Putting the Brakes on Testosterone Prescriptions

Published in Pawtucket Times on March 30, 2015

Sophisticated mass marketing pitching testosterone to combat age-related complaints combined with lax medical guidelines for testosterone prescribing can be hazardous to your physical health, even leading to strokes and death, warns an editorial in this month’s Journal of the American Geriatrics Society.
The March 2015 editorial coauthored by Dr. Thomas Perls, MD, MPH, Geriatrics Section, Department of Medicine, Boston Medical Center in Boston, and Dr. David Handelsman, MBBS, Ph.D., ANZAC Research Institute, in New South Wales, Australia, expressed concern over commercial-driven sales of testosterone, effectively increasing from “$324 million in 2002 to a whopping $2 billion in 2012, and the number of testosterone doses prescribed climbing from “100 million in 2007 to half a billion in 2012.”

Pitting Patients Against Patients

The editorial authors see the “40 fold” increase of testosterone sales as the result of “disease mongering,” the practice of widening the diagnostic boundaries of an illness and aggressively promoting the disease and its treatment in order to expand the markets for the drug. Glitzy medical terms, like “low T” and “andropause,” showcased in direct-to-consumer product advertising pit aging baby boomers against their physicians, who demand the prescriptions, say the authors.

“Clearly, previous attempts to warn doctors and the public of this disease mongering that is potentially medically harmful and costly have not been effective, says co-author Dr. Perls.

The epidemic of testosterone prescribing over the last decade has been primarily the proposing of testosterone as a tonic for sexual dysfunction and/or reduced energy in middle-aged men, neither of which are genuine testosterone deficiency states,” observes Dr. Handelsman.

According to the National Institutes on Aging (NIA), the nation’s media has increasingly reported about “male menopause,” a condition supposedly caused by diminishing testosterone levels in aging men. “There is very little scientific evidence that this condition, also called andropause or viropause, exists. The likelihood that an aging man will experience a major shutdown of testosterone production similar to a woman’s menopause is very remote.”

The authors agree with the NIA’s assessment, but go further. They point out in their editorial that for many men, testosterone does not decline with age among men retaining excellent general health, and if it does, the decline is often due to common underlying problems such as obesity and poor fitness. Those who hawk testosterone have developed advertising that focus on common complaints among older men such as decreased energy, feeling sad, sleep problems, decreased physical performance or increased fat.

But, many times a testosterone level won’t even be obtained and the patient is told that, simply based on these common symptoms alone or with minor reductions in serum testosterone, they have “late onset hypogonadism” or that their erectile dysfunction may be improved with testosterone treatment, say the authors. But the authors also point out the true hypogonadism is the cause in fewer than 10% of men with erectile dysfunction.

FDA Enters Debate

The U.S. Food and Drug Administration’s (FDA) recent dual commission findings concluded that testosterone treatment (marketed as ‘low T’) is not indicated for age-associated decline. The benefits of this “deceptive practice” remain unproven with the risks far outweighing the perceived benefits,” says the agency. Pharmaceutical companies are now required to include warning information about the possibility of an increased risk of heart attacks and stroke on all testosterone product labels.

Health Canada, Canada’s FDA, recently echoed the FDA’s committee findings that age-related hypogonadism has not been proven to be a disease-justifying treatment with testosterone. Both agencies warn of an increased risk of blood clots in the legs and lungs and the possibility of increased risk for heart attack associated with testosterone use.

In a statement, James McDonald, the chief administration officer for the Board of Medical Licensure and Discipline, says: “There is a concern in healthcare regarding direct-to-consumer prescribing of medication. At times, the prescription is not evidence-based, and can lead to misuse. There is concern with Testosterone, a schedule 3 controlled substance,that can be used as a performance-enhancing drug. The Rhode Island Board of Medical Licensure (BMLD) investigates complaints regarding all types of misuse of prescription medications as well as complaints regarding over-prescribing.”

Drs. Handelsman and Perls also warn about another drug commonly hawked for anti-aging, growth hormone. The FDA requires that doctors perform a test to demonstrate that the body does not produce enough growth hormone. “Those who market and sell HGH for these common symptoms nearly never perform the test because if they did a properly performed test, it would almost never be positive because the diseases that cause growth hormone deficiency in adults, such as pituitary gland tumors, are very rare,” said Perls. Growth hormone is well known for its side effects, including joint swelling and pain and diabetes. Ironically, opposite of anti-aging claims, growth hormone accelerates aging, increases cancer risk and shortens life span in animal studies.

In the editorial, Perls and Handelsman call upon professional medical societies and governmental agencies to take definitive steps to stop disease mongering of growth hormone and testosterone for conjured-up deficiencies.
“These steps include the banning of ‘educational’ and product advertising of testosterone for these contrived indications,” said Perls. “Furthermore, the FDA and Health Canada should require a physician’s demonstration of a disease process proven to benefit from testosterone administration in order to fill a lawful prescription for testosterone.”

Tightening Up Prescription Guidelines

The issue of prescribing testosterone is firmly on the medical profession’s radar screen with the FDA’s recent committee’s findings and Perls and Handelsman’s pointed editorial calling for the medical profession to seriously tighten up the lax consensus guidelines in order to stop the medically inappropriate prescribing of testosterone.
Rather than pushing testosterone, wouldn’t it be a “mitzvah – a good deed- if the nation’s pharmaceutical companies ran public service commercials stressing the importance of losing weight, exercising and eating nutritious meals as a way to effectively combat age-related problems, like low libido. But, this won’t happen because it is not a revenue generator or good for the company’s bottom line.

Herb Weiss, LRI ’12 is a Pawtucket-based writer covering aging, health care and medical issues. He can be reached at hweissri@aol.com.

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Study Shows Meal Deliveries Positively Benefit Seniors

Published in Woonsocket Call on March 22, 2015

In 2013, Dr. Kali Thomas, an assistant professor at Brown University’s Center for Gerontology and Healthcare Research, published a study that found home delivered meals can keep persons age 60 and older at home, allowing them to age in place.  The study’s data also indicated that some states would experience cost savings if they expanded meals on wheels because that could delay a Medicaid recipient’s entry into costly nursing home care.

The “More Than a Meal” pilot research study, conducted by Thomas, was released on March 2, 2015 the Alexandria, Virginia-based Meals on Wheels America, the oldest and largest national group representing over 5,000 community-based senior nutrition programs. The gerontologist found benefits far beyond basic nutrition identified by her earlier 2013 study — health and psychological benefits, too, particularly for those seniors who live alone.

Details of Groundbreaking Research Study

Thomas, contracted by Meals on Wheels America with funding provided by AARP Foundation, designed and executed the 15-week pilot study, involving over 600 older participants, in eight sites around the country, including the Ocean State.  Study participants either received personally delivered fresh meals daily, or weekly bulk deliveries of frozen meals, or just simply remained on a waiting list.

The Brown University researcher found those living alone who received meals showed statistically significant reductions in feelings of isolation, an effect that was greater if they received meals daily rather than weekly.  They also felt significantly less lonely, were less worried about staying in their homes, and said they felt safer. Those also receiving meals experienced fewer falls and hospitalizations.

Thomas said that based on her personal experience as a driver for Meals on Wheels of Rhode Island and as the family member of a meals recipient (her 98-year old grandmother), she was not at all surprised to see the positive benefits she observed anecdotally emerge as significant in a rigorous research study.

Elle Hollander, President and CEO on Wheels America, notes that her members have “faced tough choices forced by limited funding, rising costs, unprecedented demand and need, and increasingly for-profit competition.”  Hollander says, “We now have the research-backed evidence that confirms what we’ve all know for decades anecdotally through personal experience: that Meals on Wheels does in fact deliver so much more than just a meal.”

AARP State Director Kathleen Connell agrees.  “It really has been no secret that home-delivered meals are a critical for the older population, as well as the disabled. With  Kali Thomas’s earlier Brown data released in 2012 in our award-winning senior hunger documentary Hungry in the West End, the newest research reinforces what Thomas said in film: the nutritional benefits and relief from food preparation allows people to live in their homes longer and to stay healthier. And so, there are long term healthcare benefits as well as savings to the state if the investment in home-delivered meals delays someone’s transition from independence or home-based care into a Medicaid-supported nursing facility.”

A Call for More State Funding

Heather Amaral, Executive Director of Meals on Wheels of Rhode Island agrees with the benefits of visiting volunteers to the recipients, but stressing that the volunteer benefits, too, from the bond that develops. “There are many studies that show volunteering is good for your health and spirit, she says.

Amaral expresses pride that Rhode Island was selected as one of eight pilot sites in the study.  “This study proves what we’ve observed through the years—Meals on Wheels deliveries keeps people out of nursing homes and in their own homes longer,” she says.

According to Amaral, in 2014 Meals on Wheels of Rhode Island’s Home Delivered Meals program provided 316,524 meals to 2,298 individuals.  Over the years she has seen federal funding remain stagnant, while state funding has declined.  Last year’s budget allocated $200,000 to Meals on Wheels, down from $530,000 that was allocated by the General Assembly in 2006.   But, Governor Raimondo’s submitted budget does reinstate $ 330,000 more in funding, if approved by the Rhode Island General Assembly, she says.

Clearly, Governor Gina Raimondo recognizes the importance of Meals on Wheels as she begins to reshape Rhode Island’s long-term care continuum.  The Governor states, “Programs like Meals on Wheels are important investments. These programs are one of the strategies in our toolbox to keep people healthy and in their own homes. Particularly as we work to reinvent Medicaid to support better health outcomes and provide better value to taxpayers, we will continue to support programs like Meals on Wheels that help our most vulnerable seniors stay in their homes and in the community.”

The Rhode Island General Assembly must not be penny-wise and pound foolish.  Support the Governor’s budget to ratchet up funding for Meals on Wheels.  It is a sound policy move to put the breaks to spiraling Medicaid costs, by making the system more efficient and rooting out fraud and waste.   We must balance the State’s limited budget funds to keep older Rhode Islanders at home as long as possible.  But, if nursing home care is need, the Rhode Island General Assembly must allocate the necessary Medicaid funding to provide efficiently delivered quality of care.

Herb Weiss, LRI ’12 is a Pawtucket-based writer who covers aging, health care and medical issues.  He can be reached at hweissri@aol.com.

 

Rhode Island Can Hold Its Own When It Comes to Music

Published in Woonsocket Call, on March 15, 2015

New York, L.A. and Nashville have long been considered the music capitals of the United States. Now, with the Rhode Island Music Hall of Fame gearing up for its fourth annual induction season, Little Rhody is poised to prove it has the right combination of musical talent to hold its own against these highly regarded music communities.

Next month, trombonist/composer George Masso and 12 others join an elite group of Rhode Island musicians: those who have been recognized not only for their major impact on Rhode Island’s music scene but also on the national stage. Cranston native Masso, along with the other new inductees, will be enshrined by the Rhode Island Music Hall of Fame (RIMHOF) at this year’s induction ceremonies and concert events. Every year the Pawtucket-based nonprofit, formed in 2011, celebrates, honors, and preserves the legacy of Ocean State musicians, educators, and industry professionals.

Rick Bellaire, RIMHOF Vice Chair and Archive director, says it was an easy choice to recognize the 88-year-old musician. “During his illustrious career, George has excelled in just about every area of the music business – trombonist, composer, pianist, recording artist, arranger and educator,” adding that the George played with many of the national big bands in the 1940s and ‘50s and has toured and recorded as a sideman with some of our greatest jazz legends including Benny Goodman, Bobby Hackett and The World’s Greatest Jazz Band.

According to Bellaire, Masso has also released more than a dozen albums as a leader which feature many of his own compositions. “He also taught music in the Cranston public schools for eleven years and another eight years at the University of Connecticut mentoring some of our finest musicians including RIMHOF inductees,” says Bellaire.

George Masso will be inducted into RIMHOF along with Mark Cutler and his bands, The Schemers and Raindogs; Brenda Bennett, Nelson Eddy, George Wein, Duke Belaire, Paco Zimmer; Georgie Porgie & The Cry Babies, The Others and The Ascots (recognizing the great Rhode Island garage bands of the ‘60s); and Bob Petteruti, Marty Ballou and Marty Richards (in the new “MVP sideman award” category).

“This year, we will be honored to have some of the most senior inductees with us,” he continued, “all of whom are still active participants on the music scene, including Mr. Masso, drummer/band leader Duke Belaire (83) and bassist/educator Bob Petteruti (85).”

The Music Hall of Fame initiative,” says Bellaire, “provides a great opportunity to not only acknowledge Rhode Island’s musical greats and celebrate their achievements, but to finally have an organization whose primary goal is to promote and preserve Rhode Island’s rich musical heritage in all its forms. With actual exhibit space, coupled with our online archive, we have in place the tools to curate and showcase the best of Rhode Island’s musical artistry.”

Adds Robert Billington, Chair of RIMHOF noted, “This year’s class of inductees is especially amazing due to the variety of music styles and musical periods that we are recognizing. The thousand Saturday nights that these musicians spent on the road throughout their careers will be recognized this April as their colleagues throughout Rhode Island stand to applaud their successes.”

“Our Induction ceremony in April has become the place for a ‘who’s who’ in Rhode Island music. The Rhode Island Music Hall of Fame Induction Ceremony and Concert is the place to be and be seen at as we continue to showcase the history of Rhode Island’s musical heroes,” says Billington.

This year, Bellaire said, there will be two induction events, and 11 more displays will be unveiled to celebrate inductees. Eventually, the museum will have more than 100 displays as well as memorabilia and interactive components.

The 2015 induction ceremonies will take place on two days, April 20 and April 26, at two separate locations.

The jazz inductions will take place on Monday, April 20, 7:00 p.m. at Bovi’s Tavern, 287 Taunton Avenue, East Providence, before the weekly performance by the Bovi’s big band, the John Allmark Orchestra. Being honored on that day will be George Masso, Bob Petteruti and Duke Belaire, the founder of the Bovi’s band.

The Induction Ceremony and Concert is set for Sunday, April 26, 2:00 p.m. at The Met and Hall of Fame itself, both located within the Hope Artiste Village complex, 999 Main St., Pawtucket, RI. Sunday’s afternoon event will include the unveiling of nine new exhibits as well as performances by The Schemers and Raindogs, Brenda Bennett, The Ascots, The Others, and an all-star jam session led by two of this year’s MVP sideman award winners, Marty Ballou and Marty Richards. Sunday’s concert will be preceded by the unveiling of eleven new 2015 inductee exhibits.

Tickets for the April 26 event at The Met are $20.00 in advance and $25.00 at the door. The 2 p.m. unveiling of the inductee exhibits is free and open to the public; a ticket will be required for entrance to the 3 p.m. concert in The Met. Information regarding the April 20 event and tickets for April 26 can be found at www.rhodeislandmusichalloffame.com.

All proceeds from RIMHOF’s annual induction events go toward creating the museum displays, acquiring recordings and memorabilia, and digitizing that collection for permanent online access for future generations. All organizational work has been donated by members of the Board Of Directors and a staff of volunteers.

For general information regarding the Rhode Island Music Hall of Fame, contact Dr. Robert Billington at 401-724-2200 or at bvri@aol.com.

Herb Weiss LRI ’12 is a Pawtucket-based writer who covers aging, health care and medical issues.  He can be reached at hweissri@aol.com.