Monday, July 10, 2006

Bayh Dole Rights, Size of Clinical Trials, 2004 Approvals.

by Mike Palmedo
CPTech has looked at the patents for New Molecular Entities (NMEs) that came to the market in 2004.

Excluding antibiotics, which do not have Bayh-Dole listings in their patents, the FDA approved 19 NMEs in 2004. Nine of these received priority status for approval, meaning they were found to have significant therapeutic gain over existing medicines. The remaining 10 NMEs were given standard approvals.

For the products for which data was available, I looked up the number of patients cited by the FDA in approving the medicines. (I had to exclude three of the priority NMEs approved in 2004 for which the label did not include the number of patients) The average (mean) number of patients in the clinical trials on which the FDA approvals were based was 1073 for priority drugs and 1840 for standard drugs. The median numbers of patients in these clinical trials were 1290 for the priority drugs and 2058 for the standard drugs. These figures are considerably lower than the average size of clinical trials used by DiMasi in his often-cited research on the cost of drug development – 5,303 patients.

The Orange Book lists 45 patents on the 19 NMEs. Three of these patents include clauses citing government funding and subsequent Bayh-Dole rights to use or license the patent. These three patents cover two of the nine drugs which received priority approval – two patents for Clolar (a leukemia drug sold by Genzyme) and one for Lyrica (a diabetes drug sold by Pfizer).

A spreadsheet with the drugs, patents, and size of trials is online here:

Mike Palmedo


Dean Baker said...

It is interesting that DiMasi reports that phase III drug trials for the industry cost about 6 times as much as they cost NIH. While this could be explained in part by the types of drugs being tested, there are important differences in incentives.

NIH has limited funding and therefore would presumably try to minimize the costs of its trials. Profit maximization for the industry means maximizing the gap between its revenue and its costs.

If clinical trials can be used to curry favor among doctors (e.g. by paying high fees for their involvement) and thereby change their prescribing behavior, then profit maximization would lead them to pay considerably more than necessary for trials, since it also is effectively a form of marketing.

5:42 AM  

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