Low T Center Comments on Pending AndroGel Lawsuits Regarding Safety of Testosterone Replacement
Posted: February 13, 2014
A number of people have asked how the recent FDA inquiries into testosterone therapy, and the related lawsuits brought by AndroGel patients, affect Low T Center. “The answer is that they don’t really relate to the medicine we practice at Low T Center,” says William Reilly, M.D., national medical director at Low T Center.
“We are excited about the FDA’s inquiry into alternative testosterone delivery models. Physicians have been administering testosterone injections in cases of medical necessity since the 1950s. Clinical research places the therapeutic benefits of testosterone replacement therapy beyond question, in cases where the treatment is medically appropriate and properly managed. The key, like any treatment, is to maintain effective protocols and closely monitor the patient’s results, all in conformance with good medical practice.”
Testosterone replacement therapy is the practice of replacing the body’s hormone deficits with a medically normal level of testosterone. Generally, there are two types of therapeutic alternatives. The most established form of treatment is injection therapy. However, gels and topical treatments (like AndroGel) have come into vogue in the past couple of years. Recently the FDA announced that it was investigating gels and topicals after a study linked their use to increased incidence of heart attacks.
“Gels and topical treatments rely on the patient to treat themselves, and rest on the concept of theoretical absorption rates, which may or may not play out in real-life practice,” warns Dr. Reilly. Inconsistent absorption rates and the dangers of self-administered treatments can cause inconsistent results or abnormally elevated levels of testosterone.
Dr. Reilly also cautions against ongoing treatment without proper medical monitoring. “We regularly advise patients against the use of gels and topicals. Our treatment protocol at Low T Center involves a closely monitored regimen of injection therapy. Basically, if you have certain symptoms corroborated by a clinically low level of testosterone, we will bring you up to normal and appropriately monitor your blood levels to ensure consistent levels.”
Low testosterone levels can lead to fatigue, inability to concentrate, and other symptoms. “This is not normal aging,” says Dr. Reilly, who is himself a testosterone replacement patient. “Our patients range in age from their mid-30s to late 50s. Before they received treatment, they were suffering. Now, many lead normal lives.”
The AndroGel lawsuits, filed in US District Court in Illinois, allege that a particular patient was prescribed AndroGel when the patient did not have clinically low levels of testosterone. The lawsuits allege a causal connection between the improper use of AndroGel and heart attacks or strokes suffered by the patient. Rather than sue the prescribing physician, the plaintiffs in the lawsuits have sued the manufacturer of AndroGel. They cite a recent study that attempts to correlate high testosterone levels with heart conditions.
“Testosterone replacement therapy is a serious medical treatment for a serious medical condition. Our No. 1 complaint is, ‘You will not treat me,'” Dr. Reilly says. “Roughly 50 percent of the men who come in are not candidates for treatment under our protocol.”
According to Dr. Reilly, this fact differentiates Low T Center patients from the patients involved in the lawsuits and the research study that prompted the FDA investigation. “Generally, the patients involved in the study were given a prescription for testosterone and told to treat themselves. There was inadequate documentation as to whether these men actually suffered from low testosterone (also called hypogonadism), and many were in their 60s and 70s with preexisting heart conditions.
“These individuals would not be candidates for treatment under Low T Center protocol, which requires screening for contraindications, symptoms, and verification by comprehensive laboratory testing.”
Low T Center has an experience base of over 500,000 patient visits. “While testosterone self-administered in an uncontrolled manner could result in increased risk, many studies indicate that testosterone applied in a controlled manner is cardio-protective,” Dr. Reilly says. “Our data at Low T indicates that we have not had any significant cardiac events related to testosterone treatment, even with patients with a prior history of cardiovascular disease.”
Gallagher v. AbbVie, Inc., et. al.
Case Number 1:14-cv-776
US District Court, Northern District of Illinois
Testosterone Therapy in Adult Men with Androgen Deficiency Syndromes, Journal of Clinical Endocrinology & Metabolism, June 2010, Vol. 95(6):2536–2559
Trends in Androgen Prescribing in the United States JAMA, August 2013
Testosterone and Cardioprotection Against Myocardial Ischemia, Cardiovascular & Hematological Disorders-Drug Targets, 2007 Jun;7(2):119-25, PMID: 17584046
Disclaimer: This article is made available for general, entertainment and educational purposes only. The opinions expressed herein do not necessarily reflect those of Low T Center. You should always seek the advice of a licensed healthcare professional.