Friday, January 07, 2005
Risk, reward and the FDA
[Gregory M. Lamb, "Drug tests: too speedy - or safe enough?," The Christian Science Monitor, 6 January 2005.]
With news headlines filled with stories of drug recalls and warnings, some are beginning to question whether the FDA is fulfilling its role:
As Americans try to figure out how suspect drugs got into their medicine cabinets - and who is to blame - two startling facts are coming to the fore: 1) The consumption of all medications involves some risk and 2) The bar for establishing their safety is set much lower than many people think. Furthermore, some experts say, these risks are almost impossible to avoid.
The seeds of the current crisis were planted more than a decade ago when Congress, under public pressure, directed the federal Food and Drug Administration (FDA) to make speedy approval of new drugs, rather than safety testing, its priority.
"It's a common misperception that the FDA approves drugs that are safe and effective," says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, a nonprofit research group affiliated with Tufts University in Boston. "The FDA actually approves drugs where the expected benefits outweigh the expected risks of that drug. It's always a risk-benefit analysis."
In the 1970s and '80s, the FDA had an "overly cautious approach to drug approval," in the view of Dr. Kaitin. Research by his center at Tufts showed the United States trailed behind other countries in developing new drugs, a so-called "drug lag."
The AIDS epidemic of the late '80s helped stir public thought to demand rapid drug development, he says, and Congress responded by giving the FDA new latitude to speed up the process, including fast-track approvals.
Today no new epidemic is causing a widespread public outcry so the pendulum has swung back toward safety concerns, Kaitin says.
"You can't have it both ways," says Mr. Weisman. That means choosing between a long approval process or bringing valuable new drugs quickly to the market, he adds.
Perhaps it would be good to step back and consider for a moment the incentives at work within an agency such as the FDA. The goal from the perspective of the FDA is to avoid negatives. There is no reward for releasing a successful drug, improving lives, etc., as in the private market. There is, however, risk in being blamed for a drug that may lead to complications. As mentioned above, this is virtually impossible to avoid so the incentive would naturally be to never release anything. The agency is also exposed to political risk if it fails to release drugs that may be helpful, though. Seen from this angle, it is easier to understand the actions of the agency - the goals have less to do with the betterment of society than security within the organization. Standard bureaucratic behavior.
The question is just because a government agency acts in response to negatives, does the rest of society? Must we continue to fund a body that shifts its priorities between releasing potentially dangerous drugs and not releasing potentially beneficial drugs based on changing political tides?
Certainly, there are side effects to some drugs that do not reveal themselves except over long periods of use, or when used in conjunction with other products, or when misused by those taking them. The fact is, though, that this is the case with many products. If an agency is essentially powerless to prevent such problems without destroying a market by requiring testing for every possible scenario, then what is its value? If we applied a similar "precautionary principle" to every product on the market, would we be better off? These are the kinds of questions policymakers must ask before engaging in another round of reforms at the FDA.
[Gregory M. Lamb, "Drug tests: too speedy - or safe enough?," The Christian Science Monitor, 6 January 2005.]
With news headlines filled with stories of drug recalls and warnings, some are beginning to question whether the FDA is fulfilling its role:
As Americans try to figure out how suspect drugs got into their medicine cabinets - and who is to blame - two startling facts are coming to the fore: 1) The consumption of all medications involves some risk and 2) The bar for establishing their safety is set much lower than many people think. Furthermore, some experts say, these risks are almost impossible to avoid.
The seeds of the current crisis were planted more than a decade ago when Congress, under public pressure, directed the federal Food and Drug Administration (FDA) to make speedy approval of new drugs, rather than safety testing, its priority.
"It's a common misperception that the FDA approves drugs that are safe and effective," says Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, a nonprofit research group affiliated with Tufts University in Boston. "The FDA actually approves drugs where the expected benefits outweigh the expected risks of that drug. It's always a risk-benefit analysis."
In the 1970s and '80s, the FDA had an "overly cautious approach to drug approval," in the view of Dr. Kaitin. Research by his center at Tufts showed the United States trailed behind other countries in developing new drugs, a so-called "drug lag."
The AIDS epidemic of the late '80s helped stir public thought to demand rapid drug development, he says, and Congress responded by giving the FDA new latitude to speed up the process, including fast-track approvals.
Today no new epidemic is causing a widespread public outcry so the pendulum has swung back toward safety concerns, Kaitin says.
"You can't have it both ways," says Mr. Weisman. That means choosing between a long approval process or bringing valuable new drugs quickly to the market, he adds.
Perhaps it would be good to step back and consider for a moment the incentives at work within an agency such as the FDA. The goal from the perspective of the FDA is to avoid negatives. There is no reward for releasing a successful drug, improving lives, etc., as in the private market. There is, however, risk in being blamed for a drug that may lead to complications. As mentioned above, this is virtually impossible to avoid so the incentive would naturally be to never release anything. The agency is also exposed to political risk if it fails to release drugs that may be helpful, though. Seen from this angle, it is easier to understand the actions of the agency - the goals have less to do with the betterment of society than security within the organization. Standard bureaucratic behavior.
The question is just because a government agency acts in response to negatives, does the rest of society? Must we continue to fund a body that shifts its priorities between releasing potentially dangerous drugs and not releasing potentially beneficial drugs based on changing political tides?
Certainly, there are side effects to some drugs that do not reveal themselves except over long periods of use, or when used in conjunction with other products, or when misused by those taking them. The fact is, though, that this is the case with many products. If an agency is essentially powerless to prevent such problems without destroying a market by requiring testing for every possible scenario, then what is its value? If we applied a similar "precautionary principle" to every product on the market, would we be better off? These are the kinds of questions policymakers must ask before engaging in another round of reforms at the FDA.
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