Testosterone supplements for males haven’t been proven to support off a myriad of age-related conditions and so are not worth the perils associated with serious side effects like heart attacks, a fresh overview of scientific tests says.
The content was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a variety of disciplines-and might give 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 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 line with the plaintiffs, the prescription medication is 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 disease called “Low-T” and aggressively promoted the products to counter fatigue and other normal processes of aging.
“The prescription of natural testosterone supplements for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” the article, written by Professor Samantha Huo from 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, blood clots along with 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” regarding the article.
Even though it makes broad claims, an evaluation article is simply 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 targets complex litigation including product liability and business matters.
“No one has done that before. Companies have been cherry picking the few (very small and not validated) trials that showed benefits, but no-one had taken all the studies and determined what the overall outcome was,” he stated.
According to the article, “We identified no population of normal men to whom some great benefits of testosterone use outweigh its risk.”
“Given the known risks of testosterone therapy and the possible lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are necessary,” the authors said.
This content is “powerful evidence of the lack of any proof that it drug remains safe and secure or effective males who do not possess real hypogonadism,” Johnson said.
The authors refer to men who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels as you may age or put on pounds is typical.”
The drugs have already been “aggressively marketed to a team of men with no knowledge of what risks exist along with no evidence of any benefit,” he stated.
But Wells, the defense attorney, said, “Any time you’re examining the effectivity of the product for the purpose, you possess to take a look in the rigor of your studies,” she said.
Also important is who the authors are, and their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that you 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 at the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the Usa District Court for the Northern District of Illinois, who presides on the litigation, has begun 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, among the branded drugs, in France.
The plaintiffs produced sufficient proof of Usa AndroGel sales to offer a legal court authority to know 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 United states sales, the legal court said.
From all of these figures, the 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 from the AndroGel it manufactured would result in each of the forum states.
Eight bellwether trials are slated to begin in June 2017 for AndroGel, by far the most commonly used in the testosterone products.
Four will probably be heart attack or stroke cases; one other four will involve 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.