Welcome!

News Feed Item

Androgen Study Group Urges Investigation Into Ethical Violations By JAMA Regarding Controversial Testosterone Study

Androgen Study Group alleges violations of "medical journal ethics and editorial integrity" regarding study reporting increased cardiovascular risks with testosterone. Claims JAMA misled the public by withholding information the study had misreported resu

BOSTON, Aug. 8, 2014 /PRNewswire/ -- The Androgen Study Group (ASG) this week submitted a request to the Journal Oversight Committee to investigate violations of "accepted standards of medical journal ethics and editorial integrity" by the Journal of the American Medical Association (JAMA).  The 13-page complaint alleging multiple ethical violations was addressed to Dr. Edward Shortliffe, Chairman of the Oversight Committee. The complaint was in regard to the publication by JAMA of a study by Vigen et al in November, 2013 that reported increased cardiovascular risks in men receiving testosterone prescriptions compared with untreated men.

The article has been controversial since its publication, as it contradicted decades of research.  It raised national concerns regarding cardiovascular risks in men treated with testosterone, causing many men to discontinue treatment. It prompted the FDA to launch a safety review of testosterone products, and created a new area of medical malpractice, with plaintiff attorneys advertising nationwide for men who had suffered heart attacks and strokes after using testosterone.   

The study has already undergone two formal corrections, one for misreporting data, and another that revealed large data errors.  More than 160 leading testosterone researchers and 29 medical societies from around the world joined ASG in calling for retraction of the study following revelation of the data errors, asserting that the magnitude and quality of the errors rendered the study "no longer credible."   JAMA and the study authors have stood by their findings.  

The ASG complaint notes that JAMA's editor-in-chief was personally apprised 2 days after publication that the study's central results were misreported. One week after its initial publication JAMA replaced online the original study with a revised version.  Yet JAMA failed to disclose for two months that this highly read article had already undergone a major correction.  The ASG alleges this failure by JAMA to alert the public of this correction was an "active form of deception" that had real-world ramifications, as numerous media stories and scientific reports repeated the erroneous results.  This lack of transparency represented a "major breach of editorial ethics," according the complaint.

In March, 2014, JAMA published a second correction revealing a series of major data errors:  1) the number of men in one group was changed from 1132 to 128, representing an error rate of 89% involving >1000 individuals, 2) the number of men in a second group was changed from 397 to 1301, a difference of >900 individuals, representing an error rate of 69%, and 3) 100 of the 1132 "men," or 9% of the group, were discovered to be women.

A few months earlier, editor-in-chief Howard Bauchner published an editorial asserting that JAMA had the right to independently review study data because "the first priority in decisions about publication will always be the integrity of the research."  Given the multiple, egregious errors discovered in this study, JAMA's obligation was either to retract the article or to review the data itself to assure its accuracy.  Failure to do so violated JAMA's own critical objectives of publishing "valid" research and "maintaining the highest standards of editorial integrity."

The ASG notes the FDA's recent denial of a petition to add cardiovascular warnings to testosterone products closely followed its own submitted analysis.  With regard to this study, the FDA commented that methodology decisions were "not appropriate" and concluded, "Given the described limitations of the study by Vigen et al. it is difficult to attribute the reported findings to testosterone treatment."

The ASG complaint concludes: "This article is a mess, and JAMA has behaved badly. Something is terribly amiss when a premier medical journal publishes such an obviously weak study that contradicts well-established literature, and in so doing, fosters fear among the public. The concern is heightened when the journal's response to inescapable evidence that the study is meritless is to deceive, distort, stonewall, and dig in."

The full text of the ASG complaint can be found here.

About The Androgen Study Group (ASG)

The Androgen Study Group is a multidisciplinary group of clinicians and researchers dedicated to education and accurate reporting on testosterone deficiency in men and its treatment.

For more information, go to www.androgenstudygroup.org.  

For media inquiries please contact Lisa Fiyod at [email protected], or 617-939-1148.

SOURCE The Androgen Study Group

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
Digital transformation is too big and important for our future success to not understand the rules that apply to it. The first three rules for winning in this age of hyper-digital transformation are: Advantages in speed, analytics and operational tempos must be captured by implementing an optimized information logistics system (OILS) Real-time operational tempos (IT, people and business processes) must be achieved Businesses that can "analyze data and act and with speed" will dominate those t...
If you had a chance to enter on the ground level of the largest e-commerce market in the world – would you? China is the world’s most populated country with the second largest economy and the world’s fastest growing market. It is estimated that by 2018 the Chinese market will be reaching over $30 billion in gaming revenue alone. Admittedly for a foreign company, doing business in China can be challenging. Often changing laws, administrative regulations and the often inscrutable Chinese Interne...
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
WebRTC adoption has generated a wave of creative uses of communications and collaboration through websites, sales apps, customer care and business applications. As WebRTC has become more mainstream it has evolved to use cases beyond the original peer-to-peer case, which has led to a repeating requirement for interoperability with existing infrastructures. In his session at @ThingsExpo, Graham Holt, Executive Vice President of Daitan Group, will cover implementation examples that have enabled ea...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Apache Hadoop is a key technology for gaining business insights from your Big Data, but the penetration into enterprises is shockingly low. In fact, Apache Hadoop and Big Data proponents recognize that this technology has not yet achieved its game-changing business potential. In his session at 19th Cloud Expo, John Mertic, director of program management for ODPi at The Linux Foundation, will explain why this is, how we can work together as an open data community to increase adoption, and the i...
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...