- Posted October 15, 2013 by
This iReport is part of an assignment:
Shutdown over: What next?
- 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
WSJ Confirms NU Integrity Review Approved Testing Without Informed Consent: False Inducment
The Wall Street Journal
December 29, 2009
Doctors' Spat Exposes FDA Loophole
By ALICIA MUNDY and JARED A. FAVOLE
"One of Dr. McCarthy's early implant patients was Antonitsa "Toni" Vlahoulis, then a 38-year-old X-ray technician and a mother of two, who suffered from a life-threatening mitral-valve disorder. The heart has four valves that keep blood flowing in the right direction. Dr. McCarthy's ring is designed to keep the mitral valve closing and opening correctly so blood doesn't back up into the lungs.
Dr. McCarthy's valve repair at first appeared to clear Ms. Vlahoulis' shortness of breath. But then her breathing worsened, she says, sending her frequently back to her cardiologist.
Ms. Vlahoulis says she was surprised when she received a "warranty card" in the mail -- the kind of postcard that appliance makers send after a purchase. It was for her new implant: the McCarthy Annuloplasty Ring Model 5100.
She realized the product wasn't listed in the catalog of heart rings she says Dr. McCarthy had given her before surgery. She says Dr. McCarthy had told her she would receive one of the rings in the catalog.
Dr. McCarthy said he told her she would receive an implant of this type.
She was readmitted to the Northwestern hospital in 2007. That spring she told Dr. Rajamannan, who was following her case, that she hadn't signed a consent form specifically for Dr. McCarthy's device.
Ms. Vlahoulis did sign two forms approving the surgery in general and allowing the results to be used for research. Northwestern has said those forms amount to informed consent for use of the device.
Dr. Rajamannan learned that Northwestern hadn't convened an institutional review board, an oversight panel required whenever patients are being given experimental medicines or devices. She says she asked Dr. McCarthy why he was conducting a clinical trial without patient consent. The collaboration between Drs. McCarthy and Rajamannan fell apart.
Dr. McCarthy says it is common for surgeons to try out tweaks to devices without going through the whole clinical-trial process. Asked whether he thought he should have asked for a review board, he said: "Not even remotely."
The university says it didn't convene a review board or ask for special patient consent because there was no clinical trial.
Dr. Rajamannan says she believes the use of the ring did represent a clinical trial. She says Dr. McCarthy should have told patients that he was implanting an unproven device on which he was making money.
Dr. McCarthy says he consults for Edwards but royalties from the Myxo ring go to a Chicago food bank.
Dr. Rajamannan's accusations put the university administration on the spot. The chairman of the cardiology division separated Dr. Rajamannan from duties involving Dr. McCarthy's surgery patients, she says.
The university legal office and Dr. McCarthy scrambled to get reassurance from Edwards Lifesciences that the FDA had authorized use of the Myxo ring. In September 2007, Edwards responded that the ring had been "marketed in the U.S. since March 2006" pursuant to the FDA's 1997 guidelines. The company also stated it wasn't an experimental device."