The major news outlets gave prominent coverage to Tuesdayâ€™s release of a guidance document on pharmacogenomic data submissions for clinical trials. The New York Times said,
The Food and Drug Administration took a significant step yesterday toward the development of so-called personalized medicine, in which drugs would be tailored to individuals based on their genetic profiles.
The truth is, we are still far away from this vision. Consider the following:
- During the hype surrounding the Human Genome Project in the late 1990s, Celera Genomics, Human Genome Sciences and others talked about pharmacogenomics as though it were already here. The new guidance document points out that, â€œthe field of pharmacogenomics is still in early developmental stages, and [its] promise has not been realized.â€
- Weâ€™ve seen in our consulting assignments that innovation in clinical trials is very slow. Sponsors are reluctant to try anything new because they fear it will slow down the approval process with ethics committees and delay FDA approval. As a result, outdated endpoints with dubious significance are used routinely, just because theyâ€™ve been used in the past. One example is the Hamilton Anxiety Scale, a 40 year old measure that is a weak indicator, at best, of whether a drug works.
Itâ€™s good to see the FDA move forward with this guidance. However, well organized and assertive patient groups and clinical leaders are at least as important in spurring innovation in clinical trials. This is most apparent in HIV/AIDS, where the old ways of doing things have been discarded.March 24, 2005