fighting for medicine

When every drug failed to control the breast cancer that is killing her, Deborah Warkus was relieved to learn there was one more treatment to try.

But two months have passed since her oncologist prescribed a combination of two drugs, and other than one dose, she is unable to afford continuing treatment. Instead, the 50-year-old is caught in a medicare bureaucracy, fighting to obtain the medicine as the cancer gallops through her.

“It has progressed to the point where it has erupted through the surface of my skin,” Ms. Warkus said. “You can’t run from it, no matter how fast you run.”

To control her disease, Ms. Warkus’s oncologist recommended a combination of two drugs: capecitabine and lapatinib.

About 100 breast-cancer patients across the country have taken the combination since Health Canada approved it about seven months ago.

Ms. Warkus thought she was on her way to obtaining it when the drug company offered her lapatinib under its compassionate access program. But Ontario won’t give her capecitabine if she uses it with lapatinib because the province’s drug approval body hasn’t signed off on funding its use in that combination. And the drug company can’t give her lapatinib unless she uses it with capecitabine – the only combination for which lapatinib is approved by Health Canada.

That leaves Ms. Warkus without an effective medicine to control her cancer.

“She needs that drug and I can’t get it,” said Stephen Reingold, a senior medical oncologist at William Osler Health Centre’s Brampton and Etobicoke sites. “… The current process for accessing life-sustaining drugs for cancer patients is flawed.”

Dr. Reingold said a mechanism should be developed to allow patients with limited options and finances like Ms. Warkus to obtain drugs in a timely manner. She has not been able to tolerate other chemotherapies, and lapatinib could help control her disease, he said.

“There must be an expedited process to access these agents as requested by those physicians licensed by the college so the Deborahs in this province do not fall through the cracks,” Dr. Reingold said. “She is progressing unnecessarily; there’s no way she can afford it and you are seeing her cancer go unabated.”

Ontario’s Committee to Evaluate Drugs is studying the combination that GlaxoSmithKline Inc., maker of lapatinib, submitted for review in July, according to Health Ministry spokesman David Jensen.

Until it is approved, Ms. Warkus will not be able to obtain the capecitabine under the Ontario Drug Benefit program’s Exceptional Access Program, which provides prescription drugs at no cost to some patients, including those on disability benefits such as Ms. Warkus.

The former accounting clerk, who lives in Brampton, cannot afford the estimated $800-a-month cost of capecitabine.

Her ex-husband, Georg Warkus, who has been organizing her care, called the situation “frustrating beyond recognition.” Ms. Warkus is receiving radiation treatment to help control the fast-moving cancer.

“This is supposed to be a universal health-care system,” Mr. Warkus said. “Why can’t we get access to it?”

He asked the same question at an oncology appointment earlier this month. At that meeting, Ms. Warkus asked Dr. Reingold how much time she has left: He estimated months to one year.

“My little girl just turned 17; I promised her I wouldn’t die,” Ms. Warkus said in an interview. “It’s a promise I shouldn’t have made because it isn’t under my control.”

Fighting cancer in a bureaucratic Catch-22
The Globe And Maile
Fri Dec 18 2009
Page: L1
Section: Globe Life
Byline: Lisa Priest