Testosterone supplements males haven’t been shown to support off a number of age-related conditions and are not really worth the hazards of serious side effects like cardiac arrest, a fresh review of scientific studies says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from a variety of disciplines-and can offer a boost on the personal injury cases of 1000s of men, plaintiffs’ attorneys say.
This content, 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.
According to 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 disorder called “Low-T” and aggressively promoted the merchandise to counter fatigue as well as other normal processes of aging.
“The prescription of spartagen xt review for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous 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, blood clots and also other serious injuries.
But a defense attorney not 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 actual 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 targets complex litigation including product liability and business matters.
“No one has been doing that before. The businesses had been cherry picking the few (very small rather than validated) trials that showed benefits, but no person had taken all of the studies and determined what the overall outcome was,” he was quoted saying.
Based on the article, “We identified no population of normal men to whom the advantages of testosterone use outweigh its risk.”
“Given the known perils associated with testosterone therapy and the possible lack of evidence for clinical benefits in normal men, we do not think further trials of testosterone are essential,” the authors said.
This article is “powerful evidence of lacking any proof that it 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 as you age or put on pounds is common.”
The drugs happen to be “aggressively marketed to a small grouping of men not knowing what risks exist and with no proof of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of your product for the purpose, you may have to take a look in the rigor of your studies,” she said.
Equally important is who the authors are, in addition to their affiliations, Wells said. By way of example, the article’s “competing interests” section notes that certain of its co-authors is Adriane Fugh-Berman.
Wells pointed out that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, also is 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 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 United states AndroGel sales to give the court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has been sold in the usa for over 16 years, with more than $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten more than $600 million in AndroGel royalty payments from Usa sales, the legal court said.
From the figures, a 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 land in all the forum states.
Eight bellwether trials are slated to get started on in June 2017 for AndroGel, the most widely used of your testosterone products.
Four is going to be heart attack or stroke cases; other four involves plaintiffs who developed blood clot-related injuries.
Kennelly 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.