Survival in an overmedicated world: Look up the evidence yourself by Peter C. Gøtzsche

Author:Peter C. Gøtzsche
Language: eng
Format: epub
Publisher: People’sPress

Psychiatric drug trials are seriously flawed

Published reports of drug trials are generally flawed and exaggerate the benefits of drugs and underestimate their harms - or exclude them altogether. This is widely known. But in that respect, few people know that psychiatric drug trials are second to none.

That means if your interest is psychiatric drugs, you cannot use what I have taught you in previous chapters. Hundreds of Cochrane reviews of psychiatric drugs are available, but they are generally misleading because the trials included are unreliable. Even when Cochrane authors try hard to do their best, they cannot make up for all the flaws in the published trial literature. 1 We have done reviews of depression pills based on 64,381 pages of clinical study reports we obtained from drug regulators, and we were able to demonstrate harms omitted in the published literature (see below). It is - really - very depressing. Psychiatric drug trials are huge wastes and they abuse patients’ altruistic willingness to contribute to clinical research.

Since I have written a book about this, 1 I will only repeat some of the most important issues here and add a few more.

Cold turkey in the placebo group

In the vast majority of psychiatric drug trials, the patients were already on a drug similar to the one being tested against placebo. After a short wash-out period - typically one week - the patients were randomized to the new drug or placebo. The cold turkey that some patients in the placebo group go through in this type of trial harms them, and therefore, it is no great wonder that new drugs outperform the placebo in patients who have been harmed. Introducing longer wash-out periods does not help much. If people were permanently brain damaged before entering the trials, wash-out periods cannot compensate, and even if they were not, they could suffer from abstinence symptoms for months or years. 4,6

Thousands of trials of neuroleptics have been carried out, but when we recently searched for placebo-controlled trials in psychosis that only included patients who had not received such a drug earlier, we only found one trial. 9 It was from China, and since it appeared to be fraudulent, we could not use it. Thus, all placebo-controlled, randomized trials of neuroleptic drugs in patients with schizophrenia spectrum disorders are biased, which means that the use of neuroleptic drugs cannot be justified based on the evidence we currently have. 1

To find out how long patients need to continue taking their drugs, so-called maintenance (withdrawal) studies have been carried out. These studies are also highly misleading because of cold turkey effects in the placebo group. A large meta-analysis of 65 placebo-controlled trials (6,493 patients) found that only three patients needed to be treated with neuroleptics to prevent one relapse after one year. 10 That looks very impressive, but the result is unreliable. The apparent effect of continued treatment with neuroleptics decreased over time and was close to zero after three years. Thus, what was seen after one year was mainly iatrogenic harm - even though it was described as a benefit.

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