Fight Against Cancer: Patient vs. Process
Another fight against cancer may be patient vs. regulatory process.
May 7, 2008— -- On this relatively good morning in the course of her mom's inoperable cancer, Jackie Loughman, of Indianapolis, knows some facts about pain that she wishes she didn't.
"She is mostly in bed and in pain all the time, and, you know, it is hard to watch," Loughman said of her mother, Connie.
But the fact really throwing Jackie and Connie is that there is a drug out there that has saved at least one pancreatic cancer patient — and Connie can't get it.
Richard Jordan, a Colorado landscaper, was supposed to be dead by now, but he got into a trial for the drug TNFerade. His wife called it "a miracle."
Jordan's oncologist, Dr. Raj J. Shah of the University of Colorado, said, "The remarkable thing of his story is that he went on to surgery — but more importantly, when they removed the mass, no cancer was left or seen. With pancreatic cancer, the complete response is really rare."
Connie is disqualified from the TNFerade trial by her participation in an earlier trial for a different drug that she says made her sick.
TNFerade is made in Maryland by a small firm called GenVec, which told Jackie and ABC News in a statement: "We are working aggressively to advance our product candidate, TNFerade, through the required clinical studies and regulatory review process. ... Unfortunately, this process makes it impossible for GenVec to consider any opportunities to address the needs of individual patients outside of our clinical studies at this time.
"We are unable to take any action that might delay our development program, potentially putting many more patients at risk in the future. We will continue to try to make access to our clinical trials for TNFerade available to as many qualified patients as possible."
But the Loughmans wonder why, under the circumstances, an exception can't be made to the rule to let Connie get the drug.
"That is the most mind boggling thing," Connie said. "If there is medication out there that can make me well, why wouldn't they give it to me? Why wouldn't they give it to people that are in need of it like myself?"
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