Statin Side Effect Test: Worth the Price?

July 24, 2008— -- The tens of millions of Americans who take statin drugs to control their cholesterol levels are also taking a calculated risk -- the small chance that they might experience muscle weakness, the most common side effect of the drugs.

Now, British researchers say a screening test that could predict which patients will suffer these side effects may one day be a reality, thanks to their discovery of a gene linked to their occurrence.

But, whether the cost of this potential advance in personalized medicine can justify the returns is still a matter of contention among doctors.

"My first impression is that this is the first time that genomics can be useful in day-to-day clinical medicine," said Dr. Christopher Cannon, a heart researcher at Brigham and Women's Hospital, and an associate professor of medicine at Harvard Medical School, who was not involved with the study. "It seems to be a useful test, and could be one that patients would want to know when they are starting therapy."

Dr. Eric Topol, the chief academic officer of Scripps Health, calls the study a "fantastic jump forward" and says that it is the first to provide strong evidence of a gene that can show potential side effects that will result from a drug.

"It's an exceptionally important one, it's a real major discovery," said Topol. "[It's] not a first, but it's the most impressive one to date."

But, citing cost, not all researchers are so sure about the study's usefulness.

"It is difficult to advocate for an expensive test to determine susceptibility to an adverse effect that occurs in only 1 in 1,000 to 1 in 10,000 patients who take the drug," said Dr. Steve Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, and former president of the American College of Cardiology. "It's nice science, but not a practical screening tool."

Nissen added that since most patients who develop the muscle weakness, known as myopathy, recover completely, any screening test that may be developed in the future may be largely unnecessary.