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A leading physicians group is questioning claims that testosterone replacement therapy increases the risk of heart disease – contradicting concerns expressed by the Food and Drug  Administration.

The statement from the American Association of Clinical Endocrinologists, which heralded a new position paper, comes after the FDA last March asked drug makers to add information on product labeling about the possible increased risk of heart attacks and strokes associated with low testosterone treatments. The drugs are used to boost testosterone levels .

More recently, FDA officials cited conflicting results from these studies – which were retrospective looks at patient data – as a reason for asking drug makers to work together to conduct a new, controlled clinical trial. Their suggestion appeared last month in The New England Journal of Medicine.

The agency moves come amid ongoing controversy over cardiovascular safety and allegations of inappropriate marketing of the drugs. Testosterone treatments have, at times, been widely promoted to help reverse aging, but safety concerns prompted debate amid dueling medical studies.

In their NEJM essay, FDA staffers acknowledged “the totality of the evidence suggests a weak signal” of a cardiovascular risk. But the agency remains concerned about usage, in part, because 21 percent of men who take these drugs did not have lab work to indicate treatment was needed, according to an FDA review.

In its position paper, the AACE also called for further study and emphasized that patients need to be assessed closely before the medicines are prescribed. On these points, the organization – which has about 6,000 members in the U.S. – is largely in tune with FDA thinking.

Nonetheless, one of the six authors, Dr. Sandeep Dhindsa, chief of the endocrinology and metabolism division at Texas Tech University Health Sciences Center, acknowledged that “we are partly contradicting the FDA. I don’t think we’re in agreement with FDA on the fact there is any signal,” he told Pharmalot. “What FDA is saying is not really a scientific statement.”

This contrarian view may give drug makers, which provide financial support to AACE, a boost. How so? Because rather than simply reiterating a need for additional studies, the AACE statement in part downplayed FDA concerns. As a result, the language could  be construed as a signal that might encourage prescribing.

In 2013, the most recent year for which documents are available, the AACE received nearly $1.5 million from drug makers that sell the treatments. As a result, some experts believe the AACE skepticism about cardiovascular risks should be viewed cautiously.

“The position paper needs to be seen through the lens of industry connections, but that does not discount the claims being made,” said Art Caplan, a bioethicist who heads the Division of Medical Ethics at the NYU Langone Medical Center.

“We have a potentially serious problem brewing with the treatment of men” with testosterone replacement therapies, said Dr. Steven Nissen, who chairs of the Department of Cardiovascular Medicine at the Cleveland Clinic. “And this organization is closely tied to industry. It’s very disconcerting.”

An AACE spokesman maintains the position paper and statement are not meant to be read as taking sides. “It’s semantics,” he told us. As for the funding, he said the money is used for educational programs,  publications for members and other health professionals, and patients.  

We should also note the position paper mentions that four of the six authors received financial support from various companies that make testosterone replacement treatments, including AbbVie, Eli Lilly, and Endo Pharmaceuticals. They served as speakers or advisers or received research funding.

Of the four, two could not be reached and another pointed us toward the disclosure statement. For his part, Dhindsa dismisses concerns that financial ties influenced the paper.

“Who do you think industries should turn to for advice? Experts or someone who knows nothing about the topic?” he said. “Yes, some of us have connections to drug companies, but that should not be implied that what we are saying cannot be trusted.”

Separately, Ron Johnson, an attorney who represents some of the patients who have filed approximately 2,500 lawsuits in federal court claiming drug makers failed to properly disclose risks, welcomed the AACE paper. “I agree with any organization that says  we should do clinical trials” to assess risk, “because the manufacturers never did them.”