Why One Cancer Patient Is Fighting a Drug Company Working on a Cure

Source: abcnews.go.com
Author: John Donovan

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?”

Jackie has publicized her grievance in a video about her mom on YouTube. She also posted photos of GenVec’s management, as well as their phone numbers and e-mail addresses. Ask them, she pleads to the public, to make the life-saving treatment available.

Jackie likened the drug company’s resistance to, “My mom is drowning and they wouldn’t throw a lifesaver to save her.”

Of course, such an argument makes GenVec sound heartless, but the reality is more complicated. TNFerade is still in trials. Providing it to Connie before FDA approval — and some companies do that for patients without options — is called “compassionate use” and it carries real risks, not just for Connie.

If Connie took TNFerade under compassionate use and it hurt her somehow, the FDA could slow the entire approval process to investigate, costing GenVec money, and delay potentially thousands of people from getting a drug that otherwise would be ready.

“And if making the drug available to one patient can cause a six-month delay, that is a real concern,” said Scott Gottlieb, a former FDA official. “It is not unreasonable for a company to say that making the drug available could imperil early approval of the drug. And therefore, what we really need to do is focus on getting it out to the market as quickly as possible to help the biggest number of people.”

It’s not an uncommon dilemma. Lots of drug companies get these requests from desperate patients that pit the good of the many against the good of one.

For Jackie, the heartbreaking thought is: By the time this drug is ready for the many, the one she loves will be gone. Though neither mother nor daughter knows if the drug will work on Connie, they appear desperate.

“At this stage,” Connie said, “I need the chance.”

She said they “have tried everything,” including going through 30 stages of radiation in addition to chemotherapy. Connie also made a brief plea for herself: “Help me. I am in pain. I am in pain. Come here someday and see the pain I am in.”

Connie believes the treatment could preserve her caretakers, as well.

“My daughters’ lives are all turned upside down. Their lives have stopped, actually. I try to tell them they have jobs they have to be at, they have boyfriends they need to spend some time with. This is my life, my problem,” she said. “I don’t want them to suffer.”