Scientization is the practice of reducing policy, ethical and value disagreements to science. It is often committed by elected and appointed officials to avoid having to make difficult policy decisions. It is also widely practiced by scientists who want to make public policy decisions.
Recent stories about FDA drug advisory committee reviews give fairly obvious examples of the genre.
Thomas M. Burton of the Wall Street Journal reports:
A Food and Drug Administration advisory panel recommended that the agency approve the cholesterol-lowering drug Praluent, the first of a wave of such cardiovascular drugs expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease.
But many panelists said the use of the drug should be limited to certain high-risk groups, such as people with very high cholesterol for genetic reasons because of a condition called familial hypercholesterolemia.
Several committee members revealed that they believe their role is to make policy, not just conduct objective scientific reviews. Burton again:
Panel member Brendan M. Everett, director of the cardiology inpatient service at Brigham and Women’s Hospital in Boston, said he would limit the drug’s immediate use to certain patients with genetic high cholesterol. “I would not allow broader use,” Dr. Everett said.
A few days ago, an FDA advisory committee recommended that the agency approve flibanserin to treat hypoactive sexual desire in women. Brigid Schulte of the Washington Post reports that the committee likely was influenced by “an afternoon of emotional testimony.” No such testimony would have been needed if the committee of scientists was debating science.
Schulte quotes one committee member who unabashedly opposed approval based on her personal opinions about what women really need:
Some panel members who voted against approval said that the data wasn’t good enough, and the benefits weren’t strong enough to warrant approval, given the side effects. “I recognize people are suffering,” said Diane Aronson. “I just think they deserve better.”
Reporting on this event, Andrew Pollack of the New York Times focused on the “intense lobbying campaign” put together by the manufacturer and women’s organizations:
The controversial campaign by some women’s groups to win federal approval was waged under the banner Even the Score, which accused the F.D.A. of gender bias because it had approved Viagra and other drugs to help men have sex while leaving women without options. The participants in the campaign had been brought together by a consultant to Sprout Pharmaceuticals, the developer of flibanserin.
Again, no such campaign would have been necessary if the advisory committee limited its role to reviewing the science. Indeed, given the extent to which FDA advisory committees have a preeminent role in drug approval decisions, lobbying campaigns should be expected, not surprising. What Pollock called “controversial” is not the science; it’s that the committee of scientists was reviewing ethical and value questions on which scientists have no expertise:
Is sexual desire a human right? And are women entitled to a little pink pill to help them feel it?
Pollock missed the true controversy: scientists were empaneled to review science but made policy decisions instead.
One reason scientization is endemic in FDA drug approval decisions is that the agency explicitly seeks policy advice from these external scientists and it usually defers to their policy judgment. In short, the FDA suffers from bilateral scientization: agency officials delegate policy choices to scientists, and scientists who serve on its advisory committees are happy to oblige. A bona fide scientific review would exclude such scientists from participating.