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Fair Balance or Scare Balance

The Wall Street Journal's Melinda Beck wrote a fascinating column (11/18) on the power of suggestion. Titled “When Drug Labels Make You Sick”, Ms. Beck explores the little studied issue of how reading the litany of side effects actually can make you more prone to disease. The FDA is rightly concerned with informing consumers of the risks they take when beginning use of an Rx drug. All of us are entitled to know if the drugs we are prescribed can kill us or cause debilitating side effects.

The issue I have raised with FDA over the years is how to accurately tell consumers the real odds of getting a bad side effect. The litany approach that is common to all drug ads does not give odds. The package insert shows occurrence of side effects as a percent of people studied but that is something most consumers do not read or cannot understand.

Therefore, most consumers will get their fair balance entirely from the television or magazine ads. Some may read the attached brief summary, but most of those do not have the chart on percentage of patients getting a side effect. Now let's explore more of Ms. Beck's column.

She cites several studies which show how powerful the power of suggestion is in making us think we have side effects. In a study last year men taking a drug for prostate enlargement who were informed it could affect sexual function were three times more likely to actually have erectile dysfunction than those not told. In another study, subjects were given sugar water and told it could make them vomit. Of those told of the potential side effect, 80% actually did vomit.

The point of Ms. Beck's column is that we need to be judicious how we approach patients with side effect information. I believe we need to do a better job giving patients the real odds of something happening to them. Most side effects are minor and temporary. The serious ones are very rare. The issue for FDA and drug makers is how to properly inform prospective users without scaring them away from treatment. I certainly want to know if I could die, but I also need the odds of it happening. The ads do not give that information. A 1 in 100 chance is much different than 1 in a 1,000,000. Ms. Beck cites a study that shows that the baseline for feeling fatigue is 39%, 14% had headaches and 5% reported dizziness. This is with no drug treatment.

I propose FDA study the effect of risk communication in the context of the scare effects. They focus on adequate communication of risk and side effects but not on whether it is interpreted wrongly. It would be interesting to see consumers place the odds of occurrence after seeing ads. I bet they vastly overstate the odds of serious side effects happening to them. Clearly the media is guilty of hyping negative outcomes with their “death in your medicine cabinet” type stories. I do not want to under play sides effects but I also want a system that portrays them accurately. A fatal side effect is always tragic but that risk may be well worth it if 500,000 others are helped for every death. I am afraid that telling consumers everything that could happen to them is not protecting them or informing them. It is a shotgun approach that makes regulators feel better but does not promote real consumer protection.