The Journal of the American Medical Association Under Fire
The battle is on for plaintiff’s attorneys looking to litigate testosterone replacement therapy (TRT) cases – one of two pivotal studies in relation to TRT is being heavily criticized by the medical community. Here’s what you need to know:
The results of a testosterone therapy study published in the November 2013 issue of the Journal of the American Medical Association (JAMA) are being criticized by a growing number of researchers and medical professionals who are now pushing to get a retraction of the study printed. Forming the Androgen Study Group, this team includes more than 160 world-renowned medical professionals who are considered to be leaders in the fields of urology, andrology and endocrinology. Also joining this Group are 25 medical societies, more than 70 medical professors and 9 journal editors.
The much debated study that is the focus of the Androgen Study Group’s efforts for retraction is the “Association of Testosterone Therapy With Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels.” The widely publicized findings of this study linked the use of testosterone therapies (including gels, patches and injections) to an increased risk of heart attack, stroke and death in men. While this JAMA testosterone study has spurred a number of lawsuits against the makers of various low T therapies, it also incited the Food and Drug Administration (FDA) to issue a safety bulletin regarding the serious risks associated with the use of testosterone therapies in January 2014.
However, the growing numbers of medical professionals criticizing this study are now calling the methods of the study “sloppy,” saying that the researchers who led the study mismanaged the data and that, consequently, the results are not credible. In fact, these critics are calling for JAMA to print an official retraction to this study.
As the Chairman of the Androgen Study Group, Dr. Abraham Morgentaler, has explained:
This is the first time in history a worldwide community of distinguished researchers, scholars, and clinicians has united to demand removal of a study from the literature … This unprecedented action is a complete repudiation of the false information published by JAMA that has harmed public health, distorted medical science, and violated the trust between medical journals and the consumer. Although science must always be open to new information and ideas, the wholly unreliable data in this study by Vigen et al. categorizes these results as misinformation. JAMA has been complicit in creating a media frenzy regarding false risks and is directly responsible for the new wave of medical malpractice cases against physicians. For the good of consumers, physicians, and science, JAMA should retract the article before it causes even greater harm, accompanied by a letter explaining how its editorial process failed and steps taken to correct it.
Critics Cite Two Published Revisions of JAMA Study
Supporting their arguments for retraction, members of the Androgen Study Group have pointed out that, since its publication, the JAMA testosterone study has been revised twice due to significant problems with the presentation of the study’s data.
The first revision, which was published six days after the study first appeared in JAMA, specifically involved issues regarding the misleading disclosure of statistically generated estimates as raw data. As the Group points out, JAMA did not explain the reasons for the published revision until January 2014 (two months after publishing the revision), which puts JAMA in an ethical breach, the Androgen Study Group contends.
The second revision to the JAMA testosterone study, published in March 2014, reportedly involved significant errors in the study’s reported participants. Specifically, while the initial text of the study reported that more than 1,100 men participated in the study, the second revision corrected this to be only 128 participants, with about 10 percent of these participants being women.
The criticism regarding this study, as well as JAMA’s alleged ethical breaches in publishing it, seems to be growing steadily.
As Dr. Mohit Khera, an associate professor at Baylor Medical College, explains:
This article has caused enormous damage … this article created an unfounded negative perception of testosterone therapy. Physicians discontinued treatment for men who were benefitting from treatment. It harmed physician-patient relations, as patients ask why their physicians placed their health at risk. And a new field of medical malpractice has sprung up overnight, with plaintiff attorneys in the US advertising nationwide for patients who suffered a stroke or heart attack after receiving testosterone. And it’s all based on pure nonsense.
While JAMA has yet to respond to the Androgen Study Group’s call for retraction, Case Funding will continue to bring updates on this ongoing controversy.