Tuesday, April 05, 2005

UK lawmakers slam slack pharmaceutical regulation

The UK is often more outspoken and less "politically correct" in many ways regarding healthcare matters than the US. In this article, I agree with the need for regulatory independence and better reporting and evaluation of adverse drug reactions (in fact, I believe entire domain of AE reporting uses 1950's approaches and needs significant modernization). I also agree with the charges of "disease mongering" by a part of the medical establishment that stands to profit from such line redrawing, damaging the credibility of all clinicians still further beyond what mismanagement, corruption, and managed care have already accomplished.

-- SS

UK lawmakers slam slack pharmaceutical regulation
Tue Apr 5, 2005 03:24 AM ET
By Ben Hirschler

LONDON, April 5 (Reuters) - Regulation of the pharmaceutical industry is inadequate, leaving powerful drug companies free to promote "a pill for every ill", an influential British parliamentary committee said on Tuesday.

Recent scandals, notably the worldwide withdrawal of arthritis drug Vioxx, highlighted significant failings in the system, according to the Health Select Committee.

"Like any industry, drug companies need effective discipline and regulation, and these have been lacking," said committee Chairman David Hinchliffe.

The Medicines and Healthcare products Regulatory Agency (MHRA) -- the body charged with monitoring the industry -- lacked the discipline and leadership needed to protect patients, his committee said.

In future, new drugs should be more tightly controlled, with curbs on their promotion and restrictions on the ability of junior doctors to prescribe them, it recommended. There should also be a public inquiry whenever a drug was withdrawn on health grounds.

Overall, Hinchliffe said far greater transparency was needed in the oversight of medicines and scrutiny of clinical trials to ensure drugs were not over-prescribed before the full consequences of adverse side effects were known.


The strongly worded report is the latest sign of shift to a more cautious approach to medicines around the world in the wake of recent high-profile problems, which have triggered criticism of both drugmakers and regulators.

The global drugs industry was rocked in 2004 by the withdrawal of Merck & Co. Inc.'s Vioxx, after it was linked to increased risk of heart attack and strokes.

A serious safety problem also emerged last year over selective serotonin reuptake inhibitor (SSRI) antidepressants, such as GlaxoSmithKline Plc's Seroxat/Paxil, which have been linked to suicidal behaviour in a minority of patients.

The UK committee said the pharmaceutical industry -- led in Britain by GSK and AstraZeneca Plc -- had produced many life-saving medicines but had become increasingly focused on marketing rather than science.

This was the source of many of the current problems, including a trend towards "disease mongering", whereby increasing numbers of people are defined as abnormal and therefore eligible for drug treatment, it concluded.

Recommendations for change include greater MHRA independence from both government and the pharmaceutical industry, and better reporting and evaluation of adverse drug reactions.

The lawmakers also want to see responsibility for the pharmaceutical industry transferred from the Department of Health to the Department of Trade and Industry, to ensure health priorities are not muddied by trade considerations.

The Association of the British Pharmaceutical Industry said it supported calls for improved information for patients and better reporting of side effects.

But director general Richard Barker said the report contained a number of "fundamental misconceptions" and he challenged the view that drug consumption was excessive, since Britain had one of the slowest uptakes of new drugs in Europe.

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