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Mar 10, 2011 11:07PM
Cancer Patient: Approval For New Drugs Takes Too Long
Patient Travels 950 Miles For Treatment Not Available in Boston
POSTED: 3:12 pm EST March 10, 2011
UPDATED: 10:03 pm EST March 10, 2011
BOSTON -- How long is too long to make cancer patients wait for promising new drugs? One local couple is frustrated with the Food and Drug Administration's approval process and is demanding changes.
Lorraine Heidke-McCartin and her husband, Phil, recently returned from their sixth trip to Virginia this winter. That's the closest place offering an experimental drug to control her advanced breast cancer, the couple said.
"I just had my first CAT scan done the week before last and everything has shrunk or it's gone already," Heidke-McCartin said.
In studies, T-DM1, a combination of Herceptin and chemotherapy, has shrunk tumors in 33 percent of women with advanced disease, according to Genentech, the drug maker. It also has few side effects.
But the travel, at her own expense, has taken a toll on the 54-year-old Hanson woman.
"It doesn't have to do with the treatment itself, but it has to do with what you're putting a stage IV, critically ill, terminally ill person through to get a drug," Heidke-McCartin said.
Last summer, doctors told Heidke-McCartin she was a perfect candidate for the drug and would start receiving it in Boston at Dana-Farber Cancer Institute in September.
"Then I picked up the paper, the FDA pulled the rug out, said Phil McCartin. "It's just baffling to me why the FDA did this."
The FDA denied accelerated approval and, according to a spokeswoman, will not comment publicly on the reason.
In a statement, drug maker Genetech said the FDA told them the drug did not meet the standard for accelerated approval "because all available treatment choices... had not been exhausted" among those in the study.
That infuriates Lorraine's husband.
"She and hundreds and hundreds of other women across the country have already exhausted all those other options," McCartin said.
Sen. John Kerry fired off a letter to the FDA, writing, "Especially when patients have exhausted existing treatment options, they shouldn't have to face unnecessary obstacles to innovative treatments that are potentially life-saving."
"As a general rule, it takes too long to get drugs to people who need them," said Dr. Eric Winer, director of the breast oncology center at Dana-Farber.
Winer said the overall drug approval process needs to be accelerated.
"One of those ways. potentially, is to issue preliminary approvals, do more definitive studies and recognize they may or may not get final approval," Winer said.
Genentech spokeswoman Krysta Pellegrino said, "We are really committed to this medicine."
She said potential FDA approval isn't likely until late 2012 or early 2013.
After several doses of T-DM1, Lorraine is looking better and feeling better.
"They're asking me how I'm doing, and I got very teary, and I said for the first time in I can't tell you how long, I feel like me." Heidke-McCartin said. "I was able to play on the ground with my grandchildren, run around with them. Do those kind of things that I've always dreamed I would be doing at this age."
7/6/2009, IDC, 3cm, Stage IV, Grade 3, mets, ER+/PR+, HER2-