Leading physicians are condemning the UK's decision to allow patients to buy a cholesterol–lowering statin drug without prescriptions as a colossal “experiment.”
In May, the UK declassified Simvastatin (Zocor), a statin, as an over-the-counter pharmaceutical, following advice from its Committee on Safety of Medicines. The drug will be available without prescription in a 10-mg dose — half the usual prescribed dosage — beginning this summer.
Health Secretary John Reid says statins save lives, and this will extend access to a successful drug.
But some physicians and consumer groups say the dosage has no proven efficacy and the drug may pose dangers to some.
Dr. Ike Iheanacho, deputy editor of the Drug and Therapeutics Bulletin, says there's no clinical evidence the drug is effective at 10 mg and the over-the-counter strategy has never been tested. “The whole thing is an experiment … with all the risks and limitations of experiments.”
The British Medical Association (BMA) says the 10-mg dose may not be high enough to help people who really need it, and all statins carry the risk of side effects.
The move also means patients, not the government, will have to pay for the drug. “If a drug treatment is worth taking it should be provided equitably,” says the BMA's Dr. John Chisholm.
The British Heart Foundation and the Royal Pharmaceutical Society of Great Britain support the reclassification.
The reclassification means the manufacturer can target a whole new market by advertising directly to consumers, says Iheanacho. “You can argue that it doesn't matter if it benefits industry as long as patients do well — but where is the evidence that patients will do well? Yet it is obvious that industry will do very well.”
Johnson & Johnson–Merck Consumer Pharmaceuticals Company was formed as a joint venture to seek FDA approval for a low-dose, over-the-counter version of Merck's statin Mevacor. — Colin Meek, Wester Ross, Scotland