Mizuho analyst Irina Koffler upgraded Pacira Biosciences (PCRX) to Neutral from Underperform and raised her price target for the shares to $38 from $29. The analyst says her sell thesis on the shares is longer valid due to an unexpected delay at competitor Heron Therapeutics (HRTX) and Pacira’s stronger guidance on recently acquired iovera. However, she still remains concerned about the longer-term outlook for the company.
https://thefly.com/landingPageNews.php?id=2903485
Monday, May 6, 2019
Biohaven Pharmaceutical initiated with a Buy at Goldman Sachs
Goldman Sachs analyst Paul Choi started Biohaven Pharmaceutical with a Buy rating and $92 price target. The analyst believes Biohaven will become a “more significant presence in the attractive” calcitonin gene-related peptide/migraine space than is currently priced into the shares. Rimegepant’s profile can drive above consensus sales on conservative patient numbers, Choi tells investors in a research note.
Sunday, May 5, 2019
Studies: Weed Degrades Sperm, Spurs Lower Urinary Tract Symptoms
Men who smoked marijuana had significantly degraded sperm quality and testicular function, worse than tobacco users and comparable to men with diagnosed infertility, according to a long-term Brazilian study.
As compared with smokers, marijuana users had lower median values for sperm concentration, motility, and morphology (P<0.01). Marijuana use also was associated with reduced testicular volume and an increased rate of nonobstructive azoospermia, clinical features often found in male infertility.
Marijuana’s deleterious effects on reproductive parameters resulted from increased production of reactive oxygen species (ROS), as seminal ROS concentrations were 20 times higher in marijuana users as compared with smokers, reported Jorge Hallak, MD, of the University of Sao Paulo, at the American Urological Association (AUA )annual meeting.
“Overall, the marijuana group had semen quality equivalent to the infertile group, with the exception of higher ROS and DNA damage than infertile men,” Hallak said during an AUA press briefing. “DNA damage is higher in all groups (marijuana users, smokers, and infertile men) as compared to controls, but higher levels were found in the marijuana group and infertile men. Basic semen parameters are not sufficient to identify changes of magnitude in sperm cell function.”
A second study summarized at the press briefing provided the first reported evidence of an association between marijuana use and development of benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS).
A recent international study showed a consistent and statistically significant decline in sperm quality (count and motility) over the past 40 years. The explanation for the decline remains elusive, but multiple factors have been proposed: environmental exposures, poor nutrition, genetics, and social/behavioral factors.
Over the past 2 decades, technologic advances allowed more detailed examination of sperm. Showed that sperm are highly vulnerable to oxidative stress, which has been implicated in a multitude of major human diseases and disorders. Subfertility and infertility almost almost always arise as a consequence of oxidative stress, said Hallak.
The rationale for evaluating marijuana’s effect on male fertility parameters included a lack of information on the topic and the worldwide use of the drug. With an estimated 200 million users worldwide, marijuana is the most widely used psychoactive drug, including more than 20 million regular users in the U.S.
Since 2000, Hallak and colleagues have studied the effects of marijuana and tobacco on spermatozoa and testicular function and relationships with male infertility, hypogonadism, and sexual dysfunction. Each study participant has two comprehensive semen analyses that go well beyond usual lab assessments and include ROS, sperm DNA integrity, creatinine kinase activity, and antisperm antibodies.
Unlike many prior studies, enrollment was limited to users of cannabis and excluded use of cannabinoid-containing products. The study population comprised 125 men with diagnosed infertility, 144 tobacco smokers, 74 marijuana users, and a control group of 279 men (prevasectomy with no clinical factors for testicular dysfunction).
Current marijuana use was ascertained by self-report at the time of enrollment. Median age at first use of marijuana was 18.6, and median duration of marijuana use was 8 years.
Clinical characteristics of the infertile men included increased levels of prolactin; decreased sperm concentration, motility, and morphology; and increased seminal pH and ROS. Tobacco smokers had decreased follicle-stimulating hormone, luteinizing hormone, and prolactin; decreased testicular volume; and decreased seminal volume.
Marijuana users had a significantly lower median estradiol level (10.04 ng/dL) as compared with all the other groups (P<0.001). Marijuana use was associated with the highest median seminal ROS: 14.31 x 104 cpm/20 x 106 versus 5.66 for infertile men, 0.70 for smokers, and 0.68 for the fertile control group. Hallak noted that marijuana induces production of intracellular ROS whereas tobacco smoke creates extracellular oxidative stress.
The study of marijuana use and BPH/LUTS included 20,548 men (age >45) who had prescriptions for finasteride and or a super-selective alpha blocker during the period from January 2011 to October 2018. The primary objective was to identify factors significantly associated with BPH/LUTS, said Granville Lloyd, MD, of the University of Colorado Anschutz School of Medicine in Aurora.
A multivariable analysis identified marijuana use as a statistically significant player in the development of BPH/LUTS (odds ratio 1.253, P<0.001). Other significant predictors were depression (OR 2.015), erectile dysfunction (OR 1.847), metabolic syndrome/obesity (OR 1.586), hypertension (OR 1.576), hypogonadism (OR 1.392), and diabetes (OR 1.280, P<0.001 for all). Alcohol use did not have a significant association with BPH/LUTS (OR 0.982).
Noting that BPH/LUTS etiology is poorly understood, Lloyd said, “From this analysis we can conclude that BPH is associated with systemic diseases, depression, and marijuana use but not alcohol.”
“Men who use marijuana are more likely to be treated for BPH,” he stated. “This is a novel finding. Cannabinoids are pharmacologically active and influence voiding, which raises the question of whether marijuana is a risk factor or self-treatment?”
Hallak disclosed no relevant relationships with industry.
The study by Lloyd’s group was supported by the Health Data Compass Data Warehouse.
Primary Source
American Urological Association
Secondary Source
American Urological Association
Cardio-Oncology Services Growing in Number and Demand
Cardio-oncology is an emerging discipline and subspecialty in response to the rapidly growing number of patients with comorbid cardiovascular disease and cancer and the complexity of these conditions, according to a review published in the May 7 issue of the Journal of the American College of Cardiology.
Salim S. Hayek, M.D., from the University of Michigan in Ann Arbor, and colleagues conducted a review of dedicated efforts to meet the growing need for education and training of cardiovascular practitioners providing care to cancer patients and survivors.
The review describes how cardio-oncology specialists are involved in all aspects of cancer patients’ care, including informing them of pretreatment risk and regimen selection, addressing the complex cardiovascular adverse effects of cancer therapy, and alleviating the heightened long-term risks for cardiovascular disease in survivorship. Since 2014, the number of centers offering cardio-oncology services has nearly doubled. Nearly half of cardiovascular training programs now incorporate cardio-oncology topics in their core curriculum. Authors say barriers to developing training programs in cardio-oncology include a lack of the following: funding and support, an accreditation process, a formalized training curriculum, and evidence of clinical benefit and economic feasibility of interventions.
“Inclusion of cardio-oncology as a component of general cardiology training programs is the first step at establishing a workforce capable of recognizing and managing the complex cardiovascular burdens associated with cancer in every community,” the authors write.
More Than Half of U.S. Adults Have Medical Financial Hardship
Medical financial hardship affects more than half of adults in the United States, according to a study published online May 1 in the Journal of General Internal Medicine.
K. Robin Yabroff, Ph.D., from the American Cancer Society in Atlanta, and colleagues examined the national prevalence of medical financial hardship. A total of 68,828 adults aged 18 to 64 years and 24,614 aged ≥65 years were identified from the 2015 to 2017 National Health Interview Survey.
The researchers found that 56.0 percent of adults reported any medical financial hardship in the previous year, representing about 137.1 million adults. Hardship was more common in adults aged 18 to 64 years than in those aged ≥65 years in the material, psychological, and behavioral domains (28.9, 46.9, and 21.2 percent versus 15.3, 28.4, and 12.7 percent, respectively). In both age groups, lower educational attainment and more health conditions correlated strongly with hardship intensity. In the younger group, the uninsured were more likely to report multiple domains of hardship than those with some public or private insurance (52.8 versus 26.5 and 23.2 percent, respectively). In the older group, the trend was similar for individuals with Medicare only versus those with Medicare and public coverage or Medicare and private coverage (17.1 versus 12.1 and 10.1 percent, respectively).
"With increasing prevalence of multiple chronic conditions, higher patient cost-sharing, and higher costs of health, the risk of hardship will likely increase in the future," the authors write. "Thus, development and evaluation of the comparative effectiveness and cost-effectiveness of strategies to minimize medical financial hardship will be important."
Abstract/Full Text (subscription or payment may be required)
https://www.physiciansbriefing.com/internal-medicine-21/health-cost-news-348/more-than-half-of-u-s-adults-have-medical-financial-hardship-745745.html
K. Robin Yabroff, Ph.D., from the American Cancer Society in Atlanta, and colleagues examined the national prevalence of medical financial hardship. A total of 68,828 adults aged 18 to 64 years and 24,614 aged ≥65 years were identified from the 2015 to 2017 National Health Interview Survey.
The researchers found that 56.0 percent of adults reported any medical financial hardship in the previous year, representing about 137.1 million adults. Hardship was more common in adults aged 18 to 64 years than in those aged ≥65 years in the material, psychological, and behavioral domains (28.9, 46.9, and 21.2 percent versus 15.3, 28.4, and 12.7 percent, respectively). In both age groups, lower educational attainment and more health conditions correlated strongly with hardship intensity. In the younger group, the uninsured were more likely to report multiple domains of hardship than those with some public or private insurance (52.8 versus 26.5 and 23.2 percent, respectively). In the older group, the trend was similar for individuals with Medicare only versus those with Medicare and public coverage or Medicare and private coverage (17.1 versus 12.1 and 10.1 percent, respectively).
"With increasing prevalence of multiple chronic conditions, higher patient cost-sharing, and higher costs of health, the risk of hardship will likely increase in the future," the authors write. "Thus, development and evaluation of the comparative effectiveness and cost-effectiveness of strategies to minimize medical financial hardship will be important."
Abstract/Full Text (subscription or payment may be required)
https://www.physiciansbriefing.com/internal-medicine-21/health-cost-news-348/more-than-half-of-u-s-adults-have-medical-financial-hardship-745745.html
Device Spots Lymphedema Early in Breast Cancer Patients, to Help Stop It
An easy-to-use, noninvasive device can detect early signs of the cancer complication known as lymphedema, a new study reports.
Lymphedema is the buildup of fluid in the body’s tissues when a part of the lymph system is damaged, as can happen in cancer care, according to the U.S. National Cancer Institute (NCI).
The fluid causes swelling, usually in the arms or legs, and can be severe enough to limit range of motion in an affected limb.
Detecting lymphedema sooner can give doctors a chance to intervene when it’s possible to stop development of this chronic, painful and potentially debilitating condition.
Researchers found that when they used a bioimpedance spectroscopy device after breast cancer surgery, the risk of lymphedema dropped by nearly 70%. The device uses slight electrical currents to measure fluid volume in body tissue.
“Bioimpedance spectroscopy takes about a minute to do, and the device takes up the space of a scale. If you used this every time you saw a breast cancer patient for an appointment, you would know if they’re starting to get into trouble,” said study lead author Sheila Ridner. She directs the Ph.D. in Nursing Science Program at the Vanderbilt School of Nursing in Nashville, Tenn.
Ridner said there are several causes of lymphedema, including surgery, trauma, radiation, obesity, genetics and some types of chemotherapy.
“It’s hard to predict with 100% accuracy who will get lymphedema,” she said.
The condition often occurs in women who have had lymph nodes removed from the underarm area along with breast cancer surgery, according to the NCI.
Treatment includes wearing compression garments or bandages to prevent fluid buildup, weight loss, a special type of massage and some light exercises.
The study included just over 500 patients who completed at least a year of follow-up. All had had breast cancer surgery — either with or without lymph node involvement. The average age was 59 and 77% of the women were white. Almost 57% had stage 1 cancer; 39% had stage 2 or 3 breast cancer.
The women were randomly assigned to testing with either a tape measure (to detect swelling through increased size) or with bioimpedance spectroscopy. Ridner said the device is painless and can also detect body fat and bone mass.
Just 5% of women who had bioimpedance spectroscopy eventually needed complex interventions for swelling, compared to nearly 15% of women who had tape-measure surveillance.
Dr. Lauren Cassell, chief of breast surgery at Lenox Hill Hospital in New York City, said despite surgical advances, lymphedema is still a big concern. She wasn’t involved in the current research.
“Breast cancer-related lymphedema remains one of the most challenging problems we face in patients undergoing treatment for breast cancer,” Cassell explained. “Once a patient develops swelling of the arm, it becomes almost impossible to eliminate it. We can only hope to keep it under control.”
Cassell said identifying early swelling looks promising for preventing long-lasting lymphedema.
“Using a tape measure is just not as sensitive as the use of bioimpedance spectroscopy,” she said. “This study suggests that following these patients closely in the immediate postoperative period with bioimpedance spectroscopy may help us avoid significant lymphedema and its subsequent complications.”
The study is scheduled to be presented Thursday at the American Society of Breast Surgeons’ meeting, in Dallas.
Findings presented at meetings are typically viewed as preliminary until they’ve been published in a peer-reviewed journal.
More information
The U.S. National Cancer Institute has more about lymphedema .
SOURCES: Sheila Ridner, Ph.D., R.N., professor and director, Ph.D. in Nursing Science Program, Vanderbilt School of Nursing, Nashville, Tenn.; Lauren Cassell, M.D., chief, breast surgery, Lenox Hill Hospital, New York City; May 2, 2019, presentation, American Society of Breast Surgeons’ meeting, Dallas
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