Stopping progression of tissue injury after button battery ingestion

Button battery injuries in children have been increasingly severe–resulting in devastating injuries and even death. Button batteries damage esophageal tissue through isothermic hydrolysis reactions, resulting in alkaline caustic injury, which leads to tissue necrosis. Prompt removal of the battery is critical to minimizing damage. However, when children swallow a button battery, the injury can progress even after it is removed.

In a recent study from surgeon-researchers at Nationwide Children’s Hospital, esophageal irrigation in the operating suite with dilute sterile vinegar, 0.25% acetic acid, after button battery removal was safe and improved mucosal appearance. Household cooking vinegar is typically a 5% concentration.

“Progression of esophageal tissue damage after removal is a hallmark of button battery injury,” says Kris Jatana, MD, director of Pediatric Otolaryngology Quality Improvement at Nationwide Children’s and lead author of the study publication. “Complications may be delayed up to 9 days for tracheoesophageal fistulas and up to 28 days for aortoesophageal fistulas.”

The study, published in The Laryngoscope, followed data from six consecutive patients aged 19 months to 10 years who had a 3V lithium button battery lodged in the esophagus for 2 to 18 hours. Surgeons irrigated the injury site with sterile 0.25% acetic acid after removal.

“When we looked at the tissue in the OR, we could see that it was visually improved after the irrigation,” says Dr. Jatana, who is also an associate professor in the Department of Otolaryngology – Head and Neck Surgery at The Ohio State University. “And none of these patients showed immediate or delayed esophageal complications.”

The National Capital Poison Center Button Battery Guidelines currently recommends this new irrigation with 0.25% acetic acid during button battery removal. This is the first case series published in pediatric patients, using this initial concept that began at Nationwide Children’s. It is now being performed around the world after esophageal button battery removal.

“This study highlights the importance of rapid endoscopic removal and the need for additional strategies to neutralize the injury site. Rapid neutralization of esophageal tissue pH as soon as possible after button battery removal may prevent the continued tissue injury associated with a prolonged alkaline environment and reduce long-term complications,” concludes Dr. Jatana, who is also a Co-Chair of the National Button Battery Task Force, affiliated with the American Academy of Pediatrics and American Broncho-Esophagological Association. “This is something that all surgeons can consider to improve outcomes after esophageal button battery injury.”

https://www.eurekalert.org/pub_releases/2019-09/nch-spo090519.php

Risk for people coming off chronic opioid prescriptions

With a huge push to reduce opioid prescribing, little is known about the real-world benefits or risks to patients.

A recent study published in the Journal of General Internal Medicine found an alarming outcome: Patients coming off opioids for pain were three times more likely to die of an overdose in the years that followed.

“We are worried by these results, because they suggest that the policy recommendations intended to make opioid prescribing safer are not working as intended,” said lead author Jocelyn James, assistant professor of general internal medicine at the University of Washington School of Medicine. “We have to make sure we develop systems to protect patients.”

Physicians had already begun to reduce opioid prescribing by 2016, when the CDC issued its first guideline on opioid prescribing. That trend accelerated after 2016.

While reduced prescribing may well be intended to improve patient safety, little is known about the real world benefits or risks of this sea change in opioid prescribing.

The study looked at a cohort of 572 patients with chronic pain enrolled in an opioid registry. Chronic opioid therapy was discontinued in 344 patients and 187 continued to visit a primary care clinic. During the study period, 119 registry patients died (20.8%); 21 patients died of a definitive or possible overdose – 17 were discontinued patients and four were patients being seen at a clinic.

As the researchers concluded: “Discontinuing chronic opioid therapy was associated with increased risk of death.”

Researchers said that improved clinical strategies, including multimodal pain management and treatment of opioid-use disorder, may be needed for this high-risk group.

At the time of this study, state rules did not allow medication treatment of opioid-use disorder in the primary care setting, said co-author Joseph Merrill, professor of general internal medicine at the University of Washington School of Medicine.

But after those rules changed, he said the addiction clinic at Harborview has developed a strong program to provide medication treatment for opioid-use disorder, including those who develop problems related to prescription pain medication.

“We hope these findings encourage others who prescribe opioids to do the same,” Merrill said.

Researchers said the UW Medicine study is the third study published this year to look at the risks of stopping opioids:

• A study published in the Journal of Substance Abuse Treatment found that among patients at high dose who stopped opioids, almost half had their doses reduced to 0 in a single day and many wound up in emergency departments.
• A New York study in the Journal of General Internal Medicine found that ending opioid prescriptions was often followed by an end to the care relationship.
• This spring the United States Food and Drug Administration issued a warning that suddenly stopping opioids can present a risk to patients.

https://www.eurekalert.org/pub_releases/2019-09/uowh-rfa090519.php

Danaher’s Envista sets terms for $602 million IPO

Envista Holdings, the dental supplies and equipment unit being carved out of Danaher, announced terms for its IPO on Wednesday.

The Brea, CA-based company plans to raise $602 million by offering 26.8 million shares at a price range of $21 to $24. At the midpoint of the proposed range, Envista Holdings would command a market value of $3.5 billion.

Envista Holdings traces its roots to 2004 and booked $2.8 billion in sales for the 12 months ended June 30, 2019. It plans to list on the NYSE under the symbol NVST. J.P. Morgan, Goldman Sachs, Morgan Stanley, Baird, Evercore ISI and Jefferies are the joint bookrunners on the deal. It is expected to price during the week of September 16, 2019.

Relevant Profile: NVST

https://www.renaissancecapital.com/IPO-Center/News/64802/Danahers-Envista-sets-terms-for-$602-million-IPO

Canadian biotech BELLUS Health prices upsized $70 million US IPO at $7.10

BELLUS Health, a Phase 2 biotech developing an oral small molecule therapy for chronic cough, raised $70 million by offering 9.9 million shares at $7.10, the as-converted last close of its shares on the TSX (BLU), to command a fully diluted market value of $408 million. The company had originally planned to raise $60 million by offering 8.5 million shares at $7.03.

BELLUS Health plans to list on the Nasdaq under the symbol BLU. Jefferies, Cowen and Guggenheim Securities acted as lead managers on the deal.

Relevant Profile: BLU

https://www.renaissancecapital.com/IPO-Center/News/64823/Canadian-biotech-BELLUS-Health-prices-upsized-$70-million-US-IPO-at-$7.10

Avid Bioservices EPS misses by $0.05, beats on revenue

Avid Bioservices (NASDAQ:CDMO): Q1 GAAP EPS of -$0.08 misses by $0.05.

Revenue of $15.25M (+21.1% Y/Y) beats by $0.88M.

Shares -2.27%.

Press Release

https://seekingalpha.com/news/3497501-avid-bioservices-eps-misses-0_05-beats-revenue

More Insurers Pitch New Ways to Pay for Million-Dollar Therapies

Insurers are scrambling to blunt the expense of new drugs that can carry prices of more than $2 million per treatment, offering new setups aimed at making the cost of gene therapies more manageable for employers.

Cigna Corp. announced Thursday a new program that allows employers and insurers to pay per-month fees for a service that will cover the cost of gene therapies and manage their use. CVS Health Corp. says it plans to offer a new layer of coverage specifically for gene therapies, which would handle employers’ costs above a certain threshold. Anthem Inc. said it is looking at special insurance setups to help employers protect themselves from the financial impact of the drugs.

“You have all these new products coming to the market at these very high prices,” said Steve Miller, Cigna’s chief clinical officer. “Clearly this is a pain point in health care that needs to be solved.”

Cigna hasn’t set a fee yet, but Dr. Miller said the company is aiming for it to be less than $1 per member a month. Under the program, patients would pay nothing out of pocket for the drugs, Cigna said.

The protection plans are limited so far, and it isn’t clear that the insurers will be able to bring down the overall costs of the therapies, as opposed to simply spreading them out. Insurers say they are pushing for deals that tie payments for gene therapies and other high-cost medicines to their results in patients.

Drugmakers, for their part, say they are open to working with insurers on new payment arrangements that improve patient access to their products.

Gene therapies, which replace a faulty gene with a functioning copy, promise to cure hard-to-treat inherited diseases. But their price tags threaten the balance sheets of employers and insurers, especially as more hit the market.

Novartis AG priced Zolgensma, a gene therapy for a muscle-wasting condition known as spinal muscular atrophy, at $2.1 million.

Meantime, Spark Therapeutics Inc. listed Luxturna, which treats a form of inherited vision loss, at $850,000.

In June, Bluebird Bio Inc. said it would price a new gene therapy for a rare blood disorder at EUR1.6 million ($1.8 million) in Europe, where it has been approved.

“Employers are saying, ‘I just can’t afford it,'” said CVS Health Chief Medical Officer Troy Brennan.

So far, health insurers have tried to balance providing patients access to the new therapies with managing their cost partly by setting conditions that limit who can get the drugs.

The protection plans represent an additional approach. The Cigna program, called Embarc Benefit Protection, will launch with Zolgensma and Luxturna for 2020, and the company aims to add more drugs in the future, Dr. Miller said.

Embarc will administer the review process that decides which patients can get the drugs, and Cigna’s specialty pharmacy can dispense the drugs.

Cigna said it wants to accumulate enough clients in the new offering to gain more leverage with the drug companies and wring out better deals for gene therapies. “We’re looking for money-back guarantees,” said Dr. Miller.

A spokeswoman for AveXis, the Novartis subsidiary that developed Zolgensma, said the company hasn’t been briefed on the new insurance payment plans, but recognizes “innovative therapies like Zolgensma require innovative solutions for access.”

A Spark spokesman said the company continues to evaluate “ways to enhance patient access” to Luxturna with various stakeholders.

CVS’s new offering on gene therapies, for self-insured employers that are clients of the company’s Aetna health insurer, will include Zolgensma and Luxturna and potentially other treatments, Dr. Brennan said. The stop-loss program, which would cover an employer’s costs that exceed a set threshold, will be available for 2020. CVS is also working on a broader reinsurance product for high-cost drugs, he said.

Anthem said it is evaluating reinsurance or stop-loss options that employers could use to shield themselves from the high cost of certain drugs.

The new options may prove attractive to employers that aren’t big enough to absorb the cost of the new drugs and don’t have existing stop-loss insurance that would cover them, said Nadina Rosier, who is head of the pharmacy practice at advisory firm Willis Towers Watson.

For companies that already have stop-loss policies that cover such drugs, “You have to ask yourself, ‘why am I double paying?'” she said.

Insurers in Massachusetts have been working on a pilot program in which they would forge installment-payment plans for expensive one-time treatments like gene therapy and agree to continue making payments even if patients taking the drug switch insurers.

The effort has stalled, however, because of drugmaker concerns about Medicaid best-price rules, which require the government program to receive the lowest price of any payer, said Mark Trusheim, strategic director of the New Drug Development Paradigms, a think tank run out of the Massachusetts Institute of Technology.

AveXis is currently offering a payment option that allows insurers to receive a rebate if the drug doesn’t meet prespecified clinical outcomes for the patient, the company spokeswoman said. The rebate cannot exceed the statutory rebate of 17.1% that drugmakers pay to Medicaid for pediatric drugs, the spokeswoman said.

https://www.marketscreener.com/CIGNA-CORP-49690049/news/Insurers-Pitch-New-Ways-to-Pay-for-Million-Dollar-Therapies-Update-29165173/

Hip bone density loss persists after weight loss in older adults with obesity

Weight loss in older adults is accompanied by loss in bone mineral density (BMD) and an increased risk of bone fracture. A new study published in Obesity found that loss of hip BMD persists in the year following a weight loss intervention among older adults with obesity, regardless of whether they regain weight.

The study also found that losses in fat mass and lean mass contribute to reduced hip BMD; yet, loss in fat mass may signal improved trabecular bone score, which is a measure of bone texture and is a marker for the risk of osteoporosis.

The findings emphasize the importance of identifying and implementing interventions that can target fat mass, but not lean mass, loss to optimize bone health during weight loss in older adults.

Source:

Wiley

Journal reference:

Kammire, D.E. et al. (2019) Effect of Weight Change Following Intentional Weight Loss on Bone Health in Older Adults with Obesity. Obesity. doi.org/10.1002/oby.22604.

https://www.news-medical.net/news/20190905/Loss-of-hip-BMD-persists-after-weight-loss-intervention-among-older-adults-with-obesity.aspx