NCI Funding Complementary/Alternative Medicine Trials

BETHESDA—For many oncologists, the term “complementary and alternative medicine,” or CAM, brings to mind laetrile and other worthless cancer “cures.” Last October, the National Cancer Institute (NCI) established the Office of Cancer Complementary and Alternative Medicine and named Jeffrey D. White, MD, as its director.

In this interview with Patrick Young, Oncology News International’s Washington Bureau Chief, Dr. White discusses his office’s role within NCI and its interactions with the National Institutes of Health’s National Center for Complementary and Alternative Medicine and its Cancer Advisory Panel for Complementary and Alternative Medicine.

ONI: Why is NCI getting involved in such a controversial area of medicine?

DR. WHITE: Although stories like laetrile and others show the negative side of alternative medicine, the field itself is so large that it encompasses a tremendous number of things that probably do need to be investigated.

That is part of the answer. Another part is the tremendous public interest in complementary and alternative medicine approaches. More good-quality research needs to be done to give people valuable information on which to make decisions. I think the clinical trials that NCI has been involved with—vitamin C, laetrile, hydrazine sulfate—have yielded useful information for the public.

ONI: Useful in what way?

DR. WHITE: Useful in a negative way. They supplied the public and the general practitioners with information that educated them about the risks of using these approaches. It is useful sometimes to look at things in a hard scientific way to show that they don’t work or that they are dangerous.

ONI: How does NCI define complementary and alternative medicine, and how does it distinguish between the two?

DR. WHITE: It is hard in such a diverse area to put down a definition in one or two paragraphs. In the past, it wasn’t a major priority for NCI to have a definition because we dealt with individual projects and not with whether they were alternatives.

Now that there is a national center to deal with complementary and alternative medicine at NIH, an NIH definition will be developed.

The distinction between “complementary” and “alternative” medicine really comes about from a practice point of view of how it is utilized. Alternative approaches are used more as a sole approach or as a substitute for conventional approaches. The alternative component is rather small. There aren’t that many people who use these approaches to the exclusion of conventional medicine.

This whole area has moved. More and more MDs are getting credentials in various things such as acupuncture. I was at a conference today where it was mentioned that there are 4,000 MDs in the United States who are licensed acupuncturists. So acupuncture in their hands is a complementary approach.

ONI: Is the NCI effort driven by science or by congressional and public pressure?

DR. WHITE: This is a science-driven approach. NCI has been involved in this area for a number of years, largely in a reactive way. We saw a need for an office that would serve as a focal point to direct CAM investigations. We want to deal with complementary and alternative medicine in as rigorous a way as we do conventional medicine.

ONI: What is the role of your office?

DR. WHITE: Basically, I am the liaison from the NCI to the National Center for Complementary and Alternative Medicine [NCCAM]. In that role, we try to identify common projects.

I also work with the Cancer Advisory Panel for CAM. This is a panel put together jointly by NCI and NCCAM to advise the NCCAM about cancer projects that it should support and to recommend further research in certain areas.

Another role is to be the coordinator of complementary and alternative medicine activities for the NCI, which involves contributing to various projects that are going on in different divisions within the Institute.

ONI: How would you contribute?

DR. WHITE: If a project is done with the NCCAM, my contribution may be in the communication element between the two institutes. Or it could be helping certain NCI divisions develop their own CAM agendas or CAM projects.

Another contribution is to develop an institutional agenda in alternative and complementary medicine to try to grow research that might support future clinical research in these areas.

Also, we will interface with NCCAM on public issues that relate to complementary and alternative medicine. That includes individual citizens who may have either ideas or interest in the area. But mostly it involves dealing with practi-tioners who treat cancer patients and ways in which we interact with them—mostly through something we call the “best-case series.”

We also deal with oncologists and cancer researchers who have an interest in initiating alternative medicine projects and who would like to know the NCI’s interests in that area or which program directors to contact.

ONI: What is the best-case series?

DR. WHITE: This is a system that the NCI has had in place since 1991. A practitioner can come to us with a CAM approach to treating cancer and ask us to look at the results. We require 10 cases that include patient histories; copies of x-ray and pathology reports; and clinical, laboratory, and radiographic follow-ups. When we have all the information necessary, we present it to the Cancer Advisory Panel for review.

ONI: So the decision whether to pursue further research on such treatments rests with the advisory panel.

DR. WHITE: Yes. They would make a recommendation to the national center to either do more research or not, and maybe what specific research should be done. Then the national center would work with NCI to establish the appropriate project.

ONI: How do you determine which therapy areas, as opposed to specific treatments, are worth studying?

DR. WHITE: One approach would be to do a systematic literature review of projects we are trying to develop. Again, a lot of it will be passed to the Cancer Advisory Panel to get their opinion. There is a lot of European literature on CAM therapies about their effectiveness, some of it not even translated into English. We certainly could take a look at some of those products and assess whether they warrant more clinical investigation.

A Diverse Portfolio?

ONI: What criteria will be used in deciding which projects get priority?

DR. WHITE: Ideally, we would like to have a diverse portfolio of different types of projects, not only direct treatment of the cancer but also palliation of side effects of conventional therapy and of the cancer itself. However, priority really comes down to the quality of the project and the opportunity for getting meaningful research and results.

ONI: Are you seeking grant applications?

DR. WHITE: We are in certain forms. We have signed onto three RFAs [requests for applications] for certain projects, such as an NIH institute-wide RFA for CAM research centers. Another is the botanical RFA put out by the Nutrition Committee, an NIH-wide coordinating committee. The NCI has put in language about our interest in supporting botanical research in cancer. The third is a breast cancer RFA supported by money that came to NCI from sales of the breast cancer stamp. In it, we expressed specific interest in complementary and alternative approaches.

ONI: Have you encountered opposition to CAM research?

DR. WHITE: None at all within NCI, and I have not received any comments from the oncology community that I would characterize that way. There are groups, some call themselves “quack busters,” who are very concerned about our doing alternative medicine research, and they have contacted NCI expressing those concerns.

ONI: How do you respond to people who say you are promoting quackery?

DR. WHITE: You respond to it as honestly as you can about the rationale for doing any particular project. If it is a philosophical question about why would the NCI even consider doing research in this area, we say it is because this is an area fraught with the hazard of misleading people in directions that can harm them. The best way to prevent this is to develop quality research and disseminate it, so people can become better informed.

However, there is also the potential for new therapies, and we need to do research in these areas. This is a huge field, a field in flux, and certainly botanical research needs to be investigated in very deep ways for drug development.