Testosterone supplements for guys haven’t been shown to hold off a host of age-related conditions and so are not worth the perils associated with serious negative effects like heart attacks, a brand new article on scientific research says.
The article was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a number of disciplines-and might give you a boost towards the accidental injury cases of a large number of men, plaintiffs’ attorneys say.
The content, which examined 156 studies, “confirms what our position is 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 only 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 the items to counter fatigue and other normal processes of aging.
“The prescription of natural testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” this content, authored 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, blood clots 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” concerning the article.
While it makes broad claims, an assessment article is only as good as the underlying 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 focuses on complex litigation including product liability and business matters.
“No one did that before. The firms was cherry picking the few (very small and never validated) trials that showed benefits, but no-one had taken all the studies and determined what the overall outcome was,” he said.
In line with the article, “We identified no population of normal men to whom the key benefits of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and the possible lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are important,” the authors said.
The article is “powerful proof lacking any proof this drug remains safe and secure 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 gain pounds is common.”
The drugs are already “aggressively marketed to a small grouping of men with no knowledge of what risks exist along with no proof of any benefit,” he said.
But Wells, the defense attorney, said, “Any time you’re examining the effectivity of your product for the purpose, you possess to have a look with the rigor in the studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. For instance, the article’s “competing interests” section notes that a person from the co-authors is Adriane Fugh-Berman.
Wells pointed out that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also a specialist witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of the U.S. District Court for the 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 offer the legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the states for more than 16 years, with well over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has brought more than $600 million in AndroGel royalty payments from United states sales, a legal court said.
Readily available figures, the court said, and from plaintiffs’ evidence that Besins employees received regular updates on United states AndroGel sales, it’s reasonable to infer Besins knew which a spartagenx1 and significant flow in the AndroGel it manufactured would end up in each one of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most widely used from the testosterone products.
Four will probably be heart attack or stroke cases; one other four calls for 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.