He said he always felt he had interferon to fall back on in case temozolomide Temodar failed.
"I never dreamed that access to interferon would ever be an issue in Paula's case, or in anybody else's for that matter," he said.
He said he has two other glioblastoma patients on interferon. Both are stable and, without appeal, their private insurance companies are paying for the drug, minus a $20 monthly co-pay.
Temozolomide (Temador) seemed to work for awhile. She was started on it in March 2008 and by January 2009 she was in remission with no sign of the tumor, he said.
She went off temozolomide, as is recommended after a 12-month standard course. However, in June 2009 the tumor returned and the drug was started again.
This time there was no response, so she went back to Froedtert for a third brain surgery. She also was started on bevacizumab (Avastin), another newer drug that was approved to treat her condition.
Both drugs are expensive - temozolomide, about $2,500 a month, and bevacizumab, about $20,000 a month, Malkin said. But because they were approved, Medicare covered the cost.
Malkin said bevacizumab produced a partial response. But by February of this year the tumor was back.
"Now we have run out of FDA-approved agents," said Malkin.
Malkin is a consultant for Genentech, which makes bevacizumab, and until recently had been a speaker for Genentech and Schering-Oncology, marketers of which makes temozolomide. He said his financial relationship with those companies played no role in his treatment decisions with Oertel.
When he tried to put Oertel back on interferon, it was rejected, he said.
Malkin said he believes it is the only drug that has a chance.
But Medicare won't pay for it.
"We don't get explanations," he said. "We just get 'yes' or 'no.'"
He noted her impressive response and nine-year remission with interferon.
In addition, there is some research suggesting that interferon might be effective in some brain tumor patients. Unlike chemotherapy, he said, the drug seems to work primarily by boosting the immune system's own ability to fight the tumor.
A 2006 study involving 109 glioblastoma patients found that interferon plus conventional radiation showed a trend toward improved survival.
Indeed, there may be a small minority of patients who benefit from the drug, said Dr. Howard Colman of the University of Texas M.D. Anderson Cancer Center in Houston and lead author of the 2006 study, which was published in the International Journal of Radiation Oncology Biology Physics.
"You just don't know how to pick out those patients ahead of time," said Colman.
Colman said there needs to be more lenient rules for patients such as Oertel.
"It is very unfortunate, especially for a patient who is benefiting from a drug," he said. "The system has to figure out what is reasonable."
With tears running down her face, Oertel said she thinks her tumor would shrink if she could get back on interferon.
Malkin said he thinks there is a chance it will work.
"It might not," he said. "But that fact that it worked before is the most powerful lesson that it might work again. This isn't a crap shoot. She at least has a track record with the drug.
"But I'm worried that this thing is starting to grow back while we are being forced to spin our wheels."