Testosterone supplements for men haven’t been demonstrated to support off a host of age-related conditions and they are not worth the risks of serious unwanted effects like heart attacks, a whole new overview of research studies says.
The content was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific research from a number of disciplines-and can provide a boost on the personal injury cases of a large number of men, plaintiffs’ attorneys say.
The content, which examined 156 studies, “confirms what our position has been all along: The drugs never underwent any randomized, numerous studies 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 drugs are approved merely 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 disorder called “Low-T” and aggressively promoted the items to counter fatigue and other normal processes of aging.
“The prescription of spartagen xt video for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” this content, authored by Professor Samantha Huo of the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs in the federal multidistrict litigation allege the widely marketed products cause heart attacks, thrombus as well as 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 evaluation article is just just like 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 targets complex litigation including product liability and business matters.
“No one did that before. Companies have been cherry picking the few (very small and not validated) trials that showed benefits, but nobody had taken all of the studies and determined what the overall outcome was,” he said.
According to the article, “We identified no population of normal men for whom the key 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, we do not think further trials of testosterone are needed,” the authors said.
This content is “powerful evidence of the possible lack of any proof this drug is protected or effective for men 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 weight is common.”
The drugs have been “aggressively marketed to a group of men without knowing what risks exist together with no evidence of any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of the product for the purpose, you have to take a look at the rigor of the studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. For example, the article’s “competing interests” section notes that one from the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also an expert witness on the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the U.S. District Court to the Northern District of Illinois, who presides on 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, one of several branded drugs, in France.
The plaintiffs produced sufficient proof of United states AndroGel sales to give the legal court authority to learn suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the states for more than 16 years, with $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received over $600 million in AndroGel royalty payments from U.S. sales, the legal court said.
Readily available 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 which a spartagenx1 and significant flow from the AndroGel it manufactured would wind up in all the forum states.
Eight bellwether trials are slated to begin in June 2017 for AndroGel, by far the most traditionally used of your testosterone products.
Four will likely be stroke or stroke cases; other 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.