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Testosterone Therapy

An increasing number of men are trying testosterone therapy to help treat erectile dysfunction, loss of sex drive and fatigue – common symptoms of low testosterone (Low T). Drug companies are making record profits, but these medications are linked to serious side effects. Men filed lawsuits after suffering from heart attacks, strokes and blood clots.

What is Testosterone Therapy?

Testosterone therapy, also called androgen replacement therapy, is usually used to treat male hypogonadism (low testosterone or “Low T”) – a condition in which the body fails to make enough hormones because of a problem with the testicles or pituitary gland. A number of prescription medications are available to treat hypogonadism.

While these medications may address Low T, they also may contribute to something more serious: heart failure.

Since 2000, more than 1 million men had their T levels tested, and half a million began using hormone replacement therapy. Today, four times as many men take these drugs than did in 2000. In 2011, nearly one in 25 men in their 60s was taking testosterone.

Experts estimate that sales of these products could reach $5 billion by 2017. Today, American men spend $2 billion on testosterone each year.

Why Men Use Testosterone

Usually, men use testosterone drugs to address a medical issue – like Low T – or enhance their physical performance. There are two types that are used: bioidentical and synthetic.

Bioidentical Hormones

AndroGel and a number of other products contain bioidentical hormones. Scientists create bioidentical hormones in a lab to chemically match the hormone naturally made by the body. In theory, this results in fewer side effects.

Synthetic Hormones

Synthetic hormones are altered from the original chemical makeup, so they do not match those made by the body. These types of drugs typically have more side effects.

Treating Low T and Erectile Dysfunction

The amount of the hormone naturally made by the male body starts to decrease around age 40. Lack of this key androgen in older men can cause health issues, including osteoporosis, loss of muscle mass and coordination (sarcopenia), and psychological symptoms. Doctors prescribe these drugs to treat these symptoms.

Some men turn to testosterone to increase sex drive and treat erectile dysfunction (ED) – difficulty getting erections. In fact, according to an article published by Harvard Health Publications, some doctors used it to treat ED before Pfizer released Viagra in 1998.

Dr. Abraham Morgentaler is an advocate of using testosterone for treating men with sexual dysfunction, including ED.

“It’s well established that testosterone by itself, for men with sexual dysfunction that includes erectile dysfunction, can improve erections in the majority of men who take it,” he told Harvard.

Morgentaler does admit that some men may require testosterone and Viagra, however, in order to have adequate erections.

Testosterone can be administered in a skin patch, skin gel, by injection, a solution applied to the armpit, or a patch applied to the upper gum. A number of clinics offer testing for Low T and sell testosterone medications, and several drug companies are marketing testosterone replacement drugs to these clinics and physicians, as well as to the public.

Once testosterone therapy is initiated, the patient usually undergoes lifelong treatment. Doctors will monitor the patient’s hormone levels every six months to a year. Depending on the patient, the checkups may be more frequent.

Enhancing Physical Performance

Because testosterone allows men to increase muscle mass and performance, athletes and body builders use testosterone-boosting supplements and drugs to increase strength and improve recovery time. The practice of using these drugs is called “doping.” Athletes use both synthetic and bioidentical supplements. Body builders in particular are known for their use of synthetic hormones to rapidly increase muscle mass.

Medical Opinion on Testosterone

Medical Opinion

“Testosterone can help increase muscle mass in a much faster fashion. Athletes who use anabolic steroids may find that they’re able to increase their endurance and their strength by doing the same amount of training as they would otherwise,” Dr. Anthony Yin, an endocrinologist at California Pacific Medical Center in San Francisco, told SF Gate.

Performance-Enhancing Drugs (PEDs)

Using performance-enhancing drugs, testosterone included, is illegal in most sports. Recently, the mixed martial arts (MMA) organization, Ultimate Fighting Championship (UFC), also banned the use of the drug.

PEDs and Testosterone
Long-Term Effects of Testosterone Therapy

Long-Term Effects

While the drug is helpful to men who are clinically diagnosed with Low T, athletes who abuse these drugs solely to boost performance face a number of possible side effects. Athletes may use large doses of the drug over long periods of time to get the desired effect, and abusing the drug can cause liver damage, high cholesterol and heart problems. There are also links to possible enlargement of the prostate as well as cancer.

Heart Attacks and Other Side Effects

While research shows these drugs increase lean muscle development and sex drive in men, they are also linked to serious side effects. Heart attacks are at the center of these.

One of the more recent studies gathered data from men older than 65 and also men younger than 65 who were diagnosed with some heart disease. In both groups, men were twice as likely to have a heart attack within 90 days of starting androgen replacement therapy. Younger men with pre-existing conditions could have as much as a three-fold increased risk of heart attack in the first 90 days of treatment.

As a result of two recent studies showing an increase in heart attack risk, the U.S. Food and Drug Administration (FDA) released a safety announcement in January 2014 stating that it is “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” Furthermore, the agency stressed that “none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.”

Other health problems linked to treatment can include:
Worsening of Sleep Apnea Hormonal Imbalance
Polycythemia (high levels of red blood cells that can lead to blood clots and stroke) Dangers to Women and Children
Prostate Cancer

Testosterone Lawsuits

A number of men sued the makers of AndroGel, Abbott Laboratories and AbbVie, after using the drug and suffering from heart attacks, strokes and blood clots. Testosterone lawsuits target multiple manufacturers over their testosterone products.

Stephen Nichols, 59, had a heart attack after using AndroGel. Another man, Edward Downes, 51, says AndroGel ruined his life after he suffered a stroke. He now walks with a cane and has trouble doing daily tasks like taking out the garbage. Both men say they want the company to stop selling the dangerous drug.

In June 2014, the U.S. Judicial Panel on Multidistrict Litigation grouped all federal testosterone lawsuits in the U.S. District Court for the Northern District of Illinois. Judge Matthew F. Kennelly will oversee the proceedings. Plaintiffs’ attorneys predict thousands of testosterone lawsuits to be filed.

Critics and Risks

Some doctors say that in reality, few men are actually diagnosed with clinical hypogonadism, and that many “symptoms” are just a normal part of aging. A new study published in the Journal of Clinical Endocrinology & Metabolism shows record numbers of men are turning to testosterone therapy simply to increase their sex drive and energy levels.

Critics say that Low T is a condition marketed by drug companies to increase profits. Dr. Lisa Schwartz, a professor at the Dartmouth Institute for Health Policy and Clinical Practice, wrote a paper on drug companies marketing these hormone therapies. “We’re giving people hormones that we don’t know they need for a disease that we don’t know they have, and we don’t know if it’ll help them or harm them,” she told The New York Times.

Raising levels of testosterone can be dangerous, and researchers caution that it can cause serious health risks, including stroke, prostate cancer and even death. Doctors are concerned that the long-term effects have not yet been properly studied. Now they are focusing on the study of Low T products and heart issues.

Vanessa Blanco

Patient Advocate vblanco@drugwatch.com
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View Sources
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