November 24, 2017
Female pharmacist taking medicine from shelf
Be Well

New Drugs Not Always the Best Drugs

by John Swartzberg, M.D.  

Many Americans are neophiles. That is, they love novelty, the seeming march of progress, and all new things—the latest cell phones, car models, and clothing styles. Love of the new often carries over to medications as well. Given the choice between a tried-and-true prescription drug (one your mother may even have taken) that has done its job for years and a snazzy new one that’s heavily advertised as the latest breakthrough, many people assume that newer is better. It’s tempting to think so, especially since the new drug is pricey and the old one is probably an inexpensive generic. But as the Gershwin song goes, it ain’t necessarily so.

While many new drugs offer modestly improved treatment and some are true breakthroughs, most are simply additional options for patients. New drugs are usually tested for only a few months in pre-market clinical trials, and they are rarely tested against their older counterparts. Until the drugs are in wide use for a few years and the dust settles, no one knows how effective—and safe—they really are, especially in the long term.

A few years ago, a study in the Archives of Internal Medicine examined beliefs about drugs. It found that 40 percent of people mistakenly believed that only “extremely effective” drugs without serious side effects are approved by the FDA. It also tested scenarios in which participants got to choose between two hypothetical drugs, one with a long track record, the other a new drug. Even when they were warned that it takes time to establish safety, half chose the newer drug.

In May 2017, a study in the Journal of the American Medical Association provided clear evidence about the uncertainties of new drugs. Among more than 200 new FDA-approved drugs, it found that nearly one-third had some sort of safety problem during their first 10 years. The average time to a first “safety event” was about four years. The safety problems were rarely serious enough to require withdrawal of the drugs, but they usually led to issuance of a black box warning on the label or a safety communication to doctors and patients.

The FDA is under pressure to accelerate drug approvals, which increases the chance that uncommon or longer-term adverse effects won’t be discovered until after marketing, the new study suggests.

It’s wise to keep in mind the uncertainties inherent in all new drugs, though that shouldn’t prevent you and your doctor from considering all your options, new and old. As a general rule, I discourage pa­­tients from taking drugs that have been marketed for less than three years, unless there are no other options. That allows time for additional evaluation regarding benefits and harms. If you had followed this three-year rule, you could have avoided, for instance, rofecoxib (brand name Vioxx), which was supposed to be safer than other pain relievers but was withdrawn from the market after a few years when it was found to have increased heart attacks and strokes.

Being tried-and-true is nowhere more important than with medications. You won’t see ads for the old stalwarts—notably entire classes of hypertension and cholesterol drugs—since they are now cheap generics. And that’s a good thing.

Also see Inside the Slow Medicine Movement.