Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.
The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.
Donated by people who have survived the disease, antibody-rich plasma is considered safe.
President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.
But clinical trials have not proved whether plasma can help people fighting the coronavirus.
Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic.
They thought the study’s data to date was not strong enough to warrant an emergency approval.
The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has given infusions to more than 66,000 Covid-19 patients thanks to financing from the federal government.
An F.D.A. spokeswoman declined to comment, but Mr. Trump reacted angrily, suggesting the decision was politically motivated.
“You have a lot of people over there who don’t want to rush things because they want to do it after November 3,” he said referring to Election Day, as he proclaimed without evidence that convalescent plasma helped “way over 50 percent” of Covid-19 patients infused with it.
Plasma, the pale yellow liquid leftover after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for coronavirus vaccines.
An emergency authorization for blood plasma would most likely ease the clerical burdens on hospitals in conducting infusions.
Senior health officials have privately expressed concern about the rapid growth of the Mayo program and the perceived rush to declare plasma effective without the affirmation of results from randomized trials, which scientists have long relied on as the gold standard of evidence. Skyrocketing enrollment in the program has prompted a debate among researchers about what kind of empirical certainty is needed in treating patients in a public health emergency.
An emergency approval now would “change the way people view trials,” said Dr. Mila B. Ortigoza, an infectious disease specialist at N.Y.U. Langone Health who started a trial with colleagues at Montefiore Medical Center.
“We want to make sure that when we say it works, we are confident, with indisputable evidence,” she said. “We’re dealing with patients’ lives here.”
Unlike the malaria drugs, plasma, which has been used since the 1890s to treat infectious diseases, has earned the attention of a highly credentialed community of microbiologists and immunologists eager to prove its usefulness. The Mayo Clinic has already published analysis on tens of thousands of patients in its expanded access program showing that plasma is safe.
The most recent batch of data from the program included more than 35,000 Covid-19 patients, many of them in intensive care and on ventilators, and suggested that plasma administered within three days of a diagnosis reduced mortality rates. When calculated a month after the infusions, the death rate of patients who received plasma within three days of diagnosis was lower (21.6 percent) than it was for those who received plasma later (26.7 percent).
But the study did not have a control group of patients given a placebo to compare with those given plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it is not clear how realistic treating patients within three days of diagnosis would be.
The program’s enrollment has surged to more than 30 times as high as initially expected, complicating the ability of scientists to recruit sick patients to randomized trials.
It “ballooned to a degree that, you know, is becoming unmanageable,” Dr. Lane said.
Statisticians at the F.D.A. are now examining the Mayo data to better understand what factors other than the treatment might have influenced patient responses, such as higher-quality care in the hospital, Dr. Lane said.
https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html
The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.
Donated by people who have survived the disease, antibody-rich plasma is considered safe.
President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.
But clinical trials have not proved whether plasma can help people fighting the coronavirus.
Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic.
They thought the study’s data to date was not strong enough to warrant an emergency approval.
in an interview on Tuesday.
The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has given infusions to more than 66,000 Covid-19 patients thanks to financing from the federal government.
An F.D.A. spokeswoman declined to comment, but Mr. Trump reacted angrily, suggesting the decision was politically motivated.
“You have a lot of people over there who don’t want to rush things because they want to do it after November 3,” he said referring to Election Day, as he proclaimed without evidence that convalescent plasma helped “way over 50 percent” of Covid-19 patients infused with it.
Plasma, the pale yellow liquid leftover after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for coronavirus vaccines.
An emergency authorization for blood plasma would most likely ease the clerical burdens on hospitals in conducting infusions.
Senior health officials have privately expressed concern about the rapid growth of the Mayo program and the perceived rush to declare plasma effective without the affirmation of results from randomized trials, which scientists have long relied on as the gold standard of evidence. Skyrocketing enrollment in the program has prompted a debate among researchers about what kind of empirical certainty is needed in treating patients in a public health emergency.
An emergency approval now would “change the way people view trials,” said Dr. Mila B. Ortigoza, an infectious disease specialist at N.Y.U. Langone Health who started a trial with colleagues at Montefiore Medical Center.
“We want to make sure that when we say it works, we are confident, with indisputable evidence,” she said. “We’re dealing with patients’ lives here.”
Unlike the malaria drugs, plasma, which has been used since the 1890s to treat infectious diseases, has earned the attention of a highly credentialed community of microbiologists and immunologists eager to prove its usefulness. The Mayo Clinic has already published analysis on tens of thousands of patients in its expanded access program showing that plasma is safe.
The most recent batch of data from the program included more than 35,000 Covid-19 patients, many of them in intensive care and on ventilators, and suggested that plasma administered within three days of a diagnosis reduced mortality rates. When calculated a month after the infusions, the death rate of patients who received plasma within three days of diagnosis was lower (21.6 percent) than it was for those who received plasma later (26.7 percent).
But the study did not have a control group of patients given a placebo to compare with those given plasma, making it difficult for scientists to assess whether the treatment really worked. And given the limited supply of plasma, it is not clear how realistic treating patients within three days of diagnosis would be.
The program’s enrollment has surged to more than 30 times as high as initially expected, complicating the ability of scientists to recruit sick patients to randomized trials.
It “ballooned to a degree that, you know, is becoming unmanageable,” Dr. Lane said.
Statisticians at the F.D.A. are now examining the Mayo data to better understand what factors other than the treatment might have influenced patient responses, such as higher-quality care in the hospital, Dr. Lane said.
https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html
