Physicians skeptical of statin news
Cardiologists: More data needed on possible link to Lou Gehrig's disease
By GARY HABER, The News Journal

Posted Tuesday, July 10, 2007
A report in a New Zealand medical journal suggesting a possible link between statin drugs and Lou Gehrig's disease needs more study, cardiologists say, before they would consider cutting back on prescribing the popular cholesterol reducers.

"I'm not hearing anything that's going to make me not use them because they've had such a beneficial impact on patients," said Dr. Matthew DeCaro, director of the coronary care unit at Thomas Jefferson University Hospital in Philadelphia, about an analysis published last month in the journal Drug Safety.

The article by Ralph Edwards, director of the World Health Organization's drug monitoring center in Uppsala, Sweden, received wide publicity last week when it was featured on the front page of the Wall Street Journal.

Edwards combed through publicly available reports from doctors, patients and others reporting adverse reactions to all kinds of prescription drugs, including statins. Edwards found 172 cases of people with amyotrophic lateral sclerosis, a rare degenerative nerve and muscle disease, according to the article. Edwards' review of the data found that 40 of those patients had taken a statin.

A Food and Drug Administration analysis, however, found no difference in the number of cases of ALS among patients taking a statin and those taking a placebo, the Journal reported.

Statins are a class of drugs that help lower so-called "bad cholesterol" by interfering with the enzyme that synthesizes it. First developed nearly 20 years ago, statins have become standard therapy for patients with coronary disease and others whose cholesterol needs to be controlled.

The drugs, which include AstraZeneca's Crestor, Pfizer's Lipitor and Merck's Zocor, are widely prescribed and have proven to be highly effective, experts say.

U.S. doctors wrote 203 million prescriptions for statins last year, according to IMS Health Inc., a health care information company. That made cholesterol reducers the second-most heavily prescribed type of drug in the U.S., behind anti-depressants. U.S. patients spent almost $16.5 billion on statins last year, according to IMS.

Dr. Ken Sunnergren, a cardiologist at Beebe Medical Center in Lewes, said that while Edwards' findings merit further study, there's nothing that would make him shy away from prescribing statins for the typical patient.

"I don't think cardiologists are going to be too concerned," Sunnergren said. "It's going to take a lot more data and a lot more analysis before any recommendations can be made."

Statins have been in wide use for nearly two decades, and if there was a link between statins and ALS, one would expect a sharp rise in the number of ALS cases, which has not happened, Sunnergren said.

"I don't think this proves a cause-and-effect relationship," said Dr. Ehsanur Rahman, associate chief of cardiology at Christiana Care Health System.

Rahman said doctors would need "much more robust data" before curtailing the use of statins, which he called "markedly beneficial" for patients with heart disease.

Rahman said he'd like to see a head-to-head comparison between two groups equalized in factors such as age, gender and health, to see whether there are higher rates of ALS among patients taking a statin compared with those taking a placebo.

Patients should not stop taking their statins, but should talk to their doctor if they have concerns, Rahman said.

AstraZeneca said its monitoring of Crestor has found no link between the drug and ALS.

"AstraZeneca's primary concern is always patient safety, and we have a comprehensive safety monitoring program that enables us to identify safety issues of marketed products," said Chris Sampson, an AstraZeneca spokesman. "To date, there has been no causal relationship identified between the use of Crestor and ALS."

Analyses in which researchers pore through reports of possible drug side effects looking for patterns are becoming more widespread as computer software becomes more sophisticated and agencies such as the FDA make their data available to researchers.

The problem, said Dr. Robert Rosenson, a professor in the division of cardiovascular medicine at the University of Michigan Medical School, is that such analyses are only a starting point for further research.

"One needs to delve into these cases in more detail," said Rosenson, who directs the university's lipoprotein disorders and atherosclerosis research program. "I think we need to pay attention to these kinds of reports, but it's the lowest level of evidence."

Contact Gary Haber at 324-2878 or ghaber@delawareonline.com.

STATINS BY THE NUMBERS

Statin are a class of drugs that lower so-called "bad cholesterol" by interfering with the enzyme that synthesizes it.


U.S. physicians wrote 203 million prescriptions for statins last year, and Americans spent almost $16.5 billion on statin drugs, according to IMS Health Inc., a healthcare information company, second only to anti-depressant drugs.

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