Merck Challenges Safety & Validity of All Ivermectin Studies for COVID-19, Despite Having Donated Billions of Doses to Less-Developed World to Fight Parasites & Accumulating Positive Data

A February 4 press release from Merck is raising yet more questions about why research money is not going to ivermectin and why this seemingly effective drug is so underutilized, even in North American research. In the statement Merck, one of America’s great pharmaceutical companies and manufacturer of the Stromectol/Mectizan branded versions of ivermectin, claims that: 1) there is no evidence that ivermectin works for COVID-19, and 2) there is a “concerning lack of safety data in the majority of studies,” suggesting that the drug may be unsafe. Concern two is odd, given that Merck has proudly donated billions of doses of ivermectin to fight river blindness. On its website, Merck boasts that its own Dr. William Campbell first suggested the use of ivermectin for river blindness in the late 1970s and that from 1987 to today Merck has committed to donating, “as much as needed, for as long as needed” to eliminate river blindness. The firm notes that the ivermectin program, “reaches more than 300 million people in the affected areas annually, with more than 4 billion treatments donated since 1987.” And according to the August 2020 version of NIH’s COVID-19 Treatment Guidelines, ivermectin “has demonstrated an excellent safety profile” in past use. The Merck press release goes on to intricately detail ivermectin’s potential adverse reactions, but in the context of the NIH’s view and the efficacy issues touched on below, this focus has an element of strategic scaremongering. Could it be because not only did they just announce their intention to acquire a company for $425 million to develop a novel COVID-19 treatment but they also recently received $356 million from the government to support the effort?

Mounting Efficacy Signals

TrialSite started chronicling the use of ivermectin in COVID-19 studies after the University of Monash lab culture study revealed the generic drug destroyed SARS-CoV-2 five-fold in just 48 hours. Since then, this media platform has documented well over three dozen studies that indicate a strong efficacy signal. Importantly, TrialSite was founded to drive more transparency and accessibility in clinical research—how to bring more trust into the process to advance biomedical research.

While most media platforms wouldn’t go near the ivermectin story for whatever reason, TrialSite objectively tracked study after study—why wouldn’t low cost, generic repurposed drugs also be considered along with novel approaches? Along with methodically tracking federal government-related grants and capital injections as Operation Warp Speed launched, TrialSite in parallel locked in on ivermectin studies—could efficacy be proven? Starting later in April through today, study results accumulated. With over three dozen clinical trials–from Bangladesh, Egypt, Iraq and India—physician/research groups emerged to conduct meta-analyses—that is a statistical analysis that combines the result of multiple clinical trials.

This class of research helps when there are multiple studies addressing the same question, noting that each individual underlying study reporting measurements certainly include some degree or error and potential for bias. The Front Line COVID-19 Critical Care Alliance (FLCCC), led by Drs. Paul E. Marik  and Pierre Kory, was the first group to take on the growing number of ivermectin studies targeting COVID-19. The FLCCC meta-analysis was followed by two comparable efforts in the United Kingdom—one by Dr. Andrew Hill, affiliated with the University of Liverpool and the other by Dr. Tess Lawrie  with The evidence-based Medicine Consultancy Ltd. The Merck press release completely and utterly conflicts with these meta-analyses and over 50 studies conducted worldwide. 

Ivermectin Safety

A World Health Organization essential medicine since 2019, Ivermectin has been used for decades now to fight parasites. As noted above Merck has donated billions of doses of this medicine. But how times have changed.

As shared by one of the world’s top experts in the ivermectin field, Dr. Carlos Chaccour, the drug is certainly safe, “When used for the current indications, at the currently approved doses, ivermectin is a very safe drug. To date, more than three billion treatments have been distributed in the context of the Mectizan Donation Program alone with an excellent safety profile. Most adverse reactions are mild, transitory and associated with parasite death rather than with the drug itself.” Dr. Chaccour, who recently completed an ivermectin and COVID-19 study producing modest results, was also featured on TrialSite and most certainly has represented a voice of caution when it comes to ivermectin as applied to COVID-19.

TrialSite recently interviewed Dr. Femi Babalola from Nigeria, who has led the Ivercovid study. Dr. Babalola shared that Nigeria is perhaps the country with the most ivermectin use in the world—with about 80 million people who have taken it over the past twenty-five years to combat parasites, again as part of the Mectizan Donation Program. He shared with TrialSite that the drug is quite safe.  His small study revealed significantly positive results. While not big enough by itself to amount to strong evidence, the Nigerian story represents yet another data point of interest.

Economic Realities

Already $2 billion of government funds via Operation Warp Speed were pumped into monoclonal antibody makers and hundreds of millions as well supporting Gilead (remdesivir) earlier in NIH-sponsored trials.  TrialSite meticulously documented these transfers via the organization that was helping to determine where research dollars should be spent—the NIH’s ACTIV initiative. Out of this effort now approaching at least $15 billion has been allocated to just a handful of vaccine and therapy producers.

With a failed vaccine initiative Merck, one of the world’s most successful pharmaceutical companies, eyed the market remdesivir had already captured, leading to nearly $3 billion in revenue in just several months). They needed to develop a better product and identified potential with a couple of candidates known as EIDD-2801 and MK-7110 (formerly CD24Fc).

The latter came via a recent acquisition for $425 million in cash of the biotech firm OncoImmune. TrialSite recently reported on the $356 million Merck was able to secure from the U.S. government’s Department of Health and Human Services for its ongoing research targeting COVID-19. Securing from 60,000 to 100,000 doses of the latter experimental product from OncoImmune, the funds contribute to advanced development and large-scale manufacturing should this product work. MK-7110 according to Merck is a,  “potentially first-in-class investigational recombinant fusion protein that modulates the inflammatory response to SARS-CoV-2, principally by targeting a novel immune pathway checkpoint.” The basis for the positive momentum: interim results  from one small Phase 3 study revealing a 50% reduction in the risk of death.

Conclusion

Merck’s utter and complete dismissal of dozens of legitimate study results worldwide, combined with the growing data points indicating some level of efficacy, from court ordered ivermectin use in New York State to the NIH itself referring to the peer review ICON study could give many pause. But it is a strict business decision—like an advertisement.  The New Jersey-based multinational corporation faces ongoing pressure of continuous growth.

Merck has serious economic pressure to produce a therapy targeting COVID-19, evidenced by the $425 million cash acquisition of  OncoImmune and shortly thereafter the $356 million payment by the U.S. government for advanced development, manufacturing, and procurement. Hence Merck had to make a cold hard business decision.  Even if the company would want to explore ivermectin the economic structures in place would not allow this once American treasure to do so.  It’s unfortunate that they felt obliged to put down so many others’ research, not to mention the safety and benefits of their own product.   But that’s something they will have to live with. In the meantime as investors in this crazy world we look for a great company brand, one that stands for compelling values, ethics, and global health for all—and making good honest returns—that’s the investment we seek. Like the Merck we knew—the one that gave away billions of doses of ivermectin to the developing world.


Responses

  1. I don’t blame Merck or other Big Pharma for not investing in IVM (this is the NIH’s responsibility). Although, Merck certainly could have come up with a combo drug or a new route of administration to patent and drove it through to EUA. I do blame them for casting disparities on the small trials from all over the world that were done under extremely challenging circumstances by brave, resourceful researchers and clinicians. The ultimate sin though is their bold lies in an effort to use fear about fabricated safety concerns. Nobody knows more about IVM’s excellent safety profile than Merck. That is an stomach wrenching reckless crime that shows Merck is perfectly willing to sacrifice countless lives in the pursuit of potential future revenue.

  2. Observed in but limited to Big Pharma
    Strategic Objective # 1:
    Buy up start ups with cash offers too good to pass up before they bring product to market. Appeal to investment banks to cash out whether or not founders are on board.
    Kill the development if a direct competitor for a similar product (yeah that’s anti-competitive but hey, someone has to lose)
    Strategic Objective # 2:
    1) Socialize the Cost of Development by federal funding whenever possible (lobbying helps but well placed advocates/appointees are critical to protect and enhance interests)
    2) Privatize the profits (never let a public health crisis go without windfalls)
    3) Socialize losses if necessary.

  3. we are entering an era where the creation of false news is becoming a political necessity brought about by the publics learned inability to judge the quality of information. We see this happening in politics and, increasingly, in markets. It used to be called advertizing but that boundary has been breached. Merck is simply advancing this trend and exposing, to those who are checking, its true colors. The proper response would be to shame these people, but that requires sufficient media independence to do it. That, too, is part of the problem.