Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Tuesday, October 19, 2021

Merck's Anti-COVID Molnupiravir Skeptics

"When the data come out, they're underwhelming. We have to be a little careful."
"[While a 50 percent drop in hospitalization and death risk sounds encouraging it is still not as impressive as vaccines] which are at least 85 percent effective at preventing those same outcomes."
Dr.Donald Vinh, McGill University Health Centre, Montreal

Capsules of Merck's experimental antiviral drug Molnupiravir, which cost a reported US$700 to $800 for a five-day course of therapy.
Merck's experimental drug  Merck & Co. Inc./AFP
"Maybe it's great -- we just have no idea."
"Do you send them to an infusion centre or somewhere to get a subcutaneous injection of monoclonal antibodies, or to the pharmacy for pills? And why do you choose one over the other? These are all quite challenging."
"[Governments are damned if they do and damned if they don't. They have to make a decision around the procurement, knowing that it's very possible that this [molnupiravir -- Merck's drug], is going to become a very popular agent."
"If you’ve got infinite funds and access to the drug, you’d say, ‘Okay, give it to everyone.’ But it doesn’t make economic sense. You need to give it to the people who are highest risk. And you have to figure out, who’s the highest risk?"
"That’s the crazy thing — many people who are vaccine hesitant don’t seem to be hesitant of monoclonal antibodies, or ivermectin, or any of these other treatments, whether they’re useful or not. But there is something special about vaccines that they won’t take." 
Dr.Andrew Morris, infectious diseases specialist, Mount Sinai Hospital, University Health Network, Toronto
Georgia State University virologist Richard Plemper, speaking to the journal Nature, explained that the new Merck drug molnupiravir has "mutagenetic" properties where it is designed to stop the virus from copying itself in the process causing problematical mutations. "The virus essentially mutates itself to death", he said. The Merck press release, prior to being authorized as an anti-COVID drug by national health authorities, speaks of investigational results where the antiviral was seen to halve risk of hospitalization and death in a study of 775 people with mild-to-moderate COVID-19, compared to a placebo.
 
Should further, intensive scientific scrutiny verify Merck's claim of success it would signify that the first early COVID treatment not dependent on infusion or injection has succeeded in trials to prevent serious complications from COVID. The memory of other drugs in which hope was invested ultimately failing -- like hydroxychloroquine and colchicine -- to live up to expectations leads to a certain amount of skepticism that the Merck medication will work where others have failed.
 
Reportedly a five-day course of therapy comes in at $700 to $800, even while the the drug, if it passes further critical tests, could not be used by everyone, stocked in every drugstore, pointed out Dr.Morris. Conducted with Ridgeback Biotherapeutics, the Merck trial included people with at minimum one risk factor for developing serious COVID: obesity, advanced age (60 and up), diabetes and heart disease. All those in the study had been unvaccinated. 29 days following treatment 7 percent of those treated were hospitalized or had died.
 
The Merck pills must be initiated to those recently infected and diagnosed fairly early, with a confirmed positive test, within five days of the appearance of symptoms. Doctors, should the Merck pill be approved by Health Canada, would then have two treatments of choice for patients with mild to moderate COVID at risk of a poor outcome; monoclonal antibodies infusion or injection at a cost of between $1,500 to $2,000 each dose, or the Merck pill. 
 
There has been concern whether the molecule produced by molnupiravir allowing mutations to occur could lead to problems in patients. "But I cannot imagine that that's an issue, because it's not taken up in human cells the same way", explains Dr.Morris. Toxicity studies from all pre-clinical data showed no "untoward effects" from doses administered to people, assured Merck's vice-president of policy and government affairs. The data to date show "the drug was generally well tolerated in terms of safety and side effects", said Merck Canada's Jennifer Chan.

The drug acts by inserting itself into the viral RNA, which creates a phenomenon known as viral error catastrophe, which confuses the virus by giving it incorrect building blocks to replicate. Two capsules daily for five days comprises treatment with the Merck product. At a cost of $1.7 billion, the U.S. ordered 1.2 million courses of the formulation. According to Dr.Morris, those benefiting most from this therapeutic course would be the unvaccinated.

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