Product Liability Lawyer Blog
Manufacturing and marketing testosterone replacement therapy (TRT) drugs is a huge industry. According to data presented by Statistica, testosterone replacement hormone products brought in over $2.4 billion in 2013. That number has risen in years, recently topping $3.8 billion. The problem is there is not much evidence about what it really means to have a normal testosterone level, and there is even less medical evidence taking testosterone replacement hormone will actually do anything beneficial despite claims by drug companies. It has also been shown increasing testosterone levels also means higher chances of having a stroke or heart attack for men who didn’t need the drug in the first place.
The reason testosterone therapy drugs were invented in the early 1970s was to treat a developmental disorder known as hypogonadism. In reality, the clear majority of patients who take testosterone therapy drugs today do not suffer from hypogonadism. The reason they take these meds is because they have been told in countless advertisements and patient information pamphlets if they take TRT drugs, they will no longer “suffer” from the normal symptoms of the aging process. These symptoms include what one might expect such as the following:
- Weight gain
- Loss of Libido
- General Fatigue
- Loss of muscle tone
The marketing campaign is quite brilliant because what middle age man would not want to be thinner, stronger, and have an improved sex drive? Even though the U.S. Food and Drug Administration (FDA) has never approved testosterone replacement therapy products to reverse of halt the symptoms of normal male aging, there is a loophole in FDA regulations, which allows most drugs to be prescribed for so-called off-label use so long as they are not being promoted for those off-label purposes. Even though this is what happens all the time, FDA has limited enforcement mechanisms due to political pressure and lobbying from the pharmaceutical industry, and a lot of these advertising claims fall to the U.S. Federal Trade Commission (FTC), and as of late, FTC has not been actively prosecuting too many companies.
With respect to FDA guidelines of on-label use of testosterone therapy drugs, a patient must have a testosterone level of below 300, which is the current threshold for hypogonadism. Since most men do not suffer from this relatively rare medical condition, insurance companies are reluctant to approve payment for the treatment. If they are going to approve it, they need to see typically the results from two separate blood tests showing levels of less than 300. These tests must also be done in the morning as fasting labs because one’s levels can change throughout the day depending of a variety of factors.
For this reason, many patients are going to so-called “Low T” clinics where there is very little supervision from doctors, who are often willing to violate professional ethics rules by letting the clinic use their names and DEA numbers to write testosterone prescriptions without conducting a personal and independent medical evaluation of the patients. This is the reason for such high out-of-pocket costs for men taking testosterone levels What this leaves us with is men spending money they often can’t afford to get benefits they will never receive while significantly increasing their risk of stroke and heart attacks.
Having a Normal Level Testosterone vs Optimal Testosterone Level
Even though there is not much medical consensus on what an optimal level of testosterone would be for any male patients, there is a way to find out what average levels are. This is done by doing studies on male patients and recording their testosterone levels. Again, while doctors and researchers can get a range of what they consider average, it does not mean it is optimal. This is because there is very little consensus of the effects of any particular level on a particular patient.
Increasing One’s Testosterone Levels within in Normal Ranges
According to a recent news article from The New York Times, men typically have a testosterone level between 300 and 1,000 nanograms per deciliter of blood. This means that if a particular patient has a level of 350, we could conclusively say that have a testosterone hormone level on the low of the average range, but it would not technically be correct to say they have low testosterone. The reason for this is because doctors do not really know if all a patients for normal function is 300 nanograms per deciliter of blood for example.
What recent studies have shown is that when a patients takes testosterone replacement therapy drugs, they typically see an increase of around 200 in their respective levels. This means the majority of patients who take TRT drugs are seeing an increase, but it is simply an increase within the average ranges. Most patients with a 300 testosterone level will therefore go to a 500 when taking this expensive medication, which poses substantial risks of heart attack and stroke.
Data Suggests Little to No Benefit of Increasing Testosterone within Normal Ranges
What data also suggests, as discussed in this article, is that there is generally no discernable benefit to an increase from 300 to 500 nanograms per deciliter of blood, or most increases for that matter. As our Boston testosterone injury lawyers can explain, this means most if not all patients who take testosterone replacement drugs are seeing no benefit per many studies, but they are seeing an increased risk of serious or potentially fatal illness.
Testosterone Levels on Human Muscle Tissues
Testosterone hormone has been used along with anabolic steroids for decades by body builders and professional athletes. It has been shown this can create what league officials call an unfair competitive advantage so their use is banned in most organized sports by their governing bodies. They know that when doing an insane amount of weight lifting and taking testosterone hormone, a person will develop bigger muscles than a person who does not take the drug. However, this has not translated into helping an elderly man who walk down the aisles of a supermarket without the need of a cane. The latter is the goal of most doctors who prescribe testosterone therapy drugs, not turning their patients into a better homerun hitter in Major League Baseball (MLB).
If you are the victim of Massachusetts product liability, call Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.
Additional Resources:
The Highs and Lows of Testosterone, March.27, 2018, By Randi Hunter Epstein, The New York Times
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Transvaginal Mesh Update: Boston Scientific Settles with 350 Plaintiffs, Feb. 11, 2018, Boston Product Liability Attorney Blog