Healthy Skepticism Library item: 962

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Carey E.
Cholesterol drug spending may soar: Guidelines say 27% more patients need statins But few benefits for low-risk patients, study says
The Toronto Star 2005 Apr 12

Full text:

New Canadian guidelines for treating high cholesterol will result in huge
increases in the number of patients taking statin drugs and add millions to
health care spending. But the potential benefits are “incredibly small,” a
new study says.

Under the new guidelines, the number of people advised to take statins will
increase by 27 per cent, to 2.53 million a year. That will add $250 million
to the already staggering $1.1 billion a year spent on the
cholesterol-busting medications, says the study published today in the
Canadian Medical Association Journal.

The number of people at low risk for heart disease who will be advised to
take the drugs, under the latest version of cholesterol guidelines, will
rise from 61,000 to 595,000 a year.

“Yet the relative benefit of statin therapy for many people in the low-risk
group is incredibly small,” says the study by the Institute for Clinical
Evaluative Studies, an independent non-profit organization.

For example, a 42-year-old man with high cholesterol who took statins for 10
years would reduce his risk of a heart attack or stroke by only 2 per cent,
it says.

At the same time, the guidelines fail to recommend statin treatment for 13
per cent of Canadians in the highest risk group who should be taking them,
the study says.

Dr. Doug Manuel, the ICES study’s main author, said the drugs are generally
safe and well tolerated, especially if you are at high risk of heart
disease. But “if you’re at low risk, the benefits are really small, so the
side effects become more important,” he said.

One of the most common side effects of statins is muscle pain, but the drugs
can also cause muscle damage or myopathy, which can be a sign of a rare,
potentially fatal muscle-wasting disease called rhabdomyolysis.

Drug guidelines are usually set by experts in the field who then send them
out to groups like the Heart and Stroke Foundation of Canada for comments,
Manuel said. They are published in the medical association journal as a
guide to all physicians. Statins, such as Lipitor, Zocor and Pravachol,
which lower the body’s “bad cholesterol,” a risk factor for heart disease,
are the fastest growing class of drugs in the country. About 19.8 million
prescriptions for them were written in Canada last year.

More than 9.7 million were for Pfizer Inc.‘s Lipitor – the country’s, and
the world’s, top-selling drug.

Manuel said his group started with the same data as the guideline authors.
“We went to the next logical step,” he said. “After you screen for risk
factors, how many would benefit from the drugs? They didn’t look at that.”

But the real issue is cost, he said, and patients, family physicians and the
provinces that have to pay for the drugs should be involved in setting the
guidelines.

Lipitor was the single most-prescribed drug covered by the Ontario drug
benefit program in 2003-04, when the province spent $170 million to cover
about 325,000 prescriptions, according to provincial records.

“If we’re talking small changes that are costing hundreds of millions of
dollars, we have to involve the people who are making these resource
allocations,” Manuel said.

The four authors of the latest statin guidelines counter in a separate
article in the same journal that the ICES study is flawed.

Dr. Jacques Genest, a cardiologist at the Royal Victoria Hospital at
Montreal’s McGill University, said in an interview the study’s authors
“missed the boat” by using the wrong cardiovascular risk evaluation data.

“We call it `garbage in, garbage out’ when you don’t use the appropriate
risk models,” said Genest, who is a paid consultant for four pharmaceutical
companies, including Pfizer. “It is a little disingenuous on their part.”

The guideline authors are currently revising them to make sure some in the
low-risk group are not missed and to recommend fewer in the high-risk group
take statins – the opposite of the ICES study’s recommendations.

Genest acknowledged in an interview that he and the other doctors involved
in setting guidelines for prescribing statins have all worked as consultants
for at least some of the six pharmaceutical giants that make statins. Genest
himself has worked for four of them, including Pfizer.

That information is freely disclosed in the group’s publications, he said,
adding that there are “not enough experts in Canada to only hire people who
are not paid at all.”

Alan Cassels, of the University of Victoria School of Health Information,
called the new guidelines “a standard ploy used to increase the uptake of
drugs. You (drug companies) get your consultants on the guideline committee.

“The people at ICES are independent and they have experts who could have
served on this committee,” he said. “But the drug companies don’t want
independent people there. They stack them (committees).”

Cassels predicts that in a few years doctors won’t be prescribing statins
any longer because “the sun is setting on the whole cholesterol issue. The
benefits are marginal and the risks are small but severe.”