Welcome to this month’s edition of Comp Medical News. BMI and heart disease, the first abuse-deterrent immediate release opioid, and mindfulness as pain management technique are your headlines.
FDA Panel Approves RoxyBond
FDA advisors voted 19-0, with one abstention, that the immediate-release oxycodone formulation RoxyBond should be approved to treat chronic pain, and the majority agreed that it could carry abuse-deterrent labeling for both the intranasal and intravenous routes of abuse. The drug, developed by Inspirion Delivery Sciences, is the first immediate-release opioid formulation to receive approval to use abuse-deterrent labelling. Abuse-deterrent features have become the focus of more research and promotion of late as the country deals with surging levels of opioid addiction and overdose. However, some medical professionals have argued that abuse deterrent features are a red herring. The one abstention voter in the case of RoxyBond told a reporter with MedPage Today that he couldn’t vote for the drug on a philosophical basis.
Further coverage here.
Spinal Cord Stimulation Study Reveals High Infection Rate
A new analysis of claims databases derived from the Truven MarketScan Commercial Claims and Encounters (2009-2014) and Medicare Supplemental (2011-2014) databases found a 3.11 percent infection rate among spinal cord stimulator (SCS) patients – significantly higher than for other surgeries. The researchers included all patients aged 18 years or older with a claim for SCS generator implant or replacement during the study period. Age, peripheral vascular disease, and history of infection were identified risk factors. When compared with rates of infection for total joint replacement and pacemaker surgeries, the data reflect a need for improvement of infection control practices.
Read more via Pain Medicine News here.
BMI is Less Effective Tool for Determining Heart Disease Risk in Minorities
Obesity and the common clinical formula to determine it – body mass index – is a generally good way to predict heart disease and diabetes risk in caucasian people, however, new research suggests it does minorities a disservice. The recent study, spearheaded by the public health department at Emory University, found that among white people in their sample, only 21 percent of normal weight individuals (based on BMI) had risk factors for heart disease and diabetes. By contrast, a much higher proportion of healthy weight people in other racial and ethnic groups had heart or diabetes risk factors: 31 percent of black people, 32 percent of those with Chinese heritage, 39 percent of Hispanics, and 44 percent of South Asians.
Read more from Reuters Health here.
U.S. Prescription Drug Spending Projected to Hit $610 Billion in 2021
A new report released by QuintilesIMS Holding lowers its previously projected prescription drug spending numbers to $580-$610 billion for its 2021 forecast. The company, which compiles data for the pharmaceutical industry, had previously set average spending growth of 6-9 percent through 2021. It reduced its projections due to fewer new medications approved in 2016 than prior years as drugmakers face increasing pricing pressure and competition. Taking likely manufacturer discounts and rebates into account, spending would grow 2-5 percent to $375 billion to $405 billion in 2021, as net price increases for patent-protected branded drugs slows.
Read more here.
Mindfulness Can Improve Back Pain, but Only Slightly
Mindfulness-based stress reduction programs appear to underperform in improving low back pain, according to a new research review. Mindfulness programs combine meditation, yoga, focusing attention on different parts of the body, and incorporation of mindfulness/awareness into everyday life. Earlier studies found these techniques to be helpful for a variety of chronic pain conditions, but evidence was lacking for low back pain specifically. The authors, who hail from University of Duisburg-Essen in Germany, were surprised to find that mindfulness did not stack up when compared with conventional treatment or other psychological interventions. The studies that looked at pain intensity and pain-related disability found small improvements with mindfulness programs only over the short term, and even these improvements were of questionable significance.
Read more here.
Companies Collaborate to Reduce Post-Surgical Opioid Dependence
A new initiative to identify preoperative patients who may be predisposed to developing dependence on opioid analgesics could facilitate treatment plans that reduce their exposure to opioids and mitigate that risk. The joint endeavor by specialty pharmaceutical manufacturer Pacira Pharmaceuticals and therapeutic management firm GeneAlign has incorporated behavioral histories and pharmacogenetic and pharmacogenomic testing into the preoperative risk assessments for selected procedures at pilot institutions.
More info here.
New York County Sues Purdue over OxyContin Marketing
A county in New York state has sued Purdue Pharma LP, Johnson & Johnson and other drugmakers, accusing them of engaging in fraudulent marketing that played down the risks of prescription opioid painkillers, leading to a drug epidemic. The lawsuit was filed earlier this month in Orange County, New York, which is in the southeastern part of the state. The county claims that opioid-producing pharmaceutical companies used deceptive marketing practices which cast the drugs as safe and relatively non-addictive, even for use in long term chronic pain cases. The county argued that those misrepresentations about drugs like Purdue’s OxyContin and Endo’s Opana ER led it to incur health care, criminal justice and other costs related to addiction. West Virginia successfully sued Purdue several years ago with a similar complaint.
Read more about this case here.