Call It a Hopeful Sign


Remdesivir molecular structure

Remdesivir molecular structure

It’s Remdesivir. It’s not a magic bullet. It doesn’t cure COVID-19. It’s certainly not a prophylactic for COVID-19 (although we can expect President Trump to claim it is). What it does do is reduce the amount of time for recovery. By about 30%, based on a limited clinical trial.

Remdesivir was developed as a treatment for Ebola. Its mechanism is to bind to the enzyme that copies the RNA genome of the Ebola virus. The hope was that would make the enzyme unavailable to replicate the Ebola RNA. Since our cells don’t need to make copies of RNA to duplicate, the hope was that drugs like Remdesivir would target the viral enzyme but not any enzymes that our own cells need. Testing had already indicated it was safe for general use, suggesting that Remdesivir was successful in this regard. Unfortunately, it didn’t clearly work against the Ebola virus, leaving it in the very large collection of drugs that are proven safe but have turned out to be ineffective.

But the novel coronavirus, like Ebola, also uses an enzyme to reproduce its RNA. The novel coronavirus RNA-reproducing enzyme is similar, but not identical, to the Ebola enzyme. So Gilead, which holds the patent to Remdesivir, made the drug available for a trial. The results are in. Dr. Anthony Fauci, one of the few members of the Trump Administration who still has credibility, said that the trial, conducted in the United States and various European countries, had enrolled 1,090 patients. Those participants were randomly assigned to receive the drug or a placebo, and the primary measure of success in the trial was time to recovery—how quickly the patients could be discharged from the hospital or resume normal activities. By that measure, Remdesivir was a significant success; those receiving the drug took an average of 4 less days to recover; those receiving the drug took 11 days to recover, those on the placebo took 15 days. That’s a 30 percent faster recovery, a result that’s statistically significant given the size of the trial population.

A four day improvement may not sound like much, unless, of course, you are suffering the disease. But it also shortens the time a hospital bed is occupied and suggests that the underlying attack of the drug may be worth more research.

There are rules that apply to these kinds of drug trials. One of those rules says that if a drug is proven effective it has to be administered to the placebo group as well. That’s the ethical thing to do. But an unfortunate effect of being ethical is that it made it pretty much impossible to determine if Remdesivir lowers death rates. Those receiving the drug had a mortality rate of 8.0 percent, while the placebo group was at 11.6 percent. The standard for statistical significance in these matters is a p-value of 0.05; the results here were just outside of that at a p-value of 0.059. As Fauci delicately put it, “the mortality rate trended toward being better.”

The research journal The Lancet released a smaller randomized study of the same drug from China. Circumstances there led to a much smaller pool of patients, just 237 total, and the results are clouded because some of those patients were taking other experimental medications as well. But the results are largely consistent with the U.S. study. Other trials are in process; we may have a better idea of the drug’s efficacy fairly soon.

So: not a miracle drug, not a cure, not a preventative. But a useful tool in the health care toolbox. More than we had before.

2 thoughts on “Call It a Hopeful Sign

  1. A major concern I have is that the administration and the media continues to focus on Big Pharma and enriching the 1%. There are existing treatments that do not enrich big pharma that have been used with Ebola etc. that are suppressed by big pharma. This short excerpt from an interview Dr. Mercola did with Dr. Robert Rowen illustrates just one view and treatment.
    “In this interview, which took place March 23, 2020, Dr. Robert Rowen, who has practiced ozone therapy longer than any other physician in North America, discusses how it can be used for the prevention and treatment of COVID-19 infection and other viral illnesses.
    I previously interviewed Rowen about his contributions during the 2014 Ebola epidemic, when he and his staff went to Africa to treat affected patients and teach medical professionals on the use of ozone.
    Over the years, Rowen has treated tens of thousands of people for a wide variety of conditions, and ozone appears to work in a wide variety of clinical settings, he says.
    “I decided to go to Africa in 2014 because, knowing what I knew about the Ebola virus itself, I thought ozone would be an ideal therapy. Because of the similarity of the Ebola viral coat to coronavirus, I also believe it will be an effective treatment for coronavirus,” Rowen says.

    Ozone also modulates the immune system. The cytokine storm associated with severe COVID-19 infection is due to an out of control immune reaction. Ozone can help bring the immune system back into balance, thus allowing it to defend itself against the invader without causing excessive damage in the process. According to Rowen:
    “Ozone appears to be an incredible antiviral. In my words, it’s the ideal antiviral … Designing drugs to damage the lipid coat is probably going to fail because those drugs are going to be toxic.
    But we have a molecule that can do this. And whether you call it a drug, ozone is a natural substance — because it’s made by the body — it matters not to me. The fact is, it’s a pro-oxidant and it can ding the virus and render it inactive if the virus is exposed to it …
    One of my goals in all of this is to try to get ozone [as] standard of care. I believe it’s running up against a wall deliberately, because if ozone and oxidative therapies, including vitamin C, hydrogen peroxide or ultraviolet blood radiation got out there, you would see a change in the landscape of medicine in this country and it would really hurt Pharma … So, I have no doubt that this information is being deliberately squelched.
    I know reporters who were trying to get the story out there and they were told by their higher ups, no go. It’s a dead story. Why? Ozone could be put into the ICUs [at] no expense, no cost. I don’t want to be paid for it to go into local hospitals … But we have a system that is so corrupt, so vile, that if it’s not FDA approved, they will let somebody die.

    Like

    • Ozone is prohibited by federal regulation for all medical applications. Code of Federal Regulations Title 21 Sec. 801.415. It is an extremely dangerous, highly reactive gas. Claims for “ozone therapy” or the medical benefits of ozone are unsupported by any peer-reviewed clinical studies WC is aware of. WC had a childhood friend who suffered from Thalidomide-induced birth defects; you will have a hard time persuading WC that the FDA doesn’t serve a critical gatekeeper role. Claiming ozone has beneficial uses – other than as a sterilizing medium – is an extraordinary claim, and as the late Carl Sagan said, “Extraordinary claims require extraordinary proof.” WC has seen no proof, let alone extraordinary proof. WC has no quarrel that capitalism and medicine are uneasy bedfellows, but if there were miracle cures for coronoaviruses no conspiracy would keep them suppressed.

      /WC

      Like

Comments are closed.