Two public relations experts advising the Food and Drug Administration have been moved from their positions to heated communication over a blood plasma treatment for Covid-19. President Trump and the head of the FDA had wrongly called on the eve of the Republican National Convention that the treatment sharply reduced the mortality rate of the disease.
On Friday, the FDA commissioner, Dr. Stephen M. Hahn, Emily Miller, the agency’s chief spokeswoman, removed. The White House had installed Ms. Miller, who had previously worked in communications for Senator Ted Cruz’s re-election campaign and as a journalist for One America News, the conservative cable network, in this post just 11 days ago.
Dr. Hahn informed senior management at the FDA on Friday that Ms. Miller would no longer be the official spokeswoman for the agency, and that he would appoint someone to replace her in an interim capacity. Mrs Miller could not be reached for comment.
Ms. Miller’s removal came one day after the FDA’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations adviser who Dr. Hahn had advised to improve misleading remarks about the benefits of blood plasma for Covid-19.
“I have recommended that he improve the record,” said consultant Wayne L. Pines, who said he did not say why his contract was terminated. “If a federal official does not say something right, and chooses to clarify and say that the criticism is justified, that is surprising,” said Mr. Pines.
The Department of Health and Human Services denied that Mr. Pines was terminated because of his involvement in the plasma messages.
It was “100 percent coincidence,” said Brian Harrison, the department’s chief of staff. “HHS has reviewed and canceled similar contracts that I had sent to our attorneys, who recommended termination. It was routine, ‘he said.
Mr. Pines is president of the major healthcare practice at APCO Worldwide, a public relations and lobbying firm that represents healthcare companies doing business for the FDA. He said he did this work on his own, outside of his APCO practice. He would not say how much he was paid, but stated that as a friend of Dr. Hahn is ready to advise him for free.
The FDA had considered allowing the use of restorative plasma as a treatment for Covid-19 on an emergency basis, but last week The New York Times reported that the decision was delayed after 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. FDA officials argued that although the data were preliminary and required continuous analysis as more patients were treated, plasma still met the standard of the Emergency Use Authorization Bureau.
On Saturday morning, Mr. Trump tweeted that the “deep state” at the FDA is slowing down drug development. Late that night, the White House press secretary tweeted that the president would have a news conference the next day “about a major therapeutic breakthrough.”
The announcement would have to be a rare win for the FDA, which had spent months debating criticism of its track record on the pandemic, such as the independence of Drs. Hahn, who was previously pressured by Mr. Trump to authorize malaria drugs that have been shown to be ineffective for Covid-19 and carry risks of harmful side effects. But last weekend, the agency was finally able to reveal some legitimate good news: restorative plasma, when given early, showed promise for a subset of Covid-19 patients.
The coronavirus breaks out>
Frequently Asked Questions
Updated on 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? I’m good. If you keep it in the light, can you see through it? Min. Can you blow out a candle through your mask? Min. Do you feel most OK to wear it for hours at a time? I’m good. The most important thing, after finding a mask that fits well without yawning, is finding a mask that you will wear. Spend some time searching for your mask, and find something that works with your personal style. You should wear it when you are in public for the foreseeable future. Read more: What is the best material for a mask?
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What are the symptoms of coronavirus?
- At first, the coronavirus seemed to be primarily a respiratory failure – many patients had fever and chills, were weak and tired, and coughed a lot, although some people did not show many symptoms at all. Those who were most ill had pneumonia as an acute respiratory distress syndrome and received additional oxygen. Today, doctors have identified many more symptoms and syndromes. In April, the CDC added to the list of early signs sore throat, fever, colds and muscle aches. Gastrointestinal obstruction, such as diarrhea and nausea, has also been observed. Another sign of infection may be a sudden, profound decrease in the sense of smell and taste. Teens and young adults have in some cases developed painful red and purple lesions on their fingers and toes – nicknamed “Covid toe” – but a few other serious symptoms.
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Why does it help to stand six feet away from others?
- The coronavirus spreads mainly through droplets from your mouth and nose, especially when you cough or sneeze. The CDC, one of the organizations using this measure, bases its six-foot recommendation on the idea that most large drops that expel people when they cough or sneeze fall to the ground within six feet. But Six Feet has never been a magic number that guarantees complete protection. Sneezes, for example, can launch drops much further than six meters, according to a recent study. It’s a rule of thumb: You should be safest to stand outside six feet apart, especially if it is windy. But always wear a mask, even if you think you are far enough apart.
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I have antibodies. Am I immune now?
- As of now, that seems likely, at least for several months. There have been scary accounts of people suffering what appears to be a second attack from Covid-19. But experts say these patients may have a marked course of infection, with the virus taking a slow toll weeks to months after the first exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies can last only two to three months in the body, which may seem worrying, but that is perfectly normal after an acute infection has disappeared, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to recover the coronavirus, but it is highly unlikely that it will be possible to recover from a first infection or make people sick a second time in a short space of time.
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I own a small business. Can I get relief?
- The stimulus tickets, adopted in March, provide assistance to the millions of American small businesses. Eligible for assistance are companies and non-profit organizations with less than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some sectors are also eligible. The assistance provided, which is managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Loan Program. But many people have not yet seen payments. Even those who have received help are confused: the rules are draconian, and some are stuck on money that they do not know how to use. Many small business owners get less than they expected or hear nothing at all.
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What are my rights if I worry about returning to work?
The announcement, made on Sunday in the White House, has sparked a week of accusations, anger and mistrust between the FDA and the HHS. The officials’ statements on Sunday nuanced and inflated preliminary data in “a very historic breakthrough,” according to Mr. Trump set it. That drew criticism from scientists and at least three former bureau commissioners, who said the exaggerated statements undermined public confidence in the FDA. In a speech at the convention on Thursday night, the president again overestimated what is known about the benefits of plasma, and promised it “will save thousands and thousands of lives.”
Health experts have apologized for the failure of Dr. Hahn to check the public message about the plasma authorization.
“This is a low moment for the FDA in at least a generation,” said Daniel Carpenter, a professor at Harvard University who studies the bureau. “This was a large self-inflicted wound.”
These extraordinary missteps by a federal agency that has taken pride in its scientific independence have made the American public unwilling to accept a vaccine approved by the agency, especially when the decision is seen as being made under pressure from President Trump,
“There are almost not enough adjectives to describe how horrible this is,” said Emily K. Brunson, a medical anthropologist at Texas State University. Opinion polls have shown that many Americans are already wary of getting a vaccine for the virus.
But making the issue political, she said, “is an added component that is unique in modern times, and it has the potential to make this a really disastrous situation.”
Sharon LaFraniere contributed reports from Washington.
