If you’re a heart patient, I’m betting that you’re already taking one of the cholesterol-lowering drugs called statins. That’s because these drugs – with brand names like Lipitor, Crestor, Zocor or any of their generic forms – are routinely prescribed to those diagnosed with cardiovascular disease. Many studies (largely funded by the drug companies that make statins) suggest that, for heart attack survivors, these drugs may help to significantly lower our risk of having another cardiac event. It’s what doctors call “secondary prevention”.
Some studies further suggest that statins are also useful for those who’ve never had heart disease, but who do have high LDL (or “bad”) cholesterol – what’s called “primary prevention”. But recently, statins hit the front page of The New York Times with a big fat *splat* when new clinical practice guidelines for treating/preventing heart disease were released by the American Heart Association and the American College of Cardiology (both heart organizations that are coincidentally largely funded by drug companies, too). The guidelines essentially said: from now on, forget about your LDL numbers. It’s all about your risk factors now.
The guidelines were designed to provide physicians with expert guidance on cholesterol, obesity, risk assessment, and healthy lifestyles, but it’s figuring out who should be prescribed statins that’s been getting most of the media mileage out there.
Part of the ensuing controversy seems to lie in the guidelines’ new heart disease risk calculator that’s already been publicly described as an “embarrassment” to the two heart organizations that endorsed it. The original was basically an amateurish Excel mess compared to other existing heart disease risk calculators, like those already developed at Mayo Clinic or Vancouver‘s Therapeutics Education Collaboration affiliated with the University of British Columbia.
But the new AHA/ACC risk calculator’s most vocal critics, like Stanford School of Medicine’s Dr. Mark Hlatky, issued this warning about the guideline’s new recommendation to offer statins to anybody who has at least a 7.5% risk of having a heart attack within the next decade:
“The risk level is now set so low that many people who have optimal risk factor levels would be targeted for statin treatment simply on the basis of their age.”
Harvard Medical School professors Dr. Paul Ridker and Dr. Nancy Cook also warned in the medical journal, Lancet, that this risk calculator over-predicts risk by 75-150 percent, so much so that it could mistakenly recommend millions more people as candidates for statins. What this means is that, if doctors embrace the new guidelines, one out of every three adults could now be taking a statin every day for the rest of their natural lives.*
But as health journalist Michael O’Riordan of TheHeart.Org astutely asked during the American Heart Association’s scientific meetings in Dallas last month:
“How do you have a serious discussion about the patient’s risk if the risk calculator doesn’t accurately calculate risk?”
Statins for primary prevention have, in fact, long been controversial for women. For example, cardiologist Dr. Noel Bairey Merz of Cedars Sinai Hospital in Los Angeles (and also a co-author of the new guidelines) spoke at the AHA meetings in Dallas, specifically in response to a New York Times opinion piece called “Don’t Give More Patients Statins” that pointed to this fine print about women and statins:
“Clinical trials of LDL-lowering generally are lacking for this risk category.”
After being reminded that even the massive 2008 JUPITER study on statins also showed there was “no treatment benefit” when women who took statins were studied as a subgroup, Dr. Merz conceded to CNN that the “evidence isn’t perfect” and that “there are no clinical trials of statin use in women alone”. For a critical reappraisal of JUPITER, read this paper published in the Journal of the American Medical Association Internal Medicine, in which the authors conclude:
“The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.“
Yet after repeating her opinion that even healthy women with no history of heart disease should still take statins for primary prevention anyway if the (allegedly) flawed risk calculator assesses them as appropriate, Dr. Merz added:
“I would say that it’s time to stop the controversy and do a trial.”
But I would say that most women out there would likely prefer that researchers do the trials first, and then come up with evidence-based treatment guidelines for women based on solid research – and not the other way around as seems to be happening here.
It’s no accident that drug companies like Bristol-Myers Squibb, Merck and Pfizer (makers of statins Pravachol, Zocor and Lipitor, respectively) are major funders of AHA’s Go Red For Women heart disease awareness campaign.
Check out what the Go Red website says about statins, advise cardiologist Dr. Barbara Roberts and Martha Rosenberg in their recent Reporting On Health report called “The American Heart Association: Protecting Industry, Not Patients” (emphasis mine):
“If your doctor has placed you on statin therapy to reduce your cholesterol, you can rest easy – the benefits outweigh the risks!”
The site also proclaims “statins may only slightly increase diabetes risks.” Yet the Women’s Health Initiative (a federal study of over 160,000 healthy women to investigate the most common causes of death, disability and poor quality of life in post-menopausal women) showed that a healthy woman’s risk of developing diabetes while on statins was increased 48 percent compared to women who were not taking statins. As reported by Roberts and Rosenberg:
“Contrary to what statin apologists say about statins only increasing diabetes risk in people who are at high risk of developing it anyway (for example the obese), women on statins in the Women’s Health Initiative who were of normal weight increased their risk of diabetes 89 percent compared to same-weight women not taking a statin.”
Other cardiologists, like Dr. Roger Blumenthal, director of the Ciccarone Preventive Cardiology Center at Johns Hopkins, explained:
“Statin therapy should not be approached like diet and exercise as a broadly-based solution for preventing coronary heart disease. These are lifelong medications with potential side effects.”
Despite the risk of being labeled by health journalist Larry Husten as one of the “rabid anti-statin crowd”, let’s talk about those side effects, described by Dr. David Newman as “less publicized than benefits, but well-documented.”
Side effects of statins are generally dismissed by physicians and most others who don’t personally suffer them. As The New York Times reported, 18 percent or more of the newly expanded pool of statin users could experience significant side effects, including severe muscle pain, weakness or damage (in some cases permanent), decreased cognitive function, increased risk of diabetes (especially for women), cataracts or sexual dysfunction among others.
Here’s the good news about the new AHA/ACC guidelines: the ultimate recommendation is that the decision to take or not to take statins every day for the rest of your natural life belongs to the patient in consultation with one’s physician about personal risks and benefits. As cardiologist Dr. Richard Fogoros recently wrote:
“For people who are at intermediate risk, the question (about taking statins) needs to be answered for each individual – no matter what some expert panel determines should be the arbitrary cutoff for an entire population.”
And if you’re a lucky patient, you’ll be sitting across from a physician like Mark McConnell, MD, who practices Internal Medicine in LaCrosse, Wisconsin. Dr. M. wrote to me after he read my Ethical Nag post called “Can Statins Prevent My Head From Exploding?”
During our subsequent back-and-forth email conversations about statins, cholesterol and these new guidelines, he shared with me these five basic guidelines of his own. I believe that this common-sensical approach is so important, I plan to read this list aloud to all of my future women’s heart health presentation audiences.
With Dr. M’s kind permission, I’m now sharing his list with you:
1. “I never tell a patient they have to take a medicine – NEVER! In fact, a typical conversation goes like this:
- “Doc, do I have to take this?”
- “No! This is a free country! You don’t even have to come to doctor appointments. This is about what YOU decide is best for you. My job is to be a resource and consultant to you.”
2. “Now, many patients want me to decide for them – they simply are not willing to do the homework that you and your readers are willing to do. And that’s fine.
3. “For patients with coronary artery disease, cardiovascular disease, diabetes or really early family history of heart disease: I simply offer a low-dose statin. Regardless of lab values. THE KEY is to make sure they tell me if they have anything they think could be a side effect. They can stop the drug whenever they want to.
4. “For patients without existing heart disease: I use the best risk calculator I’ve found (the Therapeutics Education Collaboration/UBC one mentioned above). Then I just show the patient their risk with or without taking meds, and let them decide. I am careful to tell them that WE ARE TERRIBLE at predicting the future, so these are just ballpark figures. No patient has a 7.5% heart attack. They either have one or they don’t. It’s not a lot different than the stock market. We are poor at predicting, and humans want certainty. But I focus them on the fact that cholesterol is only ONE risk factor. Looking at cholesterol alone is like approaching car maintenance by ONLY changing the oil and never looking at all the other preventive care that an auto needs.
5. And all of this is predicated on the fact that medicine is art and science . . . and the science changes . . . so ALL of us have to keep learning and remain open to what lies ahead.”
♥ Important Reminder: Information on this site is NOT a substitute for professional medical advice. Consult your own physician with any concerns or questions about your health. Please read the Heart Sisters disclaimer.
.* Paul M Ridker, Nancy R Cook. “Statins: New American Guidelines for Prevention of Cardiovascular Disease”. The Lancet. 20 November 2013
Q: What do you make of the fuss over the new heart disease guidelines?
- Can statins help to prevent my head exploding?
- Statin guidelines we love to hate – and the docs who write them
- Evidence for caution: women and statin use
- Study: statin drugs overprescribed for healthy adults
- Women at greater risk for side effects when taking statin drugs for cholesterol
- When medical research is funded to favour the drug, not the facts
- How drug companies get the clinical trial results they want
- Evidence for Caution: What Women Need to Know about Statins – 2007 report from the Canadian Women’s Health Network by Harriet Rosenberg and Danielle Allard
- Number Needed To Treat – from a bunch of very brainy physicians working in emergency medicine, this site has the most helpful explanation of the statistical concept called Number Needed to Treat that I’ve seen yet, along with a list of credible resource links to check NNT stats on several therapies including statins