|By PR Newswire||
|March 21, 2014 07:39 AM EDT||
CHICAGO, March 21, 2014 /PRNewswire/ - Allegations continue surrounding the testing of two annuloplasty rings, invented by the chief of cardiac surgery, Dr. Patrick McCarthy at Northwestern University, the Myxo Ring, and the IMR Ring (invented by McCarthy, and colleagues). Both rings were implanted in patients, allegedly, without their consent. These rings considered to be similar to the pre-existing devices, which never underwent FDA approval or FDA registration for legal sales on the US market according to FDA congressional letters as reported in the Chicago Tribune, and the project of government oversight, POGO. This line of valve rings, have resulted in over 4000 adverse events, including 645 deaths according to the FDA MAUDE database.
In a letter sent to Northwestern on March 5, 2014, the Senate Judiciary committee requests a response to documents surrounding this unauthorized human experimentation which took place at Northwestern Memorial Hospital. The deadline for Northwestern University to respond to this request is today March 21, 2014.
"On December 8, 2008 and September 30, 2009, Senator Grassley wrote Northwestern University regarding troubling allegations that the Myxo-ETlogix 5100 Ring(Myxo Ring), an annuloplasty ring used in heart valve repair, had not been cleared for marketing by the Food and Drug Administration(FDA) before it was implanted in patients as part of an outcomes study."
The senator notes the inadequacies in the responses from the Northwestern entities, including contradictory statements regarding the similarity of the Myxo Ring to preexisting devices, Second, is not clear whether patients received sufficient notice of safety questions. Most alarmingly was the documents that were withheld by the University including a waiver (1532-004), which waived the patients right to know they were receiving FDA Devices as part of pre-clinical testing necessary for the eventual 2009 clearance of the devices. When asked to comment on behalf of Northwestern Entities, Senior VP for Northwestern University Alan Cubbage, declined to comment why Northwestern did not stop the testing of the devices in 2007, after the Former Valve Director, Dr. Nalini M. Rajamannan, brought it to the University's attention according to multiple news sources, the Chicago Tribune, Theheart.org, the Chronicle of Higher Education, Top Secret Writers, and AP Chicago.
Furthermore, in a FDA Congressional letter sent to Senator Richard Lugar(IN), indicates that at least 667 patients received the Myxo ETlogix devices, and that the waiver which exempted patients from knowing they were being tested on, allowed the FDA to clear not one but two heart valve rings, the Myxo and the IMR rings.
When asked to comment, the FDA said, "we relied upon Northwestern Memorial Hospital, CEO letters to patients regarding the status of the device." The letter sent by NMH CEO to the Myxo patients in January 2009, states that " we do not consider the device to be experimental," during the exact month that both devices, the Myxo and the IMR were under a voluntary recall by the FDA.
To this date, the voluntary recall has not been reported to the thousands of patients who received these experimental devices between 2003-2008.
In 2011, the head of the device section for the FDA, Dr. Jeffrey Shuren, confirmed to the Chicago Tribune, that both devices were experimental prior to 2009.
Link to the Senate Judiciary Letter to Northwestern University dated
SOURCE Robert Amaefule and Oscar Delgado
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. 29, 2015 04:00 PM EST Reads: 246
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. 29, 2015 02:00 PM EST Reads: 483
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. 29, 2015 01:00 PM EST Reads: 412
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. 29, 2015 01:00 PM EST Reads: 350
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. 29, 2015 12:45 PM EST Reads: 417
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. 29, 2015 12:30 PM EST Reads: 423
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. 29, 2015 12:00 PM EST Reads: 525
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. 29, 2015 11:45 AM EST Reads: 324
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. 29, 2015 11:30 AM EST Reads: 272
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. 29, 2015 10:00 AM EST Reads: 202
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. 29, 2015 09:45 AM EST Reads: 451
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. 29, 2015 09:15 AM EST Reads: 344
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. 29, 2015 08:45 AM EST Reads: 219
With all the incredible momentum behind the Internet of Things (IoT) industry, it is easy to forget that not a single CEO wakes up and wonders if “my IoT is broken.” What they wonder is if they are making the right decisions to do all they can to increase revenue, decrease costs, and improve customer experience – effectively the same challenges they have always had in growing their business. The exciting thing about the IoT industry is now these decisions can be better, faster, and smarter. Now ...
Nov. 29, 2015 08:00 AM EST Reads: 273
The cloud. Like a comic book superhero, there seems to be no problem it can’t fix or cost it can’t slash. Yet making the transition is not always easy and production environments are still largely on premise. Taking some practical and sensible steps to reduce risk can also help provide a basis for a successful cloud transition. A plethora of surveys from the likes of IDG and Gartner show that more than 70 percent of enterprises have deployed at least one or more cloud application or workload. Y...
Nov. 29, 2015 07:00 AM EST Reads: 499