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7/23/2004

Crisis Brewing Because of Meager Antimicrobial Pipeline, Group Says

Cheryl A. Thompson

Specialists in infectious diseases are asking federal policymakers to defend the country against a threat perhaps more real than bioterrorism: drug-resistant bacteria that kill.

The Infectious Diseases Society of America (IDSA) on Wednesday released Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates ... A Public Health Crisis Brews, a 40-page report (PDF) that asserts "the pharmaceutical pipeline for new antibiotics is drying up."

An inadequate pharmaceutical pipeline, the report says, adds to the problem of antimicrobial resistance "a frightening twist" that has received inadequate attention from federal policymakers.

Incentives are needed to stimulate the discovery and development of "new antibiotics to treat drug-resistant and other dangerous infections," according to the report.

Marianne Billeter, Pharm.D., BCPS, the clinical pharmacy specialist for infectious diseases at Ochsner Clinic Foundation in New Orleans, said she "absolutely" agrees with the overall thrust of the IDSA report.

"Most of the research in infectious diseases is geared towards HIV infection," she said. "Once you take that out, there's not a whole lot [of research] in just general bacterial infections."

Billeter is a member of IDSA and the immediate past chair of the ASHP Section of Clinical Specialists and Scientists.

"What this report says is very true, that the money just isn't there," she said, referring to the financial incentive for companies to invest in new antimicrobials.

Respiratory tract infections, she cited as an example, require antimicrobial treatment for 10 days or less. "But if you have high lipids, you go on the drugs for life. That's where the money is, basically," she said.

"We're definitely seeing increasing rates of methicillin-resistant Staph[ylococcus] aureus, or MRSA, coming out of the community," Billeter said. "We're probably running a 50-percent rate, if not more."

MRSA, she said, "is usually a bacteria that has always been associated with hospital infections, and now people are just walking into our clinic with it." Adults and children have shown up at Oschner with boils and other superficial skin infections filled with drug-resistant bacteria. "We're limited now to probably about four to five drugs to treat these [MRSA cases], two of which are available i.v. only," she said.

"We do not have a bad resistance problem within the hospital; however, the hospitals surrounding us do," Billeter said.

The hospital's efforts to stop the emergence of resistant strains—by strongly controlling the use of certain antimicrobial classes and discouraging use in the intensive care unit beyond 72 hours—have paid off, she said.

But as a referral center for the greater New Orleans area and beyond, she continued, the hospital ends up treating patients whose bacteria developed resistance elsewhere. Some of these treatments have involved older agents, such as colistin, a polymyxin, that were rarely used until recently because their toxicities are worse than the newer antimicrobials.

So many Oschner clinicians have had to resort to using colistin in their patients, Billeter said, that "it's almost like you need to reintroduce this drug as a new drug."

Colistin has been working well against antimicrobial-resistant gram-negative bacteria because the microbes have not previously encountered the old-time agent, she said.

Unless the federal government takes action soon, IDSA foresees a public health crisis arising from a lack of antimicrobials to treat "superbugs."

The organization, in its report, proposed many policy and administrative actions, including:

  • Establish a Commission to Prioritize Antimicrobial Discovery, which would decide where to provide legislative incentives and administrative solutions,
  • Create a "wild-card" type of patent extension that would enable a company to extend its patent protection on any drug in exchange for developing and receiving approval to market a priority antibiotic,
  • Provide tax incentives for the research and development of priority antibiotics, and
  • Give liability protections similar to those for companies that make childhood vaccines.

Update 26 July 2004—An IDSA spokeswoman said a copy of the report was delivered to every member of Congress and to officials at the Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.