If you’ve been anywhere near a newspaper, the Internet, or the evening news, you’ve surely caught snippets of the heated debate over the recently published Guidelines on Lifestyle Management to Reduce Cardiovascular Risk. Published by the Journal of the American College of Cardiology and backed by the American Heart Association and the American College of Cardiology, the guidelines come with a highly controversial risk calculator. Harvard University cardiologist Dr. John Abramson says, “… overtreatment [has] been built into the risk calculator.” Abramson was referring specifically to the guidelines and risk calculator expanding the pool of patients who will become candidates for statin therapy as the result of manipulated data. While statins do help save lives in the population of those with high cardiac risk, the class of medication presents severe enough risks that the risk-benefit factor should be weighed carefully with regard to prescribing considerations.

First, Do No Harm

Cardiologists across the nation are concerned not only about the of crafting guidelines that have for years consistently increased the number of Americans using statin medications—the latest guidelines will roughly double the 36 million who are currently deemed to be candidates for statin therapy— but also the motives of drug manufacturers who are major players in funding the research and who also stand to profit from the sale of statins. Raising even more eyebrows is that one of the authors of the most recent guidelines has financial ties to a drug company whose work is relevant to the outcome. In addition, the American College of Cardiology’s involvement is suspect in that the organization maintains close ties to the pharmaceutical industry.

Harvard researchers put the new risk calculator to the test to estimate the 10-year odds of a heart attack or stroke. The research involved participants in three previous landmark studies, and when juxtaposed against the numbers produced by the recently released calculator, the indications for statin use were almost twice as high as the original studies. The research team concluded that the data used in the new risk calculator is unreliable, at best, and that nearly half of the 33 million adults who will be caught in the expanding net of the new guidelines do not have the risk factors that necessitate statin use, therefore putting that group at unnecessary risk of statin dangers.

World headquarters for Pfizer, maker of Lipitor, in New York City

The Dangers of Statins

Some of the most respected and influential cardiologists in the U.S. are concerned that the new guidelines will result in an increase in the number of patients who will be prescribed statins when it is not medically necessary. Depending on which statin one is taking, severe side effects may occur. The Food and Drug Administration (FDA) has issued warnings linking statins to severe damage to muscle, kidneys, and the liver. One statin, Baycol, was taken off the market due to dangerous side effects, and numerous lawsuits have been initiated against drug manufacturers in connection with the side effects of statins.

Dr. Steven Nissen, cardiologist at the Cleveland Clinic, said the American Heart Association and the American College of Cardiology should pause and reconsider before putting the guidelines into widespread practice. The new risk calculator generates highly implausible results, he said, and “… we’re not talking about an error or miss of 20 or 30%, but of 75% to 150%,”

LDL: Is it Good or Bad?

The guidelines run counter to conventional wisdom: Over the past two decades, LDL has been ID’d as a primary culprit in heart disease. That being the case, reducing one’s LDL would seem necessary. However, trials of medications designed to lower LDL have consistently shown no benefit in terms of reducing cardiovascular risk. And yet, LDL has been branded as “bad cholesterol.” Has the vilification of LDL simply been a savvy marketing ploy by and for drug manufacturers? Seems like a valid question, when all things are considered, including this fact: LDL is not actually cholesterol; it is a low-density lipoprotein that performs the vital role of supplying needed cholesterol to cells throughout the body.

But wait, there is still a coating of irony that must not be ignored: Though the title of the new document is Guidelines on Lifestyle Management to Reduce Cardiovascular Risk, the guidelines fail completely in providing any commentary on the role of “lifestyle management” in lowering stroke and heart attack risk and instead paves the way for further expansion of statin therapy. Despite the uproar over the publication of the Guidelines, however, and the fact that the American Heart Association receives substantial funding from the same manufacturers who will benefit from the recommendations, the Guidelines will likely become the accepted template for American practitioners of cardiology.

What to Do if Statins Have Harmed You

If you have been injured by a statin that was prescribed for you, you may have a defective product liability claim or a medical malpractice claim, depending upon the circumstances. The defendants will be prepared for the fight, and even though the drugs may be known to carry serious risks, it will be crucial to the validity of your claim whether or not you were sufficiently advised of the risks before taking the medications. Some of the factors that will influence whether or not you can initiate a lawsuit are as follows:

• Does the drug cause unreasonably dangerous side effects?
• Did the manufacturer, physician, or pharmacy fail to provide adequate warnings or instruction?
• Were you injured by the drug?

However, don’t let three bullet points convince you or deter you. Anytime you’ve been injured at the hands of the medical industry, it is worth the time to consult with a medical malpractice lawyer so you’ll at least understand your options.

About the author:
Joseph G. Macaluso is a personal injury lawyer practicing at the Bronx law firm of Macaluso & Fafinski, P.C. A graduate of Brooklyn Law School, Mr. Macaluso has been in private practice since 1990 with an exclusive focus on personal injury and medical malpractice. A member of the New York State Trial Lawyers Association, he has served on the Legislative Committee of this organization and is also a member of the Bronx County Bar Association and has served on the Board of Directors of Bronx Legal Services.

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