1980 ------------------------------
November
 Genetic Systems Corp. formed.
December
 Drs. John Hansen, E. Donnall Thomas and Paul Martin, seeking to learn whether removing T-cells would prevent graft-versus-host disease (GVHD) in bone-marrow- transplant patients, submit Protocol 126 to Human Subjects Review Committee.
1981 ------------------------------
January
Genetic Systems gives Hansen 250,000 shares of penny stock and an $18,000 consulting fee, Thomas 100,000 shares and $3,000-a-year board position, and Martin 10,000 shares.
Review Committee rejects Protocol 126, saying it takes too big a leap from mouse to man and may cause graft rejections and cancer relapses.
February
Stock sells at 60 cents a share, making interest of Hansen worth $150,000, Thomas $60,000 and Martin $6,000.
March
Signs 20-year deal with The Hutch for commercial rights to 37 substances, including three to be tested in Protocol 126. Hutch receives money and a royalty agreement, and an affiliated foundation receives stock.
April
Hansen resubmits Protocol 126 in version that kills fewer T-cells. Board approves, subject to patient-consent form outlining risks and alternatives.
May
Sublicenses antibodies for $3.7 million. Sells private stock at $1 a share, making Hansen's original shares worth $250,000, Thomas' $100,000, Martin's $10,000 and the foundation's $50,000.
Dottie Thomas, founder's spouse, successfully argues against changing consent form to include alternatives.
June
Stock sells at $2 a share.
National Cancer Institute approves Protocol 126 for NCI funding.
December
Martin seeks and gets approval of revised Protocol 126 with stronger T-cell-killing enzymes and broader patient selection.
1983 ------------------------------
March
Hutch adopts new conflict policy: Scientists "shall not participate in any (research) involving the Center in which the member has an economic interest."
April
Stock sells at $9.16 a share, making original stake of Hansen worth $2 million, Thomas $916,000, the foundation $458,000 and Martin $91,000.
Review board seeks "rigorous" stopping criteria if people die, and consent-form warning of unexpected new cancers. Trial approved, but form fails to disclose risks of new cancers, relapse and graft failure.
 Leukemia patients over age 29 and with good prognoses are enrolled in Protocol 126. David Yingling, 45, of Butler, Pa., is one of first subjects.
May
Hansen named vice president for research, keeps his lab and office at Hutch.
June
Yingling dies.
August
Dr. Rainer Storb begins study of drugs for treatment of GVHD. He will enroll 93 patients and report major successes.
Couch |
Numerous people receive T-cell-depleted transplants in August and September who will have engraftment problems (Larry Haspel), graft failures (Jacqueline Couch, Lourdes Llera), relapses and infections related to the experiment.
September
Human Subjects Review Committee renamed Institutional Review Board (IRB). New members Drs. Henry Kaplan and John Pesando ask for clarification on animal tests, human risks and financial interests.
October
Thomas denies any conflicts of interest, refuses IRB request for separate tests on antibodies, and warns IRB not to impede research.
November
Kaplan writes Hutch President Dr. Robert Day to ask for independent review of Protocol 126.
Couch suffers graft rejection.
December
Day refuses Kaplan's request for outside review.
Ruth Fisher and Bina Bidasaria get transplants without T-cells.
1984 ------------------------------
January
Hansen starts one-year leave from Hutch to be medical director for Genetic Systems.
Kaplan and Pesando seek limits on Protocol 126 and question financial ties of the researchers.
Fisher |
Fisher has graft failure, second transplant and dies.
February
Three of the 16 patients have had graft rejection, 18 percent vs. expected 1 percent. Paul Mahler transplanted as one of the last relatively healthy patients in trial. Pesando says Mahler should have been excluded by the agreement of Day a month earlier. Mahler will have graft failure, a second transplant and die 10 months later.
March
Martin fails to notify IRB or medical examiner of treatment-caused deaths, as required by law.
At least eight of the 20 patients in Protocol 126 will have graft failures and five will have cancer relapses linked to T-cell depletion.
April
Thomas questions Pesando's stature to question the study. IRB approves ongoing experiment with sicker patients.
Couch dies. Martin fails to notify IRB.
May
Nancy Haldeman leaves as IRB administrator, saying Hutch didn't want independent oversight.
Llera dies.
June
IRB approves next phase of trial but says it should go through outside review.
Carolyn Sue Obermeyer receives transplant.
July
Day refuses outside review.
August
Ron Kawamura is first patient transplanted in Protocol 126.1, followed by Joyce Ford, Sandra Morgan, Thomas Thorne, Thomas Vanvick, Norman Carrico.
Hutch suspends Protocol 126.1 because two of four patients have grafting problems.
September
Clinical staff, "not unanimous," reopens Protocol 126.1, enrolling more patients.
Ford dies. Obermeyer dies.
October
Joseph Mashuda receives transplant. Thorne dies.
November
Martin, Hansen, Thomas and others submit article reporting T-cell depletion associated with graft failure. Martin seeks IRB approval of Protocol 126.2.
Draheim |
Bidasaria and Mahler die after second transplants. Dr. John Draheim receives a transplant.
December
Kaplan writes Day, Thomas and Fred Appelbaum, head of clinical research, to "once again" complain about 126 and asks for outside review. Appelbaum and Day tell Kaplan to stop complaining.
At least two of 11 patients in 126.1 will have graft failures, and five will have relapses.
1985 ------------------------------
January
Hansen returns to The Hutch full time.
Draheim dies after a second transplant.
IRB approves Protocol 126.2 for three months, excluding good-prognosis patients. Consent form still fails to mention some risks.
February
Kawamura has delayed graft failure, dies at home.
March
At least four patients from Protocol 126 die.
April
Storb closes his GVHD study early because it worked so well.
Almeida |
Elizabeth Almeida receives transplant.
May
Tells stockholders of plans to issue 20 million more shares.
Martin, Hansen and Thomas apply for 126.3, combining T-cell depletion with Storb chemicals. IRB again asks for outside review.
At least two of 12 patients in Protocol 126.2 will have graft failures, and three will have relapses.
June
IRB tells Martin to revise consent form on graft failures and Storb alternative.
Wright |
Rebecca Wright receives transplant.
August
Kaplan and Pesando leave IRB.
September
At least two of nine patients in Protocol 126.3 will have graft failures and three will have relapses linked to T-cell depletion.
October
Bought out by Bristol-Myers for $294 million, or $10.50 per share, making the original interest of Thomas worth $1.05 million, the foundation $502,000, and Martin $105,000. Hansen, who has sold some shares, holds stock worth $1.8 million.
Martin submits Protocol 126.4. Consent form tells patients graft failure is "possible" and implies it can be corrected with second transplant.
Almeida dies.
November
IRB approves Protocol 126.4. Consent form changed to say second transplants "usually not successful."
December
IRB approves Protocol 126.5, with extra dose of radiation.
At least two of eight patients in Protocol 126.4 will have graft failures and die.
1986 ------------------------------
January
NCI review notes graft failures, relapses and new cancers.
February
First 126.5 transplant. Two earlier patients die.
June
Three earlier patients die.
July
First two 126.5 patients suffer graft failures.
September
Martin tells colleagues Protocol 126 to date has prevented GVHD but caused 27 percent graft failures vs. expected 1 percent.
October
Two more 126.5 patients suffer relapses.
1987 ------------------------------
April
Wright and two others die.
September
Last patient enrolled in 126.5. Day says there are "better alternatives."
December
Martin presents paper saying T-cell depletion in certain leukemia patients led to 100 percent relapse rate vs. expected 25 percent.
First two patients in Protocol 126.6 both have graft failures.
1990 ------------------------------
May
Bristol-Myers sells Genetic Systems to Sanofi for $20 million, $274 million less than what it paid.
1991 ------------------------------
January
Martin proposes Protocol 126.7. Consent form finally says: "There is a chance that the donor marrow will fail to produce new blood cells because of rejection or other problems. In this situation, there is a high chance of infections, bleeding and death."
1993 ------------------------------
First and only patient enrolled in Protocol 126.8 has graft failure and dies after second transplant. Experiment is closed permanently.
Today ------------------------------
The value of Thomas' original stock is about $5 million, Thomas', $5 million, the foundation's $2.5 million and Martin's $525,000. Hansen's shares are worth $9 million.
Final report on Protocol 126 never published.
Eighty of 82 patients are dead, at least 20 from graft failures attributable to the treatment.
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