09/26/2006 11:11 am ET | Updated May 25, 2011

IOM Issues Half-A-Loaf Safety Report

It's a bit frightening how little physicians really know about a new drug when it first comes on the market. Unless the drug is for a common condition like high blood pressure or mild arthritic pain, it's probably been tested on fewer than a thousand people before the Food and Drug Administration approves it. It's quite likely a serious side effect that shows up once in every 1000 patients will escape the attention of the physicians and the company that ran the clinical trials.

That's not what happened in the Vioxx case, of course. The clinical trials for that run-of-the-mill pain pill did show a serious side effect - heart attacks and strokes at four times the rate of a comparison drug. But the industry-funded physicians who ran the trial and the FDA reviewers who approved it ignored that clear signal. Instead, Merck's Vioxx got the rubber stamp of approval and was prescribed for millions of Americans, tens of thousands of whom died prematurely. That spectacular disaster - one of the worst drug safety fiascos in American history - led directly to last week's blue-ribbon Institute of Medicine report calling for a complete overhaul of the way the Food and Drug Administration evaluates the safety of new drugs.

The IOM report, which received front page coverage in the national media, made a number of very good recommendations. They ranged from calls for a better surveillance system for identifying serious side effects among the patients who take new drugs to mandatory registration of all clinical trials so patients, doctors and researchers can analyze all the data companies have about their drugs.

The IOM committee, which included several well-known drug safety advocates, also wanted better warning labels on new drugs and suggested companies submit detailed surveillance and risk management plans when a drug first comes on the market. Then, the company would have to report back within five years on any surveillance data that sheds new light on the drug's safety or efficacy.

Without saying so directly, the report also called for insulating the FDA from the political manipulation, which has been the Bush administration's singular contribution to the history of the nation's oldest consumer protection agency. The committee called for giving the FDA commissioner a 6-year term.

The committee also recognized that the drug industry, whose user fees now drive nearly half the agency's budget, has become the primary "client" for drug regulators, a classic case of industry capture. To lessen those ties, they called for greater taxpayer support for the FDA. They also demanded that a "substantial majority" of scientists who sit on the FDA's outside advisory panels be free from "significant financial involvement with companies whose interests may be affected by the committee's deliberations." Currently, many committees have as many as half their scientists simultaneously pulling down paychecks from industry.

If the FDA and Congress take the recommendations to heart (that's a big if, given the pharmaceutical industry's power over both institutions), the FDA will definitely improve its ability to spot unsafe drugs and pull them off the market. However, I still am somewhat disappointed in the report. Its authors shied away from embracing the implications of many of their recommendations.

Take direct-to-consumer advertising ("Please," as Henny Youngman might have said). For years, the drug industry, physicians and patients did quite well, thank you, without this useless form of psychic abuse. Does the public really need to see television commercials touting toenail fungus cures and erectile dysfunction alleviators? Does a person on poisonous cancer drugs really need to see the smiling faces of fellow sufferers who are "ready for chemotherapy" because of the alleged benefits of some wonder drug? Believe me, if there is a drug out there that can relieve some of the side effects of chemotherapy, your oncologist will be aware of it and gladly prescribe it for you.

Yet, no sooner had the report suggested DTC be curbed than it cautioned that it might infringe commercial freedom of speech. Why this quibble? This was a drug safety committee. Say what's best for public health - and then let the industry's lawyers fight it.

But the most significant flaw in the report came from the committee's decision to ignore calls for a division of the Center for Drug Evaluation and Research, which is charged with evaluating new drug applications but also houses the FDA's safety office. The net effect of combining the two offices is to keep FDA scientists with safety concerns under tight control (except when a stray whistleblower like David Graham wanders off the reservation).

The FDA, which used to be considered the gold standard among our science-based regulatory agencies, has fallen on hard times. Giving its scientists better tools, which the recommendations in the report would provide, would be great. But those tools will be useless unless the agency has the will to use them. The ultimate problem at the FDA is a lack of leaders willing to stand up for the staff, who often already know when something isn't right. Empower them to stand up to the industry when it is warranted, and we'll once again have an FDA that can protect the public from unsafe and ineffective drugs.