Real Knife, Fake Surgery

George Doeschner had been suffering from Parkinson’s disease for 12 years when his physician told him about an experimental surgery that might offer a cure. Researchers at the University of Colorado were taking cells from embryos and putting them in the brains of Parkinson’s patients to replace cells killed by the disease. The 55-year-old electrician applied to be a part of the experiment and flew to Denver. He was prepped for surgery and sedated. A hole was drilled through his skull. Then his surgeons sewed him up and sent him home–without giving him those embryonic cells.

Surgical error? Medicare fraud? No, a deliberate sham. Bizarre as it may seem, fake surgeries–otherwise known as placebo-controlled surgical trials–are entering mainstream medical research. The first of these trials wrapped up last week, and others are under way. “This is just the beginning,” says Warren Olanow, chair of neurology at Mount Sinai Hospital. “Tomorrow if you have a [new] procedure, you will have to do a double-blind placebo trial.”

Double-blind placebo trials, of course, are standard procedure for drug developers, who know from long experience that 1 out of 3 test subjects feel better with only a sugar pill. Scientists sidestep the placebo effect in drug trials by dividing patients into two groups–giving one the real drug and the other a fake.

It turns out that the placebo effect is especially powerful in Parkinson’s disease. That’s why Curt Freed at the University of Colorado and Stanley Fahn at Columbia University decided to create a control group whose members could be fooled into thinking they were getting the full surgical treatment. “When you have something as major as surgery,” says Fahn, in defense of his experiment, “wouldn’t it be best to know there was some benefit?”

The National Institutes of Health agreed. Indeed, the NIH believes so strongly in the value of placebo surgeries that it has begun rejecting experiments from university researchers that do not employ them. Today placebo trials are being mounted for a variety of procedures, from knee surgery to the treatment of pain in cancer.

Critics of these trials–and there are many–complain that they violate the first principle of medicine: do no harm. Surgery, even sham surgery, is never risk-free. Doeschner says his doctors told him that he might get the short end of the double-blind stick and warned him before asking for his consent that even a fake operation could leave him “a vegetable.”

“Consent is irrelevant,” objects Arthur Caplan, director of the bioethics center at the University of Pennsylvania. “When you’re dealing with desperate illness, people will consent to anything.”

That’s true, but some research administrators have concluded that the scientific knowledge that may be gained justifies the risk. They find reassurance in the fact that the dangers have been reduced by advances in minimally invasive surgery. But they are also feeling pressure from HMOs that want proof that a new type of surgery works before approving it.

The biggest factor driving these experiments, however, may be that the easy questions–do patients survive or die with a new therapy?–have already been answered. Increasingly, scientists are looking for more subtle, and often more subjective benefits. Is there less pain? Is it easier to walk? These outcomes can be strongly influenced by wishful thinking.

Sorting the real benefits from the fake seemed a worthy goal to patient Doeschner. “I wanted to do something that would help everybody who has Parkinson’s,” he says. Besides, once the experiment was over, he came back for another operation. This time he got the real thing.