Healthy Skepticism Library item: 19101
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Silverman E
Who Discovers Innovative Meds? The Public Sector
Pharmalot 2011 Feb 10
http://www.pharmalot.com/2011/02/who-discovers-innovative-meds-the-public-sector/
Full text:
According to legend, academic researchers are good at discovering underlying mechanisms and pathways of disease, but less so at applied research for discovering drugs that can treat disease. Now, though, a new study in the New England Journal of Medicine debunks this myth – public sector research institutions were involved in developing more than 20 percent of new, innovative drugs approved between 1990 and 2007.
This figure was derived by examining a newly constructed patent database for meds approved by the FDA after 1962 and identifying pertinent patents filed by PSRIs – defined as universities, research hospitals, nonprofit research institutes, and federal labs. From there, the researchers determined whether patents were for applied research. They found that PSRIs contributed to the discovery of 9.3 percent of all all drugs involved in new-drug applications during that period.
And innovation was an even more interesting story. The authors examined how many drugs were new as compared with improvements to existing meds, and received priority review. They found that 21.2 percent of all new drugs receiving priority review were discovered by PSRIs. In other words, even though the proportion of meds discovered by PSRIs remains in the minority, “PSRIs tend to discover drugs that are expected to have a disproportionately important clinical effect,” the authors wrote.
Between 1990 and 2007,” they explained, “the FDA approved 1,541 new drug applications, but granted priority review to just 348 applications, 22.6 percent. Of 1,541 approvals, 143 or 9.3 percent came from PSRIs. But of the 348 priority reviews, 66 or 19 percent came from PSRIs, or twice the overall rate for priority reviews. Viewed from another perspective, 46.2 percent of NDAs from PSRIs received priority reviews, as compared with 20 percent of applications that were based purely on private-sector research, an increase by a factor of 2.3.”
“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,” lead author Ashley Stevens, a lecturer at the Boston University School of Medicine and senior research associate at the university’s Institute of Technology Entrepreneurship and Commercialization, tells HealthDay.
A few other nuggets: Overall, the researchers identified 102 new molecular entities 36 biologic drugs and 15 vaccines for a total of 153 drugs that received 206 new-drug or biologics license applications during the past 40 years. Hematology, oncology and infectious disease accounted for 76, or roughly half of the total. As the researchers note, the disease categories are “very different from the priorities of the pharmaceutical industry.” Meanwhile, 75 PSRIs discovered or co-discovered at least one product, with the National Institutes of Health taking first place with 22 products (read the complete study here).
