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OTC Zocor to be cleared but divisions persist

Published on 28/04/04 at 05:27pm

The government is shortly to announce the approval of the world's first over-the-counter statin, Zocor Heart Pro, but is unlikely to win over a number of sceptics who remain unconvinced about the wisdom of the move.

The Department of Health and manufacturers Johnson & Johnson MSD were remaining tight-lipped about the proposal's status, but the UK Committee on Safety of Medicines is understood to have approved the switch.

Dr John Blenkinsopp, Principal Research Fellow in Clinical Pharmacology, Bradford University and a consultant closely involved in the recent POM-P switch of omeprazole said: "It's going to happen. The CSM has told the MHRA that they are happy for it [Zocor Heart Pro] to be approved," adding that there had been no 'showstoppers' from consultation with stakeholders, which the committee had not anticipated.

A small but significant number of stakeholders have opposed the switch proposal, since it was first launched in November last year by Health Secretary John Reid, who endorsed the plan by saying it could potentially save hundreds of lives every year.

The Royal College of General Practitioners (RCGP) has been one of its staunchest opponents, claiming that the proposed 10mg dose will not be of significant benefit to consumers buying the drug, and that its sale would also be counterproductive to promoting healthy lifestyle changes such as weight loss and smoking cessation. Moreover, the RCGP says pharmacists' lack of access to patient records means potential danger signs could be missed altogether.

Dr Jim Kennedy, the College president, told the Daily Mail: "There are potential risks for patients from adverse reactions and interactions with other drugs. We have grave reservations about this plan."

A spokesperson for the College said it would await further details from the government about how these concerns might be addressed, but suspected that J&J MSD was "just as in the dark as we are" regarding important details of how the drug would be dispensed.

Similar concerns have been voiced by  other stakeholders, including the BMA and Joe Collier, professor of medicines policy at St George's Hospital and editor of the Drug and Therapeutics Bulletin.

Dr Blenkinsopp said there would always be vested interests influencing opinion on either side of the debate but those who put forward balanced arguments should be respected. He said: "You have got to remember that the RCGP have voted against every POM-P switch for the last 20 years," including the morning-after pill and Ibuprofen. "If they have always been against them then you start to get the feeling they are crying wolf."

As for the argument on the efficacy of 10mg, Dr Blenkinsopp says patients actually see the greatest cholesterol lowering benefit from low doses - LDL cholesterol falling an average of 27% on 10 to 20mg doses, with subsequent dose increases producing diminishing returns.

Another accusation levelled at the plan is that it shifts costs from the NHS to the consumer, but the government insists it is about increasing access for patients who would otherwise not seek out a prescription.

Dr Blenkinsopp added: "If people think this is cost shifting then they are missing the point - the people who will be buying the statins are not high risk patients who need to be prescribed a statin."

Pfizer, manufacturer of the UK's biggest prescription-only statin Lipitor also opposed the switch, citing concerns about the lack of a formal cardiovascular risk assessment and communication with GPs, as two major omissions from J&J MSD's proposal.

Pfizer and other statin marketers will also fear the switch could cannabalise the prescription market, but Dr Blenkinsopp echoes other experts in his prediction that it could actually fuel it.

"Some will be found to need a higher dose of statins and so there will in fact be an increase in the prescribing of statins as a result," he said.

The manufacturer has identified two main target groups for Zocor Heart Pro: men aged 55 or over, a group likely to be at moderate risk of CHD and men aged 45 to 54 and women over the age of 55, in high risk groups (having a family history of heart disease; a smoker or seriously overweight; or from a South Asian ethnic group).

A new campaign Pop Down Your Local aimed at encouraging men to make the most of community pharmacies, has now been launched through collaboration between The Men's Health Forum and pharmacists' body the Royal Pharmaceutical Society of Great Britain (RPSGB).

The campaign ties in with Zocor Heart Pro's imminent launch expected this summer and the wider agenda of expanding the role of pharmacists, to be embodied in a new contract currently under negotiation with the government.

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