Some of us belong to the Food and Drug Law Institute. One benefit of FDLI membership is a daily newsletter on FDA-related issues. The other day that newsletter’s top two links were both COVID-19 related – and we found both of them concerning.
The first item the newsletter featured was this story on “The Hill” entitled “Fauci: ‘I seriously doubt’ Russia’s coronavirus vaccine is safe and effective.” It’s concerning because that’s not at all what Dr. Fauci actually said – and that matters. His actual quote, from a longer interview you can watch here, is “Having a vaccine and proving that a vaccine is safe and effective are two different things.” So Dr. Fauci didn’t “seriously doubt” whether the Russian “Sputnik V” vaccine (“SVV”) was safe and effective. Rather, he questioned, quite rightly, if that vaccine had been “proven” safe and effective.
It has’t. But….
Prescription medical products frequently turn out to be safe and effective without having been “proven” to be that way. That’s what off-label use is all about. By definition, off-label use has not been “proven” to be safe and effective, at least not to the FDA’s demanding standards, but nonetheless off-label use is frequently considered by physicians to represent the medical standard of care. That means, among other things, that it can be malpractice not to use a product off label where doing so is the accepted standard of care. We’ve discussed this “proven” issue a decade ago, when we criticized plaintiffs (and an occasional court) for trying to flip the burden of proof by arguing that defendants have to “prove” their products’ safety, when the common law (as opposed to the FDCA) imposes that burden on plaintiffs. So medical products can work just fine without having been “proven.” It’s not illegal; it’s not a tort; and it happens all the time.
As one of our favorite non-legal bloggers, Skeptical Raptor, has detailed, what the Russians are doing massively violates generally accepted medical ethics. They have completed only “Phase I” trials, meaning that a small population (here, 38 people) has received the product, it has no immediately disqualifying adverse effects, and it might work. However, that “phase I trial only included the researchers who developed the vaccine,” which is an immediate red flag. Id. This kind of self-testing creates huge potential for bias:
[I]t’s the epitome of bias is having the researchers research themselves. They, of course, want the vaccine to work and to be safe, so they’ll overlook anything to make that happen. And that, my friends, is why it’s no longer ethical to use oneself as an experimental subject.
In everywhere but Russia, Phase I is only the beginning. The various developers of dozens of would-be COVID-19 vaccines elsewhere are undertaking large (many thousands of participants) Phase III clinical trials, to do precisely what Dr. Fauci advocates – prove (or disprove) their products’ safety and effectiveness.
Russia has decided to skip that step and essentially use the country’s population as guinea pigs for SVV. It’s entirely possible that Sputnik V will turn out to be Chernobyl II – a disaster that will discredit both Russia’s COVID response and its broader scientific reputation.
But what if it doesn’t? What if, like many off-label uses of prescription medical products, SVV actually works? Not every cut corner, no matter how brazen, results in a head-on collision.
That brings us to the second COVID-19 article that FDLI’s update had for us, a Reuters piece entitled “U.S.’s Azar says any U.S. vaccine would be shared once U.S. needs met.” Apparently Health Secretary Azar made some “America first”-type statements recently in Taiwan:
“Our first priority of course is to develop and produce enough quantity of safe and effective FDA-approved vaccines and therapeutics for use in the United States,” Azar told reporters while on a visit to Taiwan.
But Secretary Azar’s comments assume American medical autarky. An American company may well not produce the first safe and effective COVID-19 vaccine. It could be the Russians, if their extremely risky decision to release the scientifically unproven CVV in fact bears fruit. Or it could be one of the other “more than 200,” COVID-19 vaccine candidates from around the world that this article mentions in passing, many of which are being pursued by overseas companies. If the United States is not willing to share our breakthroughs with anyone else until all our needs are satisfied, we should not expect the Russians or anyone else to do us any favors, if some other country’s efforts grab the brass ring first. Force majeure is a two-way street, and it could result in the United States not having timely access to a safe and effective COVID-19 vaccine first developed overseas.