New drug may save man’s life
February 16, 2004
Mark Hudgens was supposed to die a year ago.
The Aspen resident had such severe neck cancer that many doctors refused to treat him ” he was a lost cause.
But Hudgens survived, and on Friday he received a package from Germany that could, at best, kill the tumor in his throat and, at worst, prolong his life for several years.
The contents of that package: Erbitux, a cancer-fighting drug that gained FDA approval Thursday.
Today, Hudgens will be one of the first in the United States to receive an Erbitux treatment outside of a clinical trial.
The drug is produced by ImClone Systems Inc., which has been at the center of a stock scandal that has Martha Stewart on trial and the company’s chief executive, Samuel D. Waksal, behind bars.
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In many test cases, it has proven to be a superior alternative to chemotherapy.
But despite its approval, Erbitux will not be available to cancer patients for several months, as final details, such as the drug’s price, are nailed down. Additionally, the drug has only been approved for colon cancer patients .
The fact Hudgens, 51, got his hands on the drug a day after its approval was the result of nothing less than sheer determination.
“I never would have gotten this drug without my wife,” Hudgens, who was diagnosed with cancer in June 2002, said through a tracheotomy tube.
Dr. Dennis T. Jordanides, who’s been treating Hudgens since December 2002, said Hudgens first came to him after leaving the Mayo Clinic in Minnesota, where he was told his cancer was terminal. Hudgens’ wife, Robyn, said doctors told her his only chance of survival was a new drug.
“Basically, he came back to Aspen to die,” Jordanides said.
But Jordanides and Dr. Ira Jaffrey, an oncologist in Glenwood Springs, weren’t ready to give up on Hudgens. Jaffrey, who was aware of Erbitux, told Robyn Hudgens that if anybody could legally get their hands on the drug, it was her.
“He’s responsible for saving Mark’s life,” Robyn Hudgens said. “If it wasn’t for him, we wouldn’t have even known about this drug.”
The drug, which was approved in Switzerland and Germany in 2003, was showing a great deal of promise in clinical trials, and Jordanides said he knew the drug would “give Mark a significant chance of prolonging his life.”
With Hudgens’ body near its toleration point of chemotherapy, the productivity of the treatment is dwindling and soon it will no longer work.
That’s where Erbitux, which is administered intravenously, shines.
The amazing thing about the drug, Jordanides said, is that it works when chemotherapy runs its course, and it causes less damage to the body.
“[Erbitux] differentiates between cancer cells and normal cells,” he said. “It targets the cancer cells, as opposed to targeting everything.”
Chemotherapy does not distinguish between cancerous and noncancerous cells.
Furthermore, the drug doesn’t cause hair loss and has a good side-effect profile, Jordanides said.
Robyn Hudgens knew Erbitux was her husband’s last hope, but with all the U.S. clinical trials full, Europe was the only option, and the chances of landing the drug were slim.
But Robyn was on a mission.
Earlier this year, after hours of Internet research and phone calls to Europe, she found a pharmaceutical company in Freiburg, Germany, that sold the drug.
Her quest, however, had just begun.
Over the next month, she spoke with the Food and Drug Administration, U.S. Customs, the Department of Agriculture, attorneys, airlines and courier services, and everything led back to paperwork: signatures, documents, verifications, etc.
In order to have any remote chance of receiving the drug, every minute detail had to be checked and double checked.
What made the situation even more complicated is the drug’s fragility. Erbitux must be kept below 7 degrees Celsius, 19 degrees Fahrenheit, and the courier’s packaging system could preserve the drug at that temperature for no more than 72 hours.
Eventually, upon working out all of the details, the Hudgens received notification last week that the drug was on its way from Germany. But the journey, and the anxiety, was not over. Once the drug landed at Denver International Airport, it still needed to be transported to Aspen. A snowstorm, and subsequent travel delays, could have destroyed the entire effort, Robyn said.
“We weren’t getting our hopes up that it would get here,” she said.
Finally, after waiting on pins and needles, they got a call late Thursday night that the drug had arrived.
“It was a long line of successions of things working out,” Robyn said. “The last year has been a miracle ” he’s been waiting around for this drug.”
“What it means is hope,” Mark said. “This is the first new thing for cancer in a long time.
“I’m lucky to be able to try this.”
Yes he is.
Mark Hudgens possesses a drug that tens of thousands of cancer patients around the country desperately need, but without its full approval, can’t have. Robyn Hudgens knows how that feels.
“It’s [been] frustrating to know that there’s a drug out there that could save my husband’s life that’s not available,” she said.
But neither the Hudgens nor Dr. Jordanides blame the FDA.
“We just want other people with cancer to know that there are other options out there,” Robyn said. “You need to educate yourself, just because a drug is not FDA approved doesn’t mean you can’t use it.”
“The FDA didn’t want to approve something that they didn’t know [about],” Jordanides said. “I just feel privileged to be able to offer this cutting-edge drug to my patient.”
Despite all the promise behind the drug, Mark Hudgens isn’t getting too excited.
“I’m not counting on it being a miracle. I’m trying to stay realistic,” he said. “When you get cancer, you get really realistic.”
Steve Benson’s e-mail address is firstname.lastname@example.org