“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'.”

Irving Kirsch

Irving Kirsch - “Our analyses of the FDA data showed...” 1

Similar quotes

“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
Read more

“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
Read more

“When conventional medicine fails, when we must confront pain and death, of course we are open to other prospects for hope.And, after all, some illnesses are psychogenic. Many can be at least ameliorated by a positive cast of mind. Placebos are dummy drugs, often sugar pills. Drug companies routinely compare the effectiveness of their drugs against placebos given to patients with the same disease who had no way to tell the difference between the drug and the placebo. Placebos can be astonishingly effective, especially for colds, anxiety, depression, pain, and symptoms that are plausibly generated by the mind. Conceivably, endorphins -the small brain proteins with morphine-like effects - can be elicited by belief. A placebo works only if the patient believes it’s an effective medicine. Within strict limits, hope, it seems, can be transformed into biochemistry.”

Carl Sagan
Read more

“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
Read more

“To condescend effectively it is clearly necessary to adhere to a narrow definition of relevant data.”

Marilynne Robinson
Read more