Global Health Institute

Both there and at many other hospitals, physicians were, as is appropriate, using broad-spectrum antibiotics to treat extremely sick patients before a definitive diagnosis could be made. But even after lab tests returned showing that less powerful drugs could be used to treat many patients' infections, patients were often continued on the broader spectrum drugs. This increased the selection of antibiotic resistant organisms, fueling what he has called a “slow emergency” that could ultimately lead to ineffective antibiotics.

Goodman worked with his partners across clinical disciplines, including medicine, surgery, pharmacy, and hospital administration, to improve how antibiotics were being used. He saw that collaborative action to safely reduce the unnecessary use of broad-spectrum drugs could lead both to a decrease in resistance and cost savings. Among new systems and approaches put in place was the reassessment of antibiotic use and choice after 72 hours of treatment, based on both results of laboratory tests and the patient’s clinical status. Through this approach, which is now part of a widely used practice called “antibiotic time-outs,” as well as other steps to optimize antibiotic choice and use, the consumption of several of the most powerful antibiotics was reduced. The selection of bugs resistant to these drugs also slowed, a success of what is now called antimicrobial stewardship (AS). A program for AS is now required by the Centers for Medicare Services (CMS) for all U.S. healthcare facilities.

Taking on Antibiotic Resistance Nationally

Driven by a global increase in antibiotic resistance (AR) and a decreasing pipeline of new antibiotics needed to fight drug-resistant infections, Goodman sought to more broadly help raise awareness for the fight against AR. In 1998, he reached out to leaders at CDC, FDA, and NIH to propose developing a national task force and strategic plan to identify and implement the steps needed to combat AMR. He was invited to work as a senior advisor to the FDA and, with support and collaboration from FDA, CDC, and NIH leadership, formed the U.S. Task Force on Antimicrobial Resistance. Also included were representatives from the DOD, VA, CMS, Agency for Healthcare Research and Quality, and, to help address AMR in the environment and agriculture, the EPA and USDA.

The team worked together for almost two years, hosting public meetings and creating the “Public Health Action Plan to Combat AMR,” which detailed needed steps the government and other stakeholders could take to help address AMR. This plan included and tracked 84 recommended actions in four major areas: surveillance, prevention and control, research, and product development. It also helped lay the groundwork for the 2015 “National Action Plan for Combatting Antibiotic Resistant Bacteria.”

At the same time, Goodman was working with FDA colleagues on the contentious issue of how to address the use of antibiotics in food production. The agency produced the first framework to require consideration of the potential risks to human health from using important antibiotics in livestock production. In part as a result of this new framework, and because of increasing resistance seen in food borne infections, FDA stopped the preventive use of fluoroquinolone antibiotics in poultry production.

An Academic Platform to Take on Superbugs

From 2003 to 2009, Goodman directed the FDA’s Center for Biologics Evaluation and Research, and in 2009 he was named chief scientist and deputy commissioner of the agency. In that position, he led the FDA’s 2009 H1N1 pandemic response, serving as part of Health and Human Services’ senior leadership team while working closely with the White House in the response to the H1N1 pandemic. He played a major role in developing the U.S. Public Health Emergency Countermeasures Enterprise to improve how the government develops medical countermeasures (e.g. drugs, vaccines, and diagnostics) to prepare for and respond to future public health threats and emergencies, including the threat of bioterrorism. He also continued to advocate for including the fight against AMR as part of preparedness for emerging infectious diseases, in parallel to preparing for more typical acute public health emergencies, like flu pandemics, Ebola, or Zika. There are many common challenges shared between being prepared for outbreaks and addressing AMR—including the gaps in science, the lack of clear financial incentives to drive costly product development, and the need for collaboration across multiple sectors, disciplines, and nations.

The problem of AMR has continued to grow but, fortunately, so has public awareness. The spread of so-called “superbugs” has galvanized the public and public health agencies worldwide. Of particular concern have been organisms called carbapenem resistant enterobactericiaie (CRE), which are resistant to almost all antibiotics, and sometimes must be treated with colistin, a relatively toxic “antibiotic of last resort.” In a replay of fluroquinolone resistance being promoted by use of those drugs in poultry in the 1990s, colistin resistance has now emerged globally and appears to have been driven by agricultural use of colistin in certain parts of the world, particularly in Asia. While Goodman has been very pleased that awareness of antibiotic resistance is increasing, he says we “are now at a point where time is short and concerted effort and resources and action are critical.” Thus, the recent attention to AMR by global leaders, including in the U.N. General Assembly, is particularly welcomed.

To help continue his work on emerging infectious diseases, including the emergence of resistant “superbugs,” Goodman joined the faculty of Georgetown University in 2014. He felt that working at and from the university would provide a terrific opportunity to partner across sectors to better prepare and, when necessary, rapidly develop, test, and deploy countermeasures against emerging infectious disease threats, including resistant organisms.

To take on this challenge, Goodman founded Georgetown's Center on Medical Product Access, Safety and Stewardship (COMPASS). COMPASS works across disciplines to develop innovative solutions for the United States and global access to safe, sufficient, and effective medical products that address the world’s pressing public health challenges.

“No One Can Do It Alone”

Under the COMPASS umbrella, Goodman and Michala Koch, M.A., COMPASS deputy director, host and support the National Capital Region Organized Against Resistance (ROAR). ROAR is a grassroots group of experts from 11 hospitals and healthcare facilities in the District of Columbia, Virginia, and Maryland, including the four regional medical schools. “We actively share information about AMR trends, promote best practices in the use of antibiotics, and work together to address resistance as a health care safety issue that crosses institutional boundaries,” said Goodman.

Whereas COMPASS may often focus on preparing for dramatic, rapidly emerging outbreaks and crises globally, the ROAR partnership helps address AMR from the ground up, as a slowly emerging problem. “The relatively long-term process of generating and spreading highly resistant bacteria threatens medical care as we know it, such as the ability to do surgery, organ transplants, and so on.”

Other COMPASS activities include using new approaches to tracking and mapping the spread of CRE and colistin resistance worldwide. COMPASS and ROAR also work closely with the District of Columbia's Department of Health to enhance understanding of and response to AMR in the nation’s capital and help long-term care facilities address infection control and antibiotic stewardship challenges. In addition, Goodman was a member of the World Health Organization’s Ebola Vaccine Working Group and served on the inaugural Scientific Advisory Board of the Coalition on Epidemic and Pandemic Innovation, a new global partnership to develop vaccines against emerging infectious diseases. Goodman also serves as an attending infectious disease consultant physician at MedStar Georgetown University Hospital, the D.C. V.A. Medical Center, and the Walter Reed National Military Medical Center.

“The bottom line is that in order to address these complex problems, either on a local level or internationally, we need to bring people together,” said Goodman. “No one person, discipline, agency, or institution can do it alone.” Despite all the challenges to public health domestically and internationally, he is optimistic. “The attention and interest being given to emerging infectious diseases and to AMR, from the highest levels of global leadership to health care and public health practitioners, students, and the general public, is unprecedented in my 30-plus-year medical career, as are the scientific and societal opportunities to prepare for and address these threats.”