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Former FDA chief grabs spotlight with coronavirus plans to ‘turn the lights back on’

Scott Gottlieb pushes testing and treatment to beat back the pandemic

April 13, 2020 at 5:10 p.m. EDT
Former FDA Commissioner Scott Gottlieb advises lawmakers, governors and administration officials on how to safely reopen the economy. (AP/J. Scott Applewhite)

A year after Scott Gottlieb resigned unexpectedly as Food and Drug Administration commissioner to return home to his family in Westport, Conn., he has never been in such demand — advising lawmakers, governors, members of the Trump administration and even the president himself about combating the novel coronavirus.

The reason is simple, say the officials seeking his advice: He’s got a plan. In fact, several of them.

At a time when many complain about the lack of a federal strategy, Gottlieb and four co-authors have published two detailed road maps on how to navigate the treacherous path back to some semblance of normalcy by emphasizing the 'Three ‘T’s’: testing, contact tracing and treatment. He has briefed members of Congress, as well as governors, including Republican Larry Hogan of Maryland and Democrat Phil Murphy of New Jersey. He serves as an informal adviser to the White House coronavirus task force, which is scrutinizing his plan as it struggles to develop its own long-term strategy. And he has met with President Trump and his top advisers.

“If you want to know what needs to happen over the next 12 to 18 months to turn the lights back on,” said Rep. Tom Reed (R-N.Y.) co-chairman of the congressional Problem Solvers Caucus, “he’s the guy.”

That wasn’t always the case. In early January, as Gottlieb began furiously tweeting about the deaths in Wuhan, he played the role of Cassandra-in-chief, with some skeptics viewing him as alarmist or attention-seeking. “A couple of my business friends snickered that my Twitter feed had become all coronavirus,” the 47-year-old physician and venture capitalist said in an interview.

Now, four months into the epidemic, Gottlieb is widely regarded as among the most prescient about the disaster, and his thoughts about how to deal with it are helping define, even if in delayed fashion, the federal, state and local responses.

Gottlieb shot up warning flares in early January about the mysterious respiratory illness. Having worked in a hospital during the 2009 swine flu epidemic, he knew how dangerous an errant strain could be. After consulting with virologists and epidemiologists, he called his former colleague, Domestic Policy Council Director Joe Grogan, on Jan. 18 to express his concerns. That afternoon, Alex Azar, the secretary of health and human services, briefed Trump.

The FDA commissioner, governors and other experts responded on April 12 to reports that President Trump is seeking to reopen the country as soon as May 1. (Video: The Washington Post)

The response was anemic, but Gottlieb kept hammering away. On Jan. 28, he authored a Wall Street Journal op-ed with Luciana Borio, former director for medical and biodefense preparedness policy at the National Security Council, headlined “Act Now to Prevent an American Epidemic.”

In early February, he warned the virus was likely circulating undetected in the United States. That was weeks before the first confirmed case of community transmission here, and as other officials dismissed that notion — a mistake that would have devastating consequences when the case count began increasing exponentially.

Former colleagues say Gottlieb’s outspokenness reflects his love of health care policy — and, also, of being in the middle of the action. Some suggest he might be interested in a higher government post someday, such as HHS secretary — speculation that he refuses to engage in. “This is what I have always done,” he said when asked directly about his motivation, noting he has written 80 to 90 opeds for the Wall Street Journal and testified before Congress more than 40 times over the course of his career.

His coronavirus efforts have often — but not always — been welcomed by former Trump administration colleagues. After all, Gottlieb is an outsider, albeit one with a much-praised two-year turn at FDA, who is now trying to influence decision-making inside.

At times, Trump aides have asked Gottlieb, whose White House allies include presidential son-in-law Jared Kushner, to reinforce a message to the president. Following the president’s widely panned prime-time speech on the crisis on March 11, Trump asked Gottlieb to come to the White House after seeing him on CNBC, according to administration officials who spoke anonymously because they were not authorized to discuss the topic.

Before the meeting, officials asked Gottlieb to stress the seriousness of the crisis and to emphasize the importance of social distancing.

“I think that people appreciate his wisdom, it’s another pair of eyes on things,” said a senior administration official involved in the response who spoke on the condition of anonymity because the person didn’t have authorization to speak on the topic.

But other administration insiders grumble about Gottlieb’s television critiques, saying it is easier to knock the administration’s performance than to make things work. And even as they agree with him on many issues, some question his loyalty when he contradicts Trump publicly on the prospects for the malaria drug hydroxychloroquine (Gottlieb thinks the drug will have a marginal effect at best); the adequacy of testing (he says much more needs to be done) and reopening the economy (he doesn’t believe restrictions should be lifted for several weeks).

One senior administration official accused Gottlieb of trying to be a “shadow FDA commissioner,” undermining agency head Stephen Hahn. “Who is the real FDA leader?” said the official, who spoke anonymously because he was not authorized to talk on the topic. “Is it Gottlieb or the real commissioner?”

Indeed, Gottlieb has not hesitated to prod Hahn, without naming him. In a recent Wall Street Journal op-ed, he urged the FDA to “place bets” on covid-19 treatments with the highest likelihood of success and to work closely with manufacturers to get the therapies to market by the end of the summer. The article ruffled some feathers at the FDA, where officials are pushing hard for treatments.

Gottlieb also has complained to White House officials that the Department of Health and Human Services should have contacted the heads of test manufacturers and laboratory companies months ago to get help in scaling up testing across the country. In 2017, after Hurricane Maria decimated Puerto Rico, causing pharmaceutical shortages, he was aggressive in asking corporate chieftains for help.

The former FDA boss doesn’t apologize for speaking his mind. “People know I say the same thing in private as I do on CNBC,” he said. “There’s no difference.”

Several weeks ago, after talking to Kushner and others, Gottlieb agreed to submit paperwork for a temporary job working with the task force on strategy. But the paperwork stalled in Vice President Pence’s office, according to administration officials.

At times, Gottlieb has gotten a warmer reception from Democrats than Republicans. On March 10, when there were about 1,000 cases of covid-19 in the United States, he briefed the House Republican Conference; some lawmakers said he was overreacting to the threat. When he talked to the congressional Progressive Caucus later that day, he was praised for his candor, said Rep. Jan Schakowsky (D-Ill.), a member of the caucus.

“There’s a difference between being an alarmist and responding appropriately to something for which there is no cure and is highly contagious,she said.

Now Gottlieb is calling for steps — such as widespread public health surveillance to spot small outbreaks before they become big ones —to prevent a rebound epidemic this fall that would bring further economic devastation.

“Unless we have a different toolbox by this fall, including therapeutics to inspire confidence and screening to detect small outbreaks, we could end up with an 80 percent economy,” with people skipping trips to Disneyland and conferences and even the movies, he said.

During the George W. Bush administration, Gottlieb worked at the FDA twice. When he finally left the FDA in 2007, he became a partner at the giant venture capital firm New Enterprise Associates, where he invested in health care companies. He also went back to the American Enterprise Institute, where he had worked before. He returned to both entities again last year after ending his third FDA stint, and has since joined the boards of drugmaker Pfizer and Illumina, a genetic sequencing company.

During the swine flu outbreak, he worked in a hospital in Connecticut. “I would come home and shower and put my clothes in the wash,” he said. “My wife was pregnant with twins.”

In 2017, when he was interviewed by the president for the top FDA job, presidential advisers warned him Trump would say he looked too young for the job. As predicted, Trump said, “Wow, young guy!” when Gottlieb was ushered in. At his FDA farewell ceremony two years later, Gottlieb joked he had thought about putting gray in his hair before the interview, people who heard the remarks say.

Some Democrats initially criticized Gottlieb’s nomination because of his strong financial ties to health care companies. He signed an ethics agreement to divest some of his holdings and to recuse himself from decisions involving companies he had done business with. He also focused on issues such as the opioid epidemic and food safety and assiduously returned calls from lawmakers, winding up popular on both sides of the aisle.

During his FDA tenure, he was known for promoting high-quality work. The former editor of his college newspaper at Wesleyan University, he also became notorious for rewriting news releases. “He rewrote every single news release, almost from top to bottom,” said an official who spoke on the condition of anonymity to speak candidly.

Early on, he extended for years key deadlines for e-cigarette regulation and was denounced by anti-tobacco advocates, then reversed course when youth vaping surged and sought restrictions on manufacturers.

Gottlieb regularly spoke to the president about vaccines, seeking to convince Trump of the merits and had a surprising amount of success, administration officials say. Trump, who had publicly expressed skepticism about vaccines before becoming president, continued to talk to Gottlieb about vaccines even as he departed the agency, officials say.

His fierce independent streak led to clashes with his boss, Azar, during the government shutdown in 2018 and 2019. Gottlieb wanted to make a case about why the shutdown was hurting federal employees and the FDA’s mission, according to a government official who requested anonymity because he didn’t have authority to speak about the topic. Azar tried to reel him in, saying he was undercutting the administration’s message.

A senior administration official familiar with the situation said that Azar “understood where Gottlieb was coming from but also realized the need for a unified message.” . The official said Azar thinks highly of Gottlieb and has talked to him about coronavirus strategy.

A year ago, Gottlieb announced his resignation, saying he wanted to spend more time with his wife and three children. Today, mostly holed up in his sprawling home, he talks frequently with governors and their staffs, whom he thinks face some of the biggest decisions about how to restart the economy.

Gottlieb tells them if business leaders are pushing for reopening their states, the companies should reduce the risks to their employees — and society — by offering rapid coronavirus tests at work and guaranteeing sick leave for everyone with covid-19.

“Maybe we lift stay-at-home orders for between 9 to 5, but bars stay closed,” he said. “Or some businesses come back, but there are no meetings with more than 10 people. How we do this is really important.”

Read more:

The U.S. was beset by denial and dysfunction as the coronavirus raged

In the absence of a national testing strategy, states go their own way

A plan to defeat the coronavirus emerges, but it’s not from the White House

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