Click here to close now.




















Welcome!

News Feed Item

Northwestern University 5pm ET Deadline Today to Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation

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.

http://chronicle.com/article/Northwestern-U-Gets-Renewed/145139

"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."

http://www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=48656

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.

http://articles.chicagotribune.com/2011-05-22/health/ct-met-medical-devices-patients-20110522_1_antonitsa-vlahoulis-medical-device-inventions

http://pogoblog.typepad.com/pogo/2011/06/doctors-experimenting-on-humans-five-questions-with-dr-nalini-rajamannan.html

Link to the Senate Judiciary Letter to Northwestern University dated 3-5-3014: http://files.newswire.ca/1315/SJIletter.pdf

For further information:

Rob Amaefule and Oscar Delgado, Independent Reporters, Medialore, 773-606-1885, [email protected], [email protected]; Nalini Marie Rajamannan, MD, 312-498-9496, [email protected], ConcieValve LLC


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
Learn how to solve the problem of keeping files in sync between multiple Docker containers. In his session at 16th Cloud Expo, Aaron Brongersma, Senior Infrastructure Engineer at Modulus, discussed using rsync, GlusterFS, EBS and Bit Torrent Sync. He broke down the tools that are needed to help create a seamless user experience. In the end, can we have an environment where we can easily move Docker containers, servers, and volumes without impacting our applications? He shared his results so yo...
Palerra, the cloud security automation company, announced enhanced support for Amazon AWS, allowing IT security and DevOps teams to automate activity and configuration monitoring, anomaly detection, and orchestrated remediation, thereby meeting compliance mandates within complex infrastructure deployments. "Monitoring and threat detection for AWS is a non-trivial task. While Amazon's flexible environment facilitates successful DevOps implementations, it adds another layer, which can become a ...
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, analyzed a range of cloud offerings (IaaS, PaaS, SaaS) and discussed the benefits/challenges of migrating to each offe...
SYS-CON Events announced today that MobiDev, a software development company, will exhibit at the 17th International Cloud Expo®, which will take place November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software development company with representative offices in Atlanta (US), Sheffield (UK) and Würzburg (Germany); and development centers in Ukraine. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobi...
Chuck Piluso presented a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. Prior to Secure Infrastructure and Services, Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000. Between 1990 and 1997, Mr. Piluso served as chairman & founder of International Te...
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
In a recent research, analyst firm IDC found that the average cost of a critical application failure is $500,000 to $1 million per hour and the average total cost of unplanned application downtime is $1.25 billion to $2.5 billion per year for Fortune 1000 companies. In addition to the findings on the cost of the downtime, the research also highlighted best practices for development, testing, application support, infrastructure, and operations teams.
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Container technology is sending shock waves through the world of cloud computing. Heralded as the 'next big thing,' containers provide software owners a consistent way to package their software and dependencies while infrastructure operators benefit from a standard way to deploy and run them. Containers present new challenges for tracking usage due to their dynamic nature. They can also be deployed to bare metal, virtual machines and various cloud platforms. How do software owners track the usag...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...