Today’s Top Story
Study: One-third of newly approved drugs required FDA safety action.
Nearly one-third of drugs approved by the U.S. Food and Drug Administration (FDA) from 2001 to 2010 had subsequent safety issues leading to some type of action by the FDA, researchers from Yale University reported in a study appearing in JAMA. The authors reported that of 222 novel therapeutics approved in those years, 71 warranted a postmarket safety event, with three of the drugs withdrawn and the remainder requiring a black-box warning on side effects or a safety announcement about newly detected risks. The median time from approval to a postmarket event for affected drugs was 4.2 years, and such action was more common for psychiatric drugs, biologics, and drugs granted accelerated approval status. Accelerated approvals typically rely on surrogate endpoints, Kaiser Health News noted in a report on the study. The researchers had previously observed that the FDA approves drugs faster than the counterpart regulator in Europe, and many pivotal trials involve fewer than 1,000 patients with follow-up of 6 months or less. The Washington Post noted that safety problems often appear years later, after drugs are used by many more individuals. “No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals,” lead author Joseph Ross told the Post.
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Plans to penalize exchange plans for noncompliance with risk-adjustment auditing put on hold.
The Trump administration has halted plans previously announced by the federal government to penalize insurers that don’t audit compliance with the risk-adjustment payment incentive program of the Affordable Care Act, Modern Healthcare reports. That provision called for verification by third-party auditors and the Department of Health and Human Services (HHS) that insurance companies receiving risk-adjustment payments were actually including commensurate numbers of sicker patients in their exchange-covered populations. HHS had said last year it would penalize companies for discrepancies found in reported sick patient volumes, but last week the government announced it would not apply penalties for nonverified high-risk claims from 2016. Insurers say logistical challenges and data gaps in claim data must be addressed and rectified before policing of reporting and financial penalties are implemented
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Senate confirms Scott Gottlieb, MD, as FDA commissioner.
In a 57 to 42 vote, the U.S. Senate has confirmed Scott Gottlieb, MD, to become the next commissioner of the FDA. Dr. Gottlieb is a clinical assistant professor at New York University School of Medicine, a resident fellow at the American Enterprise Institute, and an internal medicine specialist at NYU Langone Medical Center/Tisch Hospital.
Study: Vascularized fibular grafting may be effective for management of osteonecrosis of the femoral head.
According to a study conducted in China and published online in the journal Clinical Orthopaedics and Related Research (CORR), vascularized fibular grafting may be effective for management of osteonecrosis of the femoral head. The authors conducted a randomized, controlled trial of 21 patients (54 hips) who presented with Association Research Circulation Osseous (ARCO) stages I to IIIB bilateral osteonecrosis. All patients were treated bilaterally, with one side treated with core decompression and the contralateral side concurrently treated with fibular grafting. At 6-month and 36-month follow-up, the authors found that decompression-treated hips had lower vascularity than fibular-grafted hips based on single-photon emission computed tomography. In addition, they note that progression of ARCO staging was more severe in the decompression group than the fibular grafting group at 36 months. Further, mean Harris Hip Score was lower in the decompression group than in the fibular grafting group throughout the follow-up period, although the differences were at or below the minimal clinically important difference of 10 points early on. At 18-, 24-, 30-, and 36-month follow-up, the scores favored fibular grafting. The authors found no difference between decompression-treated hips and fibular-grafted hips regarding progression to total hip arthroplasty at 36 months.
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Study: Combination of ASCs and rBMP-12 may help speed healing of repaired tendons.
Findings from a canine study published online in CORR suggest that an application of adipose-derived mesenchymal stromal cells (ASCs) and bone morphogenetic protein-12 (rBMP-12) may help accelerate healing in the proliferative stage of tendon repair. The researchers applied ASC sheets, both with and without rBMP-12, to the surface of sutured flexor tendons in a canine model. At 14-day follow-up, they found that ASC-sheet treatment modulated the post-repair inflammatory response and facilitated healing by increasing regenerative M2 macrophages, inflammatory inhibitor, and proteins involved in tendon formation. In addition, the combined administration of ASCs and rBMP-12 further stimulated M2 macrophages and led to the increase of M2 effector matrix metalloproteinase-12 involved in matrix remodeling, reduction of a negative regulator of angiogenesis and cell migration, and facilitated the proliferative stage of tendon repair.
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Study: Years of persistent growth in imaging use tapered in 2008, then declined.
The rapid growth in the use and complexity of imaging occurring from 2000 to 2007 plateaued in 2008 and then entered a downward trend through 2014, according to a study in Health Affairs. The study reports that in most of the first decade of the millennium, the use of imaging grew faster than any other physician service in the United States. The researchers also noted that the use of imaging as well as the fees charged for it were higher than in any other developed country in 2007. Policy makers and payers reacted, and between 2008 and 2013, the authors report, CMS and commercial insurers instituted cuts in payments to blunt the rapid rise of imaging usage. Using Medicare data, the authors found that during the years 2001 to 2008, the rate of utilization of all noninvasive diagnostic imaging increased steadily from 3,520 per 1,000 beneficiaries to a peak of 4,422. Over the next 3 years, substantial declines were seen but were primarily attributable to the effect of code bundling However, no major code bundling occurred from 2012 to 2014, and the rate further declined in each of those years—by 6 percent from 2011. “Federal policies appear to have achieved the desired effect of ending the rapid growth of imaging that had been seen in earlier years,” the authors write.
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Call for volunteers: Voting panel for Management of Osteoarthritis of the Hip AUC.
The Appropriate Use Criteria (AUC) Section seeks AAOS fellows to participate on the voting panel for the Management of Osteoarthritis of the Hip AUC. The voting panel will participate in two rounds of voting during which it will rate the appropriateness of various treatments for patients who have osteoarthritis of the hip. Voting panel members will be required to attend a 1-day, in-person meeting in Rosemont, Ill. Nominees for the voting panel are required to complete the AAOS conflict of interest enhanced disclosure form online. If you are interested in participating on the voting panel for this AUC topic, please contact Mary DeMars, by Monday, May 22, 2017, at email@example.com.