Just 2% of Patients Who Need It Get Anti-Opioid Drug Naloxone

Naloxone can prevent opioid overdose deaths, but only a tiny percentage of Americans at risk are prescribed the lifesaving drug.

That’s the key finding from an analysis of nationwide data on adults with private health insurance.

The researchers found that while naloxone (Evzio, Narcan) prescriptions in this group rose between January 2014 and mid-2017, only 1.6% of those taking high doses of prescription opioid painkillers had filled a naloxone prescription by the last six months of the study period.

And the percentage of filled naloxone prescriptions was no higher among adults who had survived an overdose or had been diagnosed with opioid addiction (“opioid use disorder”), the study found.

Naloxone can help reverse an overdose of many types of opioids, including prescription pain medicines (such as oxycodone) and illegal drugs such as heroin.

The study — done by a team from the University of Michigan and VA Ann Arbor Healthcare System — was recently published in the Journal of General Internal Medicine.

U.S. Centers for Disease Control and Prevention guidelines recommend prescribing naloxone to any patient who takes high doses of opioid pain medicines or who has other major overdose risk factors, including a history of opioid use disorder or opioid overdose.

Naloxone is also recommended for patients who take opioids and the sedative benzodiazepine at the same time, because the two drugs can interact.

“The vast majority of naloxone prescribing is to patients who have received opioid prescriptions, but there are other groups at high risk for overdose but not receiving prescription opioids, including people using only street drugs, that warrant further attention,” said research team leader Dr. Lewei (Allison) Lin, an addiction psychiatrist at the University of Michigan Addiction Center.

“Over the course of the entire study period, we also found that although both high-dosage opioid prescriptions and having an opioid use disorder were associated with receiving naloxone, the same wasn’t true for those with a history of overdose or those with other substance use disorders,” she said in a university news release.

Lin said more work is needed to guide naloxone prescribing to patients at highest risk for overdose.

More information

The U.S. National Institute on Drug Abuse has more about naloxone.

SOURCE: University of Michigan, news release, Jan. 8, 2020

https://consumer.healthday.com/general-health-information-16/prescription-drug-news-551/just-2-37-of-patients-who-need-it-get-anti-opioid-drug-naloxone-753886.html

Surgical weight loss beats diet and exercise for reversing diabetes

People who have weight-loss surgery are more likely to achieve remission of diabetes than those who try to shed excess pounds by dieting and exercising, a recent study suggests.

Researchers randomly assigned 61 participants with type 2 diabetes to one of three weight-loss interventions: an operation known as Roux-en-Y gastric bypass; a type of surgery known as laparoscopic adjustable gastric banding; or an intensive weight-loss program focused on cutting calories and increasing exercise

After five years, six people who got the Roux-en-Y procedures, or 30%, achieved partial or complete diabetes remission, compared with four people, or 19%, of the participants who had gastric banding, the study found. None of the people in the diet-and-exercise group achieved remission.

“Any degree of weight loss, even that achieved by non-surgical means (typically about 5% of starting weight as shown in this study), can be helpful in controlling health issues such as diabetes, lipids, and hypertension,” said Dr. Anita Courcoulas of the University of Pittsburgh Medical Center, the study’s lead author.

“Nevertheless, the head-to-head comparison of lifestyle treatment versus surgical procedures, as in this study, shows (the) superiority of the surgical treatments for diabetes-control endpoints and weight loss,” Courcoulas said by email.

Laparoscopic adjustable gastric banding, also known as lap-band surgery, is a less-invasive procedure that involves placing an adjustable inflatable belt around the upper portion of the stomach. The band can be made of silicone and tightened by adding saline, and the effects are reversible. It effectively reduces the amount of food the stomach can hold, and people are advised to eat portions about the size of a shot glass post-surgery.

Roux-en-Y gastric bypass is a more invasive procedure in which a surgeon staples off the upper portion of the stomach and reroutes food to bypass the rest of the stomach and the small intestine. The working part of the stomach is reduced to the size of an egg, and this cannot be reversed.

Everyone in the study had type 2 diabetes, which is associated with aging and excess weight. Patients were 47 years old, on average, obese and living with dangerously elevated blood sugar levels.

Five years after the procedures, people who had the Roux-en-Y bypass surgery lost an average of 25% of their body weight, compared with about 13% with the lap-band and 5% in the group assigned to intensive lifestyle management.

In addition, 56% of the people who had Roux-en-Y procedures had stopped taking medications to manage diabetes by the end of the study, compared with 45% of the people who had laparoscopic adjustable gastric banding and none of the participants in the lifestyle group.

One limitation of the study is that researchers only tested one approach to diet and exercise for weight loss, and other approaches might have achieved different results, the study team notes in the Journal of Clinical Endocrinology & Metabolism. The study was also small, and done at a single medical center, so results might differ with more people or in other locations.

Still, the findings add to evidence suggesting that surgical weight loss may be the best approach to achieving diabetes remission, said Dr. Michel Gagner of Herbert Wertheim School of Medicine at Florida International University in Miami.

“It decreases the overall caloric intake more efficiently and sustainably than just diets,” Gagner, who wasn’t involved in the study, said by email.

Patients with poorly controlled diabetes should consider surgery when they’re obese and unable to lower their blood sugar enough with medications, said Dr. Ricardo Cohen, director of the Center for the Treatment of Obesity and Diabetes at Hospital Oswaldo Cruz in Sao Paulo, Brazil.

“The best option for medically uncontrolled type 2 and (obesity) is the Roux-en-Y gastric bypass,” Cohen, who wasn’t involved in the study, said by email.

SOURCE: bit.ly/3ageNjt Journal of Clinical Endocrinology & Metabolism, online January 9, 2020.

https://www.reuters.com/article/us-health-diabetes-obesity/surgical-weight-loss-beats-diet-and-exercise-for-reversing-diabetes-idUSKBN1ZF2VW

Risks associated with cannabis exposure during pregnancy

A new study from researchers at Western University and Queen’s University definitively shows that regular exposure to THC, the main psychoactive ingredient in cannabis, during pregnancy has significant impact on placental and fetal development. With more than a year since the legalization of recreational cannabis in Canada, the effects of its use during pregnancy are only now beginning to be understood.

The study, published today in Scientific Reports, uses a rat model and human placental cells to show that maternal exposure to THC during pregnancy has a measurable impact on both the development of the organs of the fetus and the gene expression that is essential to placental function.

The researchers demonstrated in a rat model that regular exposure to a low-dose of THC that mimics daily use of cannabis during pregnancy led to a reduction in birth weight of 8 per cent and decreased brain and liver growth by more than 20 per cent.

“This data supports clinical studies that suggest cannabis use during pregnancy it is associated with low birth weight babies. Clinical data is complicated because it is confounded by other factors such as socioeconomic status,” said Dan Hardy, Ph.D., Associate Professor at Western’s Schulich School of Medicine & Dentistry and co-author on the paper. “This is the first study to definitively support the fact that THC alone has a direct impact on placental and fetal growth.”

The research team was also able to characterize how THC prevents oxygen and nutrients from crossing the placenta into the developing fetus. By studying human placental cells, the researchers found that exposure to THC caused a decrease in a glucose transporter called GLUT-1. This indicates that the THC is preventing the placental transfer of glucose, a key nutrient, from the mother to the fetus. They also found a reduction in placental vasculature in the rat model suggesting reduced blood flow from the mother to the fetus.

The researchers say both of those factors are likely contributing to the growth restriction that they observed in the offspring.

The researchers point out that there are currently no clear guidelines from Health Canada on the use of cannabis in pregnancy and some studies have shown that up to one in five women are using cannabis during pregnancy to prevent morning sickness, for anxiety or for social reasons.

“Marjiuana has been legalized in Canada and in many states in the US, however, its use during pregnancy has not been well studied up until this point. This study is important to support clinicians in communicating the very real risks associated with cannabis use during pregnancy,” said David Natale, Ph.D., Associate Professor at Queen’s and co-author on the paper.

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More information: Bryony V. Natale et al, Δ9-tetrahydrocannabinol exposure during rat pregnancy leads to symmetrical fetal growth restriction and labyrinth-specific vascular defects in the placenta, Scientific Reports (2020). DOI: 10.1038/s41598-019-57318-6

https://medicalxpress.com/news/2020-01-real-cannabis-exposure-pregnancy.html

No Change to Medicare Doc Payments Needed for 2021, MedPAC Says

No change is needed for the current update planned for Medicare physician payments in calendar year 2021, members of the Medicare Payment Advisory Commission (MedPAC) agreed Thursday. But commissioners also emphasized the need for collecting more data on the costs of running a physician practice.

“I support the recommendation [to collect additional data], but I hope we’ll take the work up next year,” said commission member Karen DeSalvo, MD, MPH, chief health officer at Google.

“We really need to get a better handle on physician expenses from 2020 and beyond, including for health IT” and the costs of running a practice team. For physicians looking to change the way they’re paid by Medicare, “it’s expensive to hire consultants to help you move to alternative payment models,” she added.

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy, had a similar thought. “The information we have on physician practice expenditures compared to what we could know is a big gulf,” because the last Centers for Medicare & Medicaid Services (CMS) survey was based on data from 2007 and 2008, he said. “I think we should take it on ourselves to encourage CMS, because the appearance that we can’t afford a survey more than once every 10 or 15 years seems not to be a good way to manage policy.”

Under current Medicare policy, no payment increase is planned for 2021, but clinicians who participate in the Merit-based Incentive Payment System (MIPS) program will receive updates of +/- 7%, and some may be eligible for an “exceptional” performance bonus, said Rachel Burton, MPP, a senior analyst at MedPAC. Doctors who participate in advanced alternative payment models (AAPMs) are eligible for a 5% incentive payment depending on their performance.

One reason no payment changes were recommended is that beneficiaries’ access to care remains good. Most beneficiaries had no problems obtaining an appointment with a physician when they needed one, or finding a new physician who takes Medicare, said Burton. And the number of clinicians billing Medicare fee-for-service grew at a faster rate than the number of beneficiaries from 2013 to 2018, she added.

A total of 99.6% of providers’ fee-for-service claims were paid “on assignment,” meaning that the providers accepted the approved Medicare rate as full payment; that rate includes a 20% patient copay in addition to the 80% that Medicare itself pays. In addition, about 1 million providers — the vast majority of those who treat Medicare patients — received additional payments through the MIPS program or from the AAPM bonus program, Burton said. Following the recommendation to stick with current law for 2021 shouldn’t affect beneficiaries’ access to care or doctors’ willingness to furnish care, according to MedPAC staff.

Larry Casalino, MD, PhD, professor of healthcare policy and research at Weill Cornell Medical College in New York City, said that if nearly everyone is getting payment bonuses, “it must mean the bonuses are quite small.” Burton agreed, noting that the bonus amount went only as high as 1.7%.

MedPAC chairman Francis Crosson, MD, of Palo Alto, California, said the high bonus rate was not really a big surprise. “Just to be clear, it was the projection of this commission based on staff work that what is currently playing out was going to play out,” he said. “That’s one of the reasons we suggested that the MIPS program needs to be replaced with something else.” Their suggestion has not been taken up by CMS, so for now, the commission voted 16-0, with one commissioner absent, in favor of the recommendation to keep to the current update.

The commissioners also discussed Medicare payments for kidney disease treatment; currently Medicare uses a bundled payment system for care of patients with end-stage renal disease (ESRD). The commission voted to recommend that payments under the system for treating ESRD in 2021 be updated consistent with current law.

However, the commissioners were very concerned that Medicare take into consideration any new drugs that might come along for ESRD patients; Medicare should quickly update its payment bundle to accommodate new drugs, especially if they save costs overall, and not wait until the scheduled time for an update.

“Say there’s another tPA [tissue plasminogen activator] that comes along,” said commissioner Kathy Buto, a health policy consultant in Arlington, Virginia. “You’d want another manufacturer to feel that’s going to be recognized sooner” than whenever the next bundle update is scheduled, she said.

https://www.medpagetoday.com/publichealthpolicy/medicare/84440

CDC narrows recommendations on vaping

The U.S. Centers for Disease Control and Prevention has removed language from its website recommending that people abstain from vaping during its investigation into vaping-related lung illnesses.

Its updated warning recommends that people stop vaping THC, the psychoactive ingredient in cannabis, and consider avoiding vaping altogether if concerned about the risk to lungs. Evidence continues to build implicating a thickening agent, vitamin E acetate, that is added to illicit THC products as the culprit in the illnesses which have hospitalized 2,668 people and killed 60.

The CDC also recommends that former smokers who use e-cigarettes should not go back to tobacco and should contact their healthcare providers if they need help quitting the habit.

Selected tickers: JUUL, MO, BTI, PM, VGR, OTCPK:GLLA, OTCPK:VAPE, OTCQX:IMBBY

https://seekingalpha.com/news/3532833-cdc-narrows-recommendations-on-vaping

Nationwide Children’s, a gene therapy leader, launches manufacturing spinout

Nationwide Children’s Hospital, a hot spot for gene therapy research, this week launched a biotech spinout dedicated to constructing the complex one-time treatments.

In creating Andelyn Biosciences, as the new company is called, Nationwide aims to build on its decade-long experience in developing, testing and manufacturing gene therapies for deadly inherited diseases like spinal muscular atrophy and Duchenne muscular dystrophy.

Andelyn will operate as a for-profit subsidiary of the Columbus, Ohio-based hospital, producing gene therapy components for biotech and pharmaceutical companies running clinical trials. By 2023, Andelyn also plans to contract with drugmakers to make commercial products from a larger facility that’s yet to be built.

As the gene therapy field has surged forward — yielding two pioneering drug approvals and at times remarkable clinical results — manufacturing has emerged as a persistent challenge.

Current treatments are delivered via hollowed-out, inactivated viruses that must be made in enormous quantities to deliver sufficient copies of the target gene. Scaling up from small studies to late-stage tests and commercial marketing, meanwhile, requires a company either own a dedicated manufacturing plant or turn to existing contract manufacturers, many of which currently have long wait times for production.

“We’re tracking the growth, maturation and evolution of the field,” said Dennis Durbin, chief scientific officer of the Abigail Wexner Research Institute at Nationwide, in an interview. “Commercial-scale manufacturing represents one of the next significant barriers to the continued development of the field.”

For years, Nationwide has produced gene therapies for its research at a small clinical facility. As Nationwide’s work expanded, the hospital added space, increasing the number of production suites dedicated to viral vector manufacturing from one to three.

More recently, Durbin said, Nationwide’s industry partners began asking the hospital if it could make preclinical or early-stage clinical product, requests that spurred Nationwide to consider launching Andelyn.

“Part of the reason we feel we can do this is because of our track record of success in doing it at the scale we’ve been doing it for several years,” said Durbin, who joined Nationwide two years ago from the University of Pennsylvania. “We don’t feel we’re starting out from scratch here.”

That track record includes a Phase 1 study led by researcher Jerry Mendell that proved the promise of a gene therapy for spinal muscular therapy, later taken forward by the biotech AveXis and approved as Zolgensma.

Other notable examples include two spinouts, Celenex and Myonexus, later acquired by Amicus Therapeutics and Sarepta Therapeutics, respectively. Sarepta has also licensed from Nationwide a Duchenne muscular dystrophy treatment that has since become the company’s leading experimental drug.

Select biotech spinouts from Nationwide Children’s

SPINOUT	DISEASE FOCUS	LEAD DRUG	BOUGHT BUY
AveXis	Spinal muscular atrophy	Zolgensma	Novartis, for $8.7 billion
Celenex	Lysosomal storage disorders	Two programs in Batten disease	Amicus Therapeutics, for $100 million
Myonexus	Limb-girdle muscular dystrophy	MYO-101	Sarepta Therapeutics, for $165 million

With Andelyn, Nationwide expects to offer manufacturing support from the start of clinical testing all the way through to a gene therapy’s potential approval — something it’s current clinical facility can’t do.

Durbin also hopes Andelyn will be able to keep pace with a field that’s unlikely to look the same in several years’ time.

“The manufacturing methods in this space are still what I would consider barely first-generation,” he said. “So we anticipate continued improvements and innovation and we want Andelyn to be on the forefront.”

Nationwide isn’t the only academic center investing in gene therapy manufacturing. The Children’s Hospital of Philadelphia, another focal point in gene therapy research, opened in late 2018 a clinical production site to make viral vectors.

But structuring Andelyn as a for-profit contract manufacturer appears unique, particularly from a not-for-profit hospital.

Durbin, though, doesn’t see a conflict between the two, noting that Nationwide will reinvest some of the revenues from Andelyn back into its own research programs.

Additionally, by helping gene therapies advance, Andelyn could usher in new treatments for children, Durbin said. That would be in keeping with the company’s name, which honors Andrew Kilbarger and Evelyn Villarreal, two children who participated in Phase 1 gene therapy studies at Nationwide.

https://www.healthcaredive.com/news/nationwide-childrens-gene-therapy-manufacturing-andelyn-launch/570472/

Hospital-run Civica Rx to develop drugs in house

• Civica Rx, the generic drug company created by hospital systems, on Thursday said it has signed a seven-year partnership with Thermo Fisher to develop its own in-house products to supply to its members.
• The partnership will focus on nine drugs used in critical or emergency care that are in short supply or face potential shortages because of the limited number of manufacturers.
• The agreement represents another step in Civica’s strategy, as previous deals have involved contracting with existing manufacturers to produce private-label drugs for its members.

The arrangement would see Thermo Fisher producing drugs that would be distributed under an Abbreviated New Drug Application, or ANDA, owned by Civica. Until now, Civica has contracted with five manufacturers, including Hikma, Xellia Pharmaceuticals and Exela Pharma Sciences, to produce drugs under the manufacturers’ ANDAs but using Civica’s drug code.

Using suppliers’ ANDA was the first phase of Civica’s strategy, done in order to get drugs in short supply to hospitals as quickly as possible as well as providing generic makers with justification to increase or re-start production. Under these arrangements, Civica has begun supplying its members with 18 drugs, among them sterile injectables from Hikma and antibiotics from Xellia.

The seven-year agreement with Thermo Fisher is the next phase, in which Civica, a non-profit founded in 2018 by healthcare systems, builds its own internal pipeline of essential drugs using a contract manufacturer.

The drugs will be selected based on input from hospital-led panels. The company would not disclose what drugs Thermo Fisher will produce, although its focus is on antibiotics, anesthetics, heart and pain management medications, as well as other essential sterile injectable medicines.

A third phase of its strategy will see Civica buy or build its own manufacturing facilities.

The first batch of private-label Civica drug, vancomycin hydrochloride, was delivered in October to Riverton Hospital, a Utah facility owned by Civica founder Intermountain Healthcare.

Civica’s members include 50 health systems accounting for 1,200 hospitals and 30% of licensed beds in the U.S.

Thermo Fisher entered the contract manufacturing market in 2017 when it bought Pantheon for $7.2 billion. The laboratory products and services division that absorbed Pantheon saw its revenue grow 41% to $10 billion in 2018.

https://www.healthcaredive.com/news/civica-thermo-fisher-partner-drug-shortage-manufacturing/570625/