Attorneys for the parents of Parker Jensen, the 12-year-old boy who made national headlines in 2003 after his cancer prompted state officials to try to force his parents to consent to chemotherapy, claim new evidence shows that a treating physician was more concerned about getting Parker into a clinical study than actually treating the boy's illness.
According to a document filed in U.S. District Court, attorneys for Barbara and Daren Jensen allege former Primary Children's Medical Center Dr. Lars Wagner was trying to prep Parker to qualify for a clinical study of Ewing's Sarcoma, a rare form of soft tissue and bone cancer, by placing him on immediate chemotherapy, even though the Jensens wanted more tests done.
The attorneys argue that Wagner was trying to place Jensen on chemotherapy within a certain time limit to qualify for the study.
In other court documents, attorneys for the state say Parker was not eligible for the study, however, the Jensens claim Wagner never told them that he was considering their son for a clinical trial. Later, they claim Wagner never told the Division of Child and Family Services of the study when he turned the Jensens in for medical neglect after they refused his treatment recommendation.
The Jensens say this evidence, which they found in the past year during discovery for their pending lawsuit against the state, social workers and doctors, shows that Wagner knew that Primary Children's "routinely performed genetic testing for suspected Ewing's Sarcoma when it could collect a fresh tissue." The Jensens say that is what they wanted. The court document states Wagner had expressed concern about a time constraint to get Parker on chemotherapy for the study.
Shortly after reporting the Jensens to state welfare workers, Wagner left Primary Children's for Cincinnati Children's Hospital "because he would have greater research opportunities there." The Jensens contend Wagner was more interested in his research than treating their son.
On Monday, U.S. District Judge Ted Stewart set a three-week trial to begin Feb. 2, 2009. Jensen attorney Roger Christensen said his office plans to file a memorandum next month that will further lay out their case and their evidence. The state is also expected to file a more detailed outline of its position in the case later this month, containing hundreds of pages of medical documents.
The Jensens made national headlines in 2003 when they fled the state with their son to avoid a judge's order to place him on chemotherapy. While in Idaho, the Salt Lake County District Attorney's Office filed felony kidnapping charges against the Jensens with warrants for their arrests.
The ordeal sparked a national debate over the government's role in the lives of children vs. parental rights.
The Jensens sued the state, charging that several physicians and state DCFS officials conspired to force their 12-year-old son to undergo chemotherapy. Last year, a federal judge ruled the Jensens could not sue the state directly over the issue due to governmental immunity, but could press their claims against DCFS officials, two doctors and an assistant attorney general.
Primary Children's Medical Center could not comment specifically on Parker's case because of the ongoing litigation. But Dr. Edward B. Clark, medical director, explained the process that leads up to enrolling a child in a clinical trial.
The Children's Oncology Group is a not-for-profit, 220 center group born of the desire to find effective treatments for childhood cancer decades ago. Proposed treatment protocols go through many steps, including COG's safety monitoring board, critiques by the collaboration's member centers and then review by the National Institutes of Health, which has its own safety standards and other issues in mind.
Typically, all 220 centers are invited to participate in the trial. Those who join usually have their own Institutional Review Boards the panel that vets clinical trials for ethics, safety and other key factors look over the protocol, informed consent and other factors. Every clinical study at Primary is reviewed and overseen by its IRB, Clark said.
Most trials specify a window of time within which certain things have to happen following biopsy. If that time is not met, it doesn't stop someone from enrolling. Rather, he said, a repeat biopsy is requested to "note the evolving character of the tumor."
Primary gets detailed informed consent from parents and, if a child is 8 or older, from the child, as well. Informed consent includes a review of potential advantages and disadvantages, the nature of known risks and more. They often run 25 or more pages and without all that signed documentation, it's impossible to participate, Clark said. Medication wouldn't even be provided.
Physicians are not rewarded for enrolling children in clinical trials, he emphasized. The payment from COG is small, designed to cover the cost of tests, analysis, collecting and sending in data, and other expenses. Institutional support is provided for the centers themselves, but that happens whether or not the center actually enrolls even one participant.
"For physicians," said Clark, "there's no monetary or prestige value. This is a team effort with the goal to dramatically reduce the impact of cancer in children."
On Monday, Wagner's attorney Andrew Morse called the Jensens' claims "the reddest of red herrings."
Morse pointed out that Parker could not have participated in the clinical study because his parents refused a bone marrow test to determine if the cancer was localized or had spread. The study only accepted children whose cancer had not spread.
"This trial was only for a child with localized disease," Morse said. "He couldn't have been invited to the clinical trial."
In addition, Morse said had Parker taken part in the trial, he would not have received any different treatment than what Wagner had thought was necessary to treat him.
Morse also points out that despite the Jensens' claim that they wanted confirmation that the lump under Parker's tongue was indeed Ewing's sarcoma, four tests had confirmed that it was.