Tag Archives: testosterone replacement therapy

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Sloppy TRT Studies Lead to Lawsuit Threats

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.

androgel

The makers of Androgel are facing possible class action lawsuits based off of two questionable studies.

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.”

TRT lawsuit

Ads like this one are fishing for TRT patients to join class action lawsuits, despite the lack of evidence that TRT causes cardiovascular disease.

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.”

 

The Testopel pellets are quite small and slowly dissolve over the 3 months.

Testopel, the ideal testosterone replacement

by Dr Gary Bellman, Board Certified Urologist, Member Academy of Anti-Aging Medicine.

The first question is if testosterone replacement is right for you. If the answer is yes then the next question is what is the best method. The methods that I have used include topical gels and creams, injections and pellets. Over the last number of years I have been underwhelmed with the results with the topical application of testosterone. Unfortunately many men do not absorb the gel or cream well. In addition these products can be smelly and sticky as well as expensive and carry the risk of transferring the testosterone to a partner. Injections work well, however they need to be administered weekly or sometimes twice a week.

In addition, as men are a rather non-compliant group, many men skip applications of testosterone and thus the levels fall. The goal of testosterone replacement is to maintain steady levels to achieve the best results.

I now prefer the placement of testosterone pellets, called Testopel. These tiny pellets are placed under the skin and maintain excellent levels of testosterone for 3 months.

The placement takes 3-4 minutes in the office with no suturing and is relatively painless. This allows men who are interested in testosterone replacement to come to the office 4 times a year and don’t need to worry about anything else.

Testopel may be the ideal method of testosterone replacement.

The Testopel pellets are quite small and slowly dissolve over the 3 months.The skin is quickly numbed with a local anesthetic.

A row of pellets are placement under the skin.

The skin is quickly numbed with a local anesthetic.

The small trocar (tube) is placed through a tiny puncture in the skin and the pellets are carefully placed.

The pellets are placed under the skin and fat layer and generally are not felt.

After the procedure there is a tiny puncture of the skin that heals in a few days without suturing.

Small strips are placed over the site with no recovery needed.

Every man has different needs as far as his dose on the number of pellets. It depends on one’s age, body size and level of activity. I generally start around 12 pellets but for younger more active guys up to 16 or even higher may be necessary. Blood tests after 2 months of the pellet insertion helps guide the dose for the next insertion. It is important to check not only the testosterone levels but the estradiol (female hormone) as well as the blood count (CBC) and PSA (prostate).

 


Dr. Gary Bellman, M.D., is a Board Certified Urologist, interested in Testosterone replacement and men’s heath. He attended medical school at McGill University, did a fellowship at Long Island Jewish Medical Center and has taught at UCLA for many years. He is currently is private practice in the San Fernando Valley, a suburb of Los Angeles.

For more information on Dr. Bellman, visit his Websites: http://www.drgarybellman.com/

http://www.uroantiaging.com/

For questions or other inquiries, you may contact Dr. Bellman at gburomd@yahoo.com.