So if we agree that the untrammeled rise in antibiotic resistance is a bad thing — and given the unexpected World Health Day news that an incredibly resistant bacterium is in New Delhi’s water supply, I think many do agree — what do we do next?
How about charging everyone who buys an antibiotic a user fee?
That’s one of the surprisingly nervy proposals that surfaced Thursday during World Health Day, a refreshing change from the somber but predictable rhetoric put forward by the WHO and CDC. It comes from a comprehensive set of policy recommendations released Thursday by the Infectious Diseases Society of America in the journal Clinical Infectious Diseases and at a press event in Washington DC.
The direct language in the recommendations’ introduction indicates their tone:
The availability of effective antibiotics is not a ‘‘lifestyle’’ issue, and the lack of availability of these agents is not theoretical. Society worldwide is facing a public health crisis due to stagnation in the antibiotic drug pipeline combined with rapidly spreading, deadly antibiotic-resistant pathogens. The lack of effective antibiotics already is resulting in deaths and maiming of patients and the problem will only continue to worsen until Congress and the Administration act. The time for debate about the problem has passed. Immediate action is critically needed now.
The IDSA’s recommendations (which run to 37 pages) break down into eight key areas: economic incentives to improve drug development; changing regulation of drug development; improving coordination among federal agencies; improving surveillance; increasing conservation and education; investing in drug R&D; investing in rapid diagnostics; and dialing way back on agricultural antibiotic use.
A big proportion of the recommendations aims to stimulate, refocus and refund antibiotic development. Dr. James Hughes, the president of the IDSA and former director of the National Center for Infectious Diseases at the CDC, said that’s because drug development takes so long to produce results. “You could pretty rapidly improve surveillance and infection control, and put antibiotic stewardship programs in place in healthcare, if you had the resources,” he told me. “But the drug-pipeline problem needs to be addressed now, because it can’t be solved overnight. It takes 10 years to develop a new drug.”
The antibiotic user fee — technically, an “Antimicrobial Innovation and Conservation Fee” that would be charged to any wholesale purchaser, medical or agricultural — is one step toward fixing the resources problem. As proposed, 75 percent of every fee would go to funding drug development and 25 percent to funding “stewardship” programs, the industry name for programs that endeavor to keep the most useful antibiotics for the most serious infections.
At the DC event, Dr. Brad Spellberg, author of Rising Plague (about resistance and drug development), likened the fee to something you’d pay at the gate of a national park. “We need to think of antibiotics as a precious, limited resource, the way we think of forests and fisheries — something we protect and restore,” he said.
There are other funding mechanisms in the recommendations, with explicit dollars attached: $50 million for the CDC, $40 million for the FDA’s Center for Drug Evaluation and Research, $5 million for the Center for Veterinary Medicine to review antibiotics used in agriculture, and more. And there are blunt messages to Congress: Talk to the European Commission, strengthen the bioterror-focused Biomedical Advanced Development and Research Authority (BARDA), and hurry up and pass the GAIN and STAAR Acts (which will be reintroduced shortly, if the government doesn’t shut down), and PAMTA, which is already back in play.
There are specific steps under the other priorities as well: Require a stewardship program of any entity that gets Medicare/Medicaid money, including dialysis centers and outpatient clinics. Set up a true national surveillance system. Collect and publish accurate data on antibiotic use in human and veterinary medicine, including getting numbers from the businesses that mix antibiotics into animal feed. Realign the requirements for clinical trials for new antibiotics (for detailed exploration of this, see Dr. David Shlaes’ great blog The Perfect Storm.)
Overall the recommendations incorporate a commendable plainspoken urgency:
Seven decades of medical advances enabled by antibiotics are now seriously threatened by the convergence of relentlessly rising antibiotic resistance and the alarming and ongoing withdrawal of most major pharmaceutical companies from the antibiotic market. Without effective antibiotics, diverse fields of medicine will be severely hampered, including surgery, the care of premature infants, cancer chemotherapy, care of the critically ill, and transplantation medicine, all of which are feasible only in the context of effective antibiotic therapy. Our ability to respond to national security threats also is in serious jeopardy.
Update: Maggie Koerth-Baker tossed this fee idea up at BoingBoing.com, and her commenters have some interesting things to say about it.
- Antibiotic resistance: Scandinavia gets it
- Drug-Resistant Bacteria: To Humans From Farms via Food
- Farm antibiotics, human illness and what connects them. (It has …
- Running out of antibiotics — and other drugs too
- News break: FDA head promises “very serious scrutiny” of farm …
Image courtesy World Health Organization