Frontrunner to lead FDA, dogged by controversies, has developed knack for confronting them

WASHINGTON — Before he interviewed with President Trump last week to become Food and Drug Administration commissioner, Dr. Stephen Hahn had only been here once in a formal capacity: to apologize to Congress.

The veteran cancer researcher came to Capitol Hill in 2009 to take responsibility for years of botched care by a doctor under his supervision. Ninety-two U.S. military veterans had been implanted with radioactive “seeds,” meant to fight prostate cancer, at the wrong dose — or in the wrong organ entirely.

It was the first of multiple controversies that have dogged Hahn, who worked then as the chair of radiation oncology at the University of Pennsylvania School of Medicine, throughout his career. This year, regulators found MD Anderson Cancer Center, where Hahn works as chief medical executive, in such stark violation of federal rules that the transgressions “substantially limit your hospital’s capacity to render adequate care.” And this spring, Hahn came under fire from MD Anderson employees who saw the dismissals of ethnically Chinese researchers under investigation for unduly influencing U.S. research as racially motivated.

But the Capitol Hill testimony also highlighted Hahn’s political savvy and the knack he has developed for what one MD Anderson official called “institutional turnaround experiences,” even in the spotlight. His handling of both the rules violations and the dismissals at MD Anderson, as well as interviews with friends and colleagues, reveal him to be a skilled institutional operator, a gregarious man who has shot up the ranks of every organization he has worked for. Though he’s a Washington outsider, Hahn’s allies say his political savvy will serve him well if nominated.

“Clearly, you don’t work in these difficult academic environments without having a lot of political savvy,” said Karen Bird, the executive director of the Alliance of Dedicated Cancer Centers. “It’s not a straightforward job at all. Academic medical centers have lots of stakeholders within them, and you’ve got lots of people with very large egos.”

Hahn, a 59-year-old oncologist, is an accomplished researcher and longtime GOP donor. He has risen through the ranks at MD Anderson since beginning there in 2015, first as the division head for radiation oncology, then as chief operating officer, then as chief medical executive.

It’s not the traditional route to helm the FDA: The agency’s most recent commissioner, Dr. Scott Gottlieb, had previously worked at the agency before a stint at the American Enterprise Institute, a conservative think tank. Both commissioners under President Obama also held high-level health policy roles prior to assuming the position: Dr. Margaret Hamburg as New York City’s health commissioner and Dr. Robert Califf as assistant FDA commissioner.

And there’s a reason for that: The FDA job is more political than it might seem on its surface. A Washington outsider could face a steep learning curve atop an agency as political as FDA, said Hamburg, who served as FDA commissioner from 2009 to 2015.

“It’s a critical time for the agency,” she told STAT. “Someone coming in really needs to hit the ground running, so it’s a concern that no matter how smart and capable and committed he or she is, he or she is going to have an extremely steep learning curve.”

Hamburg and several other former commissioners, including Califf, Mark McClellan, and Andrew von Eschenbach, came out last week in support of Dr. Ned Sharpless, the former National Cancer Institute director who has served as acting FDA commissioner since Gottlieb’s departure. Sharpless — himself a renowned cancer researcher — was seen as an unlikely selection for the full-time job; he has angered some Democrats for what they view as a lackluster response to the youth vaping epidemic and raised eyebrows in GOP circles for a history of supporting Democratic candidates.

Hahn has been a faithful GOP contributor for years, according to a review of campaign finance disclosures. He contributed to George W. Bush’s reelection bid in 2004 and to John McCain and Mitt Romney, the Republican nominees for president in 2008 and 2012, respectively.

Despite his apparent willingness to support GOP candidates, however, Hahn did not contribute to Trump’s 2016 presidential campaign. His only recent political contribution came in 2017 — a $1,000 check to the New Pioneers PAC, which is affiliated with Rep. Greg Walden (R-Ore.), who then served as chairman of the powerful House Energy and Commerce Committee.

Between the controversies at MD Anderson and at the University of Pennsylvania, Hahn has developed a tendency for arriving at major medical institutions in the throes of controversy.

The scandal involving botched brachytherapy procedures — in which radioactive “seeds” are implanted into an organ to distribute radiation over an extended period — began before Hahn chaired the radiation oncology department at Penn. But the subpar procedures continued during his tenure for three years, between 2005 and 2008.

The Nuclear Regulatory Commission, which oversees some aspects of cancer care involving radiation, said the responsible physician, Dr. Gary Kao, had implanted the devices such that the prostate received too little radiation 57 times. On 25 more occasions, the commission said, other parts of the body received too high a dose.

Hahn testified in 2009 that, at his request, Kao had suspended his clinical practice. The transcript depicts Hahn as careful, sincere, and calm throughout; seemingly, he worked to defuse the tension in the room when Kao, who was also testifying, became defensive in the face of lawmakers’ pointed questions. He took full responsibility.

“I want to express my deepest regret that prostate cancer patients receiving brachytherapy at the Philadelphia Veterans Affairs Medical Center did not in every instance receive the best possible care,” Hahn told the House Veterans Affairs Committee in 2009.

MD Anderson, more recently, came under fire from the Centers for Medicare and Medicaid Services for a rash of regulatory violations. One botched blood transfusion even resulted in the death of a 23-year-old leukemia patient. CMS found that MD Anderson nurses were systematically neglecting to get informed consent before starting blood transfusions, and didn’t check patients for adverse reactions.

Much of the failure happened on Hahn’s watch — at MD Anderson, he is responsible for all aspects of clinical care. The violations were so systemic that, in a warning letter this year, Medicare threatened the cancer center that it could become ineligible for reimbursement from the federal program, which covers care for most cancer patients past 65.

Hahn, the hospital’s documents show, took on the responsibility of righting the ship. He quickly was placed in charge of aiding the CMS investigation, a senior faculty member at MD Anderson said in an interview. And he has played an integral role in nearly every aspect of a 94-page corrective plan submitted to CMS earlier this year, according to STAT’s review. Hahn, for example, approved a new informed consent policy for the hospital in June. Many of the corrective efforts are still ongoing.

Hahn has been doing all this on top of his role architecting a new strategy for handling MD Anderson finances, as the hospital system’s losses mounted in 2017. In one month alone, its losses totaled a staggering $58 million.

Hahn was promoted from head of radiation oncology to chief operating officer in February 2017, a senior leadership role at the gargantuan health system, though he had not sought the job himself.

“We were in a financial crisis,” Hahn told the publication The Cancer Letter in 2017. “We had to consider significant changes in the institution. … I was told that my name came up a couple of times, and that they sort of vetted that internally and thought that that would make a good choice.”

He was promoted again the next year to chief medical executive.

That fact alone — that he has helped to lead such a large institution — prepares him for the job, his allies argue.

The hospital’s finances seemed to turn around virtually overnight. By August 2017, the company was in the black. The turnaround included some tumultuous decisions, including laying off 1,000 staffers, but Hahn’s supporters have nonetheless praised his progress.

Separately, in April, Hahn came under fire from some MD Anderson staff after the cancer center dismissed several ethnically Chinese researchers in light of a federal investigation into foreign influence into taxpayer-funded research.

While the dismissals came in response to an FBI investigation, they still sparked fears of racial profiling.

In that instance, too, Hahn and MD Anderson leadership were simply acting at the federal government’s urging — the FBI had reached out to the National Institutes of Health, warning of foreign threats to U.S. research, and MD Anderson was the first research institution to take corrective action.

Hahn, again, displayed a knack for de-escalation, helping to quell the brief uproar.

“I can assure you 100% that this is not based on ethnicity,” Hahn said at a town hall for MD Anderson staff, according to Science Magazine. “This is something that we abhor and that we would never do.”

Hahn has also spent a career working, at least in part, on the kinds of drug development and research questions that ultimately fall under FDA’s purview.

Over the course of Hahn’s three decades in medicine and research, he has left behind a trail of academic work and clinical accomplishments. He holds rare dual board certifications in both medical oncology and radiation oncology. He is listed as an author of more than 200 academic works, dating back to a clinical internship at the University of California, San Francisco, in 1989.

Hahn also holds five patents, according to a federal database, two of which describe an in vitro diagnostics tool for detecting circulating tumor cells.

At MD Anderson, Hahn has supervised thousands of clinical trials. He has also facilitated a number of trials himself, including a number of efficacy-related studies for cancer drugs conducted during his time at Penn’s Abramson Cancer Center.

“MD Anderson has over 1,000 clinical trials, which I find mind-boggling,” Bird, the Alliance of Dedicated Cancer Centers executive, said, “I mean, that’s huge. And he’s had oversight for all of that.”

Hahn’s supporters insist his lack of Washington experience won’t pose a problem. He’s already a rising star in the tight-knit specialty community of radiation oncology — first as the head of that department at the University of Pennsylvania and then at MD Anderson, they insist. And, most importantly, he’s ready to learn.

“I don’t think anyone comes into this job having all of the experience necessary to do it,” said Dr. Richard Schilsky, the chief medical officer at the American Society of Clinical Oncology. “If he gets the job, he will certainly be a quick study.”

His colleagues say he’s also dedicated to everything he tries — both at and outside of work. Hahn now wakes up at 4 a.m. to work out, but that wasn’t always the case. When he suddenly jumped into pumping iron, he was so successful at getting into shape that he surprised his longtime colleagues, who feared he was going through a much more grim transition.

“I hadn’t seen him for a little while, and between the time I saw him and then maybe six months later, he lost 30 pounds and shaved his head. And I thought at first, oh my god, he must have had cancer, he had brain radiation, and he lost all this weight,” Dr. Ted Lawrence, the head of radiation oncology at the University of Michigan, and a 15-year colleague of Hahn told STAT.

“But then I looked and he had become really fit,” Lawrence added.

He is also lauded as a salt-of-the-earth Philly guy with a self-deprecating humor who hasn’t let his high-profile positions at some of the U.S. top hospitals go to his head.

They defend him as engaging, too, despite his arcane 30-page resume.

“Maybe on paper you think this guy is pretty stiff,” said Dr. Phuoc Tran, an associate professor of radiation oncology at Johns Hopkins University. “He knows his stuff, for sure, but I would not classify him as that stereotype, far from it.”

Tran remembers his first encounter with Hahn well. He was applying for residency at the University of Pennsylvania, in the department where Hahn worked.

Tran expected to find a stern, serious interviewer ready to grill him on his medical bonafides. Instead he found Hahn, one foot propped on his desk, inviting him to come in.

“I remember him just being so relaxed and open,” Tran said. “The last thing you would think about from a Penn medicine professor is him to have one leg up on the table, welcoming you in.”

That quickly built rapport only continued with Hahn’s first question: Hahn didn’t want to know where Tran went to school, or his views on proton therapy, he was more interested in hearing what it was like for him to immigrate from Vietnam.

Tran didn’t end up at Penn for his residency, but they stayed in touch nonetheless over the last two decades.

“That has held consistent throughout the time that I have known him,” Tran said. “He always manages to connect with you on a very personal level.”

“That sincerity that he gives off is one of the things that has made him so successful,” Tran added. “People see him as a leader.”