Gregory Rigano, an attorney who says he is an adviser at Stanford University Medical School, appeared on Tucker Carlson’s show Wednesday night to discuss the potential for a widely-used antimalarial drug, hydroxychloroquine, to treat the novel coronavirus. He had already appeared on Laura Ingraham’s show Monday night, where he claimed a study he’d co-authored showed that coronavirus patients who’d taken hydroxychloroquine were testing negative after six days.
On Tucker’s show, he said that President Trump, after having “cut more red tape at the FDA than any other President in history,” has the authority to green-light the use of this drug immediately against coronavirus. He said Trump has expedited drug approval before, in 2017, with a new drug for muscular dystrophy being approved after a very small clinical trial (fewer than 15 patients) that was “generally uncontrolled, in an open setting.”
Being a lawyer himself, I guess Rigano is concerned about liability if doctors prescribe the drug off-label and it causes harm. But doctors do prescribe drugs off-label quite often. The FDA takes a pretty lax attitude about that once it has approved a drug as "safe and effective."
Understanding Unapproved Use of Approved Drugs "Off Label"
Rigano noted that hydroxychloroquine has been on the market and used safely for over 50 years, and said he was breaking news on the air with his announcement that “a well-controlled peer-reviewed study...showed a 100 percent cure rate against coronavirus." (He claims this makes COVID--19 only the second virus in history to be cured, after Hepatitis C.) "The study was recently accepted to the International Journal of Antimicrobial Agents,” he said. We looked that publication up, and here it is:
The journal has published other work on the issue of treating COVID-19 with this drug.
Tucker was understandably skeptical, as we all should be, but expressed gratitude. “I very much want to believe this,” he said, “and I think we need, obviously, to immediately run it down; the federal government needs to find out if this is true, because if it is, that’s the biggest news of this moment.”
It was hard to know what to think about this while watching it, as it just came out of the blue. It didn’t help that Rigano ended the interview oddly, by saying, “Please disseminate it to the scientific community immediately.” It sounded a little like, "People of Earth...take me to your leader."
What could Tucker say? It was the close of his show. “I would hope they’d—they’d be on it,” he stammered.
We looked up Rigano’s bio, and that’s where I saw that he is an attorney, not an M.D. as TV viewers might have assumed. It goes on to say, “Gregory’s experience includes advancing various pharmaceutical assets through laboratory, animal, formulation, manufacturing, clinical trials (Phase I-III), as well as commercialization.” Here’s the whole thing:
There actually is a research paper with his name on it, called “An Effective Treatment for Coronavirus (COVID-19), linked to below. On the other hand, the paper concludes with a grammatically-challenged disclaimer that says in part, “The authors and/or its affiliates does not guarantee the accuracy of or the conclusions reached by this white paper, and this white paper is provided ‘as is.’ It goes on in similar fashion. That doesn’t do much to inspire confidence. It’s impossible to know right now if this is legit, and it appears that they rushed it out.
Whether this study is for real or not, I think perhaps the best attitude to take about trying this drug on the virus is that “it couldn’t hurt.” When something seems too good to be true, it usually is. Still, this is a drug that has been used safely for half a century, so why not fast-track the studies and also approve it now for off-label use to treat coronavirus and see how well it works? Given the circumstances, what have we got to lose?
The video from Tucker’s show can be found here: