Testosterone supplements for guys haven’t been demonstrated to keep off a myriad of age-related conditions and therefore are not well worth the perils associated with serious negative effects like cardiac arrest, a fresh report on scientific tests says.
The article was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from various disciplines-and can give you a boost to the personal injury cases of a large number of men, plaintiffs’ attorneys say.
This article, which examined 156 studies, “confirms what our position continues to be all along: The drugs never underwent any randomized, clinical studies that demonstrated safety or efficacy,” Ronald Johnson Jr. of Schachter, Hendy & Johnson PSC in Ft. Wright, Ky., told Bloomberg BNA.
In accordance with the plaintiffs, the drugs are approved merely to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-including AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a condition called “Low-T” and aggressively promoted the merchandise to counter fatigue and also other normal processes of aging.
“The prescription of natural testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” the article, created by Professor Samantha Huo from the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs within the federal multidistrict litigation allege the widely marketed products cause cardiac arrest, thrombus as well as other serious injuries.
But a defense attorney not working in the testosterone product litigation said, if she were representing the drugs’ makers, she “wouldn’t be terribly concerned” concerning the article.
Even though it makes broad claims, an assessment article is only just like the actual studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine if the studies are sound and reliable, Wells said. Her practice focuses on complex litigation including product liability and business matters.
“No one is doing that before. The firms was cherry picking the few (tiny instead of validated) trials that showed benefits, but no one had taken all the studies and determined exactly what the overall outcome was,” he said.
According to the article, “We identified no population of normal men to whom the advantages of testosterone use outweigh its risk.”
“Given the known perils associated with testosterone therapy and lacking evidence for clinical benefits in normal men, we do not think further trials of testosterone are needed,” the authors said.
The content is “powerful proof of the lack of any proof that this drug is safe or effective for guys who do not possess real hypogonadism,” Johnson said.
The authors reference men that don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels when you age or put on pounds is normal.”
The drugs have already been “aggressively marketed to a group of men without knowing what risks exist along with no proof any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of any product for a particular purpose, you have to have a look in the rigor of the studies,” she said.
Important too is who the authors are, along with their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that a person of the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also a professional witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the United states District Court for your Northern District of Illinois, who presides across the litigation, has started 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 Usa AndroGel sales to present a legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the usa in excess of 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten more than $600 million in AndroGel royalty payments from U.S. sales, the legal court said.
From all of these figures, the 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 of the AndroGel it manufactured would result in all the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most traditionally used from the testosterone products.
Four will likely be cardiac event or stroke cases; one other four involves 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.