- Posted October 9, 2013 by
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
OFFICE OF RESEARCH INTEGRITY RESPONSE TO THE PATIENTS AS PUBLISHED IN THE WALL STREET JOURNAL MUNDY AND FAVOLE, DECEMBER 2009
Doctors' Spat Exposes FDA Loophole
The story published the ongoing investigation by the Senate Finance Committee of the University, the FDA and the Company.
They published and vetted the office of research integrity statements sent to the patient.
They also published the letter sent by the Honorable Senator Grassley to Northwestern University:
December 3, 2008
Henry S. Bienen, PhD President
Northwestern University 633 Clark Street
Evanston, IL 60208
Dean M. Harrison
President and Chief Executive Officer Northwestern Memorial Healthcare 251 East Huron Street
Chicago, IL 60611
Dear Dr. Bienen and Mr. Harrison:
The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs. As a senior member of the United States Senate and as Ranking Member of the Committee, I have a special responsibility to the more than 80 million Americans who receive health care coverage under those programs to ensure that taxpayer and beneficiary dollars are appropriately spent on safe and effective drugs and devices.
I recently received troubling allegations that the Myxo ETlogix 5100 Ring (Myxo Ring), an annuloplasty ring used in heart valve repair, has not been approved and/or cleared for marketing by the Food and Drug Administration (FDA). At the same time it appears that the Myxo Ring has been, and perhaps continues to be, implanted in patients by Dr. Patrick McCarthy, a cardiothoracic surgeon at Northwestern Memorial Hospital. Furthermore, I was informed that the device is being implanted without an Investigational Device Exemption (IDE), which would allow the device to be used in a clinical study to collect data in support of an application to the FDA for approval. It is my further understanding that Dr. McCarthy invented this device, which is manufactured by Edwards Lifesciences (Edwards), and receives royalty payments from Edwards.
These allegations were brought to my attention by Dr. Nalini Rajamannan, Associate Professor and Valve Director of the Bluhm Cardiovascular Institute at Northwestern University’s (Northwestern/University) Feinberg School of Medicine. In addition, Antonitsa Vlahoulis, one of the patients who received the Myxo Ring during her operation in April 2006, expressed concern to my Committee staff that this device had not been approved and/or cleared by the FDA when it was implanted in her without her informed consent.
Dr. Rajamannan and Ms. Vlahoulis also told my Committee staff that they have both brought their concerns to Northwestern. According to a letter that the University sent to Ms. Vlahoulis, dated September 18, 2008, Northwestern’s Office for Research Integrity completed its own investigation of the allegations and concluded that the implantation of the device was “not research and did not require IRB approval.” The letter also stated that Edwards confirmed in an email to Northwestern that the device was commercially available.
I am also aware of the fact that Edwards Lifesciences wrote in an email to Dr. McCarthy that “According to the FDA guidance document dated January 10, 1997…model 5100 is a minor modification of model 4200, GeoForm Annuloplasty Ring, cleared under K032250. The applicable 510(k) number for model 5100 is K032250.” I cannot judge whether or not the Myxo Ring required FDA approval or clearance; however, Dr. Rajamannan told Committee staff that, in her opinion, the Myxo Ring is not a minor modification because, among other things, the shape of the ring is triangular whereas other annuloplasty rings are oblong. She also told my staff that after bringing this matter to Northwestern’s attention, the University began to take action against her.
My Committee staff’s own search for the Myxo Ring on FDA’s website did not produce any information regarding the Myxo Ring other than 8 adverse event reports that were submitted to FDA’s Manufacturer and User Device Experience Database (MAUDE).
In investigating these allegations, I would appreciate Northwestern’s response to the following questions and requests for information. Please repeat the enumerated question and follow with the appropriate response.
1) Please provide the Committee with a copy of the report, memorandum, or any other documentation of the internal investigation completed by Northwestern’s Office for Research Integrity.
2) Please provide a copy of all internal communications and correspondence regarding the Myxo Ring and the use of the device as part of an outcomes study. This request covers the period of January 2006 through the date of this letter.
3) Please provide a copy of all communications and correspondence with Edwards Lifesciences and FDA regarding the Myxo Ring. This request covers the period of January 2006 through the date of this letter.
4) What information regarding the Myxo Ring was provided to the Institutional Review Board during its review of the protocol and consent form for the
outcomes study entitled, “Early and Late Outcomes Following Surgical Intervention for Atrial Fibrillation Database”?
5) According to a July 24, 2008 letter to Dr. Rajamannan from Northwestern Medical Faculty Foundation, Inc., pursuant to the Foundation’s request, Dr. Rajamannan “agreed not to provide clinical care at Northwestern Medical Faculty Foundation and Northwestern Memorial Hospital.”
a. Please explain why this request was made of Dr. Rajamannan.
b. Did the University and/or Northwestern Memorial Hospital have concerns regarding her clinical performance?
c. Prior to bringing her concerns regarding implantation of the Myxo Ring to the attention of the University, did Dr. Rajamannan receive any poor job performance evaluations? Has the University taken any disciplinary actions against Dr. Rajamannan in the past?
d. Please provide the Committee with a copy of Dr. Rajamannan’s personnel records. Dr. Rajamannan provided a signed authorization on October 28, 2008, for the release of her personal information.
6) Please provide a copy of any forms filed with the University and Northwestern Memorial Hospital detailing Dr. Patrick McCarthy’s outside income and conflicts of interest from January 2004 through June 2008.
7) Because reporting practices vary widely from one institution to another, I would appreciate you also placing this income into a chart, detailing compensation from device companies to Dr. McCarthy. This request covers the period of January 2004 through June 2008. For each payment to Dr. McCarthy from a company, please provide the following information:
a. Name of company;
b. Date of payment;
c. Payment description (CME, honorarium, research support, royalties, etc.); and
d. Amount of payment.
In cooperating with the Committee’s review, no documents, records, data or information related to these matters shall be destroyed, modified, removed or otherwise made inaccessible to the Committee.
I look forward to hearing from you by no later than January 5, 2009. Sincerely,
Charles E. Grassley Ranking Member