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.

Increasing Your Odds of Living to 100 and Beyond

Published January 18, 2013, Pawtucket Times

Just barely holding onto the record for being the nation’s oldest person for about two weeks, Mamie Rearden, of Edgefield, a 114-year-old South Carolina woman, died on Jan. 2, just three weeks after a fall broke her hip. The amazing thing though, is for how long she was so healthy and living independently. According to recently published research, most people who reach the age of 110 years and beyond, only spend, on average the last 5 years of their incredibly long lives with age-related diseases.

According to the Associated Press (AP), the Gerontology Research Group, an organization verifying age information for the Guinness World Records, noted that Rearden’s Sept. 7, 1898, birth was recorded and therefore verified in the 1900 U.S. Census, making her the nation’s oldest living person after last month’s passing of 115-year-old Dina Manfredini of Iowa. Before Rearden died, she was more than a year younger than the world’s oldest person, 115-year-old Jiroemon Kimura of Japan.

Rearden, married to her husband for 59 years until his death in 1979, raised 11 children, 10 of whom are alive. The former teacher and housewife first learned how to drive a car at age 65. At this time she worked for an Edgefield County program locating children whose parents were keeping them out of school, reported AP.

Studying the Nation’s Oldest Citizens

Dr. Thomas Perls, a geriatrician who heads the Boston University-based New England Centenarian Study (NECS), considers Rearden’s longevity to be a very rare occurrence. She was one of around 70 supercentenarians (people who have reached age 110) living in this country, he says.

Almost 20 years ago, when Perls’ longitudinal study began, about 1 per 10,000 people in the United States survived to age 100. However, he notes that they are now more common at a rate of 1 per 5,000.

“Now most people think that getting to your eighties is expected,” says Dr. Perls. Simply put, more Americans are now living longer today than in previous generations because the high childhood mortality rates in the early 1900s have been slashed due to hugely improved public health measures like clean water, vaccinations and a safe food supply combined with a more educated population and improved socioeconomic conditions, he noted.

Meanwhile, vaccinations for older people, effective antibiotics and medications for what have become chronic rather than acute lethal diseases, as well as curative surgeries are now markedly improving middle-age people’s chances of living to even older ages, adds Dr. Perls.

Finding the Secrets of Longevity

Dr. Perls says his passion for working with the nation’s oldest began when at 16 years old he worked as an orderly in a nursing home. In 1986, he received his medical degree from the University of Rochester, later a Masters from the Harvard School of Public Health. His specialization in geriatrics ultimately would propel him into a life-long interest in finding the secrets as to why people successfully age well and live for more than a century.

Born in Palo Alto, California, Dr. Perls later moved to Colorado and is now residing in Boston. A professor at Boston University School of Medicine, Dr. Perls, board certified in internal medicine and geriatric medicine, has coauthored a book for the lay public, entitled, Living to 100, co-edited an academic book, and penned 106 juried articles. He is the author of the online Living to 100 Life Expectancy Calculator. It uses the most current and carefully research medical and scientific data to estimate how old you will live to be (www.livingto100.com) and provides some general advice according to your answers to about 40 questions that take about 7 minutes to complete.

Initially at Harvard University, the NECS later relocated to Boston University School of Medicine, giving his longevity initiative “room to grow,” says Perls, who is NECS’s founding director. Today this demographic initiative, now considered to be the world’s largest study of centenarians and supercentenarians, is funded by the National Institutes of Health (NIH), private foundations and “cherished” individual donors, he says. Study participants and their families fill out health and family history questionnaires, and provide a blood sample for studying their genes.

Along with the NECS, Dr. Perls also directs the Boston-based study center of the multi-center and international Long Life Family Study (LLFS) which is a study of families that have multiple members living to extreme old age. Both initiatives are enabling researchers to find out how and why centenarians and their children, who are in their seventies and eighties, live the vast majority of their lives disability-free.

As to those who participate in his NECS and LLFS initiatives, the youngest is about 45 years old (a very young child of a centenarian) and the oldest ever enrolled was 119 years old, the second oldest person in the world, ever, states Perls. Since he begun the NECS, out of 2,200 participants, 1,200 were age 100 and over, he added. The remaining participants were children of centenarians or in the study’s control group. “Because of their ages, most of these folks have now passed away,” he said, adding that at any one time about 10% of the total centenarians in the study are alive.

Unraveling the Data

During his long career studying centenarians, the research findings indicate that it is common for centenarians to have brothers and sisters who also live to be very old. “Exceptional longevity runs strong in families,” he notes.

Dr. Perls’ research also debunked long-held beliefs that the longer you live, the sicker you get. But even if centenarians were afflicted by multiple age-related diseases in their nineties, on average 90 percent functioned independently at the average age of 93 years, he says. Centenarians living to age 100 were found to have avoided age-related disabilities as well as diseases until, on average, their last 5 years.

While a healthy life style is definitely important to living into ones’ eighties with much of that time spent in good health, Dr. Perls states that having the right genes becomes more and more crucial for living to a much older age.

Research indicates that living to your mid-eighties is 70-80% environmental and habits and 30-20% genes. Seventh Day Adventists were found to have the longest average life expectancy in the United States, that is 88 years. Most of that longevity was likely due to their healthy habits which include being vegetarian, regularly exercising, not smoking or drinking alcohol and also doing things that decrease the effect of stress.

However, many Americans do just the opposite, with unhealthy diets, not exercising and still, many people smoke, notes Dr. Perls. So it is not surprising that on average, Americans die 8-10 years earlier than Seventh Day Adventists, at the average age of about 80 years. (According to the United Nations Department of Economic and Social Affairs, in 2010, the U.S. life expectancy was 75 years for males and 80 years for females.)

“We should take advantage of our genes and not fight them,” Perls says, by adopting healthier lifestyles.

Perls believes that DNA research on very old people should for now not focus on identifying genes that predict diseases. Rather the findings in the near future might just offer clues to how some genes slow the aging process and protect people from age-related diseases like Alzheimer’s and heart attacks. Such discoveries could lead to the development of drugs that protect against multiple chronic diseases.

A Final Note…

Make working to create a healthier life style a top priority on your New Year’s resolution list. This effort might just ratchet up your life expectancy into the mid-eighties and if you have longevity in your family, even longer. Why not stop smoking, and watch your drinking, too. Even make exercise, weight training and keeping your mind active as part of your daily routine. Combine these lifestyle changes with better eating habits, meditating or yoga, or even doing low impact exercises like tai chi, and you’re on your way to increased longevity.

Ultimately, a healthier life style along with good genes may well help you increase the odds of living to 100 and beyond.

If you know anyone who is 105 years old or older, please mention the New England Centenarian Study to them and/or their family. The Study can be reached at (888) 333-6327 or you can go online http://www.bumc.bu.edu/centenarian for more information.

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