As many Americans from the halls of Congress to home district town halls are debating how much health reform should preserve the current system's status quo, the journal Health Affairs has published an article questioning how U.S. pharma innovation stacks up with other nations.
In the article, Donald Light, professor of social medicine at the University of Medicine and Dentistry of New Jersey, concludes that Europe is moving ahead of the U.S. in pharmaceutical research productivity. Moreover, he finds that U.S. firms have not taken the lead from European competitors as an earlier study, also published in Health Affairs, claimed.
Preserving biopharma innovation has been a key criterion many stakeholders use in evaluating a range of health care reform provisions, from bundling Medicare payments for services to comparative effectiveness research and how it relates to coverage decisions, to the length of innovator product exclusivity in any new pathway for approving follow-on biologics.
Light's article, published online by Health Affairs Aug. 25, takes aim at a 2006 study by Duke University economist Henry Grabowski and AstraZeneca Director of Health Services Research and Policy Analysis Director Richard Wang. Grabowski is prominent in policy circles for his analyses of how much exclusivity brand companies need to recoup their investments in biologics products ('The Pink Sheet' DAILY, March 10, 2009).
Grabowski and Wang concluded that European firms had more productive research programs; the abstract for their article summarizes their conclusions this way: "We examined trends in the introduction of new chemical entities (NCEs) worldwide from 1982 through 2003. Although annual introductions of NCEs decreased over time, introductions of high-quality NCEs (that is, global and first-in-class NCEs) increased moderately. Both biotech and orphan products enjoyed tremendous growth, especially for cancer treatment. Country-level analyses for 1993-2003 indicate that U.S. firms overtook their European counterparts in innovative performance or the introduction of first-in-class, biotech, and orphan products. The United States also became the leading market for first launch."
Light reanalyzed their data on 919 new chemical entities approved between 1982 and 2003. But to measure research productivity, he compared the proportion of industry R&D funding for the U.S., Europe and Japan to their proportion of new chemical entities. Grabowski and Wang focused more on numbers of products, not whether nations were productive for the money spent.
In assessing innovation in pharma research, Light stated: "In global NCEs, European research productivity was about the same as U.S. productivity in the first period [1982-1992] but increased by 30 percent in the second period (1993-2003), while U.S. research productivity declined 26 percent."
He said that in first-in-class drugs, European relative innovativeness moved from well behind the U.S. in the first period to well ahead in the second. In biotech products, European researchers became more innovative in the second period but did not catch up with the U.S. even though U.S. productivity declined. And in orphan drugs, Europe moved from well behind the U.S. to about even in the second period.
Light also said European research productivity would have appeared stronger in the Grabowski and Wang study had they included first-in-class and orphan drugs launched in Europe or Japan but not yet available in the U.S. in their analysis.
Light further rejected their claim that most new drugs are of high quality or are important for patients. He asserted that "different organizations, using somewhat different criteria and procedures, have found that during the past forty years about 11-15 percent of new chemical entities have been therapeutically 'important,' as Grabowski and Wang put it, and 85-89 percent have not been."
For example, he noted that AstraZeneca's Nexium (esomeprazole) and Pfizer's Lipitor (atorvastatin) are among the world's top-selling drugs, but "Nexium is widely regarded as a textbook case of a me-too drug, and Lipitor has little proven clinical advantage over other statins."
"If we want new drugs to be clinically superior to existing ones, we need to reward companies for developing them and not for developing drugs that are merely superior to placebo," Light concluded.
Light's article, entitled Global Drug Discovery: Europe Is Ahead, is one of three articles dealing with pharmaceutical intellectual property appearing in the current Health Affairs issue. Another article criticizes the IP rules in the Central America Free Trade Agreement and calls for removal of data exclusivity provisions. And a third piece advocates the use of outside experts to review patents, preferably before they are granted, to help ensure affordability and access to drugs.
- Brenda Sandburg (b.sandburg@elsevier.com)
This article is reprinted from "The Pink Sheet" DAILY – Aug. 25, 2009
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