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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.
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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.
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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
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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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Mental Prep for Better Performance

“Get your head in the game!” Coaches say it to players all the time to get them to focus. The same advice can help you be more enthusiastic about your workouts. Here are five ideas:
1. Set both short-term and long-term goals based on your current abilities. Celebrate each one as you reach it and then re-set it. According to the American Council on Exercise, a goal should meet five different criteria to be effective. Make sure each goal is:
  • Specific: You should be able to articulate it in one simple sentence.
  • Measurable: The goal should be something you can see, like an amount of weight lost or duration of a workout.
  • Attainable: The goal should represent a challenge to you, but not be impossible to reach.
  • Relevant: It should be important to you and your life.
  • Time-Bound: The time you allot to reach the goal shouldn’t be open-ended, which could lead to procrastination. Set a reasonable time period for achieving it.
2. Identify what type of pre-exercise prep gets you psyched, such as quiet focused breathing or loud pulsing music.
3. Develop and repeat a mantra, an uplifting statement of what you know you can do. This will help you develop a positive attitude and have an unshakable belief in yourself. It will naturally get stronger as you reach goals.
4. Practice mental toughness. This is the mindset that helps you stay determined, focused and confident. Self-talk is a motivator that can help keep your confidence level high. Talk to yourself the same way you’d encourage a loved one: Remind yourself of your skills, your accomplishments and future goals.
5. Use mental imagery. Picture yourself reaching each goal, whether it’s completing a spin class or a 5K run. Tap into the image whenever you need to refocus during exercise.
More information
The American Council on Exercise has more specifics on setting goals that you’ll attain.
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Breast Surgeons’ Group Issues New Mammogram Guidelines

The largest organization representing U.S. breast surgeons is issuing new screening guidelines, advising women at average risk to begin annual mammograms at age 40.
Those guidelines differ from advisories from the influential U.S. Preventive Services Task Force (USPSTF), which moved first mammogram screening from 40 to 50 years of age, as well as that of the American Cancer Society, which puts the starting age at 45.
The American Society of Breast Surgeons (ASBrS) says it based the new guidelines on a different model than that used by the USPSTF.
The new guidelines recommend that all women undergo formal risk assessment by age 25. Screening based on specific risk factors is recommended for women with an increased risk of breast cancer.
Women with average risk should begin annual screening at age 40, however.
“Routine screening for women age 40 to 49 has been unequivocally demonstrated to reduce mortality by 15%,” ASBrS president Dr. Walton Taylor said in a society news release.
“However, today’s USPSTF guidelines delay annual screening until age 50 because they are based on an ‘efficiency’ statistical model that also considers the impact of potential screening risks,” he said.
Risks or adverse effects in the USPSTF’s calculations include the cost of screening, as well as the probability “of false-negative and -positive results,” Taylor explained. Mistaken findings can mean unnecessary anxiety and unnecesssary medical procedures, he said.
In contrast, the new ASBrS guidelines “are based on a ‘life-years gained’ model,” Dr. Julie Margenthaler said in the news release.
“They are based solely on the demonstrated breast cancer survival benefits. The ASBrS prioritizes life,” said Margenthaler. She directs breast surgical services at the Siteman Cancer Center and is also professor of surgery at Washington University School of Medicine, both in St. Louis.
Individual risk assessment is a key part of the new guidelines, the ASBrS said.
For example, women with a predicted lifetime breast cancer risk of 20% or more should begin mammography screening, with access to supplemental MRI imaging, starting at age 35.
Similar imaging should start at age 25 for women with breast cancer-related genetic abnormalities, the group advised.
“While mammographic screening is not as easy or accurate in younger women, when we find and treat cancer, the benefits in years of life saved are highly significant. Many current guidelines will leave a subset of these women to die,” Margenthaler explained.
Dr. Dana Smetherman is chair of the American College of Radiology (ACR) Commission on Breast Imaging. “Catching more cancers early by starting yearly screening at age 40 — rather than less frequent or later screening — increases the odds of successful treatment and can preserve quality of life for women,” she said in the news release.
“We are pleased that ASBrS has reaffirmed their support for this most sensible approach,” said Smetherman. The new ASBrS guidelines are in keeping with ACR recommendations.
Two more experts in breast cancer care supported the new guidelines.
“As breast surgeons we have long realized that one-size-fits-all screening is a problem,” said Dr. Alice Police, regional director of breast surgery for Northwell Health Breast Care Centers of Westchester County in Sleepy Hollow, N.Y.
She believes that guidelines that don’t account for individual risk profiles “sacrifice many ‘life years’ for some women for a greater good that claims to be more cost-effective and to create less anxiety.”
Breast surgeons “think the life years are more important,” Police said.
Dr. Kristin Byrne is chief of radiology at Lenox Hill Hospital in New York City. She believes the new guidelines are “individualized, in order to balance the benefits and harms of screening in each category without risking the patient’s lives.
“For example, mammography should not be used on a patient under the age of 30 [under the ASBrS guideline],” Byrne noted. Instead, young, at-risk patients “with genetic mutations or prior chest wall radiation should have annual screening MRI until they feel it is safe for mammography screening,” she said.
And at the other end of the life span, the new guidelines recommend stopping screening mammography when life expectancy is less than 10 years. This is “medically reasonable,” Byrne said.
“Many guidelines have arbitrarily chosen the age of 74 to stop screening mammography, but this does not reflect the life expectancy of many individuals, and the risk of breast cancer increases with age,” she said.
Finally, “screening every year for women of average risk over the age of 40 is essential to early diagnosis,” Byrne believes.
More information
The U.S. National Cancer Institute has more on mammograms.
SOURCES: Alice Police, M.D., regional director, breast surgery, Northwell Health Breast Care Centers in Westchester, Sleepy Hollow, N.Y.; Kristin Byrne, M.D., chief, radiology, Lenox Hill Hospital, New York City; American Society of Breast Surgeons, news release, May 3, 2019
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Alnylam posts strong Onpattro sales as competition heats up

  • Sales of Alnylam Pharmaceuticals’ rare disease drug Onpattro more than doubled between the fourth quarter of last year and the first three months of 2019, outstripping expectations and helping to ease worries of a slow start for the therapy.
  • By the end of the first quarter, more than 400 patients were on commercial treatment with Onpattro, which last year became the first RNA interference therapeutic to win U.S. approval. That figure was double what Alnylam reported at the end of 2018.
  • Onpattro remains in the early phases of its launch, however, and investors appeared cautious on how well Alnylam can identify new patients with hereditary ATTR amyloidosis, the disease Onpattro treats. A new competitor looms as well: Pfizer expects to win Food and Drug Administration approval this July for tafamidis, a potential rival.

As first-to-market with a new type of drug, Alnylam has had to build a market for Onpattro (patisiran).
While Onpattro has been commercially available for less than a year, first quarter results suggest Alnylam has had some success at accomplishing that task.
“We’re … very pleased with the overall and continued global demand this quarter even with competition from recent market entrants and the availability of investigational drugs through a very large expanded access program and clinical trials,” said Alnylam president Barry Greene, speaking on the company’s first quarter conference call.
Greene’s referring to Ionis Pharmaceuticals and Akcea Therapeutics’ Tegsedi (inotersen), which launched with a similar indication several months after Onpattro, and tafamidis, an experimental drug from Pfizer that treats a related phenotype of ATTR amyloidosis.
Tafamidis could win approval by July, potentially making the amyloidosis market more competitive.
Alnylam’s results from the first three months of 2019 help to build confidence the biotech can maintain its lead.
Sales of Onpattro totaled $26.3 million, up from $12.1 million in the fourth quarter. While start forms submitted to the company through its Alnylam Assist program fell, the company highlighted that prescriptions outside that program now account for 20% to 25% of demand for the drug — a sign of increasing physician comfort, Alnylam said.
Alnylam also noted signs that some doctors are switching patients to Onpattro from other products, including tafamidis.
“A number of patients in Europe, specifically France and Germany, are patients that a physician has deemed progressing on tafamidis and need to add or switch to Onpattro,” Greene said. Tafamidis has been approved in Europe for familial amyloid polyneuropathy, a related indication.
Yet while first quarter numbers beat Wall Street expectations, Alnylam still has its work cut out for it. Initial sales were boosted by a bolus of patients coming onto commercial drug from the clinical development program.
To sustain growth, Alnylam will need to continue identifying new patients. To do that, the biotech has set up a genetic screening program called Alnylam Act. More than 13,000 patient samples have been submitted so far, yielding 850 positive tests for the pathogenic TTR mutation.
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