Longtime cancer doctor takes the helm at FDA

WASHINGTON — In December when the Senate voted to confirm Dr. Stephen Hahn as chief of the Food and Drug Administration, youth vaping was the controversy expected to dog the beltway newcomer’s tenure.

Instead during his first full month on the job, Hahn learned of what President Donald Trump now calls “the invisible enemy.” The coronavirus silently had worked its way into the United States with all the destructive force of a Category 5 hurricane, a major earthquake and a plague of locusts.

It was his first high-profile slot in the federal government after a storied career in medicine, and Hahn would be the guy in charge of approving the production of millions of tests for a disease Americans researchers never had seen before and trying to coax a vaccine before year’s end, which most experts at the time considered impossible.

At the same time, Hahn would have to be a voice for data science while serving under a president whose shoot-from-the-hip remarks about the outbreak have often crumbled under scrutiny.

His job, as Hahn described it to the Review-Journal, has been “managing the agency during a crisis, while still learning about it.”

“It’s really easy when you’re not in Washington and the cynicism builds” about Washington, Hahn said in the assuring voice that many Americans have heard during briefings with the president’s Coronavirus Task Force. “But I’ve been really impressed at how good people came together for the benefit of the American people during very challenging times.”

Long career

Fortunately, the soft-spoken oncologist and cancer researcher had experience in “institutional turn-around experiences,” as a former colleague told the health news website STAT.

Hahn, 60, served as chief medical executive for the University of Texas MD Anderson Cancer Center when he was tapped to head FDA. Before that, he was the chairman of the radiation oncology department at the University of Pennsylvania.

When Kevin Mahoney, a former colleague now CEO of the University of Pennsylvania Health System, heard his friend would head the FDA, he said, “Of course I was surprised because I’ve not heard Stephen aspire to governmental service.”

Hahn is “not a big donor” to political campaigns, Mahoney noted, adding, “he’s not somebody I would have labeled a political mover or part of the Washington establishment.”

By beltway standards, Hahn is a modest donor. He did not write a check for the Trump campaign. According to the Center for Responsive Politics, he gave $1,000 to a Republican PAC in 2017 and $706 to Mitt Romney’s presidential campaign in 2012.

Renowned medical ethicist Art Caplan described Hahn as “an outstanding scientist” who left Penn for MD Anderson when “it was in need of a turn-around and he did it.”

“He knows his science,” Caplan said of Hahn and understands medicine. “What’ I’m not sure about, and I don’t know, is how well he can navigate FDA and federal bureaucracy.”

“There’s always a pretty big learning curve. When you take that job coming in to a big agency, even if you’re a great scientist.”

Fighting coronavirus

The “a ha” coronavirus moment came for Hahn, he said, in February “when we saw the dramatic escalation cases in Italy, which is sort of classic for an infectious disease outbreak.”

On March 1, Vice President Mike Pence and Health and Human Services Secretary Alex Azar added Hahn to the president’s Coronavirus Task Force.

Hahn joined the team as health care workers across the country and the public at large looked to Washington to provide reliable COVID-19 diagnostic tests. At the same time, clinics that had the tests had difficulty obtaining masks and other personal protective equipment needed to administer tests and treat infected patients.

It did not help that early tests developed and distributed by the Centers for Disease Control and Prevention were not reliable.

Hahn’s FDA reached out to the private sector and encouraged private concerns to develop tests under emergency use authorization which would cut back red tape. As a result, the FDA authorized 105 tests, including 12 antibody tests that can determine if individuals had had the virus.

The diagnostic tests aren’t perfect, but then, Hahn offered, “doctors know that no test is perfect.” Good physicians understand this, and know when to look beyond a positive or negative finding.

“There’s a word in front of the ‘coronavirus,’ it says ‘novel,’” Mahoney said as he talked about researchers hustling to develop tools to diagnose and treat a virus scientists had not seen before.

Mahoney added that Americans have a romanticized view that a test could be developed and distributed rapidly.

And it didn’t help when Trump said on March 6, “anybody that wants a test can get a test.”

Now Mahoney said he would like to see more clarity and rigor in coronavirus testing. “I understand the desire to get the test out, but a little more rigor I think we would benefit from.”

On May 14, the FDA released an update on the Abbott ID NOW point-of-care diagnostic test that reported 15 inaccurate negative findings.

Hahn himself got caught in the false-negative net earlier this month after Katie Miller, a Pence spokeswoman, tested positive for the virus, the day after she had tested negative.

Having worked with Miller, Hahn, too, was tested and the result was another negative finding. Nonetheless Hahn and two other task force members who also tested negative self-isolated for a time to make sure they had not contracted the virus before its presence turned up on a test.

Even with a negative finding, Hahn said, it is wise to “self-quarantine for a period of time where the risk of becoming positive is present.”

“If we had it, we would do what every other American would do, which is make sure that we were isolated and did not expose others,” Hahn said. “And if we develop symptoms, we would seek medical help. Doctors do that when they’re sick.”

Controversial drug

The stickiest subject for Hahn has been hydroxychloroquine, a drug used for treating malaria, lupus and other autoimmune diseases.

Trump has touted the drug as an effective treatment for coronavirus patients, despite what many in the medical establishment say about the drug’s potential to cause problems for people with heart conditions. Trump also recently said he had been taking the drug for two weeks as a preventive measure.

In March, the FDA authorized emergency use of Trump’s “game changer” drug in clinical trials and for adults hospitalized for COVID-19.

Asked if he was taking the drug, which has been used by health care workers to prevent their getting COVID-19, Hahn explicitly told the Review-Journal, “I am not taking hydroxychloroquine.”

Caplan noted he has not seen Hahn promote the drug, but he’d like to see Hahn come out stronger against the use of the drug outside of a medical trial. “I want him to really speak up,” Caplan said.

Vanity Fair magazine ran a story about Hahn reaching out to Dr. Vladimir Zelenko, a New York doctor who made a video in which he appealed to Trump to “advise the country that they should be taking this medication in an outpatient setting.” Zelenko added, “I personally love you.”

The headline mocked Hahn for accommodating the efforts of “Trump’s favorite chloroquine doctor” to conduct a clinical trial.

“It’s interesting to me that people always at least in this town say you want to listen to everyone, get all sides,” observed Scott Whittaker, CEO of the medical device manufacturer AdvaMed, and then they criticize Hahn for doing just that.

Progress at FDA

Whittaker offered that a lot of the progress made at the FDA – mass production of ventilators and personal protective equipment that ended scary shortages — “would not have happened without his leadership.”

Mahoney credited Hahn for making “a bold, provocative move” in pushing forward Penn’s Roberts Photon Therapy Center. “He was undaunted in his belief that this was the right thing for us to do. And we just celebrated our 10th anniversary and it was absolutely the right thing to do,” Mahoney said.

That attitude may serve the FDA as the task force hustles to deliver on Trump’s Operation Warp Speed mission to get mass-produced vaccines to the public before year’s end.

Hahn noted that it is “unknown whether we’ll have a vaccine by the end of the year” even as he spoke of his support for the Trump operation.

When Trump brags about Hahn, he likes to say that he “left one of the most important jobs in medicine” to take the FDA’s helm.

Hahn likes to tap his years as a cancer doctor as a North Star in the new job.

“I’ve sat across from countless number of patients and had to talk to them about their diagnosis and their treatment,” Hahn told reporters during a March briefing. “And one thing that really is important is to provide hope. I have great hope for now that we’re going to come out of this situation.”

Is he glad he took the job? Yes, he answered. “Hopefully this is a once-in-a-lifetime experience for all of us.”

Contact Debra J. Saunders at dsaunders@reviewjournal.com or 202-662-7391. Follow @DebraJSaunders on Twitter.