A segment on CBS’s 60 Minutes last night (Sunday, February 19th), which you can watch below, reported that antidepressant drugs are no better than a placebo for treating mild to moderate depression. I have to say that this conclusion is not a surprise to those in the alternative medicine community. But it is thrilling to see this information coming onto the light since drugs like antidepressants have been over-prescribed and can have dangerous side-effects.
Harvard scientist Irving Kirsch is the associate director of the Placebo Studies Program. His research challenges the very effectiveness of antidepressants.
“The difference between the effect of a placebo and the effect of an antidepressant is minimal for most people,” says Harvard scientist Irving Kirsch.
In an interview with 60 Minutes correspondent Leslie Stahl, he explained that his research indicated that not only was there virtually no difference between drugs and the placebo effect, but that it didn’t even matter which drugs were being taken.
Kirsch: We even looked at drugs that are not considered antidepressants: tranquilizers, barbiturates. And do you know what? They had the same effect as the antidepressants.
Stahl: Come on.
Kirsch was so surprised by his initial findings, he decided to do a second study – using data not only from the drug companies’ clinical trials that had been published in medical journals..
It also turns out that even when no real treatment was given, the patients’ condition improved, sometimes even better than with the real treatment:
Kirsch: Placebos are great for treating a number of disorders: irritable bowel syndrome, repetitive strain injuries, ulcers, Parkinson’s disease.
Even traumatic knee pain. In this clinical trial some patients with osteoarthritis underwent knee surgery. While others had their knees merely opened and then sewn right back up.
Kirsch: And here’s what happened. In terms of walking and climbing, the people who got the placebo actually did better–
Stahl: Come on.
Kirsch: –than the people who got the real surgery.
Kirsch: And that lasted for a year. At two years after surgery, there was no difference at all between the real surgery and the sham surgery.
Stahl: Is it all in your head or–
Kirsch: Well, it’s not all in your head because the placebos can also affect your body. So if you take a placebo tranquilizer, you’re likely to have a lowering of blood pressure and pulse rate. Placebos can decrease pain. And we know that’s not all in the mind also because we can track that using neuro-imaging in the brain as well.
Wow. This is an astounding admission coming from a mainstream medical researcher. That antidepressant
drugs are no better than a placebo could be a major blow to the drug companies pockets. Of course the mainstream medical community doesn’t like this at all. They maintain that the drugs do work and that prescribing drugs is better than not doing so, to save the small percentage of people who do not experience the placebo effect.
Kirsch and his studies have triggered a furious counterattack – mainly from psychiatrists, who are lining up to defend the use of antidepressants like Dr. Michael Thase, a professor of psychiatry at the University of Pennsylvania School of Medicine, who has been a consultant to many of the drug companies.
Stahl: Irving Kirsch says that [anti]depressants are no better than placebo for the vast majority of people with depression, the vast majority. Do you agree with that?
Michael Thase: No, no. I don’t agree. I think you’re confusing, or he’s confusing, the results of studies versus what goes on in practice.
He says that Kirsch’s statistical analysis overlooks the benefits to individual patients.
And while he agrees there’s a substantial placebo effect …. Especially for the mildly depressed, using a different methodology, he finds that the drugs help 14 percent of those moderately depressed, and even more for those severely depressed.
Thase: Our own work indicates pretty convincingly that this is a large and meaningful effect for a subset of the patients in these studies.
Stahl: But even by your own numbers more people, maybe twice as many people, are having a placebo effect than are actually being helped by the drug.
Thase: That’s correct.
Stahl: In the moderate range?
Thase: That’s correct.
Stahl: And this isn’t troubling to you?
I’m troubled by this, even if Dr. Thase is not. Why not try the placebo effect on all patients first. If no positive results are forth-coming THEN try drugs. But no. The 86% must be sacrificed for …. something I won’t mention. But after all he is a consultant to the drug companies. And of course no one is mentioning that diet can have a lot to do with one’s mental state. Perhaps even a change to, let’s say, the Paleo diet might reduce depression and therefore the need for drugs or the placebo effect.
What is also troubling is the methodology by which these drugs are approved. The drug manufacturers omit the studies with negative results when seeking the FDA’s stamp of approval for their product. Through the Freedom of Information Act Kirsch was able to add those studies to his research only to find that even the drug companies information agreed with his findings.
Dr. Walter Brown is a clinical professor of psychiatry at Brown University’s Medical School. He has co-authored two studies that largely corroborate Kirsch’s findings.
Brown: The number of antidepressant prescriptions over the last decade has increased and most troublesome, the biggest increase is in the mildly depressed, who are the ones who are least likely to benefit from them.
He says they’re getting virtually no benefit from the chemical in the pill. Like most experts, he says these drugs do work for the severely depressed, but he questions the widely held theory that depression is caused by a deficiency in the brain chemical called serotonin, which most of these pills target.
Brown: The experts in the field now believe that that theory is a gross oversimplification and probably is not correct.
Stahl: And the whole idea of antidepressants is built around this theory?
Brown: Yes, it is.
To approve any drug, the Food and Drug Administration merely requires that companies show their pill is more effective than a placebo in two clinical trials – even if many other drug trials failed.
Brown: The FDA for antidepressants has a fairly low bar. A new drug can be no better than placebo in 10 trials, but if two trials show it to be better, it gets approved.
Stahl: Does that make sense to you?
Brown: That’s not the way I would do it if I were the king. But I’m not.
Not surprisingly, the FDA defends the approval process. And the degree of effectiveness is not a consideration in the approval process. Shouldn’t it be?
The British National Health Service is certainly taking notice of these findings and is changing the way antidepressants are prescribed. Because the difference is so small, they are reserving drug prescriptions for the severely depressed and using other methods of therapy, such as exercise, for those with mild or moderate depression.
So what does this all mean? To me it means that you need to take your health into your own hands. If you are depressed find out why. Improving your mental state could be as simple as following the Paleo diet. Removing grains and sugars can also reduce depression as Mark Sisson writes about on Mark’s Daily Apple. Moderate exercise has been shown to help improve how one feels. In the end does it really matter if antidepressant drugs are no better than a placebo if diet and exercise can help? And the Paleo diet is no placebo!
60 Minutes segment: Antidepressant drugs are no better than a placebo