Getting with the Program: Expanded Access Programs

Through expanded access programs, patients with cancer—unable to join clinical trials—benefit from investigational drugs.
BY TONY HAGEN @oncobiz
Henry Sacks was a stoic, self-reliant man all of his life, but one day, several years after the start of his battle with colon cancer, his oncologist told him he didn’t know of any further options for treatment. Sacks, if he wanted to survive, would have to start researching on his own.

For a 72-year-old who predated the Internet revolution, this was a tough challenge. He didn’t know how to navigate the maze of websites about medical trials or understand the terminology that obscured every pathway toward information about his stage 4 cancer.

So he called his daughter, Janis Berglas, and pleaded for assistance. “He said to me, ‘I don’t know anything about computers. Is there anything you can do on the Internet?’”

The cry for help deeply affected Berglas. “I suddenly felt I had to save my father’s life,” she says. But the task was almost as overwhelming for her.“

I had no idea where to begin. I found that there were various trials, all posted, but they were posted in doctor speak, and by the end of the day I was in tears 

because I couldn’t figure it out,” Berglas says. “I’m a college-educated woman, and yet I had no idea what was promising. I would call and find that (the trial) 

was already over or there were some criteria that I didn’t understand that my father didn’t meet.”

After helping her father enroll in an expanded access program,

Janis Berglas became convinced that there should be more such

programs, and that they should be easier for patients and their

doctors to find. Photo by Susan Farley.

Eventually, a friend in the pharmaceutical industry put her in touch with an oncologist who thought Sacks would be an ideal candidate for a few drugs undergoing testing at the time.

What worked in her father’s favor was that one of the pharmaceutical companies doing testing was accepting patients for an expanded access program (EAP), an opportunity created on rare occasions to give patients access to investigational drugs showing early signs of effectiveness—outside the structure of clinical trials. That meant that though the clinical trial of the drug was closed, the EAP would enable her father to receive the same medicine. Better still, the EAP was accepting patients through Greater Baltimore Medical Center, just 30 minutes from where they lived.

In 2002, Sacks began taking the drug Erbitux (cetuximab), which has since been approved for the treatment of both colorectal and head and neck cancers. The drug extended Sacks’ life by two years, giving him what his daughter described as genuine quality time. “He definitely responded very well in the beginning,” she says. “He golfed, rode his bicycle, went to Florida. He just kept busy, and when he couldn’t anymore, the boys would come over and play poker.”

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