Statement on the CardioPump before the FDA Circulatory Systems Advisory Panel

When CEI last addressed the CardioPump issue in May, 1995, the medical assessments of this device, as compared to standard CPR, ranged from neutral to positive.  It was clear, however, that the device posed no added risk.  Dr. Michael Callaham, Professor of Emergency Medicine at the University of California, San Francisco, and the author of one of the less favorable CardioPump studies, wrote the following in an unpublished letter to Time Magazine:  “We do not yet know why it appeared to work in one study and not another.  We do know that the device has shown no significant adverse effects.”

The CardioPump thus seemed to be at least as effective as standard CPR.  It was being used in a growing number of foreign countries, and it had no offsetting risks that might warrant delaying its availability in the United States.  Nonetheless, FDA determined it to be a “significant risk device”.  Trials of the device were halted by FDA’s policy of insisting on informed consent unconscious patients–a policy that, in the words of one JAMA editorial, “astonished and dismayed the research community”.

Three years have now passed.  New data, it appears, indicates that the CardioPump may be superior in one-hour survival rates and quite possibly in survival-to-hospital-discharge rates as well.  Just as importantly, the device continues to demonstrate no significant added risk. 

Under these circumstances, we submit that the ultimate judgment on this device should be made by the medical community. 

This issue, moreover, should be addressed in the context of the medical community’s judgment of FDA itself.  In a 1996 poll of cardiologists commissioned by CEI (attached), 65% viewed FDA as being too slow in approving new drugs and devices, and over 71% believed that the agency’s approval process had hurt their ability to give patients the best possible care on one or more occasions.  FDA’s review of the CardioPump, we submit, should not become yet another such occasion.

Sam Kazman

General Counsel

June 29, 1998