There has been a great deal of debate about whether there is any medical benefit to taking testosterone replacement therapy (TRT). It should first be noted, we are talking about men who do not suffer from hypogonadism. Hypogonadism is a rare medical condition characterized by an extremely low testosterone level, especially during a time when the patient is still developing.
This condition is the reason testosterone therapy was created, and it is currently the only condition for which the United States Food and Drug Administration (FDA) approved TRT in the 1970s, and this has not changed. This is not to say that the many so-called T clinics around the country are prescribing testosterone replacement therapy illegally, but they are administering for an off-label use.
Under what is essentially a loophole in FDA regulations, a doctor can prescribe drugs to treat symptoms alone for a condition for which the drug is not labeled for use. For example, many doctors have used anti-depressants to treat patients who suffer from generalized anxiety disorder (GAD), and this is perfectly fine. Once the drug companies have enough research, they might be able to get their medication labeled for this new use.
In the case of testosterone replacement drugs, doctors are hesitant to prescribe in the regular office setting, so patients are being directed to T clinics, mainly through advertising from drug companies. They cannot technically push an off-label use, but this is essentially what is occurring. These T clinics doctors will ask men if they have experienced weight gain, reduced libido, erectile dysfunction (ED), mild depression, and many other signs of normal male aging and then administer the drug at high cost to the patients.
As a recent article from Courier Journal points out, doctors and scientist know very little about whether taking testosterone hormone will actually help a patient not experience of these problems that they are trying to address in the first place. This is not to say that they do not know if taking testosterone will raise one’s testosterone level, but rather they do not know if artificially raising one’s testosterone level will benefit a man who does not suffer from hypogonadism, which, again, is very rare disease.
On the other hand, what doctors and researchers do know is that taking testosterone replacement therapy can lead to stroke and heart disease. This potentially deadly side effect has been the basis for many testosterone replacement injury lawsuits filed in Boston and across the nation.
Another thing that researchers are not sure of is what it even means to have a low testosterone level. They know that there is an average testosterone level that is typically at its highest point at age 20 and then goes down from there, but there have not been enough controlled studies to track the normal range as men age. There are also issues with what type of testosterone to use when calculating the range. There is one measurement called normal total testosterone and another measurement called free testosterone. This is only one of many reasons more research needs to be done before drug companies drive more of these men to low T clinics.
Call the Boston Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Booming | Pros, cons of testosterone therapy, January 12, 2016, Courier-Journal, BY Anita Curpier
More Blog Entries:
FDA Announces Testosterone Meds Must Carry Broader Warning, July 7, 2014, Boston Products Liability Lawyers Blog