Cardiac patients unwitting guinea pigs for new treatment

A number of cardiac patients were used as unwitting test subjects for a new treatment method at Erasmus MC in Rotterdam, RTL Nieuws reports after speaking with two such patients. Minister Edith Schippers of Public Health ordered an investigation into this practice.

The treatment involved is called catheteriztion with a cryo-balloon - a new method to treat atrial fibrilation, better known as cardiac arrhythmia. The method was developed by Canadian researchers and involves a catheter with a frozen balloon at the end. It is considered a better treatment with fewer complications. 

But it did not work out like tat for 67-year-old Piet van der Slikke from Zeeland. In the summer of 2005 he suddenly fell sic with cardiac arrhythmia. "I had to wait half a year for my surgery, but a month later I received a call from Erasmus MC in Rotterdam that I could come. They were going to help me in a very safe manner. But I had no idea it involved a new procedure", he said to RTL Nieuws. 

The operation was a bit of a disaster. "First they hit my windpipe. They spent the whole morning trying to fix it", he said. The rest of the operation did not go well either. "Every time the balloon popped. I heard the doctors cursing. Bam! There it goes again." Van der Slikke was on the operating from 8:30 a.m. until 5:00 p.m. and ended up in intensive care afterwards. He eventually underwent the "old-fashioned" surgery at a regional hospital. 

The same thing happened to one of lawyer Mya Spetter's clients. The 54-year-old teacher also suffered from heart arrhythmia, was treated with the new method without him knowing and ended up iin intensive care. "The operation failed. His pulmonary vein tore after the balloon was inserted. He ended up in intensive care", the lawyer said to the broadcaster. "When my client was recovering at home, he investigated. He learned that he was treated with a cryo-balloon catheter, a new method. But he did not know about the new method. He never signed anything."

According to Frans van Wijmen - former professor of helath law and member of the Ethics Commoittee that assesses experiments with human subjects - hospitals can't use methods on patients without them knowning. "With this kind of new treatment methods, a hospital should make a protocol and submit it to the medical ethics committee. If they give the go ahead, patients should be informed about the new treatment. There are first conversations in which everything must be clearly explained. And the patient must sign a farom. Not playing by the rules is very serious. And contrary to law." he said to RTL.

In a comment, Erasmus MC made clear that they see the matter differently. "It was not a treatment used for the purposes of medical research because: 'it was a refinement of a much longer existing treatment.' We conclude that patients weren't unwittingly used as test subject. The new catheter has the aadvantage that it is more precise and more effective and the risk of complications is smaller than with the treatment that is already there."

Minister Edith Schippers of Public Health asked the Healthcare Inspectorate to look into the matter. 

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