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Congress should act soon to introduce and enact legislation to spur the development of new medicines and diagnostics to treat infectious diseases, particularly new antibiotics that target drug-resistant infections. That was the key message of the Infectious Diseases Society of America (IDSA) in testimony presented before a unique joint hearing of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) and the Senate Judiciary Committee.
Leaders from both Senate committees are working together to develop novel federal legislation commonly called Bioshield II intended to spur the development of treatments, preventatives, and diagnostics related to bioterrorism preparedness and response. The new legislation would build on The Project Bioshield Act (Bioshield I), which was signed into law July 21, 2004, the same day that IDSA issued a major report, Bad Bugs, No Drugs: As Antibiotic Discover Stagnates A Public Health Crisis Brews.
Through testimony, IDSA hopes to convince Senate leaders to extend the scope of Bioshield II beyond bioterrorism to remove financial disincentives in all areas of infectious diseases research and development, particularly for antibiotics to treat drug-resistant infections.
There is an inextricably linked, synergistic relationship between research and development efforts needed to protect against both naturally occurring infections and bioterrorism agents, said John G. Bartlett, MD, chief of the division of infectious diseases at the Johns Hopkins University School of Medicine and chair of IDSAs Task Force on Antimicrobial Availability. As such, we believe this approach makes perfect sense.
Worldwide, 15 million deaths are caused by infectious diseases each year, making infectious diseases the second leading cause of death and the leading cause of premature death and disability. ID physicians are seriously concerned about the need for new drugs, vaccines, and diagnostics to protect their patients against naturally occurring infections, including HIV/AIDS, tuberculosis, malaria, severe acute respiratory syndrome (SARS), and pandemic influenza.
Infectious diseases physicians also have become increasingly alarmed about the rise in drug-resistant bacterial infections and the simultaneous decline in the development of new antibiotics. About 2 million people acquire bacterial infections, such as methicillin-resistant Staphylococcus aureus (MRSA), in U.S. hospitals each year, and 90,000 die as a result. About 70 percent of those infections are resistant to at least one drug. Surprisingly, a recent analysis found only five new antibiotics in the R&D pipeline out of more than 506 drugs in development. Since 1998, only 10 new antibiotics have been approved, and only two of those are truly novel -- i.e., defined as having a new target of action, with no cross-resistance with other antibiotics. In 2002, among 89 new medicines emerging on the market, none was an antibiotic. This problem is further highlighted in IDSAs Bad Bugs, No Drugs report.
Infectious diseases and HIV physicians on the frontline of patient care see patients every day who face lengthy hospitalizations, painful courses of treatment, and death because of drug-resistant and other emerging and re-emerging infections. We desperately need new weapons to protect our patients. Major pharmaceutical companies are losing interest in the anti-infectives market because most infectious diseases drugs simply are not as profitable as drugs in many other areas of medicine, including those used to treat chronic, long-term conditions and lifestyle issues, Bartlett said.
Market forces alone will not solve the brewing crisis in infectious diseases medicine--thats why we need innovative public policy initiatives such as those that the Senate HELP and Judiciary committees are now contemplating, said Bartlett.
IDSAs testimony and the full Bad Bugs, No Drugs report are available on the Societys website at www.idsociety.org/badbugsnodrugs.