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Thursday, July 4, 2019

Hanging in the Balance: Reports Aim to Propel Obesity Care Forward

Two brief “cutting edge reports” in the July issue of Obesity propose training competencies for medical students and care standards for practitioners for treating patients with obesity, which one expert hopes will help drive the field forward.
“Hopefully, the prescribed standards of care and training competencies in this issue of Obesity will result in reformation of our systems for obesity healthcare delivery and medical education,” W. Timothy Garvey, MD, professor of medicine, Department of Nutrition Sciences, University of Alabama at Birmingham, writes in a commentary that accompanies the two reports.
The first report outlines a set of 32 obesity-focused competencies to be taught and assessed in medical education programs for graduate and undergraduate medical students and for advanced practice nurses and physician assistants.
The second report is a proposed standard of obesity care for all providers and payors.
The two articles, says Garvey, “constitute landmarks that will impel the evolution of healthcare for patients with obesity.”

32 Obesity Care Competencies to Be Taught in Medical School

The first article is by Robert F. Kushner, MD, Northwestern University Feinberg School of Medicine, Chicago, Illinois, and colleagues, on behalf of the Obesity Medicine Education Collaborative (OMEC) — an intersociety initiative spearheaded by three societies, The Obesity Society (TOS), American Society for Metabolic and Bariatric Surgery (ASMBS), and OMA, involving 15 medical societies* overall and endorsed by 20 societies.**
OMEC’s aim is to develop obesity-focused competencies and benchmarks for medical education programs.
A task force of representatives from the 15 medical societies developed 32 competencies in obesity care, internally reviewed them, adjusted them after a consensus-building process, and then sent them for external review and feedback from 16 other societies.
The competencies were developed to “standardize the process of evaluating obesity-related competencies across medical school, residency, fellowship, advanced practice nursing, and [physician assistant] training programs,” according to Kushner and colleagues.
There is a need for such a document because “a major challenge facing medical educators today is adequately training current and future healthcare providers in the prevention and treatment of obesity,” said Kushner, past president of TOS, in a statement from the organization.
The competencies, he said, “provide the framework to improve provider education and thus also improve patient care in the treatment of obesity.”
The 32 competencies cover six areas: practice-based learning and improvement (5 competencies), patient care and procedural skills (5), system-based practice (4), medical knowledge (13), interpersonal and communication skills (3), and professionalism (2).
Examples of competencies that students need to master are:
  • “Elicits comprehensive obesity-focused medical history.”
  • “Applies knowledge of obesity treatment guidelines to the development of comprehensive, personalized obesity management care plan.”
  • “Uses appropriate language…that is nonbiased, nonjudgmental, respectful, and empathetic when communicating with patients with obesity.”

Charting a Course for the Training of Healthcare Professionals

Ethan Lazarus, MD, FOMA, a weight loss physician at the Clinical Nutrition Center, Denver, Colorado, and vice president of the OMA, says a 2016 American Medical Association report showed obesity training is neither consistent nor comprehensive.
“OMEC represents a big step forward in filling these significant educational gaps and is provided as a free tool*** that can be used at all levels of medical education,” he notes in a statement from OMA.
Wendy Scinta, MD, FOMA, OMA president, agrees, noting: “For years, obesity has been misunderstood,”
“The goal of our multidisciplinary and multisociety effort is to remove bias and ensure obesity is appropriately understood as a disease by healthcare professionals in medical school, residencies, fellowships, and beyond. These competencies set the bar for obesity education and will immensely benefit patients with obesity and their providers,” she emphasizes.
Garvey writes in his commentary that the OMEC’s “groundwork provides a formidable stimulus” and “charts a course for the training of physicians, physician assistants, and advanced practice nurses in obesity medicine” that is “much needed.”
And although these competencies are aimed at MDs, doctors of osteopathy, nurse practitioners, and physician assistants, “this structure could readily be adopted in the training of other important professional members of the obesity care team including dietitians, educators and behavioralists, exercise therapists, and clinical psychologists,” he adds.
He also notes that the reader is referred to a website for access to the proposed evaluation scheme for all stated competencies.

STOP: Proposed Standards of Obesity Care Represent “Quantum Leap”

The second article is by William H. Dietz, MD, PhD, and Christine Gallagher of the Milken Institute School of Public Health, George Washington University, Washington, DC, representing the Strategies to Overcome and Prevent (STOP) Obesity Alliance, which aims to provide health professionals, payors, community organizations, policymakers, and those affected by obesity with guidance on foundational components of evidence-based obesity care.
STOP has members from business, consumer, government, advocacy, and health organizations. It held three roundtable meetings to develop the standards of care for treating adults with obesity in the community and in a clinical setting.
“Our goal,” Dietz said in the TOS statement, “was to develop a practical, tangible, measurable, and simple standard of care for the treatment of adult obesity across care settings and representing practices that positively impact the health of people impacted by obesity.”
The standards are intended to augment published guidelines developed for obesity care providers, according to Dietz and Gallagher, and “to be implementable and acceptable to payors.”
“The core principles…include shared decision-making,” which includes the involvement of patients in developing treatment plans, and help on “when to use adjunctive therapies and when to move patients to higher intensity treatments, as well as providing assurance that patients have access to appropriate levels of care, regardless of when they enter the healthcare system.”
The standards further state, “Obesity should be treated as a chronic disease” and providers “should be sensitive to bias and language” and “be trained to initiate the conversation about weight.”
Dietz and Gallagher add that clinical providers should recommend an evidence-based dietary strategy and appropriate levels of physical activity for patients with obesity, minimize the use of medications that may cause weight gain, and when appropriate, discuss and/or prescribe obesity medications and/or refer to bariatric surgery.
Garvey does find some fault with the proposed standards.
“For one thing, [they] do not address obesity prevention. Secondly, they seem to exclude patients with overweight (BMI 25-29.9 kg/m2) from the treatment paradigm,” he observes.
Thirdly, in treating obesity as a disease, “there could be more explicit integration of the presence and severity of obesity-related complications into therapeutic decisions, so risk stratification can serve as a strategy to target more intensive interventions to those at highest risk.”
Nevertheless, “the recommended standards represent a quantum leap forwarding in guiding the formulation of high-quality and evidence-based care of patients with obesity,” he stresses.

Critical First Steps: “Much Hangs in the Balance”

Garvey summarizes in his commentary, “At the heart of this issue is the bias that obesity is a lifestyle choice and not a chronic disease that merits the full force of a medical model for prevention and treatment.”
“This bias is in abject contradistinction to scientific evidence but, nevertheless, is prevalent among the lay public, many healthcare professionals, and regulators. The result is a lack of access by patients to evidence-based therapies in our healthcare systems.”
Taken together, “the two papers do not even begin to address what will be necessary to promote the prepared patient, nor efforts needed for obesity prevention requiring changes in the built environment, food supply, and messaging for a healthier lifestyle.”
Nevertheless, “these are critical [first] steps in the evolution of a comprehensive care model for obesity treatment and prevention.”
“Much hangs in the balance,” he concludes.
*American Association of Clinical Endocrinologists (AACE), American College of Obstetricians and Gynecologists, American Association of Nurse Practitioners (AANP), American Academy of Physician Assistants (AAPA), American College of Lifestyle Medicine, American College of Preventive Medicine, American Osteopathic Association, American Association of Colleges of Osteopathic Medicine, American Society for Nutrition, Endocrine Society, Society of Behavioral Medicine, and Society of General Internal Medicine.
**The obesity competencies for medical education were endorsed by the AAPA, AACE, AANP, American Board of Obesity Medicine, ASMBS, American College of Surgeons, Association for Bariatric Endoscopy, American Medical Woman’s Association, AND, American College of Osteopathic Pediatricians, American Society for Gastrointestinal Endoscopy, Endocrine Society, Obesity Action Coalition, OMA, Society of General Internal Medicine, Society of Behavioral Medicine, Society of Teachers of Family Medicine, TOS, World Obesity Federation, and Obesity Canada.   
***More information about adopting OMEC competencies can be obtained by contacting: omec@obesitymedicine.org
The authors of the report on “obesity competencies for medical education” have no relevant financial disclosures. The report on the “proposed standard of obesity care for all providers and payors” was funded through a research grant from Novo Nordisk. Dietz has reported serving on the scientific board for Weight Watchers. Gallagher has reported no relevant financial relationships. Garvey has reported receiving personal fees from Sanofi, Novo Nordisk, Amgen, American Medical Group Association, BOYDSense, and Gilead, and grants from Merck, Pfizer, Novo Nordisk, Astra Zeneca, and Sanofi outside the submitted work
Obesity. 2019;27:1045-1047, 1059-1062, 1063-1067. Report 1, Report 2, Commentary
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Medicare recipients may pay more for generics than brand-name counterparts

Medicare Part D enrollees may pay more out of pocket for high-priced specialty generic drugs than their brand-name counterparts, according to new research by health policy experts at Vanderbilt University Medical Center and the University of North Carolina at Chapel Hill.
Researchers examined differences in brand-name and generic or biosimilar drug prices, formulary coverage and expected out-of-pocket spending across all of the Medicare Part D plans available in the U.S. in the first quarter of 2018.
The study, published in the July issue of Health Affairs, found that current Medicare Part D beneficiaries can have higher out-of-pocket spending for generics than their branded counterparts if they use expensive specialty drugs and if the price differences between brands and generics are not large. This can be common for individuals prescribed specialty drugs typically used to treat rare or complex conditions such as cancer, rheumatoid arthritis or multiple sclerosis.
Ironically, even if we assume that generic drugs have lower list prices than brands, for Medicare beneficiaries with $20,000 to $80,000 in annual drug spending, using only brand-name drugs could actually save them money.
This is happening because branded drug manufacturers now pay a discount in the donut hole, which gets counted as out-of-pocket spending. This helps patients reach catastrophic coverage faster, where they pay 5% of the drug’s price instead of 25%. Generic drug makers do not pay these same discounts, so patients have to spend more of their own money to make it to the catastrophic phase of the benefit.”
Stacie Dusetzina, PhD, associate professor of Health Policy and Ingram Associate Professor of Cancer Research at VUMC, the study’s lead author

In 2019, this means people using brand-name drugs who reach the donut hole, or coverage gap, have to spend $982 to get to the catastrophic coverage phase. People using generic drugs have to spend $3,730 to reach that point. The study also notes policy changes set to take effect in 2020 will only make the situation worse by increasing patient out-of-pocket spending requirements for the catastrophic phase coverage from $5,100 to $6,350.
In response, the Trump administration and the Medicare Payment Advisory Commission (MedPAC) have included recommendations to exclude the manufacturer discount from out-of-pocket spending calculations.
“While this would level the playing field between generic drugs and brands, it would do so by making brand-name drugs more expensive instead of making generic drugs less expensive,” said Dusetzina. “Congressional committees have signaled interest in addressing this and other issues in Medicare Part D, including placing a cap on out-of-pocket spending.
“The Part D benefit needs a redesign so that it works for people needing expensive drugs. I hope Congress will take this opportunity to make changes to Part D, including making sure that generic drug users aren’t overpaying for these drugs.”
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Quorn protein builds muscle better than milk protein

A study from the University of Exeter has found that fungus-derived mycoprotein, the protein-rich food source that is unique to Quorn products, stimulates post-exercise muscle building to a greater extent than milk protein.
The study evaluated the digestion of protein, which allows amino acids (the building blocks of protein) to increase in the bloodstream and then become available for muscle protein building in 20 healthy, trained young men at rest and following a bout of strenuous resistance exercise.
The young men performed the exercise and were then given either milk protein or mycoprotein.
Their muscle building rates were then measured using stable isotope labelled “tracers” in the hours following protein consumption.
Animal proteins like milk are an excellent source for muscle growth, so they provide a useful comparison for testing other protein sources.
The results showed that while those who ingested milk6 protein increased their muscle building rates by up to 60%, those who had mycoprotein increased their muscle growth rates (MGRs) by more than double this — showing that mycoprotein, the main ingredient in all Quorn products, is a more effective source of protein to promote muscle growth.
“These results are very encouraging when we consider the desire of some individuals to choose non-animal derived sources of protein to support muscle mass maintenance or adaptations with training,” said Dr Benjamin Wall, Associate Professor of Nutritional Physiology, University of Exeter.
“Our data show that mycoprotein can stimulate muscles to grow faster in the hours following exercise compared with a typical animal comparator protein (milk protein) — we look forward to seeing whether these mechanistic findings translate to longer term training studies in various populations.”
Tim Finnigan, Chief Scientific Adviser for Quorn Foods, said “We’re excited to see this data being presented by the University of Exeter at ECSS. In a world where many people are trying to cut back on their meat consumption, either for environmental or health reasons, we’re happy to be able to offer an alternative protein that can provide exceptional nutrition and muscle growth, all while being meat-free.”
Recent research has suggested that current recommendations for protein intake are too low — some scientists have calculated that minimum protein requirements could have been underestimated by as much as 30-50% in some populations.1
The British Nutrition Foundation already recommends mycoprotein as a good source of dietary protein, both for everyday life and for sport and exercise.
However, in the UK roughly a third of total protein consumption comes from meat products — and increasing meat intake may have serious consequences for public health and for the environment.
A pivot to “alternative” sources of protein therefore may be advisable — and mycoprotein is well placed to fill the gap.
Story Source:
Materials provided by University of Exeter. Note: Content may be edited for style and length.
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DOJ asks Congress to permanently classify fentanyl-like drugs

A temporary order classifying fentanyl-like drugs as controlled substances should be enacted into law, the U.S. Department of Justice is telling Congress.
The order—which was enacted in 2018 on an emergency basis and expires in February 2020—tightened controls on fentanyl-like drugs, which had skirted federal law because their chemical makeup is slightly different than the opioid fentanyl, which is about 100 times stronger than morphine, CBS News reported. Fentanyl-like drugs can be even stronger.
“From a policy and regulatory perspective, fentanyl-like substances need to be permanently scheduled as a class,” said Katie Crytzer, the acting deputy assistant attorney general in the Office of Legal Policy at the Department of Justice, CBS Newsreported. The  is an “urgent and necessary first step,” she told reporters Monday.
Of the more than 70,000  in the U.S. in 2017, nearly 48,000 were caused by opioids, and about 29,000 by fentanyl or fentanyl-like , according to U.S. Centers for Disease Control and Prevention data, said John Martin, assistant administrator of the Drug Enforcement Administration, CBS News reported.
Explore further
More information: CBS News Article
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Soccer headgear may not reduce sport-related concussion

In season-long tests, soccer headgear didn’t reduce the overall number or severity of concussions experienced by high school players, U.S. researchers say.
Some of the five headgear models used in the trial, however, may have been better at reducing impact forces that lead to concussions, particularly among female players, the study authors report in the British Journal of Sports Medicine.
“Female soccer is late to the party in terms of recognizing the number of injuries. So much focus has been on football that we haven’t recognized that females are more at risk for knee injuries and concussions,” said Timothy McGuine of the University of Wisconsin School of Medicine and Public Health in Madison, who led the study.
High school female soccer players have about double the rate of concussions as males, he said, and based on participation numbers, that’s about the same rate reported among football players.
“Athletic trainers at schools have been saying this for years, but we couldn’t get people to take it seriously,” he told Reuters Health in a phone interview. “Now parents tell us their daughters have experienced two or three concussions during a season and missed a month of school.”
Few studies have looked at the efficacy of protective headgear during soccer practices and matches, especially among high school athletes, McGuine noted. So, he and his colleagues studied 2,766 high school players, two thirds of them girls, over two academic years.
The researchers assigned about half the teams to wear headgear during an entire season while the rest did not. Individuals were allowed to choose which headgear model to wear from among five models that met American Society for Testing Materials International standards and were approved for use by the National Federation of State High School Associations.
Licensed athletic trainers at the schools recorded information about concussions and other injuries.

Overall, there were 130 sport-related concussions during the study, with 108 of these in girls. Twelve participants, including 11 girls, were medically disqualified from soccer for the rest of the season. The others spent about five days in a return-to-play protocol and missed about 13 days from soccer during a season.
But there was no difference in rates of sport-related concussions among those who wore headgear and those who didn’t. The number of days lost due to sport-related concussion also didn’t differ between the groups.
“Most safety devices haven’t been studied beyond a company’s lab settings,” McGuine said. “We weren’t able to formally study the brands, but we did see a discrepancy in the rates between different headgear.”
About the same number of players wore a model called the Storelli ExoShield, for example, as wore one called the Ultra Forcefield Sweatband, but half as many concussions were among players wearing the Storelli model.
Future studies will need more in-depth analysis of different types of headgear, which can become expensive to test, McGuine said. Researchers and national soccer associations should work together to discuss rule changes and technique changes to help high school athletes reduce these injuries and concussions in the first place, he added, both for high school teams and local club teams.
“Many schools are required to have athletic trainers who can recognize concussions, but there’s no mandate for clubs to do that, and we’re finding two-thirds of girls don’t have access to the safety or care that they need,” he said. “As a parent, ask your coaches if they’re aware of this and if they do baseline testing.”
As studies continue, parents should consider the risks of sport-related concussion versus the benefits of physical activity and team participation, said Doug Martini of Oregon Health and Science University in Portland, who wasn’t involved in the study

In his own research looking at long-term issues after high school concussions, he didn’t consistently find long-lasting effects, Martini notes. As heading techniques change and concussion protocols improve, the benefits of sport will likely outweigh the risks, he added.
SOURCE: bit.ly/2J9Qdp0 British Journal of Sports Medicine, online May 14, 2019.
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Opioid drug defendants ask Oklahoma judge to end case

The defendants in Oklahoma’s trial against drugmakers are asking a judge to rule in their favour, arguing the state has failed to prove they’re responsible for the opioid epidemic.
Attorneys for consumer products giant Johnson & Johnson and Janssen Pharmaceuticals filed a motion for judgment Wednesday after the state rested its case.
Oklahoma called its last witness on Tuesday, a former sales representative for Johnson & Johnson. The drugmakers’ case is expected to take about four more weeks.
Oklahoma Attorney General Mike Hunter has called Johnson & Johnson and its subsidiaries a “kingpin” responsible for the state’s ongoing opioid epidemic.
Johnson & Johnson attorney John Sparks says the state is seeking damages from the company without any evidence that it caused the problem.
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Using CRISPR to eliminate HIV

Antiretroviral therapy (ART) is the standard of care for HIV. These drugs can prevent HIV from replicating but they can’t clear the virus from the body altogether. Now, in a step closer to a possible cure for the infection, a team of scientists has removed HIV from mice using the CRISPR-Cas9 gene-editing technology and long-acting ART.
HIV integrates its genetic material into the genomes of the host’s cells, which currently available ART can’t target. In a study in Nature Communications, scientists at Temple University and the University of Nebraska Medical Center said the combination of CRISPR and a newly developed ART successfully eliminated HIV DNA from about 30% of infected mice.
Excision BioTherapeutics, a biotech focused on using CRISPR to treat viral infections, has licensed the gene-editing technology from Temple University, with a plan to advance the platform into human clinical trials. Senior author Kamel Khalili, Ph.D., professor and chair of neuroscience at Temple’s Lewis Katz School of Medicine at Temple University, is the founder and principal scientific advisor of Philadelphia-based Excision.
Khalili and his Temple colleagues previously used CRISPR to cut off large fragments of HIV DNA from infected immune cells. However, similar to ART, gene editing alone didn’t completely eliminate HIV. So they figured that a CRISPR-based system could be more effective when the HIV viral load is already controlled at low levels.
For the study, Khalili’s team used a new therapeutic called long-acting slow effective release antiviral therapy (LASER ART), which was co-developed by Howard Gendelman and Benson Edagwa at UNMC. LASER ART packages HIV drugs into nanoparticles that target tissues where latent HIV resides. It dissolves and releases ART slowly, with a higher proportion of the drug entering the circulation, the researchers said. That also helps lessen off-target toxicity.
To test their idea, the team built a mouse model that was engineered to resemble human HIV infection. In two separate experiments, infected mice received either the combination therapy, solo CRISPR or solo LASER ART, or they were left untreated. In the combo group, LASER ART was given used to suppress HIV growth, and then CRISPR was used to eliminate the remaining HIV DNA.
Eight weeks following the last administration of LASER ART and five weeks after the single CRISPR treatment, the animals were observed for evidence of viral rebound. Notably, about one-third of the rodents that got the combo therapy showed no sign of HIV, according to the team. DNA and RNA analysis of the spleen, bone marrow, gut, brain, liver, kidney and lung tissues of the rodents showed no traces of the virus’ genomic material. What’s more, the researchers also found no off-target effects that could be attributed to CRISPR.

The use of CRISPR in HIV stirred up much controversy after Chinese scientist He Jiankui claimed to have used the technology to edit human embryos, resulting in the birth of babies with a mutated form of the CCR5 gene that rendered them resistant to HIV. However, in the current research, CRISPR was not used for germline editing as it was in the China study.
Khalili, Gendelman and colleagues believe that their new approach marks the first time that replication-competent HIV DNA has been eliminated from the genomes of living animals.
“The big message of this work is that it takes both CRISPR-Cas9 and virus suppression through a method such as LASER ART, administered together, to produce a cure for HIV infection,” Khalili said in a statement. “We now have a clear path to move ahead to trials in non-human primates and possibly clinical trials in human patients within the year.”
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