Testosterone supplements for men haven’t been proven to keep off a number of age-related conditions and so are not worth the perils of serious adverse reactions like cardiac arrest, a whole new article on research studies says.
This article was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from many different disciplines-and may give you a boost to the personal injury cases of thousands 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, numerous studies that demonstrated safety or efficacy,” Ronald Johnson Jr. of Schachter, Hendy & Johnson PSC in Ft. Wright, Ky., told Bloomberg BNA.
Based on the plaintiffs, the drugs are approved just to treat hypogonadism, the body’s inability to produce testosterone. They allege its makers-that include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disorder called “Low-T” and aggressively promoted the products to counter fatigue along with other normal processes of aging.
“The prescription of increasing testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” the content, created by Professor Samantha Huo of 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 and other serious injuries.
But a defense attorney not involved 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 merely as great 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 is focused on complex litigation including product liability and business matters.
“No one did that before. The companies ended up being cherry picking the few (small and not validated) trials that showed benefits, but no-one had taken all of the studies and determined exactly what the overall outcome was,” he explained.
In accordance with the article, “We identified no population of normal men to whom the key benefits of testosterone use outweigh its risk.”
“Given the known perils associated with testosterone therapy and the lack of evidence for clinical benefits in normal men, we do not think further trials of testosterone are necessary,” the authors said.
The article is “powerful evidence of the possible lack of any proof that the drug is safe or effective for men who do not possess real hypogonadism,” Johnson said.
The authors reference men that don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels while you age or put on weight is typical.”
The drugs are already “aggressively marketed to a small group of men with no knowledge of what risks exist along with no proof of any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of your product for a particular purpose, you might have to take a look with the rigor of the studies,” she said.
Important too is who the authors are, in addition to their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that one from the co-authors is Adriane Fugh-Berman.
Wells pointed out 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 of your U.S. District Court for the 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 several branded drugs, in France.
The plaintiffs produced sufficient proof of United states AndroGel sales to offer a legal court authority to listen to suits against Besins, the opinion said.
Their evidence shows AndroGel is sold in america for over 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received greater than $600 million in AndroGel royalty payments from United states sales, the legal court said.
From the 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 the spartagenx1 and significant flow in the AndroGel it manufactured would wind up in each one of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most commonly used in the testosterone products.
Four is going to be cardiac event or stroke cases; one other four calls for plaintiffs who developed blood clot-related injuries.
Kennelly also 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.