|By PR Newswire||
|August 8, 2014 11:31 AM EDT||
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."
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
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
Nov. 28, 2015 08:00 PM EST Reads: 421
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Nov. 28, 2015 01:00 PM EST Reads: 476
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
Nov. 28, 2015 12:00 PM EST Reads: 550
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Nov. 28, 2015 12:00 PM EST Reads: 231
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.
Nov. 28, 2015 12:00 PM EST Reads: 335
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Nov. 28, 2015 11:45 AM EST Reads: 405
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Nov. 28, 2015 11:15 AM EST Reads: 414
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Nov. 28, 2015 11:00 AM EST Reads: 514
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Nov. 28, 2015 10:30 AM EST Reads: 313
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Nov. 28, 2015 10:15 AM EST Reads: 253
We all know that data growth is exploding and storage budgets are shrinking. Instead of showing you charts on about how much data there is, in his General Session at 17th Cloud Expo, Scott Cleland, Senior Director of Product Marketing at HGST, showed how to capture all of your data in one place. After you have your data under control, you can then analyze it in one place, saving time and resources.
Nov. 28, 2015 10:00 AM EST Reads: 196
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Nov. 28, 2015 10:00 AM EST Reads: 399
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Sam McIntyre, Partner Enablement Specialist at eFolder, presented how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He also demonstrated how easy it is to search and restore cloud application data using Cloudfinder.
Nov. 28, 2015 09:00 AM EST Reads: 182
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, exploreed the current state of IoT connectivity and review key trends and t...
Nov. 28, 2015 08:45 AM EST Reads: 437
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Nov. 28, 2015 08:45 AM EST Reads: 331