“In 2004, the FDA urged drug companies to adopt a 'Don't ask, don't tell' policy with respect to their clinical-trial data showing that antidepressants are not better than placebos for depressed children. If the data were made public, they cautioned, it might lead doctors to not prescribe antidepressants. The FDA believed that the jury was still out on antidepressants for children. Even if the clinical trials show negative results, an FDA spokesperson was reported to have said to a Washington Post reporter, it doesn't mean that the drugs are ineffective. The assumption seems to have been that doctors should prescribe medications that have not been shown to work, until it has been proven that they don't work.”

Irving Kirsch

Irving Kirsch - “In 2004, the FDA urged drug companies...” 1

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“According to an article in the Washington Post: The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found that drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday. Regulators supressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels.”

Irving Kirsch
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“Our analyses of the FDA data showed relatively little difference between the effects of antidepressants and the effects of placebos. Indeed, the effects were so small that they did not qualify as clinically significant. The drug companies knew how small the effect of their medications were compared to placebos, and so did the FDA and other regulatory agencies. The companies found various ways to make the data seem more favorable to their products, and the FDA helped them keep their negative data secret. In fact, in some instances, the FDA urged the companies to keep negative data hidden, even when the companies wanted to reveal them. My colleagues and I hadn't really discovered anything new. We had merely revealed their 'dirty little secret'.”

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“For people who are depressed, and especially for those who do not receive enough benefit from medication of for whom the side effects of antidepressants are troubling, the fact that placebos can duplicate much of the effects of antidepressants should be taken as good news. It means that there are other ways of alleviating depression. As we have seen, treatments like psychotherapy and physical exercise are at least as effective as antidepressant drugs and more effective than placebos. In particular, CBT has been shown to lower the risk of relapsing into depression for years after treatment has ended, making it particularly cost effective.”

Irving Kirsch
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“Physicians do not systematically prescribe placebos to their patients. Hence they have no way of comparing the effects of the drugs they prescribe to placebos. When they prescribe a treatment and it works, their natural tendency is to attribute the cure to the treatment. But there are thousands of treatments that have worked in clinical practice throughout history. Powdered stone worked. So did lizard's blood, and crocodile dung, and pig's teeth and dolphin's genitalia and frog's sperm. Patients have been given just about every ingestible - though often indigestible - substance imaginable. They have been 'purged, puked, poisoned, sweated, and shocked', and if these treatments did not kill them, they may have made them better.”

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“Depression, we are told over and over again, is a brain disease, a chemical imbalance that can be adjusted by antidepressant medication. In an informational brochure issued to inform the public about depression, the US National Institute for Mental Health tells people that 'depressive illnesses are disorders of the brain' and adds that 'important neurotransmitters - chemicals that brain cells use to communicate - appear to be out of balance'. This view is so widespread that it was even proffered by the editors of PLoS [Public Library of Science] Medicine in their summary that accompanied our article. 'Depression,' they wrote, 'is a serious medical illness caused by imbalances in the brain chemicals that regulate mood', and they went on to say that antidepressants are supposed to work by correcting these imbalances.The editors wrote their comment on chemical imbalances as if it were an established fact, and this is also how it is presented by drug companies. Actually, it is not. Instead, even its proponents have to admit that it is a controversial hypothesis that has not yet been proven. Not only is the chemical-imbalance hypothesis unproven, but I will argue that it is about as close as a theory gets in science to being dis-proven by the evidence.”

Irving Kirsch
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