Testosterone supplements for men haven’t been proven to hold off a host of age-related conditions and therefore are not really worth the hazards of serious unwanted effects like cardiac arrest, a fresh report on scientific tests says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific research from various disciplines-and might offer a boost towards the accidental injuries cases of a large number of men, plaintiffs’ attorneys say.
The article, which examined 156 studies, “confirms what our position is 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.
In accordance with the plaintiffs, the prescription medication is 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 a condition called “Low-T” and aggressively promoted these products to counter fatigue along with other normal processes of aging.
“The prescription of testosterone pills for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” the content, published by Professor Samantha Huo of the 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 involved in the testosterone product litigation said, if she were representing the drugs’ makers, she “wouldn’t be terribly concerned” about the article.
While it makes broad claims, an evaluation article is merely as good as the underlying studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine regardless of if 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 firms have been cherry picking the few (small rather than validated) trials that showed benefits, but no-one had taken each of 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 benefits of testosterone use outweigh its risk.”
“Given the known perils of testosterone therapy and the lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are important,” the authors said.
This content is “powerful proof lacking any proof that it drug remains safe and secure or effective for males who do not possess real hypogonadism,” Johnson said.
The authors reference guys who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels while you age or put on pounds is common.”
The drugs happen to be “aggressively marketed to a team of men with no knowledge of what risks exist along with no evidence of any benefit,” he stated.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of the product for the purpose, you possess to have a look on the rigor of your studies,” she said.
Also important is who the authors are, along with their affiliations, Wells said. For example, the article’s “competing interests” section notes that a person of the co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is a professional witness in the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly of your Usa District Court for the 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, among the branded drugs, in France.
The plaintiffs produced sufficient evidence of Usa AndroGel sales to give the legal court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel continues to be sold in the usa in excess of 16 years, with $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received a lot more than $600 million in AndroGel royalty payments from Usa sales, a legal court said.
Readily available 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 which a spartagenx1 and significant flow of your 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, by far the most popular of the testosterone products.
Four is going to be cardiac arrest or stroke cases; the other four involves plaintiffs who developed blood clot-related injuries.
Kennelly has also 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.