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
Enterprise architects are increasingly adopting multi-cloud strategies as they seek to utilize existing data center assets, leverage the advantages of cloud computing and avoid cloud vendor lock-in. This requires a globally aware traffic management strategy that can monitor infrastructure health across data centers and end-user experience globally, while responding to control changes and system specification at the speed of today’s DevOps teams. In his session at 20th Cloud Expo, Josh Gray, Chie...
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Transformation Abstract Encryption and privacy in the cloud is a daunting yet essential task for both security practitioners and application developers, especially as applications continue moving to the cloud at an exponential rate. What are some best practices and processes for enterprises to follow that balance both security and ease of use requirements? What technologies are available to empower enterprises with code, data and key protection from cloud providers, system administrators, inside...
"Calligo is a cloud service provider with data privacy at the heart of what we do. We are a typical Infrastructure as a Service cloud provider but it's been designed around data privacy," explained Julian Box, CEO and co-founder of Calligo, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Modern software design has fundamentally changed how we manage applications, causing many to turn to containers as the new virtual machine for resource management. As container adoption grows beyond stateless applications to stateful workloads, the need for persistent storage is foundational - something customers routinely cite as a top pain point. In his session at @DevOpsSummit at 21st Cloud Expo, Bill Borsari, Head of Systems Engineering at Datera, explored how organizations can reap the bene...
In this presentation, you will learn first hand what works and what doesn't while architecting and deploying OpenStack. Some of the topics will include:- best practices for creating repeatable deployments of OpenStack- multi-site considerations- how to customize OpenStack to integrate with your existing systems and security best practices.
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and G...
"DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great team at @DevOpsSUMMIT and CloudEXPO tell the world how they can leverage this emerging disruptive trend."
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...