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
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.