Man fights FDA's slow road to drug approval

ST. PETERSBURG — In his work as a geologist, Steven Walker cleans up environmental messes. In his spare time, the St. Petersburg resident tries to bulldoze a path for dying patients through the Food and Drug Administration.

While the FDA has been widely criticized for not doing enough to protect the public, Walker and the group he helped launch say the agency goes too far in the name of safety when it comes to the terminally ill.

For the past seven years, the Abigail Alliance has been pushing the FDA to allow seriously ill patients with no other options access to promising drugs still in the approval pipeline. The alliance is named after co-founder Frank Burroughs' daughter, who died of head and neck cancer at age 21 in 2001.

"With cancer patients, the disease is far more dangerous than a promising drug," said Walker, 54, whose wife, Jennifer McNeillie, died of colon cancer. "You can't tell them to wait for something. It's gotta be now."

FDA officials say expanding access would pave the way for the sale of unproven therapies to desperate people. Richard Klein, an FDA medical officer, said dying patients often argue they should be able to gamble on an experimental drug. "But the FDA is responsible for the public's health, and we can't change the whole paradigm of how a drug is approved so an individual can take a gamble," he said.

Walker, who can barely disguise his contempt for what he calls the FDA's "culture of incompetence," rails against the slow-moving drug testing system where the effectiveness of a cancer drug is measured by how many patients die, not the quality of life. He thinks it's inhumane that trial subjects can receive placebos, rather than potentially effective drugs, in the name of research. And don't try to tell Walker that giving dying patients unproven treatments will just raise false hopes.

"Why is it that taking an investigational drug inside a clinical trial is noble, but taking it outside represents false hope?" snapped Walker, who has written a half-dozen pieces in the Wall Street Journal supporting the alliance's efforts. "It's inane."

Walker's criticism of the FDA was echoed by the agency's subcommittee on science and technology, which said the outdated evaluation system puts lives at risk. "Today, not only can the agency not lead, it cannot even keep up with the advances in science," the panel said in November.

The system's failings became real for Walker and McNeillie when they began searching for treatment options after she was diagnosed in late 2000. The couple, both scientists and graduates of the University of South Florida, were married for 20 years. Walker is founder of Terra Environmental Services in Tampa.

"Like most people, we assumed that since the war on cancer is so important, we must be doing it reasonably well," Walker said.

Trials of Genentech's promising drug Avastin were full, putting it out of reach. McNeillie got into a study of ImClone's Erbitux and showed remarkable improvement. But when a new tumor developed, she was dropped from the trial. She died less than three months later, in June 2003.

Both Avastin and Erbitux, now best-selling cancer drugs, were approved by the FDA in 2004. The alliance has pushed for early access to 14 other cancer-fighting drugs. All eventually received FDA approval, but for most of the alliance's members it was too late.

"It's not my wife's death anymore that's making me passionate," said Walker, who said he pays his own expenses and receives no drug company funding for his alliance work. "I've accepted it and moved on. But things have actually gotten worse over the past five years. Despite the FDA's talk of modernizing trials, virtually nothing is happening where the rubber hits the road."

The alliance's first attempt at legislation died in Congress in 2006. In January, the Supreme Court refused to hear the group's appeal of a lower court's rejection of its lawsuit against the FDA. In May, a bipartisan group of lawmakers reintroduced the alliance's bill calling for "compassionate access."

The major association of cancer doctors and the largest patient advocacy group have lined up against the alliance. The American Society of Clinical Oncology and the National Coalition for Cancer Survivorship said short-circuiting the research process would pose a risk to patients and threaten the clinical trial system. Since 95 percent of cancer drugs fail to make it through the clinical trial process, they said, such last-ditch efforts would be worthless.

Dr. Dan Sullivan, a researcher at Tampa's H. Lee Moffitt Cancer Center, said it's dangerous to give drugs based on preliminary results of multiyear trials. "Giving these drugs too early could hasten patients' deaths," he said.

People like Greg Luter of Jacksonville see it differently. Luter, 41, was diagnosed in March with stage four prostate cancer. He's receiving standard therapies, but has been warned those treatments will lose effectiveness over time. So Luter, a self-employed photographer, is fighting for access to two promising prostate cancer drugs still in trials.

"You would assume the FDA's goal would be looking out for patients and making it easier for them to get drugs," Luter said. "That's not the case."

Most terminal patients are too busy battling their diseases to fight the FDA, Walker said. "We're dealing with a population where there's 1,500 in and 1,500 out, every day," Walker said, referring to the average daily rate of diagnoses and deaths from cancer. But he is undeterred. "Cancer is a tough way to die. I witnessed it."

Kris Hundley can be reached at hundley@sptimes.com or (727) 892-2996.

>>FAST FACTS

Abigail Alliance

Headquarters: Fredericksburg, Va.

Founders: Frank Burroughs and Steven Walker

2007 funding: $46,000, including $5,000 from an unnamed drug company

Facts: Named after Burroughs' daughter Abigail, who died in 2001 of head and neck cancer

Proposed law

How the Compassionate Access Act would work:

Patients with terminal illnesses who have run out of approved options and are not eligible for clinical trials would have access, through their doctor, to investigational drugs as early as the end of phase 1 studies. The FDA would have to approve such access, and patients would have to waive their ability to sue and provide data on their experience with the drug.

Man fights FDA's slow road to drug approval 07/06/08 [Last modified: Monday, July 7, 2008 5:41pm]

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