Gum Health Day 2020 to be celebrated worldwide on 12 May

“Say NO to bleeding gums” is the slogan for Gum Health Day 2020, to be celebrated worldwide on 12 May. Its goal is to raise public awareness about bleeding gums, which are usually a sign of a gum disease that will require treatment at the dental practice.

Gum diseases are usually painless and the most frequent sign of suffering from them is bleeding gums. “Gums are not supposed to bleed without reason,” says Andreas Stavropoulos, co-ordinator of Gum Health Day 2020. “If your gums bleed when you brush your teeth or when you bite on food – an apple, for example – you should visit your dentist for a periodontal check-up as soon as possible.”

Prof Stavropoulos adds that “Gum Health Day 2020 aims to remind people that gum health is a key factor for general health and well-being throughout life, and that gum disease is an important public-health issue as it is linked to very serious conditions.”

Gingivitis, periodontitis, and peri-implantitis are chronic, inflammatory gum diseases that affect hundreds of millions adults worldwide.

Unfortunately, gum diseases are still poorly acknowledged by the public, even though scientific evidence shows that they may pose a threat to general health as they are associated with cardiovascular disease, diabetes, chronic kidney disease, rheumatoid arthritis, certain forms of cancer, pregnancy complications, erectile dysfunction, and other serious or chronic conditions.

More than 40 countries are joining Gum Health Day 2020 – from Europe, the Americas, Africa, Middle East, Asia, and Australasia. The EFP and its affiliated societies have organized a wide variety of initiatives – most of them digital because of the Covid-19 pandemic – which include educational videos, publications, social-media campaigns, an Instagram Live session, and other online initiatives. More details are available at

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In the framework of Gum Health Day 2020, the EFP encourages dentists, researchers, and other health-related professionals to sign and disseminate the EFP Manifesto: Perio and General Health, an international call to action for the prevention, early detection, and treatment of gum disease.

Individuals and organizations are invited to endorse it by clicking at and join the more than 1,100 professionals, dental practices, companies, and universities having supported it so far.

Last year, Gum Health Day was celebrated in 47 countries: 28 in Europe, 13 in Latin America, five in Asia, and one in Africa. Twelve countries from outside the EFP decided to take part in this campaign around the slogan ‘Healthy gums, beautiful smile’.

Gum Health Day 2020 is a major EFP initiative to get the public informed every year of the value of healthy gums for a healthy life,Even if we are living exceptional, strange times worldwide with the Covid-19 pandemic, we should not forget the role of our gum health in our global health. Taking care of our gums also applies in these days.”

Xavier Struillou, President, European Federation of Periodontology


European Federation of Periodontology

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Noninvasive PEMF to treat men suffering from benign prostatic hyperplasia

Reviewed by Emily Henderson, B.Sc.Apr 9 2020

Physicians from Sapienza University in Rome have published promising results of a small prospective interventional trial using noninvasive pulsed electromagnetic field therapy (PEMF) to treat men suffering from benign prostatic hyperplasia (BPH). After one month of treatment, prostate volume and symptoms significantly decreased. Men with moderate-severe lower urinary tract symptoms and without metabolic syndrome benefitted more from the treatment. The study was recently published in Andrology, the highest ranked journal of andrological research.

Benign prostatic hyperplasia is a common affliction of older men

Most men over the age of 50 will develop enlarged prostate, or BPH. The walnut-sized prostate gland produces prostatic fluid, which is a main component of semen. It can grow to the size of a lemon by the time a man is 60 years of age and may press against the bladder and urethra. BPH includes chronic lower urinary tract symptoms, such as frequent and urgent urination, sense of incomplete bladder emptying, and decreased force of the urine stream. A common complaint is having to get up at night to urinate. Approximately 60% of men over the age of 60, and 80% of men over the age of 80, will experience the symptoms of BPH.

A poorly understood disease

Risk factors for BPH include age, diabetes, cardiovascular disease, hypertension, and metabolic syndrome. The etiology of the disease is not completely known, but inflammatory damage is the most likely cause. Inflammation triggers fibrosis and lack of oxygen to affected tissue, resulting in structural changes in the prostate. This creates a cycle of inflammation-fibrosis-hypoxia-inflammation, which in turn causes glandular remodeling and tissue growth (Berger, et al., 2003; Mishra, et al., 2007).

Traditional treatment options for BPH include medications such as alpha-blockers and 5α-reductase inhibitors or surgical interventions. Side effects of treatments may include the inability to ejaculate, retrograde ejaculation (semen flows backwards into the bladder), erectile dysfunction, and even loss of bladder control. Some men affected have reported that taking saw palmetto, an herbal supplement, gives them relief but clinical evidence for its effectiveness is not conclusive. Clearly, effective and less invasive treatments for this common disease are needed.

Pulsed Electromagnetic Field Therapy and BPH

PEMF consists of low frequency pulsed energy waves and has been used for a variety of ailments such as various orthopedic conditions. For example, PEMF has been shown to reduce pain and improve function for those afflicted with osteoarthritis. The electromagnetic field is produced by a device that reduces inflammation by promoting growth of new blood vessels, dilation of blood vessels, and tissue remodeling. The overall effect is reduction in tissue hypoxia. These aspects of PEMF make it an ideal noninvasive option to treat BPH (Frey, 1974; Hug and Roosli, 2012).

In this regard, only a few studies have used PEMF to treat enlarged prostate. Two published studies used a desktop PEMF device to treat BPH in men with positive, but variable, results (Elgohary and Tantawy, 2017; Giannakopoulos, et al., 2011). A more recent study in 20 dogs, which also suffer from enlarged prostate as they age, found an average of 57% reduction in prostatic volume following three weeks of treatment with a portable PEMF device, without any interference in semen quality, testosterone levels, or libido (Leoci, et al., 2014).

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The current study used a similar PEMF device and treatment program as the dog study. Twenty-seven naive patients with BPH and lower urinary tract symptoms were enrolled. They received a battery of tests including transrectal ultrasound and standardized questionnaires at baseline. They then used a handheld PEMF device (Magcell® Microcirc, Physiomed Elektromedizin) for five minutes twice daily for 28 consecutive days. The tests were then repeated. Nine patients elected to continue therapy for three more months while others discontinued. A final health evaluation was completed at four months for all patients.

“The patients were happy with this simple treatment plan, and we were very pleased that their symptoms significantly improved after only one month of treatment, without any sort of side effects,” noted corresponding author Prof. Andrea Isidori.

PEMF was able to significantly reduce prostate volume after just 28 days of therapy, resulting in a median decrease of 5.4%. Symptoms also improved, with high compliance and no effects on hormonal and sexual function. There were no differences between subjects who continued therapy for three more months and those who did not, showing that one month of therapy may be sufficient for the device to effectively reduce prostate volume and symptoms. Patients with moderate-severe lower urinary tract symptoms and without metabolic syndrome (a cluster of conditions that include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels and that increase the risk of heart disease, stroke, and type 2 diabetes) seemed to benefit more from this treatment.

Next steps

The pilot study provided promising evidence for the usefulness of PEMF to treat BPH. The decrease in prostate size was less than that attained in dogs, however. This may be due to differences between dogs and humans in the architecture of prostate tissue and growth characteristics due to BPH. Additional research with a larger number of men and a control group is needed to better understand the optimal schedule and duration of treatment, the impact of treatment on prostate tissue, and the potential use of PEMF in conjunction with traditional BPH therapies.

The Parsemus Foundation supported this pilot study in men following the successful trial in dogs, with the goal of finding an inexpensive, noninvasive method to alleviate the symptoms of enlarged prostate. We look forward to partnering with other funders to sponsor additional research on the use of PEMF to treat BPH.”

Linda Brent, Ph.D., Executive Director, Parsemus Foundation


Parsemus Foundation

Journal reference:

Tenuta, M., et al. (2020) Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia. Andrology.

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Men with erectile dysfunction have higher risk of death, study suggests

Reviewed by Emily Henderson, B.Sc.Mar 31 2020

Men with erectile dysfunction have a higher risk of death, regardless of their testosterone levels, suggests a study accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting, and publication in a special supplemental section of the Journal of the Endocrine Society.

As both vascular disease and low testosterone levels can influence erectile function, sexual symptoms can be an early sign for increased cardiovascular risk and mortality.”

Leen Antonio, M.D., Ph.D., lead researcher, KU Leuven-University Hospitals in Belgium

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Low testosterone levels have been linked to a higher risk of death in middle-aged and older men, but results from large studies are inconsistent, Antonio said. Studies have also linked sexual dysfunction with mortality in older men.

The new study used data from the European Male Ageing Study (EMAS), a large observational study that was designed to investigate age-related hormonal changes and a broad range of health outcomes in elderly men. The researchers analyzed data from 1,913 participants in five medical centers. They analyzed the relationship between their hormone measurements and sexual function at the beginning of the study, and whether they were still alive more than 12 years later.

During the average follow-up period of 12.4 years, 483 men–25 percent–died. In men with normal total testosterone levels, the presence of sexual symptoms, particularly erectile dysfunction, increased the risk of death by 51 percent compared with men without these symptoms.

Men with low total testosterone levels and sexual symptoms had a higher risk of death compared with men with normal testosterone levels and no sexual symptoms.

Men with erectile dysfunction, poor morning erections and low libido had a higher mortality risk compared to men with no sexual symptoms. In men with these three sexual symptoms, the risk of dying was almost 1.8 times higher compared to men without symptoms. In men with just erectile dysfunction, the risk of dying was 1.4 times higher compared to men without erectile dysfunction.

Levels of free testosterone (the testosterone that is easily used by the body) were lower in those who died. Men who had the lowest levels of free testosterone had a higher risk of death compared to men who had the highest levels.


The Endocrine Society

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Why do men stop treatment for erectile dysfunction?

A new study published in the journal IJIR: Your Sexual Medicine Journal in March 2020 reports the most common reasons why men stop their treatment for erectile dysfunction. The most common reasons were that the treatment did not work, cost too much, or had unacceptable side effects. Loss of interest in sexual relationships was another primary reason.

Men’s beliefs about treatment for erectile dysfunction—what influences treatment use? A systematic review. Image Credit: Gorstevanovic / Shutterstock

In addition, the study also shows how important it is to educate men about the condition, how it can be treated, and the possibility of changing their beliefs to help them make use of the treatment. A good understanding of what factors modify treatment utilization decisions is necessary to help patients make better choices.

Researchers say, “erectile dysfunction can have a negative effect on men’s quality of life. However, this can potentially be improved with successful treatment for the condition. The findings from our research indicate that rates of discontinuation for treatment are high. Understanding the reasons for discontinuation of treatment is essential with regards to improving treatment use and, subsequently, quality of life in this patient population.”

What is erectile dysfunction?

Erectile dysfunction (ED) is the persistent inability to have or sustain an erection during sexual activity. It occurs in up to a tenth of men under 49 years, increasing to one in five between 60 and 69 years, but in over 70% of men past the age of 70.

ED can adversely affect self-confidence, cause depression, and reduce the quality of life.

Most men with ED are treated with oral phosphodiesterase type 5 inhibitors, but if this does not work, injectable drugs and urethral suppositories are sometimes used. As a last resort, penile implants are used.

The study

The researchers looked at the data from 50 studies, covering over 14,370 men. They asked about how they found the treatment, and what factors were linked to discontinuation of treatment.

The findings

The study found that the rates of discontinuation due to unsatisfactory response (in terms of hardness and duration of erection) varied with the type of treatment, but occurred in about a third of patients across all studies. For instance, with men on tablets, the rate was about 12%, but with injectables, about 15%. On the other hand, the use of suppositories was associated with inconsistent or poor efficacy resulting in discontinuation in about a third of patients.

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Discontinuation as a result of adverse effects such as headaches, Peyronie’s disease or priapism, and urethral pain was reported by less than 3% of men on tablets, 8% of men on injectables and 15% of men using suppositories.

A small percentage of men also reported that factors dealing with the quality of sexual relationship had to do with their discontinuation of the treatment. This factor was cited by about 7% of men on pills, 9% on injectables, 9% taking suppositories, and 7% of men with penile implants.

About 6% of men on pills said they stopped because they felt their partner was no longer interested in the sexual relationship, about 6% because they were not ready emotionally to invest in the relationship, and 4% because of conflict with their partners. Thus, there is a small but significant contribution by the quality of the sexual relationship on the continuation of treatment.

Said Williams, “Men’s perceptions of their sexual relationships and their emotional readiness for sexual activity are important when considering the most appropriate treatment for a man and his partner.”

Despite the safety and effectiveness of PDE5Is, many men stopped them because of not wanting to tie down sexual activity to their medication use, the lag time until response, and the cost of treatment.

Other misconceptions had to do with the fear of drug dependency, heart disease as a result of the medications. At the same time, embarrassment or inconvenience while buying the medication was also a factor for some people. If the medication was not on hand, such as if the patient forgot to buy it, the resulting embarrassment was also severe.


The limitations of the study were lack of data on the duration of ED, its severity, and the quality of the relationship, in many studies. The outcome was difficulty in evaluating how these factors contributed to treatment duration.

Surprisingly only 12/50 studies looked at psychological or cognitive factors leading to the cessation of treatment, despite the psychogenic origin of ED in almost all cases. The treatment cost was not explored thoroughly.

The researchers suggest that future work should explore the role of beliefs about ED and its treatment because this could play a pivotal role in the decision to continue or stop therapy.

For instance, patient expectations about treatment effectiveness play a part in awakening perceptions of treatment failure. Men who got back to their doctors about the side effects of treatment were more likely to continue the treatment, the study found. This suggests that finding out what thoughts the patient has about his treatment, and trying to correct any misconceptions therein, may help to promote the use of this treatment. This is a crucial way to help doctors avoid treatment failure.

Psychological theory could be a valuable tool, suggest the authors, to look at what hinders men with ED from coming forward to exploit current treatment modalities. It could also spot the factors which promote or enhance treatment utilization. Thirdly, it could help assess how this treatment is being viewed and used by the end-users. Such evaluation procedures could help this group of patients to use available ED treatments more effectively.

Journal reference:

Williams, P. et al. (2020). Men’s beliefs about treatment for erectile dysfunction—what influences treatment use? A systematic review. IJIR: Your Sexual Medicine Journal,

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Intense and targeted radiotherapy could slow progression of certain prostate cancers

A new study has identified that highly targeted and strong doses of a type of radiotherapy called stereotactic ablative radiation (SABR) could slow disease progression among a subgroup of men who have hormone-sensitive prostate cancer that has only spread to a few other parts of the body.

radiotherapyImage Credits: Thomas Hecker /

The findings are based on the primary outcomes of a phase II randomized clinical trial called ORIOLE. The study, which began in 2016 and was led by researchers at Johns Hopkins Kimmel Cancer Center, compared the effectiveness of the “wait and watch” approach with SABR treatment among men with recurring oligometastatic prostate cancer.

“It has been a longstanding question, especially important now in the era of immunotherapy, whether any type of radiation, and SABR specifically, can stimulate the immune system,” says study leader Phuoc Tran.

Tran, who is a professor of molecular radiation sciences at the Johns Hopkins University School of Medicine is co-director of the center’s “Cancer Invasion and Metastasis” program, along with post-docs Andrew Ewald and Ashani Weeraratna. The goal of the program is to study and understand the process of cancer metastasis in order to improve on or develop therapies for the treatment of advanced cancers.

Now, Tran says: “Our trial offers the best data to date to suggest that SABR can cause a systemic immune response.”

About oligometastatic cancers

An oligometastatic cancer is one that has spread from the primary site of disease to one to three other parts of the body

Prostate cancer is the third most prevalent cancer worldwide and the most common cancer among men in the US, where it kills approximately 30,000 every year.

An estimated 1.3 million men globally are diagnosed with prostate cancer every year. Of those newly diagnosed cases, about twenty percent have a disease that has spread (metastasis), although it is not known exactly how many of them have oligometastatic cancer.

Metastatic prostate cancer cannot be cured and men who suffer from recurrent hormone-sensitive cancers may opt to delay receiving the standard treatment (androgen deprivation therapy) because it commonly causes a number of adverse side effects, including erectile dysfunction, reduced bone density, fractures, muscle loss, tiredness, loss of strength and gynecomastia (breast tissue growth).

What did the researchers find?

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As reported in the journal JAMA Oncology, the ORIOLE trial found that among 54 patients (aged an average of 68 years) with recurrent oligometastatic prostate cancer, disease progression was observed within six months for seven of 36 (19%) participants who received SABR, compared with 11 of 18 (61%) participants who underwent the “wait and watch” observation approach.

Tran and team also found that at six months since enrollment, the risk for new cancers having developed was significantly lower among the SABR group than among the observation group, at 16% versus 63%.

Participants did not report any significant between-group differences in side effects or pain felt in relation to the two treatment regimens.

What are the implications of the study?

On analyzing immune cells in blood samples taken from the patients, the researchers found that the SABR approach was associated with the expansion of T cell populations. Tran says this suggests that the radiotherapy had induced a systemic immune response to the cancers.

The study also suggests that it could be clinically beneficial to couple SABR with other immunotherapies as a treatment approach to the recurrent cancers, but Tran also warns that such potential benefits would first need testing in clinical trials.

The researchers also identified a set of tumor gene mutations that are known to be involved in the suppression of cancer and the presence of this mutational signature was associated with an increased risk for disease progression, including among the men who received SABR.

“This may be a molecular signature which is indicative of the underlying biology of the patient’s cancer.”

Professor Tran Phuoc, Johns Hopkins University School of Medicine

He adds that this potential biomarker could help indicate to clinicians “which patients are going to benefit the most from a metastasis directed therapy like SABR” compared to a systemic treatment such as chemotherapy.”

Furthermore, Tran says the findings also suggest that treatment with SABR may reduce or even eliminate the cell signaling that promotes micrometastases in cases of recurrent oligometastatic prostate cancer, as opposed to simply halting disease until metastatic tumors become large again.  

Next, the researchers intend to conduct further phase II studies to see whether they can slow disease progression in more patients.

The team is also conducting another trial called RAVENS that targets newly formed metastatic bone lesions with a combination of SABR and the drug radium-23.


Intense form of radiation slows disease progression in some men with prostate cancer. EurekAlert! 2020. Available at:

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NCCN publishes recommendations for assessing quality improvements in cancer care

The National Comprehensive Cancer Network (NCCN) has published a curated list of high-impact measures for assessing quality improvements in cancer care. The recommendations reflect a landscape analysis from leading oncology experts; they evaluate measures that, if implemented, will move the needle on cancer care standards in America, with potential implications for policy and coverage. The article, Quality Measurement in Cancer Care: A Review and Endorsement of High-Impact Measures and Concepts, is available via open access in the March 2020 issue of JNCCN–Journal of the National Comprehensive Cancer Network.

The NCCN Quality and Outcomes Committee was first founded in 2016 in order to develop quality and outcome measures in oncology that are:

  • more standardized
  • contemporary
  • clinically relevant
  • easily implemented, and
  • broadly applicable.

The committee reviewed 528 existing oncology quality measures and new measure concepts that could be appropriate for development. This list was narrowed down into 22 recommendations–based on importance, supporting evidence, opportunity for improvement, and ease of measurement–including endorsement of 15 existing measures and seven new concepts proposed for development.

The key question underlining all of our efforts is: how can we use quality measurements to improve the experience and outcomes for people with cancer?. We reached out to a large number of people including expert clinicians, patient advocates, payers, and health information technology specialists to determine which quality and outcomes measurements would be the most meaningful across the cancer care ecosystem. We paid particular attention to cross-cutting measures that would signify better delivery of care for all different cancer types, while also drilling down into specifics for the highest incidence cancers that affect the most people. These 22 measures represent a feasible standard for documenting quality improvement in cancer care.”

Thomas A. D’Amico, MD, Duke Cancer Institute, Chair of the NCCN Quality and Outcomes Committee

“These recommendations from NCCN differ from certification programs–we are sharing them free-of-charge to allow cancer programs everywhere to be more efficient and focused with their resources while tracking quality improvements,” explained Robert W. Carlson, MD, Chief Executive Officer, NCCN. “There’s a concerted effort toward value-based care; we want to ensure that these payment models reduce costs without reducing quality, and in fact improve outcomes. The current landscape for quality measurements is broad, and it’s difficult to know how to prioritize for quality improvements. This framework from NCCN aligns processes for measuring attainable cancer care improvements that will translate into better outcomes for patients.”

The selected measures are as follows (italics indicates new opportunities for development):

  • Across Cancer Types
    • Evidence-Based Concordance Measure: Proportion admitted to the intensive care unit (ICU) in the last 30 days of life
    • Evidence-Based Concordance Measure: Performance status documented prior to initiating chemotherapy regimen
    • Patient Experience Measure: Patients are offered smoking cessation counseling if current smoker
    • Treatment Team: Proportion receiving chemotherapy in the last 14 days of life
    • Treatment Team: Chemotherapy given within 30 days of end of life
    • Treatment Team: Cancer stage documented
    • Treatment Team: Proportion dying from cancer in an acute care setting
  • Breast Cancer
    • Evidence-Based Concordance Measure: Patients with M0 disease, and 4 or more involved axillary lymph nodes, receive breast/chest wall plus regional lymph irradiation as part of their treatment
    • Evidence-Based Concordance Measure: Tumor markers are not performed during the period of follow-up surveillance for those who have completed breast cancer treatment with curative intent
    • Evidence-Based Concordance Measure: Cardiac function is assessed before starting and at least every 4 months during trastuzumab therapy
  • Colorectal Cancer
    • Evidence-Based Concordance Measure: For patients with resected pathologic stage 2 and 3 colorectal cancer in surveillance, carcinoembryonic antigen (CEA) is performed at least every 6 months for 5 years
    • Evidence-Based Concordance Measure: Patients with rectal cancer are staged with a computed tomography (CT) scan of chest, abdomen, and pelvis and pelvic MRI with contrast or endorectal ultrasound before surgery
    • Evidence-Based Concordance Measure: Adjuvant chemotherapy is not administered for patients with pathologic stage 1 colorectal cancer.
    • Evidence-Based Concordance Measure: Positron emission tomography (PET) scan is not performed for patients with locoregional colorectal cancer
    • Evidence-Based Concordance Measure: Patients with colon cancer are staged with CT scan of chest, abdomen, and pelvis before surgery
  • Lung Cancer
    • Evidence-Based Concordance Measure: Palliative care consult is offered to patients with metastatic NSCLC within 8 weeks of diagnosis
  • Prostate Cancer
    • Evidence-Based Concordance Measure: Patients in the high or very-high risk prostate cancer groups, who receive radiation therapy, receive ADT
    • Patient Experience Measure: All patients treated with surgery or radiation for localized prostate cancer should be assessed for urinary incontinence and erectile dysfunction with tools such as the UCLA Prostate Cancer Index questions and the Sexual Health Inventory for Men (SHIM)
    • Treatment Team: Prostate-specific antigen (PSA) has been measured in the last 12 months for patients with prostate cancer to monitor disease
    • Evidence-Based Concordance Measure: Patients with newly diagnosed prostate cancer have a risk group assigned
    • Evidence-Based Concordance Measure: Patients in the very low-risk and low-risk prostate cancer groups do not receive androgen deprivation therapy (ADT)

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In addition to Drs. D’Amico and Carlson, the NCCN Quality and Outcomes Committee includes:

  • Alan Balch, PhD, The National Patient Advocate Foundation
  • Lindsey A.M. Bandini, MPH, National Comprehensive Cancer Network
  • Al B. Benson III, MD, FACP, FASCO, Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Stephen B. Edge, MD, FACS, FASCO, Roswell Park Comprehensive Cancer Center
  • C. Lyn Fitzgerald, MJ, National Comprehensive Cancer Network
  • Robert J. Green, MD, Flatiron Health
  • Wui-Jin Koh, MD, National Comprehensive Cancer Network
  • Michael Kolodziej, MD, ADVI
  • Shaji Kumar, MD, Mayo Clinic Cancer Center
  • Neal J. Meropol, MD, Flatiron Health
  • James L. Mohler, MD, Roswell Park Comprehensive Cancer Center
  • David Pfister, MD, Memorial Sloan Kettering Cancer Center
  • Ronald S. Walters, MD, MBA, MHA, MS, The University of Texas MD Anderson Cancer Center

Full descriptions of the 22 recommendations, including an explanation of how they each represent important diagnostic and treatment decisions across the continuum of care, can be found at


National Comprehensive Cancer Network

Journal reference:

D’Amico, T.A., et al. (2020) Quality Measurement in Cancer Care: A Review and Endorsement of High-Impact Measures and Concepts. JNCCN.

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Hormone blocker shocker: Drug costs 8 times more when used for kids

Dr. Sudeep Taksali, an orthopedic surgeon, became worried that his 8-year-old daughter had already grown taller than his 12-year-old son. And sometimes she had an attitude more befitting a teenager. Something seemed wrong.

Taksali and his wife, Sara, realized their daughter had grown 7 inches in two years and was showing signs of puberty. They took her to the doctor, who referred her to a pediatric endocrinologist for a work-up.

Eventually, their daughter was diagnosed with central precocious puberty. It’s a rare condition that meant she would go through sexual development years earlier than her peers and would likely stop growing prematurely, too.

Adopted two years ago from India, she’s a bright, avid reader who loves to do kettlebell workouts with her dad and Zumba with her mom. Still, moving across the world and learning a new language is no easy feat.

“Having one more thing for her to deal with … where there might be maybe some negative attention drawn to her changing body,” Taksali said. “That was one of my big concerns.”

On the advice of their daughter’s doctors, the Taksalis decided to put her early puberty on hold. The recommended treatment is a product commonly known as a hormone blocker. Implanted beneath the skin in her arm, it releases a small dose of a drug each day that increases the body’s production of some hormones while decreasing others. The result is the child’s progression toward adulthood slows.

The doctors told them there were two nearly identical drug implants — each containing 50 milligrams of histrelin acetate — made by the same company, Endo Pharmaceuticals, an American drugmaker domiciled in Ireland. But one was considerably cheaper.

Taksali wanted his daughter to get the less expensive option, but his insurer said it would cover only the more expensive option. Resigned, he asked the hospital how much it would charge for the expensive drug he had been hoping to avoid.

Then the estimated bill came.

The Patient: Sudeep Taksali’s daughter, 8. She is insured through her father’s high-deductible UnitedHealthcare plan.

Total Estimated Bill: The hospital told Taksali the insurer wouldn’t cover the cheaper version of the drug, Vantas. After that, he spent hours trying to get an estimated bill ahead of the scheduled implantation. Supprelin LA would cost around $95,000 plus the cost of implantation, the hospital’s billing department told him. Under his health plan, he has a $5,000 deductible and 20% coinsurance obligation, so he was worried how much he might owe.

Service Provider: OHSU Hospital in Portland, Oregon, part of Oregon Health & Science University.

Medical Procedure: Implantation of a drug-delivery device containing 50 mg of histrelin acetate, to stave off early puberty.

What Gives: Supprelin LA was approved by the Food and Drug Administration in 2007 for central precocious puberty and has a list price of $37,300. Vantas was approved by the FDA in 2004 for late-stage prostate cancer and has a list price of $4,400.

The main difference between the two medicines is that Supprelin LA releases 65 micrograms of the drug a day, and Vantas releases 50 micrograms a day. Each implant lasts about a year.

The 15-microgram difference in daily dose with Vantas is less than the weight of an eyelash, and the doctors who recommended the treatment said it has the same effectiveness for children with central precocious puberty.

The much higher price for the children’s version of the drug grated on Taksali. “From a parent standpoint, as a physician, as a consumer, it feels abusive,” he said. “There’s sort of a predation on parents who have that sense of vulnerability, who will do anything within their means to help their children.”

Taksali questions why Endo Pharmaceuticals makes two nearly identical drug delivery implants with vastly different prices.(Kristina Barker for KHN)

Drugmakers can use the same chemical compound to create different branded drugs with different disease targets – and apply for FDA approval for each. FDA spokesperson Brittney Manchester said by email, “Generally, it is the sponsor’s decision.” Endo makes both Supprelin LA and Vantas.

Indeed, other drugmakers have used the maneuver: Pfizer makes two versions of sildenafil citrate: Viagra for erectile dysfunction and Revatio for pulmonary arterial hypertension.

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When we asked Endo Pharmaceuticals why Supprelin LA and Vantas had such different price tags, the company said the implants aren’t identical and treat very different conditions. It didn’t respond to questions about why that meant the prices should be different and whether it was somehow more expensive to manufacture one versus the other.

Resolution: Taksali spent more than a month trying to make sure his daughter could use the cheaper drug and, finally, the week his daughter was scheduled to have the procedure, it was approved. The hospital submitted the request again and UnitedHealthcare said it would cover it.

“Our coverage policies are aligned with FDA regulations and Vantas is not FDA approved to treat central precocious puberty,” UnitedHealthcare spokesperson Tracey Lempner said in an email. “In this specific case, when the provider expressed concern over the cost of Supprelin LA, we worked with them to allow for coverage of Vantas.”

Taksali’s daughter got the Vantas implant in late January.

When he got a breakdown of charges afterward, it listed $608 for the implantation and $12,598.47 for Vantas — about three times its list price. (Hospitals add markups to the list prices.) Still, that’s far less than the $95,000 the Supprelin LA bill would have been.

According to his explanation of benefits, after insurance, Taksali will owe $4,698.45 – most of his high deductible. Because it is early in the year, the family had not yet spent any of its 2020 deductible.

Taksali said he fought for the lower cost drug on principle.

“Even if it is the insurance company’s money, it’s still somebody’s money,” he said. “We are still contributing to those premium dollars.”

The Takeaway: If you need an expensive drug, the first thing you should do is ask your doctor if there are cheaper alternatives. Often different formulations of the same chemical compound carry vastly different prices. In this family’s case, the version to treat prostate cancer patients was far cheaper than the pediatric version for a hormone imbalance.

More commonly, the different formulations relate to different dosages – two 250 mg tablets may be cheaper than a 500 mg pill. Likewise, a pill you have to take three times a day may be far less expensive than the once-a-day extended-release version.

When a coverage denial leads to costly care, patients can ally with their health care providers or employers to appeal, though it can be time-consuming. Self-insured employers, in particular, won’t want to waste health care dollars either. For Taksali, using social media to direct-message UnitedHealthcare garnered prompt responses and some answers.

If there aren’t other options, drug manufacturers often offer coupons to help patients with their copays. You can find some using GoodRx or by visiting the drugmaker’s website directly.

KHN senior correspondent JoNel Aleccia contributed to this report.

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New understanding of neurovascular coupling

A new study published in the journal Nature in February 2020 reports the discovery of a control mechanism in mouse brains, which makes it possible to sensitively regulate the flow of blood to different areas of the brain, to supply enough to more active areas.

The brain is among the highest consumers of blood in the human body. In fact, an adult human brain requires about 20% of the energy output of the whole body. However, it is exquisitely dependent on the rest of the body for the energy it needs each moment because it has zero reserve and zero stores. Thus, the cardiovascular system needs to supply the required nutrition every moment.

However, the needs of the brain vary widely depending on the activity level of this organ. Thus, the body needs to gauge the amount of blood it needs at each moment – and not just to the brain overall, but to each part of the brain at any given moment.

This is achieved by an ingenious neurovascular coupling in which blood flow quickly increases to meet the needs of a highly active brain area. In some disease conditions such as high blood pressure, diabetes, and Alzheimer’s disease, this process becomes much less sensitive.

Imaging tests like functional magnetic resonance imaging (fMRI) are also highly dependent on the fluctuating blood flow to various brain areas to measure and localize brain activity.

Arteries in the brain. Image Credit: Gu Lab/Harvard Medical School

Arteries in the brain. Image Credit: Gu Lab/Harvard Medical School

The importance of neurovascular coupling is thus understandable. Nonetheless, it remained a matter of research as to how the brain communicated with the blood vessels to bring about such a precise and rapid response.

The current study carried out a set of experiments to understand how neurovascular coupling works. They found that the brain’s arteries are actively involved in this process of regulating blood flow in response to the levels of a protein called Mfsd2a. This protein has already been discovered to be a vital component of the safety cordon posed by the blood-brain barrier.

Older research by the same investigators showed that the Mfsd2a protein made the blood-brain barrier a strong unit by preventing the formation of tiny lipid bubbles called caveolae, which carry molecular signals. Caveolae originate in the brain capillaries in mice.

However, they also found that arteries, which make up about 5% of brain vessels, did not express this protein, and as a result, they showed large amounts of caveolae. This finding was explored in the current study.

To find out what happens in active areas of the brain concerning blood flow, they used whisker stimulation on live healthy mice who were being imaged for brain activity using 2-photon microscopy.

The findings

The study has done much to uncover changes in the cellular, subcellular, and even molecular components that facilitate neurovascular coupling.

In the first test, the whisker stimulation resulted in increased activity within the brain cells, with the arteries widening and increased blood flow in the sensory cortical area responsible for that sensation. On the other hand, when the test was repeated in mice that were genetically modified to eliminate the caveolae, the neural activity was replicated but not the increase in blood flow nor the arterial widening. The scientists infer that neurovascular coupling was lost in these mice as a result of eliminating caveola production.

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Next, the team inhibited the formation of caveolae by specifically suppressing the arterial endothelial cell lining. They did this by inducing the production of Mfsd1a, which is normally absent in these cells, as noted above. The result was the absence of caveolae and, again, weak neurovascular coupling. This proves how important a role is played by the caveolae in this process.

Further experiments showed that the endothelial cells of the arterial lining played a vital and irreplaceable role in this process. When one brain area becomes active, the smooth muscle cells around the arteries relax, causing arterial dilation and more blood flow to that area.  On the other hand, there is another way in which neurovascular coupling works independently via caveolae, which transfers the signals to relax from the nerve cells to the smooth muscle cells.

Researcher Brian Chow says, “For over a century, we’ve known that this phenomenon exists, where neural activity rapidly increases blood flow in a very local and temporally precise manner. But the mechanisms for how the nervous system talks to the vascular system to coordinate this event were largely unknown, and it was astonishing to find that arterial endothelial cells play such an active role in the process.”

Another important finding was the fact that the function of caveolae is not a variable of nitric oxide signaling, which is an essential determinant of blood vessel dilation. The well-known medications nitroglycerine, used for congestive heart failure, and sildenafil, for erectile dysfunction, both operate via this pathway.

To test whether this was the case with caveolae, the team suppressed both caveolae formation and the nitric oxide pathway. The result was a complete lack of neurovascular coupling. This means that both these systems are robust but independent processes in blood flow regulation as a result of nerve activity.

However, where caveolae production in arteries regulates sensitive and smaller changes in blood flow, nitric acid may be responsible for more large-scale shifts. Thus the system is not only capable of grossly modulating blood flow but of making the fine adjustments that are characteristic of this regulatory process.

The team is now analyzing the types of signaling molecules within the caveolae to uncover its detailed working. The more they know about it, the better they may be able to construct new experiments to find out its role in health and disease.

As a result of these findings, says researcher Chenghua Gu, scientists can now “dissect this process and determine, for example, whether the neurovascular coupling impairments that we see in diseases like Alzheimer’s are the result of pathology or the cause.”

Explaining this statement, Gu says, “We’ve established a very powerful set of genetic tools that allow us to not only identify but manipulate the molecular mechanisms at the heart of neurovascular coupling. For example, even if increased local blood supply is impaired, the brain still has blood flow and oxygen. What is the impact of this on neurons? How does this affect brain function? And does it contribute to conditions like neurovascular dementia? We are now in the position to perform rigorous science that could allow us to answer questions like these.”

Journal reference:

Chow, B.W., Nuñez, V., Kaplan, L. et al. Caveolae in CNS arterioles mediate neurovascular coupling. Nature (2020).

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