Dying for a Cure: Pediatric Cancer Trial Undisclosed facts – NBC, Chicago

Thu, 14 Nov 2002

How can parents protect their children from harmful medical experiments if the facts are withheld from them? So far, Congress has enacted no law to protect children from experiments that disregard their life-safety in clinical trials.

An investigative news report aired last night by WMAQ-TV, an NBC owned station in Chicago, focused on a government sponsored pediatric cancer trial– COG D9803. The station’s investigative team (unit 5) uncovered documents revealing previously undisclosed deaths of 4 children, and 16 cases of a life-threatening side effect of the drugs used to treat the cancer– veno-occlusive disease or VOD, (liver failure).

In all, 300 children had been enrolled in the trial at 250 locations in the US and abroad. See list:
http://www.nbc5.com/news/1781498/detail.html

NBC Unit-t reported that physicians received a $2,000 per case reimbursement for enrolling children in the trial, COG D9803.

On July 22, 2002, the Station filed a Freedom of Information request with the National Institutes of Health asking for information on the federally-funded study, specifics of adverse-event reports, and the number of deaths related to VOD. Less than a month later, the trial was suspended and the Office for Human Research Protections said it was beginning its own investigation.

Among those interviewed were the parents of two child casualties: twenty month old, Daniella Rogers, who died of VOD on On May 3, 2002, http://www.daniellarogers.org/ and the parents of three and a half year old Travis Whitman, who died October 21, 2001. http://www.traviswhitman.com/

The parents claim they were never warned about VOD–even though it is a life-threatening risk. Nor, they claim, were they told that children enrolled earlier had died in the trial.

~~~~~~~~~~~~
http://www.nbc5.com/unit5investigates/1785609/detail.html
NBC5.com Unit 5 Investigation: Dying For A Cure
Renee Ferguson Looks Into Deaths Of Children In Clinical Trials
POSTED: 8:36 a.m. CST November 14, 2002
UPDATED: 8:52 a.m. CST November 14, 2002

CHICAGO — More than 250 hospitals and medical centers, including six in the Chicago area, are participating in the clinical trial of a new drug — Topotecan — with a combination of three standard cancer drugs — Vincristine, Actinomycin-D and Cyclophosphamide.

Participants In Study, Resources

“We know these drugs have cured children, but we learned they have also killed children,” Unit 5’s Renee Ferguson said.

Ferguson’s investigation started with a girl named Daniella and a boy named Travis. Daniella lived in St. Louis. Travis lived in rural Texas. They lived different lives. But they died the same death.

“It’s the worst kind of heartache you can possibly imagine, not have that person here,” said Daniella’s father, John Rogers.

“They told us that it was veno occlusive disease (VOD),” Rogers said, describing his daughter’s illness.

“That’s a blockage of the veins in the liver,” said Travis’s mother, Elizabeth Whitman. “And as bad as it hurts to see him gone, I’d rather see him out of pain.”

Daniella and Travis were both part of a worldwide pediatric drug trial. They both had a rare childhood cancer called rhabdomyosarcoma.

“But it wasn’t cancer that killed them,” Ferguson said. “It was the drugs used to try to cure them.”

Rogers said Daniella’s doctor was confident about a cancer treatment for Daniella.

“He assured us that she was in the right place, in the right study and the right time,” Rogers said. “The type that Daniella had was 80 to 90 percent curable.”

Rogers, who works at Washington University Hospital, in St. Louis, said he felt that entering Daniella in a clinical trial would ensure the very best care.

To wipe out the tumor in her left shoulder, Daniella received three powerful chemotherapy drugs. But five days after her third chemo treatment, Daniella became unusually sick.

“She had never been that sick before,” Rogers recalled.

Rogers and his wife took Daniella to the hospital twice in two days. She was sent home each time.

“She had thrown up, and my wife noticed later on … it was blood,” Rogers said.

It was not until the next day in the emergency room that Daniella was diagnosed with VOD — a form of liver failure that was a side effect of chemotherapy. Earlier symptoms had been missed. And then it was too late.

“She was just lying (there), and we watched her slowly die in her hospital bed,” Rogers said.

After saying goodbye to their 20-month-old daughter, Rogers began surfing the Web for answers. That’s where he found Travis Whitman, a little boy from Texas who had the same cancer.

“I couldn’t believe it,” he said of his discovery.

Travis’s mother, Elizabeth Whitman, told Rogers that her son had died six and a half months earier, the same way that Daniella did. And he was part of the same clinical trial, although his was conducted in Texas.

“They were identical, except for the fact that Travis was in ICU a little longer than Daniella,” Whitman said.

Whitman said she placed her 4-year-old in the trial in August 2001.

“At the time, I just wanted to try something that would save my child’s life,” Whitman said.

Instead, the medications meant to cure Travis poisoned him. By October, he was in ICU. He died Oct. 21.

Both families signed informed-consent documents. Liver failure was mentioned, but there were no specifics about VOD so that doctors and families would know its warning signs.

“I would have known, knowing what I know now, that there was a problem, (that) there was something more going on,” Rogers said.

Unit 5 asked the National Institutes of Health, the agency funding the study, what doctors in the trial knew about VOD and how many of the almost 300 children in the trial had suffered from it. That question was posed on July 22. Less than a month later, the trial was suspended, and a federal investigation was started.

Dr. Gregory Reaman, chairman of the children’s oncology group that is running the trial, talked to Ferguson about her investigation.

“Misrepresentation of what happened here could sabotage clinical research,” Reaman said. “I don’t know all the specific situations at the individual institutions, but from the standpoint of conducting this clinical trial, I don’t think a mistake was made.”

But Reaman admitted that the children may have been given too much of the chemotherapy drugs.

Unit 5 obtained a document announcing the suspension of the study. The document showed that there have actually been 16 cases of VOD, including four deaths. Two more children died in June and August, months after Daniella and Travis.

Now, two sets of parents are speaking out about their experience, hoping to warn others.

“It just really broke my heart,” Whitman said. “Maybe they can learn something about what happend to Daniella and Travis and save other kids lives.”

Meanwhile, the federal investigation of the drug trial is ongoing.

“Yesterday, we sent investigators some of our latest findings,” Ferguson said. “For instance, medical records from one of Daniella’s last clinic visits were changed to say Daniella was alert and playful. The original records said nothing about her disposition.”

Ferguson said other things were added to the records, including instructions to the parents on drug side effects. Ferguson said a hospital spokesman admitted that a nurse did add the details after Daniella died, to make the records accurate.

“We know clinical trial save lives,” Ferguson said. “We’ll see what the government finds in its investigation of this study.”

Copyright 2002 by NBC5.com. All rights reserved.

http://www.nbc5.com/news/1781498/detail.html
NBC5.com
Dying For A Cure: Participating Ill. Institutions & Resources

Here is a list of the Illinois institutions that are part of the clinical trial reported on in the Unit 5 investigative report, “Dying For A Cure.” Following the list are links for more information.

• CCOP – Illinois Oncology Research Association – Peoria, Illinois, U.S.A.
• Children’s Memorial Hospital, Chicago – Chicago, Illinois, U.S.A.
• Hope Children’s Hospital – Oak Lawn, Illinois, U.S.A.
• Lutheran General Hospital – Park Ridge, Illinois, U.S.A.
• Rush-Presbyterian-St. Luke’s Medical Center – Chicago, Illinois, U.S.A.
• Saint Jude Midwest Affiliate – Peoria, Illinois, U.S.A.
• Southern Illinois University School of Medicine – Springfield, Illinois, U.S.A.
• University of Chicago Cancer Research Center – Chicago, Illinois, U.S.A.
• University of Illinois at Chicago – Chicago, Illinois, U.S.A.

Links For More Information:
daniellarogers.org
researchprotection.org
traviswhitman.com
cancer.gov (You can look up this particular trial at this link.)

Copyright 2002 by NBC5.com. All rights reserved.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.