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FDA hearing on off-label marketing, new statin recommendations, and the future of women’s health

November 17, 2016

In order to bring you more of the news you want to read, RightCare Weekly summarizes and interprets three important articles and provides headlines linking to the many other articles and editorials you’ll find interesting. As always, RightCare Weekly presents articles related to moving our healthcare system toward the right care for all patients.

Join the conversation: Post your comments in our new section at the bottom of this page.

Should drug and medical device companies be allowed to market their products to clinicians for uses for which they have not been approved or cleared by the U.S. Food and Drug Administration? On November 9 and 10, the FDA held meetings to hear from patient advocates, clinicians, industry representatives, and others on off-label marketing or marketing products for unapproved uses. Vikas Saini, MD, president of the Lown Institute, testified that off-label marketing significantly contributes to overuse, which wastes huge sums of resources and harms patients. “The vast majority of information justifying off-label use outside the FDA approval process is not of high scientific quality and drives unjustified indication creep,” said Saini. While industry claims that their marketing will be only “truthful and not misleading,” this does not mean the information is scientifically valid. Without the FDA to examine the evidence, pharmaceutical and device companies can and currently do use biased studies to market products directly to doctors. “Why would we take out the last bastion of protection from patients by loosening standards even more?” asked Saini. With the promise of a new anti-regulation administration in January, we will continue to push for restrictions in off-label marketing; the right of corporations to market unproven products for profit cannot outweigh patients’ rights to health and safety.

With apologies to Benjamin Franklin, is a ton of prevention truly worth an ounce of cure? This week, The Washington Post reports that the U.S. Preventive Services Task Force has issued new guidelines recommending that individuals between the ages of 40 and 75 take a statin if they have just one risk factor for heart disease or stroke, even if they don’t have symptoms. “People with no signs, symptoms, or history of cardiovascular disease can still be at risk for having a heart attack or stroke,” said Kirsten Bibbins-Domingo, PhD, MD, the task force chair. But there is substantial disagreement about the value of statins for this group, who are at far lower risk of a heart attack than those who have symptoms. Critics of the new guidelines are also concerned about statin side effects (which can include liver damage and a dangerous breakdown of muscle tissue). In a JAMA Internal Medicine editorial, Rita Redberg, MD, a cardiologist at the University of California at San Francisco and editor of JAMA IM, and Mitchell Katz, MD, deputy editor, warn that, “[P]ersons at low risk have little chance of benefit but equal chance of harms and thus are more likely to have a net harm.” They call for a common-sense alternative to more drugs for more people: refocused efforts on promoting a healthy diet, regular physical activity, and not smoking.

With the election of Donald Trump, the future of health care access in America, especially for women, appears precarious. Throughout his campaign, and again in an interview this week on 60 Minutes, Trump reiterated his intention to appoint Supreme Court justices who would overturn Roe v. Wade. Trump also has aligned himself with pro-life organizations that seek to limit access to some forms of birth control. And, as reported in New York Magazine, he has pledged to defund Planned Parenthood, something vice-president-elect Mike Pence already has done in Indiana. According to STAT, women have responded by sending gifts and donations to women’s health groups en masse and making appointments to obtain long-lasting contraception. However, these actions alone are not enough. “That same energy that … [has] people dropping off cookies and doughnuts at Planned Parenthood — that needs to be channeled into sustained, focused political activity,” said Willie Parker, MD, an obstetrician and abortion provider.

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