A Food and Drug Administration expert panel recently voted 12-4 to recommend the potent statin, Crestor, for patients who have no history of heart disease and who don’t fit the traditional profile for an "at-risk" patient for heart disease. The panel’s decision has cardiologists and primary care physicians at odds–with cardiologists triumphant and PCPs angry over the move.
While the FDA is not obligated to follow the panel’s recommendations, it often does. Traditionally, Crestor is prescribed to patients with a family history of heart disease or other risk factors for heart attack or stroke. Thus, if the FDA followed the panel’s recommendations, this would be the first time Crestor is approved for use in healthy patients with no risks.
The recommendation was made based on the results of a recent study called JUPITER. The JUPITER study analyzed 18,000 men and women, none of which had a history of heart disease but did have an elevated CRP, or C-reactive protein. CRPs are proteins in the blood that can indicate if a patient has inflammation of their arteries. Overall, the study found that the study participants who took Crestor had a 44% reduction in heart attacks, stroke, need for surgery or stenting to open the arteries, or deaths from heart disease when compared to the study participants who took a placebo (sugar) pill.
Nevertheless, PCPs are concerned over the fact that Crestor has several side effects, including muscle pain and weakness–but more importantly, the drug can also cause liver function changes and has a history of interactions with many other prescription medications. Cardiologists, on the other hand, are ecstatic over the news. For example, cardiologist Dr. Christopher Cannon of Brigham and Women’s Hospital in Boston, stated:
The treatment can reduce almost in half their risk of a first heart attack or other cardiac event.
Despite the study’s results, it is noticeable that the JUPITER study was funded by AstraZeneca–the pharmaceutical giant with recent legal troubles over allegedly pushing doctors to over-prescribe Seroquel. Astrazeneca also faces thousands of lawsuits for allegedly failing to reveal the risk of developing diabetes that is associated with taking Seroquel. I’ve promoted corporate transparency, especially of late. But in this case, AstraZeneca is more than happy to provide the results of their study–since the results are "overwhelmingly positive", the pharmaceutical company responsible for developing Crestor is more than happy to be transparent now. If you’re a patient without a history of heart disease, stroke, or other risk factors, maybe you want to read up on AstraZeneca’s past before you starting popping statins.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.