Jesse Goodman: Taking on a "Slow Emergency"

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SEPTEMBER 21, 2016 — On September 21, for only the fourth time in its history, the United Nations General Assembly is conducting a high-level meeting to address a critical global health issue. The topic is antimicrobial resistance, described by Georgetown’s Jesse L. Goodman, MD, MPH, as a “slow emergency” and an alarming situation that first grabbed his attention two decades ago.

Earlier on in his career, Goodman got a good feel for effective ways to attack the increasing antimicrobial resistance that he saw developing nationally and at the University of Minnesota, a major transplant center where he was professor and chief of infectious diseases nearly 20 years ago.

“Along with increasing resistance of many organisms, we noticed very high use levels of some of our most powerful antibiotics,” he recalls. “Because of limitations of diagnostic tests, we often don’t know at first whether a patient has a resistant infection or not.

Spotting trouble

As a result, Goodman says physicians were appropriately using broad-spectrum antibiotics — powerful drugs typically active against multiple types of bacteria including those resistant to other antibiotics — as initial treatment for their extremely sick patients

“However, even after lab tests came back that showed that a less powerful drug could be used to treat most of the infections, patients’ treatment often wasn’t’ adjusted,” Goodman says.

Goodman points out that using a more powerful antibiotic than needed to treat a given infection helps select for resistant bacteria and can then lead to critically important antibiotics losing their effectiveness — a threat now growing throughout the world.

His concerns helped prompt an aggressive, but collaborative approach to the problem.

Antimicrobial stewardship

“We worked together across clinical disciplines, from medicine to pharmacy to hospitaladministration, with the goal of changing how antibiotics were being used.”

Among new approaches put in place was a requirement that, unless laboratory tests documented a need for selected important antibiotics, their use beyond the first 72 hours of treatment could not be continued without approval of an infectious diseases consultant.

This approach led to a decrease in both the use of targeted antibiotics and resistance, as well as cost savings, and without harming patients.

These types of measures are now commonly included as part of antimicrobial ‘stewardship’ programs, the adoption of best practices for using antibiotics in the most judicious ways possible to preserve their effectiveness.

A call for national action

Encouraged that such measures could be successful, and alarmed by increasing drug resistance of multiple infections globally, as well as the dwindling pipeline of new antibiotics needed to fight the increasingly resistant infections being seen, Goodman took his concerns to the federal level.

In 1998, with support from then FDA Commissioner Michael Friedman, for whom Goodman served as a senior advisor, and leadership at the US Centers for Disease Control and Prevention and the National Institutes of Health, the first US Interagency Task Force on antimicrobial resistance was formed, with Goodman as co-chair. The task force also included representatives from the Environmental Protection Agency, The US Department of Agriculture, the Department of Defense, the Veterans Administration, Agency for Healthcare Research and Quality and what is now the Centers for Medicare & Medicaid Services.

The team worked together for almost two years, hosting public meetings and creating the nation’s first Public Health Action Plan to Combat Antimicrobial Resistance that detailed a path forward and needed actions in four major areas: surveillance, prevention and control, research, and product development.  

From academia to government

Goodman joined the FDA full-time in 2001, becoming director of the Center for Biologics Evaluation and Research in 2003 and in 2009 was appointed FDA’s Chief Scientist and Deputy Commissioner for Science and Public Health. In that position, he led FDA’s 2009 H1N1 pandemic influenza response, serving as part of the Department of Health and Human Services’ senior leadership team.

Goodman worked closely with the White House both in the pandemic response and in subsequently redesigning both FDA and government-wide approaches, to, in collaboration with other sectors, developing the medical countermeasures (such as drugs, vaccines and diagnostics) needed to prepare for and respond to US and global public health threats and emergencies.

Pressing on

He supported extending these collaborative approaches to include antimicrobial resistance as part of our overall preparedness for outbreaks, an approach that is now being supported though the US government’s Combatting Antimicrobial Resistant Bacteria initiative.

“Many of the same challenges and principles apply to fighting antimicrobial resistance and to preparing for other outbreaks — the need to identify and fill in gaps in science, the lack of clear financial incentives to drive product development, and the need for support and collaboration across multiple sectors, disciplines and nations,” explains Goodman.

The problem of antimicrobial resistance has continued to grow but, fortunately, so has public awareness. In particular, Goodman notes that the global spread of so-called “superbugs” has galvanized the public as well as experts world-wide.  

Of particular concern have been bacteria called CRE (carbapenem resistant enterobacteriaceae) which are typically resistant to almost all available antibiotics, and recently, even to colistin, what had been the “antibiotic of last resort” for CRE.

While Goodman says he is very pleased that awareness is increasing, he is convinced that we “are now at a point where time is short and concerted effort, resources and action are critical.”

Thus, he sees the elevation of the issue to the UN General Assembly this week as particularly welcome.

Goodman joins Georgetown

To continue his work on emerging infectious diseases, including the emergence of “superbugs”, Goodman joined the Georgetown community in 2014.

“Working at Georgetown provides unique opportunities to reach out and partner across sectors and silos to develop needed policy and better prepare globally to rapidly develop, test and deploy countermeasures against both known and unknown infectious disease threats,” Goodman says.

To take on this challenge, he founded COMPASS (the Center on Medical Product Access, Safety and Stewardship) at Georgetown University Medical Center.

 COMPASS works to develop innovative solutions to promote the development, access and appropriate use of safe, sufficient, and effective medical products to address pressing US and global public health challenges.

National Capital Region Organized Against Resistance

Under the COMPASS umbrella, Goodman and Michala Koch, MA , COMPASS deputy director, have helped form a unique regional grassroots coalition of experts from 11 Washington, DC, Virginia and Maryland hospitals and health care facilities, including the four regional medical schools, called ROAR — the National Capital Region Organized Against Resistance .

 “We’re working together to combat resistance, on a day-to-day, on-the-ground level, Goodman says. “We actively share information about regional resistance trends, share and support best practices in antibiotic stewardship and infection control, and work together to address resistance as a health care safety issue that, like the drug resistant bacteria themselves, crosses institutional boundaries” he says.  ROAR addresses antibiotic resistance at its roots and as a prevention opportunity.

“The sometimes subtle selection and spread of highly resistant bacteria, particularly absent new treatments and approaches to prevention, threatens medical care that we take for granted every day, such as the ability to do surgery, organ transplants, and so on,” Goodman explains. “Without concerted action we also face the specter of highly resistant, even untreatable, infections not just in health care settings but in our communities, from sexually transmitted diseases like gonorrhea to extremely drug resistant TB.”

Other current COMPASS activities include using new approaches to mapping the global spread of CRE (carbapenem resistant enterobacteriaceae). “CRE, also a major focus of ROAR, are typically resistant to almost all available antibiotics, and recently, even to colistin, a relatively toxic antibiotic of last resort for CRE,” he says.

“No one can do this alone”

“COMPASS is also working closely with the DC Department of Health to enhance our understanding of and response to antibiotic resistance among healthcare facilities, including long term care, in the nation’s capital.”

In addition to these activities, Goodman was recently appointed to the inaugural scientific advisory board of the Coalition for Epidemic Preparedness Innovations , a new global partnership to support development of vaccines against emerging infectious diseases.  

“The bottom line is that in order to address these very complex problems — either on a local level or internationally— we need to bring people together,” Goodman says. “No one person or agency or institution can do it alone.”

From global and community health to individual patients

In the end, Goodman says it’s patients that teach him and help keep him grounded. 

He keeps a busy schedule as an attending physician at MedStar Georgetown University Hospital, the Washington DC VA Medical Center and the Walter Reed National Military Medical Center.

Goodman says, “Caring for patients, and helping teach others to become physicians, has always been a joy and privilege for me. And staying in touch with what patients and health care providers experience is critical to helping make sensible, effective policy. I cannot be a good doctor for my patients without understanding the community and how it affects them. But, conversely, I cannot help change the big picture without understanding peoples’ everyday experiences.”