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An extra dose of hope for patients with cancer

Arvind Chaudhry, MD is medical director
of Providence Cancer Center.

Help for cancer patients who’ve run out of options

Today, people facing cancer have more options than ever before. And at Providence Cancer Center at Sacred Heart Medical Center and Holy Family Hospital, they can expect their care to be well coordinated and enhanced by research, education and support, all in one location.

Still, there will be times when cancer is particularly resistant, requiring something beyond the normal regimens of surgery, chemotherapy and radiation. For patients who seem to have run out of options, there is another dose of hope. A little-known service called compassionate care protocols—available through pharmaceutical companies and made possible by places like Providence Cancer Center—is helping people live longer and with better quality of life.

Drug therapies available for “compassionate use”

Many people with cancer consult a variety of Internet resources to learn about the latest and greatest options for their care. It’s not only educational, but therapeutic, empowering them to be more involved in their care.

But sometimes, accessing information about new therapies can be disheartening. Imagine having little relief from chemotherapy, surgery and/or radiation therapy, and then hearing that the miracle drug you just discovered online isn’t available for you.

Harry Sladich, a vice president at Gonzaga University, meets regularly with Vicki Townsend while in treatment for his cancer. Providence is one of only a few centers in the Northwest to offer the drug he is taking.

According to the National Cancer Institute, there are more than 5,000 research trials currently underway to test new disease-fighting agents. But testing drugs and actually making them available are two completely different endeavors. Drug companies have rigorous guidelines to follow and the Food and Drug Administration (FDA) must offer its final stamp of approval before a new medication can be marketed and made available for broader use.

“Patients often come across information about a new drug and go to their doctor requesting to try it, only to find out it’s not available for purchase,” says Arvind Chaudhry, MD, PhD, medical director of Providence Cancer Center. “It shatters their hope.”

The Center’s slogan, “Hope Begins Here,” is one the staff really believe. So when they discovered the FDA’s “compassionate use” program that supplies investigational drugs—for free—they were quick to become involved.

With many drugs in the research process, there is a six- to 12-month window between the time the FDA has granted its approval and the time the manufacturing company can produce, market and make the drug available for broader use. In recent years, the FDA has created a way to help more people during that window of time: allowing physicians to offer the drug to eligible patients on the condition that information is collected and reported for research purposes. And, in that time period, the pharmaceutical company provides the drug free of charge.

From the other side of care

One doctor’s experience as a patient

In December 2005, Robin Gavelin, MD, an anesthesiologist for 18 years, began a different kind of experience in health care. He started seeing it from the eyes of a patient—a cancer patient.

His was a rare case of chronic myelogenous leukemia, a kind of cancer resulting from acquired genetic damage to the DNA of a developing white blood cell. As the cell replicates, additional abnormalities occur in the leukemia cells, making them more aggressive and resistant to therapy. Dr. Gavelin’s leukemia was already in this accelerated phase.

He was on one medication for six months and felt great. Then in May 2006, his blood work indicated the cancer had developed a resistance to the drug.

“My choices were limited,” he says. “I was told a bone marrow transplant would be at least six months away and I would probably need chemotherapy unless I could enroll in a study for one of the new experimental drugs.”

Familiar with the potential of research medications, Dr. Gavelin immediately began his web search and found one that sounded very promising for his condition. He says he needed it so badly, he endured an “incredibly frustrating process,” making dozens of phone calls to the National Institutes for Health, the pharmaceutical company and research coordinators before getting through to a project manager who connected him to the right people. Finally, he was enrolled in a “compassionate use protocol” (a program approved by the Food and Drug Administration while a drug is being prepared for distribution).

“All I had to do was set things up with my doctor’s office. I was elated!” he shares.

Unfortunately, his doctor was part of a practice that wouldn’t work with this drug’s manufacturer, and said they would have to set up a study through a different company. That process would take about nine months—time simply not available to him.

“I was livid,” he shares, “that I could find a solution and then not have my doctor’s clinic support me.”

Not about to give up, he called Providence Cancer Center at 5 p.m. on a Friday and shared his story with Vicki Townsend, the research coordinator.

“She said she would see what she could do,” Dr. Gavelin remembers. “She called me on Monday at 10 a.m. and had the paperwork ready. I was able to start my medication just seven days later.”

His blood work improved, he had no significant side effects and he was pretty happy. “Life was almost back to normal,” he says.

But in October 2006, blood work showed that his leukemia was going to require a bone marrow transplant. Fortunately, the drug remained effective until he headed to Seattle for the transplant in December. Since then, there has been no trace of the leukemia. He continues to visit Providence Cancer Center for post-transplant care and monitoring, and eventually, he’ll be off all medications.

“For Dr. Gavelin, this drug saved him from an acute crisis and bridged him to the transplant,” says Arvind Chaudhry, MD. “It was lifesaving for him.”

In addition to the donor who was a perfect match for the bone marrow transplant, there was another hero in this story.

Dr. Gavelin says, “Vicki was super. She simply took charge and I could take a big breath. I could relax.”

“I’m very happy,” he adds. “Last summer, my daughter got married and I was able to make it to her wedding. That wouldn’t have happened, if not for the availability of compassionate use drugs.”

He hopes to return to work in January 2008.

“It’s a win-win situation,” says Dr. Chaudhry. “The patient gets to try a therapy at no cost and we get to contribute to research.”

The primary obstacle is lack of awareness. Pharmaceutical companies are not allowed to advertise this service, so it’s up to physicians to stay on top of research and to patients to keep seeking solutions.

Since there is no fee to participate, the only catch for the Cancer Center is the cost associated with delivering the service—mounds of paperwork to complete on every drug, for every patient, for an extended period of time.

“The only reason I could do this is because of the staff time contributed by Providence Cancer Center. A single physician could not handle this with the time it takes to process all the required components,” Dr. Chaudhry explains.

Hope indeed begins here

Dr. Chaudhry and his Providence partner, Joseph Rosales, MD, have offered half a dozen different medications for 20 patients experiencing lung, kidney and prostate cancers as well as melanoma and leukemia. People from as far away as Utah, Montana and Canada have flown to Spokane to complete the required testing for these compassionate therapies.

“When they see a shred of hope, people will go out of their way to get it,” Dr. Chaudhry says.

For those who live far away, the required weekly blood tests can be completed in their local communities, but they still have to visit the Providence Cancer Center to meet the remaining requirements of the FDA. Some are receiving complimentary drugs that would normally cost $2,000 for a one-week supply.

One patient currently enrolled in a compassionate care program has been suffering as cancer has progressed throughout her body. In the past three months on this new drug, the growth of her cancer has stabilized.

“She's feeling good and life is looking up,” Dr. Chaudhry shares. Her outlook is good, knowing she has more time with her kids and grandkids,” he proudly adds.

His pride not only comes from knowing that this particular patient has been helped, but also from knowing that the Providence team is contributing to research that can ultimately affect many more people. And as more pharmaceuticals participate in compassionate care protocols, the sphere of hope will only grow.

How it works

Once the oncologist has found an appropriate drug for a patient, Vicki Townsend, RN, Providence Cancer Center’s research coordinator, begins a menagerie of tasks. This includes making calls to the drug manufacturer, applying to the local Institutional Review Board (which must approve all research projects), interviewing the patient and arranging appointments for his or her scans, blood work, heart tests and more.

Dr. Chaudhry says, “The whole process is like a dance. Things have to come into place at the right time.”

And, adds Vicki, it requires connecting with patients and learning what their goal is for treatment. Some want to return to work. Many just want to control the symptoms of their disease so they enjoy life more.

“Others know their life expectancy is just a few months—if we don’t find something better than standard treatment,” Vicki says.

She continues, “Our motto, ‘Hope Begins Here,’ is so apropos for these patients. At a time when they have no further hope, we facilitate the opening of another door. And they have such gratitude because no one else will go to these lengths to sustain their hope for life.”

The time it takes for Vicki and all the physicians and nurses to make compassionate care protocols available to patients is time not reimbursed by insurance providers.

And that, says Dr. Chaudhry, is what makes it a perfect match for a not-for-profit center like Providence. “It really fits our mission.”

For more information:

Contact the US Food and Drug Administration:

www.fda.gov

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