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THE BLOOD-CANCER EXPERIMENT

THE WHISTLEBLOWER

THE BREAST-CANCER EXPERIMENT

THE FINANCIER

THE PROSPECTS FOR CHANGE


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THE BREAST-CANCER EXPERIMENT

What happened

1989  ------------------------------

November
  Dr. James Bianco starts to study drug pentoxifylline (PTX) to see if it will protect vital organs during high-dose chemotherapy.

1990  ------------------------------

  Her breast cancer returns after 11 years. Treatment puts it into remission.

September
  Bianco finishes first PTX study and soon writes a journal article saying PTX is amazingly effective at preventing organ damage.

December
  Bianco starts second, larger study to verify results.

1991  ------------------------------

June
  Bianco sees evidence PTX isnıt working. Begins experimenting with PTX mixed with antibiotic Cipro.

September
  Bianco and Dr. Jack Singer of The Hutch incorporate Combined Therapeutics Inc. (later to become Cell Therapeutics), plan to develop and sell PTX/Cipro combination.

October
  Dr. William Bensinger starts breast-cancer study, Protocol 681, using PTX/Cipro to prevent organ damage.

November
  Last patients enrolled in PTX study. It becomes clear PTX alone is a failure.

1992  ------------------------------

February
  Bianco and Singer leave The Hutch to run company.

July
  Learns that cancer has returned. Prognosis is death within two years.

September
  CTI abandons PTX/Cipro after FDA argues that the mixture isnıt reliable or safe. CTI files for patent on new drug derived from PTX, called Lisofylline.

November
  In midst of effort to raise $30 million from investors, cuts off PTX intravenous form from The Hutch. Austrian and German doctors publish study saying PTX doesnıt work. Bianco and Singer say in print that European study was flawed, but donıt say they had reached similar conclusion.
  Bensinger decides to stop using the IV form of PTX in his study.

1993  ------------------------------

January
  Institutional Review Board orders mention of IV form of PTX deleted from patient-consent forms for Protocol 681.
  Has informed-consent conference with Hutch doctor, a day after the IRB action. Because she has had vomiting problems in the past, she is concerned about availability of IV form of PTX. Her consent form says three times that she can have it. She signs up for 681 and begins treatment.

February
  Dies on Feb. 19, 44 days after entering The Hutch.
  Six days after Hamiltonıs death, a group of Hutch doctors, including Bianco and Bensinger, submits a journal article saying PTX doesnıt work.

June
  CTI tries to raise more money, touting positive results of PTX/Cipro study even though it has abandoned those drugs as ineffective.

October
  Negative PTX study is published in a medical journal.

1996  ------------------------------

February
  After CTI completes 60-patient study of Lisofylline, showing amazing results, it enters deal with Schering AG to develop and sell the drug.

April
  Schering looks further at research data and backs out of deal.

October / November
  CTI initiates larger study of Lisofylline, enters partnership with Johnson & Johnson.

1997  ------------------------------   At some point in the final year of Bensingerıs study, two more patients die from the treatment.

March
  Initial public offering of stock raises $26.8 million, based largely on promise of Lisofylline.

1998  ------------------------------

March
  CTI announces Lisofylline trial was not successful. Stock plummets and Johnson & Johnson eventually backs out.

April
  A week after CTI announcement, Bensinger stops Protocol 681. The results of the study are never published.



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