SYS-CON MEDIA Authors: Pat Romanski, Elizabeth White, Yeshim Deniz, Glenn Rossman, Cynthia Dunlop

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.

@CloudExpo Stories
Once the decision has been made to move part or all of a workload to the cloud, a methodology for selecting that workload needs to be established. How do you move to the cloud? What does the discovery, assessment and planning look like? What workloads make sense? Which cloud model makes sense for each workload? What are the considerations for how to select the right cloud model? And how does that fit in with the overall IT tranformation? In his session at 15th Cloud Expo, John Hatem, head of V...
Cloud services are the newest tool in the arsenal of IT products in the market today. These cloud services integrate process and tools. In order to use these products effectively, organizations must have a good understanding of themselves and their business requirements. In his session at 15th Cloud Expo, Brian Lewis, Principal Architect at Verizon Cloud, will outline key areas of organizational focus, and how to formalize an actionable plan when migrating applications and internal services to...
SYS-CON Events announced today that ElasticBox is holding a Hackathon at DevOps Summit, November 6 from 12 pm -4 pm at the Santa Clara Convention Center in Santa Clara, CA. You can enter as an individual or team of up to 10 developers. A New Star Is Born Every Month! All completed ElasticBoxes will then be sent to a judging panel - 12 winners will be featured on the ElasticBox website in 2015. All entrants will receive five full enterprise licenses for one year + ElasticBox headphones + Elasti...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, will discuss how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP ...
Ixia develops amazing products so its customers can connect the world. Ixia helps its customers provide an always-on user experience through fast, secure delivery of dynamic connected technologies and services. Through actionable insights that accelerate and secure application and service delivery, Ixia's customers benefit from faster time to market, optimized application performance and higher-quality deployments.
SYS-CON Events announced today that Calm.io has been named “Bronze Sponsor” of DevOps Summit Silicon Valley, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Calm.io is a cloud orchestration platform for AWS, vCenter, OpenStack, or bare metal, that runs your CL tools puppet, Chef, shell, git, Jenkins, nagios, and will soon support New Relic and Docker. It can run hosted, or on premise and provides VM automation / expiry, self-service portals,...
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19+ years in high tech. At Verizon Enterprise, she focuses on driving growth for the Verizon Cloud pla...
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue bu...
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce t...
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources on configuring infrastructure and multiple software licenses. In this track, you will learn about the...
Blue Box has closed a $10 million Series B financing. The round was led by a strategic investor and included participation from prior investors including Voyager Capital and Founders Collective, as well as the Blue Box executive team. This round follows a $4.3 million Series A closed in December of 2012 and led by Voyager Capital. In May of this year, the company announced general availability of its private cloud as a service offering, Blue Box Cloud. Since that release, the company has dem...
SYS-CON Events announced today that Verizon has been named "Gold Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Verizon Enterprise Solutions creates global connections that generate growth, drive business innovation and move society forward. With industry-specific solutions and a full range of global wholesale offerings provided over the company's secure mobility, cloud, strategic network...
SimpleECM is the only platform to offer a powerful combination of enterprise content management (ECM) services, capture solutions, and third-party business services providing simplified integrations and workflow development for solution providers. SimpleECM is opening the market to businesses of all sizes by reinventing the delivery of ECM services. Our APIs make the development of ECM services simple with the use of familiar technologies for a frictionless integration directly into web applicat...
The only place to be June 9-11 is Cloud Expo & @ThingsExpo 2015 East at the Javits Center in New York City. Join us there as delegates from all over the world come to listen to and engage with speakers & sponsors from the leading Cloud Computing, IoT & Big Data companies. Cloud Expo & @ThingsExpo are the leading events covering the booming market of Cloud Computing, IoT & Big Data for the enterprise. Speakers from all over the world will be hand-picked for their ability to explore the economic...
Cloudwick, the leading big data DevOps service and solution provider to the Fortune 1000, announced Big Loop, its multi-vendor operations platform. Cloudwick Big Loop creates greater collaboration between Fortune 1000 IT staff, developers and their database management systems as well as big data vendors. This allows customers to comprehensively manage and oversee their entire infrastructure, which leads to more successful production cluster operations, and scale-out. Cloudwick Big Loop supports ...
To manage complex web services with lots of calls to the cloud, many businesses have invested in Application Performance Management (APM) and Network Performance Management (NPM) tools. Together APM and NPM tools are essential aids in improving a business’s infrastructure required to support an effective web experience… but they are missing a critical component – Internet visibility. Internet connectivity has always played a role in customer access to web presence, but in the past few years use...
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, will discuss how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP ...
Software AG helps organizations transform into Digital Enterprises, so they can differentiate from competitors and better engage customers, partners and employees. Using the Software AG Suite, companies can close the gap between business and IT to create digital systems of differentiation that drive front-line agility. We offer four on-ramps to the Digital Enterprise: alignment through collaborative process analysis; transformation through portfolio management; agility through process automation...
What are the benefits of using an enterprise-grade orchestration platform? In their session at 15th Cloud Expo, Jeff Tegethoff, CEO of Appcore, and Kedar Poduri, Senior Director of Product Management at Citrix Systems, will take a closer look at the architectural design factors needed to support diverse workloads and how to run these workloads efficiently as a service provider. They will also discuss how to deploy private cloud environments in 15 minutes or less.
Headquartered in Santa Monica, California, Bitium was founded by Kriz and Erik Gustavson. The 1,500 cloud-based application using Bitium’s analytics, app management, and single sign-on services include bug trackers, customer service dashboards, Google Apps, and social networks. The firm states website administrators can do multiple tasks online without revealing passwords. Bitium’s advisors include Microsoft’s former CMO and the former senior vice president of strategy, the founder and CEO of Li...