Concerns about drugs safety have prompted critics in the Congress and the press to wonder whether the Food and Drug Administration is too financially dependent on the industry it regulates, leading it to approve new medications too quickly. But Frank Burroughs offers a different point of view.
Burroughs' organization has filed a lawsuit against the agency charging that its refusal to allow patients access to investigational drugs after they have exhausted approved treatment options is a violation of their constitutional rights. This summer, a ten-judge panel for the District of Columbia Circuit Court of Appeals is expected to rule on the suit.
The mechanical engineer in Fairfax, Virginia, is the father of Abigail Burroughs, who had developed head and neck cancer while at the University of Virginia, where she was a pre-law honors student. She died after 18 months of chemotherapy and radiation treatments failed to rid her of the disease. She had tried to get access to new drugs in clinical trials her oncologist believed could have saved her life, but she was unsuccessful.
After her death, her father said he was in the throes of what he described as the "worst grief of his life" when he had an epiphany. "I said, 'Why should I quit now?" said Burroughs. "There are other people as precious as Abigail." Ten hours after his daughter died in 2001, Burroughs launched the Abigail Alliance for Better Access to Developmental Drugs to fight for improving the availability of investigational drugs to patients with life-threatening illnesses.
The Journal of Life Sciences' Daniel S. Levine recently spoke to Burroughs about ongoing litigation against the FDA, the resistance he's faced and how the controversy over the safety of drugs approved by the FDA are affecting his efforts. Edited experts follow:
A: The arguments for the three tiers came from the Abigail Alliance not just saying what was wrong, but here's a solution to this problem. What we called that initiative was "tier 1 initial approval." Tier 3 being the regular approval that already exists and tier 2 being accelerated approval that already exists, although we feel it's become decelerated approval. And then the new tier 1 that would dovetail with that would be earlier access for cancer drugs and other drugs for serious life threatening illnesses that show safety and efficacy before they are approved.
Q: That idea was not only put forward in your citizen's petition to the FDA, but also in legislation dubbed "The Access Act." That was introduced in 2005?
A: Yes, but it's in the process of being re-introduced and it's not as stalled as it was. What we're hearing from our volunteers on the Hill—and we don't have a lot up there. Everyone has paying jobs so they do what they can and I do what I can there too. It looks like we are getting bipartisan support, which is good. It's a nonpartisan issue, but it's good to have bipartisan support.
A: The legislation would help facilitate what we are arguing in our lawsuit. It explains how it would be done—the details of how it would be implemented. For example, a patient would have to exhaust FDA-approved options, try to get into a clinical trial and when they couldn't, they would be eligible to get the drug outside of the clinical trial. The other thing that's in the bill is that the patient would do this in consultation with their doctor. It explains how you would deal with efficacious drugs that are in the clinical trial process.
A: Every drug for cancer and other serious life-threatening illnesses that the Abigail alliance has pushed for in our six-year history is now approved by the FDA. Why? There was data on these drugs at various phases of clinical development that showed the efficacy and no known serious side effects. In other words, there's a way to identify these drugs. It's interesting there's not one drug we pushed for earlier access to—and of course it sometimes ends up pushing for approval of—that was rejected by the FDA.
Q: With the high-profile safety cases at the FDA, it seems to me if anything, there's been pressure to slow down the approval of new drugs. What's your take?
A: The Abigail Alliance is not the only one that understands the risk-benefit issue as regards say a cancer drug versus say toe fungus cream. There's a big difference. These people have run out of options. Their only option is death. They can't get into a clinical trial. The drugs show efficacy. I find this really hard to believe that the people at the FDA don't understand that risk-benefit issue. Yes, there is a mindset at the FDA. Yes, the media just blares out any times there's a safety issue, but there's no reason why Dr. von Eschenbach can't get out there and say there's a difference in safety issues, there's a difference in risk benefit, instead of just cowering to this general, though important, issue of safety.
We don't want people's toes falling off with toe fungus cream, but we're talking about cancer patients and others with serious life-threatening illnesses who have run out of options. You have drugs sitting out there that are efficacious with, by the way, no known serious side effects. Whose decision is it anyway? It is no doubt in the mind of the Abigail Alliance and many others that it is a decision between a patient in consultation with their doctor and not the FDA. We strongly support the clinical trial process with the caveat of with improvements. The FDA needs to use more modern scientific tools and more modern statistical tools.
A: It's a tragic problem. You have this ridiculous mindset about safety. It's not just the FDA. It's Congress and it's the media to some extent that when anybody is discussing the issue of safety, they don't discuss the risk-benefit issue and they don't explain the difference in the situation and diseases of patients. It's not that hard to do.
A: After over two years of many, many meetings with the FDA including up to the associate commissioner and commissioner level and also filing an citizen's petition regarding our ideas, on July 28, 2003 we filed a lawsuit against the FDA with the pro bono help of the Washington Legal Foundation. The Abigail Alliance also now has the pro bono help of the law firm of Latham & Watkins. We lost the first round in district court. The judge felt we hadn't exhausted administrative avenues, which we were able later to clarify in our appeal and the appellate court agreed to hear our appeal. If we win that would be huge. If we lost, it would not be over by any means. We of course want to win for the patients we are representing and will continue to represent. [Following this interview, the Abigail Alliance said the first court dismissed its case because it had not cited precedent directly on point. It said it was unable to do so because its case was novel.]
A: The issue is people have a right to fight for their lives when there is a means right there for people to fight for their lives.
Q: You are expecting a decision this summer.
A: Our attorneys and some other people in the legal arena are saying more than likely we will have a decision by the end of the summer. That's not an absolute. Either way this case will go before the Supreme Court. We hope and we think that the Supreme Court would hear the case because it's become more and more in the public consciousness and its more and more in the media. We feel, and others are feeling that way too, that it's a landmark case and it's an important civil rights case. We doubt very highly that the FDA would give up if we were to win in the appellate court.