Should doctors who are working in COVID-19 intensive care units have access for themselves to Moderna’s potential coronavirus vaccine? U.S. health care workers are infected with the virus every day. If we have a probable vaccine that is almost certainly reasonably safe and likely to be effective, why shouldn’t doctors — who are scientifically trained to make these judgments — be allowed to vaccinate themselves to protect both their own lives and those they treat?
Yes, it’s possible that there will be unacceptable side effects. Like other medicines, a COVID-19 vaccine may be right for some people and not others. The proposed vaccine’s Phase 1 trials — the first of three specified by the Food and Drug Administration — indicate that it’s probably safe and may be effective. The earliest it may be available to the public is September, although under the standard protocols for Phase 2 and Phase 3 trials, it may not be fully validated for up to 18 months.
Doctors, along with nurses and other health care professionals on the front lines, voluntarily risk exposure to the coronavirus to help save the lives of others. If we can trust anyone to make benefit-risk decisions for themselves, it would be these brave men and women, yet they are not allowed to do so under the FDA’s precautionary stance. The agency frequently appears to be more concerned with the costs of using a drug that is not yet 100% proven than the costs of waiting months to treat a dangerous disease.
There is, of course, a tricky balance between saving lives by ensuring the quality of drugs on the market versus losing lives by not allowing their use as quickly as possible. In law, society might allow 10 guilty people to go free rather than convict one innocent person. While we do not know the exact ratio, the FDA is more comfortable keeping good drugs off of the market than allowing an unproven one (even if patients are well aware that it’s unproven).
The FDA prohibition intrinsically implies that doctors are not scientifically qualified to make benefit-risk decisions. But doctors make decisions about the most appropriate treatments for their patients every day, dealing inevitably with incomplete information. Shouldn’t a doctor be allowed to decide for themselves whether they will be injected with a safe vaccine that might be effective?
Perhaps if doctors could make that decision, it would be the camel’s nose under the tent. The next thing you know, nurses want it, too. Are nurses qualified to decide for themselves whether they should have the vaccine, perhaps by consulting the doctors around them?
And if doctors and nurses can have it, what about the orderlies — or all the people working in nursing homes? They’ll point out that if they’re protected, thousands of nursing home residents’ lives might be saved. Perhaps then we’ll need to give the vaccine to police, fire and refuse collection workers, to transit workers and grocery store clerks, to the workers in meatpacking plants and auto assembly lines.
This may be what the FDA fears, but we should remember that some doctors will also decline to accept the vaccine, and others will follow their lead.
This has happened before. It famously took years for the FDA to approve the drug azidothymidine, or AZT, to treat AIDS and HIV, even though thousands of people were dying. In another case, the FDA originally rejected a drug to treat Duchenne muscular dystrophy. The disease mostly affected young boys, causing their muscles to weaken gradually to the point where they became unable to walk and eventually succumbed to respiratory or heart problems by their late teens or 20s. It took massive pressure from parents to finally get past the FDA’s concern that allowing the drug “would undermine the integrity of the FDA.”
The 21st Century Cures Act requires the FDA to incorporate patient preferences with respect to their own benefit-risk assessments into the drug approval process. The question is, once FDA has determined that the drug is safe, should people — beginning with doctors — be able to make their own determination about taking something we don’t yet know for sure is effective?
Many doctors would likely shun the FDA’s precautionary stance and take a chance that a drug may work for them. This would produce faster final approval, which is better for everyone.
ABOUT THE WRITERS
Nicolaus Tideman is a professor of economics at Virginia Polytechnic Institute and State University and former senior staff economist for the president’s Council of Economic Advisers. Richard Williams is a senior affiliated scholar with the Mercatus Center at George Mason University and former director for social sciences at the FDA’s Center for Food Safety and Applied Nutrition.