The manufacturer of Crestor is planning to expand the market for its cholesterol-lowering drug to healthy people who do not have high cholesterol and are at low risk for heart problems. But using the drugs simply as a preventive has some experts questioning their safety.
Although statins are acknowledged as saving thousands of lives each year, the risks may outweigh the benefits in people with no risk factors. A recent Scottish study found that those who take statins increase their risk of developing Type 2 diabetes by 9 percent — a risk doctors would deem acceptable in a patient with high cholesterol in danger of heart attack and stroke. But is the risk worth it in healthy adults?
Researchers at the East Texas Medical Center found that 66 percent of patients developed heart problems similar to those that can lead to heart failure after taking the statin drug Lipitor for six months, probably due to the statin's side effect of depleting the body's store of CoQ10.
Another new study showed that the statin drug simvastatin gives a one-two punch to the immune system. Italian scientists found that simvastatin (sold under the names of Zocor and Simvacor) hinders the ability of the body's immune cells to kill pathogens, and increases the production of cytokines, which trigger and sustain inflammation.
"There's a multibillion-dollar industry ensuring that you hear all the good things about statins," said Dr. Beatrice Golomb of the University of California San Diego. Golomb is concerned about the effects statins have on mood and memory. "It's common to find patients on the drugs who report trouble finding the right word or forgetting what task they are supposed to be doing," she told the Daily Mail.
Golomb also had patients who were irritable, hostile, and had homicidal impulses. Other patients had cognitive problems while taking statins. "After a couple of months of statin use, one top accountant could no longer balance a checkbook and was fired."
According to the Mayo Clinic, additional side effects of statins include muscle pain, liver damage, digestive problems, and rashes or flushing.
What will be the criteria for prescribing statins? Instead of cholesterol levels being the main guideline used to determine who should take them, a test that measures the level of inflammation in the body will be part of the new criteria. Inflammation, some experts believe, is one of the causes of cardiovascular problems.
The new criteria will add 6.5 million Americans as candidates for the drugs. They include men aged 50 and older and women aged 60 and older who have no obvious signs of heart disease, but have elevated C-reactive protein (CRP) and one additional cardiovascular risk factor including high blood pressure, low HDL, and smoking.
The FDA's decision was based on the recommendations of advisory panels, many of whose members had close ties to the drug industry as paid consultants. And the statin study which showed the benefits of the CRP was led by Dr. Paul Ridker, the inventor of the test, and funded by AstraZeneca, the maker of Crestor, which gained FDA approval in February.
AstraZeneca could see billions in profits from the decision. Although some statin drugs will soon lose patent protection — for example, Lipitor in 2011— Crestor, the drug the FDA has approved for expanded usage, will remain under patent until 2016. And even Ridker himself stands to gain since, according to The New York Times, he receives royalties from the CPR test.
Ridker believes in the validity of his test, which will indicate which patients need statins to help lower the infection he believes leads to cardiovascular disease. “We found a 55 percent reduction in heart attacks, 48 percent reduction in stroke, 45 percent reduction in angioplasty bypass surgery,” Ridker said recently.
But critics say statin results have been misleading. Heart attacks occurred in 0.38 percent of patients who took a sugar pill and in 0.17 percent of patients taking Crestor. Even though there was a 55 percent difference between the two groups, the results actually meant that 500 people would need to take Crestor (at a cost of $638,000) for a year to prevent a single heart attack.
“The benefit is vanishingly small,” Dr. Steven W. Seiden , a cardiologist in Rockville Centre, N.Y. told The New York Times. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.”
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