Comments of Members of the Patient, Consumer, and Public Health Coalition on the USPSTF’s draft recommendation statement

January 25, 2016

Comments of Members of the Patient, Consumer, and Public Health Coalition on the USPSTF’s draft recommendation statement

Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication

As members of the Patient, Consumer, and Public Health Coalition, (an informal coalition of nonprofit organizations representing the interests of patients, consumers, health-care professionals, scientists, and public health experts), we are submitting these comments to express our strong concerns about the United States Preventive Services Task Force’s (USPSTF) draft recommendation statement.

We agree with USPSTF that there is insufficient evidence to assess the benefits and harms of statins used for the prevention of cardiovascular disease (CVD) in adults age 76 and older who do not have a history of heart attack or stroke.

However, we strongly disagree with USPSTF’s two recommendations regarding adults aged 40 to 75. The task force recommends that adults without a history of CVD use a low-to-moderate-dose statin to prevent heart attacks and strokes when they have more than one risk factor and they have a calculated 10-year risk of a cardiovascular event of 10% or greater.[end USPSTF (2016). Draft Recommendation Statement. Statin Use for the Primary Prevention of Cardiovascular Diseases in Adults: Preventive Medication.  Accessed January 24, 2016 at http://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement175/statin-use-in-adults-preventive-medication1] The task force gives this recommendation a GRADE B, stating, “there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.”2 We strongly disagree with this recommendation. It would encourage millions of healthy Americans to take statins, putting them at-risk of adverse events without evidence that it would benefit their health.

The task force also recommends that clinicians offer a low-to-moderate-dose statin to certain adults without a history of CVD when they have one or more CVD risk factors and they have a calculated 10-year risk of a cardiovascular even to of 7.5% to 10%.  USPSTF makes this recommendation despite acknowledging that “the likelihood of benefit is smaller due to a lower probability of disease and uncertainty in individual risk prediction.”

The task force gives this recommendation a Grade C, which means this services should be provided “for selected patients depending on individual circumstances.”[end USPSTF (206). Grade Definitions Web site.  Accessed January 24, 2016 at   http://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions] This recommendation would apply to millions of Americans, which does not fit the definition of “selected patients.” The task force also notes that, “the number of persons who will avert a CVD event will be much smaller than when the risk is at least 10%, and clinicians’ ability to accurately identify who will go onto experience a CVD event is limited.”1  A “C” is not good enough evidence to justify this recommendation.

Concerns about the recommendations

Statins have substantial risks. In ​a 2015 analysis of clinical trials, statin drugs given for 5 years for heart disease prevention to healthy adults saved no lives but 1% developed diabetes and 10% suffered from muscle damage.[end NNT Group (2015). Statin Drugs Given for 5 Years for Heart Disease Prevention (Without Known Heart Disease). Accessed January 24, 2016 at  http://www.thennt.com/nnt/statins-for-heart-disease-prevention-without-prior-heart-disease/] The study notes that “the harms of statins are less publicized than benefits, but are well documented.”3 It added, “most concerning, the drugs may increase diabetes, a serious and life-altering disease.”3  Data from a meta-analysis of 11 trials that included 65,229 persons found that “healthy but high-risk men and women showed no reduction in mortality associated with treatment with statins.”[end Redberg, RF, Katz, HD (2012). Health Men Should Not Take Statins. JAMA, Vol 307, No 14.]

The number of statin users who suffer muscle symptoms and damage may be underestimated.  It is difficult to measure because patients and their doctors often assume that aches and pains are caused by aging, not by statins.  Observational studies show higher rates for statin-associated myopathy in actual use than reported in clinical trials.4

In addition, statin therapy can cause cognitive impairment that “would not have been captured in randomized trials.”4 The task force notes that “further research would more definitively establish the relationship between statin use and cognitive function.”1 This research must be done before the USPSTF recommends that millions more healthy Americans begin taking statins.

Moreover, there continues to be concerns that statins may sometimes cause liver damage.  A Great Britain study “found statin use was associated with increased risks of moderate or serious liver dysfunction, [and] acute renal failure.” 4

We are also concerned that statin trials have not included sufficient numbers of women, seniors, and racial and ethnic minorities, and have not analyzed safety and efficacy separately for those subgroups. The task force notes that “a majority of participants were male and white.”  And yet, the task force’s recommendations are for all adults 40 to 75. It is inappropriate for USPSTF to assume that data based primarily on white males would be the same as data for women and people of color.

Most data on statins come from industry studies, which have “a spotty history of integrity in trial data reporting.”3 A 2011 Cochrane review found that “all but one of the clinical trials providing evidence on this issue [statins] were sponsored by the pharmaceutical industry.”4 Industry-sponsored studies have been shown to report more favorable results for drug treatments than non-industry sponsored studies.

Conclusions

It is essential that the USPSTF bases its recommendations on solid, unbiased, conclusive data based on diverse samples.  Such data do not exist regarding the use of statins for healthy adults at risk of heart disease.  The substantial risks of statins are known, although the prevalence of those risks for all major demographic groups needs more study.  Meanwhile, there is no evidence that the benefits would outweigh the risks for healthy adults.  There are alternative treatments to statin use, such as changes in lifestyle (healthier diets, smoking cessation, and increased physical activities).  When given the choice between medication and healthier habits, most Americans will choose medications.  That is why it is so important for USPSTF to encourage healthy Americans who are at risk of heart disease to change their habits to achieve cardiovascular benefits, rather than risking harmful side effects caused by statins. For these reasons, we do not support the USPSTF’s two recommendations regarding adults aged 40 to 75.

Annie Appleseed Project

Center for Medical Consumers

MedShadow

MISSD (The Medication-Induced Suicide Education Foundation in Memory of Stewart Dolin)

MRSA Survivors Network

National Center for Health Research

National Women’s Health Network

The TMJ Association

Center for Science and Democracy at the Union of Concerned Scientists

WoodyMatters

The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org