June 22, 2012
BOSTON — More than 15,000 life science professionals from around the globe have descended on Boston for the BIO International Convention. The annual gathering showcases the latest advancements in science, from drugs to biofuels to cell therapy. And while the inside remained relatively calm, about a dozen demonstrators gathered outside the convention center on June 19. The protesters wanted the U.S. Food and Drug Administration to speed up the approval process for an experimental cancer treatment known as T-DM1, which they say can save lives.
Looking for effective treatment
In the fall of 2006, Lorraine Heidke-McCartin, 54, was diagnosed with one of the deadliest forms of breast cancer: HER2-positive. The cancer is less responsive to hormone treatment and has a high recurrence rate.
“Right from the beginning I was a Stage 4 patient because the cancer had gone to my liver,” said McCartin.
Immediately she started undergoing treatment, which for the better part of 4 years, kept her cancer to a minimum. But in the spring of 2010, the medicine that had kept her stable stopped working.
“It started to grow again in the liver and I was now up to about seven tumors in my liver,” said McCartin. The lymph nodes in the area were getting enlarged and cutting off my kidney and my bladder."
So she agreed to participate in a clinical trial at Dana-Farber Cancer Institute in Boston. The experimental drug, called T-DM1, is specifically designed to attack cancer cells in HER2-positive patients.
A change in plans
Just as she was to start treatments, the Food and Drug Administration shut down the program at Dana-Farber. But there were still 13 other locations where trials were still going on. The closest one for McCartin was in Fairfax, Va.
“So we started traveling to Virginia in October and I got approved to be in the program. And we travel every 3 weeks to go to Virginia back and forth,” said McCartin.
McCartin said it was a hassle, and expensive — but within months, her tumors were shrinking.
“And in November of 2011 I was told they couldn’t see anything,” said McCartin.
She said her doctors won’t explicitly tell her that she’s in remission, but they haven’t been able to see any cancer over a year. And McCartin said the medication doesn’t have the same debilitating side effects as other treatments.
The next step: blocked
Still, the FDA has denied the application for accelerated approval from Genentech and ImmunoGen, the two companies that make the drug, and instead has sent the companies back to do more clinical trials.
Geoff MacKay is the chairman of the Massachusetts Biotechnology Council. He said the FDA has a tough job trying to measure the risk versus the benefit of any drug.
However, he said, “I don’t know why they didn’t approve this and I think that really needs to be questioned. Anything that has the potential to save lives should go through what is called an ‘expedited review process.'"
He said the process should be made as quick as possible without skirting regulations or lowering the bar. Right now, it can take up to 15 years and hundreds of millions of dollars — sometimes billions of dollars — to bring a new drug to market.
McCartin has been staging demonstrations, protesting what she calls the FDA’s slow approval process. During the week of June 18, she and about two dozen other people protested outside of the BIO International Convention at the Boston Convention and Exhibition Center. She said the FDA is holding up a drug that is saving lives.
“What we’re protesting about or demonstrating about is Stage 4 people who need this drug should be given a chance to try the drug,” said McCartin. “We need something and this might be the drug that works for us.”