Celebrated as a miracle treatment for aging, Low Testosterone (or Low T) drugs have been increasingly linked to life-threatening medical conditions such as heart attack and stroke. As evidence mounts, patients are seeking legal counsel to pursue testosterone lawsuits against the producers of these potentially fatal drugs.
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Testosterone Lawsuits: The Myth of Age Reversal
FDA-approved for the treatment of hypogonadism (a medical condition resulting in low testosterone production), Low T drugs are being touted by pharmaceutical companies as a way to revitalize a man’s energy and sex life. Advertising promotes self-diagnosis, but asks misleadingly generic questions. For example, men are asked to rate their energy levels, but aging itself will result in a natural decrease in energy over time.
A growing body of medical research suggests that the risks of testosterone drugs may outweigh their putative benefits. And with widespread allegations that Low T manufacturers have fraudulently marketed their products, Banville Law has begun to consult injured patients on their legal options.
Diagnosing (and Misdiagnosing)
Of the nearly 11 million TRT users, only half have a medically tested diagnosis of hypogonadism, as reported by The New York Times in 2013.
Many critics have argued that pharmaceutical advertising has successfully encouraged misuse of the term ‘Low T.’ Low testosterone can be medically significant or simply a part of natural age progression. But because men link testosterone to virility and youth, pharmaceutical advertising have been accused of leading many men to seek testosterone replacement therapy (TRT) for perceived low testosterone. But now studies suggest that patients prescribed Low T drugs may be at increased risks for severe health complications.
For men, testosterone is essential for normal growth and development. Testosterone helps regulate, among many other functions, sex drive, bone mass, fat distribution, production of sperm and muscle mass.
Normal male levels of testosterone vary greatly, from 300-1000 ng/dL (a measurement of levels in the bloodstream) due to genetics and health, so it can be difficult to determine if a particular male has clinically low testosterone, known as hypogonadism or simply has a lower level of testosterone that does not medically interfere with normal functions.
Clinically low testosterone with medically significant effects to the body can cause loss of muscle tone and strength, a decrease in bone mass as well as less quantitatively detectable symptoms such as loss of libido, forgetfulness, and insomnia.
After the age of 30, levels typically decrease 1% each year, with men over 65 losing more free testosterone. The Baltimore Longitudinal Study found that for men over 65, 30% had hypogonadism range levels and 50% had low free testosterone levels.
As early as 1970, studies had failed to link any negative cardiac effects in men with naturally-occurring testosterone production. The supplemental therapy, however, has an incredibly high risk for heart-related incidents. Meaning the ‘cure’ may be worse than the ‘ailment,’ as plaintiffs have claimed in testosterone lawsuits.
In a study conducted by researchers at the Wisconsin Veterans Home, the cardiac disease polycythemia was detected in over 20% of men treated with TRT. Polycythemia is an elevated proportion of red blood cells per volume in the bloodstream. This disease may lead to an increase of vascular events, including stroke and myocardial infarction.
Continued blood work in order to monitor heart health while on TRT is critical, a warning that lawsuits claim was not encouraged by drug labeling. Polycythemia is measured as hematocrit levels, and if hematocrit levels rise above the normal 42%- 54% range, therapy should be suspended until levels return to normal.
Are Drug Manufacturers Causing Panic?
TRT prescriptions have tripled since 2001, with men in their 40s being the largest growing demographic of users due to advertising campaigns and what plaintiffs in low testosterone lawsuits have alleged are misleading marketing claims.
Pharmaceutical advertising often showcases generic questions such as “Are you sad/grumpy?” “Do you have a lack of energy?” asked by healthy, barely graying, 50-year-olds, despite that most TRT drugs are designed for men over 65. Feeding into male insecurities about aging, much of these advertisements leave older male viewers feeling their virility is in question.
However, the generic questions posted on many drug company websites are based on the Androgen Deficiency In Ageing Male (ADAM) and the Aging Male Symptoms Scale (AMS), which were created over 15 years ago and are controversial at best. There is an overwhelming body of evidence that proves little correlation between generic questions and medically low testosterone in men.
A 2004 study conducted in Germany showed that despite more than 83% of patients verifying a low testosterone state based on AMS questions, only 39% associated with a positive result of low testosterone by medical testing. In the last 10 years, questionnaires have since been modified in clinical use (asking men to quantify their symptoms 1-5), but plaintiffs claim pharmaceutical companies still sensationalize the fear of aging by utilizing the outdated yes/no format.
Androgel, a major TRT drug, recently pulled its AMS-style questions from their website, and the page now only reads “We’re Sorry.”
As a result of the rise of TRT drugs on the market, the Endocrine Society published a guide for TRT use in 2010 which states that TRT should only be used in undeniably low testosterone cases supported with multiple blood tests. The medical community at large recognizes the risks of both low testosterone and TRT.
Should Patients Be Self-Diagnosing Low T?
Pharmaceutical companies have recently come under fire for allegedly misleading men into believing they have a medically significant deficiency, and company websites are even aiding men to self-diagnosis by creating a patient-to-doctor guide.
The Androgel website encourages patients to have an “open, honest conversation with your doctor,” however only the first question in their Doctor Conversation Guide centers on the potential for hypogonadism. The remaining six questions focus on treatment with TRT.
The Axiron website claims that 7 out of 10 men had their testosterone levels restored in 2 weeks. The questions remain: Restored to what? Were the changes major or minor? The purposefully vague language allows readers to define ‘Low T’ for themselves, without the assistance of a medical professional, potentially misleading patients into believing an impossible (or potentially dangerous) result.
It’s important to know that a blood test, medical history and conversation with your doctor are all important diagnostic tools that are part of a low testosterone diagnosis. A blood test alone without medical history can be misleading, as can asking questions without medical support.
Much of the testosterone in the blood is bound to a protein called sex hormone binding globulin (SHBG), while others are considered “free” testosterone. Blood tests typically test for SHBG, but those with hyperthyroidism or kidney diseases can opt to test for free testosterone. It is worth noting that as men age, levels of SHBG and free testosterone change at varying rates, increasing the difficulty of accurate testing.
What Role Does Testosterone Play?
Testosterone is not the fountain of youth. It is a naturally produced type of sex steroid hormone known as an androgen. Androgens influence how males develop and grow, with testosterone being the strongest androgen produced. Most testosterone is produced in the male testicles, while other androgens, which play a supplementary role to testosterone, are typically produced by the adrenal gland.
Even from the fetal stage, testosterone helps develop male reproductive organs. As males grow, testosterone is responsible for a variety of functions, everything from developing chest hair to maintaining healthy heart tissue. Small amounts of testosterone are converted into estradiol, an essential form of estrogen that helps males regulate body fat levels.
Testosterone also plays a significant role in the brain. Studies show that even small fluctuations in testosterone levels can significantly affect neural reactivity affecting aggression, anxiety and stress levels.
Although Androgel’s website does recommend blood tests, suggesting one to establish a baseline and another for diagnostic purposes, the wordplay can be misleading as well. Most men do not typically request bloodwork prior to a perceived drop in their testosterone levels. So having two blood samples after an identified drop is not as medically significant for diagnosis as pharmaceutical companies allegedly suggest.
Variations in Prescriptions
Creating easy-to-use gels from testosterone has allowed companies to advertise higher testosterone levels as “one finger away” or as easy as putting on deodorant in the morning. But not all FDA-approved TRT are created equal.
There are currently over 30 FDA-approved testosterone supplements and variants on the market. Twelve include the active ingredient testosterone, including Axion, Androgel, Striant and Testim, while others contain slightly different enzymes such as testosterone cypionate (Depo-Testosterone) and testosterone enanthate (Delatestryl). Cypionate, which is less common outside the Unites States, and has a slightly slower release time due to its carbon configuration. Other forms of testosterone such as methyltestosterone may be used as both TRT, steroid use or as hormone therapy for those undergoing cancer treatments.
Due to its delivery system, orally administered TRT, such as Andriol, are of the largest concern for those with chronic liver disease.
But despite their chemical differences, every form of Testosterone Replacement Therapy has been linked to an increased risk of major cardiovascular risks, including
If you or someone you know has used one of these TRT and suffered health complications as a result, The Product Lawyers is offering free consultations with a testosterone lawyer to discuss the potential of a testosterone lawsuit.
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