Testosterone supplements for males haven’t been proven to carry off a myriad of age-related conditions and they are not well worth the perils associated with serious side effects like heart attacks, a whole new overview of scientific tests says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from various disciplines-and might provide a boost towards the accidental injuries cases of thousands 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.
In accordance with the plaintiffs, the prescription medication is approved just to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-such as AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disease called “Low-T” and aggressively promoted the items to counter fatigue as well as other normal processes of aging.
“The prescription of testosterone supplements for women 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 of the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs from the federal multidistrict litigation allege the widely marketed products cause cardiac arrest, blood clots and also 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” regarding the article.
While it makes broad claims, an assessment article is only 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 concentrates on complex litigation including product liability and business matters.
“No one has done that before. Companies have been cherry picking the few (very small and never validated) trials that showed benefits, but nobody had taken each of the studies and determined just what the overall outcome was,” he was quoted saying.
In accordance with the article, “We identified no population of normal men for whom the key benefits of testosterone use outweigh its risk.”
“Given the known perils of testosterone therapy and lacking evidence for clinical benefits in normal men, we do not think further trials of testosterone are needed,” the authors said.
This content is “powerful evidence of lacking any proof that it drug remains safe and secure or effective for males who do not have real hypogonadism,” Johnson said.
The authors talk about 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 together with no evidence of any benefit,” he said.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of your product for the purpose, you may have to take a look on the rigor from the studies,” she said.
Important too is who the authors are, as well as their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that certain of the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is an authority witness in the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the U.S. 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, one of many branded drugs, in France.
The plaintiffs produced sufficient evidence of Usa AndroGel sales to offer the court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in america for longer than 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received more than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From the 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 that a spartagenx1 and significant flow from the AndroGel it manufactured would land in all the forum states.
Eight bellwether trials are slated to start in June 2017 for AndroGel, by far the most commonly used from the testosterone products.
Four will likely be cardiac event or stroke cases; another 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.