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WHO:  Commercial Pressure Compromises Clinical Trials - 2001-12-23

The World Health Organization warns that the reliability of some clinical trials of new drugs is being compromised by commercial pressures. There is an urgent need for rules and guidelines to safeguard the reliability of such trials.

WHO says most research is conducted under the highest ethical and scientific standards. But while the risk of unsafe drugs getting to the market is extremely small, the health agency notes a disturbing trend is emerging.

Jonathan Quick, WHO's director of essential drugs and medicines policy, says commercial sponsors are exerting more influence on some investigators and publications to come up with positive results. "Not too long ago," he recalled, "a company supported a trial of their brand product - it was a hormone product - against the generic. And the investigator found that they were equivalent and proceeded to want to publish the studies and they were blocked from doing that and threatened with legal action."

Dr. Quick cites another example of a pharmaceutical company which threatened a $7 million lawsuit against university researchers who published results of a trial showing that an AIDS vaccine was ineffective.

He says some pharmaceutical companies use legal means to intimidate investigators and prevent them from publishing negative results of clinical trials. He says under-reporting negative studies puts the collection of reliable clinical evidence into question. Dr. Quick says a "firewall" should be put between researchers and companies that could be helped - or harmed - by their findings. He says pharmaceutical firms should never be allowed to pay for scientific studies. "The scientific decision should be made with complete independence from the sponsor," he said. "So the sponsor helps to define the study questions. But, then there is a generally separate safety monitoring board or other oversight group that is separate from the sponsor, that is not supervised or not influenced in the content of the work. And, they are the ones that insure the scientific integrity of the study."

Dr. Quick is calling for a declaration of the rights and obligations of worldwide clinical research in order to guarantee the independence of that research. It would prohibit legal action by sponsors, except in cases of fraud, and protect so-called "whistle-blowers" who report unscientific or unethical research practices.