Women, controversial statin guidelines, and common sense

1 Dec

by Carolyn Thomas  @HeartSisters

101109expIf 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 likely result of this change, as I observed here and here, is the recommendation that, as long as you have a detectable pulse, you need to take statins. 

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?”

imageDuring 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?

.

See also:

.

24 Responses to “Women, controversial statin guidelines, and common sense”

  1. Jane June 14, 2016 at 6:23 pm #

    Should have asked this before – What does Dr. Mark McConnell consider a “low dose,” and does he have suggestions for statin type for women at high risk of heart attack?

    Like

  2. Jane March 25, 2015 at 3:16 pm #

    As risk factors go, I am at extremely high risk. I might reduce the risk by active participation in risk-reduction. As anti-medication as I am, I find it very difficult to believe that research scientists are solely working to up the profits for pharmaceutical companies.

    I hate it that studies are almost always done with men, and this is a very real problem, leading to results that just don’t fit for women. Post-menopause? How much does anyone know about the post-menopausal body as it relates to anything?

    And what about thyroid, or adrenal or whatever function as contributing factors to plaque buildup, when physicians are tied into “normal limits” no matter what symptoms a woman may be having.

    I don’t know whether I’ll take the statin plunge or not, but reports do not address the number of women who were helped by statin use, so it is impossible to make an “informed decision.”

    Liked by 1 person

    • Carolyn Thomas March 25, 2015 at 6:03 pm #

      Hi Jane – it’s a dilemma, all right. You’re so right – given that most research has been done on (white, middle-aged) males, it’s challenging to make decisions when all the facts may not be present.

      Like

      • Jane April 24, 2015 at 4:26 pm #

        Still researching statins and attempting to decide whether to take or not, and have to reiterate that this should not be “my” decision. I have a prescription for atorvastatin, but it is at 80 mg, as an initial dose. That is, I think, the highest dose available. I couldn’t help but sense that the physician who prescribed it was so frightened that I might drop dead right in front of him, that he couldn’t think straight.

        As it looks like a catheterization, et al, is fairly close at hand, and as there is some evidence that certain statins are beneficial in such matters, at this moment, my inclination is to obtain a very low 10 mg dose and take it every other day. That is self-prescribing, but if only one of the physicians I see would admit to any adverse effects whatsoever, I’d trust their appraisal more than my own.

        Liked by 1 person

  3. qualityhealthcareplease December 5, 2013 at 10:02 pm #

    Some of the problem with statin recommendations is with the statistics themselves.

    The standard for most drug studies is a 95% certainty that the drug has an effect. The problem is with the size of the effect — many drugs have an effect but not enough to be really helpful (like living years longer — not just a couple of days longer).

    So what is the cost of statins in terms of cost per year of life prolonged? vs. exercise? vs weight reduction? vs smoking cessation?

    Liked by 1 person

    • Carolyn Thomas December 6, 2013 at 6:30 am #

      Good point, Dr. Beckett. It’s ALL about the numbers. Yet a June 2013 report in Health Affairs that investigated placebo-controlled drug trials reported in four leading medical journals between 1966-2010 found that there was a significant decline in average effect size between the active treatment and placebo (from 400% down to 36%). That means even “slightly better than placebo” can earn drugs a profitable niche among doctors’ prescribing habits.

      Like

  4. Mary December 2, 2013 at 9:05 am #

    I was started on Lipitor (had muscle pain), and was switched to Pravastatin, an older statin (only 20 mg). I still had muscle pain.

    I was coincidentally blood tested for Vitamin D3 and was found to have very low values. I started the remediation protocol per my MD: 50k capsules, 1 per week x 8 weeks, plus 1-2 k more per day. THE FIRST NIGHT, my muscle pain of many years DISAPPEARED. Though nobody diagnosed me with it, what I really had was osteomalacia – a low Vitamin D condition.

    No pain – overnight. It wasn’t the statins – it was the Vit D level.

    Liked by 1 person

    • Carolyn Thomas December 2, 2013 at 9:33 am #

      Interesting. We know that symptoms like bone pain and muscle weakness can mean a vitamin D deficiency, but usually symptoms tend to be more subtle than yours. Glad your blood test caught that, Mary.

      Like

  5. Leslie Kernisan, MD December 2, 2013 at 8:57 am #

    Hi Carolyn,
    LOVE Dr. McConnell’s sensible approach. We need more clinicians to learn from him!

    Thanks for sharing his five key points, and for this post.

    Liked by 1 person

    • Carolyn Thomas December 2, 2013 at 9:27 am #

      Hello Dr. K – I too love Dr. McConnell’s approach, as it really focuses on the need for a personalized discussion with each patient. Thanks for your comment here.

      Like

    • Mark McConnell, MD December 25, 2013 at 5:11 am #

      Dr. Kernisan, I’m glad you found the approach useful. We do have many clinicians who practice this way… we have to keep encouraging them to stick to their commitment to have patients at the center of care.

      I also looked at your 7 Books To Help Us Improve Healthcare“: nice! You might want to consider an 8th: “Overdiagnosed” by Dr. Gil Welch. I think if every patient read it, we would have transformation of healthcare. It might be easier to reform healthcare by creating “demand” from patients than by working on the “supply” side (doctors, insurance companies, ‘the medical-industrial complex’). See what you think!

      Mark

      Liked by 1 person

  6. Vetia December 1, 2013 at 1:53 pm #

    I take statins, here the maximum of Zocor that can be given to a patient is 40mg. I have never had a cholesterol problem but I have trouble with collapsing arteries and I have been taking them for nearly three years.

    I started having trouble with my knees after a year, I was asked by my cardiologist to bear with it a little longer until he could do another cardiac cath at my two year mark. I have three arteries that have started to collapse but he cut the amount down to 20 and is thinking of stopping it altogether at the end of this year. I take them for one of the abnormal reasons and if I didn’t need it for that I would have been taken off at the end of the first year.

    Like

    • Carolyn Thomas December 2, 2013 at 4:36 am #

      This is an example of the dilemma faced by so many patients – good luck in your decision at the end of the year (almost here!)

      Like

  7. Ruth December 1, 2013 at 10:23 am #

    Cholesterol drugs have been my nemesis for years. It has come to the point in my life where I will no longer bring it up to any dr what these drugs do to me. I could write a book on the various answers or excuses they give me by putting the blame on me as a patient.

    The pain I suffered with my arms brought me to tears it was so bad while taking Zocor. My dr had the audacity to tell me it was related to my sleeping position. I also have type 2 diabetes which I swore came from Lipitor. I refused to take Avandia for it and my dr would not take me as a patient any longer.

    This past month they gave my Schizoaffective daughter(age 42) simvastatin. She had a breakdown as bad as when we first discovered her disease at age 19. I was horrified. She didn’t sleep for days. 1st indication for us that she was headed into a downer. Her psychiatrist was finally able to give her the right meds to get her back on track. If she wasn’t able to control the damage the cholesterol drug did our daughter would have had to be hospitalized.
    I could go on and on.

    Liked by 1 person

    • Carolyn Thomas December 1, 2013 at 10:28 am #

      Blaming your arm pain on sleeping positions was an example of your doctor not being willing to take side effects seriously.

      Like

  8. Magda December 1, 2013 at 7:17 am #

    I agree with your analysis. The new guidelines and media are pointing to statins as wonder drugs, yet the side effects and long term consequences of their use are not mentioned.

    Liked by 1 person

  9. JetGirl December 1, 2013 at 6:34 am #

    Statins did not work for me and I am ever grateful that my docs had the courage to take me off of them. Oh sure they lowered my cholesterol, but the muscle pains were real and only disappeared when I stopped the drug. Funny thing was that my cholesterol skyrocketed after that but my docs were patient enough to let it all settle down.

    JG.

    Liked by 1 person

    • Carolyn Thomas December 1, 2013 at 6:49 am #

      Hello JG – side effects like muscle pain can indeed be real for some patients taking statins. For example, the FDA has now recommended limiting high-dose Zocor (simvastatin 80 mg) because of increased risk of muscle damage (myopathy) – notably higher during the first year of treatment. Again, patients must do their homework, pay attention to ANY side effects while on statins, and report these promptly to their physicians.

      Like

      • Dr. Barbara Keddy December 2, 2013 at 4:08 am #

        My statin was recently increased because my cholesterol numbers were not under 2 (Canadian numbers). I already suffer from constant pain from fibromyalgia but the muscle pain is very much worse since the increase in dosage. The leg and arm pain is sometimes excruciating, particularly at night. My family doctor has said adamantly that I must stay on a statin because of my heart disease.

        The fear of coming off the drug is a real one yet there is so much controversy. I know the side effects are interfering with my quality of life, especially because of the pain during sleep. I’m sure physicians are as confused as patients are.

        I dare not come off of it! I am very compliant with my medications and know the research on women and heart disease, in particular statin use, is scarce, yet I am hesitant about not complying with my current regime.
        What a dilemma!

        Liked by 1 person

        • Carolyn Thomas December 2, 2013 at 4:42 am #

          Hello Barbara – you are not alone: many heart attack survivors are afraid to stop taking statins even when their quality of life suffers because of them. “Excruciating pain” that affects your ability to sleep is not good for cardiac health. Interestingly, the one thing the new guidelines stress is to NOT obsess about LDL numbers any longer – as your doctor is still doing. A dilemma indeed – but remember it is YOUR decision, as always.

          Like

          • Rebecca December 3, 2013 at 6:09 pm #

            In 2010 my husband was put on statins because of a heart attack. Over the years he has tried most of the statins. He has experienced every side effect from being on statins. His side effects are muscle pain, decreased memory function, low immune system, low energy level , sexual dysfunction and low vitamin D levels.

            After listening to a compounding pharmacist speak on statin this year, he has started taking ubiquinol CoQ10. If he takes the low dose of statins, the CoQ10 helps with his side effects. Yesterday his doctor told him he needed to take the high dose of statins or he will die of heart disease.

            There have been many studies done to prove that statins lower cholesterol. Most of all the studies done on statins have been done by the drugs companies that make the drug. Many people that have low cholesterol also have heart attacks.

            Liked by 1 person

            • Carolyn Thomas December 3, 2013 at 8:15 pm #

              Hello Rebecca – you might want to have your hubby ask his doctor to explain his plans to address the potential side effects of those high-dose statins. In one Canadian study of over 85,000 patients on statins, 75% of them discontinued statins within two years specifically because of significant side effects like your husband’s (Jackevicius et al). Sadly, some physicians do not take these side effects seriously despite their impact on quality-of-life for many patients.

              Like

Trackbacks/Pingbacks

  1. ActivistPoster - March 2, 2014

    […] Women, controversial statin guidelines and common sense (myheartsisters.org) […]

    Like

Your opinion matters. What do you think?

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 5,203 other followers

%d bloggers like this: