E-mail this article Print this article

It is completely true that the Fred Hutchinson Cancer Research Center (FHCRC) is a highly respected institution, has excellent physicians and has done much to alleviate disease and pain for many thousands of patients. However, the clinical trials mentioned in your "Uninformed Consent" series are exceptions to this notable record of achievement.

Hutch President Dr. Lee Hartwell's feeble accusation that The Times story is "blatantly false" is blatantly unbelievable in terms of the center's potential conflict of interest in this matter. Although I am a toxicologist and not a lawyer, a quick review of the FHCRC Conflict of Interest policy in place in 1983 (on the FHCRC Web site) makes it clear that the individuals at the center and those involved in the trials were in conflict with the policy as I and most people would interpret that document.

It is as clear as crystal (to me at least) that these fellows knew they could stand to benefit from ownership of Genetic Systems stock if the trials were allowed to proceed and appeared to be showing development of a successful drug. The current value of the stock certainly supports the gains made by the FHCRC stockholders.

It is sad that Dr. Hartwell wants to defend this type of association as beneficial to medicine when a financial stake in drug development can be an issue to cloud objectivity in how long a trial should proceed. It is telling that the principal benefits of this association were to FHCRC staff and not the patients who died or those other survivors who could have benefited to even a greater extent from alternative therapy that did not use "their" drug protocol.

Yes, I believe that fears voiced by the current FHCRC president - that patients might shun clinical trials in the future - have merit. However, this may be exacerbated both by the existing feeling that patients are only human guinea pigs in such trials and by the feeling that only hospital managers may have benefited from relationships with drug firms that provided the test agents in past trials.

This whole issue has resulted from their personal involvement in ignoring or squelching objections on the protocol in earlier years. Despite the claims of regulatory review and oversight on the protocol and lack of regulatory agency objections to it, the extent and quality of these reviews appear to be in sufficient doubt to use as an excuse. Your article makes it apparent that there was too little done to follow up on the repeated claims of a faulty and deadly protocol.

It is contrary to all toxicological principles to justify a protocol in escalating a human dose where a lethal dose had already been identified in a patient at a lower level. The use of mouse toxicity data to justify human dose levels is also contrary to standard toxicological principles. Finally, telling the patient that an intravenous form of the drug was available when the physicians running the trials knew this wasn't the case is inexcusable and additionally very sad when data were already available that showed that the drug was ineffective.

The Times did a good job in investigating and reporting this story.

Ronald S. Slesinski is a diplomate with the American Board of Toxicology, Arlington, Va.