Rita Redberg and Roger Blumenthal Clash Over Statins for Primary Prevention in the Wall Street Journal 8

The debate over whether statins should be used for primary prevention moved to the Wall Street Journal with opposing perspectives from cardiologists Roger Blumenthal and Rita Redberg.

Blumenthal argues that “there is a mountain of high-quality scientific evidence” to support the use of statins in people without known heart disease but “demonstrated to be at high risk for heart disease.”

Redberg argues that “for most healthy people, data show that statins do not prevent heart disease, nor extend life or improve quality of life. And they come with considerable side effects. That’s why I don’t recommend giving statins to healthy people, even those with higher cholesterol.”

Both authors cite the West of Scotland Study and JUPITER in support of their position. Blumenthal concedes that long-term studies looking at mortality have not been performed, noting that such a study “would be enormously expensive and unwieldy, and take decades to complete.” Instead, Blumenthal cites evidence from meta-analyses, and the example of the wide acceptance of primary prevention for the treatment of high blood pressure, despite a similar lack of evidence.

Redberg says that the blood pressure data is more convincing than the statin data. No evidence supports a mortality benefit, she writes. The most “optimistic projections,” she writes, suggest that “for every 100 healthy people who take statins for five years, one or two will avoid a heart attack. One will develop diabetes.”

Both authors agree that diet and exercise are important. Blumenthal writes that “treatment doesn’t have to be all or none—all statin or all lifestyle. The two can be effectively combined to help our patients.” Blumenthal rejects the idea that statin are a moral hazard:

Think of it this way. If your doctor recommended a statin to you because of high risk of heart disease, would you eat more hamburgers because of this safety net or would you try to exercise a little more?”

Redberg believes statins take resources away from lifestyle changes:

If we were to spend a small fraction of the annual cost of statins on making fruits and vegetables and physical activity more accessible, the effect on heart disease, as well as high blood pressure, diabetes, cancer and overall life span, would be far greater than any benefit statins can produce.

Comment: I call it a draw. Redberg’s all-or-nothing attack on statins for primary prevention lacks nuance. Clearly this doesn’t need to be a binary decision. Statins are undoubtedly worthwhile for some people at high risk. The problem is identifying those people and deciding at what level of risk does statin use become reasonable. These are not trivial problems. Blumenthal, on the other hand, skates over the small reduction in absolute risk in primary prevention, citing the large relative risk reductions of statins on soft endpoints. He doesn’t state a clear way to identify a population in whom statins would be safe and cost effective.

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8 comments

  1. In deciding what treatments are appropriate for patients, it is not enough to only look at risks. Decision making rests on both the benefits and risk.

    All would agree that statins (and drugs in general) have potential side effects. But then we need to consider the benefits, and I believe that Dr. Blumenthal is taking the existing data and extracting them to a broader population in a responsible and Bayesian manner.

    In looking at the long term effects of lifestyle changes, do we have enough information to make a similar extrapolation? I know that we want to believe exercise and dietary changes are good things, but aside from tobacco cessation, are there data to tell us that there is benefit to lifestyle changes?

    I’m ready for Dr. Redberg to cite the cross sectional data, but even she would need to acknowledge that cross sectional data do not permit one to see a causal relationship, only the appearance of an association.

    I’ll place my bet on Dr. Blumenthal, as I practiced and advocated for years. We know what statins do, both as benefits and risks, and that allows for a more precise decision making process than with lifestyle changes, where cause and effect (and reduction of clinical events) have not been defined during long-term interventions. And with all the generic statins and costly gyms, perhaps there is even an economic advantage to statins.

    • Rita Redberg sent the following response to Sackner-Bernstein’s comment:

      Dr Sackner-Bernstein is absolutely correct that one must look at benefits and risks, and that is why I don’t recommend statins for healthy people. Numerous scientific studies show no benefit for statins in primary prevention on mortality even in high-risk populations (Ray K et al Archives Internal Medicine June 28, 2010 and Cochrane report 2011) . In addition, the actual incidence of adverse events is closer to 20% in real world use. There is an increased risk of diabetes with statins, seen in randomized and observational trial data. There is overwhelming epidemiologic and observational data from numerous studies on the benefits of healthy lifestyle, including less depression and arthritis, decreased memory loss, improved quality of life and longer life.

  2. Larry- thanks for pointing this out. I had not seen it. One thing that I find troubling about Rita’s position (and I will ask her about this) is that she says this about West of Scotland:

    “One large study, conducted in Scotland, showed a reduction in mortality among men who used statins for a few years. The study, though, looked at a high-risk group of men for whom the benefits of statins were most likely to outweigh the risks; most were smokers and obese, and some had heart disease. Those results can’t be extrapolated to most Americans taking statins today.”

    But then she says this:

    “Until and unless further persuasive evidence is available that the benefits of statins outweigh the known side effects, their use should be limited to patients with known heart disease to help prevent recurrent heart attacks.”

    It seems hard to reconcile these two statements. Rita admits that statins do have proven benefit in high-risk people yet she says nobody should be treated with statins in a primary prevention setting. I think it is a vast over-simplification to say that use of statins should be limited to secondary prevention.

    How about the idea that people with high risk (as determined by tools like the Framingham Risk Score) are treated? In fact, the data seem to support doing this regardless of what the levels of LDL cholesterol are.

    • I agree with Dr. Weiss, who is a brilliant Hopkins trainee. It is inconceivable that a responsible clinician would not treat certain high risk individuals with a statin if their Framingham risk estimate for an MI was > 20% over the next decade. If that is too low, then how about a 50% risk of an MI over 10 years. One can used hsCRP to identify a subgroup that will derive greater benefit. Of course, Mike Blaha’s Lancet paper from MESA showed that moderate coronary calcium identifies a group in whom most of the CV events over the next 7 years occur. By the way, statin therapy using most generic agents is ~$5 per month.

  3. Larry, if you think that this debate was a draw, you must have call the Holmes-Ali fight a draw. “C’Mon Man!” as Keyshawn Johnson and Chris Berman would say on Monday Night Football. Dr. Redberg does not believe that statins yield a net a benefit in the secondary prevention setting either. Simply incredible and anathema to any reasonable Cardiologist. She doesn’t think that the high risk primary prevention subjects in West of Scotland are reasonable to look at and she apparently thinks that Paul Ridker, Rory Collins, and Bernard Gersh did funny things with the JUPITER trial results. Collins and Gersh were two of the senior persons on the DSMB that recommended early termination of the trial. Both West of Scotland and JUPITER showed decreases in total mortality – the only thing that she cares about. Every medical guideline in the world recommends that certain high risk patients (as determined by the presence of risk factors) be considered for statin therapy. Common sense, Larry. I don’t think that you realize how extreme and ridiculous the editor of the Archives of internal Medicine is being. C’Mon Man and Woman. Happy New Year to all.

    • Roger, I agree with you that high risk and even some intermediate risk people should take statins for primary prevention. And I think that Rita should take a more nuanced position. But she also makes some powerful points, and the evidence base in favor of primary prevention is much less persuasive than it should be. I think the major weakness in your statement is the reliance on relative risk. The NNTs need to be reasonably low to justify statins for primary prevention.

      In addition: I’m not sure that cardiologists are quite as unanimous about this as you think. Certainly the cholesterol mafia and the prevention mafia –but I mean mafia in the best possible sense! 🙂 — are largely in agreement here, but I’ve spoken with many cardiologists and other experts who are fairly skeptical about statins for primary prevention.

      Finally, I’ll note that 70% of Wall Street Journal readers voted against using statins in healthy people. I won’t pretend that this is necessarily a meaningful result– but it’s at least as meaningful as a participant in the debate also serving as the referee!

  4. Pingback: Statins and Diabetes: Real Concern or Much Ado About Nothing? – Forbes – Signs For Diabetes

  5. Pingback: Statins and Diabetes: Real Concern or Much Ado About Nothing? « CardioBrief

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