Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch

Death of Baby Prompts Scrutiny of Research Risks_St. Louis Post Dispatch

16 Feb 2003

Eighteen month old, Daniella Rogers, died on May 3, 2002, two months after undergoing a clinical trial of chemotherapy treatments at St. Louis Children’s Hospital.

When her parents, John and Oksana Rogers, learned that their baby daughter, Daniella, had cancer, they knew she might die. But they hardly expected that the medicine that was supposed to save her would instead take her life.

“It wasn’t the cancer that killed her. It was the treatment,” Oksana Rogers said

The St. Louis Post Dispatch reports: “The chemotherapy drugs Daniella received [ ] as part of a clinical trial caused the blood in the small vessels of her liver to clot like curdled milk. Three other children died of the same side effect before the study’s sponsor, Children’s Oncology Group of Arcadia, Calif., and the National Cancer Institute temporarily suspended the trial last year.”

The federal Office of Human Research Protections (OHRP)has ruled that the University of St. Louis medical school had not spelled out the risk of veno-occlusive disease of the liver, a rare but well-known reaction to commonly used, toxic, cancer-fighting drugs. [See http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jan03a.pdf ]

In this trial, the treatment-induced disease occurred in about 1 out of 20 patients. Four of the 360 children enrolled died of it.

However, an investigation by the FDA found “no significant deviations.” The disagreement between the inspectors of two federal agencies about what constitutes ethical / legal violations of informed consent illustrates a lack of consistent standards–even between two federal oversight agencies.

“Daniella’s case is one of the latest to raise questions about the massive clinical research industry, and to provoke debate about how far researchers must go to make sure subjects understand the risks.” The parents say they were not told about the risks or the other deaths.

The circumstances of Daniella’s death highlight once again, disturbing questions: How safe is it to enroll a child in clinical research? What constitutes informed consent? Where can a family turn for help? What compensation is there if research subjects are harmed? Who is accountable if ethical standards are violated and death results?

The Post Dispatch correctly reports that OHRP’s finding “carries no sanctions or fines.” The parents’ public complaints led Washington University to change its informed consent for the remaining participants in the cancer trial to better reflect the actual risks.

The Post-Dispatch reports that “Washington University wouldn’t allow [reporters] to interview its doctors about Daniella’s case because the Rogers family has threatened to sue. However, the university released several statements and documents that defend its actions.”

According to the Post-Dispatch, FDA’s chief of human subject protection division, Dr. David Lepay, credited the research enterprise claiming that his agency’s inspectors “find far fewer problems now than they did 25 years ago, when perhaps 20 percent of trials failed to meet key regulations. Now, the number of violators is around 2 percent.”

Given the risks in clinical trials are often involve matters of life or death, it is hard to understand FDA’s disregard for violations of federal disclosure requirements which are necessary for valid, informed consent. If the agency dismisses violations of informed consent as “not significant deviations,” it is difficult to know what violations FDA’s inspectors do consider “significant.” Dr. Lepay’s optimistic calculation –2 percent violations–is at best pulled out of a hat.

Full article with pictures of Daniella [whose age was incorrectly stated in the article] and her parents are online at:

http://www.stltoday.com/stltoday/news/stories.nsf/news/CE7A37C79420FFFC86256CCE006C9B96?
OpenDocument&highlight=2%2CDaniella&headline=Death+prompts+scrutiny+of+research+risks

Death prompts scrutiny of research risks By Sara Shipley Of the Post-Dispatch 02/15/2003 12:39 PM