News break: House hearing Wednesday on the antibiotic pipeline

The Subcommittee on Health of the Energy and Commerce Committee of the House of Representatives has announced a hearing for Wednesday: "Promoting the Development of Antibiotics and Ensuring Judicious Use in Humans."

The witness line-up is:

  • Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, Food and Drug Administration
  • Robin Robinson, Ph.D., Director, Biomedical Advanced Research and Development Authority, Department of Health and Human Services
  • Brad Spellberg, M.D., F.I.D.S.A., Associate Professor of Medicine, David Geffen School of Medicine at UCLA and Member, Infectious Diseases Society of America Antimicrobial Availability Task Force
  • Sandra Fryhofer, M.D., Council on Science and Public Health, American Medical Association
  • John S. Bradley, M.D., American Academy of Pediatrics, Chief, Division of Infectious Diseases, Department of Pediatrics, University of California, San Diego, School of Medicine, Clinical Director, Division of Infectious Diseases, Rady Children's Hospital
  • Barry Eisenstein, M.D., F.A.C.P., F.I.D.S.A., Senior Vice President, Scientific Affairs, Cubist Pharmaceuticals
  • Jeffrey Levi, Ph.D., Executive Director, Trust for America's Health

This is the second hearing the Health Subcommittee has had this spring, apparently at the prompting of the chairman of Energy and Commerce, Rep. Henry Waxman, who made the opening statement at the first such hearing in April:

We need to debate the health care bill and review its implementation. But we ought to be able to chew gum and walk at the same time. Because it is not going to make much difference if you have health insurance or not if you are going to die from something that could have been prevented from an antibiotic. And we are seeing more and more antibiotic resistance. (Transcript)

Reading between the lines, I'm going to guess this hearing will lean heavily on the IDSA's campaign to improve market conditions for pharma companies in order to revive antibiotic development (an issue I discussed recently at the old Superbug -- we're working on getting the archives moved over).


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...or at least, I was mentioned in Cell. Currently, we have very few new antibiotics in the pipeline, particularly for Gram-negative bacteria such as Acinetobacter. One of the things I'm involved with is a project to develop a not-for-profit screening library to find new antibiotics. From Cell:…

If you're going to plow taxpayer $$ into something, why not vaccines for bacterial diseases?
Syntiron will be commercializing their MRSA vax shortly. Much cheaper in the long run than developing novel antibiotics.

Not that I will argue with the significance of getting antibiotics out of the food supply, but in some ways I think we're a day late and a dollar short on that point. Still a good idea, of course, but enforcing it would be challenging, given that it's difficult to keep known nasty additives (e.g. melamine) out of the food supply.

This is one of the very few questions where a good answer could be "Increase the patent lifetime". It's applicable to both parts of the "Promoting the Development of Antibiotics and Ensuring Judicious Use in Humans." hearing. Over marketing of an antibiotic to people (and livestock, hope they discuss that too) accelerates the rise of bacterial resistance, but if the antibiotic loses protection after ~10 years on the market, a company is financially better off overselling it from the start and betting resistance won't be an issue until it has gone generic. The longer the monopoly, the longer a company has a reason to maintain its drugs' effectiveness.

Syntiron is local to me, I need to check them out. But I'm skeptical of the proposal for vaccines (which is covered, a bit, in the last few pages of Superbug the book). Right now, and until one makes it through the pipeline, a MRSA or staph vaccine is a science question. But once it does reach market, whether it gets uptake becomes a cultural question â and in a society that is increasingly turning away from vaccines, that Q. is a lot harder to answer. It *might* be that a staph vaccine could be given to, say, people about to go into surgery, or women about to deliver; whether that would be enough of a market to justify the investment is a separate Q. But a vaccine that would be broadly distributed through the population? At this point, I reluctantly have to say I can't see it.

Antimicrobial resistance is a hot topic on the Hill right now. and and we heard testimony from numerous stakeholders in the issue. The hearing concluded with three main recurring points: the FDA must be more flexible in the novel antimicrobial approval process, pharmaceutical companies need more incentive to get back into the antimicrobial development business, and health professionals need to employ more judicious use of antimicrobials. The next hearing on this topic involves use in animal agriculture. I REALLY hope that Iâm still here for that discussion because this is an issue that can have a very large impact on the veterinary profession. There are a couple of bills out there now that could really restrict antibiotic usage as we know it in veterinary medicine, namely the Preservation of Antibiotics for Medical Treatment Act (S.619/H.R. 1549) and Strategies to Address Antimicrobial Resistance Act (H.R. 2400). The AVMA opposes both of these bills largely due to the broad brush approach used in the absence of sound scientific recommendations. These bills, if passed, have the potential to carry some hefty unintended consequences for our veterinary profession and highlight the need to make our voices heard.

And who is this "we"? :-)
I think I need to push back on your description of PAMTA, Zardoz86. You make it sound like veterinarians would be negatively affected. But PAMTA requires that agricultural antibiotics be administered under the supervision of a veterinarian, not OTC as they are now. To me, that sounds like a jobs bill for vets.
It's also worth noting that, while the American Veterinary Medical Association opposes the bill, the Association of State Public Health Veterinarians supports it.

I got this letter today from Senator Durbin
Thank you for contacting me to express your opposition to the nontherapeutic use of antibiotics in animal production.

I understand your concerns about the nontherapeutic use of antibiotics in animals. For the past six decades, antibiotics have proven to be highly effective in combating bacterial infections in humans. In addition to their use in humans, antibiotics, also known as antimicrobials, are used for therapeutic and nontherapeutic purposes in animals. The nontherapeutic uses in animals include administering antimicrobial drugs in the absence of disease for purposes such as growth promotion, feed efficiency, or routine disease prevention. Livestock producers often use antimicrobials for these purposes, adding antibiotics to the feed or water of healthy animals, including cows, poultry, and pigs.

Scientists and consumers have expressed concern about the nontherapeutic use of antibiotics in animals. Recent studies have suggested that these practices have the potential to decrease the effectiveness of antibiotics in fighting bacterial infections in humans. Many of the antibiotics used nontherapeutically in animals closely resemble antibiotics that are frequently used as the last line of defense against harmful pathogens in human medicine, including such familiar antibiotics as penicillin and bacitracin.

The Preservation of Antibiotics for Human Treatment Act (S. 619) would phase out the nontherapeutic use of antibiotics in livestock by requiring the Food and Drug Administration (FDA) to deny applications for new animal antibiotics unless a manufacturer can prove that the use poses no threat to human health. This bill has been referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee. I am not a member of this committee, but I will keep your views in mind in case this issue comes to the Senate floor.

Thank you again for contacting me. Please feel free to keep in touch.


Richard J. Durbin
United States Senator

I understand antibiotics used with farm animals is same as prescribed to humans.

By henry buehler (not verified) on 24 Jun 2010 #permalink