Along with the stream of drug company revenue has come rigorous debate over the use of testosterone to treat what some doctors believe is a natural, age-related decline in male hormone levels. Perhaps most importantly, there’s division regarding the question of whether or not it is safe to use testosterone to treat a condition many doctors and researchers deny is a disease.
In January of this year, the FDA issued a “public health alert” concerning the safety of Low T medications after two studies linked the use of AndroGel, Testim and Axiron and similar type testosterone medications to heart attacks, strokes and sudden cardiac arrest in certain men.
“As one ages, testosterone levels decline,” says Dr. Ronald Lechan, a physician and researcher from Tufts Medical Center Endocrinology. “This is really a natural phenomenon. Unfortunately, with all the advertising people are exposed to, as soon as a man develops fatigue or trouble sleeping he goes to the doctor. If the test comes back under normal levels he’s put on androgen. I think this is wrong.”
Testosterone can have a number of adverse effects. It can stimulate bone marrow to produce red blood cells and cause a condition call erythrocytosis. The blood vessels become literally jammed up with red blood cells causing patients to turn a “purple-plum color.”
In his clinic at Tufts Medical Center in Boston, Dr. Lechan has seen a number of men who obtained testosterone gels from primary care doctors and then overmedicated themselves to dangerous levels.
“They’ve pushed their red blood cell count up to dramatically high levels. I have sent some of these people to have pints of blood removed because their blood pressure was so high I was worried they might have a stroke,” says Dr. Lechan.
“The androgen gel bottles are like shampoo bottles,” says Lechan. “You have to be careful not to get the gel on other people and children.”
“It’s great for the drug companies,” says Lechan. “These gels can cost $100 to $300 a month.”
Dozens of lawsuits have already been filed and hundreds more are expected from men who allege they suffered heart attacks, strokes, blood clots in the lungs or deep vein thrombosis after using AndroGel. As of this week, a US Judicial Panel on Multidistrict Litigation (JPML) is now considering consolidating the lawsuits connected to the use of topical testosterone creams for the treatment of Low T.
Meanwhile, a group of doctors, known as the Androgen Study Group, led by Dr. Abraham Morgantaler, a Canadian urologist working in Massachusetts, argues that Androgen gels improve men’s health and recently lashed out at JAMA: The Journal of American Medical Association for publishing a study linking androgen gels to cardiovascular risks such as heart attack and stroke.
“For 30 years there has been a substantial body of literature that has shown directly and indirectly that low levels of testosterone are associated with increased risk of cardiovascular risks and death, and higher levels appear to be protective against cardiovascular events,” Dr. Morgantaler told LAS in an interview in March 2014.
Dr. Lechan begs to differ.
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He compares the 1980s and 1990s campaign to encourage women to Hormone Replacement Therapy (HRT) to prevent heart disease to the androgen gel therapeutic claims currently being presented to men.
“Estrogen usually used to be given to almost every post-menopausal woman. Now it is hardly ever prescribed to women because of the knowledge we have from good, randomized, controlled studies. This is also what needs to be done for testosterone,” says Dr. Lechan.