FDA Approval Should Be Seen as a Floor, Not a Ceiling

The great thing about a consumer society is we have many choices. Unlike the old days of the Soviet Union, not only are the shelves in stores not bare, the choices presented can be overwhelming.

From the cereal aisle in a store to the cold medicine or pain medication, choices abound. And while not much of a problem for cold cereal, it can become a very big problem for prescription drugs.

It's FDA Approved!

A study reported in the Archives of Internal Medicine, entitled "Less Is More--Communicating Uncertainties About Prescription Drugs to the Public," highlights the issue.

The study measured the U.S. public's understanding of Food and Drug Administration (FDA drug approval process and tested how different brief explanations of the drugs uncertainties affected what drugs were chosen by consumers.

It found 'Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25 percent mistakenly believed that the FDA approves only drugs without serious side effects.' Thus, the report concluded that much of the public believes wrongly that the FDA approves only extremely effective drugs and drugs lacking serious side effects.

Beta Testing

The FDA has a very broad mandate. It is charged with protecting the public health by working to maintain the safety of food and drugs. While food is to be safe, wholesome, sanitary and properly labeled, drugs and medical devices are to be safe and effective.

Safe and effective does not mean it is the best drug for a given purpose or that is it "very effective." If you read the long disclosure documents the FDA requires all prescription drugs to carry, you may notice with some that their effectiveness may only be marginally better than a placebo (i.e. nothing).

As the study comments, "approval does not mean that the FDA believes benefits are large (or important) or that all serious side effects are known."

In fact, it may only be a few years after a drug is approved that we find out the full extent of the "side effects." Everyone who uses a new drug is in essence a beta tester.

Because of the duration of some drug trials and the limited number of people tested, many drug's real effects become apparent only after large numbers of people begin using them for a period of time - such as the case of DES (diethylstilbestrol), which effects are being encountered decades later.

The FDA's Role

The study suggests that the FDA's message should be clearer - instructing people to choose a drug that has had human trials, as opposed to surrogate outcomes. The FDA needs clarify its role (what does approval mean) and combat the presumption that what is new is always better that what is old, especially when both the notion of tried and true and newness are no guarantee of a drug's safety, like Fosamax.