Artificial Heart experiment without informed consent?

Artificial Heart experiment without informed consent?

Wed, 30 Apr 2003

The manufacturer of an artificial heart, Abiomed, are seeking to use incapacitated patients who suffered a massive heart attack as human subjects without their informed consent. Does anyone have the moral or legal right to subject a human being to a high risk medical experiment without their voluntary, informed consent?

According to the company, the device (Abiocor) has been implanted in 10 people since July 2001. Nine have died, one remains stable in the hospital.

The first patient to have had the device implanted was James Quinn. His ordeal was the subject of an in-depth New York Times article. Last Journey of Artificial Heart Recipient,, Oct 8, 2002 excerpt at: http://www.ahrp.org/infomail/1002/08.php

James Quinn suffered far more than he (or his wife) had expected before he died. He told the New York Times reporter: “This is nothing, nothing like I thought it would be, he said. “If I had to do it over again, I wouldn’t do it….I would take my chances on life.”

A lawsuit has been filed on Mrs. Quinn’s behalf. See: http://www.ahrp.org/SuitsDecisions/heartsuit1102.php

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Artificial Heart Plan Raises Questions
Artificial Heart Company’s Proposal to Implant Device Raises Ethics Questions

The Associated Press

BOSTON April 29 — Officials at Abiomed Inc. said Tuesday they were considering implanting their artificial heart into patients who have suffered major heart attacks and whose relatives would have to give consent.

Company officials have discussed the proposal with ethics experts and believe it could be done “without compromising patients’ rights or patient integrity,” said Edward E. Berger, the company’s vice president for strategic planning and policy.

But other experts raised questions.

“It’s such an extraordinary experiment that informed consent is absolutely essential,” said George Annas, a professor of health law and bioethics at Boston University. “I really see no way you could justify this without the individual’s consent.”

Abiomed has gained worldwide attention for its trial of the Abiocor, a self-contained, implantable replacement heart. The Abiocor has been implanted in 10 people since July 2001. Nine have died. The 10th is in stable condition at the Texas Heart Institute in Houston, more than two months after the operation.

So far, the clinical trial has used patients with end-stage heart failure who have a 70 percent chance of dying within a month and no hope of other treatment.

The company’s proposal concerns people who have suffered massive heart attacks, who still have little chance of surviving, but who are otherwise healthier because they haven’t been debilitated by a long-term progressive condition.

These patients are frequently heavily sedated or being kept alive by life support.

Berger said the company hopes it will suffice to have a previously authorized health care proxy usually a relative consent to the implant.

Proxies allow a relative to make a decision about treatment for a patient unable to express his or her wishes. But it’s not clear if laws on medical proxies would allow a relative to put a patient in a medical experiment.

“I guess the question is: Is society comfortable with the notion that somebody can give their body to science while they’re still alive, but are no longer conscious and aren’t able to give their consent?” asked Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia.

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