Testosterone supplements for guys haven’t been demonstrated to carry off a host of age-related conditions and are not well worth the perils associated with serious unwanted effects like cardiac arrest, a brand new review of scientific tests says.
The article was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a number of disciplines-and could provide a boost to the personal injury cases of thousands of men, plaintiffs’ attorneys say.
This article, which examined 156 studies, “confirms what our position has become 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.
In line with the plaintiffs, the prescription medication is approved simply to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-including 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 testerone pills for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” this content, written by Professor Samantha Huo of your Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs in the federal multidistrict litigation allege the widely marketed products cause heart attacks, thrombus 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, an overview article is only as good as the underlying 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 concentrates on complex litigation including product liability and business matters.
“No one has done that before. The businesses was cherry picking the few (tiny instead of validated) trials that showed benefits, but no person had taken each of the studies and determined exactly what the overall outcome was,” he was quoted saying.
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 the possible lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are essential,” the authors said.
The article is “powerful proof the absence of any proof that this drug remains safe and secure or effective for guys who do not have real hypogonadism,” Johnson said.
The authors refer to guys 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 have been “aggressively marketed to a small group of men not 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 your product for the purpose, you may have to take a look with the rigor of your studies,” she said.
Also important is who the authors are, in addition to their affiliations, Wells said. For example, the article’s “competing interests” section notes that one 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 professional witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the Usa District Court for the 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 several branded drugs, in France.
The plaintiffs produced sufficient evidence of U.S. AndroGel sales to give a legal court authority to listen to suits against Besins, the opinion said.
Their evidence shows AndroGel continues to be sold in the usa for over 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten a lot more than $600 million in AndroGel royalty payments from U.S. sales, the legal court said.
From these figures, the court said, and from plaintiffs’ evidence that Besins employees received regular updates on Usa AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow of the AndroGel it manufactured would land in all the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, the most traditionally used from the testosterone products.
Four is going to 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.