Federal Court Approves Experimental Drugs for Dying Patients

A Federal appeals court ruled on 5-2-06 that terminally ill patients have a constitutional right to obtain experimental drugs before the Food and Drug Administration has approved them.

The court stated that dying patients have a basic “right of self-preservation,” and held that drugs that have passed the safety phase of FDA review should be made available if they might save someone’s life.

The 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturned a lower court’s ruling. The judges sent the case back to the district court for a new hearing.

The case was brought by the Abigail Alliance for Better Access to Developmental Drugs. The Abigail Alliance advocates making experimental drugs available to dying patients. It was argued on their behalf by the Washington Legal Foundation, a public interest law firm. Richard Samp is the lawyer currently handling it for the firm.

The appeals court held that “barring a terminally ill patient from the use of a potentially life saving treatment impinges on this right of self-preservation.” It also agreed with the alliance that the Supreme Court’s 1990 decision establishing a “right to die” in the case of Nancy Cruzan, a brain-dead Missouri woman applied in reverse in this case.

Judge Judith W. Rogers wrote  “If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded ‘life,’ “

The ruling was opposed by Judge Thomas B. Griffith who said that the decision goes against the “expressed rule” of Congress and the president and that the majority’s approach injects courts into unknown questions of science and medicine.

 The Abigail Alliance was founded in 2001 by Frank Burroughs, whose 21-year-old daughter died of cancer. The family had tried to enroll her in a number of clinical trials of promising cancer medications but their requests for help to save her life were rejected.  Burroughs continued his fight to expand access to experimental drugs after his daughters’ death.

After the courts decision Burroughs said that he hopes the FDA will work with his group and others to make unapproved drugs more easily available to dying patients. It has yet to do so.

The alliance has sought access to medications that have passed Phase I of the FDA review, which  results in a determination of whether the drug is safe enough for further human testing. Phase II trials determine whether a drug is effective and Phase III studies involve larger groups and determines whether a drug is safe and useful and suitable for approval.

Comments from the Cancer Cure Coalition

The Cancer Cure Coalition supports the Abigail Alliance in its seeking access to experimental drugs for critically ill patients.  Read more about the Abigail Alliance and the Capitol Hill testimony of its founder Frank Burroughs, a very moving story about the death of his daughter.

The principles set forth in the American Declaration of Independence are supportive of the Abigail Alliance’s cause, it states:

“We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights that among these are Life, Liberty and the pursuit of Happiness.

  That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed, 

  That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety and Happiness.”

We believe that the FDA, in denying the right of people with life threatening illnesses to treatments that might save their life, is destructive of those very principles on which the United States of America was founded. The prohibiting of life saving treatments denies the right to “Life, Liberty and the pursuit of Happiness.” and we believe these rights are fundamental to all mankind.

As the Declaration of Independence states it is the right of the people to make such change as “shall seem most likely to effect their Safety and Happiness.”

We agree with the decision of the US Court of Appeals that “barring a terminally ill patient from the use of a potentially life saving treatment impinges on this right of self-preservation”

We renew our mission statement which calls “for faster government review and approval of new and better treatments for cancer” and we believe that this policy should be applicable to other illnesses as well. We join with the Abigail Alliance in seeking reform of the United States Governments treatment access policy and we are asking other health foundations to join us in this cause.

FDA Review a project of the Independent Institute has on its site www.fdareview.org a scholarly article by distinguished economists Daniel B. Klein, Ph.D. and Alexander Tabarrok, Ph.D. which examines in depth the FDA’s faulty policies and its administrative failures. See their impressive biographies on the FDA site. The article proposes life saving reform options designed to improve the FDA’s policies. We believe the proposals set forth in this article deserve serious consideration.

The FDA’s current policies are preventing important new products from reaching critically ill patients. Theses policies have caused huge increases in medical costs by the enormous cost of the clinical trials required by the FDA. These trials now cost an average of over $800 million to get a new drug approved. The cost is large even for those drugs which do not receive approval. Many drugs which might be useful do not make it past the clinical trials because of the large cost for completion and approval.

In addition, surveys of medical doctors have shown that most believe the FDA’s policies are impeding their ability to treat patients. Because of the power of the FDA most people who deal with it feel unable to make complaints or even suggestions for improvement for fear of retribution.

The health and financial well being of America is being harmed by the FDA’s policies. We believe that these policies have resulted in hundreds of thousands of deaths and an untold amount of suffering. CHANGE IN THESE POLICIES IS NEEDED!

Charles A. Reinwald

President of the Cancer Cure Coalition