RFK Jr. and the F.D.A.

But first, a word about measles: You undoubtedly know about the recent measles outbreak in Texas in which one child died, and that Kennedy, an anti-vaccine activist and newly appointed head of Health and Human Services, noted that the outbreak is “not unusual.” In fact, the outbreak is unusual. Until a few weeks ago, someone hadn’t died of measles in this country since 2015.

According to the CDC, before a vaccine became available in 1963, an estimated 3 to 4 million people in the United States were infected each year. Each year, an estimated 400 to 500 people died; 48,000 were hospitalized; and 1,000 suffered encephalitis (swelling of the brain). Since the arrival of the vaccine, endemic spread of the virus was declared eliminated. Of course, we old people were not vaccinated. As a result of my measles infection, I lost half the hearing in my left ear. (Measles can damage the nerve fibers in the inner ear.)

While scientific experts agree that Kennedy’s wacky ideas could pose a danger to human health, they also contend that the F.D.A. needs to change. (At the same time, they also say that the agency should have more resources and authority—not less—and that the FDA is the most important public health agency we have.) Here are the changes they recommend:  

• Stop relying so much on industry funding. Almost half of the F.D.A.’s budget comes from “user fees” in which pharmaceutical and medical advice companies pay the F.D.A. to review their products—an obvious conflict of interest. (The government should pay.)
• Crack down on employee-industry connections. The F.D.A. commonly hires people employed by drug or device companies and, in reverse, F.D.A. employees leave the agency to go work for these companies. Advisory committee members may also have close ties with the industry. More conflict of interest.
• Close loopholes in the approval process. While experts generally agree that the F.D.A.’s approval process for new drugs and vaccines is rigorous, some worry that such rigorous standards aren’t enforced across other divisions, most notably medical devices, food additives, and supplements.
• Break the F.D.A into two agencies, one focused on food and the other on drugs.

Happily, Dr. Martin Makary, who will head the F.D.A., seems well qualified. As one F.D.A. watcher noted, “It could have been way worse.” Fingers crossed.

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