Uninformed Consent Home






Continuing Coverage

Q&A on this Series

The Hutch's Response

Supporting Documents


Who's Who

Your Reaction

Reader Comments

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Further Reading

Using this Site


These original documents are in Portable Document Format (PDF) and require the Adobe Acrobat Reader to access them. If you do not have Acrobat Reader, you may download it from http://www.adobe.com/products/acrobat/readstep2.html. Refer to Using this Site for more information. (Due to the poor quality of some of the original documents, some PDFs might be difficult to read. Highlighting was done by reporters.)

The Blood-Cancer Experiment
  100,000 shares Genetic Systems Co. stock for Dr. E. Donnall Thomas, April 1983 (700K PDF)
  250,000 shares of stock and position for Dr. John Hansen, April 1983 (852K PDF)
  10,000 shares of stock and consulting agreement for Dr. Paul Martin, Jan. 1981 (524K PDF)
  Investment prospectus touts company ties with The Hutch, June 1981 (3.2MB PDF)
  First application of Protocol 126 to Human Subjects Review committee, Dec. 16, 1980 (580K PDF)
  Committee minutes and transcript, Protocol 126 rejected, Jan. 20, 1981 (1.8MB PDF)
  IRB Administrator John Mills comments on Protocol 126, April 6, 1981 (2MB PDF)
  Dottie Thomas' letter to board argues there is no alternative treatment, May 1, 1981 (244K PDF)
  Genetic Systems paid cash and stock for Hutchinson antibody rights, March 31, 1982 (824K PDF)
  Dr. Robert Bruce comments on Protocol 126, April 13, 1983 (424K PDF)
  Fred Hutchinson Center Conflict-of-Interest Policy, June 9, 1983 (336K PDF)
  Dr. Henry Kaplan's first letter to Dr. Thomas questioning safety of antibodies and conflicts of interest, Sept. 28, 1983 (660K PDF)
  Dr. Thomas' reply denying conflicts and warning IRB not to impede research, Oct. 14, 1983 (2MB PDF)
  Dr. Kaplan's letter to Dr. Robert Day asking for independent scientific review, Nov. 30, 1983 (416K PDF)
  Dr. Day's reply refusing an independent review but removing healthiest patients, Feb. 23, 1984 (540K PDF)
  Excerpts from published reports on the deaths, September 1985 and December 1988 (1MB PDF)
  Dr. Kaplan's third letter "once again" objecting to risks and financial conflicts, Dec. 17, 1984 (900K PDF)
  Dr. Fred Appelbaum tells Dr. Kaplan to stop complaining about financial conflicts, Dec. 20, 1984 (968K PDF)
  Patient consent form after many deaths reported still says graft failure merely "possible," March 22, 1985 (410K PDF)
  Patient consent form in 1993 finally made the risks of relapse and graft failure clear (1.2MB PDF)

The Whistleblower
  Dr. John Pesando's complaint to the Office for Protection from Research Risks, May 14, 1993 (1.1MB PDF)
  Hutch Administrator Dr. Robert Day's response to the complaint, Oct. 18, 1993 (2.4MB PDF)
  E-mail showing federal officials deciding "nothing wrong" with undisclosed financial interests, Dec. 10, 1993 (56K PDF)
  Federal investigator Kamal Mittal's analysis, questions and recommended course of action, April, 1993 (2.2MB PDF)
  OPRR closes the case, Sept. 5, 1995 (1MB PDF)
  Dr. Pesando writes two top federal officials, Dec. 01, 1995 (548K PDF)
  National Cancer Institute aide responds to Pesando, Jan. 11, 1996 (136K PDF)
  Fax shows OPRR wrote that letter for NCI, December 6, 1995 (140K PDF)
  Dr. Pesando writes Dr. Harold Varmus again, Oct. 16, 1996 (264K PDF)
  Dr. Henry Kaplan's letter to state investigator, Sept. 6, 1996 (332K PDF)
  Dr. John Pesando's letter to state investigator, Sept. 30, 1996 (444K PDF)
  Dr. E. Donnall Thomas' letter to state investigator, his only public statement on Protocol 126, Sept. 19, 1996 (608K PDF)

The Breast-Cancer Experiment
  Replica of doctors' notes showing that four women died from the experimental treatment (72K PDF)
  Kathyrn Hamilton's informed consent explains that 10 patients given PTX/Cipro suffered no organ damage. But she's not told that this wasn't a formal study and the results don't mean much, Jan. 6, 1993 (136K PDF)
  Two of four patients in a previous breast-cancer study were killed by the chemotherapy, according to the protocol, Jan. 5, 1993 (168K PDF)
  James Bianco was the second researcher listed on the breast-cancer protocol (1.5MB PDF)
  In trying to raise capital from investors, CTI touted amazing results for a drug combination that it had already concluded didn't work, June 15, 1993 (516K PDF)
  Cell Therapeutics notifed The Hutch that it was cutting off the supply of the intravenous form of PTX, Nov. 10, 1992 (52K PDF)
  The protocol explains that two of four patients in one study and three of six in another were killed by the high-dose chemotherapy that Kathryn Hamilton would take, Jan. 5, 1993 (152K PDF)
  Hamilton's informed consent includes the results of an outdated study, Jan. 6, 1993 (136K PDF)
  The protocol explains that Hamilton will get a dose of chemotherapy previously thought to be too toxic, Jan. 6, 1993 (144K PDF)
  Doctor explains that Hamilton is likely to suffer nausea from chemotherapy, Jan. 6, 1993 (164K PDF)
  The informed consent repeatedly promises PTX in IV form, even though The Hutch didn't have the drug, Jan. 6, 1993 (736K PDF)
  Nurses' notes from Hamilton's first days in the hospital showing she was anxious about throwing up, Jan. 6, 1993 (296K PDF)
  Protocol doesn't say what to do if a patient dies from treatment, Jan. 5, 1993 (428K PDF)

Continuing coverage
  Minutes of a special meeting of the Hutchinson Center's Human Subjects Review Committee, Feb. 12, 1981 (636K PDF)
  Memo from Dr. Paul Martin, Dec. 19, 1984 (339K PDF)
  Minutes of a Hutchinson center clinical staff meeting, Sept. 5, 1984 (298K PDF)
  June 15-Oct. 26, 2001, FDA Reports of Inspections allege violations of patient safety rules (444K PDF)
  Dec. 4, 2001, FDA Warning Letter to Dr. Janet Eary, University of Washington, finds violations of federal law (274K PDF)
  Dec. 31, 2001, FDA Warning Letter to Dr. Dana Matthews, Fred Hutchinson Cancer Research Center, finds violations of federal law (479K PDF)
  Feb. 8, 2002, memo from the Hutchinson Center clinical director (52K PDF)

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