One Cost of Privatized Medical Science

Scott Hensley of the Wall Street Journal, always one of my favorite reporters, has an excellent column in today's paper (subscription required) lamenting what's lost when industry funds clinical trials for new medicines. The case in point is Pfizer's research on an "anti-aging" pill, which the company discontinued a few years ago after getting the page-one treatment from Hensley.

Bravo for the reporter who follows up his own wrong-headed stories. Turns out that the drug, which promoted muscle growth to prevent frailty, falls, and the like, had the serious side effect of promoting obesity -- not exactly what you're looking for in a pill aimed at aging Baby Boomers. It also caused insomnia and raised blood sugar.

The data from that clinical trial, which was suspended several years ago, has never appeared in a peer-reviewed medical journal. Even the researchers who participated in the trial have had problems gaining access to the data on a timely basis. Hensley makes the important point that "the research behind medicines that get nixed in the trial stage could be valuable to the scientific community. . . who might be able to solve the problems or otherwise build on the results."

One other group that would like access to data, of course, is Pfizer's competitors, who might be working on something similar. By knowing where and how Pfizer's drug candidate failed, they might either drop their own programs or make changes to avoid the same pitfalls. That's why Pfizer wants to keep it secret.

The FDA is currently involved in a "critical path" initiative to help the pharmaceutical industry's research and development arms become more productive. Here's an excellent place to start. The agency should require that all human clinical trials data be made public, even data that will never be published. Publication would be a tremendous boon to companies whose developments efforts might otherwise get stuck in a blind alley for years, substantially saving resources for other, more potentially useful projects.

There's an easy answer for companies like Pfizer that say they don't want to help our their rivals. Publication is not for them. It's for the people who volunteered to be part of those trials. They deserve to know that the uncompensated risks they took to participate in clinical trials contributed to the sum total of human knowledge.