Tuesday, October 18, 2011

Event Spotlight: CHI Co-Hosts Congressional Briefing on Infection Prevention

On Oct. 12, CHI and MassBio co-hosted a congressional briefing in Washington D.C. titled, “Infection Control: Detection, Prevention, and Treatment.” Participants were joined by Reps. Jackie Speier (D-CA) and Edward Markey (D-MA). The partnership was hailed as a powerful combination of two of the most significant state powers in the biotech industry. As a father of a child suffering from cystic fibrosis, MassBio President and CEO Bob Coughlin said passionately, “I don’t care if [cystic fibrosis] is cured in California or Massachusetts. All boats rise.”

Coughlin and CHI President and CEO, David L. Gollaher, Ph.D, made opening remarks and introduced Reps. Speier and Markey, who each made their own comments. Next, a panel of experts provided educational presentations on challenges and advances in combating healthcare-associated infections (HAIs). The program, held in the Gold Room of the Rayburn House Office Building, attracted more than 50 congressional staffers, patient advocates, and industry representatives.

Speakers outlined the scope and effect of HAIs. Estimates show that HAIs take the lives of 100,000 patients a year – patients who enter healthcare facilities in good health, or without such infections yet die from exposure in healthcare settings. As Speier noted, “That’s the equivalent of 333 [Boeing] 747 airplanes crashing every year.” This makes HAIs the 10th leading cause of death, and the No. 1 cause of death in non-cardiac intensive care units. In the U.S. alone, antibiotic-resistant infections are responsible for $20 billion in excess healthcare costs, $35 billion in societal costs and $8 million in additional hospital days.

Despite these numbers, HAIs remain a dangerously under-recognized threat. Continuing her airplane metaphor, Speier said, “If that many planes were crashing every year, we’d expect the FAA to do something about it.” Dr. Arnold Huang, Ph.D., of Thermo Fisher Scientific, later polled the audience to demonstrate the high degree of recognition of October as breast cancer awareness month. He juxtaposed those numbers with the audience’s lack of knowledge about sepsis – a condition that causes four to five times as many deaths each year.

Despite the high death rate and the continued appearance of new strains of antibiotic-resistant bacterium (such as MRSA), the number of new antibiotics in the development pipeline has been shrinking during the past several decades. Rick Winningham, CEO of Theravance, described the trends that have led to diminished approvals of new antibiotics. Overall, “antibiotic drug development is dying,” he said. He attributed this to market dynamics which have led large pharmaceutical firms to exit the market entirely, leaving small firms to overcome tremendous obstacles. These dynamics include: decreases in expected returns on investment; rising costs of clinical trials and the number of required patients; and regulatory challenges and delays from the FDA. Winningham laid responsibility for these on both Congress – for having taken the FDA to task over past high-profile safety issues – and industry itself, for problems in effectively pricing previous products.

Speakers ended the day by noting the promising introduction of the Generating Antibiotic Incentives Now Act (GAIN), and giving a call to action. The GAIN Act would give developers of select antibiotic products five or more years of additional data exclusivity and provide for priority review of their products by the FDA among other provisions. Despite this positive development, participants like Kathy Warye of Becton Dickinson stressed a fundamental challenge to inspiring advocacy to address HAIs: Because they strike and kill patients relatively quickly and are not long-term chronic diseases, it’s impossible to put a face on the problem in the way that advocates for other diseases and conditions have succeeded in doing. Further, the public fails to relate deaths from these sorts of HAIs to our lack of effective antibiotics. As Winningham said, “Leadership has to drive this change.”

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