Testosterone supplements males haven’t been demonstrated to keep off a myriad of age-related conditions and therefore are not well worth the perils of serious negative effects like heart attacks, a fresh overview of scientific research says.
The article was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific research from various disciplines-and may give a boost for the personal injury cases of a large number of men, plaintiffs’ attorneys say.
This content, which examined 156 studies, “confirms what our position continues to be all along: The drugs never underwent any randomized, clinical 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 only 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 an ailment called “Low-T” and aggressively promoted the merchandise to counter fatigue as well as other normal processes of aging.
“The prescription of natural testosterone replacement for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” this content, written by Professor Samantha Huo in the Tulane University School of Medicine in New Orleans and seven other academics, said.
Plaintiffs within the federal multidistrict litigation allege the widely marketed products cause heart attacks, blood clots along with 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” concerning the article.
Although it makes broad claims, an evaluation article is simply just like 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 targets complex litigation including product liability and business matters.
“No one is doing that before. The companies have been cherry picking the few (small rather than validated) trials that showed benefits, but no-one had taken all of the studies and determined just what the overall outcome was,” he said.
Based on the article, “We identified no population of normal men for whom the advantages of testosterone use outweigh its risk.”
“Given the known perils associated with testosterone therapy and the absence 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 evidence of the absence of any proof that it drug is safe or effective males who do not have real hypogonadism,” Johnson said.
The authors talk about men that 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 not knowing what risks exist together with no proof of any benefit,” he explained.
But Wells, the defense attorney, said, “Any time you’re looking at the effectivity of a product for a particular purpose, you have to have a look in the rigor in the studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. As an example, the article’s “competing interests” section notes that one of their 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 on the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the Usa District Court for that Northern District of Illinois, who presides across 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 many branded drugs, in France.
The plaintiffs produced sufficient evidence of Usa AndroGel sales to offer a legal court authority to listen to 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 gotten greater than $600 million in AndroGel royalty payments from United states sales, the court said.
Readily available 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 which a spartagenx1 and significant flow in the AndroGel it manufactured would land in each of the forum states.
Eight bellwether trials are slated to get started on in June 2017 for AndroGel, probably the most traditionally used in the testosterone products.
Four will be cardiac event or stroke cases; the other four will involve plaintiffs who developed blood clot-related injuries.
Kennelly has additionally 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.