A government agency misled the public over the results of a consultation exercise, which it claimed had come out in favour of letting a heart drug be sold by high street chemists without a prescription.
The move to change the status of Zocor Heart-Pro, a statin which can help lower cholesterol, was so controversial that the Medicines and Healthcare Products Regulatory Authority (MHRA) launched a public consultation in December 2003. Around 100 organisations and individuals responded, including medical royal colleges and pharmacists' organisations.
Allowing people to buy the drug without seeing a doctor was a world first. The government was in favour, hoping it would reduce heart attacks and cut NHS bills since some people would buy the drug rather than get it on prescription. But there was concern about side-effects of the drug, generically known as simvastatin, and also that some people who need stronger medication would buy it rather than see a doctor.
The MHRA last year announced that two-thirds of those consulted were in favour of the drug being sold in pharmacies. Yesterday, however, after a battle with the consumer publication Drug and Therapeutics Bulletin, it conceded that the figures were wrong. Only one third of those who responded agreed unequivocally with the change of status of the drug, one third did not agree and the rest had reservations. The MHRA said there had been "an administrative error".
But the editor of the Bulletin, published by Which?, said yesterday that the episode cast doubt on the entire decision-making process at the MHRA.
"This has got to be the killer argument for a massive overhaul of the MHRA," said Dr Ike Iheanacho. "Their job is to protect people but this latest episode totally undermines faith in their decision-making process."
Dr Iheanacho said that even now, after a highly critical report earlier this year by the Commons health select committee, which objected to a lack of openness by the MHRA and its closeness to the pharmaceutical industry, too many decisions were being made behind closed doors.
"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," he said. "The MHRA displayed a mixture of arrogance and carelessness which is certainly not ideal in a body supposed to protect the public."
In April, after the Bulletin scrutinised those responses to the consultation which had been made public and told the MHRA the figure of two-thirds could not be right, the agency issued a robust denial.
Yesterday the MHRA did a u-turn and apologised "for any confusion caused by this error".
But the final count is still in question, said Dr Iheanacho. Among responses now categorised as "not opposed but raised issues to be considered" are letters which appear entirely critical of the proposal.
The National Patient Safety Agency's letter said: "If there is no direct or indirect danger to health when simvastatin is used without medical supervision, the question begs why have other countries not reclassified the drug as safe to use OTC [over the counter]?"
The Royal College of Paediatrics and Child Health expressed concern about potential long-term side-effects and worried that neither GPs nor pharmacists would know what drugs a patient was on.
The MHRA said in a statement that the full and correct facts had been put in front of the Committee on the Safety of Medicines, the experts which made the final decision.
