FDA approves controversial drug, ‘superbugs’ on the rise, and more on RCAW

September 22nd, 2016

September 22, 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.

A drug to treat Duchenne muscular dystrophy (DMD), which affects mostly boys, was approved by the FDA this week, even though the agency’s own panel of experts recommended against it.  The New York Times reports that the experts, along with FDA employees complained there was no evidence to prove the drug, eteplirsen, is effective. Lobbying by the well-organized DMD patient community and the drug maker, Sarepta Therapeutics, ultimately compelled FDA commissioner Robert Califf  to cave. As shares of Sarepta soared from the news, drug policy leaders condemned the FDA for being wrongly influenced. “The agency has set a dangerous precedent,” Diana Zuckerman, PhD, president of the National Center for Health Research in Washington, told the Times. Ellis Unger, one of the FDA employees who fought the approval, said the decision sends the message that science doesn’t guide FDA decisions. In a letter to the agency earlier this year Unger wrote: “By allowing the marketing of an ineffective drug, essentially a scientifically elegant placebo, thousands of patients and their families would be given false hope in exchange for hardship and risk.” The drug’s annual cost will be a whopping $300,000 a year. Nevertheless, many families of boys affected by the disease are elated.

Antibiotic overuse has been a public health problem for decades, and despite initiatives to address the issue, prescriptions for broad spectrum antibiotics have continued to increase. According to a recent study by the CDC, total antibiotic use remained stable from 2006 to 2012, but prescriptions for more potent drugs increased, for some drugs by more than 30%. Many of these prescriptions are not needed, writes Ateev Mehrotra, MD, MPH, of Harvard Medical School, in a JAMA editorial. Doctors often prescribe antibiotics “just to be safe” in the face of “diagnostic uncertainty,” and because they “perceive that patients want an antibiotic prescribed,” says Mehotra. In fact, the CDC found earlier this year that about a third of antibiotics prescriptions are unnecessary. Because bacteria adapt to antibiotics, overprescription increases the risk of antibiotic-resistant bacteria, or “superbugs.” And the evidence shows the risk is growing. According to a Reuters analysis, deaths from drug-resistant infections in the U.S. skyrocketed from about 8,600 in 2003 to 16,700 in 2014. One of these deaths was John McCleary, the father of Kathy Day, RN, a member of the RCA Nursing Council and the Community Engagement Council. Her dad was admitted to the hospital at age 83 with a broken ankle and died three months later from MRSA, an antibiotic-resistant infection. Since then, Day has been dedicated to changing the “culture of complacency” around drug-resistant infections. “It will take an organized, standardized, strong, and efficient approach to prevent MRSA,” says Day.

For Right Care Action Week (October 16-22), clinicians, patients, and community members around the country are planning events to demonstrate the power of listening in health care. Ricardo Correa, MD, of Brown University Alpert Medical School, will be holding two events at the Rhode Island Hospital: Hosting a Listening Booth in the hospital lobby, and handing out “What Worries You” cards to patients. Moving to the US from Panama, he was shocked to find the extent to which doctors in the United States perform unnecessary procedures. “In Panama, we don’t have so many resources, so we do a lot of clinical work instead of imaging and tests,” said Correa. “Here, there are tests that lead to more and more and more for no reason.” Correa is interested in how patients view diagnostic testing. “Do patients know why doctors are ordering these tests? Are they being informed?” he asks. Correa is also using Right Care Action Week as a way to encourage other clinicians to join the right care movement. He’s using patients’ experiences as case studies in rounds, to bring cases of wrong care to the department’s attention. He also plans to integrate stories from the Listening Booth event into research he is working on with the Rhode Island Medical Society, so physicians statewide will better understand what patients need. Read our blog about Correa’s RCAW activities, stay tuned for more RCAW profiles, and don’t forget to join us. Sign up now!


If you are in the Boston area on Monday, October 24, feel free to stop by our offices from 5-7 pm ET during our Open House unveiling our newly renovated space at 21 Longwood Ave., Brookline, MA. RSVP by Thursday, October 20 to kmerry@LownInstitute.org.

Last year Shannon Brownlee, MSc, senior vice president of the Lown Institute, was interviewed last year at the Uncharted Berkeley Festival of Ideas, which features some of the world’s edgiest thinkers. Last week KALW chose her interview to air for the  launch of the Uncharted Radio Hour. Hear it here ( #14 on the iTunes list). Randi Oster, a member of the Children’s Health Council and the Community Engagement Council of the Right Care Alliance, will be interviewed at this year’s festival, which takes place next month. Oster is the author of Questioning Protocol.







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RightCare Weekly is made possible through the generous support of the Robert Wood Johnson Foundation.