The Consumers Association has called for an overhaul of the UK drug regulator after it admitted publishing misleading information over public support for the over-the-counter sale of cholesterol-lowering drugs.
The Medicines and Healthcare products Regulatory Agency has bowed to pressure from Consumers Association publication, Drug and Therapeutics Bulletin, which criticised the survey results as inaccurate. Last May, the MHRA claimed that around two thirds of people responding to a public consultation on whether Merck & Co’s Zocor Heart Pro (simvastatin) should be sold OTC, were in favour of the proposal. Zocor Heart Pro was launched into UK pharmacies in July [[30/07/04a]].
The agency has now acknowledged that the results were incorrect due to “an administrative error”, and has clarified that in fact one third of respondents were in favour of switching the product from prescription-only to OTC status, while a third were against the move, and the remainder were not opposed, but did raise concerns. “We apologise for any confusion caused by this error,” the agency said in a statement on its website. “We in no way intended to misrepresent the results and can assure the public and other interested parties that the correct findings were given to the Committee on Safety of Medicines who made their recommendations with the full facts in front of them.”
However, the Consumers Association claims that the episode casts a dark shadow over the MHRA and echoed stark calls from the UK Government’s Health Select Committee’s investigation into the influence of the pharmaceutical industry for an overhaul of the country’s drug regulator [[05/04/05a]]. “This has got to be the killer argument for a massive overhaul of the MHRA,” said DTB editor, Ike Iheanacho. “Their job is to protect people but this latest episode totally undermines faith in their decision-making process.” Dr Iheanacho continued: “The MHRA has stated that it has made an “administrative error” but there must be concerns that it dressed up the consultation responses to support its own decision to make simvastatin available over the counter. The MHRA displayed a mixture of arrogance and carelessness which is certainly not ideal in a body supposed to protect the public.”
The Consumers’ Association is one of several bodies, including the Royal College of General Practitioners and The Lancet [[14/05/04d]], [[21/05/04b]], that opposed moving Zocor Heart Pro to OTC status, and previously accused the Government of using the UK public as guinea pigs in a “cost-cutting exercise” [[14/05/04d]].