Clinical trial results for $3.2 billion Covid drug are missing in action
The results of most clinical trials of the Covid drug molnupiravir (Lagrevio) have not been made public and remain completely unknown, a new study has found.
The drug is currently being administered to Covid patients in the United States, the UK, and India. The World Health Organisation has issued a “conditional recommendation” for its use in some patient groups. Global sales so far stand at $3.2 billion.
12 trials, zero results
The study – only published as a preprint so far – followed up on 12 clinical trials of molnupiravir aiming to recruit a total of 13,694 patients that were conducted in India.
The authors found that almost a year after their probable completion:
“[N]one of the 12 trials has been published, one was presented at a medical conference, and two were announced in press releases suggesting failure of treatment. Results from three trials were shared with the World Health Organisation.”
“A lack of transparency pervades the Indian molnupiravir trial registrations and their results. Many trial details have not been updated for months, and key details such as trial completion dates and trial outcomes are almost totally absent, as are final enrolment numbers for several trials.”
“There is also a lack of transparency about what level of access the Indian drug regulator and the WHO have to the data.”
The little existing public data from the Indian trials inspire little confidence, the authors warn, pointing to suspiciously rapid participant recruitment and the “almost unprecedented” absence of any severe adverse events whatsoever in a trial that included 1,218 patients.
(The Indian clinical trial registry, which the data on the molnupiravir trials were extracted from, is currently at risk of shutting down.)
Concerns about risks and paucity of data
The authors further note that concerns have previously been raised about molnupiravir’s “genotoxicity and potential risk to pregnant patients.” One expert has warned that "the potential for this drug to drive some very challenging variants into the public is a major, major concern".
In November 2021, FDA advisory committee narrowly endorsed emergence use authorisation for the drug. At the same time, they noted tht data about the efficacy and safety of molnupiravir were limited. According to the FDA meeting's summary minutes:
"Overall, Committee members agreed there is a need for additional safety data, as well as further studies in the vaccinated and immunocompromised."
$3.2 billion in drugs sales - and counting
Merck has shipped 6.4 million courses of molnupiravir to more than 30 countries, generating sales of $3.2 billion.
The company has signed contracts to provide 10 million courses worldwide this year. The UK government has so far procured over 2 million courses. The U.S. government pays around $700 per five-day course of the drug.
The Indian molnupiravir trials were run by Indian manufacturers, not by Merck. Responsibility for making the results public thus lies with the sponsors in India, not with Merck.
"Problematic" data
In March 2022, a BMJ editorial had warned the decision to let the drug onto the U.S. and UK markets had been premature and based on “truncated and non-replicated trial findings”.
The European Medicines Agency has not yet decided whether to approve the drug, with insiders citing concerns about “problematic” data. The results of the molnupiravir arm of the large PANORAMIC trial being run in the UK are expected to be made public soon, and should provide more clarity about the drug’s efficacy.
UPDATE 16 August: Public health officials in Thailand have stated that molnupiravir "will be the main medicine for Covid treatment" in the country.
Avoidable waste of public money
Till Bruckner, founder of TranspariMED, said:
“Governments worldwide are still spending billions on drugs whose efficacy remains uncertain because some companies refuse to make their clinical trial results public. Have we learned nothing from the Tamiflu debacle?”
“This is a completely avoidable waste of public money. Lawmakers worldwide urgently need to wake up and make it a legal requirement to publish all clinical trial results, without exceptions, as the UK is currently doing.”
Existing legislation in the United States and Europe only covers some trials, and is not being effectively enforced.
According to the World Health Organisation, the results of every clinical trial should be made public within one year of trial completion.
The new study on molnupiravir trials (preprint) can be accessed here.