Testosterone supplements for men haven’t been shown to hold off numerous age-related conditions and are not well worth the perils of serious side effects like heart attacks, a brand new review of scientific research says.
The content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific tests from various disciplines-and can give you a boost on the personal injury cases of a huge number of men, plaintiffs’ attorneys say.
The content, which examined 156 studies, “confirms what our position has been 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 prescription medication is approved just to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-such as AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disease called “Low-T” and aggressively promoted the products to counter fatigue and also other normal processes of aging.
“The prescription of spartagen reviews for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” the article, published by Professor Samantha Huo of your 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 and also 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” about the article.
Even though it makes broad claims, an assessment article is only as good as the actual studies, Mary Wells of Wells, Anderson & Race in Denver, said.
The defendants will examine if the studies are sound and reliable, Wells said. Her practice focuses on complex litigation including product liability and business matters.
“No one did that before. Companies ended up being cherry picking the few (very small and not validated) trials that showed benefits, but nobody had taken all of the studies and determined just what the overall outcome was,” he was quoted saying.
According to the article, “We identified no population of normal men for whom some great benefits of testosterone use outweigh its risk.”
“Given the known risks of testosterone therapy and the absence of evidence for clinical benefits in normal men, we all do not think further trials of testosterone are essential,” the authors said.
The article is “powerful proof of the possible lack of any proof that this drug remains safe and secure or effective males who do not possess real hypogonadism,” Johnson said.
The authors make reference to men who don’t have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels while you age or put on weight is common.”
The drugs have been “aggressively marketed to a group of men with no knowledge of what risks exist with no proof any benefit,” he said.
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 from the studies,” she said.
Also important is who the authors are, in addition to their affiliations, Wells said. As an example, the article’s “competing interests” section notes that certain of their co-authors is Adriane Fugh-Berman.
Wells remarked that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also an authority witness with the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly in the U.S. District Court for that Northern District of Illinois, who presides over the litigation, has begun setting out procedures for test trials.
A 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 U.S. AndroGel sales to offer the court authority to learn 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 received a lot more than $600 million in AndroGel royalty payments from United states sales, a 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 which a spartagenx1 and significant flow from the AndroGel it manufactured would result in all of the forum states.
Eight bellwether trials are slated to begin in June 2017 for AndroGel, the most popular of the 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, starting in January 2018; and Endo Pharmaceuticals’ Testim and Fortesta products, in November 2017 and September 2018.