Back in July 2012, I ran a post titled "If you are over age 60, "stay away from statins at all costs"
That recommendation came directly from the book Are Your Prescriptions Killing You? by Armon Neel, a board-certified geriatric pharmacist and winner of the 2010 annual achievement award from the American Society of Consultant Pharmacists. Neel wrote that statins are "among the most ineffective and dangerous drugs on the market, largely because the doctors who prescribe them haven't done their homework, relying instead on information supplied by the manufacturers of statins and the studies they've underwritten."
It's bad enough that the medical profession has ignored Neel's advice. Then came last year's new guidelines, which unfortunately created millions of new statin users, many of them over age 60.
Here are some other recent developments regarding statins:
- Contrary to earlier studies suggesting that statins might ward off Parkinson's, new research found that users of statins are more than twice as likely to develop Parkinson's later in life than those who don't.
- Another new study indicates that statins increase the risk of diabetes by 46%.
Statins, prescribed to combat high cholesterol, are the best-selling class of drugs in the United States. Estimates suggest that 25% of all Americans take statins.
The brand I took -- Lipitor (atorvastatin) -- is the best-selling prescription drug in history. I started using Lipitor when I was 60 and stopped when I was 83. Before a generic finally became available several years ago, it was one of the priciest drugs around. I was paying about $200 for a 30-day supply. That's $2,400 a year.
In the letters I received from my internist after each annual physical, he would rave about the splendid results I was getting from Lipitor. But I'm increasingly persuaded that the drug caused my serious memory problems. Those issues began long before my Parkinson's diagnosis, and -- aside from memory -- I haven't experienced any other cognitive problems.
If you don't have hardening of the arteries by the time you're 70 or 80, you most likely never will, Neel says. And if you DO have this problem, Neel thinks it's too late for statins to do any good.
Statins Can Cause Problems
According to Neel, statins' most common negative side effect involves muscles. He writes: "When I see an older patient who complains about muscle pain, fatigue, and weakness, I know from experience that a statin drug is the most likely culprit."
A study based on patient surveys that was published in the journal Pharmacotherapy in 2009 found that 75% of the subjects "experienced cognitive ADRs [adverse drug reactions] determined to be probably or definitely related to statins therapy."
The Older You Are, the More Dangerous Statins May Be
Indiscriminately prescribing statins for people over age 80 (like me) is ill advised, according to a study published in the journal Age and Aging in 2010. The researchers concluded:
A review of the few randomised controlled trials including 80+ year olds did not provide evidence of an effect of lipid-lowering treatment on total mortality in 80+ year old people. There is not sufficient data to recommend anything regarding initiation or continuation of lipid-lowering treatment for the population aged 80+, with known CVD [cardiovascular disease], and it is even possible that statins may increase all-cause mortality in this group of elderly individuals without CVD.But New Guidelines Would Have Millions Start Taking Statins
The American College of Cardiology (ACC) and the American Heart Association (AHA) released new cholesterol treatment guidelines in November, 2013. Those guidelines recommend determining a patient’s risk of atherosclerotic cardiovascular disease using a new calculator that considers risk for both heart disease and stroke, not just heart disease.
Critics have said this new risk calculator wasn't adequately tested and thus overestimated the 10 year CVD risk. As a result, they say, statins have been over-prescribed.
A recent analysis estimated that the ACC/AHA guidelines will lead to a significant increase in the use of statins, largely among adults older than 60 without cardiovascular disease (CVD). But while this group may have increased CVD risk, they are more likely prone to the adverse effects of using statins.
An editorial in the UK's The Lancet charged that the guidelines systematically overestimated cardiovascular risks and could "therefore lead to overtreatment of a substantial fraction of the 33 million Americans potentially affected by the guidelines."
An op-ed in The New York Times summed up the situation:
[The new guidelines]essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills -- namely statins -- for undefined health benefits. This announcement is not a result of a sudden epidemic of heart disease, nor is it based on new data showing the benefits of lower cholesterol. Instead, it is a consequence of simply expanding the definition of who should take the drugs -- a decision that will benefit the pharmaceutical industry more than anyone else.New Guidelines Miss Middle-Age Patients and Over-Target Seniors
According to an analysis from the Duke Clinical Research Institute, the new guidelines on statins not only overprescribe for seniors, they also exclude middle-aged adults who could benefit from the drugs. These researchers found that small adjustments to the guidelines could enable doctors to catch more people between the ages of 40 to 55 with premature heart disease, and prevent unnecessary medication for adults over age 65.
Applying the new guidelines to 3685 people who participated in the Framingham Heart Study that began in 1975, researchers found that the guidelines, by basing treatment on a risk of 7.5 percent, would have missed more than half of the participants ages 40 to 55 who ended up with heart disease and may have benefited from statins. On the other end of the spectrum, the guidelines would have over recommended statins for adults over 60, a large proportion of whom continued to be tracked and did not develop heart disease in the following 10 years.
Instead of using the one-size-fits-all guidelines, the Duke researchers suggested lowering the treatment threshold for patients ages 40 to 55 to those with a 5-percent risk or greater could capture more middle-aged adults who develop heart disease early. For older adults, by raising the threshold to 15 percent, the guidelines could identify the same proportion of men who go on to have heart disease but would reduce treatment for those who will not
Parkinson's and Statins
Previously, several studies had found that statins might offer protective benefits against Parkinson's disease.
Dr. Xuemei Huang, who led the research, expressed concern about the widespread prescription of statins:
If we blanket prescribed statins to people, we could be creating a huge population of people with neurological problems. Does mother nature create cholesterol for a reason? I think doctors are over enamored with statins and think it is a cure-all. But the body is not just for the heart, is also for the brain. It is potentially harmful for these drugs to be given out so widely and randomly.Huang acknowledges that the analysis was based on a small number of cases. Still, he thinks the preliminary results suggest that statins do not protect against Parkinson's.
Statins Increase Risk of Diabetes
A large Finnish study concluded that taking statins is associated with a 46% increase in the risk of type II diabetes. The study authors -- while believing their conclusions were reliable based on their large sample -- cautioned that all participants were Caucasian men, calling into question the usefulness of those findings for women and other ethnicities.
Other experts have pointed out various flaws in the study.