Warren And Markey Demand Transparency Over FDA Decision To Authorize Plasma Treatment

Sens. Elizabeth Warren and Ed Markey are demanding the U.S. Food and Drug Administration provide all communications between the agency and the White House to determine whether the recent emergency use authorization of convalescent plasma treatment for coronavirus patients was politically motivated.

In a letter to the agency obtained by HuffPost on Tuesday, the Massachusetts Democrats called the FDA’s authorization decision “troubling,” given limited evidence of the treatment’s effectiveness on COVID-19 patients. The EUA allows for the distribution of convalescent plasma from people who have recovered from COVID-19 in the U.S. and for health care providers to administer it as appropriate to treat patients hospitalized who have or are suspected of having the disease.

“It is essential for public health that COVID-19 patients have access to effective vaccines and treatments as quickly as possible,” the senators wrote. “However, it is also critical that the FDA’s drug approval process ― which serves as the gold standard around the world ― is guided by science, not partisan or political whims. “

Warren requested that FDA Commissioner Dr. Stephen Hahn give copies of all written communications between FDA and White House officials regarding convalescent plasma; a description of any and all verbal communications between officials; and a detailed timeline of the EUA approval process for convalescent plasma as a COVID-19 treatment.

President Donald Trump and the FDA announced on Sunday the emergency use authorization for convalescent plasma, the liquid component of blood from a recovered virus patient that’s rich in antibodies and can be used to treat the same virus in certain cases. Scientists have been looking at whether convalescent plasma can be used as a treatment for COVID-19, and have been conducting clinical trials to determine its efficacy and safety.

But while blood plasma donated from recovered COVID-19 patients is considered safe, top health officials expressed concern that the data have not yet proved whether it’s effective enough to treat the virus. The FDA largely based its decision on data the Mayo Clinic collected from hospitals using plasma on patients in differing ways ― people who received plasma with higher levels of antibodies fared better than patients given lower levels of antibodies. But because there was no control group of untreated patients, scientists can’t draw clear conclusions about its efficacy.

Scientists like Dr. Francis Collins and Dr. Anthony Fauci cautioned the FDA to wait on giving an EUA for convalescent plasma due to insufficient evidence, and medical experts decried Hahn’s comments on Sunday that overstated the treatment’s life-saving benefits.

Hahn walked back his comments on Monday, apologizing for the overstatement and assuring that the EUA decision was based on science and not politically motivated. He maintained that there is enough data to qualify convalescent plasma for an EUA, but that well-controlled randomized clinical trials “remain necessary” to properly determine if the treatment is effective.

“I have been criticized for the remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified,” he tweeted. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

The authorization raised questions about whether Hahn was pressured into the decision, given negative comments Trump has made about the agency’s response to the coronavirus pandemic and the fact that the announcement occurred on the eve of the Republican National Convention. Some public health officials called the announcement “political fanfare,” and said that “science lost today” while “politics won.”

Earlier this month, Trump and White House official Peter Navarro accused the FDA, without evidence, of being part of the “deep state” and intentionally delaying approval of COVID-19 vaccines and therapeutics in order to harm Trump’s reelection chances. The president has been pushing agencies to focus on the urgency of approving COVID-19 treatments rather than first making sure they’re safe to roll out.

“Protecting the integrity of the FDA’s approval process is even more critical given that the agency will soon be asked to approve one or more vaccines under intense political pressure, and because of its decision to issue and then revoke a rushed EUA for hydroxychloroquine for COVID-19 treatment,” Warren and Markey wrote. “Hydroxychloroquine was found to cause ‘serious heart rhythm problems and other safety issues, including blood and lymph system disorders, kidney injuries, and liver problems and failure’ ― forcing the FDA to revoke its EUA.”

Warren has made a point of scrutinizing whether the FDA is prioritizing science over politics in its decision-making process. The senator urged the agency earlier this year to track potential COVID-19 medical products for their safety and effectiveness.