UK legislators demand pharma shake-up

A tougher regulatory regime, curbs on drug promotion, financial penalties for companies that break advertising rules, and a register of industry gifts to healthcare professionals have been demanded by British legislators.

Following their investigation into the influence of the pharmaceutical industry, members of the House of Commons Health Committee said in a report that the present regulatory system is too weak to prevent the unsafe use of drugs.

They called for a fundamental review of the Medicines and Healthcare Products Regulatory Agency (MHRA) which had "failed to adequately scrutinise licensing data" and whose post-marketing surveillance was "inadequate".

"The organisation has been too close to the industry," the report said. "We are concerned that a rather lax regime is exacerbated by the MHRA's need to compete with other European regulators for licence application business."

The committee was equally critical of the industry and highlighted the comments of one star witness -- former Glaxo CEO Richard Sykes -- who said the industry had a very bad name and needed to make major changes.

The inquiry also heard that clinical trials could be designed to show a new drug in the best light, and sometimes failed to indicate the true effects of a medicine on health outcomes relevant to the patient.

"We were informed of several high-profile cases of suppression of trial results. We also heard of selective publication strategies and ghost-writing," the report said.

Once licensed, medicines were intensely promoted, it added. "At the heart of the problem may be the trend for the industry to become ever more driven by its marketing force."

The industry should be led by the values of its scientists, not those of its marketing force. "The intensive marketing which encourages inappropriate prescribing of drugs must be curbed."

The report recommended limits on the volume of promotional materials, particularly in the first six months after a drug launch. Companies that breached advertising regulations should have their marketing allowance docked under the Pharmaceutical Pricing Regulation Scheme.