Testosterone supplements for males haven’t been shown to keep off numerous age-related conditions and they are not really worth the hazards of serious adverse reactions like heart attacks, a fresh report on research studies says.
The article was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific tests from a number of disciplines-and could provide a boost to the 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, 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 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 disorder called “Low-T” and aggressively promoted the items to counter fatigue as well as other normal processes of aging.
“The prescription of natural testosterone supplement for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” the content, created 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 cardiac arrest, blood clots and 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” in regards to the article.
While it makes broad claims, an overview article is merely as great 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 focuses on complex litigation including product liability and business matters.
“No one has done that before. The firms was cherry picking the few (really small and not validated) trials that showed benefits, but nobody had taken all of the studies and determined just what the overall outcome was,” he explained.
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 risks of testosterone therapy and lacking evidence for clinical benefits in normal men, perform not think further trials of testosterone are important,” the authors said.
The content is “powerful evidence of lacking any proof that it drug remains safe and secure or effective males who do not have real hypogonadism,” Johnson said.
The authors make reference to guys who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels as you age or gain weight is common.”
The drugs are already “aggressively marketed to a group of men not understanding what risks exist and with no proof any benefit,” he said.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of your product for the purpose, you possess 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 of the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also a specialist witness in the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the U.S. District Court for the Northern District of Illinois, who presides over 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 the branded drugs, in France.
The plaintiffs produced sufficient proof of U.S. AndroGel sales to give the legal court authority to learn suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in america in excess of 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received a lot more than $600 million in AndroGel royalty payments from United states sales, a legal court said.
From the figures, the legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on U.S. AndroGel sales, it’s reasonable to infer Besins knew that the spartagenx1 and significant flow in the AndroGel it manufactured would result in each of the forum states.
Eight bellwether trials are slated to begin in June 2017 for AndroGel, the most popular in the testosterone products.
Four will probably be stroke or stroke cases; other four calls for plaintiffs who developed blood clot-related injuries.
Kennelly has also outlined procedures for test trials involving Eli Lilly’s Axiron, beginning in January 2018; and Endo Pharmaceuticals’ Testim and Fortesta products, in November 2017 and September 2018.