Antineoplastons are gene-targeted cancer medications that have completed Phase 2 FDA clinical trials in 2009, with permission granted to enter the final Phase of FDA testing. These medicines are the first in medical history to cure inoperable childhood brainstem glioma with a 27.5%-50% cure rate, among other cures. Other gene-targeted cancer medications have been given accelerated FDA-approval without demonstrating a single cure. Antineoplastons, proven to be non-toxic, remain unapproved for public use. For the sake of public health, the results from Phase 2 clinical trials of Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress. These medicines have been in FDA clinical testing since 1995—it's time for the general public to have access to them.
Response to Petition
Protecting Public Health Through Safe and Effective Treatments
By Janet Woodcock
Thank you for your petition asking the Obama Administration to accelerate the approval of antineoplastons for the treatment of cancer.
As you know, cancer treatments go through a careful research process to prove that they are safe and effective. The National Cancer Institute (NCI) has recommended that controlled clinical studies be conducted in order to assess the safety and efficacy of the therapy. To date no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals nor have all of the trials needed to approve antineoplastons as a treatment for cancer been conducted.
The timely review and approval of safe and effective new treatments are central to the U.S. Food and Drug Administration's (FDA) mission to protect and promote the public health. In fact, over the past 12 months, FDA approved 35 new medicines, including three cancer drugs that were approved in less than six months. This is among the highest number of approvals in the past decade. Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years. The approvals came while drug safety standards have been maintained.
A report released last month by FDA, FY 2011 Innovative Drug Approvals, shows faster approval times in the United States when compared to the FDA's counterparts around the globe. Of the 35 approvals in FY 2011, 24 occurred in the United States before any other country in the world, and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.
The Administration remains committed to the timely approval of safe and effective drugs to improve the treatment of cancer and other illnesses.
Janet Woodcock is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.