by Jeff Clemetson, Managing Editor
Whenever a health product becomes popular and worth millions of dollars, you can always expect a lawsuit to follow.
Citing two recent studies that concluded that testosterone replacement therapy (TRT) leads to a greater risk of heart attack and other cardiovascular diseases, lawyers groups have begun looking into filing class action lawsuits against the top makers of TRT products, such as Androgel, Axiron, Fortesta and more.
The most recent study linking TRT to heart disease was conducted by William Finkle and Associates and published in the journal Plos One. The study, which was released on Jan. 29, said it found evidence of increased risk of heart attack for testosterone users and even greater risk for those users who already had a history of cardiovascular disease. The study was’s findings were similar to a study published in the Journal of the American Medical Association in November of last year that looked at patients of VA hospitals that were undergoing TRT. Just two days after the Plos One study was released, the FDA issued a statement saying it was going to investigate the risks of TRT.
Almost immediately after the FDA warning, lawyers from across the country began a fishing expedition to find clients who may have been had heart problems and who underwent TRT or family members of men who died with on TRT. A quick Google search for TRT lawsuits will reveal pages of hits for lawyers ready to sue the pants off TRT drug makers. There are even television commercials airing that are searching for people to join the suit. It is unclear how many people have yet to sign on to these lawsuits and even the language the lawyers are using to attract people to sue seem vague and ambiguous, using terms like “…investigating claims financial compensation…” or “…likelihood of an Androgel class action lawsuit in the near future is very high…”
What is clear, however, is that the studies used to prompt action by the FDA and the trial lawyers are far from solid in their methodology. In an article written for the Huffington Post, Dr. Jen Landa M.D. pointed out that the conclusions of both the Plos One and JAMA studies are essentially meaningless because of the flawed nature in which they were held.
“Neither study assessed testosterone levels of patients before and during therapy. There are other critical blood tests that should be done that were not being done during the treatment of the VA men or in the current study, including blood counts and estrogen levels. Higher red blood cell counts and higher estrogen levels are known issues that may occur in men given testosterone therapy. Without assessment of testosterone levels, red blood cell counts and estrogen levels prior to and during therapy, it is impossible to tell if a patient is a proper candidate for therapy and if they are tolerating the therapy well.”
In addition, the Plos One study compared men who were taking ED drugs like Viagra or Cialis to ones who were on testosterone under the assumption that both groups would be equally sexually active. This gave the patients on the ED drugs an advantage in not having cardiovascualr problems because of the positive effects these drugs have on relaxing blood vessels and easing pulmonary hypertension.
According to Todd Thomas, owner and operator of Increase My T, a clinic that specializes in TRT, the doctors in the study were not following some of the most important protocols that TRT clinics like his own would follow.
“Testosterone effects people differently, which is why it is important to titrate the dosages appropriately,” he said. The doctors in the study were giving too much testosterone to the patients – 22 mg injections. If some of the patients were overweight, they should have adjusted the dose accordingly. “Also, the study noted there were patients who had high estrogen levels but none of the doctors gave those patients aromatose inhibitors. Estrogen leads to water retention that can have adverse effects on blood pressure.”
Thomas was also quick to point out that the Plos One study only looked at patients during the first 90 days of their TRT, which raises questions as to how lawyers think they can use this study as a basis for suing manufacturers of topical TRT patches like Androgel.
“Androgel, because of its low doses, can take up to six months for testosterone to get up to 600 ppm in the blood stream. So using a study that followed patients for three months to base lawsuit on is ridiculous,” he said.
Both Thomas and Dr. Landa see similarities in these poorly researched studies to ones that were conducted on the use of hormone replacement in women to ease the effects on menopause. Just when hormone replacement was showing signs of helping women, some poor practices by doctors and studies that only looked at the patients of those doctors scared women into believing that hormone replacement would lead to ovarian cancer.
“Back then, and as with this study, doctors would overprescribe the medication and then not follow up,:” Thomas said. “It was like, ‘here’s an unlimited prescription, come back and see me in eight months.'”
Despite the findings of the two studies and the FDA warning, Thomas insists that TRT is safe for elderly men if doctors and patients follow the correct protocols. He suggests that elderly men: start with low doses; monitor all testosterone and estrogen levels; get a comprehensive metabolic screening; get a full cholesterol and lipids screening; and monitor diet and weight.
“Safety is tied to monitoring and that’s the bottom line. People who monitor have longer, safer and better results from TRT.”