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
Everyone wants the rainbow - reduced IT costs, scalability, continuity, flexibility, manageability, and innovation. But in order to get to that collaboration rainbow, you need the cloud! In this presentation, we'll cover three areas: First - the rainbow of benefits from cloud collaboration. There are many different reasons why more and more companies and institutions are moving to the cloud. Benefits include: cost savings (reducing on-prem infrastructure, reducing data center foot print, redu...
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
You want to start your DevOps journey but where do you begin? Do you say DevOps loudly 5 times while looking in the mirror and it suddenly appears? Do you hire someone? Do you upskill your existing team? Here are some tips to help support your DevOps transformation. Conor Delanbanque has been involved with building & scaling teams in the DevOps space globally. He is the Head of DevOps Practice at MThree Consulting, a global technology consultancy. Conor founded the Future of DevOps Thought Leade...
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
Founded in 2000, Chetu Inc. is a global provider of customized software development solutions and IT staff augmentation services for software technology providers. By providing clients with unparalleled niche technology expertise and industry experience, Chetu has become the premiere long-term, back-end software development partner for start-ups, SMBs, and Fortune 500 companies. Chetu is headquartered in Plantation, Florida, with thirteen offices throughout the U.S. and abroad.
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
The technologies behind big data and cloud computing are converging quickly, offering businesses new capabilities for fast, easy, wide-ranging access to data. However, to capitalize on the cost-efficiencies and time-to-value opportunities of analytics in the cloud, big data and cloud technologies must be integrated and managed properly. Pythian's Director of Big Data and Data Science, Danil Zburivsky will explore: The main technology components and best practices being deployed to take advantage...
Andi Mann, Chief Technology Advocate at Splunk, is an accomplished digital business executive with extensive global expertise as a strategist, technologist, innovator, marketer, and communicator. For over 30 years across five continents, he has built success with Fortune 500 corporations, vendors, governments, and as a leading research analyst and consultant.
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
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...
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER gives detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPOalso offers sp...
Today, we have more data to manage than ever. We also have better algorithms that help us access our data faster. Cloud is the driving force behind many of the data warehouse advancements we have enjoyed in recent years. But what are the best practices for storing data in the cloud for machine learning and data science applications?
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.