Dr. Jeff Kane: Approving a COVID-19 immunization
The Food and Drug Administration maintains a rigorous pathway for approving drugs and immunizations. The process can take a decade or longer, involving billions of dollars. The stakes are high and there’s no shortage of stakeholders, so tugs-o-war abound.
If you were a drug manufacturer, for example, you’d want your product on the market yesterday. And if you suffer a malady this drug might alleviate, you’d want prompt access to it, too. Such pressures influence drug release. Look what happened with AIDS drugs in the 1990s. While people died in droves, the FDA loped along at its usual cautious pace. Thousands of patients and their families demanded speed, though, and finally even Dr. Anthony Fauci, a pillar of stringent science, conceded that time was of the essence. FDA regulations loosened, and AIDS drugs were finally released. The power of activism was obvious.
Today patients with a variety of diagnoses push for faster pharmaceutical progress. Fine, but here’s where it gets tricky.
The FDA is required to negotiate with the drug industry and also to hear from patients. In a conference of all parties that the FDA held in 2016, 42 patient organizations demanded more rapid approval of drugs. That’s not surprising, but it was learned afterward that 39 of them received funding from the drug industry, which famously is more interested in profit than patients.
The scientific path toward new drug release, then, can get contaminated by politics and economics. While no one wants unwarranted delay, premature release can beg tragedy. For example, Vioxx, an anti-inflammatory drug, was pulled from the market in 2004 after probably being responsible for 28,000 heart attacks and sudden deaths. Thalidomide, which caused thousands of serious birth defects in Europe, was blocked in the U.S. by a single FDA scientist resisting drug industry pressure. More ominously, diethylstilbestrol (DES), given to pregnant women in the mid-twentieth century to prevent miscarriage, caused genital cancers — not in the women, but in their children, more than a decade later. So how long do we need to wait until we’re confident a drug is safe?
We’ll do well to view a COVID-19 vaccine in the light of this history. At this point, six vaccine candidates are in home-stretch trials. Some interests are pushing for pre-election release, but according to a USA Today poll, two-thirds of Americans say they’ll refuse it, and a quarter say they’ll never take it. Some of this reticence must result from suspicion that science has been compromised, some from suspicion of government in general, and some from anti-vaxxing sentiment. So the issue’s in each of our own personal laps. What will you do?
Jeff Kane is a physician and writer in Nevada City.
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