MediciNova, Inc. announced that it has received a Notice of Allowance from the Chinese Patent Office for a pending patent application which covers MN-001 for the treatment of hypertriglyceridemia, hypercholesterolemia, and hyperlipoproteinemia. Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than July 2034. The allowed claims cover the use of MN-001 for reducing a triglyceride blood level, the use of MN-001 for reducing a total cholesterol blood level, and the use of MN-001 for reducing a low density lipoprotein blood level. The allowed claims cover oral administration including liquid and solid dosage forms. Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc. commented, “We are very pleased to receive notice that this new patent will be granted and we believe it could substantially increase the potential value of MN-001. Although we have an existing patent that covers the polymorphic form of MN-001 in China, this will be the first method of use patent granted in China for MN-001. We have recently been granted two patents which cover MN-001 for hypertriglyceridemia, hypercholesterolemia and fibrotic diseases in Japan. With these three new patents, we are planning to expand our development efforts in Asia.”
Thursday, April 4, 2019
Wednesday, April 3, 2019
Most with substance abuse, mental health disorders go untreated: GAO
A federal report found no generally accepted estimate of downstream healthcare costs associated with untreated behavioral health conditions.
KEY TAKEAWAYS
A SAMHSA survey found that more than 80% or respondents who reported a mental health or substance abuse problem said they did not perceive a need treatment.
SAMHSA found that people who perceived a need for behavioral health treatment but did not receive it blamed cost, stigma, and access challenges, such as not knowing where to go for treatment.
Nearly 57 million adult Americans have a substance abuse or mental health condition, and nearly 40 million of them go untreated, according to data cited by the Government Accountability Office.
“Not treating behavioral health conditions can lead to other health care costs, such as the costs of emergency care for an overdose,” GAO said in a recent report. “However, GAO found that research on such costs is limited and there is no generally accepted estimate of all the healthcare costs associated with untreated behavioral health conditions.”
Citing 2017 survey data from the Substance Abuse and Mental Health Services Administration, more than 80% or respondents who reported a mental health or substance abuse problem said they did not perceive need treatment.
A further breakdown of SAMHSA survey results showed that:
- Of the 18.7 million people with substance abuse disorders, 17.2 million are untreated.
- Of the 11.2 million people with serious mental illness, 3.7 million are untreated.
- Of the 35.4 million people with other mental illness, 22.9 million are untreated.
The SAMHSA survey found that people who perceived a need for behavioral health treatment but did not receive it blamed cost, stigma, and access challenges, such as not knowing where to go for treatment.
GAO said a review of existing literature on untreated substance abuse and behavioral health could not provide any downstream cost estimates.
“According to experts GAO met with, available research in this area is limited by methodological challenges, including determining which healthcare costs can be attributed to an untreated behavioral condition, and by limited data on the full prevalence of certain behavioral health conditions,” the report said.
The 29 studies GAO reviewed for the report compared the healthcare costs associated with treating and not treating certain behavioral health conditions in adults focused more on specific behavioral health conditions and specific geographic areas.
Depression device maker Brainsway sets terms for $30 million US IPO
Brainsway, which sells medical devices that use magnetic stimulation to treat depression and OCD, announced terms for its IPO on Wednesday.
The Jerusalem, Israel-based company plans to raise $30 million by offering 2.5 million ADSs at a price of $11.94, the as-converted last close of its shares listed on the TASE ($5.97), at two shares per ADS. At $11.94, Brainsway would command a fully diluted market value of $129 million.
Brainsway was founded in 2003 and booked $16 million in sales for the 12 months ended December 31, 2018. It plans to list on the Nasdaq under the symbol BWAY. Cantor Fitzgerald, Raymond James and Oppenheimer & Co. are the joint bookrunners on the deal.
NASH biotech NGM Biopharmaceuticals prices IPO at $16, high end of range
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.
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.
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