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Friday, January 25, 2019

Medical Cannabis Decisions Being Made by Users, Not Doctors


Many patients use medical cannabis without their mainstream health care provider’s knowledge, and further, they self-adjust their pharmaceutical use in response to cannabis use, according to a study published online Jan. 8 in the Journal of Psychoactive Drugs.
Daniel J. Kruger, Ph.D., from the University of Michigan in Ann Arbor, and Jessica S. Kruger, Ph.D., from the University at Buffalo in New York, surveyed 392 adults attending an annual public event advocating for cannabis law reform. The attendees were asked about their attitudes toward and utilization of medical cannabis and the mainstream health care system.
The researchers found that more than three-quarters of respondents (78 percent) reported using cannabis to help treat a medical or health condition. Medical cannabis users reported a greater degree of trust in medical cannabis compared with mainstream health care. Medical cannabis users rated cannabis better on effectiveness, side effects, safety, addictiveness, availability, and cost compared with pharmaceutical drugs. As a result of the use of medical cannabis, 42 percent of respondents reported they stopped taking a pharmaceutical drug and 38 percent reported they used less of a pharmaceutical drug. Just under one-third of respondents (30 percent) reported that their mainstream health care provider did not know that they used medical cannabis. The survey brought other issues to the surface, including lack of access to mainstream health care, self-initiated treatment of health issues, little knowledge of psychoactive content, and heavy cannabis use.
“Those working in public health and medicine have an obligation to reduce harm and maximize benefits to the health of individuals and society, and thus serious consideration and scientific investigation of medical cannabis are needed,” the authors write.
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Americans Used Less Eye Care in 2014 Versus 2008


Americans were less likely to use eye care in 2014 versus 2008 but had decreased difficulty affording eyeglasses from 2014 onward, according to a study published online Jan. 24 in JAMA Ophthalmology.
Varshini Varadaraj, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues updated trends in eye care use and affording eyeglasses in an analysis of data from the U.S. National Health Interview Survey from 2008 to 2016.
The researchers found that compared with 2008, in 2014, Americans were less likely to use eye care (odds ratio, 0.90) in fully adjusted models. They were also less likely to report difficulty affording eyeglasses from 2014 on compared with 2008 (2014: odds ratio, 0.82; 2015: odds ratio, 0.81, and 2016: odds ratio, 0.70). Compared with those without visual impairment, individuals with visual impairment were more likely to use eye care (odds ratio, 1.54) and had greater difficulty affording eyeglasses (odds ratio, 3.86) after adjustment for all covariates. Compared with men, women were also more likely to use eye care and report difficulty affording eyeglasses (odds ratios, 1.42 and 1.68, respectively). Black, Asian, and Hispanic individuals were less likely to use eye care than non-Hispanic whites, and Asians and blacks were less likely to have difficulty affording eyeglasses.
“While decreased difficulty affording eyeglasses may reflect post-Great Recession economic recovery and/or health care reform-related changes among Americans overall, these results suggest women, individuals with visual impairment, and racial/ethnic minorities may still be more likely to face difficulties in using and/or affording eye care,” the authors write.
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Considering Food Desensitization in Your Practice? Read This First


We are on the cusp of a revolution in the management of food allergy, with a promising treatment now on the horizon.
The results of an industry-sponsored peanut oral immunotherapy (OIT) trial recently published in the New England Journal of Medicine[1] have generated a lot of excitement. Impressively, it showed that in patients aged 4-17 years, 67.2% treated with the peanut-derived oral immunotherapy drug AR101 could tolerate 600 mg of peanut protein (about two whole peanuts) versus only 4% of controls. Nearly all patients who finished therapy could eat about 1.5 peanuts at the end, as long as they kept taking AR101. Almost 5% withdrew because of gastrointestinal (GI) side effects. Severe reactions occurred in about 5% of treated patients as well.
Comparatively, a recently published study[2] of OIT in the private practice setting using peanut flour and other commercial peanut foods reported a higher rate of patient dropout (about 20%) and frequency of GI symptoms (37%). These authors reported that only 6.5% of patients achieved sustained unresponsiveness (defined as not reacting to peanut even a few months after stopping the study drug). Of patients with peanut-specific IgE levels >100, all were still reactive to peanut challenge.
Clearly, OIT is not curative. For most patients, it seems only to be protective for as long as they take it.

Limiting OIT Risks

A number of factors may trigger allergic reactions to the OIT dose, including nonsteroidal anti-inflammatory drug use, illness (upper respiratory or GI infection), stress/fatigue, seasonal allergy, and even consuming the OIT dose on an empty stomach.[3]
This issue is highlighted by the case I heard about at a recent meeting, concerning OIT dose-related, exercise-induced anaphylaxis in an adolescent. The patient took her dose of OIT and then went to a track meet. After feeling unwell, she went to the bathroom, where she was soon discovered by friends to be swollen and vomiting. Had they not looked for her and called an ambulance, the results might have been worse. This speaks to the unwritten dangers of food allergy and OIT, especially in teenagers who have active schedules and may not appreciate the risks or consequences of ignoring medical advice.
Patient selection for OIT should, of course, only include patients actually allergic to the food. That necessitates food challenges because prior history alone is not predictive.[4] As always, food challenges must be done cautiously. The symptoms-eliciting dose (threshold) for reactivity in peanut challenges ranges widely, from 25 mg (in 28%) to over 1 g (38%). It is important to note that the allergen content[5] of peanut flours varies to some degree (about 20%), which probably raises the risk of OIT pending approval of AR101.

Other Emerging Treatments

It is estimated that OIT reduces the risk for accidental peanut allergy reactions by 95%,[6] so a strong argument can be made for OIT being superior to avoidance alone.[7] An ideal alternative, of course, would reduce accidental exposure risk without the attendant risks and side effects of OIT.
That is what the Viaskin Peanut (DBV Technologies) potentially represents. This epicutaneous therapy (EPIT) has shown some efficacy in children aged 6-11 years participating in a phase 2b trial.[8] Results showed that 50% achieved the primary endpoint of tolerating a 1000-mg peanut challenge, or a 10-fold diminution in sensitivity as assessed by challenge. Most patients had irritation at the patch test site, but the study drug did not cause any serious adverse reactions, which enabled over 95% adherence and a negligible dropout rate. A further advantage of EPIT is that it has not been reported to cause GI symptoms or eosinophilic esophagitis. Could EPIT even be a viable treatment for eosinophilic esophagitis?
Understandably, many worried parents of children with food allergies have sought out allergists in private practice who have been willing to accommodate them by performing office-based OIT. Fortunately, no OIT deaths have been reported to date, but that risk will always exist regardless of whether this treatment receives US Food and Drug Administration (FDA) approval.
One way to attenuate the risk of OIT is with the monoclonal anti-IgE antibody omalizumab, which enables more rapid up-dosing with reduced risk.[3]Omalizumab is also a viable stand-alone therapy for IgE-mediated food allergy (80-fold increase in peanut threshold), although it is not FDA-approved for this use.
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Stigma, Reimbursement Remain Barriers to Better Care for Mental Health


Poor reimbursement, workforce shortages, and lax government oversight of mental health parity laws limit access and integration of behavioral health, according to a new report from the Bipartisan Policy Center (BPC).
But of all the barriers to accessing quality and affordable mental health services, stigma may be the most powerful, said Patrick Kennedy, founder of the Kennedy Forum, a mental health and substance abuse advocacy organization.
“If this were any other disease, we’d be running towards the problem, not away from it,” he said during a panel discussion on integrating mental and behavioral health into clinical care, hosted Thursday by the BPC.
Authors of the new report said their ideas were to be taken as “policy options” or a “starting point for discussion” rather than as a specific set of recommendations. Kennedy noted that similar reports have been ignored and are now just “sitting on shelves.”
“The big narrative here is the lack of political will,” said Kennedy, a former Democratic congressman from Rhode Island. “It’s the urgency that’s missing.”
Kennedy said he views mental health parity as a civil rights issue, explaining that the medical system discriminates against patients with mental health and substance use problems. Just as the Civil Rights Act of 1964 didn’t end racism, he said, advocates can’t force an end to stigma, but they can fight for better laws and better policies.
“It may be another generation before we really make a dent in the stigma issue,” he said.
In the meantime, he urged action on expanding mental health parity laws to include the Centers for Medicare and Medicaid Services.
The Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008 was passed to prevent insurers who offer mental health and substance use disorder benefits from “imposing less favorable benefit limitations” for those services than they would for medical or surgical services. But the law hasn’t been well enforced, say advocates and stakeholders. The law also currently excludes Medicare and Medicaid.
Medicare, Medicaid Obstacles to Care
Medicaid often has carveouts that separate payment for behavioral health services from medical benefits. One policy option noted in the BPC report would require “full integration” of all services in Medicaid managed care contracts and have such carveouts be phased-out by a certain date.
But “carving in” isn’t enough, said Stephen Cha, MD, chief medical officer for UnitedHealthcare Community & State and a former director in the State Innovation Group at the Center for Medicare & Medicaid Innovation (CMMI). Care delivery needs to change, he said.
Kevin Davidson, of MemorialCare Health System in Orange County, California, explained that in his health system, primary care physicians are responsible for a care team that includes a licensed social worker and consulting psychiatrist. The physician screens individual patients and when needed, does a “warm hand-off” to a social worker during that same clinical visit.
The team’s consulting psychiatrist typically works with the care team to design a care plan and treatment. The majority of cases involve more moderate mental illness, usually anxiety and depression, and those care plans can be delivered by the primary care team with the advice of the consulting psychiatrist.
Same-day billing also presents an obstacle for providing care to some patients with behavioral health issues. Medicare does not allow reimbursing for more than one evaluation and management (E/M) visit for providers in the same specialty for the same patient on the same day, the report noted. While some states have adopted new policies to allow same-day billing, many have not, panelists explained.
This is a significant barrier to care delivery, they noted, because the chances that someone who’s really struggling with mental illness or addiction is going to wait another day, then make another visit, are slim, said Marian Earls, MD, deputy chief medical officer for Community Care of North Carolina.
Others on the panel agreed that making patients come back a second day isn’t “person-centered.”
Beyond eliminating carveouts and same-day billing, other policy ideas discussed in the report include:
  • Eliminating Medicaid’s Institutions for Mental Disease exclusion, which prevents Medicaid from paying for a patient with a behavioral health condition to stay in an institution with more than 16 beds
  • Expanding mental health parity laws to Medicaid and Medicare
  • Expanding and reauthorizing the Certified Community Behavioral Health Clinic demonstration program in Medicaid, which currently operates in eight states
  • Extending waivers for face-to-face requirements in Medicare home-health services
Workforce, Access to Care
The BPC report also examined workforce barriers, including a shortage of mental health providers, which has obvious consequences for access to mental health services and integration of care. The U.S. Bureau of Health Professions project that by 2020 about 12,624 child and adolescent psychiatrists will be needed, but only about 8,312 will be in supply.
And according to data from the Substance Abuse and Mental Services Administration (SAMHSA) cited in the report, while over 20% of the nation’s population lives in rural areas, three in four rural counties do not have an advanced behavioral health provider.
To help address these challenges, the authors described a number of policy options such as investing in more training for allied mental health professionals, promoting “pipeline programs” at community colleges, and subsidizing training programs at the federal and state level.
In addition, primary care physicians should be encouraged to “weave mental health competencies into their day-to-day practice and develop relationships in their communities with mental health professionals” Earls told MedPage Today.
Even if a physician can’t integrate a mental health provider into their practice, by developing those relationships, they can learn how to “co-manage” patients, she said.
In most states there’s a movement toward value-based payment, especially in Medicaid, and while transforming care at a “onesie and twosie” practice is more challenging than it might be at a multi-center practice, it’s important to stay active and engaged in the state chapter of your local medical society, said Earls, and to push for the kinds of support that would help your practice, added Cha.
The BPC report also touched on other policy options such as developing and sharing evidence-based best practices related to telehealth service; promoting behavioral health integration at the undergraduate and graduate level in nursing schools and medical schools; and suggesting the Secretary of Health and Human Services issue guidance to “incentivize or require” that states comply with licensure compacts, which allow clinicians to treat patients across state lines.
Accountability for Private Insurers
Data collection plays a role in enforcing mental health parity, and when there are problems, those need to be highlighted publicly, said panel moderator Chris Jennings, president of the health policy consulting firm Jennings Policy Strategy.
Jennings said that he sees some efforts at the state level, but not as much from the Department of Health and Human Services or the Department of Labor.
“My view is that the law is in place and should be being enforced … to the extent that more and more people see that it’s not [enforced], I think you’ll see actions to intervene,” he said.
Asked what clinicians can do to advance parity, Jennings urged them to report problems with enforcement.
“Don’t just throw up your hands, help us document it,” he said, adding that he was pleased to see the American Medical Association’s recent report on parity.
At the same time, Jennings said he’s noticing that private payers are acknowledging that in the long-term they can’t manage their overall health spend without managing their mental health spend.
“What I’m encouraged about is that the provider community and the purchaser community now are seeing the value of integrated care and want to see it … instituted in a rational, sustainable way,” he told MedPage Today after the panel.
Insurers are realizing that they want to keep the same enrollees in their plans longer, so that when they do invest in their care, they get a return on that investment, Jennings added.
Kennedy was a bit more critical of insurers and questioned why America’s Health Insurance Plans (AHIP) “just hangs back” rather than taking the lead on designing payment models that reward better outcomes for patients with mental and behavioral health issues.
He said there’s both the “push and the pull” to move payers to an environment where mental health is no longer seen as not real.
If a “shame factor” will help, he’s ready to use that lever too, Kennedy said.
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Head Injuries Common in E-Scooter Accidents


Head injuries topped the list of emergency room injuries involving electric scooters, yet very few e-scooter riders wore helmets, an observational study found.
About 40% of patients treated for two-wheeled e-scooter injuries at two southern California emergency departments had head injuries, but only 4.4% wore a protective helmet, reported Tarak Trivedi, MD, MS, of the University of California Los Angeles (UCLA), and colleagues.
And in a convenience sample of traffic observed in Los Angeles, 182 of 193 e-scooter riders were helmet-less, the team wrote in JAMA Network Open.
Shared electric scooters from companies like Bird, Lime, Skip, and Scoot are in over 100 cities now and can reach speeds up to 15 mph. “There are thousands of riders now using these scooters, so it’s more important than ever to understand their impact on public health,” Trivedi said in a statement.
Despite the wild popularity of rental scooters — Bird tallied 10 million rides in its first year — cities have adopted mixed responses to their safety issues. Los Angeles-area emergency departments are at the epicenter of the electric scooter phenomenon, Trivedi said: the shared vehicles first appeared in Santa Monica in September 2017 when Bird placed thousands of them around the city.
In their study, the researchers reviewed medical records of 249 emergency room patients who presented with injuries associated with electric scooters at UCLA Medical Center in Santa Monica and Ronald Reagan UCLA Medical Center in Los Angeles from September 2017 to September 2018. Patients were an average age of about 34, and 58.2% were male. Most patients (91.6%) were injured as e-scooter riders and 8.4% as non-riders.
The cases showed the following:
  • About one in 10 patients (10.8%) were younger than 18
  • Only 10 patients (4.4%) were documented as having worn a helmet
  • Head injuries (40.2%), fractures (31.7%), and contusions, sprains, and lacerations without fracture (27.7%) were most common
  • Most head injuries were minor — without intracranial hemorrhage or skull fracture — but five patients (2.0%) had an intracranial hemorrhage
  • Fifteen patients (6.0%) were admitted or transferred, including two patients to the intensive care unit — one with traumatic subarachnoid hemorrhage and another with a subdural hematoma
During three public observation sessions on Los Angeles streets, the researchers also found that 94.3% (182 of 193 e-scooter riders) did not wear a helmet.
Traumatic brain injury (TBI) is the most common cause of serious morbidity and mortality in bicycle crashes, noted Frederick Rivara, MD, MPH, of the University of Washington in Seattle, in an accompanying editorial. But the bicycle world has taken steps to prevent harm: cities have built bike lanes to separate riders from motor vehicles, and bicycle helmets can reduce TBI risk by as much as 88%.
But shared two-wheeled devices “turn all of this on its head,” Rivara wrote. “None of the companies that rent these vehicles in the increasingly common hubless system provide helmets,” he noted. And it’s not clear what kind of helmet would be best: “There are no data on whether bicycle helmets would provide adequate protection against serious TBI for these motorized devices, which can attain higher speeds than would be achieved by most bicyclists on flat roads.”
Action is needed on a number of levels, Rivara argued. “The Consumer Product Safety Commission should test different helmets for these various devices and label them according to the vehicle in which their use is appropriate,” he asserted. “Just as helmet manufacturers responded to the increased demand for bicycle helmets with new and attractive products priced very affordably, these manufacturers should develop and promote use of helmets appropriate for electric scooters and bikes.”
Companies renting two-wheeled vehicles should make helmets available — “failure to do so is like a car rental company renting cars without seat belts,” Rivara contended — and cities should require helmets as part of their contracts with the shared-vehicle companies. “We as purveyors of healthcare and public health should partner with these other players to ensure that these companies are not creating a new public health problem,” he wrote.
Trivedi and colleagues noted several limitations to their review: it was limited to clinical variables and other information, like helmet use was not always recorded. The study could not identify risk factors for injury, and outpatient visits to urgent care or primary care clinics for minor injuries were not included.
Researchers were supported by the UCLA National Clinician Scholars Program, the VA Office of Academic Affiliations, and the Korein Foundation.
Neither the researchers nor the editorialists reported having conflicts of interest.
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IBD Rates Low in Patients on Cosentyx for Rheumatic Inflammatory Conditions


Incidence rates of inflammatory bowel disease (IBD) among patients being treated with secukinumab (Cosentyx) for rheumatic inflammatory diseases were low, pooled clinical trial data indicated.
The exposure-adjusted incidence rates of IBD for patients receiving secukinumab for psoriasis ranged from 0.01 to 0.13 per 100 patient-years, according to Stefan Schreiber, MD, PhD, of University Hospital Schleswig Holstein in Kiel, Germany, and colleagues.
In addition, rates ranged from 0.05 to 0.08 per 100 for psoriatic arthritis (PsA) and from 0.1 to 0.4 per 100 for ankylosing spondylitis (AS), the researchers reported online in Annals of the Rheumatic Diseases.
Patients with psoriasis, PsA, and AS have a recognized risk for developing IBD, with significant genetic overlap between the skin and joint disorders and the intestinal condition.
Secukinumab is a monoclonal antibody that targets interleukin (IL)-17A and is associated with rapid and significant improvements in psoriasis, PsA, and AS. However, “inhibition of IL-17A may have dual effects, reducing inflammation but also potentially impairing residual function of an already damaged [intestinal] epithelial barrier,” the researchers wrote.
Moreover, cases of IBD have been reported among patients with these disorders being treated with IL-17 inhibitors.
Therefore, to examine the incidence and pattern of IBD among patients receiving secukinumab, Schreiber and colleagues pooled data from 21 randomized trials that included a total of 7,355 patients with cumulative exposure of 16,226.9 patient-years.
The analysis included 5,181 patients with psoriasis and exposure of 10,416.9 patient-years, 1,380 patients with PsA and 3,866.9 patient-years of exposure, and 794 patients with AS and 1,943.1 patient-years of exposure. Cases of IBD were defined as Crohn’s disease, ulcerative colitis, or IBD-unclassified.
Two-thirds of patients with psoriasis and AS and half of those with PsA were men, and mean ages ranged from 42 to 49 years. Up to one-third of patients had previously used tumor necrosis factor inhibitors and were smokers, which are risk factors for the development of Crohn’s disease.
A previous history of IBD was reported in 15 patients with psoriasis, in 14 of those with PsA, and in 25 of those with unclassified IBD.
During overall follow-up, 41 cases of IBD were reported. In the psoriasis group, there were 14 cases of ulcerative colitis, five cases of Crohn’s disease, and one case of unclassified IBD, with 14 of the cases being new onset.
In the PsA group, there were three cases of ulcerative colitis, three of Crohn’s disease, and two unclassified, with seven being new onset cases, and in the AS group, the respective number of cases were four, eight, and one, with nine being new onset.
Mean age at the time of the IBD diagnosis was 46.1 years, and two-thirds were men.
During post-marketing surveillance that exceeded 96,000 patient-years, the cumulative rate of events remained stable, at approximately 0.20 per 100 patient-years. “This is consistent with previously reported long-term secukinumab data, which demonstrated that the safety profile of secukinumab remains favorable through 5 years of psoriasis treatment with no increases in yearly adverse event rates,” the authors noted.
The rates of IBD observed in this study “appear to be within the range of expected background incidence rates (per 100 patient-years) of Crohn’s disease and ulcerative colitis in patients with psoriasis, PsA, and AS, which are approximately 0.1 in patients with PsA, 0.3 in psoriasis, and 0.7 in AS,” the researchers noted.
Also reflecting the background incidence of IBD, the observed incidence rate for Crohn’s disease was higher among patients with AS, at 0.4 per 100 patient-years, than in patients with psoriasis or PsA, both at 0.1 per 100. Rates of ulcerative colitis were similar for the three indications.
An area of considerable interest for further study is whether the etiology of IBD that develops in patients with inflammatory rheumatic diseases is the same as for IBD in general. “IBD is an extremely polygenic disease with a diverse range of pathophysiologies that are probably related to the individual genetic distortions in the patient. Genetic risk architecture in IBD, however, relates to the specific intestinal phenotype,” they explained.
Longer term registry data could provide additional information about the occurrence of IBD in patients being treated with IL-17 blockers, they concluded.
The clinical trials analyzed in this study were funded by Novartis Pharma AG.
The authors reported financial relationships with Novartis, AbbVie, AstraZeneca/MedImmune, Boehringer Ingelheim, Celltrion, Ferring, Janssen, Merck Sharp & Dohme, Pfizer, Sanofi, Takeda, UCB, Amgen, Celgene, Genentech, Eli Lilly, Second Genome, Seres, Shire, Theradiag, Millennium, Tillotts, Centocor, Elan/Biogen, Bristol-Myers Squibb, ActoGenix, Weeth, Teva, Serono, Albireo, Given Imaging, Salix, Novo Nordisk, GlaxoSmithKline, Vertex, and Xenoport. Several are employees of Novartis.

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Rite Aid board approves reverse stock split


Rite Aid announced that its Board of Directors has approved a reverse stock split of the company’s common stock. The reverse stock split is intended to enable Rite Aid to regain full compliance with the New York Stock Exchange listing rules. The reverse stock split is subject to stockholder approval. The company plans to hold a Special Meeting of Stockholders, at which stockholders are being asked to vote on a proposal to adopt and approve the reverse stock split, at 8:30 a.m., local time, on March 21 at the offices of Skadden, Arps, Slate, Meagher & Flom, LLP in New York. Rite Aid’s Board has set February 5 as the record date for stockholders entitled to vote at the special meeting. If stockholders approve the reverse stock split, Rite Aid’s Board will select a reverse stock split ratio of either 1-for-10, 1-for-15 or 1-for-20 so that, depending on the ratio chosen, either 10, 15 or 20 shares of issued and outstanding common stock will convert into one share of common stock. The price of each common share is expected to increase so that a stockholder would have fewer but higher priced shares. A reverse stock split would not have any impact on the voting and other rights of stockholders, and will have no impact on the company’s business operations or any of its outstanding indebtedness.
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