Inaccurate reporting on public and nonprofit sectors role in drug research

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A study just published in the New England Journal of Medicine has led to a great deal of faulty reporting and more than a few questionable claims. The study, which aimed to assess the role of drug development initiated outside of the pharmaceutical industry, showed that of 1,541 applications to the FDA for new drugs or new indications for existing medications between 1990 and 2007, 143 were based on research which, as Medpage Today put it, “originated” in the public and nonprofit sector.

Medpage Today titled its story on the subject, “Drug Innovation Often Starts in Nonprofit Sector”. There are two problems with this headline. First, the cases discussed represent only nine percent of the total. So, as ACSH's Dr. Gilbert Ross points out, “The thesis is actually almost ridiculous if you use these numbers.”

Second, says ACSH’s Dr. Josh Bloom, “The use of the word ‘originated’ is slippery. The easy part in drug research is identifying the target and developing it into an assay. This is just the beginning. The hard part is taking an early lead and developing it into an appropriate molecule, and then putting it through pre-clinical and clinical trials. This is where most of the manpower, know-how and money are needed.”

Likely the best-known of the drugs mentioned in the article are lovastatin (Mevacor), imatinib (Gleevec) and paclitaxel (Taxol). A 2008 report notes that in at least two of the three cases, the most important role in the development of the drugs was played by the private sector. Thus, while the National Institutes of Health (NIH) had suggested the use of statins, it was researchers at Merck who isolated lovastatin from fungi, not government scientists. Similarly, while a researcher at Oregon Health & Science University played the pivotal role in identifying imatinib, he credits allies at Novartis most for their role in developing it. And while the National Cancer Institute assisted with the development of Taxol, it was actually first suggested by work done at Eli Lilly, and it was commercially synthesized by Bristol-Meyers Squibb.