The FDA has done a mixed job overseeing patient side effect education. Consumers have a right to know what the possible side effects are for any medication. They also need to know the real odds of getting them. The FDA has regulated the first well. Patients do get to see and hear the litany of side effects on DTC ads under fair balance requirements. What the FDA has regulated less effectively is educating the public on how often risks and side effects are really likely to occur. Side effect and risk discussion, improperly communicated can scare people away from taking their medication.
Consumers are inundated with side effect information from inserts with their prescriptions, DTC ads, web site chat rooms and online drug sites, and their doctors. Lawyers advertise for clients touting drug side effects. So how is a consumer to know when a prescribed drug might be dangerous? After all everyone has a different risk tolerance. It is also disease dependent in terms of the seriousness of the disease and risk a patient may be willing to accept for a cure or relief of symptoms.
The FDA is exploring requiring less risk disclosure in DTC ads in order for consumers to hear the most important. That is a good first step. What really matters, however, is that consumers make a rational data driven decision on drug use. What are the odds I might die or be permanently injured? A cancer patient may think a 1/100 fatality rate is acceptable while someone considering a statin may find 1/10,000 a risk worth taking.
If you watch DTC ads you do not know how often those serious side effects might occur. Sometimes the package insert has that data, but often that is in medical terms and hard to decipher. The FDA needs to find a reasonable, quantifiable method of telling consumers what might happen. Just lessening the advertised number of risks and side effects is not enough. Our media outlets love to run stories highlighting risks of drugs. They also rarely put these risk in context, thus scaring current and prospective users off. “Deadly drug in your medicine cabinet” is a better headline than “new drug kills one in every 20,000 seriously ill patients.”
So how about a clear system listing the numerical odds of getting the serious side effect? Maybe list only the numerical odds of life threatening side effects to make it easier to communicate. Accurate data exists to provide such odds. Using vague terms like “rare case of fatality” just confuses consumers. My definition of rare might be 1/100 but the real data may show 1/100,000. Therefore, it is time to rework the fair balance in a way that is fair to the public.