NGM Biopharmaceuticals, a Phase 2 biotech developing therapies for NASH and type 2 diabetes, raised $107 million by offering 6.7 million shares at $16, the high end of the range of $14 to $16. NGM Biopharmaceuticals plans to list on the Nasdaq under the symbol NGM. Goldman Sachs, Citi and Cowen acted as lead managers on the deal.
Wednesday, April 3, 2019
How long does it take to see a doctor in a nursing home? Some patients never do
When Kira Ryskina works in Penn Presbyterian Medical Center, she usually sees her patients every day.
When it comes time for them to leave, some are too sick to go directly home or need rehabilitation in a nursing home. She tells them that another doctor will see them there.
But Ryskina, an internist and health policy researcher at the University of Pennsylvania’s Perelman School of Medicine, began to wonder how true that was. Her own experience working in nursing homes, plus feedback from patients and their families, told her that patients might not see doctors as quickly as many would expect.
Her curiosity led to a study published Monday in the journal Health Affairs that supported her theory that nursing home patients can’t be sure of seeing a doctor. Her team’s analysis of records for 2.4 million Medicare patients discharged from hospitals to nursing homes from January 2012 to October 2014 found that 10.4 percent never saw a doctor, nurse practitioner or physician assistant. Nearly 72 percent of patients were examined by a doctor or advanced practitioner within four days, but there was considerable variability among nursing homes. Smaller and rural nursing homes were the slowest. Ryskina saw little evidence that nursing homes were doing a good job of triaging patients to assure that the sickest ones were seen the most quickly.
Of the group that never saw a doctor, 28 percent were readmitted to a hospital and 14 percent died within 30 days of admission to the nursing home. Among patients who saw a doctor at least once, 14.3 percent were readmitted to a hospital and 7.2 percent died within that time period.
From a policy standpoint, these numbers are important because some modern payment systems, including Medicare’s, hold hospitals accountable for what happens after their patients leave. There can be penalties if patients need to return to the hospital too quickly.
From a patient perspective, quick readmissions and excess deaths can be a sign that patients weren’t ready to leave the hospital or needed more attentive care.
Ryskina said there is no official guideline for how quickly newly admitted patients should see a doctor, but she’d start by suggesting 48 hours. “I think we need some empirical data to support this,” she said. Medicare’s current rules specify that patients be seen within 30 days of admission, likely a holdover from days when many nursing home residents received “custodial” care, she said. The patients in her study were not long-term nursing home residents.
Physicians are rarely on site at nursing homes every day. Ensuring quicker assessments would be challenging for the facilities, Ryskina said. “I think reimbursement is a big barrier,” she said.
About 20 percent of hospital patients are discharged to nursing homes for further medical care. The rest go home or to hospice. Ryskina said it is often the most vulnerable patients who go to nursing homes, where they can receive physical therapy for joint replacements, intravenous antibiotics or skilled wound care.
While she assumes that 100 percent of nursing home patients should be seen by a doctor, Ryskina said it is possible that some patients arrived on a weekend and were readmitted to the hospital so quickly that a doctor didn’t have a chance to examine them. However, the patients in the group that never saw a doctor had a median stay of 11 days. “I think it’s concerning,” she said.
Patients in rural nursing homes waited the longest on average to see a doctor: 8.1 days compared with 3.2 in other facilities.
Geographically, doctors saw patients the fastest—2.2 days—in nursing homes in the Northeast. The average wait was 5.3 days in the Midwest. Patients in large facilities saw doctors faster than those in small ones.
Ryskina said growing numbers of doctors are specializing in nursing home care or in the needs of complex patients at risk for further hospitalization. Telemedicine could also improve access to physicians.
She said the University of Chicago is testing a model where the same physicians treat high-risk patients in both inpatient and outpatient settings. David Meltzer, a physician who is leading that effort, said the Comprehensive Care Program originally included following patients to nursing homes, but that was not “sustainable” because patients went to so many different facilities. Volumes were too small at any one place. His health system has considered developing closer relationships with specific post-acute facilities. “I do think such closer relationships of hospitals with post-acute facilities could potentially be quite valuable,” he said.
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Thai Cave Rescue: Details for Preventing Hypothermia, Panic
The harrowing details of the rescue operation that saved 12 adolescent Thai soccer players and their coach from Thailand’s monsoon-flooded Tham Luang cave were reported shortly after the effort ended, but the specifics of their medical care before, during, and after the rescue have been hazy. Now, a research letter published online today in the New England Journal of Medicine details how the medical team prepared each boy for the approximately 6-hour journey from their ledge to the cave mouth.
Initially, officials expected that the boys would need to remain in the cave for several months until the monsoon season ended, but “with impending monsoon rains and concerns about falling oxygen levels in the cave, a plan to urgently extricate the patients was developed,” write Maj. Chanrit Lawthaweesawat, MD, of the Medical Association of Thailand in Bangkok, and three colleagues on the medical team.
The team, led by coauthor Maj. Gen. Wutichai Isara, MD, included 50 to 60 physicians and more than 100 medical personnel who were on duty each day, plus a backup team standing by around the clock, Lawthaweesawat told Medscape Medical News.
Among the biggest concerns was hypothermia, the authors explain, because the boys spent approximately 2 hours submerged in water that was 2° to 3° Celsius as a certified cave diver transported them toward the exit. Throughout the rescue, two patients developed mild hypothermia, one on the first day and one on the second day of the rescue.
Initially, the greatest concern was with regard to the third day, because the last group of boys were younger and smaller than the others. However, “the transfer process was very fast” and none of the boys developed hypothermia because the group knew the protocols well by that point, Lawthaweesawat told Medscape Medical News.
Because of the length of each one-way journey to the cave mouth, much of it underwater and through narrow, flooded passages, the team also worried about the boys panicking. Each boy therefore received alprazolam 0.5 mg orally and an intramuscular injection of atropine 20 μg/kg, followed by an intramuscular loading dose of ketamine 5 mg/kg.
Sedation was atypical for such a rescue operation, but “it was one of the those on-site decisions that was certainly reasonable to proceed with,” Col. Will Smith, MD, of the US Army Reserve, who is medical director of Teton County Search and Rescue, Grand Teton National Park, and other national parks teams, told Medscape Medical News.
The boys had never dived, and after spending a week alone in the cave without food and with little water before being found, “their state of mind was certainly a concern,” Smith said. Although not involved with this particular rescue, Smith, who is also a clinical assistant professor at the University of Washington School of Medicine, Seattle, consults in search and rescue operations as owner of Wilderness and Emergency Medicine Consulting.
Ketamine was an ideal choice of sedation because it can be given intramuscularly — and therefore underwater through a wet suit, while the person is unconscious if necessary. Ketamine was able to anesthetize the boys adequately to ensure that their muscles were relaxed during the trip. This enabled the diver to carry them without the boys being aware of the dangerous, potentially frightening conditions, Lawthaweesawat told Medscape Medical News.
In addition, “ketamine is the only medicine that can still maintain respiration and blood pressure throughout the journey,” coauthor Krit Pongpirul, MD, PhD, of Chulalongkorn University in Bangkok, Thailand, told Medscape Medical News.
Because ketamine is a vasoconstrictor that impairs shivering, the authors write, it is also “associated with smaller drops in core temperature and is a good choice for patients at risk for hypothermia.”
On-site anesthesiologist Richard Harris, BM, BS, FANZCA, from South Australia Health in Adelaide, who is a coauthor of the letter, explained to the rescue divers how to determine whether each child needed more ketamine, how to determine the dose, and how to administer the injection. Most children received a rescue ketamine dose of 2.5 mg/kg in cave chamber 8 after a 350-meter dive, Harris told Medscape Medical News.
The boys’ wet suits fit poorly because they had lost weight from being a week without food. In addition, the dive team did not have child-sized face masks. The masks thus had to be tightened as much as possible, and the divers had to regularly check for air bubbles during transit.
Given their sedation, “if the full-face mask fails, then they would drown,” Smith said.
Each positive-pressure full-face mask delivered 80% oxygen during transit. Each mask was replaced with a nonrebreather oxygen mask upon arrival at Chiangrai Prachanukroh Hospital. At the hospital, because of how poorly the wet suits fit, “US Air Force and Thai Navy SEAL [personnel] facilitated the wet suit removal to maintain the airway, avoid arrhythmia, as well as to protect cervical spine,” Lawthaweesawat said.
The second boy who was rescued developed mild hypothermia, with a body temperature of 34.8° Celsius (94.6° Fahrenheit) on the first day, partly because of inefficient team coordination, lack of adequate preventive measures, and “confusion over the process,” Lawthaweesawat said.
The team therefore developed the Thailand Cave Rescue Protocol: airway, breathing, circulation, and hypothermia (ABC+H). An anesthesiologist managed airway and hypothermia while a respirologist and pediatric cardiologist managed breathing and circulation.
During the rescue and en route to the hospital, the team used a cloth blanket, a heater blanket, whole-body foil wrap, and a hair dryer to keep the boys warm. In addition, each patient received “a bolus of 100 ml of warmed 0.9% normal saline, followed by an infusion of 150 to 200 ml per hour until they were hemodynamically stable,” the authors write. Personnel checked the boys’ temperature every 5 minutes until each boy’s temperature was at least 35° Celsius for four consecutive readings.
Smith wondered how the team managed to keep the saline warm enough without the specialized equipment that keeps IV tubing warm, but Lawthaweesawat said the bags were changed quickly enough that little heat was lost during saline administration.
The research letter focuses primarily on hypothermia, although that was just one of many medical concerns the team faced during their impressive rescue effort, Smith told Medscape Medical News. “It was a very technical rescue — the ropes, the rigging, the diving, and then the medical sedation of the patients in their [cocoons]. This was something extraordinary that had never really been done as far as I know,” Smith said. “I think this was a good multifactorial approach for patients who aren’t able to care for themselves.”
Lawthaweesawat told Medscape Medical News that there were several things that he would do differently from the start or would advise other medical teams to do in similar situations in the future.
First, he would set up critical and noncritical processes from the start, including the hypothermia protocol and body temperature monitoring every 5 minutes and daily orientation for all staff members regarding the processes and protocols.
He would also set up an efficient, effective communication process within the rescue effort. During this rescue, for example, the hospital did not have ongoing communication with the on-site staff.
Lawthaweesawat also emphasized the importance of establishing a public communications strategy early on for communicating updates to the press and the public at large. At the time of the rescue, the team withheld the fact that the boys were sedated with ketamine, because they were advised it would be difficult to explain the reasoning to the public. Having strategies in place ahead of time would have been helpful.
Despite the unique, extreme challenges of the rescue, the team was ultimately successful: all the boys and their coach are in good health today and have received mental health counseling.
“Everybody at the field did a great job for their specific expertise with minimal confusing overlaps,” Isara told Medscape Medical News. “All doctors tried hard to use their ability, capability, and their specialization in various fields to overcome all obstacles under the limits of time and information.”
The authors have disclosed no relevant financial relationships. Smith is president and medical director of Wilderness and Emergency Medicine Consulting, LLC.
N Engl J Med. Published online April 3, 2019.
Liquidia Presents Phase 3 Trial Data for LIQ861 at ISHLT 39th Annual Meeting
Liquidia Technologies, Inc. (Nasdaq: LQDA) (“Liquidia”), a late-stage clinical biopharmaceutical company focused on the development and commercialization of LIQ861, announced today additional detailed safety and exploratory endpoint findings at the two-month timepoint for the Phase 3 INSPIRE trial. Nicholas Hill, MD, Chief Pulmonary, Critical Care & Sleep Division and Professor of Medicine at Tufts University School of Medicine and INSPIRE Principal Investigator, presented the data at the opening plenary session of the 39th International Society for Heart & Lung Transplantation (ISHLT) Meeting and Scientific Sessions in Orlando, Florida. Liquidia is pursuing approval of LIQ861, an inhalation dry powder formulation of treprostinil that is produced using its PRINT® Technology, as an alternative to current inhaled treprostinil therapy for the treatment of patients with pulmonary arterial hypertension (PAH) (WHO Group 1).
“The two-month results of the INSPIRE trial are promising for patients with PAH. Inhaled therapy offers the benefit of getting drug directly to the lungs and we are encouraged that the safety, tolerability and quality of life metrics suggest that LIQ861 is an attractive and more convenient therapy versus the currently available inhaled therapies,” said Dr. Hill.
In March 2019, Liquidia reported two-month top-line results of the Phase 3 INSPIRE study, which indicated that the study had met its primary endpoint of safety and tolerability of LIQ861 in (PAH) patients. The ISHLT presentation, “INSPIRE: A Phase 3 Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of LIQ861 in PAH,” provides detailed results on the treatment emergent adverse event (TEAE) profile, duration of treatment by group (including those adding LIQ861 to non-prostacyclin oral therapy and those transitioning from Tyvaso®*) along with the performance of LIQ861 against exploratory endpoints such as patient quality of life metrics.
“We are continuing to demonstrate the potential benefits of LIQ861 as we present additional data from the INSPIRE trial,” said Neal Fowler, Chief Executive Officer of Liquidia. “LIQ861 is a convenient inhaled therapy that effectively manages PAH with excellent safety and tolerability. It’s our belief that LIQ861 can help PAH patients more easily manage their disease, and more importantly, the quality of their lives.”
Agbiotech Evogene Starts Med Cannabis Unit, CEO Sees ‘Significant Impact’
It’s not unusual these days to see agri-tech and biotech stocks jumping on the cannabis bandwagon to capitalize on the opportunity presented by the geographically expanding legalization of pot.
What Happened
Israeli biotech Evogene Ltd NASDAQEVGN, which is engaged in research and development for improving crop quality and productivity, announced a new subsidiary Wednesday in a foray into the medical cannabis market: Canonic Ltd.
The company said it will initially focus on creating improved cannabis varieties by tackling problems surrounding yield, stability and specific metabolite composition.
Evogene said the development will be based on the utilization of its Computational Predictive Biology, or CPB, platform.
Why It’s Important
Evogene, with its CPB platform and leadership position in the area of plant genomics, has a significant competitive advantage for the development of next-gen products that address limitations in cannabis cultivation and production, the company said in the Wednesday release.
“Evogene’s cutting-edge genomic technology, alongside our multidisciplinary team of professionals, uniquely positions Canonic to bring to market the most advanced, stable and consistent next-generation medical cannabis products, and I am confident we can make a significant impact in the world of medical grade cannabis,” Canonic CEO Arnon Heyman said in a statement.
What’s Next
Canonic, according to Evogene, will focus on three main product types: high metabolite yield cannabis varieties, stable varieties with consistent metabolite performance and cannabis varieties with a unique metabolite profile tailored to specific medical indications such as post-traumatic stress disorder, severe chronic pain and cancer.
FDA Slates 1st Public Hearing On CBD, Sends Warning Letters To 3 Companies
In what could potentially be a breakthrough for the U.S. CBD market, the Food and Drug Administration announced the first public hearing to obtain more data about CBD products. The announcement comes as the FDA and FTC is sending warning letters to three companies that sell CBD products, accusing them of false advertising.
What Happened
The May 31 hearing is set to obtain scientific data and information regarding the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds.
The regulator plans to obtain information related to health and safety risks of CBD; manufacturing standards; methods of testing of products containing CBD; how these products are labeled; and how consumers are warned about risks associated with them.
On Tuesday, the FDA and FTC sent joint warning letters to three companies: Nutra Pure, PotNetwork Holdings Inc POTN 1.92% and Advanced Spine and Pain.
The agencies said the companies are falsely advertising CBD supplements, claiming they can treat diseases such as cancer and Alzheimer’s. The companies in question have 15 days to address the issues and notify the FTC.
Why It’s Important
The 2018 Farm Bill signed into law in December legalized hemp and hemp-derived CBD, but also authorized the FDA to regulate CBD products.
This creates a problem because CBD is an active ingredient in an approved drug — GW Pharmaceuticals plc GWPH 0.25%‘s Epidiolex — which means that CBD products violate the FD&C Act and could potentially undermine the drug approval process.
Nevertheless, CBD products have been steadily making their way to the shelves of retailers like DSW Inc. DSW, Walgreens Boots Alliance Inc WBA 0.99%, and CVS Health Corp CVS 1.3%.
Establishing a clear set of regulations for CBD products could remove many uncertainties and incentivize more retailers to start offering CBD products, while consumer packaged goods companies could warm to the space and develop new products.
“We think this is a huge step forward for consumers that are clearly very excited about having CBD included in everything from topicals to infused foods and beverages. You are seeing a surge of businesses coming out with products,” said Tim Moxey, founder of the CBD and cannabis edible company botanicaGLOBAL.
“Having guidelines and rules from the FDA would allow the industry leaders to seriously commit to introducing hemp-derived products that consumers are already familiar with in states that have cannabis existing laws.”
What’s Next
The FDA said it does not intend for the May 31 hearing to result in any decisions or regulatory action, but expects the event to be an “important step” in the agency’s continued evaluation of cannabis and cannabinoids in FDA-regulated products.
“I anticipate that the FDA will decide to stop throwing up the red flags about using CBD in food due to safety concerns,” Celeste Miranda, CEO of MACE Media and CBD Expo Tour, told Benzinga.
“I think they will hit hard on testing and proper labeling as well as rigid standards on making no claims.”
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