Lois Rogers

Journalist and Communicator

Statins expert in row over level of risk to patients

Health Policy

A leading Oxford medical researcher who says statins are safe is at loggerheads with a company that makes “misleading” claims about the drugs’ side effects to sell a diagnostic test he invented.

More than 6m people take statins — drugs which reduce cholesterol and save an estimated 7,000 lives a year — but there is a fierce debate about the benefits and side effects.

Sir Rory Collins, a professor of medicine and epidemiology at Oxford University, led a review into statins, published in The Lancet earlier this month, which found that not more than one in 50 people will suffer side effects.

Collins, who believes millions more Britons could benefit by taking statins, is also co-inventor of a test that indicates susceptibility to muscle pain from them.

In 2009, he and three co- inventors filed the patent for a genetic marker that identifies patients at increased risk of myopathy (muscular pain). The patent says the incidence of myopathy is around one in 10,000 patients per year on a standard statin dose.

The test, branded as Statin–Smart, is sold online for $99 (£76) on a website that claims 29% of statin users will suffer muscle pain, weakness or cramps. The marketing material also claims that 58% of patients on statins stop taking them within a year, mostly because of muscle pain.

Oxford University said Collins had raised his concerns “several times” about “misleading” marketing claims made by Boston Heart Diagnostics, the American company granted the exclusive licence for Collins’s patent by the university.

Royalties from the licensing of the patent can be used to fund university research, but Collins and his co-inventors have waived personal fees.

Experts warned of the damage that could be done by ‘uninformed scare stories’

Boston Heart Diagnostics said it stood by its claims about statin side effects and that they were based on published research. It also cited a US taskforce on statin safety that said randomised controlled trials — such as those used in the Lancet study led by Collins — had “major limitations” because patients with statins intolerance were often excluded.

Peter Weissberg, medical director at the British Heart Foundation, described the Lancet review as a “masterclass in how evidence should be interpreted”.

Experts at a briefing organised by the respected Science Media Centre described it as an “excellent” review and warned of the damage that could be done by “uninformed scare stories” on side effects.

However, other medical experts have said they are dubious about the “vanishingly small” level of side effect found in the trials.

Trish Greenhalgh, professor of primary health care sciences at Oxford University, said: “The authors did not highlight the huge biases that are going to happen when you exclude some people with side effects from trials. The jury is still out.”

Written by Lois Rogers