Testosterone supplements for men haven’t been proven to keep off a myriad of age-related conditions and they are not well worth the perils of serious negative effects like cardiac arrest, a fresh article on research studies says.
This article was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a variety of disciplines-and may offer a boost towards the accidental injury cases of a large number of men, plaintiffs’ attorneys say.
This article, which examined 156 studies, “confirms what our position is 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.
In accordance with 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 disorder called “Low-T” and aggressively promoted the products to counter fatigue as well as 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 clinical trials,” this article, authored by Professor Samantha Huo in 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 cardiac arrest, 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” about the article.
Although it makes broad claims, a review 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 is focused on complex litigation including product liability and business matters.
“No one did that before. Companies was cherry picking the few (very small and never validated) trials that showed benefits, but no person had taken each of the studies and determined exactly what the overall outcome was,” he stated.
In accordance with the article, “We identified no population of normal men to whom the 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 all do not think further trials of testosterone are essential,” the authors said.
The content is “powerful evidence of the absence of any proof that it drug is safe or effective for men who do not possess real hypogonadism,” Johnson said.
The authors refer to 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 have been “aggressively marketed to a small group of men without knowing what risks exist with no proof of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of a product for a particular purpose, you may have to have a look with the rigor of the studies,” she said.
Also essential is who the authors are, in addition to their affiliations, Wells said. For 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, is also a professional witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the United states District Court for the Northern District of Illinois, who presides over the litigation, has begun setting out procedures for test trials.
The 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 United states AndroGel sales to present a legal court authority to learn suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in america for over 16 years, with more than $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has brought greater than $600 million in AndroGel royalty payments from Usa sales, the court said.
From all of these 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 that the spartagenx1 and significant flow of the AndroGel it manufactured would land in all of the forum states.
Eight bellwether trials are slated to get started on in June 2017 for AndroGel, by far the most widely used of your testosterone products.
Four will probably be stroke or stroke cases; 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.