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European Medicines Agency's preference for placebo trials is misplaced

It is in the interests of healthcare professionals and patients for new drugs to be compared to existing therapies before being granted a marketing authorisation. However, the European Medicines Agency (EMA) is in favour of placebo-controlled clinical trials.

When a new drug is licensed, healthcare professionals and patients ask the straightforward question: how does this drug compare with existing treatments? Unfortunately, a satisfactory answer is rarely to be found in the marketing authorisation application supplied by pharmaceutical companies.

Now, a growing number of patients and healthcare professionals are demanding that new drugs be compared against existing therapies. Flying in the face of this fundamental demand, at the end of 2010, the EMA launched a public consultation proposing to make cases where firms had to compare their drugs to existing medicinal products the exception rather than the rule, and to consider placebo-controlled trials as the accepted norm.

Not only is the EMA breaking away from scientific standards which give precedence to trials against reference drugs rather than trials against placebo, but this also contravenes the World Medical Association’s Declaration of Helsinki – the code of ethics for clinical trials.

The Medicines in Europe Forum, the Association Internationale de la Mutualité, the International Society of Drug Bulletins (ISDB) and Prescrire have called for the EMA's proposals to be firmly rejected.

©Prescrire 1 November 2011

"European Medicines Agency: reliance on placebo studies is unacceptable" Prescrire Int 2011; 20 (121): 278. (pdf, free)

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