We will survive

NZ journal warned of drug link with paralysing disease

Thursday July 05, 2007

A World Health Organisation expert monitoring adverse reactions to drugs has contacted the New Zealand staff of a drug safety journal with concerns about a possible link between cholesterol-lowering statins and Lou Gehrig's disease.

Dr Ralph Edwards, director of the WHO drug monitoring centre, has suggested as an experiment stopping the use of statins in some patients with serious neuromuscular disease "given the poor prognosis and a possibility that progression of the disease may be halted or even reversed".

Lou Gehrig's disease, also known as amyotrophic lateral sclerosis, is a degenerative illness that slowly paralyses patients until they die. One of the best-known patients is British physicist Stephen Hawking.

Dr Edwards pitched his paper to Rosie Stather, the Auckland editor of Drug Safety, an international scientific journal, which has published it.

He found that of 172 people in his database who developed Lou Gehrig's disease or something similar while taking prescription medicines, 40 had been on statins, the extremely popular cholesterol drugs.

His database contains about four million reports of medical problems experienced by people taking prescription drugs and he sifts through them looking for "signals" of potential side effects.

He had expected a number in the single digits, judging from how often other drugs in the database were linked to the disease.

"We thought, 'This is at least a signal'," he told the Wall Street Journal.

"If this is a cause-and-effect relationship, it needs working out as fast as possible.

"The disease is rare and deadly. Anyone who has it is going to look around and say, 'My God, why me? Why should I have this?'

"And one thing they're going to think is: 'Is it the drug?' "

His paper - and its arguments linking severe neuromuscular damage with statin use, "albeit rarely", showed a need for more analysis "of what must be regarded as a potentially serious and perhaps avoidable or reversible adverse reaction".

"The diagnosis of ALS is often problematic and the insidiousness and chronicity of the disease make causality with a drug difficult to assess," Dr Edwards said. But the disproportionally high number of reports made it an important signal.

- NZPA

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