Testosterone supplements males haven’t been shown to carry off a myriad of age-related conditions and so are not worth the risks of serious unwanted effects like cardiac arrest, a brand new report on scientific studies says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting research studies from various disciplines-and could 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 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.
According to the plaintiffs, the drugs are approved only to treat hypogonadism, the body’s inability 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 these products to counter fatigue as well as other normal processes of aging.
“The prescription of testosterone supplements review for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” this content, written by Professor Samantha Huo of your 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 and other serious injuries.
But a defense attorney not working in the testosterone product litigation said, if she were representing the drugs’ makers, she “wouldn’t be terribly concerned” in regards to the article.
Although it makes broad claims, a review article is merely 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 is focused on complex litigation including product liability and business matters.
“No one did that before. The companies have been cherry picking the few (small and not validated) trials that showed benefits, but no one had taken every one of the studies and determined exactly what the overall outcome was,” he explained.
Based on the article, “We identified no population of normal men for whom the key benefits of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and the absence of evidence for clinical benefits in normal men, we do not think further trials of testosterone are essential,” the authors said.
The content is “powerful proof the absence of any proof that it drug is safe or effective for guys who do not possess real hypogonadism,” Johnson said.
The authors refer to guys who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels when you age or gain pounds is common.”
The drugs happen to be “aggressively marketed to a small grouping of men without knowing what risks exist along with no evidence of any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of a product for the purpose, you possess to have a look with the rigor of the studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. As an example, the article’s “competing interests” section notes that you from the co-authors is Adriane Fugh-Berman.
Wells pointed out that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is a specialist witness on the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the Usa District Court to the Northern District of Illinois, who presides within the litigation, has started setting out procedures for test trials.
The 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 evidence of Usa AndroGel sales to present a legal court authority to listen to suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the United States for over 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received over $600 million in AndroGel royalty payments from Usa sales, a 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 of your AndroGel it manufactured would end up in all the forum states.
Eight bellwether trials are slated to get started on in June 2017 for AndroGel, by far the most commonly used from the testosterone products.
Four will likely be cardiac arrest or stroke cases; another four will involve plaintiffs who developed blood clot-related injuries.
Kennelly has additionally 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.