Canada has pledged millions for Merck’s drug. Doctors don’t know if it works

Limited information from four trials paints a mixed picture of the antiviral molnoperavir. It is unclear whether the drug has actually been handed over to the government

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As Canada ordered huge quantities of a new anti-COVID drug last December and struck a deal to strike in Ontario, there was plenty of evidence on a key point – whether molnopiravir actually worked.

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Besides the highly publicized study by the manufacturer Merck, companies in India quietly conducted 12 separate trials of the pills on a much larger group of patients – nearly 14,000 people who received either the drug or a placebo.

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But a year after most of those Indian studies were completed, only a small portion of the results have been publicly disclosed and none have been published in a peer-reviewed journal. new british paper On the Indian search.

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The limited information from four trials suggests at best a mixed picture of the antiviral, British academics report. The rest is unknown.

It is very worrying that there is a lot of data not available

Jack Lawrence, Cancer Scientist

“It’s very concerning that there is a lot of data not available,” said co-author Jack Lawrence, a cancer scientist at University College London who has turned his attention to the “integrity of research” during the pandemic. “For all we know, all those Indian trials may have found that molnopiravir actually has no beneficial effect or even a negative effect…. Without this data we cannot know that.”

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Others are more direct. Dr Gerald Evans, chair of the division of infectious diseases at Queen’s University School of Medicine, said the fact that none of the results of the Indian trials were published in journals, and most of them were not disclosed in any way, tells the world one thing.

“What we do know is that negative experiences are not published,” he said. “It’s like that old saying you learn from your mother: If you don’t have something nice to say, don’t say anything at all.”

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The discoveries about trials in India only add to the list medical skepticism about the drug, which means few doctors in Canada are likely to prescribe it, Evans said.

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However, the federal government agreed to purchase 500,000 courses, with the option to purchase an additional half a million. Although it won’t reveal how much you paid, other countries have done so, indicating that the rate Merck charges Western countries is just under $900 a course. This means that Ottawa has pledged to buy $450 million and could receive another $450 million.

Merck and federal officials also announced with some fanfare last December that the company had partnered with Thermo Fisher Scientific in Whitby, Ontario, to make grains for markets here, in the UK, Europe and Asia.

However, it appears that the federal government still has an edge over the half-billion dollar deal.

As she noted when the Merck agreement was first struck, Public Services and Procurement Canada said on Friday that deliveries to that country are conditional on the drug’s authorization by Health Canada. However, it is unclear if any of the properties have actually been handed over to the government. Catherine Levsk at the National Post reported in February That “thousands” of processors were stored near Montreal.

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Health Canada said on Friday that its review of the drug was still ongoing and the department could not say when a decision would be made on whether or not to approve molonoperavir.

Researchers say the final word on the benefit of molopiravir should come when it is panoramic trial Chaired by Oxford University – which has registered more than 20,000 British patients – releases its findings.

Merck could not be reached for comment.

Sold under the brand name Lagevrio, the drug has certainly proven a success for US-based pharmaceutical giant and partner Ridgeback Biotherapeutics. In financial disclosures this spring, can you merck Sales total US$5-5.5 billion in 2022, with 6.4 million cycles of the drug shipped by April.

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Caroline Litchfield, Executive Vice President: “We are proud of Molnopiravir, Lagivrio, and the impact it can have on the world.” He told the investors.

Molinoperavir emerged in 2021 as one of two new oral medications for the coronavirus, and they are clear breakthroughs that provide comfort at home for patients and provide healthcare. The other is Pfizer’s Paxlovid.

Both have been described as treatments for people with mild illness. But Paxlovid showed greater efficacy — an 88 percent reduction in hospitalized COVID patients versus 30 percent for molnopiravir. It was approved by Health Canada earlier this year.

And even when a Merck product was sold all over the world, Questions have been asked About the MOVE-OUT trial that was the basis of its claims – and final approvals by regulators such as the US Food and Drug Administration.

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While the first 762 patients enrolled in the trial were 50 percent less likely to end up in the hospital, the second 646 patients actually performed better on a placebo, a statistically odd result. British research by some of the same researchers involved in the latter analysis argued that the reduction in hospitalization was in fact not statistically significant when the data was properly evaluated.

Meanwhile, Merck has agreed to allow Indian companies to make their own versions of the drug to sell in less affluent countries.

Some of the 12 trials they conducted last year included moderate patients such as those in the Merck trial, and some more “moderate” cases. The new british paper — which has not yet been published in a peer-reviewed journal — reveals that among 13,694 patients, no results of any kind were disclosed for 11,258.

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Two of the patients who considered the moderate patients announced that they had discontinued the trial for lack of positive results. Two others released limited press releases and a conference summary, reporting modestly good results for moderate patients.

Natco Pharma Ltd. concluded. , one of the companies that said nothing about its experience, told a conference call in May with investors that its investment in COVID treatments was “disaster.”

The British academics report also points to other irregularities in Indian research. For example, the heterogeneous drug study reported no adverse events, which is “almost unprecedented” for a clinical trial, and concluded in six weeks at lightning speed. Lawrence also noted that many physicians referred patients to more than one trial—a practice generally unprecedented.

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Meanwhile, Merck has declined to offer the drug for use in some independent, non-commercial trials, said Ed Mills, a McMaster University professor in British Columbia who is running the study together on potential COVID treatments, named . public trial in May by the Association for Clinical Trials.

He argues that Canada’s purchase of molnopiravir was a mistake given the results of Merck’s own trial and the presence of unpublished Indian studies.

But Evans said he’s not too critical, noting that the federal government has received criticism for not getting shipments of a COVID vaccine quickly enough and may have been keen to avoid another such controversy.

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