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Sunday, April 7, 2019

New guide to fill ‘information vacuum’ on new cannabis products for medicinal use

A clinical review, published today for the BMJ, provides new interim advice for doctors and clinicians in prescribing cannabis-based products and cannabinoids to treat certain conditions.
Since a in November 2018, specialist doctors registered with the General Medical Council (GMC), have been permitted to prescribe  which derive from cannabis. Yet, research into these products has, to date, been limited creating an ‘information vacuum’ about these medicines, their benefits or harms.
A new review authored by leading scientists and clinicians from the University of Bath and University College London (UCL) points to the array of different cannabis-based products and cannabinoids available, and a clear need to educate both patients and clinicians into what these different products do and how they might help.
In particular, it points to important differences between products containing THC (the main psychoactive and intoxicating constituent of cannabis) versus CBD (the non-intoxicating element). Although in certain medicines CBD and THC are combined for clinical benefit, in others these components can work independently, playing different roles in improving certain symptoms.
For example, several studies have found that a combination of THC and CBD can alleviate symptoms of chronic pain, while CBD alone may be effective for treatment-resistant epilepsy. By contrast THC alone may be effective for treating nausea and vomiting caused by chemotherapy. THC and CBD are both ‘cannabinoids’ that act in different ways on the body’s endogenous cannabinoid system.
The cannabis plant produces over 144 different cannabinoids such as THC or CBD. Some medicinal products contain THC and/or CBD derived from the cannabis plant, while others contain synthetically produced cannabinoids. CBD is also available in non-medicinal products such as oils and tinctures.
Lead author, Dr. Tom Freeman of the University of Bath’s Addiction and Mental Health Group explains: “In this complex and rapidly evolving field, there are several different cannabis-based and cannabinoid medicinal products. These differ in their THC and CBD content, who can prescribe them, and the conditions they may be used to treat. Here we provide an update for clinicians in advance of forthcoming NICE guidelines.
“A key message is that CBD products widely sold online and in health food shops lack quality standards and should not be treated as .”
Research on cannabis was previously restricted because it was listed in Schedule 1, implying that it had no medical value. Cannabis was recently moved to Schedule 2 in the UK.
Dr. Freeman adds: “Research on unlicensed cannabis products has been limited to date. The rescheduling of cannabis and allocation of dedicated UK research funding will improve the evidence we have to guide clinical decision-making.”
Co-author, Dr. Michael Bloomfield Head of Translational Psychiatry at University College London (UCL) added: “There have been leaps and bounds in our scientific knowledge in recent years, which combined with confusing claims about the medicinal uses of these drugs can be potentially perplexing for doctors and patients. We hope that our new guidance is helpful to doctors and patients worldwide. Much more research is needed into this new class of medicine.”
Co-author Dr. Chandni Hindocha of the Clinical Psychopharmacology Unit at UCL added: “Resources must be made available to update and educate clinicians about cannabis and  based medicines. We would like to encourage doctors to maintain a compassionate and evidence-based approach when engaging with their patients in this rapidly developing field, in order to provide the best standard of care.”
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More information: Tom P Freeman et al, Medicinal use of cannabis based products and cannabinoids, BMJ (2019). DOI: 10.1136/bmj.l1141
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Common food additive may weaken defenses against influenza

Research conducted in mice suggests the food additive tert-butylhydroquinone (tBHQ)—found in many common products from frozen meat to crackers and fried foods—suppresses the immune response the body mounts when fighting the flu. In addition to increasing the severity of flu symptoms, the study found evidence that tBHQ exposure could reduce the effectiveness of the flu vaccine through its effects on T cells, a vital component of the immune system.
Researchers say the connection may help explain why  continues to pose a major health threat worldwide. An estimated 290,000-650,000 people globally die from flu-related respiratory problems each year.
“Our studies showed that mice on a tBHQ diet had a weakened immune response to influenza (flu) infection,” said Robert Freeborn, a fourth-year Ph.D. candidate at Michigan State University. “In our , tBHQ suppressed the function of two types of T , helper and killer T cells. Ultimately, this led to more severe symptoms during a subsequent influenza infection.”
Freeborn will present the research at the American Society for Pharmacology and Experimental Therapeutics annual meeting during the 2019 Experimental Biology meeting, held April 6-9 in Orlando, Fla.
When a person is infected with , helper T cells direct other parts of the immune system and help coordinate an appropriate response, while killer T cells hunt down infected cells and clear them from the body. In their experiments, the researchers found mice eating a tBHQ-spiked diet were slower to activate both helper T cells and killer T cells, resulting in slower clearance of the virus.
“Right now, my leading hypothesis is that tBHQ causes these effects by upregulating some proteins which are known to suppress the immune system,” said Freeborn. “Expression of these proteins, CTLA-4 and IL-10, was upregulated in two different models we use in the lab. However, more work is necessary to determine if upregulation of these suppressive proteins is indeed causative for the effects of tBHQ during influenza infection.”
What’s more, when the mice were later re-infected with a different but related strain of influenza, those on the tBHQ diet had a longer illness and lost more weight. This suggests that tBHQ impaired the “memory response” that typically primes the immune system to fight a second infection, Freeborn said. Since the memory response is central to how vaccines work, impairment of this function could potentially reduce the efficacy of the flu vaccine.
T cells are involved in the  to a variety of diseases, so tBHQ could also play a role in other types of infectious diseases, Freeborn added.
tBHQ is an additive used to prevent spoilage, with a maximum allowed concentration of 200 parts per million in food products. It is unclear how much tBHQ people are exposed to, though estimates based on model diets have suggested some U.S. consumers eat almost double the maximum allowable amount of tBHQ suggested by the Joint FAO/WHO Expert Committee on Food Additives and that people in other parts of the world may consume up to 11 times the maximum allowable amount. The level of tBHQ exposure in Freeborn’s studies falls within estimates of human exposure.
“It can be hard to know if you are consuming tBHQ, as it is not always listed on ingredient labels,” said Freeborn, adding that this is often the case when tBHQ is used in food preparation, such as in the oil used to fry a chip. “The best way to limit tBHQ exposure is to be cognizant about food choices. Since tBHQ is largely used to stabilize fats, a low-fat diet and cutting down on processed snacks will help reduce tBHQ consumption.”
Freeborn emphasized that getting a yearly flu shot remains the best way to prevent influenza infection. Though it is possible to contract the flu after getting the vaccine, being vaccinated has been shown to significantly reduce the length and severity of the illness.
Building on their studies conducted in mice, the researchers plan to use human blood samples to further investigate how tBHQ affects T cell activity.
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More information: Robert Freeborn will present this research on Sunday, April 7, from 9 a.m.-4 p.m. in Exhibit Hall-West Hall B, Orange County Convention Center (abstract).
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Do Breast Cancer Patients Skip Follow-Up?

Within the 5 years following a diagnosis for stage I or II breast cancer, 21% of patients stop seeing physicians for follow-up care, according to a study in the Journal of Oncology Practice.
Breast cancer is the second most common form of cancer for women in the U.S., with about 12% of women developing the condition, according to the American Cancer Society. Breast cancer has a high level of lethality, and only lung cancer kills more women annually.
Study co-author Dawn Hershman, MD, of Columbia University Medical Center in New York, , explained why follow-up care is crucial for recovery.
“It is important for patients to know that, during follow-up appointments, they are being evaluated for recurrence, evaluated for early detection of new primary tumors, and to make sure they are up-to-date with other cancer prevention activities,” she said. “In addition, information is rapidly changing, so keeping up with the oncologist is important to make sure the care is current.”
Hershman and colleagues examined data from more than 30,000 patients, ages ≥65, and reported several key points:
  • In year 1 after diagnosis, 85.8% of patients saw a medical oncologist and 71.9% saw a radiation oncologist in addition to a surgeon
  • Two-thirds of the patients visited all three kinds of providers in the first year after diagnosis
  • In the 5 years after diagnosis, 21% of patients stopped follow-up visits
Factors predictive of discontinued follow-up care included older age, single relationship status, patients with low-grade tumors, and patients with hormone receptor-negative breast cancer.
Surgeons and oncology specialists can take steps to increase follow-up care for breast cancer, the researchers noted.
“Coordination of follow-up care between oncology specialists and other providers may reduce discontinuation rates as well as the redundancy of visits, thereby increasing clinical efficiency. Identifying patients who are at risk for early discontinuation of follow-up will eventually allow for the promotion of public health initiatives to improve access to care,” they wrote.
Hormone therapy should be a focal point of public health efforts, Hershman said. “The most important thing we do during follow-up is to make sure women on hormone therapy stay on their hormone therapy. Making sure these treatments are available to everyone is an important public health initiative.”
Educating breast cancer patients about the seriousness of follow-up care is essential, she said. “As a provider, it is hard to know when patients stop following up. Sometimes, patients move or change providers. Patients need to be active in making sure they follow with at least one provider.”

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Escalating Opioid Doses in Chronic Pain

Increases in prescription opioid doses were unrelated to most clinical outcomes among chronic pain patients, according to a 2-year prospective cohort study.
Moreover, patients who had been prescribed a stable dose of long-term opioid therapy demonstrated few clinically significant changes in pain-related outcomes over time, reported Benjamin Morasco, PhD, of Oregon Health & Science University in Portland, and colleagues, at the American Pain Society Scientific Meeting.
Long-term opioid therapy is a common treatment for chronic pain, and “little data are available about the benefits and harms associated with increasing opioid dose,” Morasco told MedPage Today. “It’s unclear to what extent escalating opioid doses can improve pain, yet still have the risk-benefit ratio of a lower dose.”
For this study, Morasco and colleagues recruited 517 adults with a chronic musculoskeletal pain from the Kaiser Permanente Northwest and Veteran Affairs (VA) Portland health care system who were prescribed a stable dose of long-term opioid therapy. The researchers excluded patients who were receiving opioids for cancer treatment or palliative care, had pending a disability claim related to a pain condition, had enrolled in an opioid substitution program in the past year, had a current opioid dose >120 mg, or whose opioid prescriptions were solely tramadol or buprenorphine.
Participants were an average age of about 60, and just under half were female. All participants completed standardized questionnaires — including measurements of pain intensity and pain interference on 100-point scales — every 6 months for 2 years. Researchers reviewed medical records each week; patients who had an opioid dose increase completed an additional questionnaire within 4 weeks of dose escalation.
The average daily opioid dose at baseline was 36.2 mg morphine equivalent dose (MED). Of the 517 participants who enrolled, 19.5% (n=101) had a prescription opioid dose increase of 15% or more from their baseline dose. The baseline dose of these 101 patients was 27 MED; the baseline dose of patients who didn’t have an increase (n=416) was 39 MED. The average increase in prescription opioid dose from baseline was 104%.
After controlling for covariates — medical comorbidities, alcohol and substance use, pain catastrophizing, pain self-efficacy, complementary and integrative treatments for chronic pain, and other factors — the researchers found no significant changes in pain intensity or pain interference over time, and no differences based on dose escalation status. Specifically:
  • Average pain intensity score decreased by 0.79 points a year, and there was no difference in average pain intensity based on dose increase status
  • Average pain interference increased by 1.42 points per year; this also showed no difference based on dose increase status
  • No significant changes in depression severity or sexual functioning over time emerged, and no difference was seen based on dose increase status
  • On average, those in the dose increase group had higher scores on risk for prescription opioid misuse, but they also had greater average reductions in risk over time
  • Those in the dose increase group had poorer sleep functioning compared to those in the stable dose group on average, and there were no differences in change over time
  • The average score for short-term medication-related side effects such as constipation, nausea, and vomiting decreased over time, and there was no difference based on dose increase status
“Clinically, we are seeing more and more people having increases in opioid doses,” said Morasco. “This is one of the first prospective studies to see the outcomes of opioid dose escalation.”
“We didn’t really see long-term improvements,” Morasco added. “People may have had changes in pain intensity soon after dose escalation, but when we really follow them for up to a year after their dose escalation, we don’t see long-term changes.”
The study was supported by the National Institute of Drug Abuse.
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Illumina (ILMN) Results Should Include Upside From Large Deals – Piper Jaffray

Piper Jaffray analyst William Quirk reiterated an Overweight rating and $384.00 price target on Illumina (NASDAQ: ILMN) after channel checks
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Aeglea BioTherapeutics announces Phase 1/2 data for Pegzilarginase

Aeglea BioTherapeutics presented new Phase 1/2 data for pegzilarginase in patients with Arginase 1 Deficiency at the 2019 Annual Meeting of the Society for Inherited Metabolic Disorders in Bellevue, Washington. The new Phase 1/2 data continues to demonstrate that pegzilarginase is highly effective in sustainably lowering plasma arginine, which is the primary endpoint in Aeglea’s single, global pivotal Phase 3 PEACE trial. In addition, the new data shows that the marked improvement in plasma arginine control is accompanied by clinically meaningful responses in mobility and adaptive behavior, which are secondary endpoints in the PEACE trial. The treatment was generally well tolerated. Hypersensitivity reactions were infrequent, manageable with standard measures, and did not lead to treatment discontinuation.
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How High Housing Costs Impact Health Care

A new national report commissioned by Enterprise Community Partners Inc. as part of its Health Begins with Home initiative found that more than half of renters surveyed delayed health care because they couldn’t afford it.
The survey revealed renters who are paying a high percentage of their income for housing—particularly those paying more than 50 percent of their monthly income—routinely make difficult decisions between paying for rent and health care. Of that group, 83 percent said they prioritize paying rent before anything else, compared with 1 percent that prioritized healthcare costs. Nearly half (45 percent) said they have not followed a treatment plan from health care professionals because they couldn’t afford it, compared with 34 percent of all renter respondents. And nearly one-third (31 percent) of severely rent-burdened respondents said they delayed a routine checkup because they couldn’t afford it, compared to 23 percent of all renter respondents.
“No one should have to choose between paying rent and paying for health care,” Laurel Blatchford, Enterprise president, said in a prepared statement. “And yet, thousands of people make that difficult trade-off every day. That’s wrong. By working closely with health care organizations, we’re creating ways for renters to afford the health care they need.”
The survey, the first to examine renters’ ability to afford health care and medical professionals’ perception of those challenges, also found that every one of the 500 medical professionals surveyed reported at least some of their patients have expressed concerns about affordable housing. Thirty-one percent of those professionals reported at least a quarter of their patients said they had concerns about affordable housing. That number increased to 42 percent among those professionals who treat a large number of lower-income patients. Forty-four percent stated they believe a lack of accessible health care hinders the health of lower-income communities.
“This survey is the first to carefully document how these challenges affect both renters and medical professionals, and will help both the health and the housing sectors collaborate to save lives. This interdependence between health and housing must remain at the forefront of our collective health equity efforts,” Brian Rahmer, vice president, Health and Housing, at Enterprise, said in prepared remarks.

PARTNERSHIPS AND COLLABORATION ARE KEY

The Columbia, Md.-based national affordable housing non-profit is working with a broad group of partners to promote health as a top priority in the development and preservation of affordable housing and is deploying $250 million over five years to spur more collaboration through the Health Begins at Home initiative launched in January. One of the groups Enterprise is working with is Kaiser Permanente, which had announced a joint Enterprise-managed $85 million Housing for Health fund in the San Francisco Bay Area and a $100 million national loan fund.
Rahmer told Multi-Housing News the survey results, while not surprising to those who work in the affordable housing and public health sectors, “give us some additional points to stand on as we bring on new partners in different regions across the country.”
He said the survey findings would help Enterprise and others “shine more light on that connection” between housing and health outcomes.
“The accumulation of data and information continues to grow about people’s health outcomes and the trajectory of those outcomes, particularly in the United States,” Rahmer said in an interview, shortly after the survey was released Wednesday morning.
The survey also showed that respondents had lower satisfaction rates with housing-related factors that impact their health, including adequate access to outdoor spaces (47 percent), lack of exposure to indoor toxins (48 percent) and air quality (38 percent).

MENTAL HEALTH IMPACTS

Perhaps just as important, Rahmer noted information gleaned from the report also revealed how the economic burdens of high housing costs impact renters’ mental health too, causing ongoing stress.
“This chronic stress has a wearing effect, a weathering effect,” he said. “That is not good for anybody.”
Inadequate medical care and family stress also affects children’s health and well being, starting with their readiness for kindergarten and elementary school and continuing to have a dramatic impact throughout their lives, commented Rahmer.
Providing quality, stable and safe affordable housing is key to creating better outcomes, he stated.
When Enterprise introduced its Health Begins with Home Initiative in January, executives said it would focus on four key areas: conducting research; awarding grants to nonprofits to fund housing and community health programs and increase partnerships between housing and healthcare organizations; providing technical assistance and connecting capital from healthcare organizations, institutional investors and social impact funds to develop and preserve affordable, healthy and well-designed homes.
Rahmer told MHN Enterprise will be putting that $250 million to work with current partners but will also be working on creating new partnerships to invest in capital programs, health equity funds and loan funds.
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