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Concern with the abuse of patients submitted to trials of toxic
chemotherapeutic combinations has lead to a move to increase the
regulation of doctors offering unconventional treatments for cancers(1).
In the US there is pressure to confine all new treatments for cancers and
even to restrict treatment of all cancers to NIH-approved cancer centers
run by oncologists and/or "cancer surgeons". Whilst these moves might
limit the abuse of chemotherapy they might not lead to dramatic
improvements because newly certified "cancer surgeons" have yet to prove
they are capable of performing large cancer operations with no mortality
and few complications. The reality is that the best surgeons may not be
"cancer surgeons" or even subspecialists such as upper gastrointesntinal,
colo-rectal, and pancreatioco-biliary and hepatic surgeons. In the US the
best surgeons treating gastrointstinal cancers are gastrointesitnal
surgeons, a subspecialty "without anatomical borders"(2).
The most effective treatment for gastrointestinal cancers is
undoubtedly surgical excision with or without the removal of involved
lymph nodes. Patients continue to die from local extension and metastatic
disease often from primary surgical failure and/or from the failure of
radiotherapists and /or oncologists to appreciate the need for more timely
and/or effective surgical treatment for primary cancers, residual disease
and/or recurrences and the limitations of their own treatments.
Radiotherapy can be effective primary treatment for small cancers. When
combined with surgery and/or with chemotherapy for the treatment of larger
tumours the likelihood of local spread may be reduced and life survial
may even be prolonged. The studies documenting these incremental
improvements have, however, not been controlled for the large variations
in surgical skills which undoubtedly exist, the development of shock
and/or the number of blood transfusions received (3). It is possible
that the recommended adjuvent therapies have little or no benefit and may
even have a adverse effect upon outcome in patients who have had the
benefit of definitive surgery performed without the development of shock
or the need for blood transfusions and without postoperative death s and
serious complications.
I believe there is an enormous opportunity to improve outcome and
even to cure the majority of patients presenting with gastrointestinal
cancers including pancreatic and oesophageal cancers. I have devised a
strategy for accomlishing this that improves the efficay of and limits the
risks of radiotherapy and avoids the risks of chemotherapeutic agents.
The strategy has not been tested in animals and has certainly has not
been approved by any regulatory body. The strategy has not been tested
in patients and might conceivably be opposed by oncologists be they
physicians or surgeons. I would, nevertheless, be happy to implement the
stategy tomorrow given the opportunity and comply with my call for zero
tolerance for deaths and complications (4).
The choice of treatment for cancer, the diagnosis of which may be a
death sentense, should be left up to the patient and the surgeon of
his/her choice. The surgeon may wish to consult with a radiologist or
radiotherapist. If the strategy proves to be as effective as I think it
will be it might be in the first cases, recognising that the strategy is
likely to be refined as experience increases, it may prove to be unethical
to perform a controlled trial ones the strategy has been refined.
Major advances in care are made by trial and error but are invariably
fine-tuned as experience grows. They might not be based upon rational
thinking, certainly from a conventional therapeutic perspective. It is
the incremental advances in care that conform to conventional thinking
that require prospective randomised studies to establish their risk-
benefit ratio. But, as observed earlier, any treatment that has a risk-
benefit trade-off violates the principle of first doing no harm.
Regulatory bodies and rigid barriers between subspecialites are
impediments to major advances. If they do not prevent advances they can
certainly delay their implementation for many years and conceivably even
decades.
1. Evaluation of an unconventional cancer treatment (the Di Bella
multitherapy): results of phase II trials in Italy
Italian Study Group for the Di Bella Multitherapy Trials
BMJ 1999; 318: 224-228
2. Kelly KA, Cameron JL. Gastrointestinal surgery: A specialty without
borders.
J Gastrointest Surg. 2003 Jul-Aug;7(5):585.
3. Failures of surgical care and outcome from cancer surgery
Richard G Fiddian-Green
bmj.com/cgi/eletters/320/7239/895#7229, 31 Mar 2000
4. Zero tolerance for complications and deaths from medical therapy.
Richard G Fiddian-Green
bmj.com/cgi/eletters/326/7383/233#34829, 24 Jul 2003
What possible measureable effect-- and more importantly, what impact
on survival was intended to be measured in the melatonin sudy? Using a
patient sample limited to those with advanced cancer and a study duration
of a few months, appears to those of us with cancer as a ridiculous and
misguided use of research time and money. For those of us dedicated to
serious and appropriate research, a rigorous study design must reflect a
competant understanding of the substance to be evaluated as well as an
understanding of the disease and its progression. What this study
produced was useless information, but an object lesson about the need for
objectivity and for design of new methodologies for many of the heretofore
"unproven" substances and protocols that many patients are already
evaluating for themselves.
The need for testing unconventional treatments for cancer
Concern with the abuse of patients submitted to trials of toxic
chemotherapeutic combinations has lead to a move to increase the
regulation of doctors offering unconventional treatments for cancers(1).
In the US there is pressure to confine all new treatments for cancers and
even to restrict treatment of all cancers to NIH-approved cancer centers
run by oncologists and/or "cancer surgeons". Whilst these moves might
limit the abuse of chemotherapy they might not lead to dramatic
improvements because newly certified "cancer surgeons" have yet to prove
they are capable of performing large cancer operations with no mortality
and few complications. The reality is that the best surgeons may not be
"cancer surgeons" or even subspecialists such as upper gastrointesntinal,
colo-rectal, and pancreatioco-biliary and hepatic surgeons. In the US the
best surgeons treating gastrointstinal cancers are gastrointesitnal
surgeons, a subspecialty "without anatomical borders"(2).
The most effective treatment for gastrointestinal cancers is
undoubtedly surgical excision with or without the removal of involved
lymph nodes. Patients continue to die from local extension and metastatic
disease often from primary surgical failure and/or from the failure of
radiotherapists and /or oncologists to appreciate the need for more timely
and/or effective surgical treatment for primary cancers, residual disease
and/or recurrences and the limitations of their own treatments.
Radiotherapy can be effective primary treatment for small cancers. When
combined with surgery and/or with chemotherapy for the treatment of larger
tumours the likelihood of local spread may be reduced and life survial
may even be prolonged. The studies documenting these incremental
improvements have, however, not been controlled for the large variations
in surgical skills which undoubtedly exist, the development of shock
and/or the number of blood transfusions received (3). It is possible
that the recommended adjuvent therapies have little or no benefit and may
even have a adverse effect upon outcome in patients who have had the
benefit of definitive surgery performed without the development of shock
or the need for blood transfusions and without postoperative death s and
serious complications.
I believe there is an enormous opportunity to improve outcome and
even to cure the majority of patients presenting with gastrointestinal
cancers including pancreatic and oesophageal cancers. I have devised a
strategy for accomlishing this that improves the efficay of and limits the
risks of radiotherapy and avoids the risks of chemotherapeutic agents.
The strategy has not been tested in animals and has certainly has not
been approved by any regulatory body. The strategy has not been tested
in patients and might conceivably be opposed by oncologists be they
physicians or surgeons. I would, nevertheless, be happy to implement the
stategy tomorrow given the opportunity and comply with my call for zero
tolerance for deaths and complications (4).
The choice of treatment for cancer, the diagnosis of which may be a
death sentense, should be left up to the patient and the surgeon of
his/her choice. The surgeon may wish to consult with a radiologist or
radiotherapist. If the strategy proves to be as effective as I think it
will be it might be in the first cases, recognising that the strategy is
likely to be refined as experience increases, it may prove to be unethical
to perform a controlled trial ones the strategy has been refined.
Major advances in care are made by trial and error but are invariably
fine-tuned as experience grows. They might not be based upon rational
thinking, certainly from a conventional therapeutic perspective. It is
the incremental advances in care that conform to conventional thinking
that require prospective randomised studies to establish their risk-
benefit ratio. But, as observed earlier, any treatment that has a risk-
benefit trade-off violates the principle of first doing no harm.
Regulatory bodies and rigid barriers between subspecialites are
impediments to major advances. If they do not prevent advances they can
certainly delay their implementation for many years and conceivably even
decades.
1. Evaluation of an unconventional cancer treatment (the Di Bella
multitherapy): results of phase II trials in Italy
Italian Study Group for the Di Bella Multitherapy Trials
BMJ 1999; 318: 224-228
2. Kelly KA, Cameron JL. Gastrointestinal surgery: A specialty without
borders.
J Gastrointest Surg. 2003 Jul-Aug;7(5):585.
3. Failures of surgical care and outcome from cancer surgery
Richard G Fiddian-Green
bmj.com/cgi/eletters/320/7239/895#7229, 31 Mar 2000
4. Zero tolerance for complications and deaths from medical therapy.
Richard G Fiddian-Green
bmj.com/cgi/eletters/326/7383/233#34829, 24 Jul 2003
Competing interests:
None declared
Competing interests: No competing interests