CRO’s : Why Are They Criticized Today?
CRO’s are used to evaluate future drugs or new care procedures. They must be conducted ethically, reliably and independently. How can medicines be no longer torn between their obligation to care and their desire to test possible treatments?
Today, doctors generally agree that any CRO’s must be conducted according to ethical principles that the World Medical Association brought together in 1964 in an international code, the Declaration of Helsinki.
Some of these principles seem indisputable, for example, the fact that anyone asked to take part in a trial must be properly informed of the ins and outs of the trial, and must give their consent. If the application of this principle raises some difficulties in certain circumstances, such as trials in an emergency situation or in a psychiatric environment, this does not call into question its validity.
On the other hand, the principles governing placebo trials have been the subject of intense controversy in recent years, especially during the major revision of the Declaration of Helsinki which took place in 2000. In these trials, some people receive the drug to be tested, the others a neutral substance, devoid of any therapeutic effect – apart from the placebo effect itself, which has been shown to represent up to 30 percent or more of therapeutic efficacy.
The objections to certain principles are sometimes of a scientific nature or concern trials conducted in specific contexts, but they all underline the contradictory interests raised by research in the medical field. Chief anesthetist at Massachusetts General Hospital in Boston, he presented, without naming the teams involved, several contract research organization protocols that he considered morally problematic, although their results had been published in prestigious journals. This article, which he struggled to publish, earned him strong criticism from his peers for breaching the customary discretion in the profession.
However, American physicians began to realize that CRO’s was playing an increasing role in the care of patients in hospitals, and that it was profoundly modifying the conditions for practicing medicine. Other revelations followed, less discreet as to the identity of the institutions and researchers incriminated. In almost all cases, the medical researcher’s misconduct involved a category of vulnerable subjects or patients – the elderly, mentally handicapped children, black people.