By Pierre Kory
October 15, 2021
AP Photo/Mark Lennihan
In our fight against a global pandemic, we need all the weapons we can get. Merck’s announcement that it’s developing an antiviral pill to treat COVID is therefore welcome news. If molnupiravir is as effective as the drug maker claims, this early treatment option should make a big difference.
But in the hype over Merck’s new pill, we’re losing sight of the fact that we already have an effective, affordable treatment for COVID that is helping to control the pandemic in many regions of the world—ivermectin. I ask those urging the Food and Drug Administration to rush molnupiravir through the approval process: why not also support using ivermectin to help patients right now?
Ivermectin is a pill originally developed to treat parasitic infections, and it also has demonstrated anti-viral properties. Merck manufactures ivermectin, but its patents have expired and it can’t generate much revenue. That may explain why in February the company issued an unprecedented public warning against using ivermectin to treat COVID. Only two weeks earlier, Merck announced its vaccine candidates failed and it would refocus investment on testing and manufacturing capacity for molnupiravir.
Merck claims that molnupiravir is highly effective against COVID, reducing hospitalizations by 50 percent. But this unpublished data hasn’t been peer-reviewed yet. Compare that to ivermectin. Numerous studies have shown it can reduce COVID hospitalization and death rates. Health ministries outside the U.S. report up to 76% reduction in hospitalization and 88% reduction in deaths when ivermectin is deployed in early “test and treat” programs. Government officials in Uttar Pradesh, India’s most populous state, credit a program centered around the widespread use of ivermectin with the near total eradication of the disease.
This is a better track record of efficacy than Merck has even claimed—let alone proven—for its new drug.
Molnupiravir appears to have few serious short-term side effects, but experts have concerns about its long-term safety. The drug works by mutating the virus and could potentially mutate human cells, raising the risk of cancer and birth defects. Ivermectin’s safety is well-established. It’s been administered over four billion times to treat many diseases.
Then there’s the cost. Although we don’t yet know molnupiravir’s price tag, the federal government has committed to buying 700 million doses for $1.2 billion. That’s 40 times the cost of producing the drug—a major expense by our deeply indebted government when we have a cost-effective option available now. It costs six cents to manufacture one ivermectin pill, and a full treatment course can be purchased for less than a dollar in many countries.
This is not to suggest Merck is doing anything wrong. The real problem here isn’t any one company’s business model. And if molnupiravir does turn out to be a game-changer, the company should be lauded for its innovation and will deserve to make serious profit. Indeed, over the last century the pharmaceutical industry has saved countless lives and conquered many diseases. Modern vaccines and therapeutics are scientific miracles.
The real problem is our dysfunctional drug approval process. The National Institutes of Health and FDA consistently and more readily approve shiny, new, more-profitable therapies—even if they’re less effective—while making it nearly impossible for currently available low-cost drugs to be approved for new indications despite their efficacy as repurposed treatments.
The pandemic has only accelerated this trend and diminished time-tested practices in the study of medicine. Until now, physicians have routinely collected observational data, interpreted studies of various sizes and designs often conducted on a sample population who take a drug, and compared them to data from another population who don’t. But today, the powers that be will only credit the outcome of complex, expensive randomized controlled trials that analyze data often from large patient populations across multiple centers. Such trials are important. But prior to COVID they were never elevated to the status of the sole criterion, precisely because they inherently provide incomplete pictures of a drug’s efficacy and safety.
We can see this dynamic playing out in real-time, as Merck’s promotion of its new pill coincides with a full-court institutional press to reject ivermectin as a possible treatment for COVID. Echoed by mainstream and social media, an array of government and civil-society voices—from the FDA to the White House to the American Medical Association—have dismissed its potential in the face of ample evidence suggesting otherwise.
If we keep heading down this path, ignoring data generated by physicians, researchers and health ministries and kowtowing to a top-down, profit-driven, novelty-chasing cycle, we will continue to see needless hospitalization and death as public confusion and mistrust rise.
When new illnesses emerge, we’ll again be forced into long waits for more expensive trials that are the only way to squeeze through the eye of our postmodern government-industrial complex needle. That’s a prescription for more suffering and death—and blowing our shot to stop the next pandemic before it knocks our world further off course.
Pierre Kory, MD is president and chief medical officer of the Front-Line COVID-19 Critical Care Alliance.