Save the FDA

doi:10.1136/bmj.330.7486.308

BMJ 2005;330:308 (5 February), doi:10.1136/bmj.330.7486.308

Letter

Save the FDA

The first 150 words of the full text of this article appear below.

EDITOR—Abbasi asks whether drug regulation is failing.¹The US Food and Drug Administration (FDA) performs a thanklesstask. Patients want new drugs available immediately and agitateto accomplish this. Patients also wish medicines to be guaranteedsafe, 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 aprotector.

Practising in the USA for 20 years, I encountered many FDA agents.A few revered regulations for their own sake. Such people areirksome, but without strict oversight valueless and toxic agentswould 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, successfullyresisted extreme public pressure to allow its marketing, savingmany lives and a multi-million dollar fraud.

The FDA faces serious accusations. . . . [Full text of this article]

Alexander S D Spiers, retired professor of medicine

Cookham Dean, Berkshire spiersuk@btinternet.com