Today’s Top Story
House passes 21st Century Cures Act.
In a 392-26 vote, the U.S. House of Representatives has passed the 21st Century Cures Act, which among other things allocates $4.8 billion for biomedical research over a decade and includes provisions to streamline the U.S. Food and Drug Administration (FDA) drug and device approval process. The New York Times notes that a provision that would have exempted physicians from reporting certain speaking fees was not included in the final version of the bill. Supporters of the legislation say that it will streamline the federal drug regulatory structure to keep up with advances in biotechnology and medical research. However, some critics have argued that the bill lowers FDA drug and device approval standards in exchange for increases in funding for the National Institutes of Health. The bill now moves to the Senate, where observers say passage is likely. Read more…
The American Association of Orthopaedic Surgeons (AAOS) released a statement in support of the bill’s passage.
Johnson & Johnson ordered to pay more than $1 billion damages in lawsuit over hip replacement device.
Bloomberg reports that a jury in Texas has ordered Johnson & Johnson to pay more than $1 billion to six patients, agreeing with plaintiffs that the company knew there were flaws in the design of the DePuy Pinnacle metal-on-metal hip replacement system, but failed to properly warn physicians and patients regarding the risks. The award includes more than $30 million in actual damages and more than $1 billion in punitive damages. The company still faces nearly 9,000 additional lawsuits on the issue. The company stopped selling the devices in 2013. Read more…
Study: Day surgery at an ASC may be more cost-effective than hospital for certain procedures.
Data from a research study published in the Journal of the AAOS suggests that for certain orthopaedic procedures, day surgery at an ambulatory surgery center (ASC) may be more cost effective than the same surgery performed in the hospital. The researchers analyzed data from 1,021 surgical cases covering eight procedures:
- Shoulder stabilization
- Anterior cruciate ligament reconstruction
- Meniscal repair
- Osteochondritis dissecans fixation
- Osteochondritis dissecans drilling
- Loose body removal
For seven of the eight procedures, the researchers found that direct cost savings at the ASC ranged from 17 percent to 43 percent. They write that 80 percent of the cost savings was attributed to time reduction and 20 percent was attributed to supply utilization. Of the time savings in the operating room, 73 percent was attributed to surgical factors and 27 percent was attributed to anesthesia factors. Read more…
Read the abstract…
Endocrinology organizations issue CPGs for diagnosis and treatment of postmenopausal osteoporosis.
The American Association of Clinical Endocrinologists and the American College of Endocrinology have issued a set of clinical practice guidelines (CPGs) for the diagnosis and treatment of postmenopausal osteoporosis. Recommendations given the highest evidence rating include:
- Provide counseling on reducing risk of falls, particularly among the elderly
- Strongly recommend medications for patients with osteopenia or low bone mass and a history of a fragility fracture of the hip or spine
- Medications that reduce the risk of fractures include alendronate, risedronate, zoledronic acid, and denosumab
- Treatment with teriparatide should be limited to 2 years
- Successful treatment of osteoporosis is defined as stable or increasing bone mineral density with no evidence of new fractures or fracture progression
In addition, the guidelines recommend a “drug holiday” for patients with moderate fracture risk after taking an oral bisphosphonate for 5 years or an intravenous (IV) bisphosphonate for 3 years. Patients at higher fracture risk should continue oral therapy for up to 10 years and IV therapy for up to 6 years. Read more…
Read the guidelines (PDF)…
Opportunity for young orthopaedic entrepreneurs—apply to earn a space in competitive 2017 symposium.
AAOS and the Orthopaedic Research Society (ORS) are calling early- to mid-career MDs, PhDs, and MD/PhDs with novel ideas to improve patient care looking to connect with entrepreneurs, CEOs, surgeons, and leaders in the field of orthopaedics. Submit your application for the opportunity to present your idea to an expert panel of judges and invited guests that span the fields of surgery, business, academia, and investors in orthopaedics at the AAOS/ORS Translating Orthopaedic Technologies into Clinical Practice: Pathways from Novel Idea to Improvements in Standard of Care Research Symposium, May 11-13, 2017 in Rosemont, Illinois. As many as 20 young entrepreneurs will receive all-expenses-paid invitations to attend the symposium. Of those, the top five participants will be selected to pitch their ideas to an expert panel. Applications are open to AAOS and/or ORS members and must be submitted by Feb. 6, 2017. Learn more and submit your application…
OKOJ updates now online!
Check out the new topics and video in the Orthopaedic Knowledge Online Journal (OKOJ) on the AAOS website. The following topics have been recently added or updated: “Ankle and Hindfoot Fractures,” “Coagulation and Blood Management,” and “Vertebral Compression Fractures.” View these topics and more…(member login required)
Call for volunteers: Political Action Committee of the AAOS.
Dec. 21, 2016, is the last day to submit your application for treasurer of the Political Action Committee (PAC) of the American Association of Orthopaedic Surgeons (AAOS). The PAC oversees all AAOS activities relating to political fundraising and financial support for candidates for federal office. Applicants for this position must be active fellows and U.S. citizens with specific knowledge of the many research and health policy positions of the AAOS, and have experience interacting with federal officials. Learn more and submit your application…(member login required)