The head of the Food and Drug Administration ousted its top spokeswoman from her position on Friday in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Trump.
The decision came just a day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the F.D.A. commissioner, Dr. Stephen M. Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”
The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.
The ousted spokeswoman, Emily Miller, had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network. She was in her agency post for just 11 days.
“This is a low moment for the F.D.A. in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Dr. Hahn’s failure to control the public message about the plasma authorization. “This was a major self-inflicted wound.”
The most recent controversy over plasma follows a series of missteps by the F.D.A. that have fueled concerns that the agency is losing the public’s trust as the nation faces a presidential election in November and a pandemic that has taken more than 180,000 American lives.
Also this week, the nation’s premier public health agency, the Centers for Disease Control and Prevention, was accused of bowing to political pressure after it revised its testing guidelines to say people without symptoms of the virus didn’t need to get tested.
Dr. Hahn has already been criticized for a series of worrisome actions, including authorizing the emergency use of two malaria drugs Mr. Trump had favored — a decision that was later revoked — and for having allowed the sale of shoddy antibody tests early in the U.S. outbreak.
“The agency needs to work very hard to regain the trust of the American people — there have been too many unforced errors,” said Dr. David A. Kessler, who was F.D.A. commissioner under Presidents George Bush and Clinton, and is advising Joseph R. Biden Jr.’s presidential campaign. “It needs to focus on what it does best, which is to put the data in front of the medical and scientific community and the American public, and stick with the data.”
Dr. Hahn notified senior leadership at the F.D.A. on Friday that Ms. Miller would no longer be the official spokeswoman for the agency, and that he would be appointing someone to replace her in an interim capacity. Ms. Miller could not be reached for comment.
The consultant who was removed by the health and human services department, Wayne L. Pines, said he wasn’t told why his contract was severed.
“I did recommend that he correct the record,” he said. “If a federal official doesn’t say something right, and chooses to clarify and say that the criticism is justified, that’s refreshing.”
The Department of Health and Human Services denied that Mr. Pines’s contract was terminated because of his involvement in the plasma messaging.
It was “100 percent coincidence,” said Brian Harrison, the department’s chief of staff. “H.H.S. has been reviewing and canceling similar contracts, so I had it sent to our lawyers, who recommended termination. This was routine,” he said.
Nevertheless, the decision by Dr. Hahn to clarify his remarks and to grant a series of media interviews appears to have rankled H.H.S. officials, who saw it as ill-timed, given that the Republican convention was underway. Trump administration officials are often reluctant to publicly admit error out of concern that doing so provides political ammunition to their critics.
Mr. Pines is president of the large health care practice at APCO Worldwide, a public relations and lobbying firm that represents health companies that do business before the F.D.A. He said he did this work on his own, outside of his APCO practice. He would not say how much he was paid, but noted that as a friend to Dr. Hahn, he is willing to continue advising him for free.
Meredith McGehee, executive director of Issue One, which promotes bipartisan political reform, was critical of the contract, noting the potential for conflicts of interest in Mr. Pines’s work for the F.D.A., and his company’s health care client base.
“This notion that, ‘Oh, I’m doing it in my private capacity, on the one hand, and I’m representing health care interests, on the other,’ it doesn’t pass the smell test,” said Ms. McGehee.
The F.D.A. did not respond to requests for comment on Friday about Mr. Pines’s contract or whether it was vetted for conflicts of interest.
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated August 27, 2020
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What should I consider when choosing a mask?
- There are a few basic things to consider. Does it have at least two layers? Good. If you hold it up to the light, can you see through it? Bad. Can you blow a candle out through your mask? Bad. Do you feel mostly OK wearing it for hours at a time? Good. The most important thing, after finding a mask that fits well without gapping, is to find a mask that you will wear. Spend some time picking out your mask, and find something that works with your personal style. You should be wearing it whenever you’re out in public for the foreseeable future. Read more: What’s the Best Material for a Mask?
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What are the symptoms of coronavirus?
- In the beginning, the coronavirus seemed like it was primarily a respiratory illness — many patients had fever and chills, were weak and tired, and coughed a lot, though some people don’t show many symptoms at all. Those who seemed sickest had pneumonia or acute respiratory distress syndrome and received supplemental oxygen. By now, doctors have identified many more symptoms and syndromes. In April, the C.D.C. added to the list of early signs sore throat, fever, chills and muscle aches. Gastrointestinal upset, such as diarrhea and nausea, has also been observed. Another telltale sign of infection may be a sudden, profound diminution of one’s sense of smell and taste. Teenagers and young adults in some cases have developed painful red and purple lesions on their fingers and toes — nicknamed “Covid toe” — but few other serious symptoms.
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Why does standing six feet away from others help?
- The coronavirus spreads primarily through droplets from your mouth and nose, especially when you cough or sneeze. The C.D.C., one of the organizations using that measure, bases its recommendation of six feet on the idea that most large droplets that people expel when they cough or sneeze will fall to the ground within six feet. But six feet has never been a magic number that guarantees complete protection. Sneezes, for instance, can launch droplets a lot farther than six feet, according to a recent study. It's a rule of thumb: You should be safest standing six feet apart outside, especially when it's windy. But keep a mask on at all times, even when you think you’re far enough apart.
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I have antibodies. Am I now immune?
- As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.
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I’m a small-business owner. Can I get relief?
- The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.
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What are my rights if I am worried about going back to work?
- Employers have to provide a safe workplace with policies that protect everyone equally. And if one of your co-workers tests positive for the coronavirus, the C.D.C. has said that employers should tell their employees -- without giving you the sick employee’s name -- that they may have been exposed to the virus.
Ms. Miller started at the agency on Aug. 17 after a career in both politics and journalism. In 2004, while working for the Department of State, she made headlines after she apparently cut off an interview for a taped segment between Tim Russert, the host of NBC’s “Meet the Press,” and her boss, the then Secretary of State Colin L. Powell, who could be heard apologizing to Mr. Russert and saying “Emily, get out of the way.” In 2015, reporters cast doubt on whether Ms. Miller had been a victim of a home invasion, a story that she had repeatedly included in public remarks and in a book, “Emily Gets Her Gun: But Obama Wants to Take Yours.”
The decision to hire Ms. Miller as the agency’s top spokeswoman was seen as puzzling by outside observers, given that she had little experience in health care. On May 30, Ms. Miller tweeted, “Remember coronavirus?”
The F.D.A. had been considering allowing the use of convalescent plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision had been delayed after top health officials Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened and expressed concern that the available evidence on the effectiveness of the treatment was too weak. F.D.A. officials argued that although the data was preliminary and needed continued analysis as more patients are treated, plasma still met the agency’s standard for emergency use authorization.
On Saturday morning, Mr. Trump tweeted that the “deep state” at the F.D.A. was slowing drug development. Late that night, the White House press secretary tweeted that the president would have a news conference the next day “concerning a major therapeutic breakthrough.”
The announcement should have been a rare win for the F.D.A., which for months had fended off criticism of its track record on the pandemic, and questions about the independence of Dr. Hahn, who was previously pressured by Mr. Trump to authorize malaria drugs that turned out to be ineffective for Covid-19 and carried risks of harmful side effects. But last weekend, finally, the agency could reveal some legitimate good news: convalescent plasma, the antibody-rich plasma donated by Covid-19 survivors, showed promise for a subset of patients when given early.
The announcement, made at the White House on Sunday, has instead spurred a week of recriminations, anger and mistrust between the F.D.A. and H.H.S. The officials’ statements Sunday cast nuanced and preliminary data as “a very historic breakthrough,” as Mr. Trump put it. The exaggerated statements drew criticism from scientists and at least three former agency commissioners.
Within the F.D.A. and H.H.S., officials have offered conflicting accounts for how a single misleading statistic — that plasma led to a 35 percent reduction in deaths — appeared in the remarks of Mr. Trump, Dr. Hahn and Alex. M. Azar II, the health and human services secretary. It was also unclear why Dr. Hahn, a longtime cancer doctor, and Mr. Azar, a former pharmaceutical executive, did not themselves catch the overstated statistic. No randomized trials have found a survival benefit for convalescent plasma. The 35 percent number referred to a tiny subset of patients, and was a relative comparison between two groups, not an absolute reduction in deaths.
At a speech at the convention on Thursday evening, the president again overstated what’s known about the benefits of plasma, promising it “will save thousands and thousands of lives.”
Missteps by the F.D.A., a federal agency that has long prided itself on its scientific independence, have heightened concerns that the American public may not be willing to take a vaccine approved by the agency, particularly if the decision is seen as having been made under pressure from Mr. Trump.
“It’s very important for the leadership of the agency, especially the commissioner, to be accurate about the information he’s providing and to do it in a way that really sticks to the facts,” said Dr. Mark McClellan, who was F.D.A. commissioner under President George W. Bush.
“There’s almost not enough adjectives to describe how appalling this is,” said Emily K. Brunson, a medical anthropologist at Texas State University. Opinion polls have shown that many Americans are already wary of taking a vaccine for the virus.
If approval of a vaccine is viewed as politically motivated, she said, “it has the potential to really make this a disastrous situation.”
Sharon LaFraniere and Maggie Haberman contributed reporting.
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