Are Low-T medications worth the risk?

Battle over safety of testosterone replacement products headed to court

By Sean Lavin - Producer

ORLANDO, Fla. - Commercials touting the benefits of testosterone replacement therapy are all over the airwaves.

And lately, commercials from law firms claiming testosterone therapy can harm you are dominating the airwaves as well.

Several lawsuits filed nationwide by users of testosterone therapy gels have recently been consolidated through a federal court in Illinois, paving the way for the legal system to ultimately decide if testosterone therapy is safe, and if the testosterone therapy industry has been honest enough about the risks in its ads.

Orlando's Morgan and Morgan law firm is one of many law firms advertising that "these drugs may dramatically increase the risk of heart attack, stroke -- and yes -- even death."

"This is a classic example of a solution looking for a problem," attorney Frank Petosa of Morgan and Morgan said of the advertising by AndroGel, Axiom and other members of the testosterone therapy industry. The industry is estimated to see sales increase to $5 billion by 2017, according to one of the lawsuits filed.

"What was originally broadcast as about a million potential men in this country that could suffer from this condition in the early part of 2000, the industry has expanded to say it could be up to 20 million," Petosa said.

Petosa contends that the industry's advertising didn't properly warn people of risks, like strokes and heart attacks.

"We have families calling us because their father, or husband or grandfather has died as a result of complications from using this drug," Petosa said, adding that he has injured clients from Orlando and across the country.

But while one side of the debate says taking testosterone can end your life, the other side says testosterone could actually save it.

"If a guy has a testosterone level below a 300, that puts him at risk for sudden cardiac death, and long term, for increasing risk of prostate cancer," said Dr. Daniel Thomas of MoreTClinics in Altamonte Springs. "We don't try to scare them, but in those cases testosterone therapy could literally save their life."

Dr. Thomas closely monitors his patients and makes sure blood work is done regularly. He also prescribed testosterone injections -- and will not prescribe the gels seen on TV. Dr. Thomas says the problem with gels is that most of the hormone gets grabbed by the lymphatic system, rather than the blood system.

"So when doctors check blood work, that's really under representing the amount that's in your body," he said. "So they'll use a stronger dosage, because they want to get that blood level up to that ideal range. But as they're doing it, the rest of your body is getting a dosage that's completely unnatural, it's way too high."

Bart Malone is the president and CEO of MoreTClinics. He's also a client and a strong believer in the benefits of testosterone.

"I feel like I'm 30," said Malone, who is 43.

Malone was critical of how ads push patients to see any old doctor -- who may not have proper expertise -- to ask to be prescribed gels. He believes that situation can lead to problems that would not happen to patients seeing a specialist using more traditional injections. He believes part of the problems are coming from what he sees as a man's tendency to over-medicate using the gels.

"If one click is good and I'm feeling better, well maybe two or three clicks will make me feel really good," Malone said. "So you're already prescribed a high dose -- way more than you should be ingesting into your body, and then you double or triple that -- of course you can have a heart attack!"

But while Petosa and Malone both have problems with the ads used to promote testosterone gels, they disagree over whether using injections helps solve the problem.

"The risks are all still the same," Petosa said. "It's not the method of delivery of the testosterone to the body, whether it be a pill, injection, a cream, a roll on underarm, a patch -- it's what the testosterone does to your body."

Malone and Dr. Thomas strongly believe the testosterone injections are safe.

Dr. Thomas shared more information about why he stands by testosterone injections, which he says do not lead to the problem that stems from the topical gels that are "absorbed and transported primarily by the lymphatic system, and not the bloodstream as nature intended. This disallows the liver to oxidize the testosterone and the kidneys to excrete it. This causes testosterone levels to build up, and build up and build up, until it becomes toxic."

AbbVie, the company that makes AndroGel, defended its advertising and product in a statement posted on its website.

"AbbVie's education efforts follow FDA's guidance and are developed to educate men about hypogonadism to encourage dialogue with their physician," the statement read.

The statement went on to tout how its AndroGel products "have more than 10 years of clinical, safety, published and post-marketing data, with known therapeutic risks well documented in their prescribing labels. Additionally, AbbVie conducts ongoing comprehensive and robust approaches to monitor the safety of our products."

Both sides have pointed to studies to back up their position, and it may be up to the legal system to sort out which studies hold the most weight and apply to the cases at issue.

Dr. Thomas pointed to a May 2014 study that backs up his position that testosterone therapy is safe when administered properly, and can even help prevent heart attacks for certain men.

That study came after the FDA released a statement on January 31 stating that it is "investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy."

The FDA's statement went on to point out that at this time it "has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals."

According to, the study that piqued the FDA's interest was published by the Journal of the American Medical Association.

Petosa pointed out that the FDA released a new statement on June 19 requiring manufacturers of all testosterone to include a general warning in the drug labeling of the risk of blood clots in the veins.

"Because these clots occur in the veins, this new warning is not related to FDA's ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products," read a portion of the FDA statement. The FDA went on to say it is still "evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31, 2014."

Following the June 19 statement, Dr. Thomas reaffirmed his position that testosterone administered through injections, below the skin, "does not lead to the problems being warned of."

Previous studies have also touted benefits of testosterone therapy.

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