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Saturday, January 11, 2020

After opioid overdose, poor teens rarely get addiction treatment

Less than one third of teens and young adults who overdose on opioids receive addiction treatment afterward, and the few who do get help receive counseling instead of medication to combat substance misuse, a U.S. study suggests.
Researchers examined data on more than 4 million youths aged 13 to 22 with coverage through Medicaid, the government insurance program for the poor, between 2009 and 2015. During that period, 3,791 young people had nonfatal opioid overdoses.
In the month after overdoses, 69% of these teens and young adults didn’t receive any addiction treatment, researchers report in JAMA Pediatrics. While 29% did get help, nearly all of them received only behavioral health services. Just 2% received anti-addiction medications that are considered the gold standard for combatting opioid abuse.
“It is unacceptable that so few youths are receiving the recommended treatment after opioid overdose,” said lead study author Dr. Rachel Alinsky of Johns Hopkins University School of Medicine in Baltimore.
“In pediatrics, we would not accept it if only 1 in 50 youth with asthma got the standard treatment when they came into the emergency department, or if 1 in 50 youth with diabetes got the standard treatment if they were hospitalized,” Alinsky said by email.
Roughly one in four overdoses involved heroin. The remainder were caused by misuse of other forms of prescription or illegal opioids.
Youth who used heroin were more than twice as likely to have repeat overdoses during the study.
Within 30 days of a heroin overdose, 4.1% of young people had another overdose, and within three months, 8.1% of them had a repeat overdose, the study found.

Among youth whose initial overdose involved other types of opioids, 1.2% had a repeat overdose within 30 days and 2% had a recurrence within 90 days.
Despite higher rates of repeat overdose, youth with heroin overdoses were 35% less likely to receive any addiction treatment than youth who overdosed on other types of opioids.
Less than 10% of the youths who had overdoses were diagnosed with opioid use disorder, the study also found. Even among those with heroin overdoses, less than half got this diagnosis.
A combination of factors may make it hard for young people to receive opioid addiction drugs, Alinsky said.
Pediatricians may not be familiar with treatments for opioid use disorder, and many clinicians who treat this condition may not accept younger patients, Alinsky said. Some providers may also be resistant to treating drug addiction with prescription medications.
“There is widespread stigma against medication for opioid use disorder within the healthcare and recovery communities, who sometimes inaccurately view medication for opioid use disorder as replacing one drug with another,” Alinsky said. “This stigma may be even stronger when it comes to prescribing medication to adolescents, where a common view is that medications should be used as a last resort despite the evidence-based guidelines from the American Academy of Pediatrics that recommend its use.”
All of this can put parents in a position where they have to push hard to get their children needed care, said Lucas Hill of the University of Texas at Austin College of Pharmacy.
“Given the increasing prevalence of ultra-potent synthetics in the illegal opioid supply, initiating medications immediately after a non-fatal overdose should be the top priority for any family,” Lucas, who wasn’t involved in the study, said by email. “Available evidence indicates these medications are far more effective than other treatment approaches, such as medically-supervised withdrawal (i.e. detox).”
When patients don’t get medications in the hospital where they receive overdose treatment, Hill advised, parents should seek out further care. In the U.S., they can search on the Department of Health and Human Services website findtreatment.gov for local providers who can prescribe buprenorphine.
“I would call until I found an active prescriber who accepted my insurance, would consider initiating medication on the day of our first visit, and could schedule that first visit within a few days,” Hill said.
SOURCE: bit.ly/2s6l541 JAMA Pediatrics, online January 6, 2019.

Idorsia pairs with Neurocrine in potential $400 million epilepsy drug deal

Swiss biotech group Idorsia on Friday lifted the lid off a 2019 deal for its investigational epilepsy medicine, revealing the pact that is potentially worth more than $400 million is with U.S.-based Neurocrine Biosciences.
Last year, Idorsia got a $5 million payment for a licensing option for ACT-709478, but kept Neurocrine’s identity a secret.
Their agreement calls for Idorsia to get $45 million in cash, $7 million for research and up to $365 million in development and regulatory milestone payments if Neurocrine exercises its option within 30 days of the U.S. Food and Drug Administration’s accepting an investigational new drug application that is now expected for mid-2020.
Royalties are also in the offing if ACT-709478 makes it to market.

Idorsia Chief Executive Jean-Paul Clozel is striking agreements with partners like Neurocrine, a small drugmaker based in San Diego, for some of his pipeline’s dozen investigational medicines.
He is augmenting his coffers as he tries to build Idorsia into another Actelion, the Swiss biotech Clozel sold in 2017 to Johnson & Johnson for $30 billion.
ACT-709478, designed to target calcium channels throughout the central nervous system believed to play a role in epilepsy, has completed an early safety study in healthy adults and is slated to start a Phase 2 trial in rare paediatric epilepsy this year.
“We are excited to leverage the scientific expertise of Idorsia in T-type calcium channel inhibition to potentially advance a Phase 2 ready compound to help people suffering from epilepsy,” Neurocrine CEO Kevin Gorman said in a statement.

New talc testing standards urged amid asbestos worries

An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs who allege contaminated talc products caused their cancers.
The most significant recommendation from the panel of government experts is that mineral particles found in talc products small enough to be drawn into the lungs – even those the industry would not call asbestos – should be counted as potentially harmful.
Because both asbestos and look-alike minerals are suspected of causing “similar pathological outcomes, the distinction is irrelevant,” the expert panel said in a summary of its preliminary recommendations posted this week on the FDA’s website.
The panel also underscored the view of the World Health Organization and other public health authorities that there is no known safe level of asbestos exposure and called for talc powders and cosmetics to be tested with the most sensitive methods available.
The recommendations – which came from experts from eight government agencies, including the U.S. Geological Survey and National Institute for Occupational Safety and Health – are set to be considered Feb. 4 at the FDA campus in Silver Spring, Maryland. It will be the first FDA hearing focused on testing methods for asbestos in talc and cosmetics since 1971, according to the agency.
The panel’s assessment marks a sharp departure from that of previous advisers. In late 2018, at an FDA-sponsored meeting closed to the public, numerous experts with industry ties downplayed the potential hazard of talc contamination with asbestos lookalike minerals, according to a Reuters report in December. [LINK] The gathering and resulting reports drew criticism from other scientists, consumer advocates, a congressman and plaintiffs’ attorneys.
The agency declined to comment Friday on the substance of the new recommendations in advance of the meeting. In a statement, the FDA noted that its panel of government experts “worked independently and has not solicited recommendations from cosmetic manufacturers, industry groups or any other non-governmental groups.”
A spokesman for market leader Johnson & Johnson said the company looked “forward to a thorough review of the most effective and reliable ways to test for asbestos in cosmetic talc.”
In October, the FDA announced that it had found asbestos in a bottle of Johnson’s Baby Powder, prompting the recall of 33,000 bottles. The move marked the first time the company had recalled the iconic brand for possible asbestos contamination, as well as and the first time U.S. regulators had announced a finding of asbestos in the product.
After that, J&J hired outside labs to conduct a series of tests that it said found no asbestos in its talc.
J&J’s “test methods exceed industry standards, and just recently, 155 tests by third-party labs using state of the art methods, including those outlined by the FDA, show there is no asbestos in our talc,” said J&J spokesman Jake Sargent.

A spokeswoman for the Personal Care Products Council said the national cosmetics trade group had not had any interactions with the FDA about the upcoming meeting and declined to comment further.
The recommendations are an early step in U.S. regulators’ reconsideration of testing standards and safety parameters for the talc powders and cosmetics used by millions of people. Although talc and asbestos are similar minerals and are often found together in the ground, the FDA has never required manufacturers to test for the known carcinogen, allowing them to vet their products as they see fit.
FDA officials will consider the guidance in deciding whether to propose standardized testing methods and have not announced a timetable.
The panel’s recommendations could by themselves influence scientific practice and courtroom strategy, experts said.
Adam Zimmerman, a professor at Loyola Law School in Los Angeles, said the recommendations could be used in courtrooms to strengthen plaintiffs’ cases and were particularly valuable because they come from “experts looking out for public safety who don’t have any skin in the game.”
Mark Lanier, a plaintiffs’ lawyer for a group of women with ovarian cancer who won a $4.6 billion verdict against J&J, said he would use the recommendations in future trials. The FDA panel shot several of J&J’s defenses “out of the water,” he said.
Steven Compton, a director of a Duluth, Georgia-based lab that conducts tests for talc companies and has worked for plaintiffs, said the recommendations could provide guidance for scientists now operating in a vacuum, without recognized standards.
“It’s helpful for labs to understand what they should be counting — whether it’s for the courtroom or for a client in industry,” Compton said.
The FDA tests last year, which found asbestos in a number of widely sold cosmetics besides Johnson’s Baby Powder, renewed concerns among some members of Congress and consumer advocates about the risks of asbestos contamination in talc and the potential need for stricter safety standards to protect public health. Thousands of pending consumer lawsuits allege talc powders caused their ovarian cancer or mesothelioma, an incurable cancer of the lining of the lungs and other organs.
For decades, the cosmetic talc industry has largely been allowed to police itself, with little intervention from the FDA.
A 2018 Reuters report [link] showed that although J&J knew its raw talc and powders sometimes tested positive for asbestos from the 1970s into the early 2000s, the company did not report those findings to the FDA. The Dec. 3 Reuters report showed that, since the 1970s, the FDA downplayed health concerns about talc in powders and cosmetics and deferred again and again to manufacturers.
More recently, the agency has taken a tougher stance amid heightened scrutiny in Congress, a criminal investigation into J&J’s statements regarding the safety of its talc powders and jury verdicts against talc manufacturers.

Fitbit, Garmin, other wearable devices under U.S. scrutiny

The U.S. International Trade Commission says it will investigate wearable monitoring devices made by Fitbit (NYSE:FIT) and Garmin (NASDAQ:GRMN) following allegations of patent violations by rival Philips (NYSE:PHG).
Philips and Philips North America are calling for tariffs or an import ban and allege the other companies have infringed on Philips patents or misappropriated its intellectual property.
While the U.S. ITC agreed to launch a probe, it says it “has not yet made any decision on the merits of the case.”

Bayer cuts CRISPR stake to 7.2%

Bayer Global Investments (OTCPK:BAYRY) has cut its stake in CRISPR Therapeutics (NASDAQ:CRSP) to 7.2%, according to a filing.
It got there (from a previous stake of about 9.5%) by selling about 1.4M shares on a range of dates from Dec. 18 to Jan. 8, according to the filing.
As of its original filing date, Bayer beneficially owned 12.8% of CRISPR.

Friday, January 10, 2020

Walgreens Sees More Doctors Connected To Its Drugstores

Walgreens Boots Alliance sees the physician inside or attached to its drugstores as key to the company’s long-term survival as a community healthcare provider.
Though two partnerships Walgreens has to strengthen the drugstore chain’s relationships with physicians remain in testing stages, company executives say they are performing well and a future expansion could be around the corner. Walgreens provided an update on its physician partnerships Wednesday during its fiscal 2020 first quarter earnings call after inquiries from analysts who in the past have wondered when these partnerships are going to start contributing financial results to the company.
One relationship involves the big health insurer Humana and its Partners in Primary Care Centers inside two Walgreens stores in the Kansas City area and a third in Anderson, South Carolina. The Walgreens-Humana Partners in Primary Care relationship is a joint venture developing senior health clinics that treat patients covered by the insurer’s Medicare Advantage plans.
“It looks very good and is operating really well (and) the relationship between the pharmacist and doctors is really close,” Walgreens co-chief operating officer Alex Gourlay told analysts Wednesday on the company’s fiscal first quarter earnings call. “We continue to feel really good about that very small, but important, test joint venture.”
The effort is designed in part to keep people out of the more expensive hospital setting and make sure Medicare patients have their care more closely monitored by Walgreens pharmacists and physicians in Humana’s health plan networks. The two companies think they can do a better job of reaching patients who visit Walgreens retail locations and making sure they get better care upfront before they get sick.
The other partnership Walgreens has with physicians involves the Chicago-based startup VillageMD, which operates primary care clinics that have contracts with physicians. The 2,500-square-foot clinics are being located next to five Walgreens stores that will be open in the Houston area by the end of February and are called “Village Medical at Walgreens.”
“We are very, very pleased with how that’s operating already,” Gourlay said of VillageMD, which Walgreens has invested a “small” undisclosed stake in. “We see that partnership of the doctor and the pharmacist as … fundamental to the future of community health care delivery going forward and core to our model.”
Walgreens developing partnerships with doctor-staffed clinics is in contrast to rival CVS Health’s primary care services via its MinuteClinics, which are staffed by nurse practitioners. CVS is also rolling out a new “HealthHub” format that will be in 1,500 stores by the end of 2021.

Kadmon to present KD025 data at conference

Kadmon Holdings (NYSE:KDMN) is up 2.2% after hours following the acceptance of a late-breaking abstract of its trial of KD025 in chronic graft-versus-host disease for the 2020 Transplantation & Cellular Therapy Meetings.
That’s set for Feb. 19-23 in Orlando, Fla.
The expanded data set from the ROCKstar trial will include repsonse rate across key subgroups and initial safety data.
In November, Kadmon had said that KD025 met the primary endpoint at the interim analysis.