Nurse Charged With Rape After Incapacitated Woman Gave Birth

Police today arrested Nathan Sutherland, a 36-year-old licensed practical nurse (LPN) at Hacienda HealthCare facility in Phoenix, Arizona, alleging he raped and impregnated an incapacitated woman who had been at the center for 26 years, according to multiple news reports.

The woman, age 29, gave birth to a boy on December 29. According to a 911 call during the birth, staff members frantically trying to resuscitate the newborn said they had not known the woman was pregnant until labor began.

AZcentral.com reported that Sutherland, who worked at Hacienda since 2011, was primarily responsible for the care of the victim at the time of the assault, according to Phoenix police.

The news site reported that the Phoenix police crime lab on Tuesday found that a DNA sample taken from Sutherland matched the baby’s. Sutherland was then taken into custody. Police had tested the DNA of all male employees.

Hospital Says It Did Extensive Background Check

Hacienda spokesperson David Leibowitz said in a statement to Medscape Medical News, “Every member of the Hacienda organization is troubled beyond words to think that a licensed practical nurse could be capable of seriously harming a patient. Once again, we offer an apology and send our deepest sympathies to the client and her family, to the community and to our agency partners at every level.

“Nathan Sutherland, who held a current state of Arizona practical nurse’s license and who had undergone an extensive background check upon hiring — was terminated from Hacienda the moment our leadership team learned of his arrest.”

The statement continued, “In the past two weeks, the Hacienda team has increased security measures to ensure the safety of all our patients. We will continue to do so. We also will continue to review and improve what is already an in-depth vetting process for caregivers at Hacienda.”

Hacienda HealthCare has also hired former Maricopa County Attorney Rick Romley to conduct an independent investigation of patient safety at the long-term care center, according to AZCentral.

Phoenix police Sergeant Tommy Thompson said in a news briefing today that Sutherland was in custody, charged with one count of sexual assault and one count of vulnerable adult abuse. He said Sutherland did not answer investigators’ questions after he was arrested Tuesday.

AZCentral.com reports that court records show Sutherland has not been charged with any other major crimes.

Thompson said they are investigating whether Sutherland assaulted other victims in the 60-bed center.

Azcentral.com said court records show the woman is “not alert,” needs maximum care and had been a patient at Hacienda for 26 years.

Doctor Suspended, Another Physician and CEO Resign 

Additionally, Thanh Nguyen, MD, was suspended earlier this month in the wake of the assault, according to CBS Phoenix affiliate KPHO-TV, which obtained a copy of the suspension letter.

KPHO reports that sources close to the case confirm Nguyen was the primary doctor caring for the woman, who had been at the facility since she nearly drowned as a toddler.

The suspension letter, dated January 14, sent by the Arizona Health Care Cost Containment System said, “Based on Quality of Care Review, AHCCCS has determined that the health or welfare of one or more AHCCCS members is endangered by leaving AHCCCS member in your care,” and directed the doctor to see an attached confidential statement. 

Nguyen’s attorney told KPHO Tuesday night that his client has no comment.

A second, unnamed physician who cared for the woman resigned following reports of the assault, as did longtime Hacienda CEO Bill Timmons.

Meanwhile, the Associated Press reported that John Micheaels, a lawyer for the woman’s family, said the woman isn’t in a coma but has “significant intellectual disabilities” and does not speak. She does, however, have some ability to move, responds to sounds, and can make facial gestures.

The baby and her mother are in good health, Thompson said at the briefing. “We can’t always choose how we come into this life, but we as a community can choose to love this child,” he said, according to the Washington  Post .

https://www.medscape.com/viewarticle/908193#vp_1

Price of Insulin Doubled From 2012 to 2016

In October, Minnesota Attorney General Lori Swanson filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. In the lawsuit, Swanson said Eli Lilly,Sanofi and Novo Nordisk “deceptively raise the list price of insulin” and that the hikes have made the life-saving medication “less affordable.”

One month later, in November, the American Diabetes Association published recommendations and public policy solutions to address the problem of affordable insulin. The ADA’s call-to-action was based on data that showed the average price of insulin nearly tripled between 2002 and 2013. In 2017, the ADA said that diabetes, including both Type 1 and Type 2, was the most expensive chronic illness in the U.S. The disease has a total cost of more than $327 billion per year including $15 billion for insulin, the ADA said.

The argument from the advocacy group has additional weight this morning after a cost analysis for insulin was released by the nonprofit Health Care Cost Institute that showed the price of insulin doubled between 2012 and 2016. The HCCI analysis, as reported by Reuters, noted that an individual with Type 1 diabetes paid on average $2,864 for insulin in 2012. Four years later, in 2016, the annual average cost of insulin jumped to $5,705. Those average costs represent the combined amount paid by a patient and health plan provider for the insulin. It does not reflect any rebates that may have been paid later, Reuters said.

According to the HCCI report, from 2012 to 2016, the average price of insulin increased from 13 cents per unit to 25 cents per unit, Reuters said. For a patient using 60 units of insulin per day, an average amount, the daily cost of the medication rose from $7.80 in 2012 to $15 in 2016, Reuters reported.

The Minnesota AG lawsuit lays out some of the increased pricing of insulin. As an example, the cost of Novo Nordisk’s Levemir increased from $120.64 for 100 units/ml vial in 2012 to $293.75 in 2018, the lawsuit said. Likewise, the cost of Eli Lilly’s Humalog jumped from $122.60 for 100 units/ml vial in 2011 to $274.70 in 2017 and Sanofi-Aventis’ Lantus increased from 99.35 in 2010 when it first entered the market to $269.54 in 2018, the lawsuit said. So far this year, Sanofi has increased the prices on some insulin products between 4.4 percent and 5.2 percent, Reuterssaid. Novo Nordisk raised prices on some of its insulins by 4.9 percent, while Eli Lilly has not yet announced any price hikes on its insulin products for the year.

Both Sanofi and Novo Nordisk told Reuters that the majority of patients who are insulin dependent spend less than $50 per month on their insulin products. Indianapolis-based Eli Lilly did not respond to that news outlet’s request for comment.

The higher costs of insulin have caused many patients to begin to ration their insulin supply, which is dangerous to their health, the ADA said.

In its analysis, HCCI said the increase in insulin cost to patients was primarily driven by higher overall prices, as well as some patients being shifted toward more expensive insulin products. While the costs increased over that period of time it analyzed, average daily insulin use only rose 3 percent, Reuters said, citing the report.

The rising price of insulin has been a concern for diabetics and healthcare professionals for some time. The rising prices have sparked concern from members of Congress have launched inquiries into the pricing of the medication and in June, the American Medical Associationurged the Federal Trade Commission and the Justice Department to monitor insulin pricing and market competition.

https://www.biospace.com/article/new-report-shows-price-of-insulin-doubled-from-2012-to-2016/

J&J Forecasts Increased Biosimilar Competition for 2019

In its year-end financial report, Johnson & Johnson (J&J) predicted product sales for 2019 to range from $80.4 billion to $81.2 billion, about $1 to $2 billion below what Wall Street analysts projected. The company thinks this will largely be due to increased biosimilar competition for its Remicade (infliximab) for inflammatory diseases, and for generic competition to its Zytiga (abiraterone acetate), a prostate cancer drug.

Average analysts estimates for the 2019 sales, according to IBES data from Refinitiv, was $82.69 billion.

For the fourth quarter, J&J sales rose to $20.39 billion, or about 1 percent, which beat out Wall Street’s average estimate of $20.20 billion. Sales were assisted by Stelara sales for Crohn’s disease, which were up 29 percent to $4.15 billion. J&J’s Tremfya (guselkumab) for psoriasis also added $544 million for the year.

Remicade sales were down about $1 billion compared to 2017, largely due to biosimilar competition, but even more so due to discounting. J&J still has 93 percent of the U.S. market for this indication.

Pharmaceutical sales are responsible for about half of J&J’s revenue. For 2018, pharmaceutical sales brought in $40.73 billion. Consumer sales raked in $13.85 billion, while medical devices accounted for $26.99 billion.

Consumer sales of baby care products, including baby powder, washes and lotions, dropped to $439 million from $490 million in the fourth quarter of 2017. J&J relaunched the line with new products in the summer of 2018 hoping to boost sales. It’s possible that the market is being hit by all the news of lawsuits and asbestos contamination.

The company’s litigation expenses doubled in the fourth quarter because of the baby powder litigation. J&J has reserved $1.29 billion for legal costs during the quarter alone, double the $645 million it spent in the fourth quarter in 2017. For the entire year, litigation expenses totaled $1.99 billion, a 59 percent increase from 2017.

There have been a number of significant trial losses from the talc-asbestos litigation. In May 2018, a Los Angeles jury sided with 68-year-old Joanne Anderson, who was diagnosed with mesothelioma allegedly linked to J&J’s talc product. The jury awarded Anderson compensatory damages of $21.7 million, with J&J being responsible for 67 percent of the award. The company is fending off approximately 9,000 to 10,000 lawsuits claiming that its baby powder causes ovarian cancer because of asbestos contamination.

J&J’s chief executive officer, Alex Gorsky, said at the analyst conference that pricing is likely to be a big issue for the sector this year. He also said he was concerned about the U.S. federal government’s plans for reference pricing, saying it could have “unintended consequences around access and innovation.” He went on to say J&J is “obviously engaged with the (Trump) administration and a lot of different groups right now on the issue of pharmaceutical pricing.”

Gorsky also argued that medicines and medical devices together account for about 20 percent of costs to patients, with the remaining 80 percent coming “from outside our industry.”

During the call, the company indicated that net prices of its drugs dropped 6 to 8 percent in 2018, after dropping 4.6 percent in 2017. The company raised U.S. list prices on about two dozen prescription drugs earlier this month.

In the conference, Chris DelOrefice, vice president of Investor Relations, said, “As we enter 2019, we are confident in the strength of our business. We believe our Pharmaceutical business will deliver growth while absorbing significant impacts from biosimilar and generic competition. We expect Consumer to maintain above-market growth, and we anticipate our Medical Devices segment will continue to improve. We plan to deliver innovation that will have an enduring impact on patients, caregivers and consumers while also delivering solid financial performance.”

https://www.biospace.com/article/j-and-j-forecasts-increased-biosimilar-competition-for-2019/

KKR, Viking Global lead $299M round for BridgeBio

BridgeBio Pharma has bagged a whopping $299.2 million to advance its genetic disease pipeline, which includes more than a dozen assets in preclinical and clinical development.

Founded in 2015, BridgeBio is working across several therapeutic areas and taking aim at a wide range of indications, including transthyretin amyloidosis (ATTR), pantothenate kinase-associated neurodegeneration (PKAN), Gorlin syndrome and frequent basal cell carcinomas, Netherton syndrome, molybdenum cofactor deficiency Type A, and FGFR, SHP-2, and K-RAS-driven cancers, just to name a few.

KKR and Viking Global Investors led the round and Sequoia Capital chipped in alongside BridgeBio’s existing backers, Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital and Hercules Capital. The fundraise comes after a busy year for BridgeBio—after raising $135 million in September 2017, the biotech in-licensed or acquired a number of genetic disease treatments and spun out subsidiaries to work on them.

This “hub-and-spoke” structure puts each drug in its own subsidiary with access to “centralized resources” and a “central research and development platform.” It allows BridgeBio to develop multiple programs simultaneously with the ability to “efficiently redistribute” staff and funding between the different assets as needed, the company said in a statement.

The company started 2018 by spinning out QED Therapeutics with $65 million in funding. The unit is working on an FGFR inhibitor licensed from Novartis for the treatment of bile duct cancers and achondroplasia, a form of short-limbed dwarfism. In June, BridgeBio launched a trio of subsidiaries. Origin Biosciences will tackle molybdenum cofactor deficiency type A—an ultrarare, fatal genetic disease that causes seizures in infants—and CoA Therapeutics is developing a treatment for PKAN. They licensed their respective assets from Alexion and St. Jude Children’s Research Hospital. Fortify Therapeutics in-licensed NeuroVive’s NVP015 program for Leber hereditary optic neuropathy, a mitochondrial disease that can cause the optic nerve to atrophy, leading to sudden, severe loss of central vision.

Origin’s and QED’s programs are in phase 2/3 and phase 2 respectively and are among BridgeBio’s most advanced. Its lead program, a treatment for ATTR polyneuropathy and cardiomyopathy being developed by Eidos Therapeutics, is in phase 3. Eidos pulled off a $106 million IPO in June, which will bankroll its ATTR candidate, AG10, through the clinic.

https://www.fiercebiotech.com/biotech/kkr-viking-global-lead-299m-round-for-bridgebio

J&J seen eying multibillion-dollar deal for surgical robotics company Auris Health

Johnson & Johnson is eyeing robotic surgery maven Auris Health as a potential acquisition, with plans to purchase it at a premium over its most recent $2 billion valuation, according to a report from Bloomberg.

While a final agreement has not been reached, such a move could slot in the 2016 Fierce 15 winner’s FDA-approved system for diagnosing and treating patients with lung cancer alongside J&J’s other robotic surgery offerings, including those currently under development in orthopedics and general surgery.

Launched by Frederic Moll—who previously helped put Intuitive Surgical at the center of the map with its da Vinci surgical robot—Auris has raised more than $700 million in financing to date, including a $220 million haul last November to help commercialize its lung-focused Monarch platform.

Auris has previously rubbed elbows with J&J, including through a collaboration with a subsidiary of the Big Pharma’s Ethicon unit. Last year, Auris and NeuWave Medical launched a project to add microwave ablation capabilities to the end of Monarch’s robotic bronchoscope—a thin, guided, flexible tube designed to reach difficult lung nodules and burn out cancer lesions—with the goal of detecting and treating lung tumors during the same procedure.

Meanwhile, J&J and Verily have been working together on digital surgery since 2015, back when the latter was known as Google Life Sciences. The two formed a joint venture, Verb Surgical, which unveiled its first prototype to its executive benefactors two years later. Currently, the two companies are looking to leverage their different skill sets, including in data analytics and artificial intelligence, in the creation of a new type of general surgery robot.

J&J aims to take a broader view of digital health when it comes to robotic surgery, by not only developing a more efficiently performed procedure, but by also pairing it with data gathered in the months before and after surgery to help better prepare patients and track improvements down the line.

“Our concept is using digital technologies to expand the continuum of care,” Euan Thomson, J&J’s global head of R&D for digital technology and advanced innovation, told FierceMedtech in an interview last year. J&J’s work in orthopedic surgery brought in over $8.8 billion in 2017 sales, giving the company a 24.2% market share, according to EvaluateMedtech.

“We can start to better understand the impact a patient has on outcomes, plus the impact that surgical technique and process has on outcomes—as well as on the performance of the devices, which the corpus of research has been focused on in the past,” Thomson said.

Elsewhere, J&J’s medtech competitor Medtronic moved to acquire Mazor Robotics last year, with a $1.6 billion deal for the company and its spine surgery guidance systems.

Medtronic had previously invested in the company and plans to merge Mazor’s systems with its own line of spinal implants, navigation and imaging products to create an integrated surgery suite while maintaining Israel-based Mazor’s site and team.

https://www.fiercebiotech.com/medtech/j-j-considering-multi-billion-dollar-deal-for-surgical-robotics-company-auris-health-report

Site of Teen’s Murder Becomes New York City’s First ‘Safe Haven Bodega’

The store where 15-year-old Lesandro “Junior” Guzman-Feliz was murdered last June has become the first “Safe Haven Bodega” in the city.

The bodega on East 183rd Street is taking part in the NYPD’s new program to prevent gang assaults and robberies.

Participating businesses will be outfitted with panic buttons, magnetic locks, security cameras, bright lighting and shatterproof glass.

“We know that if the bodega owner could lock the door and prevent people from entering, at least it would give him enough time to contact the local authority and hopefully get them there on time,” said Fernando Mateo, a spokesman for the United Bodegas of America.

The program was implemented after the United Bodegas of America met with police during a safety summit last month and asked for recommendations. The group is encouraging all 20,000 bodegas to install the safety measures, CBS2’s Hazel Sanchez reported.

It will cost bodegas between $3,000-4,000 to participate in the program.

“I feel this is going to be … we gonna feel more secure,” said Radames Rodriguez, president of the United Bodegas of America. “We’re saving our employees and our community, too.”

Guzman-Feliz was dragged out of a bodega and stabbed to death by several alleged members of the Trinitarios gang in what police called a case of mistaken identity.

Some residents said the bodega’s owner did not do enough to protect the teenager, but he defended himself, saying he called 911 twice and did all he could.

Site Of Lesandro ‘Junior’ Guzman-Feliz’s Murder Becomes New York City’s First ‘Safe Haven Bodega’

Look for Q4 surprise from BMS’ Opdivo, but Merck’s Keytruda seen staying on top

When the dust settles on the fourth quarter, analysts expect Merck’s Keytruda to maintain its lead over archrival Opdivo from Bristol-Myers Squibb. But it’s Opdivo that could surprise Wall Street, one analyst says.

Data from analytics firm Symphony Health put Opdivo’s Q4 sales in the U.S. at $1.24 billion, which would far surpass the $1.12 billion consensus estimate. Credit Suisse analyst Vamil Divan, for his part, doesn’t expect to see sales hit that high mark—“actual sales for Opdivo have come in below this estimate by 5-10% in the past quarters,” he wrote in a note to clients. But even after making that adjustment to Symphony’s figure, “Opdivo still appears to beat ours as well as Street estimates,” he said.

It certainly wouldn’t be the first time in recent memory that Opdivo surprised industry watchers, many of whom have braced for the drug’s demise as Keytruda picks up steam in previously untreated lung cancer patients. Thanks to Keytruda’s indications in that setting, “lung cancer patients who previously would have been coming off chemotherapy will instead be coming off of Keytruda and unlikely to end up on another PD-(L)1 agent for 2nd line treatment,” Divan wrote. And that, of course, would leave Opdivo out of the running in that patient group.

But Opdivo has shown up. In last year’s second quarter, it blew past estimates on the back of a big second-line lung cancer performance; at the time, execs said the drug was hanging onto a leadership share of 30% to 35% in that setting. And after the following quarter, they pledged the drug would keep growing in 2019.

One reason? It’s not all about lung cancer, as Divan noted. “While investors have been especially focused on the dynamics in the 1L NSCLC market, we have consistently highlighted the overall I-O market opportunity, which we believe is still underappreciated,” he said, adding that “use in other indications is clearly boosting sales of both” Opdivo and Keytruda.

Bristol’s execs have been quick to make that same point, especially as Opdivo’s own future in first-line lung cancer grew more uncertain. Kidney cancer, though becoming increasingly crowded with treatments, is one area where they see continued success for the PD-1 blockbuster.

Meanwhile, Keytruda’s win for the quarter will likely be maintaining the lead over Opdivo it finally nabbed last summer. Symphony data put U.S. sales of the drug at $1.13 billion, but Symphony has historically come in low with its Keytruda estimates; adjusting for that trend, “Keytruda could come in slightly lower than our estimates, and in-line with Street expectations” of $1.26 billion, Divan said.

https://www.fiercepharma.com/marketing/for-q4-expect-to-see-bms-opdivo-surprise-again-but-merck-s-keytruda-stay-top-analyst