Testosterone supplements for men haven’t been proven to carry off a number of age-related conditions and so are not worth the perils associated with serious unwanted effects like cardiac arrest, a fresh overview of scientific studies says.
This content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a number of disciplines-and could give you a boost to the accidental injuries cases of 1000s of men, plaintiffs’ attorneys say.
The article, which examined 156 studies, “confirms what our position has become 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 simply to treat hypogonadism, the body’s inability to produce testosterone. They allege its makers-which include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disease called “Low-T” and aggressively promoted these products to counter fatigue and other normal processes of aging.
“The prescription of spartagen xt ingredients for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” the article, published by Professor Samantha Huo from 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 heart attacks, blood clots and also 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” regarding the article.
While it makes broad claims, a review article is just as good as the actual studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine whether or not the studies are sound and reliable, Wells said. Her practice focuses on complex litigation including product liability and business matters.
“No one did that before. The companies have been cherry picking the few (tiny instead of validated) trials that showed benefits, but no one had taken all the studies and determined what the overall outcome was,” he explained.
Based on the article, “We identified no population of normal men for whom the advantages 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, perform not think further trials of testosterone are necessary,” the authors said.
This content is “powerful proof of the absence of any proof this drug remains safe and secure or effective for guys who do not possess 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 as you age or put on weight is common.”
The drugs happen to be “aggressively marketed to a small group of men with no knowledge of what risks exist along with no proof any benefit,” he stated.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of your product for the purpose, you might have to have a look in the rigor of your studies,” she said.
Also important is who the authors are, in addition to their affiliations, Wells said. As an example, the article’s “competing interests” section notes that a person from the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is an expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the United states District Court for your Northern District of Illinois, who presides within 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 Usa AndroGel sales to provide the legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in the usa in excess of 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 court said.
From these figures, a 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 a spartagenx1 and significant flow in the AndroGel it manufactured would result in all the forum states.
Eight bellwether trials are slated to start in June 2017 for AndroGel, one of the most traditionally used from the testosterone products.
Four will likely be cardiac event or stroke cases; one other four will involve 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.