Testosterone supplements males haven’t been proven to support off a host of age-related conditions and therefore are not definitely worth the perils of serious adverse reactions like cardiac arrest, a fresh overview of research studies says.
This content was published by PLOS One-a peer-reviewed, open-access online resource reporting research studies from many different disciplines-and could provide a boost to the accidental injuries cases of 1000s of men, plaintiffs’ attorneys say.
This article, which examined 156 studies, “confirms what our position is all along: The drugs never underwent any randomized, clinical trials that demonstrated safety or efficacy,” Ronald Johnson Jr. of Schachter, Hendy & Johnson PSC in Ft. Wright, Ky., told Bloomberg BNA.
Based on the plaintiffs, the prescription medication is approved just to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-that include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a condition called “Low-T” and aggressively promoted the items to counter fatigue and other normal processes of aging.
“The prescription of spartagen xt side effects for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” this content, written by Professor Samantha Huo from the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs from the federal multidistrict litigation allege the widely marketed products cause cardiac arrest, blood clots as well as other serious injuries.
But a defense attorney not active in the testosterone product litigation said, if she were representing the drugs’ makers, she “wouldn’t be terribly concerned” concerning the article.
Although it makes broad claims, an evaluation article is merely as effective as the actual studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine regardless of if the studies are sound and reliable, Wells said. Her practice focuses on complex litigation including product liability and business matters.
“No one has done that before. Companies was cherry picking the few (small and never validated) trials that showed benefits, but no person had taken all the studies and determined what the overall outcome was,” he explained.
In accordance with the article, “We identified no population of normal men to whom the advantages of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and lacking evidence for clinical benefits in normal men, we do not think further trials of testosterone are important,” the authors said.
This content is “powerful proof of the absence of any proof this drug is protected or effective males who do not possess real hypogonadism,” Johnson said.
The authors refer to men that don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels while you age or gain pounds is typical.”
The drugs have already been “aggressively marketed to a small grouping of men not knowing what risks exist with no proof of any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of the product for a particular purpose, you may have to have a look in the rigor from the studies,” she said.
Also important is who the authors are, in addition to their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that certain of its co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also a specialist witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the United states District Court to the Northern District of Illinois, who presides across the litigation, has begun setting out procedures for test trials.
A legal court also recently denied a dismissal motion by Besins Healthcare, S.A., a Belgian corporation that manufactures AndroGel, among the branded drugs, in France.
The plaintiffs produced sufficient proof of United states AndroGel sales to offer the legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel continues to be sold in the states for longer than 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received greater than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From these figures, the legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on U.S. AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow in the AndroGel it manufactured would land in each of the forum states.
Eight bellwether trials are slated to start in June 2017 for AndroGel, by far the most popular of the testosterone products.
Four is going to be heart attack or stroke cases; other four will involve plaintiffs who developed blood clot-related injuries.
Kennelly also has outlined procedures for test trials involving Eli Lilly’s Axiron, starting in January 2018; and Endo Pharmaceuticals’ Testim and Fortesta products, in November 2017 and September 2018.