WASHINGTONThe National Cancer Institute and the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health are jointly launching a Quick Trials research grants program that will enable more rapid evaluation of promising complementary and alternative medicine (CAM) therapies.
The Quick Trials program is designed to simplify the grant application process and provide a rapid turnaround from application to funding, NCCAM director Stephen E. Straus, MD, told the House Committee on Government Reform. Its features include accelerated peer review, with the goal of issuing new awards within 5 months of application receipt, he said.
The program was initially announced as a pilot program for prostate cancer. It will give researchers rapid access to support for pilot, phase I, and phase II clinical trials testing new agents, as well as patient monitoring and laboratory studies, to ensure timely development of new treatments, the NCCAM director said.
Dr. Straus was one of several federal health officials, including the FDAs Richard Pazdur, MD, and the NCIs Robert Wittes, MD, who testified at a hearing on integrative oncology, called by committee chairman Dan Burton (R-Ind). Rep. Burton, a CAM advocate in Congress, summoned the officials to explain what their organizations were doing to advance CAM research.
Dr. Straus said that rigorous scientific evaluation of CAM therapies for cancer are among our highest priorities. He noted his centers support for a 90-patient pilot trial at Columbia-Presbyterian Cancer Center, New York, of a therapy advanced by Nicholas Gonzalez, MD, which preliminary data suggest might prolong the lives of pancreatic cancer patients. It includes pancreatic enzymes, magnesium citrate, papaya, vitamins, minerals, trace elements, animal glandular products, and coffee enemas.
NCI currently supports a number of CAM-related investigations, said Dr. Wittes, NCIs deputy director for extramural science and director of the Division of Cancer Treatment and Diagnosis. These studies include projects examining the effects of dietary interventions in cancer treatment, the therapeutic value of vitamins and minerals in cancer prevention and treatment, studies in stress and pain management to enhance the quality of life for cancer patients, and studies of natural inhibitors of carcinogenesis.
Dr. Wittes said that NCI is working closely with NCCAM to encourage traditional cancer researchers to initiate CAM studies at NCI-sponsored cancer centers. Through its own Office of Cancer Complementary and Alternative Medicine, NCI is forging collaborative relationships between the conventional cancer research and CAM communities, he said.
NCI is also incorporating information about CAM into its cancer communications network. PDQ summaries and fact sheets detail what is known about a number of such therapies, including Cancell, Gerson therapy, immunoaugmentative therapy, and laetrile. The public availability of accurate, up-to-date information about CAM therapies is important to all of us, Dr. Wittes said.
Dr. Pazdur, director of the FDAs Division of Oncologic Drug Products, defended the agencys approval process for CAM therapies, stressing that good science is the key.
We are indifferent as to the source and nature of any potential therapy, as long as consistent, good manufacturing standards and laboratory and clinical practice are used, he said. FDA is eager to see formal controlled studies of CAM and has advised potential sponsors of such studies on study design and control.
Dr. Pazdur also defended the agencys actions in the case of Thomas Navarro, who at age 4, was diagnosed last year with medulloblastoma. His parents sought to have him entered into an ongoing clinical trial of antineoplastons, a CAM therapy devised by Stanislaw Burzynski, MD, PhD, of Houston.
Their request was denied because the boy failed to meet the trial protocol and FDA refused to support compassionate use of the treatment because young
Thomas had not gone through conventional therapy for his disease.
This conventional therapy is curative in the vast majority of patients, with a risk-to-benefit profile accepted by the oncology community and by patients, Dr. Pazdur said.
Rep. Burton has introduced the Thomas Navarro FDA Patient Rights Act (HR3677), which would amend the Food, Drug, and Cosmetic Act to restrict the FDAs authority to issue clinical holds regarding investigational drugs or to deny patients expanded access to such drugs.
This would allow patients access to another protocol outside the standard cancer protocols of chemotherapy and radiation, Rep. Burton said.
The proposed bill, which Dr. Pazdur referred to as a form of reverse informed consent, would allow patients access to investigational drugs if they state in writing that they are aware that there is a comparable or satisfactory alternative therapy, aware of the risk involved in receiving the investigational drug, and choose to receive the drug notwithstanding such risk and notwithstanding the comparable or satisfactory alternative therapy.
Rep. Burton asked Dr. Pazdur why the Navarro family should be required to subject their child to what they perceived as a real danger to their child, chemotherapy and radiation? Dr. Pazdur replied that the conventional treatment for medulloblastoma is one of the true success stories of pediatric oncology, in that it allows a curative potential in over 75% of patients.
Rep. Burton reponded that he had seen some of the children who were cured by this treatment. They were mentally retarded, they couldnt talk, they couldnt speak. The cancer was supposedly cured, but the child was a vegetable.
He then brushed off Dr. Pazdurs attempts to explain that recent advances have reduced the toxicity of medulloblastoma therapy and the reasons the antineoplaston trial required that participants have failed a curative treatment.
So the child and the parents are taken out of the decision-making process, Rep. Burton said.
Jeffrey Kang, MD, director of HCFAs Office of Standards and Quality, said that the Health Care Financing Administration has limited its coverage of CAM therapies because of a paucity of reliable scientific evidence to support their use. He noted, however, that Medicare covers spinal manipulation by chiropractors and massage therapy by physical therapists when it can be shown that such treatments improve a patients health.