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Many Breakthrough Drugs Come From Publicly Funded Research: Study

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, Feb. 9 (HealthDay News) -- A surprising number of valuable new drugs and vaccines approved in the United States have arisen wholly from research funded by the public sector, new research finds.

The authors of a study published Feb. 10 in the New England Journal of Medicine count 153 new drugs and vaccines from public sector research institutes over the past 40 years. They include Remicade (infliximab), considered a giant step forward in the treatment of rheumatoid arthritis and other inflammatory and autoimmune disorders, and Lyrica (pregabalin), used to treat pain neuropathy, fibromyalgia and pain from shingles.

"Not only do federal funding programs, such as those from the National Institutes of Health and the National Science Foundation, advance the scientific knowledge base of the country, but they contribute practical advances that can help people and create economic opportunity," said study author Ashley J. Stevens, a lecturer at the Boston University School of Medicine and senior research associate at the university's Institute of Technology Entrepreneurship and Commercialization.

Traditionally, publicly funded researchers tended to dig up the causes and vulnerabilities of a particular disease while the sexier follow-up of actual drug development was left to pharmaceutical companies.

That apparently has changed, according to the study team, which included researchers from Norway and from the Office of Technology Transfer at the U.S. National Institutes of Health (NIH).

Thanks to legislation passed in 1980, universities, teaching hospitals, nonprofit research institutes and federal laboratories could start owning and licensing intellectual property coming from federally funded research, the authors stated.

This coincided with the boom in biotechnology research, which made so many new biologic drugs possible.

The 153 new entities identified by the authors included 93 small-molecule drugs, 36 biological agents, 15 vaccines, eight diagnostic tools and one over-the-counter drug. More than half were to treat or prevent cancer or infectious diseases. And many were fast-tracked to approval, suggesting that their effect was considered substantial. The therapeutic effect of these public sector-developed drugs will likely be disproportionately large, the researchers said.

The news comes in the midst of looming concerns about budget cuts and the future of government-funded research.

"This study helps justify sustained federal support for the NIH," said Jon Retzlaff, managing director of science policy and government affairs at the American Association for Cancer Research (AACR) in Washington, D.C.

"The AACR is extremely concerned about the current funding environment, and specifically the threats of budget cuts to the NIH and the National Cancer Institute. It is imperative that at this critical juncture Congress not waver in its longstanding commitment to providing the resources and support for research and discovery efforts," he said.

"These are what fuel advances in cancer prevention, diagnosis, care and treatment," he added.

"Long-term flat funding or, worse, a reduction in funds for biomedical research and cancer research will slow research progress and squander invaluable scientific opportunities to the detriment of our nation's health, our fragile economy and our global competitiveness," Retzlaff said.

As legislators try to balance the federal budget, these funds must not be considered discretionary, he added. "This data shows that these are part of our economic development," he said.

More information

The U.S. Food and Drug Administration has more on how drugs are developed and approved.

SOURCE: Ashley J. Stevens, D.Phil, lecturer, Boston University School of Medicine, and senior research associate, BU Institute of Technology Entrepreneurship and Commercialization; Jon Retzlaff, managing director, science policy and government affairs, American Association for Cancer Research; Feb. 10, 2011, New England Journal of Medicine

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