Pharma’s Cutting Edge

Scott Hensley of the Wall Street Journal describes how Pfizer has yet to publish results of clinical trials on capromorelin, some four years after the WSJ published a story of the “anti-aging” drug’s trials and tribulations on its cover. For those of you who didn’t follow this category, capromorelin, aka CP-424,391-18, is a GH secretagogue previously under study by Pfizer for aging-related conditions associated with muscle wasting (e.g. hip fracture) and congestive heart failure. Other GH secretagogues were killed by Merck (MK-0677) and BMS 604992 (currently under development by Elixir Pharmaceuticals) after advancing the compounds into late-stage development. The reason for the late-stage failures? Pfizer and Merck gave the usual explanations, BMS gave none. Privately, it became widely appreciated that the drugs’ efficacy to stimulate GH secretion wasn’t sufficient to produce desired “hard” endpoints and therefore presented unfavorable benefit to risk profiles. Merck published a great deal of clinical work on MK-0677, including the Phase 3 hip fracture study, which sealed the drug’s fate. In contrast, neither Pfizer nor BMS published one of its clinical studies.

Sometimes a single, late-stage investigational product represents a company’s hopes for an entire therapeutic area; if it fails so does the company’s efforts in the area. When this happens, as apparently it did at Pfizer and BMS, priorities shift rapidly and resources shift with them. As a result, the data managers, medical scientists and statisticians needed to publish findings from clinical trials often find themselves on other projects that demand their full attention. As well, key medical personnel often leave the company to work on similar drugs at other companies.

This movement of people and priority is typically rationalized with long-range plans that do not include further work in the therapeutic area. I can certainly understand this attitude, but I think it’s short-sighted, because it does not account for the negative effects of the type of publicity evidenced by this WSJ article. Furthermore, abandoning a therapeutic area does not mean that clinical researchers from that area will not be important collaborators and opinion leaders to the company in the near future. It is not wise to undermine these key relationships with short-sighted (in the guise of long-range) policies. More than ever, this industry needs to consider the public and private relations implications of its policies. When this is done, I believe that the costs of publishing all available data on failed drugs as quickly as possible will seem small in relation to the benefits.