NEWS

By Julie A. Steinberg

Oct. 13 — Testosterone supplements for men haven't been shown to hold off a host of age-related conditions and are not worth the risks of serious side effects like heart attacks, a new review of scientific studies says.

The article was published by PLOS One—a peer-reviewed, open-access online resource reporting scientific studies from a variety of disciplines—and could give a boost to the personal injury cases of thousands of men, plaintiffs’ attorneys say.

The article, which examined 156 studies, “confirms what our position has been 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.

Schachter is co-lead plaintiffs' counsel in a federal multidistrict litigation that includes 6,000 suits ( In re Testosterone Replacement Therapy Prod. Liab. Litig., J.P.M.L., MDL No. 2545 ).

According to the plaintiffs, the drugs are approved only to treat hypogonadism, the body's inability to produce testosterone. They allege its makers—which include AbbVie Inc., Eli Lilly & Co. and Endo Pharmaceuticals Inc.—invented a condition called “Low-T” and aggressively promoted the products to counter fatigue and other normal processes of aging.

“The prescription of testosterone supplementation for low-T for cardiovascular health, sexual function, physical function, mood, or cognitive function is without support from randomized clinical trials,” the article, written by Professor Samantha Huo of the Tulane University School of Medicine in New Orleans and seven other academics, said.

Plaintiffs in the federal multidistrict litigation allege the widely marketed products cause heart attacks, blood clots and 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” about the article.

Although it makes broad claims, a review article is only as good 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 focuses on complex litigation including product liability and business matters.

Volume ‘Significant.'

Johnson said it's “very significant” that the authors looked at many studies.

“No one has done that before. The companies had been cherry picking the few (very small and not validated) trials that showed benefits, but no one had taken all the studies and determined what the overall outcome was,” he said.

According to the article, “We identified no population of normal men for whom the 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 do not think further trials of testosterone are necessary,” the authors said.

The article is “powerful evidence of the lack of any proof that this drug is safe or effective for men who do not have real hypogonadism,” Johnson said.

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

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

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

Also important is who the authors are, and their affiliations, Wells said. For example, the article's “competing interests” section notes that one 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.

Hope Freiwald of Dechert LLP in Philadelphia, liaison counsel for the MDL defendants, wouldn't comment on the article.

Neither would Endo, AbbVie or Eli Lilly.

Jurisdiction Over Belgian Defendant

Meanwhile, Judge Matthew F. Kennelly of the U.S. District Court for the Northern District of Illinois, who presides over 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 the branded drugs, in France.

The plaintiffs produced sufficient evidence of U.S. AndroGel sales to give the court authority to hear suits against Besins, the opinion said.

Their evidence shows AndroGel has been sold in the United States for more than 16 years, with over $4 billion in net sales between 2011 and mid-2015. Additionally, Besins has received more than $600 million in AndroGel royalty payments from U.S. sales, the court said.

From these 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 regular and significant flow of the AndroGel it manufactured would end up in each of the forum states.

Eight bellwether trials are slated to start in June 2017 for AndroGel, the most widely used of the testosterone products.

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

Kennelly has also 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.

Test trials involving Actavis products are expected to be scheduled soon, Johnson said.

In March 2015, the FDA issued a safety advisory about testosterone therapy and also announced it was requiring labeling changes for all prescription testosterone products, to reflect the possible increased risk of heart attacks and strokes associated with testosterone use (43 PSLR 306, 3/9/15).

The suits were consolidated before Kennelly in 2014. There are 6,099 actions in the MDL, according to a Sept. 15 statistics report.

To contact the reporter on this story: Julie A. Steinberg in Washington at jsteinberg@bna.com

To contact the editors responsible for this story: Steven Patrick at spatrick@bna.com and Jeffrey D. Koelemay at jkoelemay@bna.com

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