Could COVID pills help turn the pandemic tide in Michigan?
A single pill to fight COVID — that’s the promise the Food and Drug Administration will consider this month when its advisers weigh the evidence of the first of two antiviral drugs that manufacturers say stop coronavirus before it takes hold.
The drugs by Merck and Pfizer could be crucial in saving lives, especially in states like Michigan, where 3 of 5 people over 16 are vaccinated.
An antiviral pill “could definitely change the mortality and morbidity (illness) rate,” said Dr. Mark Hamed, director of the emergency and hospitalist departments at McKenzie Health System in Michigan’s Thumb region and medical director for public health in several counties in the area.
With effective vaccines, the success of monoclonal antibodies treatment, and now possibly a COVID antiviral pill, the virus may become increasingly manageable as an endemic illness, much like the flu, rather than a pandemic, he said.
But one big caveat: The pills are meant only for patients at the greatest risk and they must be taken early in the disease.
“The kicker is that you have to take it in the three days” of symptoms, Hamed said of the pills.
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The FDA’s Antimicrobial Drugs Advisory Committee is scheduled to meet Nov. 30 to consider data around molnupiravir, a drug named after Thor’s hammer. Its manufacturer, New Jersey-based Merck, says it cut the risk of hospitalization or death by about half.
In a clinical trial, 14 percent of the participants who received the placebo were hospitalized or died, while just more than 7 percent of the participants, or 28 of 385, who received the drug were hospitalized — and none died, according to its press statement. All patients had some risk factor — obesity, older age diabetes, and heart disease, for example.
Merck said it’s on course to produce 10 million courses of treatment by the end of this year, and it has agreed to supply the United States with about 1.7 million treatment courses if the FDA authorizes the product. (Britain’s Medicines and Healthcare Products Regulatory Agency authorized its use last week.)
Another antiviral pill, Paxlovid, has shown even better results, according to data supplied by its manufacturer, Pfizer. Patients received treatments within three days of COVID symptoms, taking the medication every 12 hours for five days.
The pill cut by 89 percent the odds of hospitalizations or death, according to Pfizer. In its trial, 7 percent of the patients who received a placebo were hospitalized or died, but less than 1 percent of those patients, or 3 in 389, that received the drug were hospitalized. In the later group, none died.
“People are calling it a game changer. I'm not sure I want to go that far yet,” said Susan Davis, interim associate dean at Wayne State University’s College of Pharmacy & Health Sciences.
She and others note the data must still undergo the scrutiny of its scientific peers and in front of the FDA’s advisors.
Among the questions are whether at least one of the two drugs is safe for pregnant women. Additionally, the trials were too small to fully determine their effect on death rates from COVID.
“A lot of that still remains to be seen because so much of the data is preliminary,” Davis said. “We're operating off of press releases, and making some good guesses of what we expect to see.”
It appears that such drugs could be made easily accessible to the public — a simple prescription.
While most treatments now attempt to suppress the dangerous inflammatory symptoms from COVID-19, the two drugs stop the coronavirus from replicating.
The promise of saving patients from COVID with a prescription pill gives options to family doctors such as Dr. Sanjoy Mukerjee, who primarily works in Lincoln Park at the Western Wayne Family Health Centers.
Until now, most patients go to urgent care clinics or emergency rooms when they are very sick — likely too late for antiviral pills to have the most impact. And for those patients that come to primary care doctors early in the disease and with mild or moderate symptoms, there are few things he and other primary care doctors can offer.
“I would say ‘Take care of your symptomatic control. If you have a little bit of fever, take Tylenol. Drink lots of fluids. Take some cough suppressant,” said Mukerjee.
But to be able to treat COVID before it spins out of control is astonishing, said Hamed.
“Last year at this time, we had nothing - no vaccines, no real treatment, no monoclonal antibodies — nothing,” he said.
But some worry, too, that such a pill will be another reason for the vaccine-hesitant to skip the shot altogether.
Hamed in the Thumb said some nurses have talked about the “COVID pill,” and he wonders if it’s another reason to “buck the vaccine mandate,” referring to mandates like the federal rule that millions of workers must be vaccinated by Jan. 4.
It’s unclear to what extent the drugs — even if they are as effective as the manufacturers say — halt transmission of the virus. Nor is it clear how well they protect against long COVID symptoms that can occur even with mild disease.
“It’s always going to be better to prevent a disease than to try to treat it,” said Hamed.
Vaccine refusal is no reason to withhold the drugs’ development or the treatments they promise, said Dr. James Terrian, medical director for LMAS Health Department, which covers four counties in the eastern Upper Peninsula.
“Some folks have said they won’t be immunized. I’m not able to get into their heads” to understand the reasons, he said, adding about the antiviral drugs: “Whatever helps them stay alive, I’m all for it.”
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