Like mountain goats locking horns to determine supremacy, testosterone battles are raging between researchers not beholden to Big Pharma and researchers who are.
The Wall Street Journal reported yesterday that researchers paid by companies promoting testosterone therapy have come out in full-throated attack against a study published in Nov. 2013 in the Journal of the American Medical Association (JAMA). The study found that testosterone therapy to boost testosterone increased the risk of heart attack, stroke and other cardio events in men with heart disease history.
The study published in JAMA referenced the VA records of some 8,700 men diagnosed with low testosterone from 2005 to 2011. It was one study which the FDA said prompted it in Jan. 2014 to announce it was reassessing safety concerns of possible cardiovascular risks associated with testosterone therapies.
That JAMA study has now been heatedly challenged in letters written to the medical journal. JAMA has published those letters, which criticized the study’s design and its authors’ conclusions, but the group who wrote them isn’t stopping there. Some of them have formed what they call the Androgen Study Group, nomenclature derived from the hormones which affect the male reproductive system. The group says it has enlisted the support of dozens of researchers in seeking a retraction of the study from JAMA.
The group says that a recent correction JAMA published and an explanation for it shows JAMA needs to rethink the piece. The group has focused on the specifics of how the study excluded some patients and used that exclusion as a springboard to question the study’s results.
Blame the Media
Abraham Morgentaler, who holds financial stake in at least one drug company producing testosterone therapy, said – in a press release – that looking at the “big picture, what matters is they can’t get the numbers right. (So) there’s nothing that’s believable in this paper.”
Mr. Morgentaler, an associate clinical professor of urology at Harvard Medical School, heads the Androgen Study Group. In a page that could have been taken from Fox News playbook, he added that the study represents “unwarranted, unscientific attacks on testosterone therapy in the medical press and public media.”
Blame the Lawyers
Mr. Morgentaler continued, “They looked at one part of the data and what they reported is so different. It’s gross data mismanagement. When the data are so off, it’s impossible to believe anything that was originally published in the paper. And now we have ads from lawyers on television looking for men who had heart attacks or strokes while on testosterone. The article that set the stage for this concern and prompted the FDA to issue a safety alert [that is] based on data that is no longer reliable.”
Mr. Morgentaler has received payments from AbbVie, the maker of AndroGel, the most popular testosterone treatment. The Wall Street Journal also reported that several other academics and physicians who have signed his letter also have relationships with drug makers, including those selling testosterone therapies. Mr. Morgentaler openly admits and categorically dismisses notions that their scientific opinions could be influenced by their pocketbooks.
“A great number of the people who do research in testosterone do have some financial relationships or have received grants with some of those companies,” said Mr. Morgentaler.
A co-author of the JAMA piece, Dr. Michael Ho, a cardiologist at the VA Eastern Colorado Health Care System, responded to Mr. Morgentaler’s group. Dr. Ho said he and his colleagues “stand firmly” by the study results. Dr. Ho said his and his co-authors’ conclusions drawn from the study “remain unchanged even if we include the patients that were questioned with regard to exclusion criteria.”
Dr. Ho further responded to Mr. Morgentaler’s criticism, according to WSJ, thus:
“In the original publication, there was mis-classification of the reasons why patients were excluded. This was corrected in [our] response letter that was provided to and published in JAMA. But this did not change the results of the paper. Changing the reasons for study exclusion does not alter the study results. Mis-perception about that could suppress research that raises important questions about patient safety.”
A JAMA spokesman sent WSJ a statement it attributed to editor-in-chief Howard Bauchner:
“Numerous letters to the editor regarding this paper were published in March, including one from Dr. Morgentaler. JAMA has no plans to retract the paper and was, indeed, pleased to allow critics to voice their concerns and have the authors respond. Dialogue between authors and readers is always encouraged.”
Stay tuned for further developments on this story, and remember to follow the money.
Want to check out any potential financial conflicts of interest your own doctor may have with Big Pharma? Visit Dollars for Docs at Propublica.org, which now shows some $2.5 billion being passed to doctors from pharmaceutical companies and medical device makers. That kind of money could be buying some science.