NEWS

Jeffrey White Directs NCI's New Office of Alternative Medicine

Nancy Nelson

The National Cancer Institute has taken an official step toward evaluating alternative medicine therapies by naming Jeffrey D. White, M.D., as the director its newly established Office of Cancer Complementary and Alternative Medicine. White's appointment began on Oct. 26, 1998.



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Dr. Jeffrey D. White

 
As a graduate of Cornell University in Ithaca, N.Y., and Howard University College of Medicine in Washington, D.C., White trained in internal medicine, oncology, and hematology at the Washington Hospital Center and, since 1990, has been in the Metabolism Branch of NCI. For the past year, he was director of the Clinical Trials Program where his interests focused on the use of monoclonal antibodies for patients with adult T-cell leukemia as well as other malignancies involving over-expression of the IL-2 receptor.

During his tenure as an intramural researcher, White also served as a consultant for 3 years for the National Institutes of Health's National Center for Complementary and Alternative Medicine (formerly the Office of Alternative Medicine) on issues relating to cancer. This interview was conducted by News correspondent Nancy Nelson on January 22, 1999.

What is the mandate of NCI's Office of Cancer Complementary and Alternative Medicine ?

I am the official liaison from NCI to the National Center for Complementary and Alternative Medicine. Now it's congressionally mandated that each Institute have a full-time liaison to the Center. We were actually ahead of the game — my position was put through before the mandate.

As the NCI liaison, I direct all our collaborations with the national center, so if they want to develop a project, they will have one person to work through. In this capacity, I work with the center's cancer advisory panel, which is composed of a variety of people — some oncologists, research nurses, alternative medicine practitioners, someone from FDA. We had our first meeting on November 16th and are trying to identify common projects in which both the center and NCI have joint interests; projects that we can co-fund or that can be conducted through an NCI mechanism for doing clinical research.

I also function as an interface between the alternative medicine community and the NCI scientists. For example, if researchers from the alternative medicine community have preclinical information and want NCI to get involved, I direct them to places in NCI where they can get support — to CTEP [Cancer Therapy Evaluation Program] or the Developmental Therapeutics or Prevention Programs.

And finally, I play a coordinating role with other institutes at NIH, so that when NCI communicates with other institutes about alterative medicine, there is a unified presentation of our point of view or interests.

How much staff and budget do you have?

Basically, I have a budget to run an office for myself, a secretary, and a research assistant. The budget can be supplemented for various projects as they come up. For example, Dr. [Richard] Klausner [NCI's director] has agreed to co-sponsor a conference in June on alternative and complementary approaches to the treatment of cancers with James Gordon, M.D. [Gordon directs a center for mind-body medicine in Washington, D.C.]

Is NCI currently supporting any alternative medicine studies?

Yes. One project is a phase III trial involving a dietary regimen, called the Gonzalez protocol. The diet includes fresh fruits, vegetable juices, whole grains, nuts, seeds, and a plethora of supplements — vitamins, minerals, trace elements, and glandular extracts — plus oral pancreatic enzymes and a "detoxification" regimen with coffee enemas.

Investigators are in the process of accruing 72 to 90 advanced pancreatic patients who will be randomized for gemcitabine alone versus the Gonzalez regimen. The principal investigator for the dietary regimen is John Chabot, M.D., an oncologist at Columbia Presbyterian Cancer Center in New York. As of 3 weeks ago, no patient had been treated on the protocol, but they're screening patients now.

Is there any reason to think that the Gonzalez protocol might work?

Nicholas Gonzalez, M.D., a New York endocrinologist, presented a best case series in 1993 to NCI. He had treated 10 patients with diverse cancers. Because there wasn't enough information to say that there was clear-cut benefit, NCI recommended that he do a prospective trial with advanced pancreatic patients. Now he reports that nine of the 11 pancreatic patients he originally treated have survived for 2 years or more. The results will be published this spring in Nutrition and Cancer. They were impressive enough to interest the group at Columbia and the NCCAM to sponsor a prospective, randomized trial.

Is NCI supporting any other alternative medicine research?

We may be very soon. The National Center for Complementary and Alternative Medicine along with several other institutes, including NCI, issued a Request For Applications in September 1998 inviting applications for "Centers for Complementary and Alternative Research" using the Specialized Center (P50) grant mechanisms. The centers, each with a different disease focus, will provide the resources necessary for a rigorous scientific investigation of complementary and alterative research. The application deadline is today [Jan. 22, 1999].

NCCAM anticipates making six to eight awards, each for 3 to 5 years of support for $1.5 million per year, in September 1999. We've received 10 letters of intent for centers with a cancer focus. NCI will provide additional budget support for applicants considered to be outstanding. [Besides cancer, other research areas called for by the RFA were arthritis, asthma, diseases of the aging, HIV/AIDS, and sleep. Three NIH centers for CAM research, for cardiovascular disease, pediatrics, and substance abuse, already exist.]

Are there any other clinical trials in alternative medicine that NCI is supporting?

The only other trial besides the Gonzalez regimen is a phase III clinical trial to test shark cartilage. Jim Pluda, M.D., in CTEP will involve 500 to 700 patients with stage IIIA and stage IIIB lung cancer. Both arms of the trial will get standard therapy. One arm will get shark cartilage and the other a placebo. The supply of the drug is expected to be available in April and the first patients will be treated around the end of the summer or early fall.

Why was shark cartilage chosen?

One of the reasons is that shark cartilage is widely used in the United States by cancer patients. Another is that in vitro studies show that extracts of shark cartilage have anti-angiogenic activity and inhibit matrixmetalloproteinases, enzymes involved in metastases. In terms of clinical data, there is nothing very definitive in the literature; a few single-arm studies in patients.

Once it was decided to test shark cartilage, researchers in CTEP tried to identify the best product out there — one that showed reproducibility in the lab as well as preclinical and clinical information from early human trials. The product chosen is made by Aeterna, a Canadian company that not only had reproducible laboratory data, but had looked at toxicity and maximum tolerated dose in a phase I trial and has begun phase II testing.

Why did you take the job?

I was a consultant for the Office of Alternative Medicine for 3 years and I found it very interesting. There's a lot of potential in the field. Also several people at NCI, Robert Wittes, M.D., [Deputy Director for Extramural Sciences] in particular, are very interested in looking at these alternative treatments in a hard scientific way. That's one of the main things that convinced me. It's also a good opportunity to learn about the extramural parts of NCI.



             
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