Public health demands integrity, said Margaret Hamburg, MD, former commissioner of the US Food and Drug Administration (FDA), at the Centers for Disease Control and Prevention’s 65th Annual Epidemic Intelligence Service (EIS) Conference in Atlanta, Georgia.
Public health demands integrity, said Margaret Hamburg, MD, former commissioner of the US Food and Drug Administration (FDA), at the Centers for Disease Control and Prevention’s 65th Annual Epidemic Intelligence Service (EIS) Conference on May 5, 2016 in Atlanta, Georgia.
"The late Senator [Ted] Kennedy once said that integrity is the lifeblood of democracy. I think that’s true and I think it’s also the lifeblood of what we do in public health, what we must stand for and how we must act," she began. “For me, integrity is such an essential foundation for everything else: integrity of leadership, integrity of systems, integrity of science and data of course, and integrity of actions.”
Dr. Hamburg offered this advice to EIS officers and other public health professionals during her Alexander D. Langmuir Memorial Lecture, From Antibiotic Resistance to Zika: Reflections on Working at the Intersection of Science and Public Health Politics.
She has accomplished a lot at that intersection. During her six years as commissioner of the New York City Department of Health beginning in 1991, Dr. Hamburg improved services for women and children, helped stop HIV transmission with a needle-exchange program, brought tuberculosis (TB) under control, and started the first public health bioterrorism and preparedness program in the United States. She served as assistant secretary for planning and evaluation in the US Department of Health and Human Services and as the founding vice president for biological programs at the Nuclear Threat Initiative. As FDA commissioner from 2009 to 2015, Dr. Hamburg led efforts to regulate tobacco products, establish a prevention-based national food safety system, and updated the medical products evaluation and approval process.
"This is a time of great ferment and opportunity in this realm,” she said. “Few understand better than you the importance of data, how best to collect, analyze and act on it. Despite all the uncertainties in the world around us, one thing for sure is that your skills will be needed. Public health epidemiologists are being called on to address persistent and emerging challenges. You’ll be needed to study some of the most complex problems of our day," she noted.
When she became New York City health commissioner, Dr. Hamburg explained, the city had one of the highest TB case rates in the country, five times the national average and almost 18% of the country’s total cases. TB was considered a disease of poverty, so it was ignored.
"The rates of drug resistance were astoundingly high... Nearly half the patients previously treated for TB were resistant to one or more drugs and nearly one-third were resistant to isoniazid and rifampin. It was clear that the treatment regimens we were using were increasingly ineffective and in fact were likely making things worse.”
So Dr. Hamburg and her colleagues collected data, developed a comprehensive control strategy and were given the resources, the political backing from the mayor and other officials, and the publicity they needed, including the attention-grabbing New York Post headline, “Killer TB on Subways.”
"It took political and public health leadership, it took an integrated systems approach that engaged the homeless shelters and jails and prisons just as much as the city physicians, clinics and hospitals so that patients needing treatment didn’t fall through the cracks. And it took a blueprint for action that clearly defined priorities, goals and objectives and the specific responsibilities of the various players involved.”
In two years, the city's TB numbers dropped more quickly and dramatically than expected, and in five years, TB cases declined by about 46% overall and about 86% for resistant strains.
"The complacency and mistaken assumptions that led to the TB resurgence and the lessons we learned in developing and implementing a comprehensive treatment and control plan remain, for better or for worse, [are] just as relevant today as they were more than twenty years ago," Dr. Hamburg said, adding, "And now, after many years of working at the perilous intersection of science, medicine, public health and politics, particularly in New York City and then at the FDA, I’ve had a lot of opportunity to grapple with difficult problems."
"I quickly came to understand that the FDA is charged with an enormous... task: to promote and protect the health of the American people, and increasingly, people all over the world... It’s a science-based data-driven regulatory agency with a public health mission," she said. The FDA regulates important and often life-saving products -- human and animal drugs, vaccines, medical devices, the blood supply, cosmetics and dietary supplements, tobacco, and most of the country's food supply -- that account for between 20 and 25 cents of every consumer dollar in the United States.
"Reality demands flexibility but we must be honest about what needs to be done and address it based on data, not what is comfortable or politically desirable or opportune, and not what the loudest voice in the room demands.” The agency makes decisions based on the best available data-driven science, which can be difficult, considering political, stakeholder and other pressures, Dr. Hamburg explained, and violence prevention, sex education, reproductive health, HIV-AIDS, trans fats, sodium reduction, obesity and tobacco fueled the most powerful conflicting interests during her term at the FDA.
Public health professionals sometimes need to decide what to do even though they lack critical information, as with Ebola and Zika: Whether, when and how should they deliver drugs, vaccines, diagnostic tools, protective and other gear that are only in early development stages but desperately needed now? What advice should they give about pregnancy and risks of travel? How much of what kind of evidence, from what source, is enough? What level of uncertainty is acceptable?
Food-borne, product-related outbreaks force difficult choices: is recall timing too soon or too late? Is it too aggressive or not aggressive enough? “And on medical product evaluations at the FDA, we always felt pilloried between two extremes, two speeds of approval: too fast and too slow. We wanted too much data, or not enough. We accepted too much risk, or not enough.”
As for current pressure on the FDA to lower its regulatory standards and allow other forms of deregulation to speed innovation, Dr. Hamburg cautioned, "Rigorous science is not an obstacle to innovation. It’s the foundation for real innovation... If we rely on sloppy or inadequate science, we may get new products onto the market more quickly but we’ll have no idea whether they really work, whether their benefits truly outweigh their risks to patients, or whether they are better or worse than existing products. And frankly, in this era of cost constraints, who is going to want to pay for these products?"
Our culture rewards success, not failure, she acknowledged, so the results of negative studies are often not published or shared, even though they may lead to discoveries and breakthroughs. Solid, transparent, reproducible data are the goal, of course, but in areas of complicated or emerging science, replication failure may most likely involve the need to correct basic conditions and techniques, system or setting inconsistencies, study design or interpretation flaws — not fraud or falsehood, although they do occur.
"At [the] FDA, there are actually legal constraints that prevent information about why a product did not get approved. It can’t be made available without the express permission of the company, who often doesn’t want to do so.”
New technologies and ways of working with and sharing data should soon help verify earlier findings, reveal safety and other information, examine subgroups, and identify responders and those likely to have side effects, she predicted. Once issues of privacy and consent, tools, standards, analytics, agreements, data access and control, authorship, quality control and financial support are resolved, scientists will use predictive toxicology, biomarkers, innovative clinical trial design, bioinformatics, and other new scientific advances and technologies to better understand biology and the mechanisms of disease.
“The scientific process must underlie problem solving. Anecdote, wishful thinking and powerful personal and professional convictions cannot substitute... You may have to ask awkward questions, but . . . always use the best available scientific evidence to inform your actions... New analytic tools and approaches will expand your repertoire just as the dimensions of the problem before you will also grow in scope, complexity and likely urgency as well. You’ll be asked to work across disciplines, sectors, levels of government, and across borders. But whatever the setting and whatever the task, I trust that you will bring to it both the scientific rigor and the responsiveness that have long characterized the EIS, and that you will do it with integrity," Dr. Hamburg concluded.
The Langmuir Lecture, given at the EIS conference every year, honors Alexander D. Langmuir, MD, MPH, the CDC’s long-term chief epidemiologist who created its Epidemiology Program and established the Epidemic Intelligence Service (EIS) in 1951 at the then-called Communicable Disease Center.
Lorraine L. Janeczko, MPH, is a medical science writer who creates news, continuing medical education and feature content in a wide range of specialties for clinicians, researchers and other readers. She has completed a Master of Public Health degree through the Department of Epidemiology of the Johns Hopkins Bloomberg School of Public Health and a Dana Postdoctoral Fellowship in Preventive Public Health Ophthalmology from the Wilmer Eye Institute, the Johns Hopkins University School of Medicine and the Bloomberg School.
EIS 2016 Conference Program, p 103: Session N: Alexander D. Langmuir Memorial Lecture (Conference Program at http://www.cdc.gov/eis/downloads/eis-conference-2016.pdf)
Quotes: audio recording and print transcript