Today I Learn… I make a point of learning something new everyday. This is what I learn each day

1, Aug 29, 2011

Nancy F. Olivieri, a Whistleblower in Clinical Trials

Filed under: Clinical Research — admin @ 12:05 am

From AAAS award speech,
“In 1997, while conducting a clinical trial of a drug that showed promise in improving the lives of patients suffering from thalassemia—a blood disorder that can be fatal if not treated—Dr. Olivieri discovered possibly life-threatening side effects of the medication. She informed the pharmaceutical company, Apotex, of this risk and of her intention to notify the hospital’s Research Ethics Board, her patients, and other clinicians. The company, disagreeing with her findings, informed Dr. Olivieri that such actions would be in violation of a confidentiality agreement she had signed and that they would seek “legal remedies” if she carried out her intentions.”

“After publishing her findings, she suffered a series of adverse actions from the company and the hospital, including being relieved of one of her positions and referral to a physicians’ disciplinary board. The press received anonymous letters accusing her of misconduct, later traced to a colleague who received money from the company. The university where she had an appointment, which had been promised a large donation by the company, supported her only after an investigation by the Canadian Association of University Teachers completely vindicated her, as did the physicians’ board. Dr. Olivieri continues to fight legal battles brought against her by the drug company.”

“Her struggle in defending these principles has brought world attention to the importance of scientific integrity for public health and safety. Editors of leading biomedical journals have imposed new publishing standards, the university changed its policies on industry-supported research, and her findings regarding the drug have stood.”

This case touches many issues related to clinical trials. Do patients have the right to know the truth of the study drug that they are in? Are doctors obligated to be ethical toward patients, even if it means violation of any agreement with the drug company? How much academic freedom is guaranteed when academic institutions have to be sustained by other money?

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