The Cancer Chronicles

Autumn 1998

© 1998 by Ralph W. Moss, Ph.D.


DR. NIEPER PASSES AWAY

October, 21, 1998--It is with a profound feeling of loss and regret that I have just learned that my friend and colleague, Hans Nieper, MD, passed away last night. Dr. Nieper was an amazing man, a dynamo and true pioneer on the frontier of medicine. He was generous in his praise and support for many of us, and paved the way for the publication of my book, Questioning Chemotherapy, in Germany. He also is responsible for my present connection with the German Society of Oncology, of which he was a founder. Although he suffered a heart attack in 1997, I was shocked by the news: I just had a letter from him last week and was looking forward to visiting him at his clinic and his home in early November. I miss him already.

I have attached a copy of my Foreword to his Autobiography, A Curious Man, which will be published shortly by Avery Press.

Dr. Nieper's death follows that of other pioneers of CAM cancer medicine in the past year: Emanuel Revici, Georg Springer, Rudy Falk, Josef Issels, and most recently John Prudden. It will be difficult to fill the giant footprints left by these pioneers.


CANCER ADVISORY PANEL (CAP)

The Office of Alternative Medicine and the National Cancer Institute have announced the formation of a new Cancer Advisory Panel (CAP). The CAP will meet twice per year. Its stated purpose is "to assist the National Institutes of Health in evaluating the claims of efficacy related to complementary and alternative therapies for cancer."

Its responsibilities will include:

  • Reviewing and evaluating summaries of evidence for CAM cancer claims submitted by practitioners;
  • Making recommendations to the Office of Alternative Medicine (OAM) and the National Cancer Institute (NCI) on whether and how these evaluations should be followed up; and
  • Being available to observe and provide advice about studies supported by the OAM and NCI, and about communication of the results of those studies.

The CAP is not intended to replace the functions of existing review and oversight groups such as Institutional Review Boards (IRB), Data Safety and Monitoring Boards (DSMB) or Investigational New Drugs (INDs) or grant application procedures. The CAP will not review grant applications, which must go through usual NIH procedures of peer review.

will be to provide advice to the OAM as it works through the NCI oncology groups for present and future cancer clinical trials. It represents a further stage in cooperation between OAM and NCI, and between the overall NIH and the complementary and alternative communities.

I am proud and happy to have been chosen a member of the Cancer Advisory Panel. The current panel is listed below:

  • Ernst L. Wynder, MD, chairman, American Health Foundation
  • June Brazil, BS
  • Peter L. Choyke, MD, Diagnostic Radiologist, National Institutes of Health
  • Ian Coulter, PhD, RAND Corp.
  • Susan Ellenberg, PhD, Food and Drug Administration
  • William R. Fair, MD, Memorial Sloan-Kettering Cancer Center
  • Richard M. Goldberg, MD, Mayo Clinic
  • James S. Gordon, MD, Center for Mind-Body Medicine/Georgetown University
  • Michael Hawkins, MD, Lombardi Cancer Center, Georgetown University
  • Fran Jacobs, RN
  • Sheila Moriber Katz, MD, Allegheny University of the Health Sciences
  • Caryn Lerman, PhD, Lombardi Cancer Center, Georgetown University
  • Ralph W. Moss, PhD, The Moss Reports
  • Douglas L. Weed, MD, PhD, Chief, Preventive Oncology Branch, NCI
  • Jeffrey D. White, MD, Director, Clinical Trials Groups, Metabolism Branch, NCI
  • Several ex officio members

There are still profound questions to be answered about the scope of activity of this panel. Nevertheless, the formation of this committee is a big step forward, and one which I argued for in my February, 1998 Congressional testimony and elsewhere.


NATIONAL CENTER FOR CAM

On October 21, 1998, the Senate passed the multi-billion dollar Appropriations Act of 1999 (S. 2440). A little noted provision of that Act authorized creation of a new National Center for Complementary and Alternative Medical Research. This effectively ends the existence of the Office of Alternative Medicine (OAM) and requires appointment of a new director by the Secretary of HHS. The Center will have its own funding authority to make grants and contracts. The funding level for the first year will be $50 million--quite a step up from the $2.2 million that OAM got in 1992! The Center will also have a new advisory council, which will include CAM practitioners and patient representatives. It will focus on the integration of CAM with conventional medicine, will deal with the various disciplines and systems, and will have a provision for "outcomes research." The new Center is an exciting and historic development, which we will be covering in future issues.


TRIP TO GERMANY

At this writing, I am preparing for my upcoming annual trip to Germany. I will be speaking to the German Society of Oncology (Deustsche Gesellschaft für Onkologie) on October 31, 1998. After the speech, I will be officially inducted as an Honorary Member of the Society. This is a wonderful occasion, as I am the first American to be so honored. The German Society of Oncology meeting is part of the 32nd annual Medizinische Woche, or Medicine Week, during which various groups representing complementary and alternative medicine (CAM) "take over" the spa resort town of Baden-Baden from October 31 to November 6. Those unfamiliar with the scope of CAM in Germany are usually astounded by this week-long event. To give some idea, the program of the meeting is itself full-color book of 285 pages! There are lectures, workshops, courses, huge displays of publications and products, etc. People come from all over the world to attend this event. To me, it is one of the high points in the world struggle for integrative medicine.

Before and after the meeting my wife and I will be touring German cancer clinics for several weeks. These clinics represent such approaches as Anthroposophy, Ayurvedic medicine, biomedicine, immunotherapy, and the like. We also intend to experience some of the many therapeutic spas in Germany, as the CAM clinics tend to be located in spa towns. The information I gather on innovative German treatments becomes an integral part of The Moss Reports.


NEW ENGLAND JOURNAL
GOES ON THE ATTACK

The New England Journal of Medicine is waging a campaign against complementary and alternative medicine (CAM). On September 17, 1998 they issued a coordinated attack on seven CAM treatments, including the herbal formula, PC SPES. The demand for good science in evaluating alternative treatments is quite justified. However, the NEJM attacks are entirely one-sided. For instance, they fail to put the potential toxicity of herbal treatments into the overall context of medical care. An article earlier this year in the Journal of the American Medical Association showed that prescription drugs kill over 100,000 people per year in United States hospitals. (This does not include malpractice cases.) How many people are killed by herbal preparations? I know of less than 10 in 1997, and all of those were due to the injection of herbs by doctors who later lost their licenses.

The New England Journal is counting on their self-declared position as America's "acknowledged leader in medical publishing" to turn the tide against CAM. I don't think that will happen. The Journal itself is coming under increasing scrutiny within the medical and journalistic establishments. On June 28, an article in the New York Times magazine referred to the editors of both JAMA and the NEJM as "brilliant manipulators of the press." Anyone who watched with dismay as the NEJM attack on CAM was disseminated to virtually every newspaper, radio and television station in the world knows what they mean!

The Lancet referred to the NEJM as "a competitive business, not an altruistic academic enterprise." It points out that "the NEJM is nothing if not a successful business--at least $19 million in display advertising sales accrue to the journal each year." The majority of those funds come from the pharmaceutical industry, never a big fan of herbalism or CAM.

The Times writer, Boston University science writer Ellen Ruppel Shell, called Jerome P. Kassirer, MD, Editor-in-Chief of NEJM, "cocky," "defensive," with an "arrogance [that] is so transparent as to seem affected." NEJM shot back that she was "confused" and didn't understand the role of an editor.

Dr. Lundberg, editor of the competing JAMA, is quoted in the Lancet as saying that "most American physicians don't see the Boston journal [i.e., NEJM], and even fewer read it. It is predictable, elitist, and stultifying dull."

A front-page article in the Boston Globe suggested that the NEJM may have launched its campaign on CAM as a covert attack on JAMA, which is about to bring out a special issue on complementary medicine. It is generally believed that the JAMA issue will be more balanced and neutral in tone. In other words, scientific.


"PORT" STUDY RAPS
POSTOPERATIVE RADIOTHERAPY
FOR LUNG CANCER

A July 25, 1998 article, as well as an accompanying editorial in the Lancet has thrown cold water on the use of postoperative radiotherapy ("PORT") in the treatment of non-small cell lung cancer (NSCLC). Yet this rigorous analysis received little attention in the media or among doctors or government officials who make treatment decisions (1998;352:250-51;57-63).

The study, carried out by the PORT Meta-analysis Trialists Group of Cambridge, England, sought to review all the evidence from randomized clinical trials (RCTs) to find out whether patients benefit from receiving radiation treatment after lung surgery. They therefore reviewed the data on 2,228 patients in nine such trials, published and unpublished. Some patients received surgery alone (the standard and sometimes curative treatment). Others received surgery plus radiation treatment afterward, a common procedure.

Overall, there were 707 deaths among the 1,056 patients assigned to postoperative radiotherapy in these trials but just 661 among 1,072 assigned to surgery alone. The median follow-up time was just under two years (23.9 months) for the surviving patients.

"The results show a significant adverse effect of postoperative radiotherapy on survival," the authors conclude. There was a 21 percent relative increase in the risk of death, which lowers the chances of overall survival at two years from 55 percent to 48 percent. This unexpected adverse effect was greatest for patients with early stage diseases (stage I-II), who had no or few involved lymph nodes. For those with advanced disease, postoperative radiotherapy seemed to make no difference at all. The conclusions of the paper are sobering and strongly worded: "Postoperative radiotherapy is detrimental to patients with early-stage completely resected NSCLC and should not be used routinely for such patients."

Some radiologists have argued that higher doses and more up-to-date methods used today would show a benefit for PORT. But the Lancet study concluded that "there is no evidence that the results were influenced by radiotherapy dose and therefore no indication that any one of the individual schedules used was any less detrimental than others. These results therefore reiterate that postoperative radiotherapy should not be routinely used to treat patients with completely resected early-stage NSCLC" (p. 262).

AVOIDING PUBLICATION BIAS

The Lancet is considered by many the best medical journal in the world. The lead authors of the study was Dr. L.A. Stewart of the MRC Cancer Trials Office, Cambridge, England as well as S. Burden, M.K.B. Parmar, and R.L. Souhami. The trials themselves were carried out in Great Britain, Chile, France, Slovenia, Belgium, the USA, and China. A meta-analysis is a compilation of results achieved in many randomized clinical trials. It is considered more definitive than any single such trial, since it incorporates the results of all the RCTs on a particular treatment, whether published or not. Oftentimes, because of so-called "publication bias," only positive results are published in medical journals, while negative results remain in the researchers' file drawer.

In a strongly worded Lancet editorial, Alistair J. Munro of the Department of Radiotherapy, Ninewells Hospital, Dundee, UK, drove home the main point of the article:

"The rationale behind postoperative radiotherapy is simple--kill any malignant cells remaining in the tumour bed, at the resection margins, or in the adjacent lymph nodes after surgery and so reduce local and regional recurrences and improve survival. Nice hypothesis, shame about the facts.

"The PORT study, reported in this week's Lancet, apparently shows that, far from saving lives, postoperative radiotherapy for non-small cell lung cancer (NSCLC) kills people..."

Worldwide, carcinoma of the lung is the leading cause of cancer death. More than half a million new cases are diagnosed each year, about 80 percent of which are of the non-small-cell type. Surgery is the treatment of choice for this type of cancer and about a fifth of all cases can potentially be cured by this means. How many patients with NSCLC are also receiving postoperative radiotherapy is not stated, but is probably in the thousands.

This astounding conclusions of this article went virtually unnoticed by the mainstream media. I can find no mention of it in the archives of the Washington Post, for instance, and assume it was not covered there, or in most other newspapers. I did not see it mentioned on the evening news. An Internet search has turned up virtually nothing. Major media, which breathlessly reveal medical "breakthroughs" on an almost daily basis, do not deal as well with the sobering realities of cancer therapy, as demonstrated through rigorous testing on thousands of patients.

My guess is that the "cancer establishment" is not going to give up the use of postoperative radiotherapy in NSCLC very quickly, either. It is too ingrained and too lucrative a practice to be abandoned because of a mere factual analysis. On paper, everyone agrees that all treatments need to be evaluated scientifically. But it is galling to listen to lectures on the need for "rigor" in the evaluation of non-conventional treatments, but then see the cavalier way in which a negative study on conventional treatment is ignored. We need a level playing field, if we are to play at all.

NCI'S LACK OF RESPONSE

At their Web site, the National Cancer Institute (NCI) still describes radiation therapy as a viable treatment for many cases of non-small-cell lung cancer.

At their professional PDQ Website they state, "[R]adiotherapy can produce cure in a small minority and palliation in the majority of patients" with NSCLC. For NSCLC stage II, they state that one treatment option is "radiotherapy combined with curative surgery." The source they give for this recommendation is EC Holmes, "Adjuvant treatment in resected lung cancer," Seminars in Surgical Oncology 1990;6: 263-267--a reference that is now eight years old. Similarly, for stage IIIA, they state that a viable treatment option is "surgery and postoperative radiotherapy." They continue: "Although most retrospective studies suggest that postoperative radiotherapy can improve local control for node-positive patients whose tumors were resected, it remains controversial whether it can improve survival." They do not cite the Lancet Meta-Analysis, although their own article was updated in September, 1998.

In their article on the topic for laypeople, they state that for stage II NSCLC, appropriate treatment may be "surgery and/or radiation therapy with or without chemotherapy." For stage III, it may be "surgery and radiation therapy." There is no mention of the fact that PORT may actually kill early-stage NSCLC patients sooner, or that it is ineffective in the later stages of the disease.

Patients facing postoperative radiotherapy (PORT) for lung cancer should bring the Lancet article to the attention of their physicians. It raises serious questions about the value of such treatments. You might be better off to just surgery alone, followed by a less invasive or harmful form of experimental treatment.


Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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