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8Oct/170

Testosterone Supplements Review – Look Into A Large Number Of Well Being Attributes Of Low Testosterone Treatments.

Testosterone supplements for men haven't been proven to hold off a myriad of age-related conditions and so are not well worth the risks of serious negative effects like cardiac arrest, a brand new article on scientific tests says.

This content was authored by PLOS One-a peer-reviewed, open-access online resource reporting research studies from many different disciplines-and might give you a boost to the injury cases of a large number of men, plaintiffs’ attorneys say.

This article, 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 simply 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 how to increase testosterone for low-T for cardiovascular health, s-exual function, physical function, mood, or cognitive function is without support from randomized clinical studies,” the article, published by Professor Samantha Huo from 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 also 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 only as effective as the actual 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 did that before. The firms had been cherry picking the few (really small rather than validated) trials that showed benefits, but nobody had taken all of the studies and determined exactly what the overall outcome was,” he was quoted saying.

In line with the article, “We identified no population of normal men for whom the key benefits 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 all do not think further trials of testosterone are needed,” the authors said.

This article is “powerful proof the lack of any proof that the drug remains safe and secure or effective for men who do not possess real hypogonadism,” Johnson said.

The authors talk about men who don't have real hypogonadism as “normal men,” Johnson said. “Apropos because lower testosterone levels as you may age or gain weight is typical.”

The drugs have already been “aggressively marketed to a group of men without knowing what risks exist and with no proof of any benefit,” he said.

But Wells, the defense attorney, said, “Any time you're examining the effectivity of a product for the purpose, you have to take a look on the rigor of your studies,” she said.

Also essential is who the authors are, as well as 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, also is a professional witness in the request of plaintiffs in litigation regarding pharmaceutical marketing practices.

Meanwhile, Judge Matthew F. Kennelly in the Usa District Court for that Northern District of Illinois, who presides on 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 the branded drugs, in France.

The plaintiffs produced sufficient proof U.S. AndroGel sales to offer a legal court authority to know suits against Besins, the opinion said.

Their evidence shows AndroGel is sold in america for longer than 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 United states sales, a legal court said.

From the figures, the 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 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 in June 2017 for AndroGel, probably the most commonly used in the testosterone products.

Four will be heart attack or stroke cases; the other four involves plaintiffs who developed blood clot-related injuries.

Kennelly 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.

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