June 11, 1999

Congressman Dan Burton
Barrie Cassileth, Ph.D.
Mary Ann Richardson, Dr.P.H.
Robert Wittes, M.D.

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Congressman Burton

Congressman Burton opened his presentation with a recollection. About 22 years ago, as a freshman legislator in Indiana, he was approached by a doctor whose cancer patients believed that they had been helped by laetrile. At the time, laetrile was an illegal substance. Following conversations with this doctor and several of her patients, Congressman Burton sponsored the laetrile bill in the Indiana general assembly. He fought an arduous battle to pass the bill through the state house and senate. Today, laetrile is legal in Indiana. However, the Interstate Commerce clause of the Constitution and the Food and Drug Administration (FDA) dictate that the parts of the substance that have not been approved by the FDA cannot cross state lines. This means that laetrile cannot be produced and assembled in Indiana.

Since that experience, Congressman Burton stated, he has had problems with the FDA, which seems to exhibit callousness toward people who are suffering from debilitating chronic and terminal illnesses. Congressman Burton argued that when people are diagnosed with a terminal illness, the government should not abandon them. "I think every opportunity should be given to people," he stated, "so that they can survive and have a healthy life, and many times, hope alone and belief that they are going to get better is one of the ingredients that makes them get better."

About 5-6 years ago, Congressman Burton’s wife was diagnosed with breast cancer. Her physician told her that she had a 50% chance to live 5 years. Congressman Burton found this statement to be callous. He read an article about Dr. Springer, a physician from Germany now living in Illinois. He was conducting an experimental program with 71 women, stimulating their immune system to fight off cancer recurrence. He then contacted Dr. Springer to find out if his wife was eligible to join the study. Dr. Springer deemed his wife appropriate, and she enrolled. At that time, Congressman Burton started speaking with a significant number of Dr. Springer’s patients. Many told him that Dr. Springer’s program had enabled them to far outlive their prognoses. As chair of the Government Oversight Committee, Congressman Burton informed the FDA about the importance of Dr. Springer’s program. He asked that Dr. Springer’s treatment be allowed to be administered by the women’s hometown physicians in order to spare them the regular travel to Chicago.

After looking into Dr. Springer’s program, the FDA decided to close it down. It reported that Dr. Springer had not complied with a number of FDA requirements. The FDA’s decision "went through all the 71 women like a knife," recalled Congressman Burton. In response to this decision, Congressman Burton told the head of the FDA that if the agency closed Dr. Springer’s program, he would hold a congressional hearing every week in which the FDA would be asked to explain to the American people why it had taken away a promising cancer treatment. The FDA reconsidered its position and agreed to assist Dr. Springer to meet its requirements. Dr. Springer’s program is still in operation and most of the women enrolled in it are doing very well. Congressman Burton calls for the expansion of this and other experimental programs that aim to help people with terminal illnesses.

Congressman Burton has had extensive experience holding hearings on the FDA’s response to promising experimental programs. He has worked long and hard to guarantee the patients of Dr. Stanislaw Burzynski access to their physician and their medication. "Nobody likes to see chicanery in medicine," he said. "But at the same time, it’s inconceivable to me that any government agency or any person in this country would want to take the last vestige of hope away from some parent or some individual who wants to survive by saying that ‘We’re going to close down a program that has shown some promising results’. And this has gone on, and on, and on."

Congressman Burton mentioned that on June 10, 1999, the Government Oversight Committee held a hearing that revealed the following:

In response to these findings, Congressman Burton asked the National Institutes of Health and the National Cancer Institute to give him a list of every alternative therapeutic program that is being tried in Europe and not tried in the United States. He also wants to know the amount of time that these programs have been tried and the results they have brought. With this list, Congressman Burton plans to show his colleagues and the American people that there are alternative and complementary therapies that can be used to improve and save lives. Moreover, he wants to try to force the FDA to speed up the process of examining and approving such new therapies. He is also putting great effort to get the Access to Medical Treatment Act and the Inclusion of Alternative Approaches in Cancer Research Act passed in the coming year.

"I’m with all of you in this fight," concluded Congressman Burton, "to make sure that the patients and the people of this country have every opportunity to have the best quality of life possible, that pharmaceutical companies working with the FDA to block many of these things – and I believe that does occur—will not be successful, and alternative therapies will be realized and that we’ll be able to work together to make the quality of life for Americans better in the years to come." For anyone who needs his help, Congressman Burton recommended that they contact his aide, Beth Clay, or Dr. Gordon.

Barrie Cassileth, Ph.D.; Mary Ann Richardson, Dr.P.H .(presenting in the place of Ralph Moss, Ph.D.); Robert Wittes, M.D.

I. Abstract

As leaders and keen observers in the field of alternative and complementary cancer therapies (ACCTs), Barrie Cassileth, Mary Ann Richardson, and Robert Wittes were asked to give a "report card" on the latest developments in ACCTs. Specifically, the three speakers were asked to comment on the most noteworthy milestones of progress that took place since last year’s Comprehensive Cancer Care Conference I.

II. The Cancer-Related Issue Addressed

A. Barrie Cassileth, Ph.D.

Dr. Cassileth, in part representing the American Cancer Society (ACS), focused on five benchmarks of progress. She stressed that she considered the second Comprehensive Cancer Conference, itself, to be the sixth and most important of these benchmarks. The five benchmarks were:

1. Acceptance of complementary and alternative medicine (CAM) in cancer medicine: In the last two years, Dr. Cassileth reported, an increasing number of the comprehensive cancer centers and the cancer programs in university-affiliated institutions have incorporated some type of CAM program. These programs vary in scale, emphasis, and scope, but they all place great emphasis on issues involving quality of life. Dr. Cassileth asserted that CAM therapies have much to offer quality of life and that increasing numbers of people are beginning to appreciate this potential.

2. Standards of Merit: There has been an important elevation in the way in which the merits of CAM are evaluated. Increasingly, researchers are looking for the same kind of hard data required in mainstream medicine. They want to generate "outcomes data" by taking a close look not only at descriptive information on CAM, but also at the outcomes of CAM therapies. Dr. Cassileth asserted that CAM deserves no less than the highest level of quality control and investigation.

3. Disentangling the CAM monolith: Dr. Cassileth mentioned that in the past health professionals thought of CAM as one large collection of a vast array of disparate activities and programs. This collapsing of CAM into one, monolithic category lead them to accept or reject all CAM uncritically. Such acceptance and rejection of CAM as a monolith is wrong. One needs to tease CAM apart and look at each therapy individually. One can evaluate it and a) accept it if it is effective, or b) reject it if it is not effective. The main goal of mainstream medicine should be to discard the therapies that are not effective and adopt the ones that are.

4. The growth of public sophistication worldwide: Among the general public, there is a growing recognition of problems and benefits associated with CAM. Moreover, very valuable information is coming from practitioners of oriental medicine regarding the benefits and dangers of herbal remedies, herb-herb interactions, and herb-drug interactions.

5. The shifting perspectives in the ACS: Over the past 50-60 years, the ACS has undergone a significant change in its approach to CAM. The Society started out using derogatory terms to refer to unconventional treatments. But today the committee that works on such treatments is called the Committee on Complementary and Alternative Medicine. Dr. Cassileth explained that this change in terminology represents a major and long-fought shift in perspective, openness, and willingness of the ACS to look with greater interest at the potential benefits of many complementary therapies.

The major focus of the ACS with regard to CAM is on quality of life. Quality of life involves psychological, social, and spiritual issues as well as symptom management. In the last few weeks, the ACS dedicated their interest in issues concerning quality of life. The Society is interested in receiving—and is ready to fund—good research proposals pertaining to the evaluation of complementary therapies aiming at enhancing quality of life.

Dr. Cassileth closed her talk with a brief comment about her vision of the future. The rapid acquisition of knowledge about CAM as well as the accelerating pace of CAM research will provide mainstream medicine with more answers. These answers will place us all in a better position to cast aside therapies—both conventional and CAM—that prove ineffective. They will also enable us to make better use of effective therapies. The future holds much promise for CAM. The same can be said about mainstream medicine, which through the human genome project, is likely to lead to important cancer cures.

B. Robert Wittes, M.D.

As a representative of the National Cancer Institute (NCI), Dr. Wittes opened his talk by stressing the need for solid evidence for the efficacy of CAM. He said that the NCI and most practitioners in clinical cancer are pragmatic and non-doctrinaire about the origins of medical advances. They want to learn about therapies that improve or prolong patients’ lives, regardless of the roots of those therapies or of the intellectual owners of the hypotheses that brought them attention. "When we start fighting about evidence and we stop fighting about where the hypothesis comes from," he said, "we’ll know we’ve made more than just incremental progress. We’ll know we’re talking about the right thing." Dr. Wittes asserted that his perspective is now shared more widely by the NCI and the clinical community at large. This represents a noteworthy change from previous years. The milestones on which he focused included:

1. The creation of the Office of Cancer, Complementary and Alternative Medicine (OCCAM) headed by Jeffrey White, MD. According to Dr. Wittes, Dr. White has made a real effort to contact practitioners in the CAM community. He tries to engage them in the processes that the NIH, NCI, and NCCAM have put in place to promote the conduct of research on CAM.

2. The formal establishment of the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM). CAPCAM is an expert panel organized jointly by the NCCAM and the NCI to serve as an expert and unbiased group of evaluators to make judgments about claims of efficacy and offer recommendations for research to the NIH, NCCAM, and NCI. The 15 members of CAPCAM—the majority of whom are not members of federal agencies—have diverse expertise in CAM modalities, clinical trials, biostatistics, oncology, pathology, diagnostic radiology, and ethics. These individuals are especially knowledgeable about issues concerning the intersection of CAM with mainstream medicine. What gave birth to this panel was the need to develop the ability to separate claims of efficacy that are strongly based on information from claims of efficacy that are not. The meetings of CAPCAM are open to the public. For further information, contact Dr. White or look at the NCI web site.

In its effort to promote the fair evaluation of treatments, the NCI has established criteria for prioritizing claims of efficacy and allocating resources. There criteria include:

Based on these criteria, a number of trials are either planned or are in progress. Therapies that are being examined include the regimen of Dr. Nicholas Gonzalez, shark cartilage, green tea, and selenium.

Drs. White and Wittes have been working on developing ways to safeguard the even-handed review of investigator-initiated grant applications. Dr. Wittes stated that the Center for Scientific Review, the part of the NIH which is responsible for grant reviews, is in the middle of an enormous reevaluation under the auspices of the National Academy of Sciences. Lastly, the NCI is in the middle of recreating their entire information system, which includes its subsection on CAM. Last year, they had already withdrawn some of the CAM statements made by NCI’s informational computer system (PDQ), because they took notice of the criticism that these statements were biased.

C. Mary Ann Richardson, Dr.P.H.

Dr. Richardson started with the observation that the Comprehensive Cancer Care II Conference had brought together important figures in the complementary and alternative cancer therapy field. Among them were Dr. Gebest from Germany who is setting up a rehabilitation clinic in Heidelberg and will be working with Germany’s equivalent of the National Cancer Institute to design programs that will offer cancer patients ACCTs and rehabilitation services. Dr. Yung from Korea who did some of the pioneering work on the therapeutic properties of gingseng and is presently involved in a randomized controlled trial examining the cancer-preventive capacities of this substance. Dr. Beltran from Colombia who was appointed by the Colombian government to explore the area of complementary and alternative medicine. Dr. Beltran is also involved in a program to credential Colombian physicians to practice complementary and alternative medicine. There are also some physicians from Canada who have established an integrative cancer care program in Vancouver that supplements conventional treatments with vaccines, nutritional supplements, herbs, yoga, massage, Tai Chi, and other complementary and alternative therapies. To this list of participants, Dr. Richardson added the American Cancer Society. They have made "quantum shifts" in moving forward to advance the field of CAM. She also cited the National Cancer Institute; and clinicians, physicians, and researchers from the many comprehensive cancer centers across the country. "It’s time that we come together," she said, "because we need to advance a science, and that’s going to be done through a dialogue."

Dr. Richardson mentioned a recently published New England Journal of Medicine article (Vol. 340, No. 22) documenting the use of CAM among early stage breast cancer patients. This study found that 28% of the patients began using CAM after their diagnosis. At baseline, users and non-users had fairly comparable scores on quality of life and psychosocial measures, but users appeared to be younger and better educated than non-users. The study indicates that at three months, users scored significantly lower than non-users on mental health measures. Moreover they reported higher fears of recurrence, an increased number of symptoms, and greater depression. At twelve months, many of these scores had stabilized, but the users still reported greater fear of recurrence. The authors concluded that:

1) Users of CAM are not rejecting conventional medicine—rather, they are adding CAM to their biomedical treatments.
2) Patients who add CAM to their conventional treatment might be distressed. As a result, they may feel the need for additional ways to help themselves cope with their illness.
3) The psychosocial vulnerability that users appear to experience can possibly be addressed through the integration of CAM programs into conventional treatment centers.

Dr. Richardson mentioned that Jimmie Holland, M.D., head of psychosocial oncology at Memorial Sloan Kettering Cancer Center, has stressed the importance of treating the person and not the disease. At the same time, she has observed that this goal is jeopardized when patients don’t feel comfortable talking about ACCTs with their physicians and can’t receive ACCTs in their conventional medical setting. Dr. Richardson asserted that at the University of Texas M.D. Anderson Cancer Center 83% of a sample of 480 patients were using some form of ACCTs and 75% wanted more information about these therapies. She stressed the need to expand comprehensive cancer programs that combine nutritional, physical, emotional, and spiritual therapies and to push the envelope on nutritional supplements, herbs, and vitamins. Some important trials that seem to take mainstream medicine in this direction include an M.D. Anderson Cancer Center study on whole shark cartilage extract; a Columbia trial on enzymes, nutritional supplements, and a detoxification program; a UCSF initiative to study a Tibetan herbal formula; and an M.D. Anderson Cancer Center study on melatonin.

As the funding for the study of CAM therapies increases one should expect to see increased quality and quantity of research. The proposals that will be funded by the NCCAM should:

1. conduct pilot studies with basic science and clinical research;

2. establish formal training programs; and

3. develop developmental research programs for the collection of preliminary data.

"We are just starting in this field," said Dr. Richardson. In her view, the challenge to the CAM community lies in the area of data acquisition. Providers of CAM need to begin to provide information on patient outcomes. To facilitate this process, the M.D. Anderson Cancer Center is about to start a pilot project that will help practitioners collect outcomes data in collaboration with an outside group of conventional oncologists/pathologists. The Center is also developing forms for the reporting of best cases.