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Congress Faces Resistance of a Different Sort
June 14, 2010
House Energy and Commerce Committee Chair Henry Waxman (D-CA) and his staff are worried about something, and it’s not politics. The Energy and Commerce Subcommittee on Health is holding a series of hearings on antimicrobial resistance. Waxman’s staff is notorious for their hard-hitting investigatory work on behalf of the Congressman’s former committee of jurisdiction, the House Oversight and Government Reform Committee. Maybe the bugs should start to worry. As in drug-resistant bugs.
Working with Health Subcommittee Chair Frank Pallone, the committee staff has organized three hearings on AMR, the second of which was held last week before a full hearing room. (I wrote about the first hearing here.) So far, the hearings have focused exclusively on antimicrobial resistance (commonly referred to as AMR), and the most visible ways that AMR is manifested in the U.S., including MRSA (Methicillin-resistant Staphylococcus aureus) and Acinetobacter baumannii (sometimes called “Iraqibacter” because soldiers increasingly are sent home with resistant infections of this bug.) While this political attention is encouraging, it must extend to drug resistance across all infectious diseases and move beyond a U.S. focus.
Most of the committee members at last week’s hearing seemed genuinely concerned about the two issues on the agenda: the poor pipeline for new antibiotics, and overuse and misuse of currently available antibiotics. A stream of public and private sector witnesses did not shy from using words such as “crisis” to describe the drug pipeline. During her testimony, Janet Woodcock, who is responsible for new drug approvals at the FDA, said, “The pipeline is diminished when the need could not be greater.”
It is not yet clear what kind of bill the subcommittee might try to get through Congress, or even if it will try, before the end of the current session. Congressional Quarterly recently reported on Pallone’s plans. “It’s clear that action is needed,” Pallone said after the hearing. But “the problem is we need to know what to act on.” Pallone offered no timetable for when a decision would be made, or any guarantees that legislation would be moved this year.
In the spirit of support for the efforts of the subcommittee, I offer some thoughts about what to include in new legislation. Some of these steps don’t require any new money– which should be a plus in the current environment!
Encourage USG agencies to address drug resistance globally. Antimicrobial resistance is clearly a global issue, with huge increases in drug use occurring in emerging and developing countries–including many of the same drugs relied on in the U.S. and Europe. A stronger awareness of drug resistance is needed in developing parts of the world to reduce the inappropriate use of medicines that speeds resistance. Through existing programs at CDC and NIH, the U.S. is a world leader in disease detection and infectious disease research. We need to build on what we’re doing with greater emphasis on drug resistance surveillance–not just disease surveillance, basic science research into resistance mechanisms, and incentives for resistance-specific technology–not just new drugs.
USAID is also a global leader in building capacity in developing countries for monitoring and improving drug quality and appropriate use of medicines, but its important role in supporting global work through WHO and other partners has been hobbled by inadequate funding. USAID’s line item funding for antimicrobial resistance was zeroed out in recent years. It needs and deserves a shot in the arm with the green medicine.
Beyond enhancing existing programs, Congress could incorporate language into the Strategies to Address Antimicrobial Resistance Act (STAAR) Act introduced by Congressman Matheson and others, or into new legislation, recognizing the global nature of drug resistance and the need for greater coordination to fight it. Congress should also appropriate funding to the EU-US Task Force on Antimicrobial Resistance and give it some useful tasks, such as producing a credible picture of drug resistance worldwide. It may seem like a small thing, but a step toward global awareness has already been achieved with a common Antimicrobial Awareness Day in the U.S. and EU on November 18 for the first time this year (actually, in the U.S. it’s an entire week.) Next goal: make it global.
Leverage U.S. donor funds to improve drug quality and resistance monitoring. Congress could also get tough in its role as a global health donor. Through Pepfar, the President’s Malaria Initiative, and contributions to the Global Fund to Fight HIV/AIDS, TB, and Malaria, the U.S. is purchasing drugs by the semi-trailer to distribute in poor countries. Congress should require that all drugs procured with U.S. taxpayer funds be monitored for quality throughout the entire supply chain, not just at the point of manufacture, thereby reducing opportunities for resistance to emerge. Drug producers that demonstrate greater responsibility for the quality of their products should be recognized and rewarded. This is among the recommendations made in a new report from CGD to be released on Tuesday at the National Press Club.
My final thought for Congressmen Waxman, Pallone and their colleagues on Capitol Hill: don’t wait for new drugs to solve the antimicrobial resistance problem. Prioritize the steps that can prolong the usefulness of drugs we already have, and reduce drug use where it’s not needed.
2 Responses to “Congress Faces Resistance of a Different Sort”
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June 14th, 2010 at 10:12 pm
Thanks for the timely post. This week also brought news of
VRE (Vancomycin-resistant Enterococcus) isolates resistant to daptomycin and linezolid-resistant MRSA in June 8 JAMA.
I’ve cared for patients this week with MRSA, VRE, and ESBL gram-negative rods resistant to almost every antibiotic.
Many factors fuel the rise in resistant organisms. Some that are not often addressed include inadequate education (e.g. that asymptomatic Foley catheter related cultures should not be treated);
fear of peer review or legal liability for not treating a culture;
the demands of family or religious groups that “everything be done” even when the patient is clearly terminal and the treatment is futile—and where the treatment of one such patient puts many others at unnecessary risk.
As an Infectious Disease physician who has been involved in clinical research for new antibiotics as well as patient care, I would urge that these issues also be considered as part of a broader analysis to this critical issue.
Judy Stone, MD
Author, “Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators”
http://www.conductingclinicalresearch.com
June 23rd, 2010 at 4:10 pm
Growing drug resistance of some of the world’s most life-threatening bacteria underscores the power of vaccines as a global health tool, forcing us to lean even more on vaccines to do the critical job of preventing infections before they start. In the case of Streptococcus pneumoniae (pneumococcus), increasing resistance of some strains to penicillin and other antibiotics is particularly worrisome in the developing world where the majority of pneumococcal deaths occur and where access to healthcare is often limited. Each year, more than 800,000 children under the age of five die due to pneumococcal disease, mostly in low-resource countries. These deaths could be largely prevented through the use of vaccines, yet natural market forces often fail to catalyze the availability of vaccines in low-income settings. This lack of access has prompted groups such as the GAVI Alliance to step in to help accelerate the introduction of current pneumococcal vaccines in countries where the need is greatest.
The ‘race against drug resistance’ accentuates the need to remain vigilant in our efforts to facilitate global access to existing vaccines, and to develop novel vaccine technologies that low-income populations can sustainably afford without assistance. Several novel vaccine technologies against pneumococcal disease under development today could provide inherently affordable options for poorer populations?including conjugate vaccines that provide targeted coverage against strains prevalent in the developing world and protein-based vaccines that offer broad protection across virtually all of the numerous pneumococcal strains. As part of a comprehensive global health strategy against pneumococcal disease that combines treatment and prevention strategies, existing vaccines and the development of new ones could help save millions of lives, even in the face of drug resistance.
For information about PATH’s pneumococcal vaccine development work, please visit: http://www.path.org/projects/p.....roject.php.