Testosterone supplements for males haven’t been demonstrated to support off a myriad of age-related conditions and they are not really worth the hazards of serious side effects like heart attacks, a new review of scientific research says.
The content was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from various disciplines-and may offer 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 has been all along: The drugs never underwent any randomized, clinical trials 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 just 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 spartagen xt scam 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 from the federal multidistrict litigation allege the widely marketed products cause heart attacks, blood clots as well as 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, a review 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 targets complex litigation including product liability and business matters.
“No one has done that before. Companies had been cherry picking the few (tiny instead of validated) trials that showed benefits, but nobody had taken each of the studies and determined precisely what the overall outcome was,” he was quoted saying.
Based on the article, “We identified no population of normal men for whom the key benefits of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and the lack of evidence for clinical benefits in normal men, we all do not think further trials of testosterone are needed,” the authors said.
This article is “powerful proof the possible lack of any proof that this drug is safe or effective for guys who do not possess real hypogonadism,” Johnson said.
The authors reference men who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels when you age or put on weight is common.”
The drugs happen to be “aggressively marketed to a small group of men not knowing what risks exist with no proof of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of the product for a particular purpose, you possess to take a look at the rigor of the studies,” she said.
Also essential is who the authors are, in addition to their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that a person of their 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 with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly from the U.S. District Court for your 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 several branded drugs, in France.
The plaintiffs produced sufficient proof of Usa AndroGel sales to provide a legal court authority to learn suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in america for longer than 16 years, with more than $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten over $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From these 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 a spartagenx1 and significant flow from the AndroGel it manufactured would result in each one of the forum states.
Eight bellwether trials are slated to begin in June 2017 for AndroGel, one of the most popular from the testosterone products.
Four will be stroke 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.