1991 ------------------------------
May
 Dr. John Pesando writes an unsigned letter to The New York Times, with documents attached, detailing the unexpected deaths and financial conflicts in Protocol 126.
1992 ------------------------------
April
Writes the federal Food and Drug Administration a signed letter detailing the problems.
 The FDA sends no reply, takes no action.
1993 ------------------------------
March
Writes The New York Times a signed letter with documents; gets no reply.
April
Phones the federal Office for Protection from Research Risks (OPRR) to complain about Protocol 126.
Puglisi |
Dr. Thomas Puglisi of the OPRR asks Pesando to send a letter and supporting material.
May
Sends packet of material to the OPRR.
Puglisi assigns Kamal Mittal, a veterinarian, to investigate.
June
The OPRR recommends asking Dr. Robert Day, Hutch president, to respond to Pesando's complaint.
July
Authorizes the OPRR to use his letter and name in pursuing his complaint. He will hear nothing back for the next two years.
August
Writes to Dr. William Hutchinson, dean of the University of Washington School of Medicine, which has a partnership with The Hutch.
Mittal writes to Day outlining the complaint, attaching Pesando's letter and requesting a written response.
September
Writes to U.S. Rep. Ted Weiss, D-N.Y.
Puglisi talks by phone to Hutch lawyers.
October
Day sends a long response to the OPRR defending Protocol 126.
November
Writes Donna Shalala, secretary of the Department of Health and Human Services, and U.S. Rep. John Dingell, D-Mich.
OPRR officials review the case. Mittal says he is concerned about medical and ethical aspects of the experiment.
December
Mittal reviews Protocol 126 records at the offices of a Washington, D.C., law firm hired by The Hutch. He writes a summary of the complaint. An aide to Shalala tells Pesando his complaint is being investigated.
1994 ------------------------------
January
The OPRR reports being seriously understaffed.
February
Mittal identifies four key problematic issues: The Hutch's Institutional Review Board (of which Pesando was a member) may have felt compromised; the risks to patients may have been too great; patients may not have been "fully and correctly informed"; and researchers may have violated conflict-of-interest rules.
March
Mittal takes another job.
May
Puglisi asks F. William Dommel, an OPRR policy adviser, to review Mittal's analysis.
November
Hutch President Day writes to Mittal, complaining he hasn't heard anything about the investigation since February.
December
Files complaint with the Washington state Medical Quality Assurance Commission.
 The commission assigns Dr. Robert Miller to investigate.
1995 ------------------------------
January
Miller calls Puglisi and is told the OPRR is about to issue "very narrow" findings.
June
Writes to Puglisi, saying he's heard nothing in two years.
July
Puglisi asks Dommel to wrap up the case.
Miller again asks Puglisi for the OPRR findings.
August
Dommel drafts a letter with his conclusion based on Mittal's file. Puglisi tells him, "Excellent work on the Fred Hutch case."
September
Receives letter from Puglisi saying that The Hutch was not at fault and that if there were problems with Protocol 126 the Institutional Review Board should have stopped it.
The OPRR closes its investigation.
The Medical Quality Assurance Commission reviews the federal findings.
December
Writes Shalala and National Institutes of Health Director Harold Varmus to complain about the OPRR investigation.
Dommel, who handled the case, drafts the reply defending it.
1996 ------------------------------
January
Writes Washington Gov. Mike Lowry.
Lowry sends no reply.
June
The Medical Quality Assurance Commission begins an investigation of Protocol 126 and two related clinical trials.
August
Appelbaum |
Miller and Bill Crowell of the commission meet with Day and Dr. Fred Appelbaum of The Hutch.
September
Interviewed by state investigators.
October
Writes Shalala and Varmus a third time.
Varmus asks an underling to summarize the complaint for him - "briefly!" Neither he nor Shalala replies to Pesando.
November
Writes The New York Times a fourth time, signed; gets no reply.
1997 ------------------------------
July
Investigators send Pesando's complaint to an attorney to review. By this time, they still have not conducted other interviews or reviewed records.
September
Miller retires.
1998 ------------------------------
February
The state commission orders the case closed.
1998 ------------------------------
Begins talking with The Seattle Times, which takes up the investigation.
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