Healthy Skepticism Library item: 19833

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Abraham J.
Transnational industrial power, the medical profession and the regulatory state: adverse drug reactions and the crisis over the safety of Halcion in the Netherlands and the UK.
Soc Sci Med 2002; 55:(9):1671-90
http://linkinghub.elsevier.com/retrieve/pii/S0277953602001600

Abstract:

Taking the controversy over the safety of the hypnotic, Halcion, in the Netherlands and the UK, as a case study, this article examines the problems for public health associated with responses to warnings about drug hazards by regulatory agencies, governmental expert advisers, the pharmaceutical industry and the medical profession. It is argued that regulators and the medical profession rely too heavily on manufacturers to investigate warnings from doctors’ spontaneous reporting of adverse effects of drug products on the market. It is demonstrated that a pharmaceutical firm’s commitment to search effectively for evidence against the safety of its own product in order to confirm doctors’ warnings can have severe limitations. Deficiencies in the socio-institutional responses to post-market ‘early warning systems’ about drug hazards imply that the regulatory policies of ‘early licensing’ and minimal pre-market checks for new drugs are misconceived and threaten public health. To improve public protection from drug injury, the regulators should abandon their conviction that compelling evidence of drug hazards are required to confirm doctors’ warning signals prior to regulatory intervention. Instead, they should adopt a policy of measured regulatory intervention as an immediate response to warning signals, while investigators, independent of the manufacturers, assess the significance of the signal.