What Ails the FDA?
http://www.100md.com
《新英格兰医药杂志》
To the Editor: Okie's Perspective article (March 17 issue)1 on the Food and Drug Administration (FDA) covers important ground but misses a key issue. No drug is absolutely safe; drug safety is always assessed in relation to the disease being treated. We tolerate greater risk from beneficial therapy when the alternatives are bad.
Risk–benefit analysis requires us to define the target population for the drug. Clinical trials are the best way to define this population. Direct-to-consumer marketing campaigns, on which drug companies spend billions of dollars, circumvent this process and often encourage patients to demand prescription drugs inappropriately. Rofecoxib (Vioxx) was an important beneficiary of such a campaign. As a result, many people were put at risk although their medical needs could have been met with less toxic drugs.
Today, patients for whom rofecoxib provided the best relief are no longer able to obtain it. In short, pharmaceutical-company greed created an unmet medical need. There is a cost-free way to help the FDA protect patients: stop direct-to-consumer advertising and let trained and knowledgeable physicians determine the best treatment for our patients.
Kenneth J. Gorelick, M.D.
1 Maplewood Dr.
Newtown Square, PA 19073
References
Okie S. What ails the FDA? N Engl J Med 2005;352:1063-1066.
To the Editor: What ails the FDA is the political influence that limits the agency's resources and interferes with its regulatory decisions.1,2,3 The FDA has always been underfunded and understaffed in relation to the scope of its responsibilities.1 Surveillance of drug safety has been impaired by a decrease in the personnel and resources devoted to it because of the emphasis on the rapid review of new drugs and unfunded congressional mandates. The other problems noted by Okie — intimidation of staff scientists, weak leadership, and the pro-industry bias of the former chief counsel — are manifestations of the political manipulation of the FDA by the administration.
Two changes are necessary to restore the FDA to health: a budget that is commensurate with its responsibilities and scientific independence. The FDA could be shielded from political manipulation through the appointment of an independent scientific advisory board to advise Congress about the performance and needs of the agency. By making its recommendations public, the advisory board could help Congress to resist pressure from lobbyists and advocacy groups.
Donald M. Marcus, M.D.
Baylor College of Medicine
Houston, TX 77030
dmarcus@bcm.tmc.edu
References
Hilts PJ. Protecting America's health: the FDA, business, and one hundred years of regulation. New York: Alfred A. Knopf, 2003:117-28.
Drazen JM, Greene MF, Wood AJJ. The FDA, politics, and Plan B. N Engl J Med 2004;350:1561-1562.
Harris G. Regulation redefined: the F.D.A. shifts focus: at F.D.A., strong drug ties and less monitoring. New York Times. December 6, 2004:A1.
To the Editor: Okie's article could lead the reader to the conclusion that an independent drug-safety agency would protect patients better. But Okie omits certain events surrounding the withdrawal of rofecoxib from the market that illustrate the potential downside of separating the FDA's drug-approval function from post-marketing safety surveillance. In particular, she does not mention the fact that experts in drug safety and the relevant therapeutic field who gathered at an FDA advisory committee meeting in February to discuss the safety of cyclooxygenase-2 (COX-2) inhibitors and nonsteroidal antiinflammatory drugs (NSAIDs) voted 17 to 15 that rofecoxib ought to be allowed to be marketed. Nor did Okie mention that David Graham, the FDA epidemiologist who has heartily criticized the agency's handling of the rofecoxib review, is rather more certain in his views of the benefit–risk equation for the drug; he has said that "there really doesn't appear to be a need for COX-2 selective NSAIDs." The point is that drug-safety experts tend to downplay therapeutic benefits, and clinical practitioners tend to downplay risks. What is needed at the FDA is an unrestrained voice for experts on both sides of the equation.
Fredric J. Cohen, M.D.
Crownstone Investment Research and Consulting
Bensalem, PA 19020
fred@crownstonegroup.com
To the Editor: To redress the institutionalized influence of the pharmaceutical industry on the FDA's drug-approval process, perhaps third-party payers such as insurance companies and health
maintenance organizations need to be invited to join the fray. These payers cover not only the costs of expensive new technology, but also any costs incurred because of unanticipated adverse effects. Who is more motivated to expose problems with efficacy and safety that are deliberately obscured by the pharmaceutical industry? Rather than perpetuate the sham of an unbiased partnership between government and industry committed to protecting and enhancing health, why not expose the powerful financial motivations that drive health care decisions? If drug companies are treated as agents of science and discovery, payers ought to be viewed as the corrective agents of scientific scrutiny. A more open discourse involving parties with admittedly different agendas may more successfully illuminate the issues critical to decisions that have consequences for public health and public coffers.
Elizabeth R. Jenny-Avital, M.D.
Albert Einstein College of Medicine
Bronx, NY 10461
jennyavita@earthlink.net
Risk–benefit analysis requires us to define the target population for the drug. Clinical trials are the best way to define this population. Direct-to-consumer marketing campaigns, on which drug companies spend billions of dollars, circumvent this process and often encourage patients to demand prescription drugs inappropriately. Rofecoxib (Vioxx) was an important beneficiary of such a campaign. As a result, many people were put at risk although their medical needs could have been met with less toxic drugs.
Today, patients for whom rofecoxib provided the best relief are no longer able to obtain it. In short, pharmaceutical-company greed created an unmet medical need. There is a cost-free way to help the FDA protect patients: stop direct-to-consumer advertising and let trained and knowledgeable physicians determine the best treatment for our patients.
Kenneth J. Gorelick, M.D.
1 Maplewood Dr.
Newtown Square, PA 19073
References
Okie S. What ails the FDA? N Engl J Med 2005;352:1063-1066.
To the Editor: What ails the FDA is the political influence that limits the agency's resources and interferes with its regulatory decisions.1,2,3 The FDA has always been underfunded and understaffed in relation to the scope of its responsibilities.1 Surveillance of drug safety has been impaired by a decrease in the personnel and resources devoted to it because of the emphasis on the rapid review of new drugs and unfunded congressional mandates. The other problems noted by Okie — intimidation of staff scientists, weak leadership, and the pro-industry bias of the former chief counsel — are manifestations of the political manipulation of the FDA by the administration.
Two changes are necessary to restore the FDA to health: a budget that is commensurate with its responsibilities and scientific independence. The FDA could be shielded from political manipulation through the appointment of an independent scientific advisory board to advise Congress about the performance and needs of the agency. By making its recommendations public, the advisory board could help Congress to resist pressure from lobbyists and advocacy groups.
Donald M. Marcus, M.D.
Baylor College of Medicine
Houston, TX 77030
dmarcus@bcm.tmc.edu
References
Hilts PJ. Protecting America's health: the FDA, business, and one hundred years of regulation. New York: Alfred A. Knopf, 2003:117-28.
Drazen JM, Greene MF, Wood AJJ. The FDA, politics, and Plan B. N Engl J Med 2004;350:1561-1562.
Harris G. Regulation redefined: the F.D.A. shifts focus: at F.D.A., strong drug ties and less monitoring. New York Times. December 6, 2004:A1.
To the Editor: Okie's article could lead the reader to the conclusion that an independent drug-safety agency would protect patients better. But Okie omits certain events surrounding the withdrawal of rofecoxib from the market that illustrate the potential downside of separating the FDA's drug-approval function from post-marketing safety surveillance. In particular, she does not mention the fact that experts in drug safety and the relevant therapeutic field who gathered at an FDA advisory committee meeting in February to discuss the safety of cyclooxygenase-2 (COX-2) inhibitors and nonsteroidal antiinflammatory drugs (NSAIDs) voted 17 to 15 that rofecoxib ought to be allowed to be marketed. Nor did Okie mention that David Graham, the FDA epidemiologist who has heartily criticized the agency's handling of the rofecoxib review, is rather more certain in his views of the benefit–risk equation for the drug; he has said that "there really doesn't appear to be a need for COX-2 selective NSAIDs." The point is that drug-safety experts tend to downplay therapeutic benefits, and clinical practitioners tend to downplay risks. What is needed at the FDA is an unrestrained voice for experts on both sides of the equation.
Fredric J. Cohen, M.D.
Crownstone Investment Research and Consulting
Bensalem, PA 19020
fred@crownstonegroup.com
To the Editor: To redress the institutionalized influence of the pharmaceutical industry on the FDA's drug-approval process, perhaps third-party payers such as insurance companies and health
maintenance organizations need to be invited to join the fray. These payers cover not only the costs of expensive new technology, but also any costs incurred because of unanticipated adverse effects. Who is more motivated to expose problems with efficacy and safety that are deliberately obscured by the pharmaceutical industry? Rather than perpetuate the sham of an unbiased partnership between government and industry committed to protecting and enhancing health, why not expose the powerful financial motivations that drive health care decisions? If drug companies are treated as agents of science and discovery, payers ought to be viewed as the corrective agents of scientific scrutiny. A more open discourse involving parties with admittedly different agendas may more successfully illuminate the issues critical to decisions that have consequences for public health and public coffers.
Elizabeth R. Jenny-Avital, M.D.
Albert Einstein College of Medicine
Bronx, NY 10461
jennyavita@earthlink.net