Headliner: Frank Burroughs of Abigail's Alliance
Burroughs, a gnat in the agency's ears for the past six years, isn't giving up. He has vowed to take Abigail Alliance's case to the Supreme Court, if they'll hear it, and to keep pressing Congress to pass the ACCESS Act, which would grant patients who can't get into clinical trials access to promising developmental drugs such as Provenge.
“We were dumbfounded by the decision,” says Burroughs, whose Abigail Alliance partnered with the Washington Legal Foundation on the case. Their attorneys—from the WLF and Scott Ballenger of Latham & Watkins—had been expecting a closer ruling, he said.
In his majority opinion, DC circuit court judge Thomas Griffith wrote: “Recognizing a right of self-defense cannot justify creating a constitutional right to assume any level of risk without regard to the scientific and medical judgment expressed through the clinical testing process.”
Burroughs says the court failed to take into consideration the circumstances of the patients his group represents, who are certain to die without experimental drugs, or Abigail Alliance's track record for spotting breakthrough treatments long before they're approved. The group has agitated for early access to Eloxatin, Revlimid, Velcade, Alimta, Tykerb, Tarceva, Bexxar, Nexavar, Sutent, Iressa and Erbitux, which Burroughs believes could have prolonged the life of his daughter Abigail, the group's namesake.
“The reason we have this 1,000 batting average is because the doctors and patients we hear from are seeing the data on these therapies. These aren't unknown drugs—they're known for their safety and efficacy, but the FDA is playing doctor.”
Abigail was a 21-year-old honors pre-law student at University of Virginia when she died of head and neck cancer in June 2001. Months before her death, her oncologist at Johns Hopkins told the family that, due to the high EGFR expression of her cells, her only hope was Erbitux. ImClone Systems had just completed Phase I clinical trials, “but because of the economics, ImClone had to go after the larger market, for colon cancer, and leave the head and neck patients behind,” Burroughs says bitterly. “She had the right kind of cells in the wrong part of the body.” It would be four years before the drug was approved for head and neck cancer.
He and Abigail had started a 501c3 group to lobby ImClone, AstraZeneca and Congress for expanded access to Erbitux and Iressa. They won some high-profile coverage and made friends in Congress, but it was too late for Abigail. Ten hours after she passed, Burroughs had an epiphany. “I got this shot of strength and said, ‘Why should I quit now? There's other people out there as precious as Abigail.'” A mechanical engineer by trade who had majored in broadcast journalism in college, he launched a second career in advocacy.
Relying on a small team of volunteers, Abigail Alliance has since counseled several thousand patients on getting into—and around—clinical trials for experimental drugs. It's also made some powerful allies—notably, WLF and The Wall Street Journal Op/Ed page, which has made Burrough's cause its own. Burroughs' latest picks are Dendreon's prostate cancer vaccine Provenge and Genta Corp.'s Genasense for advanced melanoma. Recently the group held a demonstration with prostate cancer patients and their families in front of FDA headquarters to protest the approvable letter on Provenge, which Burroughs says has brought a boomlet of interest in the group from the patient and medical communities. “There are a lot of prostate cancer patients out there,” he says. “We're not talking about a toe fungus cream. We're talking about people fighting for their lives.”
Founder & president, Abigail's Alliance
Founder and president, Abigail's Alliance
Manager, mechanical design, Atlantic Research Corp.
Design engineer, TRW