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Scientists and public health officials said on Monday they were skeptical that convalescent plasma is an effective treatment for patients hospitalized with Covid-19, even after the Food and Drug Administration issued an authorization for use emergency treatment and that President Donald Trump has touted it as a “breakthrough”. “
There are no officially approved drugs or vaccines for the coronavirus. Convalescent plasma is one of the many therapies being tested as a potential treatment.
Plasma, taken from patients who have recovered from Covid-19 and who have developed antibodies against the virus, is infused into sick patients. Scientists hope this will help jump-start the immune system to fight the virus. A study of 35,000 patients published earlier this month by the Mayo Clinic and sponsored by the National Institutes of Health suggested that plasma may reduce mortality in some hospital patients. Although the study did not have a placebo group to compare results, it is difficult to determine whether the treatment actually worked.
The FDA said on Sunday it was granting emergency use, allowing healthcare providers in the United States to treat suspected or laboratory-confirmed Covid-19 in hospitalized patients with the disease. The agency said it was reasonable to believe that the treatment could be effective in treating patients with Covid-19, and that the known and potential benefits outweigh the known and potential risks.
Adequate and well-controlled randomized trials “remain necessary” for a definitive demonstration of efficacy and “to determine the optimal product attributes and appropriate patient populations for its use,” FDA said in granting emergency use .
“It’s a potent therapy that transfuses very, very potent antibodies from the blood of recovered patients to help patients with infection. It has had an incredible success rate,” Trump said in a briefing Sunday night. in the White House, calling the treatment a “breakthrough.” “Today’s action will dramatically expand access to this treatment.”
Scientists and public health officials have doubts, saying more data from randomized controlled trials, which are considered the “gold standard” in science, is still needed to know if they are safe and effective. The trial results were inconclusive, were relatively small, and provided “very low-quality evidence,” according to the World Health Organization.
“We have followed this,” WHO chief scientist Dr Soumya Swaminathan said in Geneva on Monday. “We’re doing continuous meta-analyzes and systematic reviews to see where the evidence is changing or pointing, and at the moment it’s still very low quality. We therefore recommend that convalescent plasma always be an experimental therapy. It should be well evaluated. -designed randomized clinical trials. “
She said countries can use it urgently “if they feel the benefits outweigh the risks, but this is usually done pending more definitive evidence, which is yet to come.”
The FDA has issued emergency use authorization for several coronavirus tests and certain drugs. In May, the agency granted authorization for antiviral remdesivir, allowing hospitals and doctors to use the drug on Covid-19 hospital patients. Hydroxychloroquine also received emergency clearance, but the FDA subsequently withdrew the designation after the agency concluded that the malaria drug was unlikely to be effective.
The results of the Mayo Clinic study that the FDA cited in its approval of plasma treatment indicate that patients under the age of 80 who were not on a ventilator and were receiving plasma with high levels of antibodies in the three days after diagnosis were approximately 35% more likely to survive an additional 30 days compared to patients who received plasma with low antibody levels.
The study acknowledged, however, that its results are limited, especially because it did not compare with a placebo.
Dr Scott Gottlieb, a former FDA commissioner, said the treatment could help patients, but “doesn’t look like a home run.” He agreed that convalescent plasma “certainly” met the standard for an emergency use authorization “in a public health emergency.”
“I think it might be beneficial. It might be of little benefit,” Gottlieb said on “Squawk Box.” “It doesn’t look like a circuit, but right now we are looking for singles and doubles. There won’t really be any circuits on the horizon until we can get the other therapeutic antibodies on the market and I hope eventually for vaccines and better therapies. ”
Lawrence Gostin, professor and faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University, is skeptical of the treatment’s effectiveness. He also said he was concerned that the FDA had come under political pressure to authorize the treatment before data showed whether it was safe and effective. Trump’s Sunday night announcement came on the eve of the start of the Republican National Convention and 10 weeks before the November 3 presidential election.
On Saturday, Trump accused FDA Commissioner Stephen Hahn of delaying enrollment in clinical trials for Covid-19 vaccines or therapies due to political motives.
“The EUA was granted without a peer-reviewed study and deployed with political fanfare,” said Gostin, also director of the WHO Collaborating Center on National and Global Health Law. “I am concerned that the scientific integrity of the FDA is seriously compromised.”
Dr Jeremy Faust of Brigham and Women’s Hospital in Boston and Harvard Medical School lambasted the FDA, tweeting that “science has lost today” and “politics has won”.
“The breakthroughs come from randomized controlled trials,” he said. “It’s not about picking out subsets of existing data sets and finding a promising discovery out of a sea of disappointment.”
–CNBC Wants fire, Kevin stankiewicz and Emma Newburger contributed to this article.
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