Mis-informed Consent

Townsend Letter for Doctors and Patients,  August, 2001  by Jule Klotter

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A primary protection of the rights of medical research subjects revolves around the concept of informed consent. Unfortunately, surveys have shown that most patients have difficulty understanding medical language; in a University of Chicago survey, only a third of the cancer research patients were able to explain the purpose of the trial in which they were taking part. Also, many informed-consent documents insinuate a possibility of cure even when the trial is designed merely to test for a safe dose of an experimental drug. In such phase 1 cancer trials, tumors respond to experimental drugs less than 5% of the time.

In March 2001, as part of a five-part investigative series on cancer research at the respected Fred Hutchinson Cancer Research Center in Seattle, Washington, reporters from The Seattle Times illustrated how the concept of informed consent can go awry. The case involved Kathryn Hamilton who signed a patient consent form on January 6, 1993, which said: "This new treatment program has been designed with the hope that it will prove to be much more effective than standard treatments now available. We hope that your life will be lengthened by this treatment...." Kathryn was confronting bone cancer for the second time, twelve years after having been treated for breast cancer. The consent form voiced a hope that was not part of the study's actual purpose. The goal of the treatment program she signed up for was to determine how much chemotherapy patients could tolerate in preparation for a stem-cell transplant. It was, in effect, a phase-one study. Kathryn was not informed that one woman in the trial had already died from taking lower doses of the chemotherapy drugs than Kathryn would receive.

Secondly, Kathryn was told: "Recent studies suggest that PTX prevents kidney, lung and liver damage in patients receiving transplants." She was not told that even more recent studies showed that PTX did not reduce organ damage. In fact, patients taking PTX had more kidney damage than patients not taking the drug. In the hope that PTX might actually prove to have some benefit, researchers decided to use it in conjunction with the antibiotic Cipro. Kathryn was reassured that PTX was available in IV form. Past experience made her fear that vomiting would prevent her from keeping the protective drugs down. Although the investigators knew that PTX was no longer available in intravenous form, they did not tell her. The patient consent form stated that "Either drugs [sic] may be given through your Hickman catheter if your physician thinks you may not be absorbing the medicine if you take it by mouth."

Kathryn signed the consent form. Severe vomiting prevented her from absorbing the medication that was supposed to protect her from organ damage. After the stem-cell transplant, she developed an infection. Then, her liver showed signs of damage, and her kidneys failed. Kathryn died 44 days after submitting to high doses of chemotherapy that would kill 4 of 68 women in this study before research was finally stopped. Perhaps most disturbing of all, a group of Hutchinson doctors that included Dr. William Bensinger, who headed this study to test PTX/Cipro's ability to prevent organ damage, submitted an article to the journal Blood, stating that PTX doesn't work - six days after Hamilton's death. The doctors had been working on the article for months.

The Seattle Times article suggests that financial concerns may have encouraged the researchers to continue the experiment, even though these deaths showed that the dosage was unsafe. Fred Hutchinson Center owned shares in Cell Therapeutics Inc. (CTI), a company built on developing PTX as a cancer therapy, and received a $50,000/year licensing fee. Kathryn's physician owned stock options in CTI. Hutchinson co-founder, E. Donnall Thomas also held stock options and was on the company's scientific advisory board. CTI, which is now focusing on developing a compound that combines PTX and the antibiotic Cipro, is worth more than $469 million.

"The Breast-Cancer Experiment: With a year or two to live, woman joined test in which she was misled - and died" by Duff Wilson and David Heath. The Seattle Times, March 13, 2001.

http://seattletimes.nwsource.com/uninformed_consent/hutchresponds.htm l

"Many patients think that joining testing will help them, but often they're mistaken" by David Heath and Duff Wilson. The Seattle Times, March 13, 2001.

COPYRIGHT 2001 The Townsend Letter Group
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