Friday, March 04, 2005
The perfect drug
[Gilbert Ross, "The Myth of Absolute Safety," National Review, 2 March 2005.]
Is it possible for the FDA to guarantee us perfectly safe medicine? American Council on Science and Health executive and medical director Gilbert Ross reminds us that we cannot expect miracles:
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.
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.
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.
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, "The Myth of Absolute Safety," National Review, 2 March 2005.]
Is it possible for the FDA to guarantee us perfectly safe medicine? American Council on Science and Health executive and medical director Gilbert Ross reminds us that we cannot expect miracles:
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.
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.
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.
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.
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