Testosterone supplements for men haven’t been shown to hold off a host of age-related conditions and so are not definitely worth the risks of serious adverse reactions like heart attacks, a fresh review of scientific studies says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a number of disciplines-and might offer a boost on the injury cases of 1000s 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 prescription medication is approved just to treat hypogonadism, the body’s inability to produce testosterone. They allege its makers-such as AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a condition called “Low-T” and aggressively promoted these products to counter fatigue and also other normal processes of aging.
“The prescription of increasing testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” this article, 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 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” about the article.
Even though it makes broad claims, an overview article is merely as effective as the underlying 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 concentrates on complex litigation including product liability and business matters.
“No one is doing that before. The businesses was cherry picking the few (really small and never validated) trials that showed benefits, but no one had taken every one of the studies and determined what the overall outcome was,” he stated.
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 hazards of testosterone therapy and the lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are necessary,” the authors said.
The article is “powerful proof the absence of any proof this drug is protected or effective males who do not possess 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 while you age or gain pounds is usual.”
The drugs have already been “aggressively marketed to a team of men without knowing what risks exist along with no proof any benefit,” he stated.
But Wells, the defense attorney, said, “Any time you’re examining the effectivity of the product for the purpose, you may have to have a look at the rigor of your studies,” she said.
Important too is who the authors are, in addition to their affiliations, Wells said. For instance, the article’s “competing interests” section notes that you of the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is a specialist witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the United states District Court to the Northern District of Illinois, who presides on 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 give the legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel continues to be sold in america for longer than 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten a lot more than $600 million in AndroGel royalty payments from Usa sales, the 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 that the spartagenx1 and significant flow of the AndroGel it manufactured would land in each of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, the most traditionally used in the testosterone products.
Four will likely be cardiac arrest or stroke cases; another four calls for plaintiffs who developed blood clot-related injuries.
Kennelly 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.