Welcome!

News Feed Item

Low T Center Comments On The Pending AndroGel Lawsuits Regarding The Safety Of Testosterone Replacement

SOUTHLAKE, Texas, Feb. 13, 2014 /PRNewswire/ -- A number of people have asked how the recent FDA inquiries into testosterone therapy, and the related lawsuits brought by AndroGel patients, effect Low T Center.  "The answer is that they don't really relate to the medicine we practice at Low T Center," says Dr. William Reilly, M.D., Executive Director of the physician practice group treating patients in Low T Centers.  "We are excited about the FDA's inquiry into alternative testosterone delivery models," says Reilly.  "Physicians have been administering testosterone injections in cases of medical necessity since the 1950's.  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," explains Reilly, "is to maintain effective protocols and closely monitor the patient's results, all in conformance with good medical practice."

(Logo: http://photos.prnewswire.com/prnh/20140213/DA65138LOGO)

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 Reilly, who trained at the Cleveland Clinic, and has been in medical practice for over thirty years.  Inconsistent absorption rates, and the dangers of self-administered treatments can cause inconsistent results, or abnormally elevated levels of testosterone, causing Reilly to shun their use.  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, as well as other symptoms.  "This is not normal aging," says Reilly, who is trained in age management medicine, and is himself a testosterone replacement patient.  "Our patients range in age from their mid-thirties to late fifties.  Before they received treatment, they were suffering,  Now, many lead normal lives." 

The AndroGel lawsuits, filed in US District Court in Illinois, each 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 which attempts to correlate high testosterone levels with heart conditions.

"Testosterone replacement therapy is a serious medical treatment for a serious medical condition.  Our number one complaint is, 'You will not treat me,'" continues Reilly.  "Roughly one-half of the men who come in are not candidates for treatment under our protocol."  According to 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 sixties and seventies with pre-existing heart conditions.  These individuals would not be candidates for treatment under Low T Center protocol," Reilly explains.  "Our protocol requires screening for contraindications, symptoms, and verification by comprehensive laboratory testing." 

Low T Center has an experience base of over 500,000 patient visits.  Dr. Reilly opines, "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.  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."

For More Information Contact:

Dr. William Reilly, M.D.


Low T Center Corporate Offices


1920 East Highway 114


Southlake, Texas 76092


817-417-3800



Reference:

Gallagher v. AbbVie, Inc., et. al.


Case Number 1:14-cv-776


US District Court, Northern District of Illinois


Filed:  2/4/2014




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

SOURCE Low T Center

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In recent years, containers have taken the world by storm. Companies of all sizes and industries have realized the massive benefits of containers, such as unprecedented mobility, higher hardware utilization, and increased flexibility and agility; however, many containers today are non-persistent. Containers without persistence miss out on many benefits, and in many cases simply pass the responsibility of persistence onto other infrastructure, adding additional complexity.
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning inf...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said "No to LUNs." With Tintri they manage only virtual machines, in a fraction of the footprint and at far lower cost than conventional storage. Tintri offers the choice of all-flash or hybrid-flash platform, converged or stand-alone structure and any hypervisor. Rather than obsess with storage, leaders focus on the business app...
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
SYS-CON Events announced today that Tintri, Inc, a leading provider of enterprise cloud infrastructure, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Tintri offers an enterprise cloud platform built with public cloud-like web services and RESTful APIs. Organizations use Tintri all-flash storage with scale-out and automation as a foundation for their own clouds – to build agile development environments...
Building custom add-ons does not need to be limited to the ideas you see on a marketplace. In his session at 20th Cloud Expo, Sukhbir Dhillon, CEO and founder of Addteq, will go over some adventures they faced in developing integrations using Atlassian SDK and other technologies/platforms and how it has enabled development teams to experiment with newer paradigms like Serverless and newer features of Atlassian SDKs. In this presentation, you will be taken on a journey of Add-On and Integration...
SYS-CON Events announced today that Outlyer, a monitoring service for DevOps and operations teams, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outlyer is a monitoring service for DevOps and Operations teams running Cloud, SaaS, Microservices and IoT deployments. Designed for today's dynamic environments that need beyond cloud-scale monitoring, we make monitoring effortless so you...
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Column Technologies exhibited at SYS-CON's @DevOpsSummit at Cloud Expo, which took place at the Javits Center in New York City, NY, in June 2016. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principals and help our customers meet today’s DevOps and Dig...
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with budd...