Comprehensive Cancer Care: Integrating Complementary & Alternative Therapies
Healing Ourselves, Healing Our Planet
Samuel Epstein, MD
June 12, 1998 .
The title of my talk is "Healing
Ourselves, Healing Our Planet." Healing, in the fullest meaning, reflects
a complementary duality of prevention and treatment, both on a macrocosmic
level as far as environment is concerned, and a microcosmic level as far as we
personally are concerned. Losing the war against cancer, losing a winnable war
against cancer, is a paradigm of failed healing. This reflects
institutionalized failure to prevent cancer, in spite of overwhelming
documented evidence on its avoidable causes.
It also extends to institutionalized failure
to recognize that the claims for major advances in the treatment of cancer
the institutionalized failure to recognize that there is little evidence for
efficacy for the overwhelming majority of cancer chemotherapeutic agents. Dr.
Wittes this morning, in his very well-balanced address, talked about the need
for the respect for evidence. Such respect for evidence demands a frank and an
open dialogue.
A frank and open dialogue has got to extend
today to the following: First of all, are we losing the winnable war against
cancer? My answer is yes. Two, is there any evidence for decline, significant
decline, in the escalating incidence and mortality rates? The answer is a
qualified no. Thirdly, is there evidence of institutionalized recognition of
the importance of prevention? The answer, with some rare but important
exceptions which I will point out, is no. And finally, Ill discuss the
question of efficacy, the dual standards that persist for evaluation of
conventional chemotherapy and also alternative chemotherapy.
Let me just give you a little bit of
history. In December 1969, a full-page advertisement appeared in The New York
Times. The headline was "Mr. Nixon, You Can Cure Cancer." It was paid
for by the Citizens Committee for the Conquest of Cancer, headed by my old
boss, Sidney Farber. (I was with the Children’s Cancer Research Foundation, now
known as the Dana Farber Center, for 10 years, and know Mary Lasker and Solomon
Garb.) Farber went on to say, "Were so close to a cure for cancer. We
lack only the will and the kind of money and comprehensive planning that went
into putting a man on the moon. Why dont we try to conquer cancer by Americas
2000th birthday?"
Farber was the key man who helped set up a
national panel of consultants to the Senate on the conquest of cancer. Shortly
after these headlines appeared, Farber sent me a draft of the plan for the
conquest of cancer, with a request that I come and give him my comments on it.
One reason Farber sent this to me was that, at that time, I was a consultant to
Senator Randolph and Senator Muskie, and the Committee on Public Works. We were
drafting legislation on air and water pollution. We had just drafted
legislation on toxic substances regulation. Farber thought it might be an
interesting idea to have an additional perspective on this.
A week or so later I went back to Dr.
Farber, and he said to me, "What do you think about it?" I said,
"Sir, its a wonderful dream, but I see little basis of evidence for these
expectations. Furthermore, I am somewhat puzzled by the fact that the word
prevention is not mentioned once in this report." He said, rather
irritably, "Youve got to understand. Preventions got nothing to do with
us or the National Cancer Institute. We are scientists, and you, sir, should be
more the scientist, and leave prevention to the politicians and regulatory
agencies." That was that.
On the 23rd of December, 1971, President
Nixon launched the war against cancer, and the objectives of the National
Cancer Act were severalfold. First, make NCI semi-autonomous, so the budget
could be presented directly to the Office of Management and Budget and not go
through the director of NIH. Secondly, establish national cancer centers. The
exclusive fixation on treatment and diagnosis virtually no mention of prevention.
And finally, substantially increase the NCI budget. The NCI budget in 1971 was
about $223 million. By 1972 it went up 70% to $379 million. It progressively
escalated, and from 1972 to 1979 it went up from $379 million to $3.2 billion.
Thats a tenfold increase. Now a very crude question that arises from that is,
what have we got for our money?
First of all, about incidence and mortality
and cancer survival rates. From 1950 to 1994, the incidence of cancer on an
overall basis went up by 53%, about 1% an annum, and this has been maintained
over recent years from 1973 to 1994 it's gone up about 23%. Thats overall.
Now as far as age distribution is concerned, rates over 60, 65 are roughly
tenfold the rest of the ages under 60, 65. Don't forget these are
age-standardized data. It's not an expression of increased longevity of the
population. Cancer affects all ages. Childhood cancers, brain and other system
cancers in children have gone up by 38% in the last two decades or so.
Non-Hodgkin's lymphoma, multiple myeloma, melanoma, testicular cancer, kidney
cancers, a wide range of non-smoking cancers.
Incidentally, as far as the overall increase
in cancer rates since 1950, when you subtract lung from them (the major cause
of lung cancer is smoking), you find that lung only is responsible for about
28% of the increase. We also know that there is a wide range of other causes of
lung cancer besides smoking. Nevertheless, there is no question that smoking is
the single most important cause of cancer, no question at all about that. Of
course, you have high-risk groups. You have occupational groups, and in some
occupational groups we find rates of cancer over tenfold those of the rest of
the population. You've got second generation cancers. By second generation cancers
I mean that we have very, very strong evidence that children born to men and
women working in various industries exposed to a wide range of petrochemical
and other carcinogens have very high excesses of childhood cancers. And then we
have the ethnics.
Let's now turn to the recent NCI report card
which was mentioned this morning. This was based on a comparison of cancer
rates between 1973 and 1990, and 1973 to 1995. This report was heralded by a
statement, "Recent reversal of an almost 20-year trend of increasing
cancer cases and deaths." What we're seeing, according to the National
Cancer Institute, based on this 1998 press release, is a dramatic recent
reversal. Now lets just examine this. As far as mortality is concerned, a 3%
reduction in cancer mortality was claimed. In fact, this is largely due, not to
any successes in treatment, but to reduction in smoking, particularly in males,
and to increased access to health care. Secondly, with due respect, these
figures could be regarded as statistically questionable. A 3% drop could be
regarded as statistically highly questionable because it was based on age
standardizing to 1970, rather than more appropriately to 1990. When you do the
mathematics of it, you find that this 3% increase actually is only a 1%
increase. However, one shouldn't trivialize that. But more importantly, this
statement of the reversal in the trend was unaccompanied by any evidence of
improved survival rates.
Let's look at incidence. A reduction in
incidence was claimed for all sites, for leukemia and prostate and all sites,
but this was statistically insignificant. Also it was admitted when it came to
prostate that in fact this may represent overdiagnosis because of PSA
screening. In fact, when you look at other sites you find major increases, like
statistically significant increases for uterus, melanoma, non-Hodgkin's
lymphoma, for breast cancer it was admitted there was no change. There was no
data, interestingly enough, for two of the cancers for which we've seen the
most dramatic increases, testicular cancer and childhood cancer. The childhood
cancer rates, particularly brain and nervous system, have gone up nearly 40% in
two decades. For testicular cancer were seeing rates of increase in men from
28 to 35 of nearly 250%. No reference at all was made to that.
Now let's look at the five-year survival
rates. Lets look from 1974 to 1994. If you look at the whites and blacks
together, the total population, the changes were from 49 to 54%. This is pretty
small and minimal, but significant. In general this represents early diagnosis,
what we call "lead time bias." For instance, if you have a patient
with lung cancer, and he comes to you with a great big mass in his chest, and
you base your survival rates on that, thats one thing. But if you do sputum
cytology and specialized investigations, you'll pick up this lung cancer about
six months or a year earlier, and that will extend the so-called survival
times. We also have overdiagnosis of certain cancers like ductal carcinoma in
situ for breast cancer and also for pre-invasive prostate cancer. When you look
at the five-year survival rates for most cancers, you see very little evidence
of improvement over the last few decades.
Now let me broaden the perspective of this
by telling you something about the concerns of the public health community and
independent experts in cancer causation and prevention. On February 4, 1992, a
press conference was held at the National Press Club. On behalf of some 65
leading public health scientists, experts in preventive medicine, cancer causation,
including past directors of federal agencies, NIOSH, National Institute for
Occupational Safety and Health, National Institute for Environmental Health
Sciences, Occupational Safety and Health Administration, the following
statement was released: "We express grave concerns over the failure of the
war against cancer since its inauguration by President Nixon and Congress on
December 23, 1971. This failure is evidenced by escalating incidence of cancer
to epidemic proportions over recent decades. Paralleling and further
compounding this failure is the absence of any significant improvement in the
treatment and cure of the majority of all cancers. Notable exceptions are
successes with some relatively rare cancers, particularly those in children. We
express further concerns that the generously funded cancer establishment, NCI,
ACS and some twenty comprehensive cancer centers, have misled and confused the
public and Congress by repeated claims that we're winning the war against
cancer. In fact, the cancer establishment has continually minimalized the
evidence for increasing cancer rates, which it has largely attributed to
smoking and dietary fat, while discounting or ignoring the causal role of
avoidable exposures to industrial carcinogens in air, food, water and the
workplace. Furthermore, the cancer establishment and major pharmaceutical
companies have repeatedly made extravagant and unfounded claims for dramatic
advances in the treatment and cure of cancers. Such claims are generally based
on initial reduction in tumor size, tumor response, rather than on prolongation
of survival, let alone on the quality of life, which is often devastated by
highly toxic treatment."
Reflecting these concerns, the group of
experts made recommendations including the following: "The NCI must give
cancer cause and prevention at least equal emphasis, in terms of budgetary and
personal resources, as its other programs, including diagnosis, treatment and
basic research. This major shift in direction should be initiated immediately
and completed within the next few years. This shift will also require careful
monitoring and oversight to prevent misleading programs under the new guise of
cancer cause and prevention. The NCI should provide Congress and regulatory
agencies the scientific expertise necessary in the development of legislation
and regulation of carcinogens. The NCI should be enjoined from making or
endorsing claims for cancer cures unless these are clearly validated by data on
reduced mortality rates, and unless they conform to standard regulation on
claims of therapeutic efficacy."
It should be recognized that claims for
therapeutic efficacy, as you know, as far as cancer chemotherapy, are tumor
response, in other words, a shrinking in the size of tumors by about six months,
irrespective of what happens after that. And, in fact, we have substantial
evidence that initial tumor response bears little or no relationship to
survival.
Let' briefly turn to the position of the
National Cancer Institute and the American Cancer Society on prevention. The
basic professional mindset of the NCI and the ACS is on diagnosis, treatment
and basic research. With the exception of smoking, on which the Surgeon
General's 1964 report had a trailblazing impact, they have really paid little or
no attention to overwhelming well-documented scientific data on a wide range of
avoidable causes of cancer. At the same time, there's been a tendency to
explain away escalating cancer incidence rates as due to aging of the
population and smoking. What is ignored is the 100% or greater increase in the
incidence in recent decades of a wide range of non-smoking cancers, including
multiple myeloma, non-Hodgkin's lymphoma, testicular cancer, etc.
The National Cancer Institute and American
Cancer Society have both stated categorically that breast cancer is simply not
a preventable disease. And the American Cancer Society states that there's
nothing a woman can do to reduce her risks of breast cancer. This is blatantly
questionable. Theres a strong body of evidence incriminating a wide range of
lifestyle factors, wide range of medical factors, including prolonged use of
the pill, starting in adolescence, prolonged use of estrogen replacement
therapy, and environmental and occupational causes.
Many of you may not know that over a million
women are exposed in the workplace to agents which have been clearly identified
as causes of breast cancer. To say that there's nothing a woman can do to
prevent risk of breast cancer is highly questionable. An even more disturbing
trend is recent statements by NCI trivializing the significance of animal
carcinogenicity tests. These have been repeated by senior representatives and
spokesmen of the NCI. The ACS has a long-term record for dismissing animal
carcinogenicity tests, and actually for fighting the Delaney Amendment, the law
that says thou shalt not add any carcinogen to foodstuffs.
Let's review some recent damage control
initiatives in regard to this area of prevention. You heard some claims this
morning that we've turned the corner. Within a decade or so, were told,
incidence and mortality rates will drop to this or to that. In 1984, the Cancer
Prevention Awareness Program assured the nation that there will be a reduction
in mortality rate to half the 1980 rate by the year 2000. In 1984 there was an
unequivocal statement and assurance that mortality rates will be reduced to
half the 1980 rates by the year 2000. In fact the rates have increased. In
1994, NCI put out a report called "Cancer at a Crossroads." There was
a frank admission that we've lost the war against cancer. However, the reasons
were that NCI doesnt have enough money, hasnt been given enough funds, and
even more importantly, NCI has not been offered a position at the White House
on the Cabinet level. That was a good one I thought.
In April 1996, a Cancer Prevention Program
Review Group was appointed, of 19 non-governmental experts, to prepare a report
on cancer prevention. There were discussions on the need for behavioral
modification and genetic predisposition, etc. The word prevention received
minimal, minimal reference, and was dismissed by saying this isnt really a job
for NCI. It really belongs to the regulatory agencies.
In September 1997: Cancer Control Program
Review Group. This equates cancer prevention with behavioral modification, or
what we used to call "blame the victim." If only we could teach
people to be more intelligent about the way they lived, you'd have no problem
with cancer. Not a single word about occupational and environmental causes.
November 1997: Consumer Liaison Group. This
was composed of cancer survivors only, with no interest or representation of
prevention.
Let's now talk about some of the recent
discussions on budget. The NCI in its blueprint request to Congress for 1999
asked for $3.2 billion, saying that, a quote from Klausner, "Knowledge
about the fundamental nature of cancer is exploding." Emphasis there was
placed on genetics, diagnosis and treatment. Not a single word on prevention.
Let's see how the budget is spliced down.
The Division of Cancer Prevention and Control, in 1992 when the budget was
about $2 billion or so, received $500 million. The Division of Occupational
Research received $20 million, less than 1% or just about 1% of the total
budget. At the same time as these discussions were going on, NCI has upped the
ante, and in recent discussions and questioning from Congressman Obie, they
insisted that they need $5 million by the year 2003.
Let's again go back a little more to
history. In January 1995 the National Coalition for Cancer Research came out
with a program, Research Cures Cancer. This was entirely sponsored by the
cancer drug treatment industry.
In October 1997, the launching of the
Million Man March on Washington, headed by Schwarzkopf. This was to encourage
government to increase woefully inadequate funding for research to cure cancer.
This encompassed hundreds of events nationwide, and was largely supported by
cancer industry groups with minimal other funding. With this barrage of recent
onslaughts and claims, no wonder the public has been misled into believing that
cancer rates are not on the increase, and that were making dramatic increases
in treatment and survival.
Let's very briefly talk about the new
generation of cancer drugs. Youve all seen these headlines recently announcing
the latest newest generation, which is going to really solve the problem. Ill
just quote the following: "The first reports from the laboratory
electrified the scientific world. Researchers had inoculated mice with cancer
causing cells, then treated half the mice with salt water, and the rest with a
mysterious biochemical substance. The mice that got the salt water were dying
of cancer, while those that received the new treatment were tumor free."
That headline is from 1967, referring to
Interferon, and with these headlines the M.D. Anderson Center was basically
founded. Reflecting the belief that Interferon was going to be the answer to
cancer, M.D. Anderson was founded. There is an interesting recent development
with the M.D. Anderson Center. At the beginning of this year they sent out a
brochure, a fund-raising appeal, asking for more money. This is very
reasonable, but they said one in every two cancer patients coming to our center
is cured of cancer. Now that was, I thought, remarkable. There must be
something Id been missing out on. An attorney, Robert Novak, has recently
filed a False Claims Act against the M.D. Anderson Center demanding evidence of
this.
The history of cancer chemotherapy over the
last few decades is littered with a highly touted array of cancer drugs, tumor
necrosis factor, alpha interferon, monoclonal antibodies and interleukin-2. The
initial promise of success for each was greeted with a flurry of breathless
headlines. With subsequent realization of high toxicity, drug resistance
following temporary tumor response, and failure to improve survival rates,
initial enthusiasm was followed by sober reality and disillusion.
We are seeing now a new generation of
bio-technology drugs, which we could call bio-therapies. Theyre based on
naturally occurring proteins or genetic materials which are more specifically
focused in their action and with less or minimal toxicity. They include
anticancer vaccines, antisense gene therapy, matrix metalloprotein inhibitors,
more specific monoclonal antibodies and angiogenesis inhibitors. There have
been some particularly interesting examples, such as the monoclonal antibody
Herceptin, for treatment for breast cancer, and Rituxin for non-Hodgkins
lymphoma. However, in the absence of any evidence of improved survival rates,
which will take many years to develop, most oncologists and the media are
reacting with certain qualified caution.
As far as angiogenesis inhibitors are
concerned, theres no question that the work of Folkman over the last 30 years
has been terribly important. However, I should point out that there are serious
questions. First of all, the trials with TNP-470, which was one of the
angiogenesis inhibitors, had, to say the least, very poor or limited success.
Secondly, there's been no consideration at all of problems of effects on
healing, ovulation, menstruation, fetal development. Nevertheless, these are
important developments which shouldn't in any way be dismissed. We hope that
something is going to come of it. But I should point out that the evidence for
these angiostatins comes entirely from studies on mice. The mouse screening
test was abandoned by NCI some five or six years ago as being unreliable and a
poor predictive indicator of efficacy. And yet on the basis of this jettisoned
screen, these very, very exaggerated claims were made.
Now, as far as chemoprevention of breast
cancer is concerned, you've heard reports about remarkable successes with
tamoxifen in chemoprevention, attempts to prevent breast cancer in high-risk
women. This drug has been clearly shown some seven or eight years ago to be one
of the most potent liver carcinogens that have been described in the
literature. In addition to being very potent in terms of producing a high incidence
of liver cancers at very low dose rates, it induces stable DNA adducts, which
is very exceptional. The women in these trials have never been informed about
these risks (nor were the women in planned trials with Evista informed of the
serious risk of ovarian cancer).
When you actually dissect the results of the
tamoxifen trial, you find that, while indeed there has been a reduction in the
incidence of invasive breast cancer over a very short study period, and in fact
the reduction was about 1.7%. The incidence of complications, sometimes fatal
complications, has gone up to about 2.2% fatal complications including
pulmonary embolism, deep vein thrombosis, uterine cancer, and cataracts. I have
similar reservations when it comes to the planned trials on Evista for which
the evidence, or suggested evidence, of efficacy comes from only studies on 50
women which havent been published.
Finally, I'd like to illustrate my overall
thesis with a brief discussion of non-Hodgkins lymphoma. The current status of
non-Hodgkin's lymphoma offers a very powerful paradigm of NCI's and ACS's
unbalanced policies and priorities with regard to research on cancer treatment
and related genetics in contrast to research on outreach and prevention. The
age-adjusted incidence of non-Hodgkin's lymphoma has escalated dramatically by
nearly 200% from 1950 to 1994. Decades of research on chemotherapy and genetics
have met with extremely limited therapeutic success, although we're all holding
our breath when it comes to Herceptin therapy. Yet, a substantial body of
well-documented data since the 1970's, including some from NCI's minimally
funded comprehensive occupational study section, has provided substantial
evidence on occupational exposures to pesticides and the cosmetic use of hair
dyes as major avoidable causes.
For instance, we have started showing up to
a sevenfold increased risk in farmers exposed to 24D herbicides for over two or
three weeks a year. Also, we have evidence that the use of black and dark brown
permanent and semi-permanent hair dyes accounts for 30% of non-Hodgkin's
lymphoma in women. In spite of all of this, in spite of this well-documented
evidence, NCI and ACS have not provided a scrap of evidence to the public. They
have not gone to Congress and advised them of this and a wide range of other
well-documented scientific information on avoidable causes of numerous cancers,
cancers involved in the escalating rates over the last few decades. They have
never developed any public outreach. You heard this morning about the great
public outreach of NCI and ACS. Not a word goes out on avoidable causes such as
non-Hodgkin's and these two sets of causes of cosmetic hair dyes and pesticides
and herbicides. This is illustrative of a professional mindset.
In addition to these questions of
professional mindset of NCI and ACS, which are fixated on diagnosis, treatment
and basic research, to the exclusion (when it comes to treatment) of
alternative medicine, there have been very serious questions of conflicts of
interest. These I have documented and published in great detail.
I believe that if we are to have a frank and
open dialogue, we have to recognize that there are strong hurdles to be
crossed. Some stark truths have to be recognized and accepted. We can't have a
cosmetic discussion of a need for dialogue and establishment of committees with
a pre-set dialogue. We have to recognize there is a profound schism between the
NCI and the ACS and various public health and preventive medicine experts.
These are experts interested in cancer prevention in a wide range of areas.
Thank you so much.