Steven Zecola Files a Citizen's Petition with the FDA for a New Approach to Address Metastatic Cancer

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Petitioner requests the FDA to establish a Center for Metastatic Cancer and to adopt a two-phase process for the clinical trials of compounds targeted at metastatic cancer.

Cancer causes over 550,000 deaths in the United States each year 1_/, and 90% of those deaths derive from metastatic cancer. 2_/ Yet, only 8% of the federal funding for cancer goes toward metastatic cancer. 3_/

Additionally, under the FDA’s procedures for clinical trials, a new drug takes 12 years on average to make it through the FDA process 4_/ at an average cost of over $1 billion. 5_/

The burden imposed by the FDA’s rules is even greater for the compounds designed to treat metastatic cancer. First, the FDA’s rules require the compounds to reduce the primary tumor, but that is not the purpose of these compounds and they often do not pass this test. 6_/ Second, the objective of the compounds is to delay the recurrence of cancer, which by definition implies an even further elongated trial approval process and even more costs.

Nor does the FDA recognize the poor prognosis of metastatic cancer patients to establish distinct procedures for clinical trials with these participants. 7_/ Yet many of these patients have been told to get their affairs in order and many would be willing to take greater risks than others to participate in research. But the FDA applies its standard safety guidelines to the trials with these patients which cover six categories of safety including adverse events unrelated to the drug. 8_/

The Petition requests the FDA to adopt procedures specific to the circumstances surrounding metastatic cancer. For example, the trial design to ensure a compound’s efficacy would be limited to two phases. _9/

With the requested changes in place, the journey to finding a cure for metastatic cancer can begin in earnest.

The Petition can be read at:!documentDetail;D=FDA-2013-P-0695-0001

The FDA is now accepting online comments from the public on these matters at the above location.

1_/ See, e.g., the National Cancer Institute website at:
2_/ See, e.g., “Molecular networks that regulate cancer metastasis”, Spano D, Heck C, De Antonellis P, Christofori G, Zollo M., Semin at Cancer Biol. (2012).
3_/ The National Cancer Institute reports an annual budget for cancer research of about $5 billion. See: The category labeled “metastasis” receives about $400M per year, or about 8% of the total. See:
4_/ See, for example, California Biomedical Research Association, “Fact Sheet: New Drug Development Process”, (June 2008).
5_/ See, for example, Manhattan Institute for Policy Research, “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials”, Avik S. A. Roy, Senior Fellow (April 2012).
6_/ See, for example, Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).
7_/ See, FDA: “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”, (May 2007).
8_/ See, FDA: “Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies”
(December 2012).
9_/ For a discussion of the proper trial design, see Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).

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