When bias isn’t bad

When bias isn’t bad

From the Washington Post (Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals):

The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group’s analysis released yesterday…The group’s report also said the FDA is more likely to accept its panels’ advice when they recommend approving a product than when they vote against approval.

Bias is a word with strong negative connotations (e.g., “racial bias”) but bias is not always a bad thing. When I worked at the Boston Consulting Group, one of the attributes we looked for in job candidates was a “bias for action.” In other words, all else being equal we wanted the consultant to do something rather than sit still.

The FDA was quick to reject the allegation of bias –and is especially sensitive about accusations of conflicts of interest– but I think it’s ok to have a bias toward approval of new drugs. The FDA should allow drugs with borderline safety and efficacy profiles make it to market, but as a society we should insist that other segments of the health care system exercise judgment. In particular, physicians should have a bias toward using tried and true drugs –in my experience most already have this bias– and should be skeptical of claims made by interested parties.

Consumers need to exercise similar judgment, but they also have the right to expect their physicians to look out for them. Consumers (and doctors) may be swayed by clever advertising and marketing. I advocate addressing this issue in the broader context of educational reform –teaching students to be skeptical (not cynical). I don’t think it’s wise to hold potentially promising drugs back from the market or place undue restrictions on advertising.

Meanwhile, payers are stepping into the void to guide drug decisions. They have a bias toward cost control, which is good for the system overall but not always the best for a specific patient.

August 29, 2006

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