Perfecting COVID Pills

That giant whoooshing sound you heard last Thursday was not an approaching Atlantic hurricane. It was the global sigh of relief after Britain’s Medicines and Healthcare Products Regulatory Agency became the first officials to approve molnupiravir (Lagevrio), Merck’s experimental anti-COVID pill. Then on Friday, there was a second whoosh as Pfizer announced that a trial of its own drug Paxlovid plus the antiviral ritonavir was so successful that they stopped it early. The Brits, who had stockpiled 250,000 courses of Pfizer’s combo earlier in the year, liked that too.

The drugs work in different ways. Merck’s one pill twice a day confuses the virus’ genetic code so it cannot multiply. Pfizer’s 3 pills twice a day block an enzyme the virus needs to multiply.

In short, it looks at last that there are two paths to COVID treatment. Getting here has been a two-year journey mirroring the old rhyme

One for the money

Two for the show

Three to get ready

And four to go

Here’s how it went:

Step One: Follow the money. Remember hydroxychlorophine? Back then, without charging malfeasance, The New York Times reported that Donald Trump had a small stake in Sanofi, the French company that produces the brand-name version. Commerce Secretary Wilbur Ross was also linked to Sanofi, and generic drug makers, including one co-founded by a Trump golfing buddy, were gearing up to crash the market. They were not alone in attempting to cash in. Currently the House Subcommittee on the Coronavirus Crisis is investigating America’s Frontline Doctors and the telemedicine SpeakwithanMD, which seems to have scammed customers out of about $15,000,000 for drugs that were either non-approved or never delivered.

Step Two: Watch the show. Once upon a time it seemed Ivermectin might turn in a star performance, but it turned out to be an anti-climactic rather than anti-COVID. Studies touting the drug’s effectiveness were missing important research elements like enough patients and reliable results. One, published last May in the journal Viruses, actually had to be retracted because “the ‘original set of data was rigged, sabotaged or mistakenly entered in the final file.’” Worse yet, the FDA warns that doses of this pill large enough to produce an antiviral effect could “interact with other medications to cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.”

On September 1, after an alarming increase of calls to poison control centers, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists called for an “immediate end to the prescribing, dispensing, and use of ivermectin for the prevention and treatment of COVID-19 outside of a clinical trial.” But some dreams never die. Ivermectin remains in play with at least 77 studies and 139 trials listed in the WHO’s International Clinical Trials Registry Platform. Two here at home are evaluating Ivermectin along with fluvoxamine and other meds. The first is at the University of Minnesota Medical School. The second, ACTIV-6, funded by the National Institutes of Health, with data collection done by Vanderbilt and Duke universities, is enrolling volunteers nationwide. Want to join? Check it out here: https://combatcovid.hhs.gov/joinaclinicaltrial/activ-6

Step three: Getting ready. Remdesivir is an injectable med that makes it hard for viruses to replicate. Based on five well-done trials with nearly 14,000 hospitalized patients who went home faster following remdesivir therapy, it was approved by FDA to treat adult and pediatric COVID patients. The drawbacks? It’s best given in the hospital. And it’s got side effects including possible allergic reactions, upset stomach, slow blood clotting time, and liver damage. At the same time, a study of 1,500 Brazilian COVID patients at risk of severe illness because of other health problems, such as diabetes appeared to show that the inexpensive antidepressant Luvox could reduce hospitalization. The effect was so clear that independent experts quoted in the journal Lancet recommended stopping the study and moving straight to prescription.

Step Four: On to the go. When will molnupiravir be available here Maybe by the end of the year. Last week Merck applied for an emergency use authorization and an FDA advisory committee is set to meet on Nov. 30 to consider it. Pfizer said it plans to add interim trial results for Paxlovid as part of the FDA emergency use application it opened in October. Neither company has submitted complete results, including specific data on side effects. Merck says its are minor. Pfizer says 20 percent of its patients had some unspecified problem but is moving ahead to study whether its pill can prevent coronavirus infection. Both companies expect to produce millions of doses by next year.

Stay tuned.

Stay healthy.

But don’t wait to get your vaccine booster.