Testosterone supplements for men haven’t been proven to hold off a number of age-related conditions and therefore are not worth the perils associated with serious unwanted effects like cardiac arrest, a new report on scientific research says.
This content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific tests from a variety of disciplines-and could offer a boost for the personal injury cases of thousands 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 trials that demonstrated safety or efficacy,” Ronald Johnson Jr. of Schachter, Hendy & Johnson PSC in Ft. Wright, Ky., told Bloomberg BNA.
In line with the plaintiffs, the prescription medication is approved merely to treat hypogonadism, the body’s inability to produce testosterone. They allege its makers-such as AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a condition called “Low-T” and aggressively promoted the products to counter fatigue and also other normal processes of aging.
“The prescription of top testosterone boosters for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” the content, authored 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 as well as 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.
Though it makes broad claims, an evaluation article is merely as effective as the actual 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 focuses on complex litigation including product liability and business matters.
“No one has been doing that before. The companies have been cherry picking the few (very small instead of validated) trials that showed benefits, but nobody had taken every one of the studies and determined just what the overall outcome was,” he said.
According to the article, “We identified no population of normal men for whom the advantages of testosterone use outweigh its risk.”
“Given the known perils of testosterone therapy and the lack of evidence for clinical benefits in normal men, we do not think further trials of testosterone are important,” the authors said.
The content is “powerful proof the possible lack of any proof that the drug remains safe and secure or effective for guys who do not have real hypogonadism,” Johnson said.
The authors make reference to 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 team of men not understanding what risks exist along with no proof of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re considering the effectivity of the product for a particular purpose, you have to have a look in the rigor from the studies,” she said.
Also essential is who the authors are, in addition to their affiliations, Wells said. As an example, the article’s “competing interests” section notes that a person from the co-authors is Adriane Fugh-Berman.
Wells pointed out that Fugh-Berman, a professor at Georgetown University Medical Center in Washington, is also an authority witness in the request of plaintiffs in litigation regarding pharmaceutical marketing practices.
Meanwhile, Judge Matthew F. Kennelly from the U.S. District Court for that Northern District of Illinois, who presides on 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 the branded drugs, in France.
The plaintiffs produced sufficient evidence of Usa AndroGel sales to give the legal court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in the United States for over 16 years, with $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has brought greater than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
From these figures, the 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 from the AndroGel it manufactured would wind up in all the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, the most commonly used of the testosterone products.
Four is going to be cardiac event or stroke cases; other four calls for 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.