Post by DrSchadenfreude on Apr 30, 2020 18:43:28 GMT -5
Urging Caution On Remdesivir
by Dr. William Haseltine
April 30, 2020
There is palpable excitement today among many regarding the potential of remdesivir to help patients with severe Covid-19 recover. Many are saying there is clear cut evidence that it works, based on a news release issued yesterday by the National Institutes of Health (NIH). Yet, an equally important study about remdesivir was published the same day in the Lancet, with markedly different results and noticeably less attention paid.
According to the NIH, preliminary data analysis from a randomized, controlled trial involving 1063 patients showed that patients who received remdesivir had a 31% faster time to recovery than those who received the placebo. It also suggested — but didn’t statistically prove — that there was a survival benefit to the drug, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
The Lancet article describes results from a randomized, double-blind, placebo-controlled trial involving 237 patients at ten hospitals in Hubei Province, China. That study found that patients who received remdesivir did not recover any faster than patients given the placebo. They also found that the 28-day mortality was similar between the two groups, with 22 patients (14%) who died in the remdesivir group versus 10 (13%) in the placebo group.
In such a time of despair, it is no wonder that we cling to the more positive results from the NIH trial and all but ignore the news from China. But our hope is premature and may be misplaced. The NIH has not released any comprehensive data from their trial, nor were their findings made public or peer reviewed before the public announcement.
While I have enormous respect for the Institutes and their leaders, releasing the preliminary news without sharing the data behind it is highly irresponsible. We have, unfortunately, already seen what unfounded trust in an unproven medical solution can do, with the death of a man in Arizona who ingested chloroquine from his fish tank in the hopes that it would protect him from Covid-19.
Remdesivir is not a drug without risk.The peer reviewed study out of China showed that 18 patients (12%) had to discontinue remdesivir because of adverse or serious adverse events. These adverse and potentially life-threatening events included gastrointestinal issues and liver function abnormalities — side effects that we have known about for a while already.
It is impossible to know with certainty why the NIH released unpublished preliminary results without accompanying comprehensive data on the same day that a definitive peer reviewed paper with disappointing results was being published. It is possible that they are aware of a credible beacon of hope and they wanted providers and patients alike to know. It is also possible that the decision was done for economic, geopolitical, or political reasons.
But we should not allow hope, nor politics, nor economics to cloud our vision. Viruses do not care much for any of them. If we are to have drugs and vaccines to control this pandemic, we must keep an open mind regarding what works. But we must be equally open to what doesn’t and not base policy or actions on undocumented assertions that may put all of us more at risk than necessary.
I am a scientist, businessman, and philanthropist. For nearly two decades, I was a professor at Harvard Medical School and Harvard School of Public Health where I founded two academic research departments, the Division of Biochemical Pharmacology and the Division of Human Retrovirology. I am perhaps most well known for my work on cancer, HIV/AIDS, and genomics. My work now also includes efforts to improve access to high quality, affordable healthcare for people in low, middle, and high income countries alike. I am chair and president of ACCESS Health International, a nonprofit organization I founded that fosters innovative solutions to the greatest health challenges of our day. Each of my articles at Forbes.com will focus on a specific healthcare challenge and offer best practices and innovative solutions to overcome those challenges for the benefit of all.
