anyway. It isn’t only my friend who worries. A survey by the inspector general at the federal Department of Health and Human Services found that many scientists within the FDA’s Center for Drug Evaluation and Research (CDER) question the adequacy of the current drug evaluation system. More than a third of the 376 surveyed scientists were only somewhat – or not at all -- confident that the FDA’s approval process adequately assessed the safety of drugs. Two-thirds of surveyed scientists lacked confidence that FDA could adequately monitor drugs already on the market.
The FDA alone is not at fault here. Always under-funded, the FDA has been forced by Congress into a shotgun marriage with pharmaceutical companies. In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which required drug companies to help fund reviews of their drugs. Pharmaceutical company money now accounts for half of CDER’s budget. In exchange for this bounty, FDA must review a minimum number of drugs every year. While reviews don’t guarantee approval, the FDA is under pressure to approve new drugs (which often aren’t novel drugs but only minor variations on old drugs). Eighteen percent of surveyed scientists said that they had been “pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of a drug”.
Faster drug approvals may also mean less-tested drugs in the market. More importantly, the FDA has been forced to cut back on safety studies of existing drugs in order to meet their quota of new drug reviews. This is an issue that directly affects your health. Obviously, Congress should allocate enough money to the FDA to evaluate drugs completely independently of pharmaceutical companies. But until that happens, here’s a way to help protect yourself.
Don’t take new drugs.
Seem extreme? Or old-fashioned? Shouldn’t you insist on the latest, greatest drugs touted on TV? Look at it this way. New drugs are, well, new. There is no way to know the long-term effects of drugs that have been used only short-term. Some drugs have been approved after human studies lasting only for a month or two before they’re unleashed on the public. We simply have more information on drugs that have been out for a decade or more. Usually more studies have been done, perhaps including comparative efficacy studies with other drugs. More importantly, problems have a chance to come to light. Serious adverse effects or drug interactions often aren’t discovered until a drug has been on the market for years.
How can you ensure that you’re taking a time-tested drug? That’s easy: demand generics. If a drug is available in generic form, it’s survived in the marketplace for over a decade, which is enough time for most serious adverse effects to become known.
Manufacturers of a new drug have the exclusive right to market their drug for about 20 years (this 20-year clock starts early in the approval process). When the patent expires, the drug can be manufactured as a generic by other companies. Generic drugs are not substandard drugs. They are exactly the same drugs as branded preparations, prepared in FDA-approved laboratories, and have passed stringent tests showing that they achieve the same blood levels as the branded drug.
Pharmaceutical companies need new drugs to keep their profits high. Only patented drugs are promoted to doctors – and consumers. Once a drug becomes generic, the original manufacturer phases out promotion, because promotion now helps competitors. Prescriptions dwindle, and the generic drug slinks into obscurity, while new drugs make their glittering debut.
Would more consumers take generics if we called them “classic” drugs? The best-kept secret in medicine is that some oldies but goodies are even more effective than branded drugs. For example, many drugs effectively treat hypertension. But for preventing heart failure and other cardiovascular complications, generic diuretics (including hydrochlorothiazide and chlorthalidone) and beta-blockers (including propranolol), are actually superior to newer classes of drugs (calcium channel blockers, ACE inhibitors and alpha-agonists).
Sure, there are rare cases in which a brand-name drug is a truly unique drug for a specific condition. But for most common conditions (including high blood pressure, diabetes, chronic pain, depression, ulcers, etc., there are plenty of great old drugs that are equal to – or better than -- new drugs.
Brand name prescription drugs are more expensive than classic drugs; but branded drugs may also be more hazardous to your health.
Adriane Fugh-Berman, M.D., is an associate professor in the department of physiology, Georgetown University School of Medicine, and a former chair of the NWHN.