Miss a day, miss a lot. Subscribe to The Defender's Top News of the Day. It's free.
Black-market prescription drugs, sold by as many as 11,000 online rogue pharmacy sites, cause up to 144,000 deaths a year, according to a 2017 World Health Organization report.
Consumers are motivated by cheaper costs and easier access to medication. But black marketeers and counterfeiters often use faux and even deadly active ingredients as substitutes for legitimate ones, according to The Conversation, which last month reported on a new study showing the U.S. Food and Drug Administration (FDA) took 130 enforcement actions against counterfeit medication rings from 2016 through 2021.
Now, a black market has emerged for sales of the COVID-19 antiviral medicines Paxlovid (nirmatrelvir/ritonavir), made by Pfizer, and Lagevrio (molnupiravir), made by Merck, according to an investigation by The BMJ.
In the U.S., the drugs feature prominently in President Biden’s taxpayer-funded “Test to Treat” initiative, which allows people who test positive for COVID-19 at a pharmacy to get antiviral pills on the spot at no cost.
The initiative drew criticism from the American Medical Association, which said bypassing physicians and allowing pharmacists to dispense the pills directly to patients, “flaunts patient safety and risks significant negative health outcomes.”
That was before a black market emerged.
According to The BMJ, the COVID-19 antiviral drug black market presents a new set of significant public health dangers, from lack of medical supervision for patients to little or no verification of drug ingredients.
Here are four takeaways from the BMJ investigation:
1. The drugs may not work and could be dangerous.
Despite the burgeoning interest and popularity of the antiviral drugs — factors that are driving black-market demand — efficacy and safety questions persist.
Merck’s Lagevrio, the older of the two drugs, is similar to Tamiflu and has been used to treat other viruses, including Venezuelan equine encephalitis, influenza, Ebola, chikungunya and various coronaviruses.
However, reports The BMJ, its efficacy in treating COVID-19 and preventing clinical progression may have been exaggerated. Merck originally claimed Lagevrio reduced risk of hospitalizations and death by around 50% in people with mild-to-moderate COVID-19.
But a later Merck study put that figure at only 30%, and a New England Journal of Medicine study late last year concluded the drug “did not demonstrate clinical benefit.”
Because of its mode of action, scientists also worry Lagevrio could drive new COVID-19 mutations. It is an “oral prodrug of beta-D-N4-hydroxycytidine (NHC), a ribonucleoside that has broad antiviral activity against RNA viruses,” according to U.S. government COVID-19 treatment guidelines (under the subhead “Molnupiravir”), and “NHC uptake by viral RNA-dependent RNA-polymerases results in viral mutations and lethal mutagenesis.”
Moreover, because Lagevrio is only authorized and not licensed, “anyone injured by the drug cannot sue for damages and is unlikely to collect any benefits,” said Dr. Meryl Nass, a physician and member of the Children’s Health Defense scientific advisory committee.
For these reasons, some experts will not prescribe it because they question whether the drug’s emergency approval was “premature,” according to The BMJ.
In a clinical trial, on the other hand, Pfizer’s Paxlovid showed a reduction of deaths and hospitalizations of over 90% — but the drug is contraindicated with many common drugs which limit its usefulness.
Again, according to the National Institutes of Health COVID-19 treatment guidelines, “clinicians should carefully review a patient’s concomitant medications and evaluate potential drug-drug interactions.”
Also, patients are beginning to report they are experiencing COVID-19 “rebound infections” after a five-day course of Paxlovid.
A study yet to be peer-reviewed found that such Paxlovid users could be infectious even while asymptomatic, and the U.S. Centers for Disease Control and Prevention (CDC) in new guidance advises people to isolate themselves for five days if they experience a rebound.
2. The drugs could endanger unborn children and pregnant mothers.
One of the dangers of black market-obtained drugs is the lack of medical supervision — and such extra-medical care is an especially risky prospect for pregnant women, in whom neither of the drugs was found safe, according to The BMJ.
No human data exist for Paxlovid on the risk of birth defects, miscarriage, or the effect of the drug in human milk and when given to infants.
In laboratory animals, however, a reduction in offspring weight was seen in both rabbits and rats when mothers were given Paxlovid — which is a biomedical red flag and serious safety signal.
Similarly, the FDA warns that Lagevrio “may cause harm to your unborn baby” and advises a “reliable method of birth control (contraception) [should be used] consistently and correctly during treatment with Lagevrio and for 4 days after the last dose.”
Breastfeeding should be paused during treatment and for four days afterward, according to the European Medicines Agency.
Andrew Hill, a research fellow in the pharmacology department at Liverpool University, told The BMJ if Lagevrio is sold through the black market and used without medical supervision, patients may not use adequate birth control or contraception, which “could then increase the risk of birth defects.”
3. Sketchy online sellers offer ‘generic’ versions of drugs.
When The BMJ reporters posted a request on the website, IndiaMART, India’s largest online business-to-business marketplace, to buy 100 boxes of generic molnupiravir to be shipped to Mexico, they were surprised to find three eager sellers who quickly surfaced — despite the fact that generic versions of the drug are banned by Mexican authorities.
Because “the customs in Mexico are crazy and the clearance process is not so easy,” said one willing vendor, “[m]ost of our Mexican customers prefer to have it shipped to the USA and then they carry it across,” to avoid customs.
“We regularly do this for a lot of Mexican clients … Each country has their own set of rules for importation and none is easier than the USA. We ship to Chile, Peru, Colombia, and Brazil every day.”
While the vendor used contact information from a company called Bull Pharmachem, the company told The BMJ that it “categorically denies” its employee offered to ship molnupiravir to Mexico and other countries or gave advice on avoiding customs, and said an impostor was speaking under its company name, according to The BMJ.
“We have not exported a single bottle of molnupiravir to the U.S. or Mexico, ever,” said company officials.
The BMJ also found a website, evidently based in London, that seems to offer a course of Lagevrio without a prescription or a review by a doctor.
According to The BMJ, the U.K. Medicines and Healthcare Regulatory Authority said:
“Websites that offer to supply prescription-only medicines without a prescription are not only in breach of UK legal requirements and likely to be committing a criminal offence but are putting patients’ health in jeopardy.”
4. Strong drugs require medical supervision.
Whether bought on the black market or procured at a pharmacy under Biden’s “Test To Treat” program, many experts say the antiviral drugs should have the supervision of a doctor to monitor effectiveness and any interactions with other drugs.
FDA spokesperson Chanapa Tantibanchachai said in an email to Bloomberg Law that “at this time,” both molnupiravir [Lagevrio] and Paxlovid “should only be prescribed by traditional prescribers,” including physicians and physician assistants, who “are licensed or authorized under state law to prescribe” anti-infective therapeutics.
Paul Little, professor of primary care research at the University of Southampton told The BMJ that “high-level public campaigning” about the dangers of black-market antivirals was necessary and also noted that the unregulated black market use of antivirals could encourage viral resistance.
According to the BMJ, patients can often not tell the difference between legitimate and illegitimate generic drugs, especially since the United Nations’ Medicines Patent Pool has authorized production of inexpensive generics that are more affordable for poor countries through shared intellectual property and licenses. Confusion could ensue.
“If the drugs have not been tested for bioequivalence they may be substandard, which means less of the drug gets into the bloodstream and there is a risk of reduced efficacy,” Paul Newton, head of the Medicine Quality Research Group at the Infectious Disease Data Observatory, told The BMJ.
U.S. continues to heavily promote, despite concerns cited by BMJ
In announcing his “Test to Treat” initiative, Biden cited the fact that both antiviral pills are most effective when they are started within five days of symptoms as justification for ensuring rapid access to the pills via pharmacies.
As of May 24, according to the pharmaceutical marketing site, Endpoints, almost 3.8 million doses of Paxlovid had been supplied to states by the U.S. federal government and 831,000 courses had been administered.
Twenty thousand courses of Lagevrio were administered in the U.S. during the same time period.
In June, Pfizer said it would spend $120 million to accelerate production of Paxlovid, reported Forbes.
South Korea, Israel, the United Kingdom, the European Union and Canada adopted Paxlovid. Lagevrio is sold in more than 30 countries, including the U.S.
