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Conventional medical journals often publish case reports, that
is, descriptions of individual patients whose disease might have
taken an unusual course in response to some new treatment. Such
“anecdotal” evidence, as it is technically called, contrasts with
a controlled clinical trial, in which different treatments are given
to large groups of patients with a particular illness, and the results
compared. Some scientists stubbornly insist that only such rigorous
exercises, ideally pursued under the most stringent rules and regulations,
can “prove” to everyone’s satisfaction that a new treatment for
a disease has any value. They often argue that case reports, these
histories of individual patients, though perhaps interesting or
entertaining, have little scientific merit.
My mentor Dr. Good, one of the finest scientists of the 20th century
and the most published author in the history of medicine, always
insisted case reports, if properly written and carefully documented,
can teach us much about the potential of a new approach. When I
first began to evaluate Kelley’s records, Dr. Good said that if
I could find even one patient with appropriately diagnosed, biopsy
proven metastatic pancreatic adenocarcinoma who had lived five years
under Kelley’s care he would be impressed, since no one else in
medicine anywhere to his knowledge had such a case. Dr. Good’s knowledge
was indeed extensive, since he was at the time President of Sloan-Kettering
and an expert in the disease. A single example might not prove to
everyone’s satisfaction that the enzyme therapy had value, but it
certainly should grab the attention of any fair-minded researcher.
In terms of cancer, a case report, to have value, must meet certain
basic criteria; as a start, the diagnosis must be confirmed by biopsy,
and the stage by appropriate radiographic studies or surgical procedures.
Then, the unusual response to treatment must be carefully defined,
carefully explained and carefully documented. The endpoints of most
importance for cancer case reports include objective evidence of
improvement in the underlying disease, or unusual prolonged survival.
For patients with the typical solid epithelial tumors, disease
regression can be verified by serial radiographic studies, such
as PET or CT scans. For blood cell malignancies such as leukemia
or myeloma, normalization of blood parameters, such as white count
or blood protein, might be the marker followed over time.
Survival, if particularly unusual, can be a valid endpoint with
or without evidence of disease regression. If this be the chosen
criterion, the patient in question must have lived far beyond the
accepted medians and means for the disease. Such information on
expected survival can be culled with some effort from a number of
sources, both governmental and private, so comparisons can be made.
The SEER
and American
Cancer Society websites, for example, provide survival statistics,
including medians and means, for many cancers. However, no precise
definition of “significantly” prolonged survival really exists,
so it becomes more of a judgement call in each case. When I first
presented at the NCI in July 1993, Dr. Michael Friedman, then Associate
NCI Director, said that if a patient of mine diagnosed with inoperable
pancreatic cancer lived three months beyond the reported mean of
six months, he wouldn’t be impressed, whereas survival six months
in excess of the standard averages would be meaningful. Of course,
absolute values for “significance” will vary from cancer to cancer:
six months of extra life might be unusual for a patient with a pancreatic
neoplasm, but not so for a woman with metastatic breast cancer.
In this case, two years beyond the mean would, to me, indicate an
interesting response to treatment.
Traditionally the National Cancer Institute, which sets the standards
for all oncology worldwide, hasn’t considered survival as a valid
endpoint, only objective response as documented by radiographic
or other tests. At the time I presented to the NCI in 1993, for
epithelial cancers the NCI experts defined “response to treatment
“ as a 50% or greater reduction in tumor size that lasted at least
four weeks. Unfortunately, as it has turned out, many chemotherapy
drugs easily shrink tumors to this degree and within this time span,
but the patients live no longer than if they had received no therapy.
Tumor reduction, in chemotherapy studies, generally does not translate
into longer life for the patient. Though the phenomenon has long
perplexed the research establishment – logically, one expects if
tumors shrink, patients should live longer - scientists now recognize
that chemotherapy may kill the less aggressive population of cells
and shrink tumors nicely, but then leave a small drug resistant
clone that quickly takes over and proliferates explosively. So,
the selection for more virulent cells cancels out the initial benefit.
In any event, I have long believed this particular definition of
response, 50% reduction lasting four weeks, to be rather meaningless,
since patients care more about their length of life, not necessarily
the size of their tumors.
With our treatment, Dr. Isaacs and I learned early on that at times
tumors will reduce significantly or blood parameters will improve,
to the great joy of patients, but at other times, the disease does
not objectively regress, but instead stabilizes. We find patients
in the “stabilized” group often survive as long as those enjoying
radiographic or laboratory evidence of benefit, as long as they
determinedly stick to their nutritional regimen.
During my 1993 NCI presentation, though
I discussed a number of patients from my practice with documented
disease reduction on standard testing, I also described several
cases with long term stabilization without proof of regression.
I argued that in such instances the unusual survival should be considered
as a response, regardless of what the radiographic or blood tests
showed. I know if I had cancer, and had a choice between ten year
survival but no radiographic evidence of improvement, or a six week
lifespan but impressive tumor reduction, I would choose the former
within about a millisecond. Though I hardly assume my comments influenced
anyone’s thinking at the NCI, today the scientists there have reworked
their definition of response to include not only radiographic or
laboratory evidence of regression, but significantly enhanced survival,
with or without correlating “objective” documentation.
In the following case reports, I describe patients appropriately
diagnosed with cancer who have survived far beyond what normally
would be expected for their situation. For most, but not for all,
I also provide evidence of tumor regression, often with complete
resolution of their disease.
I would also like to make a point or two about our practice in
general. Over the years, I have repeatedly heard the claim, from
any number of sources, that Dr. Isaacs and I must be processing
and treating thousands and thousands of new cancer patients each
year. This is simply not the case, nor will it ever be, for a number
of reasons. First of all, our approach to patients is extremely
time consuming, requiring Dr. Isaacs or I spend at least 4-5 hours
with each new patient divided into two sessions over two separate
days. Our patients tend to be very sick people with often very long
and complicated stories, so even basic history taking can be laborious.
Furthermore, we individualize each protocol, also a time intensive
process. Then, we must spend hours with each new patient reviewing
the details of our complex therapy, which for most will be very
new and oftentimes very bewildering. Few, for example, will have
experience with coffee enemas prior to meeting one of us.
Our practice is not local in nature, and in fact most patients
live some distance from New York. Consequently, Dr. Isaacs and I
spend considerable time each day on the phone – in my case at least
two hours daily - dealing with the inevitable questions that come
up regarding the protocol and its management, as well as the medical
issues that our patients encounter as they fight their disease.
Since most of our patients have serious medical conditions, even
office visits can run up to 90 minutes - not the ten minutes most
conventional physicians might allocate. We don’t have a revolving
door, assembly line practice, nor would we want to. On the other
hand, such time commitments reduce the number of new patients we
can possibly see in any given week.
A good friend of mine, a scientist by training and a strong supporter
of what we do, recently remarked that I must be seeing “350-450”
new cases of pancreatic cancer yearly, because we are well known
for our success with this particular illness. I still don’t know
how he came up with these numbers, but he was completely surprised
when I told him in reality we might see a handful of new pancreatic
patients a year, and no more. True, we do get many calls from those
diagnosed with the disease, but most have already been heavily –
and unsuccessfully – treated with aggressive chemotherapy and radiation.
By the time they learn of us and call the office, most have already
deteriorated into the final terminal stages of the disease, at a
point we cannot help.
I also want to add that a substantial number of patients, perhaps
30% of our total practice, come to us with non-cancer problems,
such as chronic fatigue, multiple sclerosis, environmental illness,
and any manner of situations for which orthodox medicine offers
little. We don’t treat only cancer.
So, with those thoughts in mind, I present the following case reports,
culled from our files.
Individual Cancer Types
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