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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