With heart disease the leading cause of death in the United States for men and women -- killing about 450,000 people each year -- it's no wonder that any potential treatment advance is greeted with enthusiasm and headlines. That was the case when a team of researchers led by a Harvard Medical School cardiologist released a new study of the drug Crestor at an American Heart Association annual meeting on Sunday. Although the findings are significant, there are some important caveats.
Crestor is a statin drug and belongs to the same well-known pharmaceutical family as Lipitor, Zocor and Mevacor -- drugs already taken by an estimated 16 million to 20 million Americans. In a massive study of nearly 18,000 people -- research funded by Crestor's maker, -- researchers found that the drug cut the risk of cardiovascular death by 20 percent in people who did not have high levels of LDL ("bad") cholesterol, but did have high levels of a protein considered a gauge of heart disease risk.
About half of heart attacks occur in those who have levels of LDL cholesterol currently considered acceptable. The study suggests that Crestor and other statin drugs could be used even more aggressively to prevent heart disease in millions more people. "It's absolutely paradigm-shifting," Dr. Steven E. Nissen, a well-respected Cleveland Clinic heart specialist, told the Los Angeles Times. Experts were already updating treatment guidelines. It's likely that the new ones -- issued next year -- will reflect this study's findings by expanding the universe of people who should use the drugs.
With all the excitement, it's no wonder that a crowded Monday morning session at the American Heart Association meeting had the tongue-in-cheek title of "Statins in the Water? Responsible use of Lipid-Modifying Drugs." No one, of course, is seriously considering adding the drugs to the water supply like fluoride.
But according to one physician at the meeting, the grabber of a title generated a lot of good discussion, including some that rightfully tempered the drug's potential. The nation is already grappling with sky-high increases in health care costs. What happens if millions more people start to take a daily regimen of prescription drugs? It's also not known if all statins would have the same benefit as Crestor, which is one of the newest and most expensive statins on the market.
Most importantly, there are risks from putting a good chunk of the population on these drugs. Statins are helpful but potent. Side effects can include muscle aches and liver damage. Once started, statins are typically taken for life. Unfortunately, physicians don't know what the downsides are from decades of use. Or, if there are risks from cholesterol levels that are too low. Right now, cardiologists strongly believe that the benefits of reducing heart disease outweigh the risks of long-term use.
But it's not hard to find examples of drugs once thought to be safe that instead, once they were used on a widespread basis, proved to cause an even more serious problem than that which they were intended to treat. The prescription pain reliever Vioxx, for example, was pulled from the market in 2004 because it significantly increased risk of heart attack and stroke.
Experts contemplating statins' expanded role in treatment guidelines have weighty questions to answer. A bill currently languishing in Congress -- the Physician Payments Sunshine Act -- would enhance the public's confidence in the foundation on which the recommendations are based: medical research. Earlier this year, there were revelations that the maker of the heart drug Vytorin deliberately withheld research showing that the drug was no better than a less expensive alternative.
In April, a medical journal detailed how Vioxx's manufacturer ghostwrote scientific studies. The bill, cosponsored by Sen. Amy Klobuchar, D-Minn., would require drug and medical device companies to disclose payments to doctors. The high-profile Crestor study, with its implications for treatment guidelines, is a reminder that action is needed on the Act, which would provide a much-needed shot of accountability at a time the industry sorely needs it.
