APA Blasts 60 Minutes Program on Antidepressants

Fran Lowry

March 20, 2012

March 20, 2012 — A recent episode of the news program 60 Minutes featuring psychologist Irving Kirsch, PhD, and his book The Emperor's New Drugs, which claims there is no effective difference between antidepressant medications and placebo, is not just wrong "but irresponsible and dangerous reporting," according to the American Psychiatric Association (APA).

"Antidepressants do work, particularly for patients with major depression," APA president John Oldham, MD, who is also Chief of Staff of the Menninger Clinic at Baylor College of Medicine in Houston, Texas, told Medscape Medical News.

Dr. John Oldham

"In studies where there is a placebo arm, patients are taking what they think is the active medication, but they are also participating in the entire design of the study, which means they have regular visits with concerned and caring, always available personnel, so there is a fabric of supportive help. This is very different than just a sugar pill, but Kirsch, in saying that antidepressants are no better than placebo, didn't go to much effort to clarify this," he said.

Dr. Oldham said he was contacted by the CBS network to be interviewed for the segment but was cancelled at the last minute.

"This was a show that had been in the works for a while, and they were going to interview me, but they ended up cancelling that interview the day before. The word was that Leslie Stahl had been called urgently to the Middle East. At least that's what they told us, and I assumed it was correct.

"We figured they would just reschedule; this is what they implied, but we never heard from them. And then we got a call just a few days before the airing of the program, telling us that it was going to be on. That was a surprise," Dr. Oldham said.

After the program, he wrote to the producer, outlining his concerns.

I felt that the overall message that was pretty strongly delivered...was that if you're depressed and you're taking antidepressants, they aren't going to help you because they aren't much better than a placebo. I have problems with that.

"I felt that the overall message that was pretty strongly delivered through the extensive amount of time that was devoted to the interviews with Kirsch and his ideas was that if you're depressed and you're taking antidepressants, they aren't going to help you because they aren't much better than a placebo. I have problems with that," he said.

No Meaningful Difference

Medscape Medical News spoke with Dr. Kirsch, who is professor of psychology at the University of Plymouth in the United Kingdom and also a lecturer in medicine and the associate director of the Program in Placebo Studies at Harvard Medical School in Boston, Massachusetts.

Dr. Irving Kirsch

Dr. Kirsch said he and some colleagues approached the US Food and Drug Administration using the Freedom of Information Act and obtained the data files for all of the clinical trials that had been conducted by the pharmaceutical companies when they were seeking approval for their antidepressant medications.

"That meant that we were able to look at the unpublished literature as well as the published literature, because the drug companies do not publish their most unsuccessful or least successful trials. Almost half of the trials that were conducted by the pharmaceutical companies were never published, and these were the trials showing the worst results," he said.

Most of the other meta-analyses that have been done have included only published studies. "By including the unpublished data as well, we got a more accurate estimate of the benefit of the drugs," he said.

From his research, Dr. Kirsch concluded that the difference between the antidepressant and the placebo effect in depression is not clinically meaningful.

"To get a clinically meaningful drug effect, you must have a difference on the Hamilton Depression Inventory of 3 points or more between drug and placebo. The difference between drug and placebo for depression is well under that.

"It's around 2 points on that 51-point scale, and that is in the relatively few patients with extremely severe depression. With moderately and mildly depressed patients, you don't even get the 2 points, it's close to nothing," he said.

And Dr.Kirsch is not alone in this assertion. A study published in JAMA in 2010 by investigators from the University of Pennsylvania and reported by Medscape Medical News at that time suggested that although antidepressants offer significant benefit for severe depression, they may have little or no benefit over and above placebo in patients with mild to moderate depression, who account for the majority of cases.

CBT as First-Line Therapy

For major depressive disorder, psychotherapy, particularly cognitive behavioral therapy (CBT), should be tried first. Self-help books and physical exercise have also been shown in clinical trials to work very well, Dr. Kirsch said.

My recommendation for treatment, what I think psychiatrists and psychologists ought to do, is try a less invasive, less problematic treatment first and save antidepressants as a last resort, especially for people who are not at the extreme end of severity in depression.

"My recommendation for treatment, what I think psychiatrists and psychologists ought to do, is try a less invasive, less problematic treatment first and save antidepressants as a last resort, especially for people who are not at the extreme end of severity in depression," he said.

In the epilogue to his book, Dr. Kirsch writes: "Depression is a serious problem but drugs are not the answer." He also adds that reducing social and economic inequality "would also reduce the incidence of depression."

Dr. Kirsch also writes that reporting these conclusions and "the evidence on which they are based has not always been an easy task," noting that he has faced "some rather hostile crowds at medical schools...."

He also recounts the adverse consequences that young and upcoming researchers face when they attempt to challenge the results of clinical trials conducted by big pharmaceutical companies.

Data Misinterpreted?

Jeffrey Lieberman, MD, the incoming president elect of the APA and chairman of psychiatry at Columbia University in New York City, told Medscape Medical News that Dr. Kirsch is misinterpreting the data from his meta-analysis.

Dr. Jeffrey Lieberman

"By making these statements and publishing the book, he is badly and potentially dangerously misleading people," Dr. Lieberman said.

"Using his criteria, he included a relatively small number of the total number of antidepressant studies that have been done, and he looked at the mean effects of the different treatments. Clearly there are some people who received medication who improved tremendously, but there are some who did not improve," he said.

"Dr. Kirsch is mistaken and confused, and he's ideologically biased in his thinking. He is conducting an analysis and interpreting the data to support his ideologically biased perspective.

What he is concluding is inaccurate, and what he is communicating is misleading to people and potentially harmful to those who really suffer from depression....

"What he is concluding is inaccurate, and what he is communicating is misleading to people and potentially harmful to those who really suffer from depression and would be expected to benefit from antidepressant medication. To say that antidepressants are no better than placebo is just plain wrong."

60 Minutes Responds

Medscape Medical News asked 60 Minutes for its response to the APA's criticism of its report.

The program replied by sending a copy of the letter sent to Dr. Oldham by 60 Minutes producer Richard Bonin, who said the program stands by its report.

"I assure you that all of us here at 60 Minutes — in some cases, personally — appreciate the burden and hardship of depression. And we are sensitive to the impact our broadcast can sometimes have.

We went to great lengths to educate ourselves on the subject, both sides of it, and to report them and the attendant nuance in a fair and equal way.

"For that reason, we went to great lengths to educate ourselves on the subject, both sides of it, and to report them and the attendant nuance in a fair and equal way. And it's why we ended our report with Lesley Stahl urging viewers to see their doctor if they're feeling depressed and warning those already taking the medication not to go off of it on their own."

Dr. Oldham emphasized that the APA's practice guidelines recommend that "for periods of mild to moderate depressive symptoms," the recommended treatment is psychotherapy. "No mention was made in the 60 Minutes program of this APA-recommended, evidence-based standard of care," he said.

He also reiterated that Dr. Kirsch "badly misinterpreted and vastly oversimplified the data by saying that these medications are no better than placebo."

Dr. Oldham emphasized that antidepressants are particularly effective for patients with severe depression and who are at risk for suicide. In addition, "They have been shown to prevent relapse far more effectively than placebo," he said.

More on the APA's response to the 60 Minutes program can be found on the APA's Web site. The full program can be viewed on the 60 Minutes Web site . Reporter Leslie Stahl's 60 Minutes post-show interview is also available for viewing.

Dr. Kirsch and Dr. Oldham have disclosed no relevant financial relationships. Dr. Lieberman reports financial relationships with Acadia, Bristol-Myers Squibb, and GlaxoSmithKline.

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