The FDA has its heavy regulatory hand on almost one quarter of the nation’s economy, so its leadership is of deep concern to all Americans, not merely those involved in public health. Recently, President Bush nominated Lester Crawford as permanent FDA commissioner. Although Crawford has been acting chief of the agency for much of the past four years, everyone is wondering what his approach will be now that he’s the boss.
Almost contemporaneously, Crawford and his boss, Health and Human Services secretary Mike Leavitt, announced the imminent formation of a drug-safety board to assess the safety of newly released drugs in the marketplace and of a website that will release the results of earlier-stage drug trials. I hope this new oversight does not signify a step backward for the FDA.
It would clearly be in the best interests of America’s health system–as well as our economy in general–for Crawford to stick to the science and sidestep the politics in his regulatory decision-making. He should aim to further streamline, rather than impede, the onerous drug-approval process.
Crawford will be under intense pressure from every across the political spectrum, especially from self-styled “consumer advocates” demanding that the FDA tilt toward safety over all other considerations. The FDA is responsible for the safety of our food supply and for evaluating the safety and efficacy of our pharmaceuticals. That is
quite a burden–especially in a society increasingly paranoid about miniscule health “risks”–and ready to litigate about each one.
The quest for safety in our drug supply is an admirable one–to a point. But activists refuse to understand the most elementary concept of drug evaluation–indeed of science itself: There is no such thing as “absolute safety.” All of life’s activities come with a baseline of unavoidable risk. As a public-health educator and former clinician, I’ve seen many lives lost and much needless suffering faced as a result of excess caution in the quest for “total safety.”
Currently, even a slight risk of adverse effects has become unacceptable. Even drugs long on the market, such as Advil, have come under assault. For those who espouse the precautionary principle, the FDA has been “asleep at the wheel,” unleashing lethal drugs on an unsuspecting populace, and should be reined in. To them, Crawford’s appointment represents “business as usual”–and he has already become a target for some well-known opponents of the pharmaceutical industry. Sidney Wolfe of Public Citizen, who was recently described as “hating all drugs,” asserted that the FDA head should not be a veterinarian (as is Crawford) but a “doctor or pharmacist” (Crawford is also a Ph.D. pharmacologist).
I believe that the FDA should be even more flexible and proactive in its drug-approval process. If Crawford caves in the face of the current uproar about allegedly lax oversight, the effect would be to make the approval process even more burdensome.
I encourage the new commissioner to consider the damage done by undue delay. The desperate need for new, more powerful remedies–for cancer, AIDS, resistant infections, and other ailments with ineffective or toxic therapies–should hold sway over the fear of novel medicines. Some toxicity is the price we pay for a vibrant, innovative drug industry, which remains the most productive and safest in the world.
The new drug-safety board may be helpful in clarifying the real risks of adverse drug reactions post-marketing, but I am not optimistic. Merely putting the results of clinical trials on a website will not benefit the public. Giving excessive information to a public untrained in scientific analysis is at least as bad as withholding it. Crawford and his FDA colleagues must educate the public about real risks without merely dumping information on citizens.
Take for example the COX-2 drugs: There is plenty of blame to go around for the current situation, including excessive blanket DTC marketing and poor patient selection by physicians. That said, physicians and patients the world over owe a serious debt of gratitude to the FDA panel that (surprisingly) spared these drugs. The American public should not lose their potentially huge benefits; if for no other reason, their likely efficacy in the chemoprevention of cancer should keep them on the market while further studies identify those groups whose risk-benefit profiles support effective use.
Crawford’s challenge will be to continue efforts to minimize the risks inherent in all drugs without kowtowing to politically motivated demands for excessive caution. When it comes to choosing to take a risk by prescribing or taking a drug, the doctor and his or her patient should make the decision, not the FDA or activist groups.
–Gilbert Ross is executive and medical director of the American Council on Science and Health.