Northwestern University Fails to Adequately Respond to Senate Judiciary Committee Inquiry Regarding Unauthorized Human Experimentation: Investigation Heats Up Regarding Secret Protocol Withheld from Previous Senate Committee Investigation
CHICAGO, May 5, 2014 /Christian Newswire
/ -- 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, without their consent, allegations now confirmed with secret documents produced by Northwestern during Senator Grassley's investigation. 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 by the Chronicle of Higher Education and The Heartwire. This line of valve rings, have resulted in over 5000 adverse events, including 645 deaths according to the FDA MAUDE database, including serious life threatening adverse events not provided to the FDA compliance review and is the cornerstone of a malpractice and fraud lawsuit against Northwestern filed in the Circuit Court of Cook County(08-L-012426).
In a letter sent to Northwestern on April 28, 2014, the Senate Judiciary committee requests a response regarding documentation of an agreement between senate staffers and the University legal counsel to not produce documents related to the testing of the device.
"WASHINGTON – Sen. Chuck Grassley of Iowa continues to press Northwestern University on whether the university withheld key documents in an earlier inquiry into whether a cardiologist used an unapproved heart-valve repair device on patients without their proper consent.
"Moreover, the … documents which you belatedly disclosed bear directly on the question that precipitated my investigation in 2008 and remains unanswered: did Northwestern implant an unapproved device -- which it knew, or should have known, required approval -- in patients without obtaining their informed consent?" Grassley writes in an April 28 letter to the presidents of Northwestern University and Northwestern Memorial Hospital.
Grassley wrote to Northwestern last month after new information came to light about documents on the Myxo Ring that Northwestern did not disclose to him in 2009. Northwestern responded and claimed Grassley staff agreed to a limited document production then. However, Grassley's correspondence at the time made clear he sought all documents on the Myxo Ring. Grassley's April 28 letter seeks any documentation of any agreement to limit the document production. In addition, the letter asks how the university reconciled the cardiologist's description of the Myxo Ring as "significantly larger than existing commercial remodeling rings" with the device maker's assurance that the device was merely a "minor modification" of an existing device. The distinction is critical to whether FDA approval of the device was necessary before use in patients and whether patients were required to give informed consent to receive the device."
In 2009, the FDA approved not one but two devices using the results of clinical studies performed in Chicago, New York City and Cleveland Ohio, in unsuspecting patients while under general anesthesia. It was later determined that the FDA did not have knowledge of the clinical trials, or of the sales of the newly patented devices(7,951,196, Myxo Ring, 7,935,145, IMR Ring) with major differences in size and shape.
In 2009, the FDA approved not one but two devices using the results of clinical studies performed in Chicago, New York City and Cleveland Ohio, in unsuspecting patients while under general anesthesia, but the FDA is not planning to inform the patients of the trials, the voluntary recall, or the 5,000 adverse events caused by this product line of devices manufactured by Edwards Lifesciences as per Sarah Clark-Lynn FDA spokesperson in 2012.
"FDA has reviewed the adverse event reports from Edwards LifeSciences. Although there is a high volume of reporting for the company's entire annuloplasty product line our analysis concluded that the large number of reports does not point to a specific problem with one of their rings….we relied upon Northwestern to inform the patients of the voluntary recall of the rings"
Vlahoulis the first patient to report no informed consent to Northwestern University in 2007 and to the Senate Committee in 2008, "I am in shock that Northwestern University waived my rights to know I was a human subject in McCarthy's clinical trial. This is fraud, and justice should be served now that the truth is revealed. Why is the FDA not doing anything to protect the patients who received the ring?"
Rob Amaefule and Oscar Delgado