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A Canadian research group press release raised hopes that treating people recently diagnosed with Covid-19 with colchicine, a drug commonly used to treat gout, could reduce the risk of needing to be hospitalized .
But outside experts said the data provided was too limited to draw conclusions, leading to discussions of the risks of conducting science via a press release, rather than in more detailed manuscripts in peer-reviewed journals. Everyone hoped that colchicine, a cheap generic drug available around the world with manageable side effects, would prove beneficial.
“I’m not, ‘Oh, I’m not buying it,’” said Ashish Jha, dean of Brown University School of Public Health. “It’s possible. There’s enough plausibility here. It might be a real find, and if it does, that would be great. But this press release doesn’t get us there.”
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In the statement, released Friday evening, the Montreal Heart Institute said the rate of hospitalization or death was 21% lower in patients in its COLCORONA study who received colchicine compared to those who received colchicine. were randomly assigned to placebo. The study enrolled 4,488 patients.
But here’s a caveat: The press release said those results were not statistically significant, although the numbers were close. When researchers excluded 329 patients who were diagnosed with Covid-19 based on family contacts or clinical symptoms, but who did not have positive PCR tests, there was a 25% reduction in hospitalizations and substantial reductions in the need for mechanical ventilation and fatalities.
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Outside experts consider these results to be less reliable because the trial did not achieve its main objective. They also agreed that the number of patients who have required mechanical ventilation or who have died is likely low, making it difficult to draw firm conclusions. The press release does not include absolute numbers on the number of people who have been hospitalized, required ventilators or have died.
“No one is going to jump to conclusions when someone says something is approaching statistical significance and you can’t see the data,” said Craig Spencer, director of global health in emergency medicine in New York. Presbyterian / Columbia University Medical Center. to be huge would be wonderful, but I need more – we all need a little more.
The story of failed apparently promising drugs, including, most famously, the antimalarial drug hydroxychloroquine, has left many researchers wary.
“How many therapies seemed to have promising results and see what happened?” said Ethan Weiss, a cardiologist at the University of California at San Francisco. He gave the example of remdesivir, carried out by Gilead, where the results of the trials are considered contradictory. “Let’s see what the actual results look like and then we can have a conversation.”
In 2019, the same researchers at the Montreal Heart Institute published a study showing that colchicine, which is believed to soothe inflammation and the immune response, may benefit patients who have had a heart attack, by partly by preventing returns to hospital. These results were published in the New England Journal of Medicine. Researchers began their Covid-19 study on colchicine in March, as the pandemic began to hit North America hard.
Jean-Claude Tardif, the lead investigator for the 2019 study and the current study, said his team felt it was important to disseminate the results quickly, but that they would publish them in a medical journal and also thought it was important to leave. most of the data from the press release.
The press release qualifies the results as “clinically convincing” and Tardif cites in it that colchicine is “the first oral drug in the world whose use could have a significant impact on public health and potentially prevent complications of Covid-19 for millions of patients. ”
Tardif said he was rushing – he doesn’t expect to sleep this weekend – to prepare a full data report for a medical journal. It is not clear why it was necessary to prevent the journal from being published with a statement that did not include clear numbers. This is more likely to be done by pharmaceutical companies, who have a duty to inform investors of events that may affect the market.
The COLCORONA trial was funded by governments and philanthropies, including the Government of Quebec; the US National Institute of Heart, Lungs and Blood; philanthropist Sophie Desmarais; and the Covid-19 Therapeutics Accelerator, launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, so there was no obligation to immediately publish the results.
The results were also less detailed than those of some other press releases during the pandemic, including the result of the RECOVERY trial, which showed efficacy against Covid-19 of another cheap drug, dexamethasone. This press release contained detailed statistical information and the results were published in the New England Journal a month later.
“The result is believable but it is so vague – and we don’t have a lot of details – that it’s very difficult to know how to interpret it,” said Steven Nissen, cardiologist and clinical researcher at the Cleveland Clinic.
Nahid Bhadelia, an infectious disease physician at Boston University, also said she needed to see the data – and that she didn’t like the science via a press release. But she was optimistic. “I think it makes sense,” she said. “We have to see the data, but it fits the picture that SARS-CoV-2 leads to some kind of innate immune dysfunction.”
The study, initially scheduled until March 2021, aimed to recruit 6,000 voluntary patients who had not been hospitalized and who would be randomly assigned to receive either half a milligram of colchicine twice a day for three days, followed by ‘once a day. dose or placebo for 27 days. Neither the researchers nor the patients knew which group a patient belonged to. The patients had been newly diagnosed and had not been hospitalized, an earlier stage of the disease than most other studies. All were over 40 years old and each had at least one risk factor for developing severe Covid-19.
It is possible to make educated guesses about the results. Tardif said about 5% of patients were hospitalized. The results with 225 or 250 hospitalized patients – meaning that around 30 hospitalizations were avoided – seem generally in agreement with the results described in the press release. David Boulware of the University of Minnesota, an infectious disease physician-scientist, called it “a significant step forward but no leap.”
Eric Topol from the Scripps Research Translational Institute emailed me that although “many data points are missing” the potential for early therapy would be “welcome” as the only similar therapies are monoclonal antibodies that need to be administered. intravenously and ‘are in short supply not yet used. “
The decision to stop the trial earlier than planned was made, Tardif said, because waiting would have meant waiting for months when the drug could be of use to patients now. He said when the Data Security and Oversight Committee, a group of outside experts overseeing the trial, met on Friday evening, he asked them if they thought the results were convincing and if they were would advise a patient or family member diagnosed with Covid-19. take colchicine. All said yes.
This story was confirmed by Marc Pfeffer, a Dzau professor of medicine at Harvard Medical School, who is a member of the trial’s data safety and oversight committee. Pfeffer said he is convinced colchicine is safe, although it does have side effects. In the NEJM report on its usefulness for people with heart disease, people taking colchicine were more likely to have diarrhea and develop pneumonia.
Pfeffer praised Tardif’s group for successfully conducting a large randomized trial in patients who were not hospitalized, which others struggled to do. He said that, through the results, the data was compelling.
“I think the results are clinically compelling and I’m sorry you don’t have the results to see this,” Pfeffer said. “But you will be soon.”
There are also other studies testing colchicine, including an arm of the RECOVERY trial, which is evaluating the drug in sicker patients.
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