Ethics, Patient Protection & Medical Research - Shorts

Townsend Letter for Doctors and Patients,  April, 2002  by Jule Klotter

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Medical research has its risks, as the family of Jesse Gelsinger well knows. Eighteen-year-old Jesse had ornithene transcarbamylase deficiency (OTC), a genetic liver disease in which ammonia, produced when protein is metabolized, builds up in the body instead of being eliminated. Jesse was lucky because he had a mild form of the disease that was being controlled with drugs and diet. Interested in helping researchers find a cure for the illness, Jesse volunteered to take part in a University of Pennsylvania gene-therapy safety trial. He was the second volunteer to receive the modified cold virus that contained a normal version of the OTC gene. The investigators did not expect any complications. After the modified virus was injected into an artery that leads to the liver, ammonia levels rose to toxic levels in Jesse's brain. He was declared brain-dead and removed from life support four days later. The investigators halted the experiment.

Not all researchers are so conscientious. A minimum of 18,000 women had suffered through and paid for high-dose chemotherapy before researchers finally admitted that the high dose "appears no more likely to cure breast cancer than standard treatment." In their investigation of patient safety and research ethics, reporters from US News & World Report reviewed records from the FDA, the National Cancer Institute, and the Office for Protection from Research Risk (QPRR), which oversees the safety of participants in federally funded research: "A review of these records, plus interviews with scores of researchers, regulators, test subjects, and their families, shows that the rules developed to protect research subjects are regularly ignored."

The principle of informed consent is too often being violated by researchers. Patients report being misled about their options and about the risks and side-effects of the therapy being tested. Some report being pressured by medical personnel, who want them to agree to take an experimental drug. Others discover, after the fact, that the therapy that they had received was experimental and had not been approved for use.

Federal investigations of cancer trials being held in over 100 medical centers found: "Researchers neglected to record or report serious adverse reactions to experimental drugs -- including deaths.... Patients were coerced into waiving their legal rights in case of malpractice.... Researchers placed patients in trials that were medically inappropriate, which may have reduced their chances for survival.... Doctors failed to accurately inform patients of the benefits and risks of a study or to describe alternatives that might be more efficacious."

The US News & World Report article indicates that the medical centers that aggressively pursue grant money for research tend to show more violations of subject protection laws. In May 1999, after its auditors found dozens of protection law violations at Duke University Medical Center, the OPRR suspended the medical center's 2,000 trials until the university agreed to address the problems. In August 1999, nearly all of the 1,600 trials being held at the University of Illinois-Chicago were suspended by OPRR until the school developed a safer review system for evaluating research projects. Because OPRR has only 15 employees assigned to investigate subject protection law violations, these two schools may be just the tip of the iceberg.

"A promising experiment ends in tragedy" by Leslie Roberts. US News & World Report, October 11, 1999, p.43.

"Dying for a Cure" by Sheila Kaplan and Shannon Borwnlee. US News & World Report, October 11, 1999, pp.34-43.

COPYRIGHT 2002 The Townsend Letter Group
COPYRIGHT 2002 Gale Group