Did Merck Bilk the UK Government? About $1b Spent on Molnupiravir, Yet the Drug Shows Little to No Benefit
Merck’s molnupiravir has failed to lower the risk of hospitalization or death based on a recent clinical trial reported in The BMJ. In “COVID-19: Antiviral purchased by UK government does not lower risk of hospital admission, trial shows,” Jacqui Wise of Kent, England reports that the government of the UK sought a benefit when acquiring 2.23 million doses, yet now determine that the antiviral authorized under pandemic conditions isn’t better than the placebo at reducing risks of hospitalization and death according to the findings of a pivotal study.
Published in The BMJ, Wise, a freelance medical journalist affiliated with this journal for many years now, wrote that:
“The UK was the first country to authorize Merck Sharp and Dohme’s molnupiravir (Lagevrio) for the treatment of mild to moderate covid-19 in adults with at least one risk factor for severe illness.”
While the European Medicines Agency hasn’t yet approved the drug, the UK’s health secretary, Sajid Javid, announced that when his government made the molnupiravir purchase that it was a “gamechanger for the most vulnerable and the immunosuppressed.”
Was the government acting as marketing agencies for the pharmaceutical companies? One must wonder. TrialSite has chronicled during the pandemic some data points evidencing regulatory capture. Wise reports that the editors of the Drug and Therapeutics Bulletin raised concerns as the government announcements about the purchase of the Merck drug were “over promotional and sensationalized.”
Safety concerns were raised with this drug. In fact, in India, the top medical official for the Indian Council of Medical Research, Balram Bhargava, went on the record that his group has “major safety concerns” associated with Merck’s molnupiravir.
TrialSite raised concerns associated with this drug early on during the pandemic. See “Merck’s Incredible Quest for the COVID-19 Blockbuster: A Tainted Path to Early Onset-Mild-to-Moderate COVID-19 Therapy.”
Importantly, despite possible health risks, the Merck drug was used for a public health program in Ho Chi Minh City, Vietnam even though it was not yet authorized on an emergency basis or approved. See “Ho Chi Minh City Dept. of Health Rolls out Investigational Molnupiravir: But Not in a Clinical Trial.”
Approved Early
Based on the early results of the Move-Out clinical trial in October 2021, the UK approval ensued. This was premature, and as Leo Goldstein reported in TrialSite 2021, “The UK authorization of Molnupiravir for mild/moderate COVID-19 says a lot about the current COVID-19 derangement syndrome.” While in this opinion piece Goldstein suggested the drug’s efficacy was marginal, the researcher highlighted again the specter of safety concerns, declaring, “mutagenicity and carcinogenicity are real.” See the link.
Merck first released interim analysis data, using press releases as a means of driving demand in various governments. Its deal units used these press releases to drive momentum for business.
TrialSite observed that once the company released its interim analysis of 762 patients demonstrating a 50% reduction in hospital admission (risk of hospital admission or death equaled 7.3% in study drug arm compared with 14.1% in the placebo arm), it fully exploited this via press releases in key markets. Yet a more complete analysis prior to their EUA for the FDA revealed less robust results.
As reported recently in The BMJ, “When the full results of 1422 unvaccinated participants were published in the New England Journal of Medicine, the difference was much smaller (6.8% vs. 9.7%).” Combine Move-Out and Panoramic studies and the drug offers no significant benefit in regard to hospital admission or death (P=0.53).
How much did the UK government pay for the product?
While confidential, Wise refers to Andrew Hill, a visiting research fellow and an individual with his own controversy involving his ivermectin research, who estimated that the government paid about 1 billion UK pounds or about $1.1 billion USD. This equaled about £600 ($668.80) per course.
Some Performance Data
The study team found that when it came to endpoints of hospital admission or deaths comparing molnupiravir plus standard of care to a standard of care arm, the author reports they “found no significant difference between the two groups.”
The most recent Panoramic study group hasn’t been peer-reviewed yet. But as reported in The BMJ, there was literally no difference:
Study Arm
N admitted to hospital/died first 28 days
%
Molnupiravir group
103 of 12516
.8%
Standard of care group
96 of 12,484
.8%
The adjusted odds ratio was 1.061 (95% Bayesian credible interval 0.80 to 1.40).
Some positive data however was that the molnupiravir group participants recovered faster than the standard of care group (nine days vs. 15 days). Challenges, however, include that the study was open-label, and that recovery could be a subjective observation.
According to Andrew Hill: “There was no benefit for molnupiravir in terms of clinical recovery in the placebo-controlled Move-Out trial when the patient did not know if they were taking active drug or placebo.” Hill suggested in the Jacqui Wise interview that drugs like budesonide were far cheaper and improved recovery times as in the Principal trial led by Oxford.
Shocking lack of use
Despite the fact that the UK government spent about $1 billion in public money, based on NHS data up to the end of September 25, 2022, Andrew Hill shared with The BMJ author that the UK government has only used 13,944 of the U K’s 2.33 million doses of the drug that were administered outside of research in the UK. Hill shared, “The NHS has used less than 1% of the antiviral treatments it ordered, and it is not clear how the other 99% will be used before they pass their expiration dates.”
It would appear that the Merck drug didn’t have to produce any tangible results evidencing a fair economic exchange. Did the pandemic truly expose the extent and scope of pharmaceutical regulatory capture in major nations worldwide?
