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
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.
