March 6, 2013 in Business, Health

Providence caps heart studies after cardiologist reprimanded by FDA

By The Spokesman-Review
 

A federal reprimand of a Spokane cardiologist for not properly managing a heart-valve clinical study has led Providence Health Care to stop accepting patients in about three dozen cardiology research programs in the area.

The uncommon step follows a formal warning letter sent by the Federal Drug Administration to Dr. Michael Ring, a cardiologist who works at Providence Sacred Heart Medical Center.

Like many other area physicians, Ring is conducting medical research projects involving heart patients receiving test devices, new drugs or test procedures.

Ring, considered one of the region’s foremost heart specialists, has been conducting research on the CoreValve, an experimental artificial valve being developed by Medtronic, a medical-devices company.

The letter doesn’t assert that the CoreValve study at Sacred Heart endangered patient safety.

After visiting Spokane last summer, FDA investigators cited Ring, the study’s lead investigator, for three problems:

• Ring and the study managers failed to properly obtain informed consent from some patients who took part in the study.

• Study managers failed to notify a designated review panel within five days about “significant” events, as required. In two cases patients underwent emergency procedures that deviated from standard practice. And, in 2011, two test participants died but the review panel wasn’t notified until months later.

The test device had nothing to do with the patient deaths, according to the FDA summary.

• The FDA cited “failure to maintain accurate, complete, and current records” relating to the trial.

In a column appearing in Forbes magazine, Ring responded with a written statement: “Prior to and since the FDA inspection, we have made improvements to our procedures, and additional research staffs have been recruited and appropriately trained. We welcome guidance from the FDA and will continue to fully cooperate with them.”

Ring declined to comment further Tuesday, instead deferring to Joe Robb, director of marketing and public relations for Providence Health Care.

The CoreValve project is one of two studies Ring is conducting through sponsorship by Medtronic. Medtronic has said it has 40 hospitals involved in testing the CoreValve device across the country. Medtronic said no other hospitals testing the device have been flagged by the FDA.

As a result of the FDA visit last summer, in August Providence officials stopped admitting new candidates in all of the cardiology research projects taking place in its Spokane hospitals.

Robb said many of those roughly 35 cardiology studies were already under way by physicians in clinics acquired by Providence in the past few years.

Because of those acquisitions, Providence now has an obligation to ensure no discrepancies occur in the estimated 270 research projects Robb said are managed by Providence and cover many medical specialties, not just cardiology.

“When we saw that one study (for CoreValve) had issues, it led us to close all new enrollments in the cardiology studies,” Robb said, adding the research projects will continue moving forward.

Ring’s study has about 38 participants. He launched it in February 2011 while at a Spokane heart clinic. He later moved to Spokane Cardiology, which Providence acquired in 2012.

The Forbes article quoted Medtronic officials as saying Sacred Heart Medical Center is not currently implanting the CoreValve device and will not resume implanting the device until all the problems “are addressed to the full satisfaction of the FDA.”

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