Testosterone supplements males haven’t been demonstrated to keep off numerous age-related conditions and therefore are not really worth the perils associated with serious unwanted effects like cardiac arrest, a fresh report on scientific tests says.
This content was authored by PLOS One-a peer-reviewed, open-access online resource reporting scientific research from a number of disciplines-and might give you a boost to the accidental injuries cases of a large number of men, plaintiffs’ attorneys say.
The content, which examined 156 studies, “confirms what our position continues to be 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 line with the plaintiffs, the drugs are approved only to treat hypogonadism, the body’s lack of ability to produce testosterone. They allege its makers-that include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.-invented a disease called “Low-T” and aggressively promoted these products to counter fatigue and other normal processes of aging.
“The prescription of testosterone pills for men for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized numerous studies,” this content, created by Professor Samantha Huo of the 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 cardiac arrest, thrombus and 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” concerning the article.
While it makes broad claims, an overview article is only as good 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 done that before. Companies was cherry picking the few (tiny and not validated) trials that showed benefits, but no one had taken all of the studies and determined just what the overall outcome was,” he said.
According to the article, “We identified no population of normal men to whom the benefits of testosterone use outweigh its risk.”
“Given the known hazards of testosterone therapy and the lack of evidence for clinical benefits in normal men, perform not think further trials of testosterone are essential,” the authors said.
This content is “powerful proof the possible lack of any proof that the drug is protected or effective males 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 as you age or put on weight is normal.”
The drugs are already “aggressively marketed to a group of men with no knowledge of what risks exist and with no evidence of any benefit,” he was quoted saying.
But Wells, the defense attorney, said, “Any time you’re examining the effectivity of a product for a particular purpose, you have to have a look in the rigor from the studies,” she said.
Equally important is who the authors are, as well as 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 an expert witness at 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 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, among the branded drugs, in France.
The plaintiffs produced sufficient proof of U.S. AndroGel sales to provide a legal court authority to know suits against Besins, the opinion said.
Their evidence shows AndroGel has become sold in the states for over 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received greater than $600 million in AndroGel royalty payments from U.S. sales, a legal court said.
Readily available figures, the legal court said, and from plaintiffs’ evidence that Besins employees received regular updates on United states AndroGel sales, it’s reasonable to infer Besins knew that a spartagenx1 and significant flow from the AndroGel it manufactured would end up in each one of the forum states.
Eight bellwether trials are slated to start out in June 2017 for AndroGel, probably the most popular of your testosterone products.
Four will likely be cardiac event or stroke cases; other four will involve plaintiffs who developed blood clot-related injuries.
Kennelly has also 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.