Doctors make case for more drug spending

Drug-research advocates descended on Capitol Hill on Tuesday to kick off a campaign against microbial infections that kill 19,000 Americans a year and cost billions of dollars to treat.

The advocates are demanding that Congress and the White House create new incentives for drugmakers to develop antimicrobial drugs and simplify the regulatory approval process.

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Dr. Brad Spellberg, an infectious-diseases physician at UCLA, said during a briefing with Rep. Jim Matheson (D-Utah) that research into new antibiotics is dwindling just as drug-resistant microbes proliferate, creating a public health crisis. Antimicrobial resistance is adding 8 million days to hospital stays nationwide, he said, at a cost of $21 billion to $34 billion a year.

“These organisms are killing patients,” Spellberg said, “and we’re running out of drugs to deal with them.”

The briefing, organized by the Infectious Diseases Society of America (IDSA), was called to draw attention to the group’s “10 by 20” campaign, aimed at developing 10 new antibiotics by 2020. The group is working alongside Matheson, whose STAAR Act — Strategies to Address Antimicrobial Resistance — is one of five steps the group is pushing for.

“This is our opportunity to develop effective strategies and interventions,” Matheson said.

Matheson’s bill would:

• Reauthorize the Antimicrobial Resistance Task Force, establishing an advisory board of outside experts and an Antimicrobial Resistance Office reporting to the secretary of Health and Human Services. Its director would coordinate government efforts to combat antimicrobial resistance;

• Create an antimicrobial resistance strategic research plan, as well as establish the Antimicrobial Resistance Surveillance and Research Network;

• Collect data to allow government to better assess the antimicrobial resistance problem; and

• Establish demonstration projects to encourage more appropriate use of  existing antibiotics.

The bill authorizes $45 million over five years that would still need to be appropriated.

Matheson said that lawmakers have been working on the issue since at least the 103rd Congress but that he remains confident something can happen this year.

Matheson’s bill has three Democratic co-sponsors — Rep. Tammy Baldwin (Wis.), Del. Donna Christensen (Virgin Islands) and Rep. Gene Green (Texas). Matheson said he hopes the Senate will introduce a companion measure in the next couple of weeks; Sens. Sherrod Brown (D-Ohio) and Orrin Hatch (R-Utah) introduced it last Congress.

Twenty-six organizations have endorsed the bill, from the American Medical Association to the National Parent-Teacher Association.

But Robert Guidos, IDSA’s vice president for public policy and government relations, said the Matheson bill does not go far enough.

“It does not get at the pipeline problem,” he told The Hill, “which is why we think there’s a need to create incentives to draw pharmaceutical companies in this area.”

In addition to the STAAR Act, the IDSA wants to:

• Create new statutory incentives, assuring a clear regulatory pathway at the Food and Drug Administration (FDA), and potentially creating a new public-private partnership. Spellberg said unlike chronic-disease drugs, antibiotics are only given to patients for a few days before they’re cured and their use is actually discouraged so they can stay potent longer; that makes profit-seeking pharmaceutical companies unlikely to invest in such research.

 • Stop inappropriate uses of antibiotics for farm activities such as animal feed and routine disease prevention. A bill sponsored by Rep. Louise Slaughter (D-N.Y.) and Sen. Dianne Feinstein (D-Calif.) would address those concerns, Guidos said.

 • Promote good antibiotic stewardship practices in both human and veterinary clinical settings.

• Treat antibiotic resistance as a global health issue.

The group is also requesting more money, including an extra $36 million for FDA’s antibiotic resistance and antibacterial drug review programs and to support new regulatory science initiatives.

The group also wants funding increased to $500 million for antibacterial resistance and antibacterial drug discovery and development research funding at the National Institute of Allergy and Infectious Diseases within the National Institutes of Health. And it objects to the Obama administration’s proposed cut to the Antimicrobial Resistance program at the Centers for Disease Control and Prevention, instead favoring increasing this program to a total of $40 million.

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IDSA officials said they were encouraged that the White House was paying attention to the problem. They point out that President Barack Obama and the Swedish prime minister, acting on behalf of the European Union, created a Transatlantic Task Force last November to encourage global research and development of new antibiotics and to address antimicrobial resistance.

Obama also mentioned a new initiative focused on biodefense and infectious diseases during his State of the Union address, but details are still sparse.

 “We are launching a new initiative,” Obama said at the time, “that will give us the capacity to respond faster and more effectively to bio-terrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.”