As the pandemic continues to rage, new vaccines are making their way to the public in record time. But epidemiologist Diana Zuckerman remains cautious about how well the Food and Drug Administration is performing.
The Pfizer/BioNTech COVID-19 vaccine, authorized for emergency use by the FDA on December 11, is “probably quite effective, and probably quite safe in the short term,” she says. But she offers a caveat: “The trials have been going on for two months or less, way too short a time to know how lasting the vaccine will be … If we want to know for sure how long it lasts, and we don’t want to find out the hard way by people thinking they’re protected, and they’re not, then the FDA must ensure that clinical trials continue.”
But beyond COVID vaccines, Zuckerman has also long sought more systemic change at the FDA. She hopes to convince the Biden team to choose a new FDA head with the right credentials. She was not willing to disclose her preferred candidates, but she did say that former FDA Commissioner Dr. David Kessler and FDA Deputy Commissioner Dr. Joshua Sharfstein both performed well at the agency. It’s not enough to be a “terrific doctor” or a “wonderful researcher,” she says. An FDA head must understand how the agency works, preferably with prior experience at the agency or a background running an equally “huge, complex” agency. Most importantly, a new leader must have “a public health focus,” she adds. And preferably, the best candidate would not have ties to any industry that the FDA regulates.
Largely unsupported by progressive groups
Zuckerman, who got her training in epidemiology at Yale Medical School, has often been in the news this year as reporters covered the race to develop a COVID-19 vaccine and effective new treatments for the coronavirus. The education she’s provided in recent months about the limitations of clinical trials and increasing pressures on the FDA to prioritize speed over safety is the same advice she’s been providing for the past 21 years through her small nonprofit, the National Center for Health Research.
Nevertheless, she and her work have been largely unsupported in the larger world of progressive nonprofits. To be sure, a few nonprofits have also fought for safer drugs and medical devices, among them, Public Citizen, Consumers Union and the National Consumers League. But FDA oversight and reform have never been major progressive priorities in the same way other issues have, according to Zuckerman.
That’s made it difficult to effect systemic reform at the FDA, Zuckerman says: “Nothing frustrates me more than when I reach out to another progressive nonprofit, even ones that … understand the importance of the FDA. And I say, ‘There's this important FDA meeting coming up … Is anybody from your organization going to be speaking during the public comment period?’ And they'll say, ‘No, we just don't have the bandwidth to do it.’” In reality, Zuckerman insists, while FDA policies may seem “esoteric,” what the agency does “affects our lives every day, in ways large and small, that are invisible to most of us.”
Without a critical mass of public attention and grassroots support, it’s been difficult to oppose well-funded and largely successful efforts by drug and device companies to gain congressional approval of laws that weaken FDA regulation of their products, she says. Progressive support would be especially helpful because so many grassroots patient groups are funded by PhRMA. That doesn’t mean that these groups are accepting money to support a corporate agenda, she adds. Rather, these groups often lack medical or scientific staff and rely on the information the companies offer, she says: “They don’t have the expertise to question it.”
Zuckerman’s group takes no money from drug and device makers or from any groups “that have a vested interest in anything we evaluate.” Foundations have not filled the vacuum left by its strict donor policies. Raising money has been “very challenging,” she says.
She recalls that the Robert Wood Johnson Foundation once gave them seed money for a project, with the promise of more funds in the future. But the program officer they were working with left the foundation, Zuckerman says, and the larger grant fell through.
There have been several other times when a foundation “liked us” and asked the National Center for Health Research to assess a program it was currently funding, but seemed to be displeased when informed that the program was ineffective and a waste of money. “Maybe we were too honest,” she concedes. That assessment would end the relationship.
Don’t fit easily into foundation portfolios
Nor is the National Center for Health Research easy to fit into a foundation’s issue portfolio. “Think tanks don't usually help individuals, and support groups that help individuals don't usually work as watchdogs,” Zuckerman observes.
“What's unique about us is that we do all of these things. We help individuals. We work on a systemic level with FDA and other federal agencies. And we work with Congress and we provide information directly to the public on the website,” Zuckerman says.
What’s helped the nonprofit survive are a couple of factors. Funders for whom the National Center for Health Research was a “good fit” have become steady and reliable supporters. One major source of support has been the Patient-Centered Outcomes Research Institute, a nonprofit created by the Affordable Care Act and now funded by the federal government, supported in part by fees on health insurers.
And Zuckerman has always been able to attract bright young scientists with graduate degrees in public health, including new physicians, to be senior fellows on the staff. They were willing to earn $50,000 a year, she says, even though their skills could have commanded far higher salaries.
Zuckerman didn’t create a nonprofit out of a great passion to be her own boss. “That entrepreneurial spirit, I never had that,” she says. “I always would much prefer reading articles about research findings than talking to somebody.”
She’d worked as a staffer in the House and Senate, doing oversight of FDA and other agencies, and spent some time at the Department of Health and Human Services and as senior policy advisor in the Clinton White House. Neither HHS nor working at the White House proved as rewarding as working on Capitol Hill, she recalls. But by 1999, there were few options for congressional work “that could be effective and influential,” she says. “I started the center to do the kind of watchdog work I’d done in Congress in a nonpartisan way that would be taken seriously by scientists and people who respected scientists.”
That’s what prompted her decision to start the National Center for Health Research. Over the past 21 years, Zuckerman has consistently alerted consumers and doctors to the dangers of medical devices, many of which do not undergo rigorous evaluation before FDA approval, even if their failure could cause serious harm.
She’s been an outspoken critic of breast implants, and recently pushed the FDA to release stricter guidelines about their use. Certain types of implants have been linked to cancer.
She understands why progressives shy away from these issues, which seem remote from other urgent concerns like poverty, access to healthcare and racial justice.
FDA policies have huge impacts
But she contends that FDA policies “have a huge impact on the cost of medical products.” For example, when her center looked at new cancer drugs, it found that 17 out of 18 drugs that were not proven to extend life also failed to demonstrate they even improved quality of life. Worse, they cost just as much as effective drugs.
Likewise, racial disparities in healthcare have been considered a problem of access, but Zuckerman says that the problem is bigger than that. It concerns how companies choose subjects for the clinical trials for their new drugs. The science shows that Black women do not get breast cancer as often as white women, but they die of breast cancer more often, she says. Because women of color were not included in clinical trials testing new cancer drugs, companies failed to recognize Black women’s increased susceptibility to a certain type of aggressive breast cancer and failed to develop drugs to treat them.
Similar problems have resulted in inadequate treatment for high blood pressure in Black men, she says, as certain “very popular” blood pressure medications didn’t work on Black men. So if you have an agency that doesn't require diversity in clinical trials, you're going to have a country with health disparities. That lack of diversity, she adds, “can be fatal” to people of color.
She hopes that the pandemic might increase public and political support for change. There “may be a possibility of undoing some of the damage” of lax approval of drugs and devices at the agency and “even improving some things,” she says.
