Testosterone supplements males haven’t been demonstrated to keep off a host of age-related conditions and so are not worth the risks of serious negative effects like cardiac arrest, a new article on research studies says.
The article was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a number of disciplines-and may give a boost on the accidental injuries cases of 1000s of men, plaintiffs’ attorneys say.
The article, which examined 156 studies, “confirms what our position has become 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 only to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-which 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 also other normal processes of aging.
“The prescription of spartagen xt in stores for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” the content, written by Professor Samantha Huo of 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 heart attacks, thrombus and 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.
Though it makes broad claims, an overview article is simply as effective as the actual studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine whether the studies are sound and reliable, Wells said. Her practice targets complex litigation including product liability and business matters.
“No one is doing that before. The companies had been cherry picking the few (very small and never validated) trials that showed benefits, but no one had taken all of the studies and determined exactly what the overall outcome was,” he explained.
According to the article, “We identified no population of normal men for whom some great benefits of testosterone use outweigh its risk.”
“Given the known perils associated with testosterone therapy and the absence of evidence for clinical benefits in normal men, perform not think further trials of testosterone are necessary,” the authors said.
The content is “powerful proof the absence of any proof that the drug remains safe and secure or effective for males who do not have real hypogonadism,” Johnson said.
The authors talk about men who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels when you age or put on pounds is usual.”
The drugs happen to be “aggressively marketed to a small group of men not understanding what risks exist along with no proof any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of a product for a particular purpose, you may have to have a look in the rigor in the studies,” she said.
Also important is who the authors are, and their affiliations, Wells said. For instance, the article’s “competing interests” section notes that a person from the 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 at the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the U.S. District Court for that Northern District of Illinois, who presides within 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 of Usa AndroGel sales to present the legal court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the United States for over 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received a lot more than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From the figures, a legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on Usa AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow of the AndroGel it manufactured would wind up in all the forum states.
Eight bellwether trials are slated to get started on in June 2017 for AndroGel, the most commonly used of your testosterone products.
Four will probably be cardiac arrest or stroke cases; one other four involves plaintiffs who developed blood clot-related injuries.
Kennelly has additionally outlined procedures for test trials involving Eli Lilly’s Axiron, beginning in January 2018; and Endo Pharmaceuticals’ Testim and Fortesta products, in November 2017 and September 2018.