COVID-19 has introduced a new infectious disease that has caused significant morbidity and mortality worldwide with significant economic and cultural effects. At the same time, researchers worked quickly to study the virus that causes COVID and develop effective treatments. In one year, several vaccines have been approved and in production, giving us a powerful tool to reduce the pandemic. It took longer to develop effective antiviral treatments for the active infection (after some false starts with drugs like hydroxychloroquine and ivermectin that were found to be ineffective).

However, recently two antiviral drugs have been approved and have been shown to be very effective in the early treatment of COVID disease. Molnupiravir (from Merck) is an oral medication that has been shown to reduce the risk of 50% hospitalization and death, if taken early for mild COVID. Benefits are less if taken later in the course of illness, and more research is needed to see if it is effective in moderate to severe COVID. The most recent analysis of this data, however, only show a 30% risk of hospitalization. An independent study is also underway and regulators are waiting to see if even this 30% reduction holds up.

Nirmatrelvir (from Pfizer), on the other hand, has been shown reduce the chances of progress from mild COVID to severe COVID by 89% compared to placebo. This medicine is given in combination with ritonavir as a ‘pharmacokinetic enhancer’ to block metabolism and prolong the effectiveness of nirmatrelvir.

Adding these drugs (especially nirmatrelvir) to existing treatment and prevention vaccines will help turn COVID into a more manageable disease and also ease the transition to life with endemic COVID, just as we live with the flu. endemic. One of the greatest burdens of COVID is the dramatic increase in hospital admissions, especially during peaks, which overwhelms staff and resources and further crowds out routine care, resulting in negative health outcomes. health. Reducing hospitalizations among those who contract COVID is therefore very helpful.

The World Health Organization (WHO) has added molnupiravir to its list of recommended COVID treatments and states:

molnupiravir should only be given to non-severe COVID-19 patients at the highest risk of hospitalization. These are usually people who have not received a COVID-19 vaccine, the elderly, immunocompromised people and people living with chronic diseases.

There are two reasons to limit the use of these antivirals. The first is that although they appear to be safe with few side effects in clinical trials so far, they are new drugs. When we start giving them to millions of patients, it is possible, even probable, that new side effects will appear. On a risk-benefit basis, therefore, they should be limited to those who need them most.

The second reason is that the availability of these antivirals is limited. Production can only be accelerated so quickly. At first, supplies were limited even in the countries where production was located, but now there is enough availability that they are available to anyone who needs them. That is to say in the developed Western countries. Supplies are still extremely limited in the poorest countries.

Unfortunately, as has now been documented in a recent BMJ article, this has led to the creation of a black marker in the generic versions of these drugs. Their reporters contacted an online marketplace, Indiamart, and report:

Within hours, three vendors got in touch with offers, even though Mexican authorities did not allow generic versions of the drug to be imported into the country. A seller gave advice on how to avoid customs.

Black markets for generic versions of these drugs arose almost instantly when initial studies created hype about their effectiveness. As the BMJ the article points out, this is problematic on several levels. First, online black markets do not require a prescription (of course) or the intervention of a doctor. Like all medications, these antivirals may not be safe for certain populations (such as pregnant women) and may have drug interactions. They should only be taken under the supervision of a doctor or as part of a clinical trial.

Indiscriminate use of these antivirals is also of great concern, as it can cause antiviral resistance (just as indiscriminate use of antibiotics can cause antibiotic resistance). Those who do not really need the drug incur costs and risks with no probable benefit, and may possibly reduce the effectiveness of these drugs for those who do need them.

Moreover, there is no quality control for black market drugs, and there is every reason to believe that the sellers involved are less than scrupulous. This opens the door to many risks, such as taking worthless substances, unknown substances that can cause allergies or negative interactions, and the risk of contamination and adulteration.

The BMJ the authors rightly point out that it is a high risk whenever there is an extremely unequal distribution of healthcare resources. However, the risk goes beyond that. Even the perception of scarcity will drive the black market, and that perception can be entirely fabricated for that purpose. A drug can be “rare” because it is not approved, because it is not safe and effective. The lack of approval can then be attributed to a conspiracy, with the black market as a remedy.

The BMJ The study also highlights that the availability of online marketplaces can quickly establish a black market infrastructure for new products. Additionally, online marketplaces may exist in places with lax regulations but supply anywhere in the world. Local regulations may therefore be of little benefit, especially if these same black merchants are adept at avoiding customs.

One solution to the exploitation of black market drugs (which tends to target the most vulnerable) is stricter regulation and more international regulations. However, this only concerns supply. We must also respond to demand. In cases of inherently fraudulent or unnecessary drugs and products, education is the best tool. But when it comes to generic counterfeits of effective drugs, improving supply, especially in poor countries, can also be effective. Merck has announced, for example, that they will offer voluntary licenses to generic manufacturers in poor countries, and steps like this can be of great help.