Testosterone supplements for males haven’t been shown to keep off numerous age-related conditions and are not definitely worth the risks of serious negative effects like cardiac arrest, a new review of scientific studies says.
This article was published by PLOS One-a peer-reviewed, open-access online resource reporting scientific studies from many different disciplines-and might provide a boost to the personal injury cases of 1000s of men, plaintiffs’ attorneys say.
This article, which examined 156 studies, “confirms what our position has become 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 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 these products to counter fatigue and other normal processes of aging.
“The prescription of testosterone supplements for women for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” this article, created by Professor Samantha Huo of your 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, blood clots along with 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” concerning the article.
While it makes broad claims, an assessment article is just 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 concentrates on complex litigation including product liability and business matters.
“No one has been doing that before. The businesses was cherry picking the few (very small and not validated) trials that showed benefits, but nobody had taken all 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 key benefits of testosterone use outweigh its risk.”
“Given the known risks of testosterone therapy and the lack of evidence for clinical benefits in normal men, we all do not think further trials of testosterone are needed,” the authors said.
The article is “powerful proof of the absence of any proof that this drug remains safe and secure or effective for men who do not have real hypogonadism,” Johnson said.
The authors refer to men that don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels as you age or put on weight is usual.”
The drugs happen to be “aggressively marketed to a small group of men without knowing what risks exist together with no evidence of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re taking a look at the effectivity of a product for a particular purpose, you might have to have a look on the rigor of the studies,” she said.
Equally important is who the authors are, along with their affiliations, Wells said. For example, the article’s “competing interests” section notes that you of its 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 of the U.S. District Court for your Northern District of Illinois, who presides on the litigation, has started 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 many branded drugs, in France.
The plaintiffs produced sufficient proof of Usa AndroGel sales to provide the court authority to hear suits against Besins, the opinion said.
Their evidence shows AndroGel continues to be sold in the United States in excess of 16 years, with more than $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has gotten over $600 million in AndroGel royalty payments from Usa sales, the court said.
From all of these figures, a legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on Usa AndroGel sales, it’s reasonable to infer Besins knew a spartagenx1 and significant flow of your AndroGel it manufactured would result in all of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most commonly used of your testosterone products.
Four will likely be cardiac arrest 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, beginning in January 2018; and Endo Pharmaceuticals’ Testim and Fortesta products, in November 2017 and September 2018.