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Senator’s investigation found a “lack of transparency” surrounding the donations...A new report from Senator Claire McCaskill found that five opioid manufacturers paid nearly $9 million to 14 outside groups between 2012 and 2017, alleging that the advocacy groups often “amplified messages favorable to increased opioid use.”...The groups—many of which work on chronic pain and other opioid-related issues—lobbied to defeat prescriber limits on opioids...and many criticized facets of 2016 guidelines from the Centers for Disease Control and Prevention that limited the prescribing of painkillers...“The financial relationships between these groups and opioid manufacturers should be clear to the general public,” McCaskill said. “We passed a law ensuring the public had information on payments to doctors by pharmaceutical companies, and I can’t imagine why the same shouldn’t be done in this space.”...

Gilead Sciences’ new HIV treatment Biktarvy has been approved by the Food and Drug Administration — but its novel component is also the subject of patent infringement litigation from GSK...Biktarvy is a triple-therapy HIV treatment that brings together bictegravir’s unboosted integrase strand transfer inhibitor with the dual nucleoside transcriptase inhibitor backbone of emtricitabine, tenofovir alafenamide — which are the two components of Gilead’s Descovy...However, now bictegravir is at the center of GSK’s lawsuit, which was filed in the U.S. District Court for the District of Delaware, as well as in Canadian Federal Court in Toronto. GSK’s majority-owned Viiv Healthcare said it is looking to prove that Biktarvy’s use of bictegravir infringes on a patent covering its dolutegravir and other compounds that use dolutegravir’s chemical scaffold. The company said it would seek financial redress...

Wearable device identifies convulsive epileptic seizures and sends alerts to caregivers...The FDA has cleared the Embrace smart watch (Empatica, Inc.) for use by patients with epilepsy. Embrace uses advanced machine learning to monitor for the most dangerous kinds of seizures, known as “grand mal” or “generalized tonic-clonic” seizures, and sends an alert to summon caregivers’ help...The smart watch stands apart from any seizure detection system in that it measures multiple indicators of a seizure. Its unique property is its use of electrodermal activity, a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the "fight-or-flight" response. Embrace has been approved in Europe as a medical device for seizure monitoring and alert since April 2017.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

As Nevada’s suicide rate has jumped to No. 5 in the nation and to its highest level since the late 1990s, the state’s doctors are being asked to be the frontline in recognizing suicidal tendencies of their patients and get them help before they take their lives...The effort is part of a state law passed in 2017 requiring physicians in all specialties to receive two hours of training on suicide prevention as a way to deal with the epidemic. The training for Southern Nevada started on Jan. 23 when Dr. Lesley Dickson, executive director of the Nevada Psychiatric Association addressed more than 90 doctors, medical residents and medical students in a presentation called “Suicide Prevention: How to Save a Life.”...“Interventions by mental health professionals are very important, but many suicidal individuals never see a therapist,”...“It’s important that all people who interact with a suicidal person know how to help.”...Nevada had 650 suicides — just under two a day — and a suicide rate of 22.1 per 100,000, in the latest numbers from the American Association of Suicidology. That’s up from 2015’s 558 deaths and 19.3 rate per 100,000 when Nevada was ranked 11th. The state is typically in the top 10...

The federal government...approved a device made by a private company...that will allow the first domestic production of a medical imaging isotope...a move the government said would enhance national security by reducing the need to transport weapons-grade uranium...The Food and Drug Administration granted the approval to NorthStar Medical Radioisotopes, which said it would begin delivering systems to make technetium-99...the most common isotope in medicine and is used in 40,000 procedures a day in the United States...consumers have long had to depend on a complicated and risky supply chain for the materials...The current process involves shipping weapons-grade, or highly enriched, uranium from the United States to research reactors in Australia, South Africa and Europe where it is irradiated to make molybdenum-99, which decays into technetium-99..."This is a win for our national security," said Peter Hanlon, an official with the National Nuclear Security Administration office of material management and minimization...

No one doubts that Teva Pharmaceutical Industries CEO Kare Schultz has been making all the right moves to turn around the troubled drug maker’s dwindling fortunes...Burdened by more than $32 billion in debt from past acquisitions, the world’s largest generic drug maker is cutting costs at feverish pace. The company suspended dividend payments to investors, amended debt covenants and eliminated low-value research projects...hopes for 2018 just got dashed to pieces...Following the delivery of estimate-beating fourth quarter financial results early Thursday, Teva unveiled full-year sales and profit forecasts for 2018 that were a sliver of what had been expected by Wall Street analysts, due largely to falling prices for its U.S. drugs...Teva now sees 2018 revenue falling between 16% and 18% and expects to earn as little as $2.25 a share this year...

Purdue Pharma says it will stop promoting oxycodone (OxyContin) and other opioids to U.S. doctors. The company will continue selling the products, but Purdue's sales force "will no longer be visiting offices to engage in discussions about opioid products," the company says. Doctors and other prescribers who have questions about the drugs will have to contact Purdue's medical affairs department, the company says. Purdue is also cutting its U.S. sales force by more than 50%, to about 200 people. The remaining sales representatives will market non-opioid products. Purdue's halting of its opioid marketing comes as the company faces growing legal scrutiny. More than a dozen states and about 400 cities and counties in the U.S. have sued Purdue or other opioid analgesic makers, accusing them of fueling addiction by misrepresenting the risks of their drugs. In response to the suits, Purdue has said it is "dedicated to being part of the solution" to the opioid crisis.

Nevada is taking steps toward leaving the federal healthcare.gov and setting up a separate exchange operated by the state...the Legislative Interim Finance Committee...authorized state officials to spend $1 million to prepare a request for proposals and find a private provider...Heather Korbulic, executive director of the state system, says changes are needed because healthcare.gov is steadily raising the rates it charges states that link their front-end systems to the federal exchange...Korbulic says the federal rate increases by 2019 will leave the state with almost nothing to run the front-end system...Nevada tied its state exchange to the site after...using Xerox as a contractor failed, but Korbulic says several vendors now have proven systems.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.