Testosterone supplements for males haven’t been proven to carry off a number of age-related conditions and are not really worth the perils associated with serious side effects like cardiac arrest, a whole new article on scientific studies says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific tests from many different disciplines-and may give you a boost to the injury cases of a large number of men, plaintiffs’ attorneys say.
The content, which examined 156 studies, “confirms what our position continues to be 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 prescription medication is approved only to treat hypogonadism, the body’s lack of ability 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 also other normal processes of aging.
“The prescription of supplements to increase testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” the article, written by Professor Samantha Huo in the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs inside the federal multidistrict litigation allege the widely marketed products cause heart attacks, thrombus along with 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 just as great as the actual 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 targets complex litigation including product liability and business matters.
“No one did that before. The businesses had been cherry picking the few (small and never validated) trials that showed benefits, but no-one had taken all the studies and determined just what the overall outcome was,” he said.
According to the article, “We identified no population of normal men to 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 all do not think further trials of testosterone are important,” the authors said.
This content is “powerful evidence of the lack of any proof that it drug is protected or effective males who do not have real hypogonadism,” Johnson said.
The authors reference guys who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels as you age or gain pounds is common.”
The drugs happen to be “aggressively marketed to a small group of men without knowing what risks exist along with no proof any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of any product for a particular purpose, you might have to take a look at the rigor from the studies,” she said.
Also important is who the authors are, and 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 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 United states District Court for your Northern District of Illinois, who presides on the litigation, has begun 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 many branded drugs, in France.
The plaintiffs produced sufficient proof United states AndroGel sales to provide the legal court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in america 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 United states sales, the legal court said.
From these figures, a 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 the spartagenx1 and significant flow in the AndroGel it manufactured would end up in all of the forum states.
Eight bellwether trials are slated to start in June 2017 for AndroGel, by far the most commonly used in the testosterone products.
Four will likely be stroke or stroke cases; other 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.