That is the key message of the report, Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates ... A Public Health Crisis Brews, which the Infectious Diseases Society of America (IDSA) presents today to Congress and federal policymakers. The report is the product of a year's worth of research by some of the country's top infectious disease physicians.
"There simply aren't enough new drugs in the pharmaceutical pipeline to keep pace with the evolution of drug-resistant bacteria, the so-called 'superbugs,'" said Joseph R. Dalovisio, MD, IDSA president. "This crisis has the potential to touch us all because drug-resistant infections can strike anyone--young or old, healthy or chronically ill."
"The emergence and prevalence of antibiotic resistant organisms and lack of research in antibiotics for such organisms is a growing concern. I compliment IDSA for raising awareness of the problem," said Senator Judd Gregg (R-NH), Chairman of the Senate Health, Education, Labor and Pensions Committee.
"With the threat of bioterrorism, the growing number of microorganisms resistant to drug therapy, the reemergence of previously deadly infectious diseases, and the emergence of new infectious diseases in the United States, there is an urgent need for new antimicrobials," Senator Jack Reed (D-RI) stated. "Infectious disease physicians clearly have valid reason to be concerned and to bring this issue to policymakers. It is vital that antibiotics research and development is reinvigorated so doctors have the medicines they need to protect the health of millions of Americans."
This year, nearly 2 million people in the United States will acquire bacterial infections while in the hospital, and about 90,000 of them will die, according to estimates from the Centers for Disease Control and Prevention (CDC). More than 70 percent of the bacteria that cause these infections will be resistant to at least one of the drugs commonly used to fight them. In a growing and frightening number of cases, these bacteria are resistant to many approved drugs. For many patients, there simply are no drugs that work. Even more alarming, resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) are beginning to strike healthy people outside of hospitals.
While the number of drug-resistant infections continues to rise, the number of new antibiotics in the pipeline to treat these infections is drastically declining. 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.
Major pharmaceutical companies have abandoned or drastically cut back their antibiotic development efforts because of the unique challenges to making antibiotics profitable. For example, antibiotics produce a weak return on investment for manufacturers because they work so well and so fast. Antibiotics are commonly prescribed for only seven to 14 days, as opposed to drugs that patients take for life, such as insulin for diabetes or statins for elevated cholesterol. Furthermore, when bacteria evolve to resist a drug, this limits the drug's effectiveness over time and therefore decreases its long-term profitability.
"Market forces alone will not overcome these challenges and provide new antibiotics when we need them," said John G. Bartlett, MD, chief of the division of infectious diseases at the Johns Hopkins University School of Medicine and chair of IDSA's Task Force on Antimicrobial Availability, which helped to prepare the report. "Policymakers must act now because it can take 10 or more years to bring a new antibiotic to market, and drug-resistant bacteria are evolving fast."
"In the past, Congress has stepped in with innovative solutions when there were unique challenges to the availability of life-saving drugs," Dr. Bartlett continued. "The Best Pharmaceuticals for Children Act, the Orphan Drug Act, and Project Bioshield, which President Bush is signing today, are three examples. It is time for Congress to take similar action to ensure the availability of effective antibiotics for patients who need them."
Bad Bugs, No Drugs explains the resistance problem with data, charts, and graphs; identifies the obstacles that pharmaceutical companies face in developing new antibiotics; and proposes a range of specific, innovative policy and administrative measures designed to head-off the impending health crisis. The report includes recommendations for Congress, the Food and Drug Administration (FDA), and the National Institute of Allergy and Infectious Diseases (NIAID) as well as funding increases for the CDC and other programs.
Highlights of proposed policy and administrative actions in the report include the following:
- Establish an independent Commission to Prioritize Antimicrobial Discovery. This commission would decide which infectious pathogens to target using legislative incentives and administrative solutions.
- Create a new type of "wild-card" patent extension: A company that develops and receives approval for a priority antibiotic could extend the market exclusivity period of another FDA-approved drug as long as the company commits to invest a portion of the profits derived during the extension period back into antibiotic R&D.
- Provide tax incentives for R&D of priority antibiotics.
- Establish measured liability protections similar to those that exist for childhood vaccines.
The report can be accessed and downloaded from the IDSA home page (www.idsociety.org).