Last Tuesday, a U.S. appeals court ruled that terminally ill patients do not have a constitutional right to experimental drugs that are not approved by the FDA. Advocacy groups were seeking access to unapproved medicines that have cleared early safety tests. Early safety tests usually include 20 to 80 people."The FDA's policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects," Judge Thomas Griffith wrote in Tuesday's majority opinion.
The Abigail Alliance, one of the groups fighting for such access, was founded by Frank Burroughs to advocate for the right of the terminally ill to access experimental drugs that have cleared early safety tests.
In 2001, according to the Abigail Alliance Website, Abigail Burroughs, age 21, had run out of conventional options in her squamous cell carcinoma cancer battle. Her oncologist urged her to try to get the EGFR targeted drug C225 (Erbitux) from Imclone or Iressa from Astra Zeneca. Her oncologist felt that this was her best hope as her cancer cells had a very high EGFR expression. Abigail worked together with her parents to lobby the pharmaceutical companies and Congress but were unsuccessful.
The Abigail Alliance and the Washington Legal Foundation say they plan to appeal the latest ruling to the Supreme Court.
