Statins Have Risks

[Guest guest]

Statins have risk

2/5/2005 12:00 PM

By: Ivanhoe Broadcast News

Although statin drugs are highly effective at lowering cholesterol,

they still pose risks.

Dr. Beatrice Golomb, from the University of California, San Diego,

heads up one of the largest studies of its kind to look at the side

effects of statin drugs.

Golomb is particularly looking at the studies that confirm the safety

of statins are set up.

" Problems arise when, having excluded the population at risk of

having harm, people interpret absence of evidence of harm as evidence

of absence of harm. In fact, the populations that tend to enroll in

clinical trials are very small, non-representative, more robust,

healthier subsets of the population. And it's quite routine to find

that rates of adverse effects and quote 'observational studies' where

you follow people who are actually put on drugs tend to be much

higher than they are in clinical trials because of the selection

issue, " Golomb said.

Golomb also says side effects of the drugs have not been extensively

studied.

" The question is how much have these adverse effects been studied?

Well, very little. There certainly isn't any interest group

who wants to invest lots of money looking at harms of drugs because

there really isn't any financial gain behind that, " Golomb said.

Some studies suggest the use of statins is linked to: memory loss,

muscle weakness, nerve damage, cancer, insomnia, personality and

behavior changes and gastrointestinal problems.

Golomb is worried doctors aren't telling their patients about these

risks.

" Physicians have heard so many of the wonderful things about statins

and so little about the potential downsides that the physicians are

persuaded that the statins can't possibly be related, and then the

individuals stay on the drug, and the problem progresses and becomes

very severe and debilitating, " Golomb said.

According to Golomb only white, middle-aged men who have or are at

high risk for heart disease should take statins, which contradicts

current guidelines set by the National Institutes of Health.

" People who are female, even if they are at high risk of heart

disease, people who are middle-aged males if they're at low risk, or

people who are elderly, even if they are male and high risk, none of

those groups receive survival benefit with assignment to statins

compared to placebo. So there's really not evidence that the benefits

exceed the harms for women, for elderly or for men who aren't at high

risk … I don't believe that the current evidence supports

elements of

the current guidelines, Golomb said.

In January 2005, members of an FDA panel opposed a proposition to

sell statins over-the-counter. They cited numerous side effects and

also said the drugs can pose serious birth defects when taken during

the first trimester of pregnancy.

Golomb agreed statins should not be sold over-the-counter.

" What I fear is what I see everyday, which are people contacting us

who develop problems, many of whom actually spoke with their

physician about whether statins could be related to these problems. I

worry that there will continue to be patients who wouldn't

necessarily be getting benefit from these drugs in the first place

who will be experiencing severe quality of life-impairing adverse

effects and won't have a source of information to let them know that

this is one possible consideration that should be taken into

account, " Golomb said.

Doug F