http://www.abcnews.go.com/onair/2020/transcripts/2020_990510_placebo_trans.html The Placebo Effect 20/20 May 10, 1999 This is an unedited, uncorrected transcript.) CONNIE CHUNG Our next story is a controversial twist on a standard medical practice. It involves the use of placebos. These are usually dummy or fake drugs, like a sugar pill, given to some patients in order to test theeffectiveness of a real drug. Sometimes patients getting a placebo can experience as much improvement as those getting the real thing. That is called the placebo effect. But what if, instead of taking a fake pill, you are being given fake surgery? Our medical editor, Dr Timothy Johnson, looks at the ethics and consequences of this highly controversial procedure. DR TIMOTHY JOHNSON, ABCNEWS MEDICAL EDITOR (VO) The placebo effect is one of the most powerful healing forces in medicine. For more than 50 years, countless drug studies have shown that people often get a 30 percent improvement just by taking placebos. But giving patients placebo pills is one thing. Lynda McKenzie (ph) got placebo brain surgery, which meant having holes drilled in her head. Medical ethicist Arthur Caplan says this time, science has gone too far. ARTHUR CAPLAN, MEDICAL ETHICIST The key moral principle in medical research, the key central principle is “do no harm.” Do not harm the patient in the pursuit of new knowledge. I think the time is here to simply take this one off the table. DR TIMOTHY JOHNSON (on camera) The idea of placebo surgery is not new, nor is the controversy surrounding it. For example, back in the 1950s, doctors tried fake surgery on patients with chest pain. Some patients in the experiment got real surgery. Their chest was opened up. An internal artery was tied off, then they were sewn back up. But other patients got fake surgery. Their chest was opened up, but nothing was done inside. Then they were sewn back up. But they were never told they were in an experiment. They were never told they got fake surgery. They were totally deceived. Nonetheless, the results were amazing. (VO) Ted Kaptchuk (ph) of Boston’s Beth Israel/Deaconess Hospital has studied the history of the placebo effect. TED KAPTCHUK, BETH ISRAEL/DEACONNESS HOSPITAL The people that got the fake surgery, sham (ph) surgery, 100 percent of them improved for six months on objective and subjective measures. That’s how long they followed them. The people who got the real surgery, 72 percent improved. That’s an amazing example of the power of surgery as a placebo. DR TIMOTHY JOHNSON (VO) Placebo surgery without patient knowledge raised obvious ethical questions and was abandoned in the 1960s. But these doctors from the University of Colorado and New York’s Columbia Presbyterian Medical Center have announced the results from a placebo brain surgery study on Parkinson’s patients in which the patients were fully informed. Lynda McKenzie was one of 40 people who agreed to take part in the study. You can see in her wedding video six years ago that medication was successfully controlling her symptoms at that time. But slowly, her condition deteriorated as her brain was less able to produce dopamine, a brain chemical necessary for normal movement. LYNDA MCKENZIE, PARKINSON’S PATIENT The Parkinson’s got worse, and the drugs didn’t seem to have the same effect that they used to have. DR TIMOTHY JOHNSON (VO) Because medicines eventually fail in most Parkinson’s patients, 11 years ago, Dr Curt Freed of the University of Colorado and others started to experiment with the implanting of fetal cells into the brain as a possible new way to raise dopamine levels in Parkinson’s patients. DR CURT FREED, UNIVERSITY OF COLORADO In this condition, the dopamine—producing cells in the brain have died off. What we’re doing is putting in brand—new cells, and they will grow into the brain and replace the missing dopamine. That’s the whole concept behind the study, replacing a dead cell with a living cell. DR TIMOTHY JOHNSON (VO) But drug studies have already proved that patients with Parkinson’s are very responsive to the placebo effect. So to avoid the possibility that the experimental surgery was simply causing a placebo effect, the doctors insisted that their new study compare real surgery with implants against fake surgery with no implants. The 20 placebo patients had holes drilled in their heads, but no needles penetrated their brains, and no tissue was injected. Lynda knew the odds when she entered the study, that she had a 50—50 chance of being a placebo patient. (on camera) You had no idea when you were having it, and after you had it, which one you had? LYNDA MCKENZIE Oh, no. I was sure I had the tissue. DR TIMOTHY JOHNSON You were sure you got the real surgery? LYNDA MCKENZIE Yes. DR TIMOTHY JOHNSON (VO) But in fact, Lynda got the sham surgery, though she didn’t learn that until the end of the one—year study. Indeed, she was convinced at first that her symptoms were improving. (on camera) And how did you feel afterward? LYNDA MCKENZIE Pretty good, actually. I felt pretty good. DR TIMOTHY JOHNSON How long did it take you to start doubting that you might have gotten the real thing? LYNDA MCKENZIE It was about four or five months, I guess. We realized that I wasn’t getting any better. DR TIMOTHY JOHNSON (VO) Ruth Ashley (ph) was also a placebo patient in the study. Within a month after her placebo surgery, Ruth’s symptoms began to improve. Here are videos she took before the fake surgery, showing how difficult it was for her to walk. But these videos, taken after the placebo surgery, show her walking much more easily. Ruth’s husband, Ed, says even her doctors at Columbia were fooled by her progress. ED ASHLEY They thought she had the real operation at that time because of her positive attitude. RUTH ASHLEY, PARKINSON’S PATIENT And they took a vote on how many thought I had gotten the real thing. They all voted that I had gotten it. They were flabbergasted that I didn’t. DR TIMOTHY JOHNSON (on camera) Were you, as a doctor, fooled? UNIDENTIFIED DOCTOR Well, certainly in the beginning. DR TIMOTHY JOHNSON (VO) Both Ruth and Lynda say they improved initially after sham surgery. However, both went on to get real implants, which were promised to all placebo patients who wanted them after one year in the comparison study. (on camera) When you learned that you had, in fact, gotten the fake surgery, how did you look back on that and interpret it? How did you think you felt so good? LYNDA MCKENZIE I think I put it down to the fact that that’s just me. DR TIMOTHY JOHNSON You’re a positive thinker? LYNDA MCKENZIE Yeah. UNIDENTIFIED MAN (This was Al, Lynda's husband) I personally chalked it up to a placebo effect. DR TIMOTHY JOHNSON (VO) Experts say the placebo effect is real and that healing occurs because the patient believes in the treatment, not from the treatment itself. For example, one study found that 42 percent of balding men taking a placebo kept or grew more hair. And there’s another placebo surgery study going on right now on arthritic knees, comparing full arthroscopic surgery to fake surgery to see if it also reduces pain and swelling. The results from this trial are expected in the year 2000. Placebos do have limits. A broken leg needs to be put in a real cast. And people cannot believe themselves into a cure for diseases like AIDS or cancer. But there are a number of diseases like Parkinson’s that are highly responsive to placebos, at least temporarily—diseases such as depression and anxiety, asthma and allergies, hypertension, ulcers, angina and various kinds of pain. So the big question for scientists is not whether placebos work, but how? At the University of Connecticut, psychologist Irving Kirsch (ph) is discovering how thoughts and beliefs can actually heal bodies. IRVING KIRSCH, UNIVERSITY OF CONNECTICUT The underlying psychological mechanism is a person’s belief or expectancy. DR TIMOTHY JOHNSON (VO) Expectancy theory says that our past experience tells our brain what to expect next. Those thoughts in our brain are linked to our immune and endocrine systems, which trigger a series of chemicals that reach our cells and tissues and organs. IRVING KIRSCH If you give someone a placebo that’s supposed to be a tranquilizer, for example, it leads them to think that they’re going to feel more relaxed, and that belief makes them feel more relaxed. You give them the same placebo in the guise of a stimulant, and they think they’re going to get more energized, and that belief will make them more energized. DR TIMOTHY JOHNSON (VO) Phony pills, fake injections, even sham surgeries are just some of the ways to get our bodies to respond to our thoughts, says Dr Kirsch. There are other ways. IRVING KIRSCH There are a bunch of different ways in which you can get somebody to believe that something’s going to happen. Giving a suggestion is one. Using hypnosis is another. Faith healing is another. Giving a placebo, a medical placebo, is yet another. And all of these work by means of the same thing. DR TIMOTHY JOHNSON (VO) But in the brain surgery study, did the doctors really have to drill holes to achieve the placebo effect? UNIDENTIFIED DOCTOR Our choice, as we saw it, it was two—fold. One, we could drill a hole and people would be convinced that they had the surgery. Two, we could put them under general anesthesia, and everybody would wake up feeling exactly the same. Our estimate was that the risk of the general anesthesia was in and of itself far greater than the risk of making a skin incision and drilling a burr hole. DR TIMOTHY JOHNSON (on camera) You became convinced, obviously, that you had to drill the hole in order to achieve a real placebo effect, pure and simple? DR CURT FREED Absolutely. That’s right. DR TIMOTHY JOHNSON (VO) But Arthur Caplan thinks it’s unnecessarily risky, no matter what we learn from comparing real surgery against sham surgery. ARTHUR CAPLAN All too often, what we’ve seen is people saying, it’s just a minor or a small thing, nothing to worry about. You’re not going to wind up making the person a lot worse off. And then, you see people who are desperate, who are fanatical about finding a cure, who have no hope. And they will say, “I’ll consent to any kind of sham surgery you make me in order to have the prospect of getting some hope of getting at the curative surgical intervention.” DR TIMOTHY JOHNSON What do you say to the critics who say there’s still some risk involved in this procedure, this sham surgery, and no benefit? LYNDA MCKENZIE I would say, try having Parkinson’s for a little while and then decide what you think. HUGH DOWNS Overall, most of the 20 patients who received placebo surgery reported improvements in their condition nearly equal to patients who had the actual cell transplants. However, new cell growth has been seen only in patients who got the actual cells. The controversy over placebo surgery continues. But the medical community defends it as good science, and the National Institutes of Health has refused to fund similar Parkinson’s research studies that do not contain placebo surgery. Copyright ©1999 ABCNEWS and Starwave Corporation. -- Judith Richards, London, Ontario, Canada <[log in to unmask]> ^^^ \ / \ | / Today’s Research \\ | // ...Tomorrow’s Cure \ | / \|/ ```````