ALEXANDRIA, Va. -- Infectious diseases experts are applauding the introduction of the "Project Bioshield II Act of 2005," a bill that is designed to better protect the nation against the growing threats of antibiotic-resistant infections and pandemic influenza, as well as bioterrorism and emerging infections.
The bill has the enthusiastic support of the Infectious Diseases Society of America (IDSA), representing some 8,000 infectious diseases physicians, researchers, and other health care professionals.
"Reports of antibiotic-resistant infections have been steadily growing in the scientific literature and at local public health agencies, while the pipeline of new antibiotics has been drying up," says IDSA president Walter E. Stamm, MD. IDSA has documented the problem in a report published last July called “Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates, a Public Health Crisis Brews.”
Recent research shows local communities reporting a significant rise in methicillin-resistant Staphylococcus aureus (MRSA) and other drug-resistant infections among people with no known risk factors, such as healthy children, athletes, and military recruits. In addition, 2 million hospital-acquired bacterial infections result in 90,000 deaths each year in the United States; approximately 70 percent are resistant to at least one antibiotic.
While antibiotic resistance has been increasing, the number of new antibiotics approved to fight these infections has been declining steadily over the last two decades. Several major pharmaceutical companies have abandoned antibiotic research and development altogether in favor of more profitable drugs for chronic conditions like heart disease and arthritis.
Concerns about the product pipeline aren't limited to drug-resistant infections. This year's influenza vaccine shortage has demonstrated how unprepared the nation is for the next pandemic. The Centers for Disease Control and Prevention estimates that a flu strain as deadly as the one that caused the 1918 pandemic could kill as many as 2 million people in the United States alone. However, the nation lacks the manufacturing capacity to produce enough influenza vaccine or antivirals to protect itself, among other problems.
Bioshield II is aimed at reinvigorating the pharmaceutical industry's commitment toward infectious diseases medicine. "We need the pharmaceutical industry to get back in the fight before it's too late," Stamm says. "While IDSA believes Bioshield II can still be strengthened, we applaud its sponsors, Sens. Joe Lieberman (D-CT), Orrin Hatch (R-UT), and Sam Brownback (R-KS) for producing a solid, pragmatic, and insightful bill. IDSA calls upon Congress to quickly pass comprehensive Bioshield II legislation this year."
IDSA has been working with congressional leaders on legislation for two years, after consulting with experts from industry, government, and other stakeholders. "Bioshield II adopts many of the ideas we suggest in the Bad Bugs report," notes IDSA's Antimicrobial Availability Task Force chair John G. Bartlett, MD. "We're happy to say this proposal goes a long way toward meeting the needs of the infectious diseases community."
The bill includes measures to fuel action by players ranging from small biotech companies to large pharmaceutical firms. They include tax credits, advance-purchasing commitments by government and others, intellectual property rights benefits to encourage private investment, liability protections for health care workers and manufacturers, and other measures.
Bioshield II is also designed to spur the development of essential tools to fight bioterrorism, including new vaccines, antimicrobials, and diagnostics. IDSA expects it will encourage the development of similar products to prevent, treat, detect and identify other infectious disease threats such as HIV, tuberculosis, malaria, and neglected diseases; and frightening emerging diseases such as severe acute respiratory syndrome (SARS), West Nile Virus, and Ebola and Marburg hemorrhagic fevers.
"Since the dawn of human history, naturally occurring infectious diseases have caused incalculable devastation to families and communities around the world. Bioterrorism has increased the threats significantly," Stamm says. "IDSA believes, as do Sens. Lieberman, Hatch, and Brownback that Bioshield II provides a major opportunity to limit our vulnerability to both Mother Nature and those individuals who would intentionally cause us harm."