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Public health officials around the country want the Food and Drug Administration to warn people about the risks of taking opioids along with common anti-anxiety drugs...Forty-one public health officials and researchers signed a petition, which will be submitted to the FDA... It calls for so-called black box warnings on both opioids and benzodiazepines, indicating that their concurrent use "contributes to the risk of fatal overdose." Opioids are intended primarily for pain relief; benzodiazepines, like Valium and Xanax, are tranquilizers that can treat anxiety...A 2015 study in the British Medical Journal found that US veterans taking opioids who took more benzodiazepines were more likely to die than those who took fewer benzodiazepines...Deaths from both opioids and benzodiazepines have been on the rise...

One-third of clinical trials conducted at 51 major U.S. universities and academic hospitals were never published in a peer-reviewed journal or in a government registry online, according to a new study...The researchers looked at 4,347 trials that were completed between October 2007 and September 2010. Of those, only 29 percent had results published within two years of finishing data collection, and 13 percent were posted on the government database ClinicalTrials.gov within the same period...about 67 percent of the studies disclosed their results by...2014...You’d like to think that academic institutions are role models for science...The truth is we’re not doing very well...University of Florida and Ohio State University joined Yale with some of the highest rates of publication in peer-reviewed journals...Boston University, Cornell and Oregon Health and Science University...had among the lowest rates...Pharmaceutical companies, the government and foundations invest a lot of money in clinical trials...If the results aren’t made public, that’s wasted money...Disclosure of results is critically important to advance science...Whether those results are positive or negative, and are important as a part of our agreements with funders as well as the participants in clinical trials...Beyond creating a data void that makes future research more difficult, unpublished results also may represent an ethical issue. Patients in clinical trials undergo experimental treatments with the understanding that doing so will advance medical knowledge, which can’t happen if the results aren’t published...

You may not know the name of one of the most talented and innovative forces in healthcare but there is a high probability that you have seen one of his video parodies about health. This is because Zubin Damania, M.D., goes under the alter ego ZDogg MD...He is creator of ZDogg MD and the Founder and CEO of Turntable Health, a direct primary care clinic in Downtown Las Vegas...He has been called the Weird Al of healthcare and uses humor and pop culture to education populations about important health issues... So by creating this outlet for humor, satire, and creativity, I sort of found that unique part of my voice that had been suppressed, and I was able to feel like I was reaching people and effecting real change that I couldn’t do in the hospital...As a hospitalist in practice for 10 years, I was deep in the trenches of medicine, deep in the daily paradox of joy and horror...So I speak the language of that world, a language that emerges from the shared experience of healthcare people. Very often this tribe feels voiceless, so my goal has always been to find a new way of expressing not just our dissatisfaction, but our vision for how to make things better...Payment models and primary care are at the top of my list...Fix that base of the pyramid and other stuff will fall in place. Fixing that culture is crucial...

The U.K.'s cost-effectiveness gatekeepers think Alexion's newest rare-disease drug, Kanuma (sebelipase alfa), may be worth using in babies with lysosomal acid lipase deficiency. But it's going to need to see more research on the pricey med's costs and benefits before it shells out...At £491,992 ($704,630), the therapy doesn't represent good value for all patients, the National Institute of Heath and Care Excellence said in draft guidance. But there's still time for the company to change the watchdog's mind before it makes a final decision...Alexion...said in a statement that NICE had "failed to recognize the transformative clinical innovation of Kanuma" as a treatment for LAL deficiency, which can be particularly serious in babies. The inherited genetic disease causes fat to build up in cells, with survival for babies pegged at less than 12 months...it'll be up to the...drugmaker to prove the treatment's worth...

...Dr. Robert Califf...Obama’s choice to head the Food and Drug Administration, may be getting back on track to win final approval from the Senate...In a move designed to circumvent opposition to Califf, who was nominated in September, Senate Majority Leader Mitch McConnell has scheduled a procedural vote for Monday afternoon. If Califf wins the support of at least 60 senators in that vote, he would move on to a final confirmation vote — likely Tuesday — and his Senate opponents would lose their leverage to stop him...The move will likely vanquish the remaining senators — led by Democrats Bernie Sanders of Vermont, Edward Markey of Massachusetts, and Joe Manchin of West Virginia — who disapprove of Califf because of his close ties to industry and what they consider a poor FDA response to the opioid epidemic...

Nevada's health insurance exchange disputes a federal report claiming it misallocated funds for creating its program and recommending it consider refunding $893,000 to the Centers Medicare and Medicaid Services...A refund is not needed, the Silver State Health Insurance Exchange stated in a written response to the report from the Office of Inspector General, Department of Health and Human Services...We believe that this conclusion is based upon an erroneous interpretation of federal guidance regarding cost allocation accounting principles and the timing of cost allocation adjustments...It also pointed to comments from CMS that not only back up the state agency's take on the matter but are also included in the OIG's own report...In its report, however, the OIG was not swayed, stating it believes "our first recommendation is valid." The OIG cited the Nevada agency for using outdated data when it was establishing its marketplace despite the availability of updated data, having no internal controls, allowing insufficient staff oversight, and having no written policy on the allocation process...The Nevada marketplace should have used the updated, better data to update its cost allocation methodology...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

...one of the lesser-known provisions of the ACA (Affordable Care Act) calls for the federal government to pay physicians and hospitals bonuses if they deny health care to seniors and the disabled...Section 3022 of the ACA establishes the Medicare Shared Savings Program. The MSSP establishes the notion of Accountable Care Organizations. These are groups of health care providers (hospitals, physicians, other providers) who join together for purposes of a obtaining bonus payments based on their participation in the MSSP and Medicare fee-for-service incentive program...ACOs are paid to "reduce costs" for treating their patients...For patients assigned to ACOs, the ACO receives bonus payments based on the total amount Medicare pays for care of those patients. That total includes all care those patients receive from all providers – specifically, including providers who are not members of the ACO. Bonuses are based on reducing total costs relative to what would be expected risk-adjusted cost based on each patient’s health status...Because this program is part of Medicare’s fee-for-service system, "reduce costs" means "reduce services" – that is, "give patients less health care."...the ACO program encourages hospitals and physicians...to encourage patients to use less health care...It is highly ironic that a law proposed, in part, because of the allegation health insurance companies were increasing their profits by denying care to patients – is now the means by which the federal government pays physicians and hospitals bonuses to, in effect, deny care to patients...

A big hospital chain’s surprise decision to write off a slug of bad debt may be a signal of much deeper consumer healthcare strains being caused by ObamaCare...Community Health Systems surprised analysts this week...the company would take a $169 million provision for bad debt. The write off was a big part of Community’s dismal fourth quarter earnings report...The rising amount of uncollected co-pays and deductibles may be an early sign of consumer stress as the economy weakens. But more likely, it also reflects changes in the healthcare market that are saddling consumers with a much bigger share of their medical costs...ObamaCare is playing a big role...The structure of the insurance products offered under ObamaCare was deliberately skewed toward hollowed-out health plans. These plans sport large out-of-pocket limits and often skimpy or no co-insurance on drugs and doctors purchased outside a health plan’s increasingly narrow drug formularies and provider networks...Americans are now less insured for medical costs…The earnings report from Community Health was an early financial harbinger of this trend. Collecting on these rising out of pocket costs will get more difficult for healthcare providers as the ObamaCare insurance designs become the new market standard. This will be ObamaCare’s legacy – a new standard for hollow health coverage.

A simmering battle in Canada over the cost of a rare disease drug took a new twist as a government entity ended talks with the manufacturer because it failed to agree on evidence for justifying the price...The pan-Canadian Pharmaceutical Alliance, which negotiates drug prices on behalf of provinces and territories, was holding coverage talks with Alexion Pharmaceuticals over its Soliris (eculizumab) treatment for six months before reaching a dead end. The medicine costs up to $525,000...Patients and physicians want to try anything that may work to help them cope with their disease...public drug plans cannot provide coverage for all individuals who may wish to try Soliris or any drug — regardless of its cost — where the clinical evidence does not demonstrate improved health outcomes...Soliris is used to combat paroxysmal nocturnal hemoglobinuria...a genetic disease that destroys red blood cells, and also atypical hemolytic uremic syndrome...which is a progressive and life-threatening disease affecting the immune system...Alexion...negotiated in good faith and had not received any feedback until the decision to end talks was made...the UK government watchdog agency for cost-effectiveness, which is notoriously stringent about assessing drug values, last year recommended coverage for Soliris...