Former FDA chief Margaret Hamburg speaks out about Califf, Cruz, and Congress
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WASHINGTON — Dr. Margaret “Peggy” Hamburg has a reputation for turning beleaguered government agencies around.

Named the youngest-ever health commissioner for New York City in 1992, at age 36, Hamburg helped slow the spread of AIDS, boosted childhood immunization rates, and reversed a crippling tuberculosis epidemic.

Seventeen years later, as commissioner of the US Food and Drug Administration, Hamburg inherited an agency battered by a series of drug scandals and food poisoning outbreaks. And although her tenure wasn’t without controversy, when she left last April, after a nearly six-year stint, she was widely seen as having cleaned up the FDA and laid the groundwork for speedier drug and device approvals, more oversight of tobacco products, and a modernized food safety system.

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Hamburg, now 60, is working part-time, traveling the world as a foreign secretary of the National Academy of Medicine. In her first interview since stepping down from the FDA last year, she spoke out about her successor, the challenges facing public health, the presidential campaign, and even her own son’s quarantine at Harvard for having mumps.

The conversation that follows, at STAT’s offices in downtown Washington, has been edited and condensed.

After an intense confirmation process, Dr. Robert Califf, a cardiologist from Duke University, is now your successor at the FDA. You had appointed him to the number two spot in January 2015. What’s your advice to him?

Fasten your seatbelt because it’s a bumpy ride — but enormously rewarding.

I had no idea when I started just how vast the responsibilities of FDA were and how critical they were, not just to the public, but in terms of that we regulated products that accounted for between 20 and 25 cents of every dollar that people spend on products in this country.

The challenge for Rob is he doesn’t know how long he’ll be there. Of course, you never know how long you will be in a job like that. He needs to both think about what are the things that absolutely need to get accomplished before this administration ends, as well as never forgetting the longer-term issues.

Of course, there are many, many components of FDA that he’s not as familiar with. He hasn’t had the experience working in government, apart from the year he’s had at FDA, and he hasn’t worked on a range of issues such as food safety or nutrition or tobacco-related issues. He has already had and will continue to have a very steep learning curve.

Has he approached you much, asking, ‘What do I do?’

In the very beginning, I spent a lot of time as he came on board as deputy commissioner for medical products [and tobacco], and then as it looked like he was going to be taking on the larger role. We talked a lot about some of the broader issues. Before I left, he did shadow me as I prepared and did the budget hearings — I thought it was noble of me at the end of the day not to saddle my successor with having to do the budget. That was his first opportunity to really see the range of issues, and I think it was an eye opener for him.

White House Photo courtesy Peggy HamburgHamburg and her mother meet with President Obama in the Oval Office.

Does it hurt the FDA when top people like your general counsels leave and then become lobbyists or lawyers for industry?

This perception of the revolving door is damaging to everyone, and as a principle I am not considering doing any boards of any company big or small that was regulated by the FDA for a couple of years — a cooling-off period — even though some of the smaller biotech companies are technically really interesting and it would be fascinating to see from the other side. It’s unfortunate that people really think there has to be a complete division between the work of FDA and the industry.

Isn’t it tempting to leave government and make money?

People are being asked to come for salaries that are much lower than in the private sector or academia. Increasingly, we’re asking highly trained professionals to share offices, to not even have their own desks.

Hoteling?

Yes. “Hoteling’’ or “hot desking.’’ It sounds almost pornographic to me. There’s a very unfortunate tendency to think that if a bunch of scientists from the FDA are going to a medical conference, it must be a boondoggle. But in fact, you want the scientists at the FDA to be as up to speed as possible.

I gave up a lot of money to take the job, in fact. I mean, Rob got a pay cut when he got confirmed.

I didn’t know that.

The commissioner’s salary, I think, is capped to $150,000, and I think we brought him in at a lot higher than that.

Were you surprised that even some Democrats opposed Califf for his industry ties?

I was a little surprised by that because he’s in fact never actually worked in industry, but his programs have been supported by industry dollars. The world is changing and most academic research centers get money from companies to do clinical trials.

You say that the National Institutes of Health tends to get better funding than the FDA. Is it a sexier agency in some ways?

Biomedical research is a more clearly recognized public good and everybody can get around the idea of more research will result in benefits down the road. FDA suffers from being a regulatory agency and people automatically think government bureaucrats, think burdensome regulation. People don’t understand you’re actually slowing progress and innovation if you tie the hands of FDA.

What do you think of Senator Ted Cruz’s legislation that would force the FDA to approve “life-saving” products for which there is a medical need if those drugs have been endorsed in Europe, Canada, or other trusted countries?

Ironically, I met Ted Cruz like two days before he dropped that legislation, but he didn’t tell me he was going to do it. I think that would be an extremely dangerous world. The FDA makes science-based decisions, they look at the data. Congress is not an appropriate body to be assessing whether a drug or a medical advice should be approved.

Peggy Hamburg -- FDA
Alex Wong/Getty ImagesHamburg testifying during a Senate committee hearing in November 2012.

Does the name Martin Shkreli outrage you?

It’s absolutely outrageous to take a really important drug usually used by people that are disadvantaged and don’t have a lot of access to even fundamental medical care and then jack up the price. It was terrible. I don’t think that he represents the common practice of the industry. But the industry needs to really address how it can assure the public that it’s looking out for the needs of the patients first and foremost.

What should they be doing?

I don’t think they help themselves showing their Viagra ads during the Super Bowl. It’s mystifying to me how they went from being one of the most admired industries in America to now.

What about drug prices?

There are potentially life-saving drugs that are so costly that it’s breaking the bank to pay for them. Sadly this isn’t about to happen, but if even moderately effective treatment for Alzheimer’s became available and it was a costly drug, imagine what would happen to our health care system because the numbers are so large.

You see it with the hepatitis C drug. Here’s a drug that actually cures a devastating disease. We should be dancing in the streets that we have this opportunity to cure hepatitis C, and yet, Medicaid programs in many states can’t afford to pay for it for all the people who need it. We’ve got to figure something out.

You were appointed by Obama. Which of the two Democrats running for president best understands these issues?

Well, Sanders misunderstood the role of FDA in terms of drug pricing because he said to Dr. Califf, “I don’t think that as FDA commissioner you’re doing enough to control the price of drugs” — which isn’t actually the mandate of the commissioner of the FDA.

FDA, sadly, is an agency that very few politicians love. One of the things that was challenging throughout my tenure was we didn’t have a lot of advocates on the Hill. Often, even the White House really was a little bit suspect about what FDA was and what was our value.

I want to underscore the importance of protecting the FDA from politicization. FDA frequently finds itself working at the interface of science, health care, public health, and politics. This can be precarious terrain, and I was determined to make sure that science and evidence were always our compass and our guide.

Like your parents, both physicians, you’ve been a trailblazer. Your mother was the first African-American woman to attend Vassar College and to earn a degree from the Yale University School of Medicine. Your Jewish father and grandmother taught you to fight discrimination and oppression. How much progress has been made in health and science?

I don’t think there’s any excuse for not having more diversity in medical school classes and in the medical workforce. The medical community should reflect the communities they serve, and I know it’s not a problem of having qualified people.

What happens where there is not sufficient diversity?

Women make terrific physicians and caregivers and terrific scientists and terrific leaders and administrators because I do think that women tend to work in a more collaborative way, are really not as interested in puffing up their chests and saying, “Look at me,” and, “How smart I am,” or, “How important I am,” but, “Let’s look at the problem and find a way to solve it.”

Was the presidential candidacy of Dr. Ben Carson, a surgeon and African-American, good for the public’s view of the medical profession?

[Laughs uproariously] I really don’t feel I can comment on that. But Ben Carson’s certainly made many contributions to the field of medicine.

Peggy Hamburg -- Health and Human Services
Chris Kleponis/AFP/Getty ImagesHamburg served as an assistant health secretary in the Clinton administration.

What are you most worried about right now in public health?

Something like Zika, an acute infectious disease, reminds us how connected we all are, about how important continuing investments and fundamental health programs are, because mosquito control was really allowed to deteriorate.

Then there’s the problem of opiates and heroin, which is not a new problem but is taking hold in ways today that are extremely frightening and challenging. Physicians don’t know enough about how to identify addiction and how to refer patients. So we really need to work on strengthening addiction treatment services.

Looking back, what are your biggest accomplishments?

I came on board at a time of low morale within the agency and decreased respect, appreciation, and support of the agency from outside. There had been a series of crises, congressional hearings, and harsh media stories. We were able to reenergize the agency. We opened ourselves up, engaged with stakeholders, and enhanced confidence. I refocused the agency on its mission as a science-driven, evidence-based regulatory agency with a public health mission, strengthening science but also enhancing opportunities for collaboration at various academic institutions.

Let’s talk about your son. I understand he’s one of a handful of undergraduates at Harvard who was hit by a mumps outbreak in recent weeks. What special advice did you give him given your background?

I got a call in the middle of the night — I was in South Africa — that he was being pulled from class and quarantined. He said to me, “Mom, do I really have to follow the quarantine?” It really was hard because he’s a kid that’s not terribly academic and much more of a party boy. But he actually wanted to go to class, and I was telling him you can’t go, that, “Yes, you really do have to follow the quarantine.”

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