Posted by Michael Sola on August 12th, 2007
By Robert Erwin
Robert Erwin, founder of the Marti Nelson Cancer Foundation, is a member of the Board of Directors for C3: Colorectal Cancer Coalition. His first wife, Marti Nelson, M.D., died of breast cancer in 1994 after unsuccessful attempts to obtain access to the experimental drug now known as Herceptin.
Fifteen years ago, patients diagnosed with metastatic colorectal cancer lived an average of nine months after diagnosis. Today, the average is approximately two years – and that number is increasing. This was accomplished through well controlled and rigorously conducted clinical trials. Randomized clinical trials are the only way to truly tell if a particular drug or treatment works.
In 2003, the Abigail Alliance for Better Access to Developmental Drugs, a patient advocacy group, filed a lawsuit against the Food and Drug Administration, seeking to establish a Constitutional right for terminally ill patients to obtain experimental drugs that have passed only limited safety testing but have not been proven safe and effective.
On August 7, 2007, the U.S. Court of Appeals for the District of Columbia Circuit ruled against the Abigail Alliance and the Washington Legal Foundation, stating that terminally ill patients do not have a Constitutional right to experimental drugs.
Articles detailing this case can be found here:
C3 supports the Court’s ruling. We believe that it is vitally important to look past the emotion surrounding this case and do what is right for cancer patients – which is to support science, reason and evidence in the practice of medicine.
Additionally, C3 disagrees with the dissenting opinion of Judge Judith W. Rogers who sought to portray the issue before the Court as “the right to try to save one’s life.” Rather, we believe the Court correctly prevented the creation of a Constitutional right to profit from the marketing of unproven and potentially dangerous products to seriously ill people. We applaud the Court’s wisdom in ruling to sustain a functional regulatory system that keeps potentially toxic drugs off the market and out of the clinic.
Many of us at C3 have faced, or are currently facing, a terminal illness, either personally or through a close family member. We understand the desire to do all that can be done to save or prolong a life. However, we remain committed to the belief that reason must guide us beyond the emotional arguments that have characterized much of this debate to examine some of the realities of cancer and the development of drugs to treat cancer.
For those new to this issue, it is important to understand the five stages to drug study, as illustrated at the bottom of the this page here on C3′s site.
A recent Journal of Clinical Oncology article found that of 266 randomized Phase II cancer clinical trials conducted between 1986 and 2002, only 14 percent recommended or started Phase III studies. This unfortunate failure rate is not because of the lack of good science or poor trial design. It is simply because cancer drug development is complicated.
As we all know too well, cancer is tenacious. The fact of the matter is, even with the many advances in newer drugs and biologic agents, there still is no cure.
Hope for miracles forms the basis of much of the popular support for the position of the Abigail Alliance. Unfortunately, there are far too many money-motivated people willing to exploit this hope with offers of empty promises at high prices.
Effective cancer drug development is hard, slow work and seldom yields miracles. Most advances in treatment have been incremental and generally ineffective in reversing the inevitable course of terminal disease.
Still, progress is being made in the development of new drugs and biologic agents. The worst thing that could be done for cancer patients now would be to lower the standards for approval and create a system that produces profits without performance and replaces medical evidence with hope and faith.
Frequently overlooked or dismissed in this debate is the fact that the FDA has proposed rules for providing seriously ill patients with access to experimental drugs. These rules:
- Do not allow commercial marketing of unapproved drugs;
- Provide a mechanism for companies to recover the actual cost of supplying a patient with experimental drugs; and
- Reduce financial barriers to patients seeking access to experimental drugs before they are approved for marketing.
While seldom used, properly designed expanded access protocols do not interfere with enrollment in clinical trials and can be administered relatively easily by companies who value compassion. The sad fact is, even in these cases, many sick patients do not receive the clinical benefit they need.
C3 will work with the FDA and industry to strengthen expanded access programs and efforts to increase awareness that such programs exist and are waiting to be utilized.
