Testosterone supplements males haven’t been proven to hold off numerous age-related conditions and therefore are not definitely worth the hazards of serious unwanted effects like heart attacks, a new review of scientific 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 might provide a boost for the accidental injuries cases of thousands of men, plaintiffs’ attorneys say.
This content, which examined 156 studies, “confirms what our position has become 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.
According to the plaintiffs, the drugs are approved only to treat hypogonadism, the body’s inability to produce testosterone. They allege its makers-that include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disease called “Low-T” and aggressively promoted these products to counter fatigue as well as other normal processes of aging.
“The prescription of over the counter testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” the content, written by Professor Samantha Huo in 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 cardiac arrest, 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” concerning the article.
Though it makes broad claims, a review article is merely as effective as the underlying 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 focuses on complex litigation including product liability and business matters.
“No one has done that before. The firms had been cherry picking the few (small and not validated) trials that showed benefits, but no person had taken every one of the studies and determined just what the overall outcome was,” he stated.
According to the article, “We identified no population of normal men for whom the advantages of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and lacking evidence for clinical benefits in normal men, perform not think further trials of testosterone are necessary,” the authors said.
This content is “powerful proof of the absence of any proof that the drug remains safe and secure or effective males who do not possess real hypogonadism,” Johnson said.
The authors talk about men that 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 are already “aggressively marketed to a small group of men with no knowledge of what risks exist and with no evidence of any benefit,” he stated.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of the product for a particular purpose, you possess to take a look with the rigor of the studies,” she said.
Also essential is who the authors are, as well as their affiliations, Wells said. As an example, the article’s “competing interests” section notes that one of its 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 with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the U.S. District Court to the Northern District of Illinois, who presides over the litigation, has begun 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, one of many branded drugs, in France.
The plaintiffs produced sufficient proof U.S. AndroGel sales to offer the court authority to learn suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in the usa for more than 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received greater than $600 million in AndroGel royalty payments from United states sales, the court said.
From all of these figures, the legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on United states AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow of the AndroGel it manufactured would result in all of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most popular in the testosterone products.
Four will be cardiac event or stroke cases; one other four will involve plaintiffs who developed blood clot-related injuries.
Kennelly also has 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.