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Monday, January 14, 2019

Five Prime to Present at 2019 Gastrointestinal Cancers Symposium


 Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating Bemarituzumab and mFOLFOX6 in Advanced Gastric and Gastric Esophageal Junction (GEJ) Cancer 
 Trial Design of a Randomized Phase 2 study of cabiralizumab + nivolumab ± chemotherapy in advanced pancreatic ductal adenocarcinoma 
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, today announced two upcoming presentations at the 2019 Gastrointestinal Cancer Symposium being held in San Francisco, January 17-19, 2019. Data will be presented from the Phase 1/3 FIGHT Study evaluating bemarituzumab and mFOLFOX6 in advanced gastric/GEJ cancer. The study design of the randomized phase 2 study of cabiralixumab in combination with nivolumab and chemotherapy in advanced pancreatic ductal adenocarcinoma will also be presented. Here are the details of the two poster presentations:
Title:Phase 1 Results from the Phase 1/3 FIGHT Study Evaluating bemarituzumab and mFOLFOX6 in Advanced Gastric/GEJ Cancer
Abstract Number:Board J1, Abstract #91
Poster Session:A – Cancer of the Esophagus and Stomach
Date & Time:Thursday, January 17, 19, 11:30-1pm and 5:30-6:30pm
Title:A Randomized Phase 2 Study of cabiralizumab (cabira) + nivolumab (nivo) ± chemotherapy (chemo) in Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Abstract Number:Board Q4 Abstract #TPS465
Poster Session:B – Pancreatic, Small Bowel, Hepatobiliary
Date & Time:Friday, January 18, 2019, 11:30-1pm and 5:30-6:30pm
The poster abstracts will be available on January 14, 2019 at 5:00 PM EST at the ASCO Meeting Library and the posters can be found on Five Prime Therapeutics’ Scientific Publications page after presentation at the conference.

Mednax upgraded to Buy from Neutral at Citi


https://thefly.com/landingPageNews.php?id=2848586

Osteopathic Medical Schools Graduate a Record Number of New Physicians in 2018


With one in four American medical students choosing to attend an osteopathic medical school, the American Osteopathic Association reports a record 6,504 new osteopathic physicians graduated in 2018.

In total, the newly published 2018 Report on the Osteopathic Medical Profession found 114,425 osteopathic physicians (DOs) in the United States and nearly 31,000 students enrolled in a college of osteopathic medicine. Nearly 22,000 new DOs participated in residency training, which is required for licensure and independent practice, during the 2017-18 academic year, according to the report.
“The growth of our profession is important to the overall health care system, which is feeling the impact of a widening physician shortage, particularly in rural and underserved areas,” said William S. Mayo, DO, American Osteopathic Association president. “Currently, 65 percent of practicing DOs are younger than 45 and our numbers have tripled over the past three decades. These rising osteopathic physicians will serve patients in their communities for multiple generations.”
A majority of DOs, about 57 percent, trained in primary care specialties, including family medicine, internal medicine and pediatrics. A September 2018 editorialpublished in the Journal of the American Medical Association found a quarter of family medicine residency positions were filled by DOs, concluding that “graduates of osteopathic schools are disproportionately helping to fill the gap in primary care.”
About 20 percent of DOs also choose to work in medically underserved areas or with underserved populations, adding to the overall impact of the osteopathic profession, Dr. Mayo added.
“As an ophthalmologist and Mississippi native who is proud to care for the people of my home state, I can tell you that physicians in all specialties are needed, particularly in our rural communities. The osteopathic medical schools developed during the last decade are strategically located in areas where they can significantly improve the overall health of their communities by attracting local students who remain in the state after graduation,” Dr. Mayo said.
Key findings from the 2018 report include:
  • 65 percent of practicing DOs are age 45 or younger
  • Women comprise 41 percent of practicing DOs
  • 74 percent of all practicing female DOs have entered the profession within the past 14 years
  • Nearly 50 percent of DOs practice in seven states: PennsylvaniaCaliforniaFloridaNew YorkMichiganTexas and Ohio
  • The top 5 non-primary care practice specialties are emergency medicine, anesthesiology, obstetrics and gynecology, surgery and psychiatry
Currently, the American Osteopathic Association and the Accreditation Council for Graduate Medical Education (ACGME) are transitioning to a single system for training new physicians, known as graduate medical education (GME). At the end of the five-year transition, all new physicians will be eligible to apply for osteopathic and non-osteopathic residencies in every specialty.
Historically, ACGME and AOA maintained separate accreditation systems for residencies and fellowships, although osteopathic physicians could join programs accredited by either organization. The final AOA Match takes place in February 2019.

Baby steps head off a fussy eater


Getting kids to try new foods can become a daily showdown. One promising approach: expose babies early on to varied tastes and textures.
Researchers in Brisbane, Australia, found that experiences when just 14 months old can influence the eating habits that children will exhibit at age 3. And introducing a variety of fruits and vegetables and other types of foods early on is key to a better diet quality later on.
The result: A child who eats more than just chicken fingers and cheese sticks.
For the purpose of the study, the children were exposed to 55 different food items. The researchers found that having a great number of vegetables, fruits and other foods at age 14 months predicted more varied food preferences, higher food intake and less fussiness when the children’s eating habits were re-evaluated at 3.7 years of age.
Babies can start eating  at about 6 months. Once they reach this milestone, don’t hesitate to offer a wide variety of healthy foods in a variety of textures. Ask your pediatrician for guidelines if you’re unsure of the best foods or how to prepare them.
Your baby may already show a preference for one or two foods, but don’t let his or her responses deter you—keep introducing others. According to the American Academy of Pediatrics, it can take up to 15 tries before a child actually accepts a new food.
Also, try different cooking methods. For instance, one day steam carrots. Another day, mash them. Offer different shapes, too, from shreds to slivers. A healthy dip can also make eating more fun.
Keep in mind that young  model parents’ behavior so you should enjoy the same wide variety of foods as you serve them.

Explore further

More information: The American Academy of Pediatrics has detailed information on how to help picky eaters become healthy eaters.

Technology use ‘explains at most 0.4% of adolescent wellbeing’


Researchers at the University of Oxford have performed the most definitive study to date on the relationship between technology use and adolescent mental health, examining data from over 300,000 teenagers and parents in the UK and USA. At most, only 0.4% of adolescent wellbeing is related to screen use—which only slightly surpasses the negative effect of regularly eating potatoes. The findings were published today in Nature Human Behaviour.
“Our findings demonstrate that screen use itself has at most a tiny association with youth mental health,” says lead researcher Professor Andrew Przybylski, Director of Research at the Oxford Internet Institute, University of Oxford. “The 0.4% contribution of screen use on young people’s mental health needs to be put in context for parents and policymakers. Within the same dataset, we were able to demonstrate that including potatoes in your diet showed a similar association with adolescent wellbeing. Wearing corrective lenses had an even worse association.”
In comparison, smoking marijuana and being bullied was found, on average, to have a 2.7 times and 4.3 times more negative association with adolescent mental health than screen use. Activities like getting enough sleep and eating breakfast, often overlooked in media coverage, had a much stronger association with wellbeing than technology use.
The method used by the researchers, called Specification Curve Analysis, revealed the reason there seems to be no firm scientific consensus on screen use and . “Even when using the same datasets, each researcher brings different biases with them and analyses the data slightly differently,” says Amy Orben, College Lecturer at the Queen’s College, University of Oxford, and author on the study. “Of the three datasets we analysed for this study, we found over 600 million possible ways to analyse the data. We calculated a large sample of these and found that—if you wanted—you could come up with a large range of positive or negative associations between technology and wellbeing, or no effect at all.” In other words, “We needed to take the topic beyond cherry-picked results, so we developed an approach that helped us harvest the whole orchard,” adds Przybylski.
In order to remove bias and examine practical significance (rather than ), the researchers used information from other questions in the same dataset to put the statistical findings on screen use in context. “Research’s reliance on statistical significance can yield bizarre ‘results'”, says Orben. “We need to look at the size of the association to make a judgement on practical significance. If you told me the amount of time a teenager spends on , I could not do very well predicting their overall wellbeing, as only 0.4% is associated with technology use.”
“Bias and selective reporting of results is endemic to social and biological research influencing the screen time debate,” says Przybylski. “We need to put scientific findings in context for parents, policymakers and the general public. Our approach provides an excellent template for data scientists wanting to make the most of the excellent cohort data available in the UK and beyond.”
Method:
The data was drawn from three large-scale representative datasets: Monitoring the Future (USA), Youth Risks and Behaviour Studies (USA) and the Millennium Cohort Study (UK), totalling over 300,000 individuals surveyed between 2007 and 2016. The findings were derived using Specification Analysis Curve method, which examined the full range of correlations relating digital technology use to child and adolescent psychological wellbeing. Details on methodology and all necessary code to reproduce the analysis are available in the paper’s supplementary material.

Explore further

More information: The association between adolescent well-being and digital technology use, Nature Human Behaviour (2019). DOI: 10.1038/s41562-018-0506-1 , https://www.nature.com/articles/s41562-018-0506-1

Buprenorphine Prescribing Restrictions Threaten Progress in the Opioid Epidemic


The American opioid epidemic is like no other drug crisis in history, spanning all ages and socioeconomic classes. We emergency physicians have unique access to patients with opioid use disorder, yet few of us are able to treat patients after an opioid-related overdose with medications such as buprenorphine in the emergency department (ED).[1,2,3,4,5,6] Federal restrictions on prescribing medication-assisted therapies (MATs) are largely to blame.
Multiple studies have shown that MATs, such as buprenorphine, significantly reduce mortality and illicit opioid use.[2]Unfortunately, many persons with opioid abuse disorder do not have access to these potentially life-saving therapies. The Drug Addiction Treatment Act (DATA), passed by Congress in 2000, limits the availability of MATs by mandating that physicians obtain a waiver from the Drug Enforcement Administration (DEA), known as the “X-waiver,” which effectively hamstrings their capacity to respond to this crisis.[5]
The waiver is particularly rare among emergency physicians, with less than 1% participating in the program.[5] Opioid overdoses and withdrawals are treated on a daily basis by most ED physicians in the United States, and the rates of these visits continue to rise. For instance, opioid-related ED visits increased 30% from 2016 to 2017.[7]
To obtain the waiver, physicians must pay $200 for an 8-hour training course. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the US Department of Health and Human Services, only about 5% of all physicians have completed the process, most of whom are family physicians and psychiatrists. After obtaining the X-waiver, physicians can treat only 30 patients in the first year, and then they must reapply to treat more patients.
To ensure compliance with the limit on patient numbers, physicians are subjected to additional oversight by the DEA, and they must keep track of all the patients they are treating with MATs. This requirement was designed for outpatient specialties that monitor and treat patients for extended periods, but these restrictions are impractical and burdensome in the ED because emergency physicians do not manage patients after discharge.

Why Aren’t More Patients Receiving MAT After Opioid-Related Overdoses?

Emergency medicine needs to be a larger part of the solution in the opioid epidemic. The legislation needs to better reflect the standards of emergency medicine if broad utilization is desired. In 2000, when the DATA legislation was created, no one could have anticipated the severity of the epidemic to come. The time has come to eliminate counterproductive restrictions and make the legislation more inclusive to all medical specialties.
In a recent study published in Annals of Internal Medicine , of 17,568 patients, only 30% of them were receiving an MAT after an opioid-related overdose.[4]This is shockingly low, considering that the risk for a deadly overdose is markedly higher in individuals who have previously overdosed.[4]
SAMHSA has been outspoken regarding the underutilization of MATs. The current secretary of the Department of Health and Human Services, Alex Azar, told the National Governors Association that not offering MAT for opioid addiction is like “trying to treat an infection without antibiotics.”[1]
The X-waiver has also created a significant disparity between counties and states. The Healthcare Cost and Utilization Project statistical report in 2016 showed that more than half the counties in America have no provider with the X-waiver, and the majority of authorized providers actually treat few or no patients.[8] With most US counties having no physicians able to prescribe MATs, more than 30 million people do not have access to buprenorphinetreatment.[7]
Opioid-related visits to the ED have increased 99.4% over the past decade.[7]Detox, one of the alternatives an ED physician has to discharging a patient who is in withdrawal, usually provides a short period of MAT while inpatient. However, this often isn’t an option, owing to overcrowded facilities and strict requirements for patient participation.
Detox has also been shown to be ineffective in preventing patients from illicit opioid use after discharge. A survey published in the Journal of Substance Abuse Treatment of 164 patients who had inpatient opioid detoxification reported a 27% relapse rate the day they were discharged, 65% within 1 month, and 90% within 1 year.[2] Despite 63% reporting that they wanted to continue MAT, these medications are generally not prescribed upon discharge.

A Strong Argument for Considering Buprenorphine

Starting a patient with opioid abuse disorder on buprenorphine upon discharge has repeatedly shown to be a critical step for patients who seek treatment in the ED. A randomized trial, published in JAMA, of patients discharged from the ED with a prescription for buprenorphine showed a decrease in illicit opioid use from 5.4 days per week to less than 1 day per week compared with patients who received only a single dose of buprenorphine while in the ED.[3]
Initiating buprenorphine therapy not only decreases opioid abuse in the short term, but also has long-term implications for a patient’s recovery. Engagement with comprehensive addiction treatments is the most important action a patient can take for long-term success. In 2017, 290 patients who were initiated on buprenorphine from the ED were found to have increased engagement with addiction treatment and reduced illicit opioid use during the 2-month study period.[2,3] Seventy-four percent of patients who were referred to an addiction treatment center and were also initiated on buprenorphine from the ED followed through with formal addiction treatment.[3] These were significantly higher rates compared with patients who only received referral to a treatment center (53%) or only received brief counseling in the ED (47%).
Buprenorphine is more than a substitute for more dangerous opioids. It is a bridge to thorough treatment after an opioid-related ED visit. A near-death overdose is a strong motivator for getting treatment, and without MAT, most patients will go right back to using when withdrawals begin. Restarting illicit drugs puts patients back in the same cycle of using, extinguishing all momentum and motivation toward treatment.
The current administration is allocating billion dollars to fight the opioid crisis, when increasing accessibility comes down to one critical action: lifting the DATA waiver for emergency physicians to prescribe MAT.
The ED does not need to become a glorified Suboxone® clinic; however, emergency physicians need to play a larger role in fighting the opioid epidemic. Physicians have a responsibility to familiarize themselves with the indications, contraindications, side effects, and drug interactions of all medications they prescribe, and MAT is no different. Emergency physicians across the country treat opioid use disorder every day, and training should be part of residency. The current model of optional training, which is required to appropriately treat a condition, has proven ineffective.
The DEA X-waiver has proven to significantly limit the emergency physician’s role in fighting the opioid epidemic. MAT education should be integral to residency training in emergency medicine, and the restrictive DEA waiver should not apply to the specialty. The opioid epidemic is costing the country billions of dollars, and people are dying at an unprecedented rate. Changing the restrictions to increase MAT use will decrease the immense strain on healthcare and save thousands of lives.
Comments:
Dr. Vivian Hasbrook|  Psychiatry/Mental Health
As several of the other commenters have mentioned there is more to treating opioid addiction than just “giving a script of Suboxone”. It is necessary that it is initiated properly and the dose adjusted individually to the point that they are not having any withdrawal symptoms but also not getting a “high”. The success of taking Suboxone also requires fairly strict follow-up with urine drug screens, counseling and groups for support to maximize the best outcome for the patient. This is nothing like prescribing an antibiotic for an infection as the author indicated.
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Dr. BRIAN RAGONA|  Internal Medicine
Ed physicians should not be allowed to prescribe suboxone or its equivalents as there needs to be a prescribed period of abstinence from the patient’s opiate of choice
this may be at a minimum of 24 hours post the patient’s last dose of the opiate in the case of short acting medications or as long as 48-72 hours for longer acting opiates.
I doubt that there is and ED MD that can substantiate this type of use and safely prescribe the medication
The waiver and its required reading covers the initiation of medication and appropriate follow through
I think that the 200 dollar fee is appropriate considering the waiver is and add on to our DEA licensing this does not speak to the fact of the sparcity of qualified individuals who should prescribe the medication but these physicians should be familiar with the medication and be able to facilitate its safe and affective use I strongly agree with Dr. Mike Atkins comments
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brianne fitzgerald|  Nurse Practitioner (NP)
“Why don’t more prescribers offer buprenorphine”??? Good question.  In my experience it is minimally helpful.  It is abused and sold on the street.  In detox we are regularly seeing folks come in “on suboxone” to be treated for opioid/alcohol/benzo withdrawal and at the same time they tell us “I don’t want to use my suboxone, I will just detox from everything here”.  The consensus is that they are squirreling up there strips to sell upon discharge and then go back to their outpatient provider for yet another script.  Over 90% of patients I see in detox refuse to provide an ROI so that I may speak with their prescribing doctor.sold.  The dosing regimen is ridiculous, some are prescribed it 3x a day and the doses are also too high.  Just ask your patients
Dr. craig turner|  Urology
ED prescribing makes sense if there is a clear handoff to a provider that will continue the care. Patients are not “cured” of the addiction with medication. It is a major part of overall treatment that must continue for sometime.
Sending an addict out the door with no follow-up and an rx worth at least $10 a pill on the street needs to be avoided.
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Dr. MIKE ATKINS|  Internal Medicine
The author may not be aware (or at least did not mention) –  an ER physician in the United States can currently legally dispense buprenorphine to a patient with opioid use disorder in withdrawal.
Notice – “dispense”, not “prescribe”
there is a significant difference, and it is outlined in the SAMHSA ” 3 day rule”.
The three day rule is well thought out, the patient in withdrawal on Friday night can be dispensed buprenorphine on Friday in the ER, Saturday in the ER, and Sunday in the ER, with arrangements made for follow up in a MAT program the following week ( it doesn’t have to be Monday).
I would strongly recommend to the author, and any ER physician considering buprenorphine dispensing, or prescribing – take the 8 hour course. Read every article you can on the topic. Learn as much as you can before dispensing, or as I advise the ER docs in my area – call a physician experienced in MAT, and follow their advice for the patient in your ER.
It’s one thing to have the ability to prescribe an opioid buprenorphine to a patient with opioid use disorder.
It is quite another thing altogether to have the knowledge as to how and when one should prescribe buprenorphine, vs. alternatives to a patient with opioid use disorder. Not everyone who shows up in the ER with opioid use disorder should be given buprenorphine. Yes, you can make things worse, as in 3 days in the ICU on a ventilator worse. Seen that, never done that. (References available on request)

After cruise outbreak, passengers might feel ill (again) when they eye recourse


After an outbreak of gastrointestinal illness on Royal Caribbean’s Oasis of the Seas sickened hundreds of passengers, the cruise line has offered travelers full refunds for the cost of the cruise fare.
But cruise passengers generally have very little recourse if they get sick during a vacation.
The Oasis of the Seas returned to Port Canaveral, Fla. on Saturday, a day earlier than scheduled, after gastrointestinal illness sickened 277 guests and passengers since the ship departed on Jan. 6, Royal Caribbean told MarketWatch. That number reportedly grew to nearly 500 people since then.
In a somewhat unusual move, the cruise line has decided to provide travelers with full refunds of their paid cruise fares. The 7-night Western Caribbean voyage on the Oasis of the Seas starts at $626 per person before taxes and fees for an interior stateroom.
In addition to a full refund of the cruise fares, a letter allegedly delivered to the ship’s passengers noted that the company will provide up to $200 per person for re-booked domestic flights, up to $400 per person for international flight change fees or up to $200 per stateroom for one night’s stay at a hotel. Consumers need to contact Royal Caribbean to receive those reimbursements.
The company did not immediately confirm whether the letter was accurate.
The cruise line also said it will be refunding internet and beverage packages and prepaid gratuities on a prorated basis for the day the cruise won’t be sailing.
Passengers have noted in message boards on the travel site Cruise Critic that the ship’s crew was taking extra precautions to prevent further spread of the illness, including extra cleaning of public areas and preventing passengers from serving themselves at the buffets.
Still, some passengers have expressed frustration with the experience while the ship was still at sea. “This is just crazy. We’re hunkered down in our room because I’m so scared of getting sick,” Cruise Critic member Raycin posted. “This is our first cruise in 15 years and will most likely be our last.”
A spokesman for Royal Caribbean said the early return was designed, in part, to give the company more time to clean and sanitize the ship before its next sailing.
“We think the right thing to do is to get everyone home early rather than have guests worry about their health,” Owen Torres, corporate communications manager at Royal Caribbean, said in an email.
“Our guests sail with us to have great vacations, and we are sorry this cruise fell short,” he added.
In recent years, outbreaks of gastrointestinal illness have become less common. Last year, there were only 11 confirmed outbreaks, according to the Centers for Disease Control and Prevention, which left only 658 people ill.
Of those 11 outbreaks, only five were confirmed to be norovirus, one of viruses that most commonly causes gastroenteritis, which is the lowest figure in years.
“Considering 28 million took a cruise in 2018, the number of those who reported ill was a tiny fraction of those who took a cruise,” said Ben Souza, editor of travel website Cruise Fever.
Here is what cruise passengers need to know about what they can do if they get sick on a cruise:
Don’t expect a refund — even if you get norovirus
Cruise lines are under no obligation to provide a refund, said Colleen McDaniel, executive editor at Cruise Critic. Typically, they will provide compensation in the form of cruise credits for future sailings or onboard credit for the remaining duration of the cruise.
The choice to offer a full refund was somewhat unusual on Royal Caribbean’s part, as a result. “Cruise lines look at this sort of thing on a case by case basis and how disruptive this was to passengers,” McDaniel said. Given that Oasis of the Seas had to skip two ports of call and return a day early, McDaniel said it was abundantly clear to Royal Caribbean that the illness outbreak adversely affected passengers’ experience even if they weren’t sick.
The company would not confirm what it has offered in the case of previous gastrointestinal illness outbreaks. But Miami-based cruise-industry lawyer Jim Walker said that following a large outbreak on the Explorer of the Seas back in 2014, Royal Caribbean only offered a 50% refund on the cruise fare and a 50% credit toward a future cruise.
“In most cases the cruise line will not offer any compensation, implying that it is the customers’ fault for not washing their hands, even though the CDC and the FDA state that contaminated food or water are the most common explanations for norovirus,” Walker said.
Arguing for more in compensation can also be something of a fool’s errand. Walker said his law firm doesn’t even take on cases involving these outbreaks. “Don’t call us if you get sick on a cruise,” he said. “Establishing where the virus came from, or that the cruise line was negligent, is virtually impossible to prove.”

Consumers’ best avenue for compensation is through travel insurance
Moreover, those who did fall ill while on board could be on the hook for the cost of any medical treatment they’ve received.
“Incidents like this illustrate why it’s a good idea to consider buying travel insurance before you go,” said Christine Sarkis, deputy executive editor of the travel site SmarterTravel.com.
For example, a travel-insurance policy with trip interruption coverage would help passengers defray the cost of returning home early. Other policies may also cover the expenses associated with medical treatment and an emergency evacuation from the ship if they are hospitalized while traveling.
Additionally, refunds like the one Royal Caribbean offered don’t always cover additional travel expenses incurred, such as rebooking airfare.
While on the ship, wash your hands
Passengers’ experience on the Oasis of the Seas is a strong reminder of the need to exercise good hygiene when traveling.
“Wash your hands,” McDaniel said. “Wash them before you eat, and wash them after you use the restroom.” That could help prevent the spread of illness, but may not be so helpful, however, if the contamination came from the kitchen.
Buffets can be a hotbed of germs: If you see someone grab food from the buffet with their hands rather than a utensil, they should notify the ship crew to ensure that the potentially-tainted food is disposed.