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://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

SOURCE Robert Amaefule and Oscar Delgado

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
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to o...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
For financial firms, the cloud is going to increasingly become a crucial part of dealing with customers over the next five years and beyond, particularly with the growing use and acceptance of virtual currencies. There are new data storage paradigms on the horizon that will deliver secure solutions for storing and moving sensitive financial data around the world without touching terrestrial networks. In his session at 20th Cloud Expo, Cliff Beek, President of Cloud Constellation Corporation, w...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that EARP Integration will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. EARP Integration is a passionate software house. Since its inception in 2009 the company successfully delivers smart solutions for cities and factories that start their digital transformation. EARP provides bespoke solutions like, for example, advanced enterprise portals, business intelligence systems an...
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developers ...
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs oft...
Interested in leveling up on your Cloud Foundry skills? Join IBM for Cloud Foundry Days on June 7 at Cloud Expo New York at the Javits Center in New York City. Cloud Foundry Days is a free half day educational conference and networking event. Come find out why Cloud Foundry is the industry's fastest-growing and most adopted cloud application platform.
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
As cloud adoption continues to transform business, today's global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
SYS-CON Events announced today that Cloud Academy will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Cloud Academy is the industry’s most innovative, vendor-neutral cloud technology training platform. Cloud Academy provides continuous learning solutions for individuals and enterprise teams for Amazon Web Services, Microsoft Azure, Google Cloud Platform, and the most popular cloud computing technologies. Ge...
When NSA's digital armory was leaked, it was only a matter of time before the code was morphed into a ransom seeking worm. This talk, designed for C-level attendees, demonstrates a Live Hack of a virtual environment to show the ease in which any average user can leverage these tools and infiltrate their network environment. This session will include an overview of the Shadbrokers NSA leak situation.
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.