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In May, when President Donald Trump announced the emergency approval of remdesivir, the first antiviral to treat Covid-19, he hailed its developer Gilead as a “big American company” with “the hot thing.”
Six months later, Mr Trump is set to exit, California biotech stocks have fallen 29% from their April highs, and remdesivir is being compared to Tamiflu: a wonder drug that wasn’t not.
On Friday, an independent group of experts from the World Health Organization advised doctors not to use the drug in hospitalized Covid-19 patients, concluding, based on four randomized trials, that it did not had “no significant effect” on mortality, need for mechanical ventilation, or time in hospital.
“This is not a battle of scientific publications; this is not a drug fight; it is not a battle between the pharmaceutical companies, ”said Mike Ryan, executive director of the WHO emergency health program. “It’s about getting the best information possible from clinical teams that save lives in the wards.”
The WHO guidelines stifle early hopes that the drug – which is designed to prevent viruses from replicating – could transform patient care. Almost a year after the start of the pandemic, vaccines are about to be rolled out, but doctors still lack good options for treating millions of patients.
Experts are now divided on whether remdesivir has a role to play. In one corner is the WHO and some national regulators in Europe who are considering removing the drug from doctors’ treatment guidelines.
In the other, Gilead and the US National Institutes of Health, which claim the drug works based on their own trials.
Gilead said it was “inaccurate” to say the drug had no benefit for hospital patients. The company criticized the WHO study on its drug, saying that “the data gaps were characterized as conclusive results that should replace the results of a benchmark, randomized, double-blind, controlled trial by placebo”. WHO has rejected the criticism.
“There are two smart groups of people with the same data who interpret it in different ways,” said Roy Gulick, head of infectious diseases at Weill Cornell Medicine in New York City.
A dear reputation
Many drug companies are hoping the pandemic will bolster reputations that have sometimes been tainted by criticism of drug prices. Activists and politicians have sometimes accused Gilead of preventing the poorest patients from accessing successful drugs to prevent HIV and cure hepatitis C.
Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering, said Gilead has often prioritized “revenue, market share and pricing power” and so it was no surprise that the company chose to reject the WHO trial on remdesivir. . “This is the worst form of distillate in the industry that doesn’t care about public health at all,” he said.
Gilead dismisses this, saying his contributions to public health have been transformative over the past 30 years, including for patients with HIV and hepatitis C. He pointed to the donation of remdesivir, the licensing duty free to manufacturers of generic drugs for the developing world during the pandemic and the setting of a single government price for richer countries that is “significantly less than the value the drug offers”.
Buyer’s remorse?
Andrew Hill, a visiting senior pharmacology researcher at the University of Liverpool, said remdesivir could join the ranks of other drugs, such as hydroxychloroquine, that the pandemic has seen “rise and fall”.
Before the WHO announced its negative data, European countries were eager to get their hands on enough remdesivir, as the United States bought almost all the supplies, leaving them short. Now some may have doubts.
Gilead was told of the first negative results from the WHO as it negotiated a € 1 billion supply deal for remdesivir with the European Commission, finalized in October, but the commission told the FT it did not had not been informed before the publication of the study.
Gilead said he behaved appropriately. He said the commission appeared to already be aware of the WHO preliminary findings, as it raised them with the drugmaker on October 9. The commission declined to comment further.
Gilead added that many countries had agreed to purchase more remdesivir since the study was published.
The committee stressed that no money had been committed up front, but that some European countries had entered into separate agreements before the publication of the study. Italy paid 51 million euros for a remdesivir order as cases rose and supplies dwindled, according to two senior health officials.
Italy’s health ministry addressed questions to the national medicines regulator, whose chief Nicola Magrini told the FT that the agency was reviewing the use of remdesivir in the country’s health system.
Remdesivir reminds some of Tamiflu, a drug co-developed by Gilead and Roche. Fearing avian and swine flu pandemics, many governments put it in storage – but in the end, its effect was modest and not worth the expense. Like Tamiflu, remdesivir may only have a small window at the onset of illness to have any real impact against the virus, which doctors say is impractical for an expensive drug administered by intravenous route.
There are also questions about security. Dr Hill said the WHO Adverse Events Database reported “a higher than expected rate of adverse events related to the liver and kidneys” for people taking the drug.
Gilead says the drug’s label tells doctors to watch for these events, but there is no evidence that remdesivir causes problems, noting that kidney damage can also be caused by Covid-19 itself.
The impact on sales
Gilead warned that sales of remdesivir would be difficult to predict. In the third quarter, hospitals stockpiled at a slower than expected rate, generating sales of $ 873 million. It’s a big race for a drug that wasn’t even on investors’ horizon last year, but fell short of the consensus forecast of $ 1 billion.
The WHO study does not prevent American doctors from prescribing the drug. Sudha Narayanaswamy, vice president of pharmacy at Premier, a group purchasing organization that represents more than 4,000 healthcare systems, said US hospitals “were seeing increased use over the past two weeks in response to spikes in case”.
However, while some healthcare providers may throw everything at a problem – like Mr. Trump’s doctors, who treated him with remdesivir as part of a cocktail of drugs – the negative results will exacerbate concerns among cost conscious people. Remdesivir can cost up to $ 3,120 per five-day course.
“The WHO study will hurt Gilead’s chances of getting the government and other payers to pay hospitals more for the use of remdesivir than they pay for the use of cheaper steroids,” said Erik Gordon, clinical assistant professor at the Ross School of Business at the University of Michigan.
The inexpensive generic steroid dexamethasone, backed by the WHO, is not a competing treatment – it targets inflammation later in the disease – but has been shown to significantly reduce mortality, unlike remdesivir.
Amesh Adalja, an infectious disease physician and senior researcher at Johns Hopkins, said the drug was being prescribed less in his hospital. “When you actually look at the data, it wasn’t as strong as we had hoped,” he says. “And if there is a benefit, it’s very marginal and it’s probably in a selected subgroup of patients.”
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