Government Reform and Oversight Committee
February 4, 1998
Dr. Ralph Moss
Mr. Chairman and Members of the Committee.
Congress was deceived when the war on cancer was launched
in 1971. Experts swore under oath that they would deliver
a cure for cancer in time for the Bicentennial (1976). That
is ancient history. But Congress continues to be fooled by
a new generation of experts" who testify that the war on cancer
is being won, and that all we need to do is trust them to
conquer this terrible disease.Recently, Dr. Richard Klausner,
M.D., director of the National Cancer Institute (NCI), appeared
before this Congress and claimed that we have turned the corner
in the fight against cancer. He promised that advances in
genetics were ushering in a golden age of research. However,
I believe that the rosy picture he paints is misleading.
Back in 1962, 278,000 Americans died of cancer.
Last year, cancer deaths were over 560,000, double the figure
of 35 years ago. Certainly, part of this increase is due to
the growth and aging of the population. But even when one
adjusts for these factors, the overall U.S. mortality rate
from cancer increased over 10 percent from 1950 to 1991. And
the incidence rate during that time increased nearly 50 percent.
There has been a leveling off in recent years. But we have
still witnessed a tremendous worsening of the cancer situation
throughout this century. In particular, the rates of lung
cancer have risen astronomically, more than 500 percent among
women. There has been a tripling in the incidence of melanoma,
and nearly a doubling of cases of prostate cancer and multiple
BREAST CANCER STATISTICS
Many of us are understandably alarmed at the prevalence of
breast cancer in America today. When President Nixon launched
the war on cancer in 1971, a woman's lifetime risk for contracting
breast cancer was one in fourteen. Today, it is one in eight.
Between 1973 and 1992, the incidence of breast cancer rapidly
increased by 34 percent, and among black women by 47 percent.
And the chances of being cured have not improved very much.
Since 1960, nearly one million American women have died of
breast cancer. Dr. Klausner has made much of the recent leveling
off or even downturns in some of the cancer statistics. These
However, a slight downturn in mortality does not make up
for millions of personal tragedies.
WHEN THE DIAGNOSIS IS CANCER
Let us consider what happens to a person who is diagnosed
First of all, there are the so-called "proven" methods, surgery,
radiation therapy and chemotherapy. Sometimes these are brutal
methods, that involve the loss or damage of body parts and
functions. Surgery is an ancient approach, known to the Egyptians,
Greeks and Romans. It is a sad commentary that this is still
the mainstay of therapy. New ideas are urgently needed in
the treatment of even so called "curable" cancers.
But what about those patients whose tumors are inoperable
or widespread at the time they are discovered? Similarly,
what about the patients whose tumors have returned after being
"successfully'' treated with "curative" therapies?
Such cancers are, by and large, incurable with today's conventional
methods. The best that conventional medicine has to offer
is palliation. And despite the war on cancer about half of
all cancer patients will eventually find themselves in this
What are they supposed to do?
THE PITFALLS OF CLINICAL TRIALS
If you read the statements of the NCI, they urgently appeal
to cancer patients to join their clinical trials. This message
is picked up and amplified by all the beneficiaries of the
war on cancer. You can even see it on billboards in airports.
A "clinical trial" is made to sound very attractive to cancer
patients. However, as the President's Commission for the Study
of Ethical Problems in Medicine stated (in 1983), "Patients
who are asked to participate in tests of new anticancer drugs"
should "not be misled about the likelihood (or remoteness)
of any therapeutic benefit they might derive."
In fact, there is little chance of therapeutic benefit to
patients in such trials. Studies in both the United States
and Japan have shown that only about one percent of patients
in Phase I clinical trials have a complete response to the
treatment, and only about 5 percent have any response at all.
You may think that five percent is not bad odds when you
are in a desperate situation. But here you have to understand
some of the peculiar terminology of the field. For a "response"
is not a "cure." Far from it. The FDA defines a response as
the shrinkage of 50 percent or more of the measurable tumors
for a period of one month or more.
It is a change in size of a mass. This might be important,
if the tumor is painfully pressing on a nerve or another vital
structure. But usually such shrinkages are absolutely meaningless
to the patient. It is essentially a numbers game played among
oncologists - who can shrink tumors the most. In the majority
of cases, these temporary shrinkages do not correlate with
an increase in median overall survival, which is the most
meaningful measurement of patient benefit in such trials.
Sometimes, in fact, a high response rate actually correlates
with a lower period of survival. It may do more harm than
I want to call your attention to the fact that these trials
can be very dangerous for patients. The drugs approved by
the FDA for treating cancer are all toxic. Some of them have
astonishing toxicity, especially when given in combination.
In one clinical trial of drugs on patients with the leukemia-like
myelodysplastic syndrome, 42 percent of participants were
killed by the treatment itself.
In another study, of a three-drug regimen called "ICE," 13
patients (8 percent of the total) died as a consequence of
the treatment itself, so-called "treatment deaths." But the
scientists in charge had the nerve to conclude that this regimen
was "well tolerated, with acceptable...side. effects and predictable
Acceptable to whom? Not the patients who died after contracting
raging bacterial infections, capillary leak syndrome, bleeding
inside the brain, and irreversible kidney failure - all caused
by these drugs. And certainly not their families.
This is the "scientific" approach of the NCI. Not surprisingly,
there is tremendous resistance among patients and doctors
to such trials. Only three to five percent of cancer patients
go into them. Many oncologists want nothing to do with them.
In fact, just 10 percent of all oncologists enroll 80 percent
of the patients in clinical trials.4 In New York oncologists
have given their patients small doses of standard chemotherapy
to make them ineligible for useless clinical trials.
LOOKING FOR ALTERNATIVES
Drugs that don't work clinical trials that measure meaningless
shrinkages, doctors who think that horrible side effects are
perfectly acceptable...no wonder cancer patients today are
desperately looking for alternatives. They are exploring the
realm of un-approved, complementary, non-toxic treatments
in record numbers.
You can be sure that one of the reasons the NCI and FDA so
hate these alternative treatments is that they siphon away
"adventurous" patients who might otherwise go into clinical
Historically, all of the agencies involved in the war on
cancer have lied about the nature of these alternatives. They
have painted a distorted picture of them as quackery. They
have prejudged them, refusing to carry out the most basic
tests that could evaluate their efficacy. Tests were only
performed under duress (often because the Congress insisted)
and these tests were at best ill-conceived and at worst marked
by outright fraud.
Yet the history of medicine tells us that many treatments
and techniques once considered"alternative" or "fraudulent"
later became an established part of the mainstream. Radiation
and chemotherapy themselves started out on the fringe. Acupuncture
was derided as "quackupuncture" for decades. But a recent
Consensus Conference of the National Institutes of Health
endorsed its use for such conditions as pain and nausea related
to cancer. The Office of Alternative Medicine (OAM) was established
by Congress at the National Institutes of Health precisely
because of the historic failure of the NCI to fulfill its
mission and examine all possible options in the fight against
cancer. But little progress has been made because of the intransigent
attitudes of the cancer establishment.
Are there frauds among the alternatives? Certainly. How can
we separate the wheat from the chaff ? We need good research,
with open-minded attitudes and adequate funding, to carry
out studies of these alternatives. The OAM is ready to perform
these studies. But the NCI stands in the way. Along with its
police partner, the FDA, it is the great roadblock to the
examination of promising new ways of treating cancer.
Dr. Klausner is betting on the genetic revolution to produce
a cure for cancer. Even some geneticists warn that cancer
breakthroughs, if they do come from this field, may be decades
away. I believe there is enormous potential in the various
alternative and complementary approaches to cancer.
In my book Cancer Therapy (1992), I discuss over 100 such
methods. One could add another hundred or so of promise. These
include vitamin and mineral regimens, herbal formulas, unusual
drugs from land and sea, immunological techniques, electromagnetic
treatments, and utilization of the mind-body connection.
On a recent trip to Germany I was astonished to see the scope
and freedom with which many progressive oncologists treat
cancer. They use a combination of the conventional approaches
with such things as tumor vaccines; mistletoe therapy; local,
regional and whole-body hyperthermia; thymus and other organ
extracts; fever therapy; orthomolecular and antioxidant therapies;
psychoneuroimmunology; music and art therapy; sports and physical
therapy; and many, many others. Their government not only
allows such approaches, but encourage and pay for them as
It is astonishing that the average American oncologist knows
little or nothing about any of these approaches. The FDA has
done everything in its power to block their development over
here. The NCI has not seriously examined a single one of these.
Our war on cancer has fallen woefully behind developments
in other parts of the world, not just Germany but Japan, China,
and many other countries as well.
The approach of the war on cancer has been relentlessly that
of chemotherapy. Reliable estimates put the sales of cancer
therapeutics at over S 12.3 billion this year. 5 Most of that
is controlled by American firms. And so it has been a big
business success story, with double-digit growth rates every
year for over a decade. But it has done little for the cancer
The FDA has approved approximately 40 drugs for the treatment
of cancer. But it has never approved a non-toxic agent or
one that was not patented by a major pharmaceutical company.
The approved drugs are all toxic and many of them cause second
cancers in those who are lucky enough to survive the treatment.
And the NCI, FDA, and comprehensive cancer centers are tied
by a thousand strings to the multi-billion dollar pharmaceutical
industry. Recently, a top FDA official went to work for Elan
Pharmaceuticals. But this is nothing new. Two past directors
of the FDA became drug company officials, as did Dr. Klausnerps
predecessor at the NCI. It is a time-honored tradition, the
Meanwhile, the FDA spends a good deal of its resources hunting
down and harassing those who use innovative methods in treating
They have carried out a vendetta against Dr. Stanislaw R.
Burzynski, MD, PhD, a Texas physician who has used non-toxic
peptides in the treatment of brain cancer and other kinds
of malignancy. They have repeatedly raided his clinic, seized
his records, harassed his patients. In 1995, they instigated
charges that would have put him in federal prison for life.
Luckily, the jury saw otherwise and Dr. Burzynski is a free
man. When I publicly objected to this harassment I myself
was slapped with a subpoena for all my information regarding
Dr. Burzynski. When I pointed out the illegality of this request,
and indicated my willingness to fight the FDA, the subpoena
was just as suddenly quashed by the U.S. Attorney.
FDA has also impeded the work of Dr. Georg Springer of the
Finch Medical School, who has developed a promising vaccine
for breast cancer. It has hindered the work of Arnold Eggers,
M.D., of Downstate Medical School, who has a promising treatment
based on concepts first proposed by William B. Coley a century
ago. And it has used its resources to attack the distributors
of non-toxic medications. The most recent victim was a distributor
of the non-toxic drug hydrazine sulfate, who was raided by
FDA enforcement agents on January 16, 1998.
The approach of the NCI and FDA is overwhelmingly in support
of toxic chemotherapy. They have abrogated their duties as
the defenders and protectors of the cancer patients. They
function today on behalf of the industry they were supposed
to challenge and oversee. They are the drug testing and law
enforcement arms of a vast $100 billion a year business, the
The promotion of toxic treatments and the venomous hatred
of alternatives is not restricted to court battles. Both FDA
and NCI are active in the court of public opinion, trying
to destroy confidence in any non-toxic or less-toxic treatment.
Their main vehicle in this regard is the Cancer Information
Service of the NCI. Their reckless attacks on alternative
and complementary treatments are disseminated at taxpayer's
expense via print, fax, and especially the Internet.
Their statements are filed with prejudice, errors and innuendo.
Each one contains an "advertisement" for NCI's clinical trials.
When I was an advisor to the Office of AlternativeMedicine,
I tried to find out exactly who wrote these erroneous statements
and what sort of "peer review" they possibly could have undergone
before being released. I never could find out. It is clear
that no bona fide experts were involved in their creation,
and that the proponents of such methods were not consulted
or even interviewed before these statements were drawn up
These harmful, hateful statements have become an integral
part of the "war on cancer" which, quite frankly, more often
looks like a "war on alternative practitioners" than a war
on any disease. Treatment approaches that threaten the hegemony
of the drug industry are prone to vicious attack.
The NCI's statements on alternative and complementary cancer
treatments should be immediately withdrawn. New statements
that are factual and unbiased, should be drawn up for release
by the Cancer Information Service.
The statements that have already been prepared by Dr. Mary
Ann Richardson and her group at the University of Texas School
of Public Health could provide a good starting point for these
REFORM OF FDA
In addition, the FDA should be reformed so that it no longer
exerts a stranglehold on innovators in cancer treatment and
diagnosis. That is why I strongly support passage of the Access
to Medical Treatment Act and urge you all to cosponsor this
The FDA does little to protect citizens from the ravages
of chemotherapy, which is overwhelmingly given without any
proof of patient benefit. In the past, FDA at least paid lip
service to the idea that anticancer drugs should extend life
or improve quality of life. But in 1996, they caved in and
agreed that new drugs could be approved based on partial remissions
in clinical trials. Such partial remissions are nothing but
the shrinkages of tumors. As we have shown, such temporary
and partial shrinkages do not necessarily lead to improvements
in survival or quality of life.6
Finally, Mr. Chairman and members of the committee, I have
an urgent request.
In August, 1997, the Office of Alternative Medicine (OAM)
in conjunction with the National Cancer Institute (NCI) convened
a meeting in Bethesda, MD to consider how they could evaluate
the practices of doctors who use unconventional methods to
treat cancer. The name of this meeting was POMES, which stands
for "Practice Outcomes Monitoring and Evaluation Systems.
Over 100 leaders of the cancer field attended, including not
just alternative researchers and practitioners, but the director
of the Comprehensive Cancer Center of the University of Wisconsin,
the president of the American Health Foundation, two department
chairs from Memorial Sloan-Kettering Cancer Center, representatives
from major food companies, and many others.
There were great hopes for this meeting, since we were told
that it was funded by Dr. Klausner's office at the NCI. Perhaps
this signaled a change in attitude at NCI, the change we have
all been waiting for. But not only was Dr. Klausner unable
to attend, but his key deputy, Robert Wittes, M.D., Director
of the Division of Cancer Treatment, Diagnosis and Centers,
also failed to put in an anticipated appearance. The FDA and
NCI scientists who did appear lacked decision-making power
in this area.
After several days of heated discussion, the participants
finally hammered out statements that could lay the basis for
future evaluations of alternative cancer treatments. It felt
like history in the making. These guidelines called for the
creation of an Oversight Board, a body of experienced people
who could guarantee a "level playing field" in the evaluation
of alternative practices. No longer would NCI have complete
power to serve as lawyer, judge and jury in every case.
Most of the participants left that meeting excited by the
prospects before us. Then, silence. Since August, we have
not received a single official communication regarding POMES.
Has POMES died a natural death...or did someone kill it?
I know for a fact that the problem does not lie with the
Office of Alternative Medicine, whose leaders remain enthusiastic
about the prospect of fairly evaluating such treatments. I
can only conclude, therefore, that the roadblock is the top
leadership of the NCI and possibly the NIH as well.
You have to ask yourself why these high-placed medical leaders
so fear an impartial test of unconventional approaches to
cancer? Why do they hate the idea of an impartial Oversight
Board, which could detect fraud or malfeasance on either side
of the cancer controversy?
Perhaps they are afraid of the competitive threat such non-toxic
and less-toxic methods might pose to the cancer industry?
Do they fear the ridicule of prejudiced colleagues? Or perhaps
they fear the repercussions in Congress, if it turns out that
an effective treatment for cancer was overlooked - or even
suppressed - by NCI and FDA?
Mr. Chairman, I urgently appeal to you to help revive POMES.
I am sure you agree that patients and their caregivers need
reliable information about the safety and potential effectiveness
of alternative and complementary cancer treatments.
Many American citizens are impatient with the foot-dragging
at NCI and the obstructionism of the FDA. Yet we as individual
citizens have no way to force these agencies and individuals
to act properly or fairly. It is up to you, our elected representatives,
to do that. There is no time to waste. Since August, another
270,000 Americans have died of cancer. Many of them were desperately
seeking reliable scientific information on alternatives at
the time they died.
The Congress created the CAM to bring about the fair evaluation
of alternative methods. Weappreciate the fact that you have
increased OAM's funding to $20 million this year. It is a
heartening vote of confidence in the future of this field.
And, in some respects, under the leadership of Wayne Jonas,
M.D., it has done a brilliant job. But OAM by itself does
not have the political clout to force the testing of alternative
cancer treatments. That is the main reason that OAM has not
carried out a single evaluation of a controversial cancer
treatment. It has not and it will not, because at every turn,
the NCI has been there, insisting on a major role. It now
turns out that the role NCI wanted was to block and obstruct
such trials from taking place.
BLOCK NCI'S APPROPRIATIONS!
Just one month ago, Dr. Klausner appeared before the Appropriations
Committee and requested S2.2 billion for his agency for fiscal
year 1998. This is an increase of $61 million over last year.
I am here to ask you to do everything in your power to block
that appropriation until NCI changes its attitude towards
alternative and complementary treatments. As a first step
they should actively implement the POMES process.
In his speech to Congress, Dr. Klausner stated that "there
is no one intervention or even one type of intervention that
will successfully conquer the many diseases we call cancer.
Our approach must be open and broad-based.
Fine words! But it happens to be the exact opposite of the
course that NCI is actually pursuing. It is only an aroused
Congress that can make Drs. Klausner and Wittes open the doors
of NCI to alternative treatments. They must not be allowed
to serve as a branch of the pharmaceutical industry, but must
be convinced to test a wide variety of treatments, as they
are currently practiced around the world. If these individuals
will not comply, they should be replaced by open-minded scientists
Mr. Chairman, for the 1.2 million Americans and the 9 million
people worldwide who will develop cancer this year, such reforms
cannot come a moment too soon.
1 Ries, LAG, et al. SEER cancer statistics review. 1973-
1991, Tables and Graphs, Bethesda,NCI, 1994.
2 J Clin Oncol 1996;14:287.
3 J Clin Oncol 1995;13:323
4 J Clin Oncol 1994;12: 1796
5 Frost & Sullivan, World cancer therapeutics markets [executive
summary]. Mountain View,CA: Frost & Sullivan, 1993. Cited
in Moss, Questioning Chemotherapy, p.75.
6 Stout, H and McGinley L. Cancer drugs to get speedier FDA
review. The Wall Street Journal,March 29, 1996.