The ever-evolving world of fake coronavirus treatments, like Donald Trump’s push for hydroxychloroquine, has made it difficult for many people, even those who are well-informed about pharmaceutical research, to see when potential coronavirus treatments are overhyped.
Like my critique of the over-optimistic timelines for vaccines, we need to also carefully examine information about coronavirus treatments, especially antiviral drugs that are currently being rushed through development.
For example, the antiviral, remdesivir from Gilead Sciences has been in clinical trials as a treatment (I think using the word “cure” might be an overstatement at this time) and has shown good results. Even Dr. Anthony Fauci, who has expressed valid skepticism of every claim from Trump about COVID-19 treatments, has stated that the results are “very optimistic.” In fact, the FDA may authorize the emergency use of remdesivir as a coronavirus treatment.
Let’s take a look at how we should evaluate various coronavirus treatments, using remdesivir as a model.
I’m going to walk through a stepwise process to evaluate any new drug or treatment, not necessarily just coronavirus treatments. I almost always answer questions about a new drug with a simple statement:
Call me when Phase 3 clinical trial data has been published in a respected peer-reviewed journals.
Too many times we get clickbait headlines about some new miracle drug or treatment that is based on preclinical data, usually in a press release. That’s why I won’t get excited until I see that phase 3 clinical trial data.
However, things are different today, at least with respect to the COVID-19 pandemic. The disease is deadly and highly infectious, and as of today, we don’t have a good treatment for the disease. Of course, there are quacks and scam artists who are pushing pseudo-medicine that doesn’t work.
- Always ignore press releases. Companies that are studying new treatments or vaccines have only one audience – investors. They have an incentive to overpromise, knowing that when they underdeliver, all will be usually forgiven. Gilead Sciences has been careful with their statements about remdesivir, probably because they knew they had something.
- Always ignore preclinical studies. Less than 1% of drugs or vaccines that seem to work in preclinical studies (usually in animal or cell culture models) ever get FDA approval. And even for that 1%, it could take up to 10 years for those results to become available. Never get excited about a mouse study. For example, a vaccine candidate from Oxford University, ChAdOx1, has been shown to be effective in a challenge study in six rhesus monkeys – a tiny number, no placebo group, and no peer-reviewed publications. Ouch.
- Always ignore anecdotes from research sites. As we all know, anecdotes are not data, even if they come from a “research center.” Often these reports, as we’ve seen with remdesivir, only make positive comments about the drug group, but fail to give us any analyses comparing that group to the placebo.
- As long as Trump as President, be skeptical of the FDA. The FDA has a sterling reputation across the world as one of the most intellectually and scientifically credible regulatory agencies. However, they have lately bowed to political expediency like allowing studies of hydroxychloroquine. Just because they may issue an Emergency Use Authorization for remdesivir, we should still wait for results.
- Always wait for Phase 3 clinical trial results. Since I’m going to be skeptical about the FDA Emergency Use Authorization for remdesivir, and we really do need useful coronavirus treatments, just getting the data, compared to a placebo, may give us a good idea about the ability for this drug to improve outcomes.
The National Institutes of Health has released preliminary data that shows positive results. But it is only one study, though encouraging.
However, a peer-reviewed study was just published in The Lancet that analyzed a small, double-blinded, randomized clinical trial in China – “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits.” The study also had to be stopped early because of the high level of adverse events in the remdesivir group. OUCH.
So, we have conflicting results about the safety and effectiveness of remdesivir, although the preliminary NIH results are in a much larger study group than the ones from China.
I don’t want to say I’m outright skeptical of the clinical results of remdesivir or other coronavirus treatments. But I’m concerned that remdesivir is being overhyped.
The NIH results, which are being touted across the internet, do show a reduction in the mortality rate from 11.6% in the placebo group to 8.0% in the drug group. That’s a 31% decrease. But it’s not a miracle cure that everyone wants, though I suppose a 31% better chance of surviving the disease is a miracle. However, these are very preliminary results, and there are other clinical trials with remdesivir that might show contradictory results.
Furthermore, remdesivir is not a prophylactic like a vaccine. It can only be used once a person is diagnosed with COVID-19. So don’t go to your physician demanding a 30 day supply of the drug just because you think you might have the virus. In fact, remdesivir needs to be delivered intravenously, not something that most of us could do in a home setting.
This is a drug that will probably only be used with the sickest patients in a hospital.
I want to stick by my rule that “don’t bother me until the phase 3 data are published in a peer-reviewed journal.” But the pandemic probably overrides my desires for good science. However, I think we should be careful with claims and not overstate that drugs, like remdesivir, can end this pandemic.
But as we go forward, there will be more coronavirus treatments that will appear on our news feeds. Some will be outright scams from immoral quacks. Some will be ridiculous claims from Trump. Some might be based on animal studies. Some might be early results that could have some validity.
Just be careful out there. There are no miracle treatments or cures for coronavirus.
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