Ruling may impact FDA’s authority
2/19/2007 Springfield, MA Robert Cohen The Republican (www.masslive.com) Abigail Burroughs fought head and neck cancer for 18 months, desperately seeking access to promising experimental drugs after chemotherapy and radiation therapy failed. She was unable to get into a clinical trial for ImClone's now widely available Erbitux, because it was for colon cancer patients only, and she failed to meet the clinical trial inclusion criteria for Iressa, an AstraZeneca cancer drug that later proved largely unsuccessful. At the end of May 2001, Burroughs was finally accepted into a clinical trial for OSI Pharmaceutical's subsequently approved cancer drug Tarceva, but she was too ill to travel from Virginia to the Texas testing site. She died two weeks later at age 21. "It was a horrible, horrible nightmare. When your child is terminally ill, you want to do everything you can," said her father, Frank Burroughs of Fredericksburg, Va. "People just want a chance to live when they are facing death." Burroughs soon formed the Abigail Alliance, an organization dedicated to helping cancer patients and others with life-threatening illnesses break down barriers imposed by the Food and Drug Administration and the pharmaceutical industry to obtaining potentially helpful experimental drugs outside the clinical trial setting. His relentless campaign has resulted in a court ruling that threatens to shake the foundations of the FDA's regulatory authority covering pharmaceuticals and lead to greatly expanded use of unapproved medications that haven't been fully tested for safety or effectiveness. The legal battle, ironically, comes as medical experts, members [...]