Save the FDA
http://www.100md.com
《英国医生杂志》
EDITOR—Abbasi asks whether drug regulation is failing.1 The US Food and Drug Administration (FDA) performs a thankless task. Patients want new drugs available immediately and agitate to accomplish this. Patients also wish medicines to be guaranteed safe, and blame the FDA when toxicity leads to a drug's withdrawal. Clinical scientists complain that the FDA obstructs their investigations. Pharmaceutical companies see the FDA as an adversary, not a protector.
Practising in the USA for 20 years, I encountered many FDA agents. A few revered regulations for their own sake. Such people are irksome, but without strict oversight valueless and toxic agents would be marketed. A prime example is Laetrile (laevo-mandelonitrile-beta-glucuronoside), a useless and poisonous drug promoted for cancer treatment. The FDA, supported by the National Cancer Institute, successfully resisted extreme public pressure to allow its marketing, saving many lives and a multi-million dollar fraud.
The FDA faces serious accusations. Attempting to suppress David Graham's whistleblowing on rofecoxib assaults scientific honesty.2 3 The FDA's refusal to allow non-prescription sales of emergency contraception indicates unacceptable political pressure from the religious right. Unduly close relations between the FDA and pharmaceutical companies may lead to premature marketing approvals.
How should the FDA be saved?
Firstly, officials ordering withdrawal of a drug should be independent of those who approve marketing.
Secondly, making the FDA a quango would protect from political pressures.
Thirdly, conflicts of interest involving FDA employees and consultants must be rigorously scrutinised, even more severely than editors scrutinise the interests of contributors.
The UK's Medicines and Healthcare products Regulatory Agency is accused of proindustry bias. Housecleaning there and at the FDA will benefit patients, doctors, and the pharmaceutical industry itself.
Alexander S D Spiers, retired professor of medicine
Cookham Dean, Berkshire spiersuk@btinternet.com
Competing interests: None declared.
References
Abbasi K. Editor's choice. Is drug regulation failing? BMJ 2004;329. (27 November.)
Lenzer J. Public interest group accuses FDA of trying to discredit whistleblower. BMJ 2004;329: 1255. (27 November.)
Lenzer J. FDA is incapable of protecting US "against another Vioxx." BMJ 2004;329: 1253. (27 November.)
Practising in the USA for 20 years, I encountered many FDA agents. A few revered regulations for their own sake. Such people are irksome, but without strict oversight valueless and toxic agents would be marketed. A prime example is Laetrile (laevo-mandelonitrile-beta-glucuronoside), a useless and poisonous drug promoted for cancer treatment. The FDA, supported by the National Cancer Institute, successfully resisted extreme public pressure to allow its marketing, saving many lives and a multi-million dollar fraud.
The FDA faces serious accusations. Attempting to suppress David Graham's whistleblowing on rofecoxib assaults scientific honesty.2 3 The FDA's refusal to allow non-prescription sales of emergency contraception indicates unacceptable political pressure from the religious right. Unduly close relations between the FDA and pharmaceutical companies may lead to premature marketing approvals.
How should the FDA be saved?
Firstly, officials ordering withdrawal of a drug should be independent of those who approve marketing.
Secondly, making the FDA a quango would protect from political pressures.
Thirdly, conflicts of interest involving FDA employees and consultants must be rigorously scrutinised, even more severely than editors scrutinise the interests of contributors.
The UK's Medicines and Healthcare products Regulatory Agency is accused of proindustry bias. Housecleaning there and at the FDA will benefit patients, doctors, and the pharmaceutical industry itself.
Alexander S D Spiers, retired professor of medicine
Cookham Dean, Berkshire spiersuk@btinternet.com
Competing interests: None declared.
References
Abbasi K. Editor's choice. Is drug regulation failing? BMJ 2004;329. (27 November.)
Lenzer J. Public interest group accuses FDA of trying to discredit whistleblower. BMJ 2004;329: 1255. (27 November.)
Lenzer J. FDA is incapable of protecting US "against another Vioxx." BMJ 2004;329: 1253. (27 November.)