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Deaths Lead to Complete Safety Review of Heart Drugs

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The Sunday Times - Britain
March 06, 2005
Lois Rogers, Medical Editor


EXPERTS are calling for a complete safety review of heart drugs taken by millions of Britons. Government figures released last week show that 92 deaths have been linked to the statin drugs developed to lower cholesterol.

It is believed that the death toll could be higher because doctors are reluctant to blame drugs they prescribe for harming patients.

More than 37 of the deaths were attributed to a formulation called simvastatin which is now being sold over the counter in low doses under the brand name Zocor.

Many specialists are concerned that the drug, produced by Merck, should be available without a prescription. A statin called Lipitor, made by Pfizer, was associated with 36 of the deaths.

Three other leading statin brands — Novartis’s Lescol, BMS’s Lipostat and AstraZeneca’s Crestor — have been associated with 19 deaths since they were introduced in the late 1980s and early 1990s.

As well as the deaths there have also been reports of 7,000 side effects reported to the Department of Health by doctors, including kidney and liver damage and muscle weakness.

Doctors accept that the cholesterol-lowering effects of statins have saved thousands of people from dying prematurely of heart disease, but question whether they should have been distributed so widely. There are an estimated 3.9m people taking the drugs, almost a third more than a year ago.

The drug companies are targeting at least 4m more middle-aged Britons said to be at “moderate risk” of a heart attack in the next 10 years because they are over 55 and overweight.

Anxiety about overuse of the drugs is coupled with a growing body of research suggesting the connection between cholesterol levels and health is more complex than previously thought. A number of investigations have found that people with higher amounts of cholesterol live longer than those with lower levels, suggesting it may only be a cause of heart disease in much younger people.

Next month an inquest is to take place into the death of Ivor Meacher, 71, a fit former tennis coach from Okehampton, Devon, who became ill and died within weeks of being prescribed a statin for an irregular heartbeat.

Research by his daughter, Jay Ballard, has produced what she says is irrefutable evidence that his death was caused by the drug atorvastatin, manufactured by Pfizer and marketed in Britain as Lipitor.

She was, however, unable to persuade her father’s doctors to make an official report of the death through the government’s “yellow card” scheme for adverse drug reactions.

Eventually she contacted Andrew Herxheimer, emeritus fellow of the United Kingdom Cochrane Centre and co-founder of DIPEx (an electronic database of patients’ experiences) in Oxford. He has filed a yellow card on her behalf.

Cholesterol, a type of fat, is needed in the body for the production of hormones, but if there is too much it sticks to the walls of blood vessels and eventually blocks them. Statins block a liver enzyme needed to produce cholesterol.

The body reacts by pulling in cholesterol from the bloodstream, thus lowering circulating levels.

Until now statins have been regarded as a wonder drug. The worldwide market for them is worth upwards of £30 billion.

Herxheimer, however, has questioned the heavy promotion of the drugs. “We don’t know what other things statins do apart from reducing lipids in the liver,” he said.

The most severe adverse effect of statins is called rhabdomyolysis, where muscle is “dissolved” and the breakdown products block the kidneys, with fatal consequences.

Michael Zaiac, associate medical director for Pfizer UK, said the company was happy that the benefits of the drug far outweighed the risks.

A spokesman for Zocor said they were confident the drug had an acceptable safety profile.

The Food and Drug Administration, which licenses medications in America, has been forced to review the safety of one statin in particular: Crestor. This came after David Graham, the FDA’s leading drug safety expert, turned whistleblower last autumn to raise concerns about levels of kidney damage.

Last week the FDA said patients taking Crestor or other statins might be at higher risk of kidney failure for reasons other than the drug. Graham is not convinced, “When I looked at the benefits and risks of Crestor, I saw a lot of unanswered questions. Statins have multiple effects,” he said.

Beatrice Golomb, a scientist at the University of California in San Diego, has been sponsored by the National Institutes of Health to investigate the effects of statins on mental function in 1,000 patients. It is understood she has recorded a number of problems ranging from memory lapses to changes in personality.

Last year a study of almost 150,000 people in Austria found that those with lowered cholesterol were more likely to die of cancer.

Andrew Clark, a cardiologist at Castle Hill hospital in Hull, was the co-author of an international study of 417 heart failure patients that showed those with higher cholesterol levels actually lived longer.

“A higher cholesterol level seems to be linked to more efficient metabolism,” he said.

The Drug and Therapeutics Bulletin, which advises doctors on drug safety, is concerned about the marketing of statins and is planning a review of the sale of Zocor over the counter. “We are concerned there is no research data on the efficacy of the recommended dose, and there is also a potentially lethal effect if you drink grapefruit juice while taking it,” said its editor, Ike Iheanacho.

Another statin drug called Lipobay was withdrawn in 2001 after unacceptably high death rates among patients.

Mark Harvey, a solicitor who represented more than 50 British patients who claimed they had suffered adverse effects from taking it, said last week: “There is an increasing crisis of confidence in public authorities. They keep telling us they are looking after us, but we keep having drugs taken off the market after too many people have been damaged by them.”

On-the-spot checks by The Sunday Times suggest cholesterol tests may not be accurate.

We sent two healthy middle-aged reporters to undergo repeated cholesterol tests. The results varied widely.

Cholesterol level is expressed in millimoles per litre of blood. A level of less than 5.0 is considered healthy, but there is no agreement on an optimum level.

Anyone with a level over 5.0 would become eligible for cholesterol lowering drugs.

The first reporter, Simon Trump, who is in his forties, was given a reading of 4.77 in a Bristol branch of Boots, yet half an hour later a Bupa clinic in the city showed it to be 5.42.

The following day his cholesterol had gone down to 5.02, according to Boots in Exeter. A trip to Boots in Torquay that day showed 6.44.

Tests at Boots branches in Manchester gave George Dearsley levels of 3.8 and 4.1. A test at a private hospital gave a reading of 6.1.

Boots said that a single test was not always accurate. Two should be performed — and one should be done after 12 hours without food.



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