A call for bias-free trial analyses, reporting device hazards, and burnout survey results

June 23rd, 2016

June 23, 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.

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On Naked Capitalism and Health Care Renewal, Bernard Carroll, MD, former chair of the Psychopharmacologic Drug Advisory Committee of the FDA, calls for independent analyses of clinical trials data, citing pharmaceutical companies manipulation of study findings that are published and ultimately lead to patient harm. As an example, he provides details of a clinical trial of an antidepressant, citalopram, which was conducted by drug maker Forest Laboratories. Intending to expand the drug’s use in children, the company left out in published papers study information from its own European partner that had raised concerns about the drug’s suicide risk in children. Forest also did not acknowledge the author of their paper was a hired writer who took direction from company marketing executives, and that academic authors were added only after the manuscript had been written. Because only the FDA sees all the data from trials, (medical journals’ peer reviewers do not) Carroll recommends “corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight.” In Vox, reporter Julia Belluz writes about bias affecting mainstream news outlets. “Instead of trying to translate what the best-available research evidence tells us about how to live, we report on the latest studies out of context, with little focus on how they were designed, whether they were unduly conflicted by study funders, and whether they agree or disagree with the rest of research.” She argues reporters need access to research evidence, evidence-based news releases, and better training in research methods. “We need help making sense of research, and in turn, helping readers (who include patients, policymakers, and doctors to do the same.” We’d add that reporters also need access to expert sources, like the members of the Right Care Alliance Science and Evidence Council, who do not have financial conflicts of interest with manufacturers.

If Hooman Noorchashm, MD, hadn’t raised a ruckus he did after his wife developed cancer from fibroid surgery performed three years ago, the Medical Device Guardian’s Act, a bill almost certainly would not have been introduced in Congress this month requiring doctors to report medical-device hazards to the FDA. Noorchashm, a cardiothoracic surgeon, blames the power morcellator, the device used during his wife’s surgery, for causing undiagnosed cancer to spread. He and his wife, Amy Reed, a critical care physician, only found out after the surgery that the hospital and her surgeons knew of the device’s risks but did not reveal them to the couple ahead of time. As reported in Boston Magazine, a Change.org petition, set up by the couple, calling for an end to gynecological morcellation, helped bring this issue to light and garnered more than 90,000 signatures. Hospitals and device makers are now required to report serious injuries and deaths linked to medical devices to the FDA, and informed consent law requires that physicians inform patients of potential harms. But in practice, patients are often left in the dark. The couple, in an opinion piece this month on philly.com, urged Congress and the president to support the bill. In The Wall Street Journal, Rita Redberg, MD, from the University of California San Francisco, applauds the proposed legislation. “Requiring doctors and doctors’ offices to report would be a huge step forward…”

Physician burnout remains a big problem in the United States, and it’s not being adequately addressed, according to the market intelligence firm, InCrowd. In May, the group surveyed 200 primary care physicians and emergency medicine physicians who had practiced for more than a decade, and as reported in Healthcare Finance, they found that 74 percent of the physicians felt their healthcare facility or practice was not taking steps to address and prevent burnout. Time pressures were the top reason for the burnout, followed by electronic medical records “which nearly double the time and expense of medical practice for most direct patient care physicians, including physicians in training—without increasing any type of reimbursement,” one respondent commented. Fifty-eight percent of respondents said they were not sure that they’d recommend a career in medicine to a family member. InCrowd defines burnout as “decreased enthusiasm for work, depersonalization, emotional exhaustion and a low sense of personal accomplishment.” Another recent survey, involving 5,000 physicians, which was conducted by Medscape, asked who’s happier, employed or self-employed physicians. Fifty-five percent of employed physicians said they were, compared to 63 percent of self-employed doctors.



RightCare Weekly will take a short hiatus starting next week and will return after the Independence Day holiday.

Right Care Action Week 2016 plans are underway! We are looking for people to help spread the word and recruit friends and colleagues to lead RCAW events to make a big, national splash this year! You can learn more about RCAW this year here. Please contact Stephanie Aines to join the outreach team and make RCAW a huge success.





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