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The Abigail Alliance

September 2007

By Sue Kovach

Founded in November 2001 after the tragic cancer death of its young namesake, Abigail Kathleen Burroughs, the Abigail Alliance is working for FDA regulatory changes that would allow patients with cancer and other life-threatening illnesses—and no other treatment options—to have access to promising investigational drugs.

The Abigail Alliance is seeking to have legislation passed that will remove the regulatory barriers currently preventing seriously ill patients from gaining early access to developmental drugs showing efficacy in clinical trials. The Alliance also aims to modernize the FDA’s antiquated scientific approval process for drugs intended to treat life-threatening diseases, and seeks to place the decision to use experimental treatment options with patients and their physicians, rather than the FDA.

Abigail Burroughs: Inspiring Change

Abigail Kathleen Burroughs was only 21 years old when she succumbed to squamous cell carcinoma that had invaded her neck and lungs. Her cancer diagnosis at age 19 was a tremendous shock, as the type of cancer she had is particularly rare in one so young. Typically, older men who smoked and drank for decades receive this devastating diagnosis. Abigail was an honor student and high school athlete, a confident yet humble person who was wise beyond her years, according to her family and friends. And she was compassionate, devoting much of her young life to charity work, making beds at homeless shelters and creating a free tutoring program for 50 families who couldn’t afford tutors. Abigail had a great love of life and a deep respect for all beings.

Not long after her diagnosis, the Burroughs family learned of an investigational cancer drug, Erbitux®, that showed good response in early trials. Abigail’s prominent oncologist at Johns Hopkins Hospital believed the drug had a significant chance of saving her life. But every effort on the part of her family, physician, and supporters to procure the drug for Abigail failed. She was ineligible for a clinical trial and the drug company couldn’t provide her with Erbitux® for compassionate use. The FDA was unmoved by her life-and-death situation.

In November 2000, Abigail was recovering from a round of chemotherapy and radiation treatment when she said to father, Frank: “Dad, if I make it, I’d like you and I to devote our lives to helping people with cancer and other illnesses where there’s an unmet need.” After seven months of battling to acquire Erbitux® for Abigail, she died, her young life tragically cut short by an indifferent system that has cost an untold number of lives.

Hours after she died, through his tremendous grief, Frank Burroughs realized that the inability of seriously ill patients to obtain effective drugs still under study was a critical unmet need. His daughter had wanted to help not only herself, but others like her, and Burroughs knew then that he had to continue fighting the system.

Burroughs explained, “Hundreds of thousands of Americans die every year awaiting drug approval, a catastrophe of immense proportions. I said to myself, ‘Why should I quit now? There are other people out there who are just as precious as Abigail.’ She had planted the seed of an idea. She was the embodiment of the unmet need. But we certainly weren’t the only ones.”

The Abigail Alliance: What You Need to Know
    • Under the FDA’s outdated system of drug approval, it can take years before beneficial drugs become available to seriously ill people. Every year, hundreds of thousands of patients with cancer and lifethreatening illnesses die while waiting for promising investigational drugs to receive approval.

    • Abigail Burroughs was a young cancer victim who perished because she was not able to access an experimental cancer drug. After Abigail’s death, her father Frank Burroughs formed the Abigail Alliance.

    • The mission of the Abigail Alliance is to make potentially life-saving investigational therapies readily available to patients with cancer and other life-threatening illnesses.

    • One of the key objectives of the Abigail Alliance is to pass a bill that would allow seriously ill individuals to gain early access to promising investigational drugs that have not yet been approved by the FDA.

    • The Alliance’s other objectives include helping cancer patients to gain better access to experimental therapies such as Erbitux® and Nexavar®, promoting better awareness of clinical trials, and supporting efforts that would eliminate the use of placebos in clinical trials.

After his daughter’s death, Frank Burroughs formed a non-profit advocacy group, the Abigail Alliance for Better Access to Developmental Drugs. He gathered volunteers and supporters to raise awareness on Capitol Hill and in the general public of the issues surrounding compassionate use of developmental drugs, and to push for change in the FDA system that denies seriously ill patients access to possibly life-saving therapies.

In its short six years of existence, the Alliance has gained favorable media coverage for these issues and has presented the heartbreaking stories of the patients behind them. With the help of the Washington Legal Foundation, the Alliance has shown that it won’t be ignored by filing a Citizen Petition and even taking the FDA to court. Its practical solutions to fix a flawed and deadly system are contained in the proposed legislation, which could save countless lives.

Drug Approval System Fails Patients in Need

The problems inherent in the FDA clinical trial and drug approval system can be fully illustrated by looking at how it failed Abigail Burroughs and others, such as Jennifer McNellie, wife of Abigail Alliance co-founder Steve Walker. Jennifer was diagnosed with colon cancer at age 45 and ran out of treatment options after her first regimen. The couple, both scientists, did their own research and learned about several drugs under study that were found to be effective in trials. But they, too, discovered that the drugs were beyond their reach and that approvals could be years away. Jennifer McNellie died at age 47, another victim of the clinical trial system.

Says Steve Walker: “I delved into the regulations, trying to figure out why the system wasn’t working. As scientists, Jennifer and I both understood how the trials were being conducted. It didn’t take us long to determine that the FDA is an ineffective agency. I lobbied senators and representatives, and I lobbied the FDA, which was completely non-responsive.”

The FDA’s drug study and approval system is meant to protect patients, certainly, but shouldn’t it also reap the benefits of billions of research dollars and years of drug development and testing by bringing medical progress to those who need it most? No seriously ill person should have to die merely because the FDA stamp of approval on a drug is years away. Yet that’s exactly what is happening. The reason it’s happening was a shock to Burroughs, Walker, and Abigail Alliance supporters.

Legislation that the Abigail Alliance seeks to pass will:
  • Allow seriously ill patients who have exhausted all other treatment options to receive developmental drugs outside of clinical trials. The drug company would provide the drug and control this process, and the medications could be provided as early as completion of Phase I trials, but only if there is compelling evidence for efficacy.

  • Protect clinical trials by requiring patients to have exhausted approved treatment options for their disease, including clinical trials and expanded use programs, before acquiring a developmental drug under the Tier 1 Approval Program.

  • Ban the use of placebo and no-treatment arms in trials involving seriously ill patients.

  • Return some risk-benefit decisions to patients and their physicians, eliminating current law and policy that places risk-benefit decisions solely with the FDA.

  • Remove cost disincentives that prevent small biotech firms who develop most innovative investigational drugs from participating in expanded use programs.