Last week the country’s foremost cardiologists issued revolutionary new guidelines under the auspices of the American Heart Association and The American College of Cardiology. These are two of the most prestigious organizations in American medicine.
The experts spent millions of dollars and took five years to create guidelines and a CV Risk Calculator that were supposed to prevent heart attacks and strokes. Instead, their recommendations have ignited a firestorm of controversy and completely undermined trust in the American medical establishment.
At issue are the sweeping new guidelines that could double the number of Americans who are prescribed statin-type cholesterol-lowering drugs from 36 million to 72 million. That means that roughly one-third of all adults should take drugs like atorvastatin (Lipitor), lovastatin (Mevacor), pitavastatin (Livalo), rosuvastatin (Crestor) or simvastatin (Zocor).
Over a decade ago some cardiologists were so enthusiastic about these medications that they half-jokingly suggested the drugs should be put in the water supply. Now, the experts have virtually sanctioned this strategy. But the tool that is supposed to guide doctors in their decision-making process is fatally flawed.
New York Times journalist Gina Kolata revealed in her front page article on November 17th that the flaws were uncovered at least a year ago by two Harvard professors. Epidemiologist Nancy Cook, ScD, and cardiologist, Paul Ridker, MD, discovered that the calculator seriously overestimated risk by as much as 150 percent. Even though these two eminent scientists pointed out the problems, the committee apparently ignored the warnings and on November 12, 2013, announced its new guidelines with great fanfare.
What a colossal misstep! As soon as we began testing the CV Risk Calculator we discovered that it produced ridiculous recommendations. A 58-year-old man who runs 5 miles every day, adheres to a Mediterranean diet, has no history of heart disease, with a total cholesterol of 160 and a good HDL cholesterol reading of 50 would be told to take a statin because his barely elevated systolic blood pressure (130) is being treated. Nonsense!
A fascinating analysis published in the BMJ (October 22, 2013) reveals the lie behind the new guidelines. People who are at low risk for cardiovascular disease (despite elevated cholesterol levels) would barely benefit from statins. Doctors would have to treat 140 such people for five years for one to be saved from a heart attack or a stroke. That means 139 people would be taking a statin for years with no measurable benefit but significant likelihood of harm.
By now the whole world should know that statins can cause substantial muscle pain and weakness for millions of patients. The discomfort can become so debilitating that people can barely get out of a chair, let alone exercise. And yet exercise is one of the most important things you can do to reduce your risk of heart disease. Joint pain, diabetes, cataracts, liver and kidney problems, cognitive dysfunction (confusion, forgetfulness, memory problems), sexual difficulties and neuropathy are just some of the other complications of statins.
Is it any wonder that half of patients stop taking their statin within a year? Studies suggest that only one out of four people over 65 stay on their statin after two years. The BMJ authors offer the following bottom line:
“Statin therapy in low risk people does not reduce all cause mortality or serious illness and has about an 18% risk of causing side effects that range from minor and reversible to serious and irreversible… Broadening the recommendations in cholesterol lowering guidelines to include statin therapy for low risk individuals will unnecessarily increase the incidence of adverse effects without providing overall health benefits.”
Even with such a clear admonition, the American College of Cardiology and the American Heart Association forged ahead with their new guidelines. Cardiologist Steve Nissen recognizes what a disaster this is. In his interview with Gina Kolata for the New York Times he is quoted as saying “It’s stunning. We need a pause to further evaluate this approach before it is implemented on a widespread basis…Something is terribly wrong.” In the same article, Dr. Peter Libby, chairman of the department of cardiovascular medicine at Brigham and Women’s Hospital in Boston said, “We’re surrounded by a real disaster in terms of credibility.” Some have taken to calling this mess CalculatorGate.
And yet the leadership of the committee that drew up the new guidelines seems to be standing pat. Dr. Sidney Smith told Gina Kolata, “What we have come forward with represents the best efforts of people who have been working for five years.” Despite substantial criticism from the public as well as from prominent cardiologists, the committee that wrote the new guidelines and oversaw the risk calculator are circling the wagons and resisting any modifications.
Yikes! If this is the best American medicine has to offer, then we are all in trouble. It makes us distrust guidelines from other committees, especially where the pharmaceutical industry has had even more influence determining recommendations for treatment of ailments such as diabetes, hypertension, osteoporosis and reflux.
THE BOTTOM LINE:
Where does this leave us? Perhaps it is time for physicians and patients to wake up. Do your own homework. Find out exactly how beneficial any treatment recommendation really is. Just because a drug receives FDA approval does not mean it is very effective. Ask for the number needed to treat (NNT) any given condition. If 185 people need to take a blood pressure pill for one person to possibly avoid a heart attack, those are not very good odds, especially if dizziness, drowsiness or diarrhea are likely outcomes of the medication.
Let’s bring common sense back into American health care. The pill-for-every-ill approach that has been promulgated over the last 40 years needs to change!
To learn more about non-drug approaches to heart health, check out our book, Best Choices From The People’s Pharmacy.
Share your own thoughts about American medicine below. Do you think the new guidelines from the American Heart Association and the American College of Cardiology represent a tipping point in credibility? We’d love to hear from you in the comment section below. Share your own statin story as well.