AP

FDA chief apologizes for overstating plasma effect on virus

Aug 25, 2020, 4:04 PM

FDA convalescent plasma...

President Donald Trump listens as Dr. Stephen Hahn, commissioner of the U.S. Food and Drug Administration, speaks during a media briefing in the James Brady Briefing Room of the White House, Sunday, Aug. 23, 2020, in Washington.(AP Photo/Alex Brandon)

(AP Photo/Alex Brandon)

WASHINGTON (AP) — Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.

RELATED:  Intermountain Healthcare asks recovered COVID-19 patients to donate plasma

Hahn’s mea culpa comes at a critical moment for the FDA which, under intense pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing COVID-19.

The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.

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

The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways — and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.

Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups. Former FDA officials said the misstatement was inexcusable, particularly for a cancer specialist like Hahn.

“It’s extraordinary to me that a person involved in clinical trials could make that mistake,” said Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest. “It’s mind-boggling.”

The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communication staff. The number did not appear in FDA’s official letter justifying the emergency authorization.

Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets preset standards for safety and efficacy.

Lawrence Gostin of Georgetown University said Hahn’s performance Sunday undermined those efforts.

“I think the integrity of the FDA took a hit, if I were Stephen Hahn I would not have appeared at such a political show,” said Gostin, a public health attorney.

Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said, appearing on “CBS This Morning.”

Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”

The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November’s election.

At Sunday’s briefing Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals.

Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it’s needed most. A vaccine will only be effective against the virus if it is widely taken by the U.S. population.

“I think the constant pressure, the name-calling, the perception that decisions are made under pressure is damaging,” said Dr. Jesse Goodman of Georgetown University, who previously served as FDA’s chief scientist. “We need the American people to have full confidence that medicines and vaccines are safe.”

Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.

The FDA emergency authorization is expected to increase its availability to additional hospitals. But more than 70,000 Americans have already received the therapy under FDA’s “expanded access” program. That program tracks patients’ response, but cannot prove whether the plasma played a role in their recovery.

Some scientists worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment actually works. Those studies require randomizing patients to either receive plasma or a dummy infusion.
___
Associated Press writer Lauran Neergaard contributed to this report.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

AP

FILE - A branch office of Capital One Bank is pictured on May 7, 2009, in New York.  Capital One Fi...

KEN SWEET AP Business Writer

Capital One to buy Discover for $35 billion in deal that combines major US credit card companies

Capital One Financial is buying Discover Financial Services for $35 billion, in a deal that would bring together two of the nation's biggest lenders and credit card issuers.

9 hours ago

An open-air double decker sightseeing bus stops on the slopes of Table Mountain, overlooking the ci...

GERALD IMRAY Associated Press

A ship carrying 19,000 cattle caused a big stink in the South African city of Cape Town

CAPE TOWN, South Africa (AP) — What stinks? Authorities in Cape Town launched an investigation Monday after a foul stench swept over the South African city. City officials inspected sewage facilities for leaks, and an environmental health team was activated before the source of the smell was discovered: a ship docked in the harbor carrying […]

13 hours ago

Republican presidential candidate former President Donald Trump holds gold Trump sneakers at Sneake...

MICHAEL R. SISAK Associated Press

Here’s a look inside Donald Trump’s $355 million civil fraud verdict as an appeals fight looms

On the witness stand last year, Donald Trump proclaimed: "I have a lot of cash." After Friday's eye-popping penalty in his New York civil fraud trial, he's going to need it.

3 days ago

The likeness of George Washington is seen on a U.S. $1 bill, March 13, 2023, in Marple Township, Pa...

BEN FINLEY ASSOCIATED PRESS

Presidents Day: From George Washington’s modest birthdays to big sales and 3-day weekends

NORFOLK, Va. (AP) — Like the other Founding Fathers, George Washington was uneasy about the idea of publicly celebrating his life. He was the first leader of a new republic — not a tyrant. And yet the nation will once again commemorate the first U.S. president on Monday, 292 years after he was born. The […]

3 days ago

former president trump shown, his fraud case just ended...

MICHAEL R. SISAK

Donald Trump fraud verdict: $364 million penalty in civil fraud case

Former President Donald Trump’s lawyers had said even before the verdict that they would appeal.

4 days ago

Motorists drive past a sign outside a branch of Wells Fargo bank, Wednesday, Sept. 20, 2023, in Dea...

KEN SWEET AP Business Writer

US eases restrictions on Wells Fargo after years of strict oversight following scandal

The news sent Wells Fargo's stock up sharply Thursday as investors speculated that the bank may be able to rebuild its reputation.

5 days ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

FDA chief apologizes for overstating plasma effect on virus