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John Fish has prostate cancer. Since 1999, the retired engineer has been through all the approved treatments, from radiation to chemotherapy to hormone therapy, but the cancer has spread to his bones. An Ohio resident and by extension an enthusiastic Cleveland Browns fan, Fish, with the urging of his doctor, wanted to try a new immunotherapy vaccine called Provenge, which has been through all three phases of clinical trials and shows remarkable promise as a cancer fighter. But Fish can’t get the drug. Its maker, Dendreon, still hasn’t received the go-ahead from the Food and Drug Administration, which cites the need for further testing even though the agency’s own panel recommended approval in March. “There are going to be a bunch of us who are just going to kick the bucket,” he says, referring to other cancer patients. He hopes for a change in the current system, “for us guys who would like to live a little longer.” One patients’ rights group, the Abigail Alliance for Better Access to Developmental Drugs, is pushing for this kind of change. The group advocates for patients with terminal illnesses and argues that for those who have run out of approved options, drugs still under development ought to be available. Under current regulations, the FDA denies access to drugs until they pass at least three clinical trials proving safety and efficacy, a process that can take seven or eight years. The FDA does have an “expanded use” system in place for patients who have exhausted approved options. If a patient can’t get into a clinical trial due to space or eligibility, then drug manufacturers can allow patients to use their products while the manufacturers recoup some of their costs. However, the drug manufacturers are not allowed to make a profit or include in the drug’s price the cost of research and development, making expanded use programs an economic impossibility for many small startups. The Abigail Alliance, which was founded in 2001 by Frank Burroughs and his daughter, Abigail, is seeking a faster process for terminally ill patients and more incentives for drug companies to provide developmental drugs. The cause stems from personal experience. In 1999, Abigail, a University of Virginia student, found out she had head and neck cancer. She died in 2001 at age 21 after being denied access to a clinical trial for a cancer drug called Erbitux. “This is a difficult issue because, on the one hand, you have very ill patients who have a desire to have drugs with the hope that they will do some good,” says William Schultz, an attorney with Zuckerman Spaeder who represents several groups that support the FDA’s position. “On the other side, you have patients and future patients and the health care system in the United States.” The Abigail Alliance has taken its case to the courts. In 2003, the group, which initially was represented only by attorneys from the Washington Legal Foundation, filed suit against the FDA in U.S. District Court for the District of Columbia, arguing that patients had a fundamental right of access to developmental drugs. They lost. The Abigail Alliance, with the help of attorneys from Latham & Watkins who handled the work pro bono, appealed the decision in summer 2005. They received a favorable ruling from a three-judge panel, but that win was overruled by the full U.S. Court of Appeals for the D.C. Circuit last month. So the group is taking the case to the Supreme Court. J. Scott Ballenger, an appellate lawyer at Latham, plans to file the petition this month, and he, along with third-year associate Allyson Maltas and others, have put in about 1,900 hours on the case since taking it in 2005. Ballenger’s office is on the seventh floor of Latham & Watkins’ D.C. building, which is under renovation. A bobble head of Supreme Court Justice Antonin Scalia, whom Ballenger clerked for, perches on his desk next to coffee cups, stacks of paper, and two seascape paperweights. The sound of hammering and the electric whir of power tools mixes with his arguments on case law, substantive due process, and privacy. “A patient’s right to decide for themselves is a matter of basic human dignity,” Ballenger says. “All we are really fighting about at this point in the case is that these are fundamental rights.” Ballenger argues that other rights protected under the Constitution — such as the right for parents to home-school their children, the right to use contraception, and the right to refuse medical care — provide the backbone for his case. “It’s an individual freedom case,” he says. “I just find it shocking that in this country any government official would presume to intervene between a patient and their doctor in providing end-of-life care.” And fundamentally, he says, it’s about self-defense in a medical context, meaning that people have the constitutional right to defend themselves and that cancer is just as much of an intruder as a thief breaking and entering. But as with any issue this emotionally charged, others do not agree. “We believe that the goals of the Abigail Alliance can be met by expanding or using the existing expanded access programs,” says Dr. Nancy Davidson, president of the American Society of Clinical Oncology. “Part of what we’re charged with doing is making sure that we look carefully at the risk-benefit ratio.” Safety and maintaining a strong, scientifically sound testing system are enormous concerns, as is the exploitation of very sick people by drug companies that might be tempted to sell hope instead of viable and effective remedies. “The real issue here is whether or not somebody will be licensed by the FDA to sell a product for a profit when that product has not been tested to show a beneficial effect for anything,” says William Vodra, a health care attorney at Arnold & Porter who formerly worked as associate chief counsel for drugs at the FDA. “I accept the fact that some people will die, but it’s better than people being exploited.” And Zuckerman Spaeder’s Schultz, who filed an amicus brief in support of the FDA’s stance, says the current system of expanded use tries to accommodate people with late-stage illnesses. But in the end, it’s up to the drug companies to provide the treatments. “I think FDA has gone very far in working with companies so that these drugs can be available to those people.” Ray Matyshyn was diagnosed with prostate cancer in 1995. Matyshyn is also an Ohioan with a love of the football Browns, even though they consistently fail to post a winning season, and like Fish, he has been through all of the approved treatments for prostate cancer. Matyshyn was, however, able to get into a clinical trial for Provenge, and he found out two weeks ago that he did receive the drug in a double-blind test. He admits that he isn’t as passionate about this issue as others are. He says that he is not a politician. But he believes strongly that people should have access to medication. “I don’t pretend to understand all the pros and cons of either side of this thing,” Matyshyn says. But he adds, Provenge “has bought me time, and time is very important to a person in my situation.”
Attila Berry can be contacted at [email protected].

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