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The Washington Post is reporting on new U.S. Preventive Services Task Force (USPSTF) guidelines for statin drugs. The headline is that “Everyone 40 and older should be considered for the drug therapy.”
The recommendations apply to adults 40 to 75 years who have 1 or more cardiovascular disease risk factors and a calculated 10-year CVD event risk of 7.5% or more.
That’s not everyone.
And while the Post’s framing may make it sound like statins are a slam dunk for heart disease prevention, even among healthy adults who aren’t at increased risk, that’s hardly a unanimous opinion among experts in cardiovascular disease.
This disagreement was front and center in the coverage of journalist Larry Husten, who headlined his piece on the guidelines at Cardiobrief: Debate Ensues As USPSTF Finalizes Statin Primary Prevention Guideline; Broad disagreement about how, when, and if to use statins.
The second paragraph of Husten’s story gives an overview of the wide-ranging concerns that have been raised:
But accompanying the guideline, published in the Journal of the American Medical Association, came a slew of editorials and viewpoints, most expressing disagreements with many key details of the recommendation. No common theme emerged in the articles, suggesting that there is little consensus on how to implement or even think about primary prevention. Most— but not all— the experts expressed strong support for the concept of primary prevention with statins. but with different underlying philosophies and widely varying ideas about how it should best be implemented.
Specific issues that critics have called attention to include:
The absolute reduction in risk is small for individuals at lower risk; advocates for broader use have emphasized relative risk reductions which may be misleading.
Trials failed to rigorously collect data on adverse effects such as muscle pain, which may lead to systematic underestimation of those effects.
Sponsors of industry-funded trials haven’t shared individual patient-level data from the studies with other investigators. This could bias the results of the meta-analysis that USPSTF relied on for its recommendations.
The Post does eventually get around to voicing some of these concerns, and that’s a good thing, but only after the headline and 8 paragraphs of copy hammer the need for “everyone” over 40 to think about filling a statin prescription.
With data from 2012-13 showing that the U.S. rings up some $17 billion in statin costs annually, we need to think about the impact of such broad recommendations not just on an individual level but as a society. I’m reminded of a post last year by Dr. John Mandrola headlined: “Statins in Primary Prevention: Welcome to the Gray Zone” (registration required).
Drugs are not free. Aspirin and statins come with side effects and dollar costs. The patient who takes these drugs in hopes of preventing future events makes the gamble that the costs are worth the benefit. Policy makers who recommend these drugs expose millions of people to a therapy that turns on delicate balance between future benefit and harm.
If the new recommendations – and/or news coverage thereof – lead a significant percentage of Americans over age 40 to schedule screenings, it could have profound policy implications.
How many more billions will be spent on office visits, further testing, prescriptions, and followup care for any harms caused by statins (even if only in a very small number of users)? And how will a Trump administration, one of whose bedrock promises is the end of the Affordable Care Act, deal with what those additional costs do to the nation’s health care cost burden?
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