Wednesday, June 8, 2011

Drug Companies: Creating the Myth of Antidepressant Drugs

Unhinged: The Trouble with Psychiatry - A Doctor's Revelations about a Profession in CrisisAnatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America
The Emperor's New Drugs: Exploding the Antidepressant Myth
Marcia Angell has provided an article that all adults, particularly parents with small children should read. It is titled The Epidemic of Mental Illness: Why? Angell is reviewing three books by three separate authors.

The Emperor’s New Drugs: Exploding the Antidepressant Myth
by Irving Kirsch
Basic Books, 226 pp., $15.99 (paper)

Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America
by Robert Whitaker
Crown, 404 pp., $26.00

Unhinged: The Trouble With Psychiatry—A Doctor’s Revelations About a Profession in Crisis
by Daniel Carlat
Free Press, 256 pp., $25.00

There is so much material to cover here that Angell breaks her effort into two articles—with the second yet to come. We will look at some of the facts she presents as introductory material and discuss the book by Kirsch.

Angell begins by convincing us that there really is an epidemic, and, given that, there has to be an explanation.

“The tally of those who are so disabled by mental disorders that they qualify for Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI) increased nearly two and a half times between 1987 and 2007—from one in 184 Americans to one in seventy-six. For children, the rise is even more startling—a thirty-five-fold increase in the same two decades. Mental illness is now the leading cause of disability in children, well ahead of physical disabilities like cerebral palsy or Down syndrome, for which the federal programs were created.”

Mental illness “is now the leading cause of disability in children.”?!! Something is terribly wrong here.

“The authors emphasize different aspects of the epidemic of mental illness. Kirsch is concerned with whether antidepressants work. Whitaker, who has written an angrier book, takes on the entire spectrum of mental illness and asks whether psychoactive drugs create worse problems than they solve. Carlat, who writes more in sorrow than in anger, looks mainly at how his profession has allied itself with, and is manipulated by, the pharmaceutical industry. But despite their differences, all three are in remarkable agreement on some important matters, and they have documented their views well.”

“First, they agree on the disturbing extent to which the companies that sell psychoactive drugs—through various forms of marketing, both legal and illegal, and what many people would describe as bribery—have come to determine what constitutes a mental illness and how the disorders should be diagnosed and treated.”

“Second, none of the three authors subscribes to the popular theory that mental illness is caused by a chemical imbalance in the brain.”

We have elaborated on the behavior of drug companies in the past. One should not miss or downplay the content of the quote above on the actions of those who sell psychoactive drugs. It is well documented that drug companies will use illegal means to market drugs for unapproved applications. They know that the profits will exceed any monetary fine they will receive. We also observed how they are in the practice of paying doctors and researchers to put their name on research papers that the drug companies had themselves written (bribery). We have also observed how the “condition” known as bipolar disorder was launched with a public relations campaign that would be the envy of any detergent manufacturer.

The rest of this essay will cover the findings uncovered by Kirsch.

Kirsch spent fifteen years trying to discover whether antidepressant drugs actually work. His interest arose from a study of the effect of placebos. In reviewing a large number of published clinical trials he discovered:

“Most such trials last for six to eight weeks, and during that time, patients tend to improve somewhat even without any treatment. But Kirsch found that placebos were three times as effective as no treatment. That didn’t particularly surprise him. What did surprise him was the fact that antidepressants were only marginally better than placebos. As judged by scales used to measure depression, placebos were 75 percent as effective as antidepressants.”

Angell explains how drug approval works.

“When drug companies seek approval from the FDA to market a new drug, they must submit to the agency all clinical trials they have sponsored. The trials are usually double-blind and placebo-controlled, that is, the participating patients are randomly assigned to either drug or placebo, and neither they nor their doctors know which they have been assigned. The patients are told only that they will receive an active drug or a placebo, and they are also told of any side effects they might experience. If two trials show that the drug is more effective than a placebo, the drug is generally approved. But companies may sponsor as many trials as they like, most of which could be negative—that is, fail to show effectiveness. All they need is two positive ones.”

The FDA ignores negative results and only counts positive results? Someone will have to explain that one to me. The FDA deems this proprietary information of the drug companies which allows these companies to publish only the positive results. Angell provides an appropriate comment on this procedure.

“This practice greatly biases the medical literature, medical education, and treatment decisions.”

In any event, Kirsch’s next step was to look at the broader set of data held by the FDA, using the freedom of information path to gain access. He examined data on six drugs.

“Altogether, there were forty-two trials of the six drugs. Most of them were negative. Overall, placebos were 82 percent as effective as the drugs, as measured by the Hamilton Depression Scale (HAM-D), a widely used score of symptoms of depression. The average difference between drug and placebo was only 1.8 points on the HAM-D, a difference that, while statistically significant, was clinically meaningless. The results were much the same for all six drugs: they were all equally unimpressive. Yet because the positive studies were extensively publicized, while the negative ones were hidden, the public and the medical profession came to believe that these drugs were highly effective antidepressants.”

Kirsch then drew a correlation with the results of other studies that indicated drugs that were not antidepressants were just as good as antidepressants at alleviating depression provided they generated a recognizable side-effect. What did all this mean? Kirsch’s conclusion was that in doing even double blind tests, the subjects participating in the clinical trials would assume they were receiving a drug that might help them, rather than a placebo, if they experienced symptoms. Quoting from Kirsch’s book

“....the relatively small difference between drugs and placebos might not be a real drug effect at all. Instead, it might be an enhanced placebo effect, produced by the fact that some patients have broken [the] blind and have come to realize whether they were given drug or placebo. If this is the case, then there is no real antidepressant drug effect at all. Rather than comparing placebo to drug, we have been comparing “regular” placebos to “extra-strength” placebos.”

Angell describes this as a “startling conclusion” that will be contested by the legions of dispensers and users of antidepressants who claim to observe benefits from their use. But would their claim be inconsistent with that of Kirsch? His results say that if you believe you are receiving a drug that might help you will tend to feel better. The users and dispensers can only say the exact same thing. Depression is not something that can be measured like a voltage. Depression can also come and go on its own for unknown reasons.

What seems incontrovertible is that the antidepressants have only a small beneficial effect, if any. One might argue that as long as the patients feel better, why be concerned?

When we return to this subject we will discuss another of the books that will argue that psychoactive drugs are worthless—but far from benign. The argument will be made that they cause long lasting side effects and their use might be responsible for the “epidemic” of mental illness we observe.

Stay tuned—and as always, keep your kids away from drugs.

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