Testosterone supplements for males haven’t been proven to carry off numerous age-related conditions and are not well worth the perils associated with serious negative effects like heart attacks, a new overview of scientific studies says.
This content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific tests from a number of disciplines-and could offer a boost on the personal injury cases of a large number of men, plaintiffs’ attorneys say.
The article, which examined 156 studies, “confirms what our position has been 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 line with the plaintiffs, the drugs are approved simply 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 disorder called “Low-T” and aggressively promoted the products to counter fatigue and other normal processes of aging.
“The prescription of best testosterone supplements for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” this content, 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 and also other serious injuries.
But a defense attorney not in the testosterone product litigation said, if she were representing the drugs’ makers, she “wouldn’t be terribly concerned” about the article.
While it makes broad claims, an assessment article is only as effective as the underlying 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 focuses on complex litigation including product liability and business matters.
“No one has done that before. The businesses ended up being cherry picking the few (really small rather than validated) trials that showed benefits, but no one had taken all the studies and determined just what the overall outcome was,” he stated.
In accordance with the article, “We identified no population of normal men for whom the advantages 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, we all do not think further trials of testosterone are needed,” the authors said.
The article is “powerful proof the absence of any proof that it drug remains safe and secure or effective for men who do not possess real hypogonadism,” Johnson said.
The authors reference men who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels when you age or gain pounds is typical.”
The drugs are already “aggressively marketed to a group of men not knowing what risks exist and with no proof of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re examining the effectivity of your product for the purpose, you possess to take a look on the rigor in the studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. For instance, the article’s “competing interests” section notes that you of their co-authors is Adriane Fugh-Berman.
Wells pointed out that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is an expert witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the United states District Court for the Northern District of Illinois, who presides across the litigation, has started setting out procedures for test trials.
The court also recently denied a dismissal motion by Besins Healthcare, S.A., a Belgian corporation that manufactures AndroGel, one of many branded drugs, in France.
The plaintiffs produced sufficient evidence of Usa AndroGel sales to offer the court authority to listen to suits against Besins, the opinion said.
Their evidence shows AndroGel is sold in the usa for longer than 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten greater than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From these figures, a legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on United states AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow from the AndroGel it manufactured would result in each of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most widely used in the testosterone products.
Four will probably be stroke or stroke cases; one other four calls for plaintiffs who developed blood clot-related injuries.
Kennelly has also 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.