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The headline I wish I’d seen about the new PCSK9 cholesterol drugs

The following is a guest post by Kevin Lomangino, managing editor of HealthNewsReview.org. He tweets as @Klomangino

 

“New Drugs Cut Heart Risks by One Percentage Point: Study”

That”s the headline I didn”t see from any stories yesterday about two new cholesterol drug studies presented at the American College of Cardiology meeting.

While it might sound like something out of The Onion, this would actually be an accurate way —  I would argue, the most accurate way — to characterize the effect that these drugs had an on the cardiovascular risk of study participants.

In one of the studies, patients taking the experimental drug evolocumab had about a 1% risk of cardiovascular events compared with 2.2% in the control group — for a 1.2% reduction. The difference was slightly larger — 1.6% — for patients taking the second drug, alirocumab.

Many of the stories about these drugs, called PCSK9 Inhibitors, had these absolute risk reductions buried deep within the body of their text. But the main thrust of most stories was on the eye-popping relative risk reductions.

Consider Bloomberg’s headline trumpeting the potential for these drugs to ““Cut Heart Risks in Half.”

Similarly, Reuters led with news of a “signal” that the drugs “can reduce by half the risk of heart attack and other major cardiovascular problems compared to standard treatment alone.”

CBS headlined the results a “”breakthrough”” and suggested that the studies “boost hope” that these drugs “can greatly lower the risk for heart attacks, death and other heart-related problems.”

Sure, the drugs did “halve” the risk of cardiovascular problems, but going from 2% to 1% isn”t what your typical reader is picturing when they hear a claim like that.

Then again, studies show that many people seem to have an exaggerated perception of how much they benefit from health interventions. And the use of relative risk figures has been identified as an important factor contributing to that misperception.

Look, I hate to be the guy to call the cops on the PCSK9 party, but the celebration was premature to begin with.

These studies were designed to look at safety and the cholesterol-lowering effect of these drugs — not whether the drugs prevent heart attacks.

And it looks like we’ve got plenty to keep us busy on the safety front before we prematurely start promoting benefits.

The study authors themselves noted in one of the papers that “the number of cardiovascular events was relatively small, which limits the robustness of these data and the confidence that they are not simply a chance finding.”

We”ll know soon enough whether these drugs provide meaningful benefits to patients from large outcomes studies that are already underway.

In the meantime, let’s put a moratorium on overblown statistics that are more marketing than they are useful information.

Update: We’ve also scrutinized coverage of these studies with a head to head comparison of stories from the New York Times and Associated Press.

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Comments (5)

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Kevin Lomangino

March 17, 2015 at 8:43 am

The imaginary headline I reference in my introduction originally read: “New Drugs Cut Heart Risks by 1%: Study.” But I was reminded by @NoGimmicksNutri on Twitter that it would actually be more accurate to say “one percentage point,” which reflects the change in absolute value. “One percent” would indicate a relative risk reduction. He said it would be even more interesting if the headline had read, “from 2% to 1%.” I agree.

    Miljenko Zuanic

    March 17, 2015 at 2:20 pm

    Have you any idea what 0.5%-, 1%-, or 2%-rate reduction/year mean? Zetia have 0.22%/year MACE rate reduction and changed by 360 degree cardiologist view!

M. Alton

March 22, 2015 at 11:05 pm

I take issue with the scores you gave the two stories about PCSK9 cholesterol drugs. Isn’t it a form of disease mongering to set forth, without qualification, as both stories do, the “conventional wisdom” that cholesterol is the grand marshal of the heart disease parade? And that taking LDL lower and lower will change or has changed the entire cardiology landscape? Shouldn’t part of medical reporting be to suggest that there could be differing points of view on the main topic of any story. In this case, it would be whether the cholesterol hypothesis is subject to challenge.

Just once, I would like to see an article about the magic of low cholesterol and its eradication of heart disease that also mentions that not every doc and researcher on the planet agrees with conventional cholesterol wisdom. See the work of Malcolm Kendrick, Uffe Ravnskov, and many others.

So, disease mongering in the PCSK9 stories, or not?

    Kevin Lomangino

    March 23, 2015 at 8:36 am

    Thanks for taking the time to comment.

    You raise a valid point, but the short answer to your question is, no, I don’t think there was disease-mongering in these stories. And I don’t agree that these stories set forth the benefits of cholesterol-lowering without qualification. Had the stories used language suggesting that high cholesterol is a disease and that these drugs were beneficial simply because they lowered cholesterol, then that would have been something we’d comment on either in the “Evidence” or “Disease Mongering” sections. However, the studies did look at real outcomes that matter to patients — heart attacks and strokes — not just cholesterol. And both of the stories commented appropriately on important limitations in the study designs. The Times story addresses the issue you are raising with this: “But merely looking at cholesterol levels can be misleading. The drug niacin did not protect against heart attacks and strokes even though it raised so-called good cholesterol and modestly lowered bad cholesterol.” That’s probably not as strong a caveat as you’re looking for, but we thought it was useful and well-calibrated language.

    Regards,

    Kevin Lomangino
    Managing Editor

Marilyn Mann

March 26, 2015 at 11:31 am

Sorry for the delay in commenting on this. I agree with you that one should always look at absolute benefits and absolute risks when making a decision on whether to undergo a medical intervention. However, my primary concern with some of the stories on the PCSK9 inhibitors is that they did not sufficiently emphasize that the studies just published in the NEJM, coinciding with the 2015 American College of Cardiology conference, were not designed to answer the question of whether evolocumab and alirocumab prevent cardiovascular events. These studies did not have cardiovascular events as a primary or even a secondary endpoint. Rather, the studies measured LDL reduction and tabulated adverse events over a 52- or 78-week time period. Among the adverse events being tabulated were cardiovascular events and there were fewer cardiovascular events in the patients who were in the evolocumab and alirocumab groups, as compared to patients who received placebo or usual care. One of the studies had prespecified an exploratory analysis of cardiovascular events. For the other study the investigators did a post hoc analysis of certain cardiovascular events. Neither study was powered (i.e., big enough) to provide a reliable estimate of the benefits of these drugs in reducing heart attacks, strokes and deaths. In other words, statistically speaking the studies were pretty thin gruel and the companies as well as the investigators acknowledge that fact. So, as of now, we really do not know that these drugs reduce the risk of cardiovascular events, let alone by how much. Nor do we really know how safe the drugs are.
Fortunately, the sponsors have started large cardiovascular outcomes trials in high risk patients (e.g., the alirocumab trial will involve 18,000 patients and a minimum of 1613 primary endpoint events and a minimum two year followup. See here for a description of the trial: http://www.sciencedirect.com/science/article/pii/S0002870314004943).
All these studies do is tell us that as of now there drugs appear to be progressing satisfactorily along the path to approval and we just have to be patient for a couple of years until the results of the outcomes trials are available.
I suggest taking a look at this short video of Harlan Krumholz speaking from the conference — I completely agree with his comments.
https://www.medpagetoday.com/ACC2015VideoOnTheScene/Cardiology/ACC-Videos/1050
(website registration may be required)