Oct 25 2004
In the midst of the current national shortage of influenza vaccine, the Infectious Diseases Society of America (IDSA) has renewed its call for Congress and the Administration to implement innovative public policy geared toward removing financial disincentives that have caused pharmaceutical companies to leave the vaccine market.
“Infectious disease physicians in hospitals and communities across America are grappling with thorny questions about how to ration this year’s vaccine among patients who are at highest risk for complications of flu,” said Walter E. Stamm, MD, IDSA president. “We are dealing with the consequences for the short term, but we need to think about innovative, long-term policy solutions.”
One possible vehicle for addressing the problem is legislation commonly called “Bioshield II,” which would build on “The Project Bioshield Act,” (Bioshield I), which was signed into law in July 2004. Bioshield I is intended to stimulate the development of treatments, preventatives, and diagnostics related to bioterrorism preparedness and response. IDSA has consistently urged Congress to extend the scope of both Bioshield I and II beyond bioterrorism to include research and development of vaccines and antibiotics to prevent and treat naturally occurring infections.
“Whether we’re talking about vaccines to prevent diseases such as the flu or antibiotics to treat drug-resistant infections, the infectious diseases market is simply not as attractive to manufacturers as is the market for chronic diseases, like diabetes or high cholesterol, where patients take a drug for life,” said Andrew T. Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah and chair of IDSA’s Pandemic Influenza Task Force.
As compared with a blockbuster drug, many vaccines are used only once or twice in a person’s lifetime, or once a year in the case of influenza. But even though the infectious diseases market is relatively small compared to other fields of medicine, the public health need is great. Every year in the United States, influenza causes approximately 36,000 deaths and 200,000 hospitalizations. Despite this critical need, pharmaceutical companies have pulled out of influenza vaccine production because it is financially risky and less profitable than other markets.
Because the flu virus changes from year to year, a new vaccine must be created each flu season. This is a difficult and time-consuming process. The demand for flu shots fluctuates from year to year as public interest waxes and wanes. Last influenza season, for example, 87 million doses of vaccine were made, but only 83 million doses were used. In recent flu seasons, as many as 13 million doses have gone unused and have had to be discarded. Given the challenges, many experts say it is not surprising that so few manufacturers see the market as viable. In the 1970s, there were several pharmaceutical companies producing flu vaccine for the United States. Now there are only two.
“It makes sense for the country to reinvest in the infectious diseases market,” said Dr. Pavia. “Vaccines and antibiotics will help to save lives and should be cost-effective for society in the long run. Money we put into incentives should be returned by savings from decreased disease,” he said.
“This is why IDSA has been urging federal policymakers to create new incentives--such as tax credits, strengthened intellectual property rights, liability protections, or some type of federally guaranteed purchase program--to make the infectious diseases market more attractive to industry,” 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. Other ideas for making the market more attractive may be worth exploring, he added.
In July, IDSA published a major report, Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates … A Public Health Crisis Brews, which outlined possible incentives to spur development of new antibiotics. IDSA believes that many of these incentives could also make the vaccine market more attractive to pharmaceutical companies, and that Bioshield II offers a means for putting policy into action.
“Vaccines and antibiotics have been among our chief tools for preventing and treating infectious diseases,” said Dr. Stamm. “How can we as infectious disease physicians tell our patients that our tool box is empty? Market forces alone are not going to solve this problem. We need innovative federal policy to protect public health.”