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
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. 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 mana...
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
IoT is fundamentally transforming the auto industry, turning the vehicle into a hub for connected services, including safety, infotainment and usage-based insurance. Auto manufacturers – and businesses across all verticals – have built an entire ecosystem around the Connected Car, creating new customer touch points and revenue streams. In his session at @ThingsExpo, Macario Namie, Head of IoT Strategy at Cisco Jasper, will share real-world examples of how IoT transforms the car from a static p...
Web Real-Time Communication APIs have quickly revolutionized what browsers are capable of. In addition to video and audio streams, we can now bi-directionally send arbitrary data over WebRTC's PeerConnection Data Channels. With the advent of Progressive Web Apps and new hardware APIs such as WebBluetooh and WebUSB, we can finally enable users to stitch together the Internet of Things directly from their browsers while communicating privately and securely in a decentralized way.
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Kubernetes is a new and revolutionary open-sourced system for managing containers across multiple hosts in a cluster. Ansible is a simple IT automation tool for just about any requirement for reproducible environments. In his session at @DevOpsSummit at 18th Cloud Expo, Patrick Galbraith, a principal engineer at HPE, discussed how to build a fully functional Kubernetes cluster on a number of virtual machines or bare-metal hosts. Also included will be a brief demonstration of running a Galera M...
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of (at least) three separate application components: the software embedded in the device, the back-end service, and the mobile application for the end user’s controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target –...
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of So...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...