Topic of Cancer

South San Francisco biotech firm Genentech just says no to women battling breast cancer

Judith Fried, 31, speaks with a certain exhausted urgency. The cancer has taken a large toll.

Her diagnosis -- a malignant lump in her breast -- came three years ago, when she lived in New York City. The lumpectomy, the chemo, the radiation didn't make a dent: Her cancer quickly spread to her lungs, spleen, and liver. But there was one thing that did seem to help: HER-2/neu monoclonal antibody, an experimental drug currently being developed by Genentech, the biotech company in South San Francisco.

As reported in the Aug. 16 issue of SF Weekly ("As They Lay Dying"), a number of Bay Area women have been struggling, unsuccessfully, to convince Genentech to give access to HER-2/neu, which is not yet approved by the Food and Drug Administration (FDA). Fried counted herself as lucky: She was able to receive the high-tech substance when she gained entry to a Phase 2 clinical trial in San Francisco. It was, as it so often is, a difficult feat -- a feat made even more trying when a hospital lab lost the tumor sample she was required to give. The lab didn't find it until the clinical trial was already full. Fried complained vociferously.

"And Genentech agreed to let me in," Fried says, from the Castro Street apartment where she now lives with her sister. The results were worth the aggravation.

When Fried started taking HER-2/neu -- a genetically engineered substance that helps control certain malignancies -- an estimated 10 to 25 percent of her liver was filled with tumors. By trial's end, Fried says, "the cancer had shrunk to the point where it was not visible by CAT scan."

Another benefit: HER-2/neu didn't induce the sickness, hair loss, and body-wracking side effects of chemotherapy.

Which is why Fried and other women -- two of whom died while waiting for the drug -- are demanding that Genentech dispense the HER-2/neu on an individual, compassionate-use basis, something that a number of drug companies do for AIDS patients (a step taken only after years of lobbying by AIDS activists).

Fried and her sister, Elise, have called Genentech and told officials they understand the risks involved. They've agreed not to file suit should the drug do harm or fail to help. Fried's doctor has requested the drug from Genentech on her behalf (request denied). And Fried, meanwhile, was buoyed by an announcement from the company last month -- following nearly a year of protests by breast cancer activists from ACT UP/Golden Gate and other groups -- that it would indeed start dispensing the drug on an experimental basis, in what's called an "expanded access program."

What the company didn't mention was its target date: early 1996.
"They've told me nothing can be done," Fried says. "They've told me they'll put my name on a list and get back to me in December."

Elise Fried has tried to argue that her sister, at the very least, deserves a maintenance dose -- particularly if one considers the language of the Phase 2 trial she attended at Mount Zion Hospital. "Patients having a minor, partial, or complete response at Day 70" -- which Judith Fried had -- "may be continued on maintenance therapy," the description reads.

Genentech officials and researchers, both Frieds say, have interpreted the language to their own benefit. Though Judith Fried's liver tumors subsided while on HER-2/neu, her other malignancies kept growing, which researchers interpreted as "disease progression." People with disease progression are not eligible for maintenance therapy, officials told Fried. And they kicked her out.

Since stopping HER-2/neu, her liver has swelled with even more tumors than before she started.

Such news enrages activists like Marilyn McGregor, chief of the HER-2/neu negotiating team for ACT UP/Golden Gate.

"It makes sense that it's going to take time for Genentech to set up their expanded access program," McGregor says. "But we think there can be individual compassionate access before the large-scale program is set up, for people who are nearly at death's door."

To that effect, McGregor wrote Genentech in late June, asking -- as she had before -- that the company offer "compassionate drug access on an individual case-by-case basis."

Genentech will be meeting this week with McGregor and other breast cancer activists to discuss this and other matters, McGregor says.

In the meantime, Fried is relying on chemotherapy. A bone tumor, which had stopped growing during the HER-2/neu study, has started to flare. Her liver cancer, which subsided on HER-2/neu, has now accelerated to the point where it disqualifies her from other experimental studies, she says.

"I'm not sure I'll make it to December," Fried says. Genentech is aware of this, she adds. "They don't care. They don't care."

Genentech also denied compassionate use of HER-2/neu to Marti Nelson, 40, a physician, who died Nov. 9, 1994. (As with Fried, one of Nelson's most critical lab reports somehow fell through the cracks: It took three months, says Nelson's husband, for Genentech to notify Nelson that her cancer might respond to HER-2/neu. She died the next day.) Evelyn Moulton, 51, a teacher and Ph.D. psychologist, died Aug. 2. Both women had been dedicated activists who sought better treatment options for all those in need.

1
 
2
 
All
 
Next Page »
 
My Voice Nation Help
0 comments
Sort: Newest | Oldest
 
©2014 SF Weekly, LP, All rights reserved.
Loading...