Seattle Times Series
Fred Hutchinson Cancer Center
2001 Seattle Times Series, UNINFORMED CONSENT
An in-depth, documented, 5-part investigative series, in The Seattle Times, beginning Sunday, March 11, 2001, turned the spotlight on cancer research at the world renowned Fred Hutchinson Cancer Center in Seattle -- with supporting documents available online.
In one bone marrow protocol 126 (1981-1993), The Times reported, at least 20 people died at the "Hutch."
"The final toll: 82 people from around the world enrolled in the Seattle experiment, 80 of them are dead today."
In 1985, Bristol-Myers bought Genetic Systems the sponsor of protocol 126 in which (the Times documents) the investigators had holdings, for $294 million.
The Times focused in graphic detail on pervasive systemic failure to protect patients from scientifically and ethically questionable medical experiments--even as patients died. The series demonstrates how financial and professional conflict of interest by investigators and the institution, deception of patients, coercion of Institutional Review Board members, and a Federal whitewash /cover-up by the Office of Protection from Research Risks (OPRR, now OHRP)--all leave unwitting patients without protection.
In a breast cancer protocol 681 (1990-1998), the Times reported, doses were escalated until patients died.
"Medical experts are baffled as to why researchers at the Fred Hutchinson Cancer Research Center kept escalating the amount of high-dose chemotherapy they gave breast-cancer patients even after it killed some of the women..."
The Times reported that the sponsor of the experiment, Cell Therapeutics, is reported to be worth $764 million today.
The series demonstrates in compelling detail how unprotected patients in clinical trials are, and it demonstrates the utter failure of both local institutional review, and of existing Federal oversight agencies to deal with the abuse--failure even to conduct a credible investigation after the damage has been done.
The series was prompted by two independent complainants-- the son of a victim, and Dr. John Pessando, the hero in this deadly saga. Dr. Pessando, a physician-researcher who served on the Institutional Review Board, tried to stop the bone marrow experiment, then wrote letters from 1991-1999 to every conceivable oversight agency--including FDA, OPRR, Dr. Varmus (NIH), Donna Shalala, to congressmen, The New York Times (4 times).
11 families who have filed suit since The Times published its prize winning, investigative series
**The series has garnered the Seattle Times, and its reporters, Duff Wilson and David Heath, multiple honors, accolades, and awards for excellence in investigative journalism. They include: Harvard University's Goldsmith Prize for Investigative Reporting; the Scripps Howard Foundation National Journalism Awards for Public Service Reporting; the National Headliner Awards; the Associated Press Managing Editors Public Service Award, and the George Polk Award for Medical Reporting.
The judges acknowledged that the series "was distinguished for us above all by its degree of difficulty. The authors faced a revered, secretive, self-protecting local institution that cloaked itself in an aura of infallibility and expertise."
The Seattle Times is the first three-time winner, and Wilson is the first two-time winner, in the 10-year history of the Goldsmith Prize.
The Alliance for Human Research Protection applauds the Seattle Times and its reporters for their courage and exemplary investigative reporting. It may yet lead the federal oversight agency charged with protecting human subjects, to conduct a credible investigation.
~~~~~~~~~~~~~ THE SEATTLE TIMES:
UNINFORMED CONSENT:by Duff Wilson and David Heath http://seattletimes.nwsource.com/uninformed_consent/
PT 1: THE BLOOD-CANCER EXPERIMENT http://seattletimes.nwsource.com/uninformed_consent/bloodcancer/
PT 2: THE WHISTLEBLOWER http://seattletimes.nwsource.com/uninformed_consent/whistleblower
PT 3: THE BREAST-CANCER EXPERIMENT http://seattletimes.nwsource.com/uninformed_consent/breastcancer/
THE FINANCIER http://seattletimes.nwsource.com/uninformed_consent/financier/story2a.html
FDA WARNING LETTER to Dana Matthews, M.D., Frederick Hutchinson Cancer Center http://www.fda.gov/foi/warning_letters/g2083d.pdf