The Antibiotic Pipeline
http://www.100md.com
《新英格兰医药杂志》
To the Editor: In his Perspective article (Aug. 5 issue),1 Wenzel accurately describes the dismaying problem of the decreasing number of new antimicrobial drugs in the pharmaceutical pipeline. He notes that the Infectious Diseases Society of America (IDSA) has suggested extending the life of drug patents as an incentive to industry. Many other approaches need to be considered before making a radical change in a patent system designed to protect investment but eventually foster competition.
The IDSA has proposed a better idea. It recommends that the National Institutes of Health (NIH) remove roadblocks to antibiotic research and development and increase the number and size of grants that support the discovery of new drugs that treat targeted pathogens. These changes are long overdue. The NIH and other government agencies are currently constrained from competing with industry. Why not unleash these potent forces and allow investigators to submit grant proposals to the NIH to develop new drugs?
I am concerned by the article's emphasis on prolonging patent rights in order to solve difficult scientific, economic, and policy issues. This approach might lead to unintended consequences.
Calvin M. Kunin, M.D.
Ohio State University
Columbus, OH 43210
ckunin@columbus.rr.com
References
Wenzel RP. The antibiotics pipeline -- challenges, costs, and values. N Engl J Med 2004;351:523-526.
To the Editor: Since high prices for new drugs or extending patents on current drugs is likely to be politically unpopular, other incentives need to be considered. The best example is the Orphan Drug Act, which provides both research-and-development tax incentives as well as seven years of market exclusivity for new drugs that are used to treat rare diseases. This U.S. legislation has greatly improved the availability of orphan drugs for more than two decades, and similar legislation has been passed in Australia, Japan, and the European Union. Extending the Orphan Drug Act to antibiotics would not only spur the development of new classes of drugs but might lead to the reconsideration of old classes. Many natural-product antibiotics were discovered decades ago and were not developed fully for reasons of toxicity and pharmacokinetics. Modern formulations may address these issues. Furthermore, new legislation would spur venture-capital investments in new companies focused on creating new antibiotics.
A. Bruce Montgomery, M.D.
Corus Pharma
Seattle, WA 98121
bmonty@coruspharma.com
The IDSA has proposed a better idea. It recommends that the National Institutes of Health (NIH) remove roadblocks to antibiotic research and development and increase the number and size of grants that support the discovery of new drugs that treat targeted pathogens. These changes are long overdue. The NIH and other government agencies are currently constrained from competing with industry. Why not unleash these potent forces and allow investigators to submit grant proposals to the NIH to develop new drugs?
I am concerned by the article's emphasis on prolonging patent rights in order to solve difficult scientific, economic, and policy issues. This approach might lead to unintended consequences.
Calvin M. Kunin, M.D.
Ohio State University
Columbus, OH 43210
ckunin@columbus.rr.com
References
Wenzel RP. The antibiotics pipeline -- challenges, costs, and values. N Engl J Med 2004;351:523-526.
To the Editor: Since high prices for new drugs or extending patents on current drugs is likely to be politically unpopular, other incentives need to be considered. The best example is the Orphan Drug Act, which provides both research-and-development tax incentives as well as seven years of market exclusivity for new drugs that are used to treat rare diseases. This U.S. legislation has greatly improved the availability of orphan drugs for more than two decades, and similar legislation has been passed in Australia, Japan, and the European Union. Extending the Orphan Drug Act to antibiotics would not only spur the development of new classes of drugs but might lead to the reconsideration of old classes. Many natural-product antibiotics were discovered decades ago and were not developed fully for reasons of toxicity and pharmacokinetics. Modern formulations may address these issues. Furthermore, new legislation would spur venture-capital investments in new companies focused on creating new antibiotics.
A. Bruce Montgomery, M.D.
Corus Pharma
Seattle, WA 98121
bmonty@coruspharma.com