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New statin guidelines prompt concerns about the data, and about expanded use

Cholesterol crystals in synovial fluidCreative Commons/Ed UthmanCholesterol crystals in synovial fluid — a viscous, non-Newtonian fluid found in the cavities of synovial joints.

The new cardiovascular-disease treatment guidelines released Tuesday by the American Heart Association and the American College of Cardiology is expected to significantly increase the number of American adults taking cholesterol-lowering statin drugs.

Indeed, under the new guidelines, about one-third of all adults in the United States would be advised to take statins. That’s because the guidelines have dramatically lowered the threshold for estimating a person’s risk of cardiovascular disease.

And that has some medical experts very concerned, although it was difficult to find their viewpoint yesterday among the generally enthusiastic media coverage of the new guidelines.

An op-ed from two of those concerned experts appeared this morning in the New York Times. It offers a different perspective on statins and heart disease — one that all of us should consider as we discuss these drugs with our physicians.

The authors are Dr. Rita Redberg, a cardiologist at the University of California, San Francisco Medical Center and the editor of JAMA Internal Medicine, and Dr. John Abramson, a lecturer at Harvard Medical School and the author of “Overdosed America: The Broken Promise of American Medicine.”

“We believe,” they write, “that the new guidelines are not adequately supported by objective data, and that statins should not be recommended for this vastly expanded class of healthy Americans.”

Here, in part, is why they have taken this position:

This announcement [of the new guidelines] 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.

The new guidelines, among other things, now recommend statins for people with a lower risk of heart disease (a 7.5 percent risk over the next 10 years, compared with the previous guidelines’ 10 to 20 percent risk), and for people with a risk of stroke. In addition, they eliminate the earlier criteria that a patient’s “bad cholesterol,” or LDL, be at or above a certain level. Although statins are no longer recommended for the small group of patients who were on the drugs only to lower their bad cholesterol, eliminating the LDL criteria will mean a vast increase in prescriptions over all. According to our calculations, it will increase the number of healthy people for whom statins are recommended by nearly 70 percent.

This may sound like good news for patients, and it would be — if statins actually offered meaningful protection from our No. 1 killer, heart disease; if they helped people live longer or better; and if they had minimal adverse side effects. However, none of these are the case.

Statins are effective for people with known heart disease. But for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness — as shown in a recent BMJ article co-written by one of us. That article shows that, based on the same data the new guidelines rely on, 140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.

At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes (especially for women), cataracts or sexual dysfunction.

Redberg and Abramson also raise another concern:

The process by which these latest guidelines were developed gives rise to further skepticism. The group that wrote the recommendations was not sufficiently free of conflicts of interest; several of the experts on the panel have recent or current financial ties to drug makers. In addition, both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies.

The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.

You can read the op-ed on the New York Times website.

Comments (4)

  1. Submitted by Ray Schoch on 11/14/2013 - 11:31 am.

    Amen

    …to Drs. Redburg and Abramson.

    The negative side effects of statins have been massively underreported, while the positives have been overemphasized. After more than a decade of taking low-dose statin drugs to deal with cholesterol issues, I’d read enough about negative side effects that I announced to my doctor that I was — as an experiment — going to quit taking them. His response, somewhat skeptical, was “OK, but if the numbers aren’t controlled, I’m going to push for you to get right back on them.” Six months later, a full blood workup showed that my “bad” cholesterol numbers had not only not increased, but had actually decreased somewhat from what they’d been at the previous full blood workup when I WAS taking statins.

    Results were the same 6 months later. LDL cholesterol remained well below 200, other numbers were relatively unchanged, my BP remains in the low 120s over 60s, pulse in the 60s, and so on. I’m medication-free, and in my 70th year. Not everyone will be so lucky, certainly, but there are plenty of good reasons to shy away from the quintessentially-American syndrome of trying to medicate our way to good health.

    Eat a lot less beef, lots more fruits and veggies, and get up out of that chair, turn off the TV, and DO something. It’s a combination that will have health benefits far beyond what a statin pill can offer.

    • Submitted by Lance Groth on 11/14/2013 - 04:31 pm.

      One quibble

      Good for you, and your advice is sound, except that I have one small “bone” to pick with this:

      “Eat a lot less beef” This should be cast as “eat a lot less grain-fed (commercial) beef”. Because grass-fed beef is not an issue re-cholesterol, and is in fact a healthy source of protein, just as is grass-fed bison. Eat all of that you want. The old saw about red meat being bad for you is true only because of the way commercial beef is raised and fed with corn, which is bad for both cattle and humans.

      The other problem with the statin recommendation, in addition to those noted, is that there are 2 kinds of LDL cholesterol molecules, one of which is a health concern, while the other is not. Lumping them together as just “LDL” only muddies the issue. Blood levels of each need to be parsed out before an intelligent decision can be made about possible intervention.

      I would not take statins regardless.

  2. Submitted by Ann Spencer on 11/14/2013 - 03:59 pm.

    It always surprises me

    that people are so quick to shout “Rationing!” whenever this or that group recommends LESS treatment but seem blind to the financial incentives favoring MORE treatment.

    We ought to be highly skeptical of any recommendation that 1/3 of adults take a prescription medication with known adverse side effects daily, year in and year out, for decades. The money to be made is enormous. We need to be darn sure that the recommendations are based on sound science and truly objective analysis, uninfluenced by the pharmaceutical companies.

  3. Submitted by Paul Brandon on 11/14/2013 - 07:09 pm.

    One problem with medical research as a basis

    for action is publication bias.
    Given the funding for most researchers and journals, positive outcomes are more likely to be published than negative ones. Benefits are weighted more highly than risks.
    For that reason, given a choice between equivalent medications I’ll pick the one with the longest track record, so that side effects are more likely to have been reported.

    The other problem is markers vs. end points.
    It’s much easier to collect data 5 or ten years down the road on markers for mortality, such as high cholesterol or triglyceride levels, on the assumption that this will eventually be followed by actual effects on mortality.
    The few studies that have in fact compared markers to mortality have found that the relationship can be quite weak.
    That’s why the study questions whether a correlation between natural blood measures and mortality implies that lowering those measures through drugs will have a causal effect on mortality.
    So I’ll second Ray’s recommendation that ‘when in doubt, don’t’.

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