P
Peter Moran
Guest
Those claiming to be curing advanced cancer should be able to say how they know their treatment
works. What they invariably produce are impressions of benefit in some patients, which are mostly
meaningless in such a variable condition. That, and the testimonial. But the informal testimonials
used to promote alternative treatments to cancer sufferers are of very variable quality and rarely
provide enough verifiable information.
What more can they do to show "how they know it works"?
The quacks and frauds that riddle alternative cancer care claim that elaborate and expensive placebo-
controlled trials are demanded of them. That is not true. It never has been true. Historically
medicine has shown a willingness to explore "alternatives" further on the basis of "best case
series" or small prospective studies, or even just with a little public or political pressure. The
NCCAM has been formed as the result of such pressures, and among others, is currently funding
further study of a homeopathic clinic in India on the basis of a best case series, and also a large
controlled trial following the small prospective study of pancreatic cancer by Gonzales.
A "best case" is not quite the same thing as a "testimonial" . It requires a high standard of
diagnosis and staging, good documentation and follow-up, and enough detail for it to be reasonably
certain that not only is there a beneficial effect, but that only the target treatment could have
produced it. It is still an anecdotal report, but of a standard that would get published in a good
medical journal.
This is only fair. These are serious claims, in which a whole planet's population has an interest.
They are already being used to extract very large sums of money from desperate cancer sufferers. .
(Ideally there should also be a lot of "best cases" in proportion to the number of people being
treated, as spontaneous remissions are bound to be responsible for some).
If you read the minutes of the NCCAM at http://nccam.nci.nih.gov/about/advisory/capcam/minutes/ you
will see how much difficulty there is in getting an adequate best case series out of even well-
established clinics like those offering ImmunoAugementative Therapy (Burton).
The Gerson clinic, which treats about five hundred patients yearly, admitted this --- "The genesis
of this inquiry occurred during a landmark study by the U.S. Congressional Office of Technology
Assessment [Ref 2] to which one of us
(G.H.) was an advisor. In its report, OTA put forward a protocol for best-case reviews based on the
premise that, no matter how many patients failed, as few as 10 or 12 cases with objective
evidence of tumor response would be enough to propel an investigation by the National Cancer
Institute (NCI).
Because we had proposed the original best-case review protocol to OTA, we were eager to construct a
best-case review. However, we found OTA's (and later NCI's) protocol to have a serious shortcoming
when used retrospectively: its focus on only tumor regression. Adequate documentation of tumor
regression is unlikely to be collected in most alternative medical practices."
This is from their paper ----- Hildenbrand GLG, Hildenbrand C, Bradford K, Cavin SW. 5-year survival
rates of melanoma patients treated by diet therapy after the manner of Gerson: a retrospective
review. Altern Ther Health Med 1995-09;1(4):29-37
So after treating thousands upon thousands of patients, and advertising with hundreds of
testimonials, The Gerson clinic is unable to satisfy a request for 10-12 best cases??. Yet they
felt able to chase up the results for 153 of their patients with melanoma for this poorly
conceived study?
So I still have to ask: "How do they know it works?". It is time the alternative cancer clinics and
practitioners were forced to lift their game. They are not short of funds, and excuses are wearing
very thin in the present favourable climate.
Peter Moran
--
records tend to be bad
Ms. Holloran questioned the need for best case series. Dr. Nahin said that
RAND was hired to try to provide the type of data that CAPCAM providers have
said they need. If RAND can't get it, it may not be attainable. Dr. Coulter
talked about the time involved, and the need to pick the programs in which
this is attainable. Dr. Tripathy talked about needing to find a fairly
cohesive group of patients. Dr. Coulter stated that their statistician asked
for the same thing, and he agreed it's a problem. Dr. Hawkins posed the
rhetorical question: what are we trying to learn from a best case series? He
explained that CAPCAM needs finished studies to see if they are worth
pursuing further, although none of these studies will be definitive, since
only the best case examples will be used. But he said that trying to put
statistical conclusions on this type of data would slow the process. Dr.
Coulter agreed, saying that they just need good, promising cases that are
documented. Dr. Hufford asked about prospective analysis studies, as they
might be a way to get systematic data if best case study fails. Dr. Nahin
added that they might make a good second phase after best case study. Dr.
Moss explained that historically, one group of patients claimed something
was a cure; and on the other side, fraud was claimed. The best case study is
used to determine whether anything is there before running a clinical trial.
The goal is to find plausibility only. Mr. Williams noted that patients are
quite anxious to find out if anything is there.
works. What they invariably produce are impressions of benefit in some patients, which are mostly
meaningless in such a variable condition. That, and the testimonial. But the informal testimonials
used to promote alternative treatments to cancer sufferers are of very variable quality and rarely
provide enough verifiable information.
What more can they do to show "how they know it works"?
The quacks and frauds that riddle alternative cancer care claim that elaborate and expensive placebo-
controlled trials are demanded of them. That is not true. It never has been true. Historically
medicine has shown a willingness to explore "alternatives" further on the basis of "best case
series" or small prospective studies, or even just with a little public or political pressure. The
NCCAM has been formed as the result of such pressures, and among others, is currently funding
further study of a homeopathic clinic in India on the basis of a best case series, and also a large
controlled trial following the small prospective study of pancreatic cancer by Gonzales.
A "best case" is not quite the same thing as a "testimonial" . It requires a high standard of
diagnosis and staging, good documentation and follow-up, and enough detail for it to be reasonably
certain that not only is there a beneficial effect, but that only the target treatment could have
produced it. It is still an anecdotal report, but of a standard that would get published in a good
medical journal.
This is only fair. These are serious claims, in which a whole planet's population has an interest.
They are already being used to extract very large sums of money from desperate cancer sufferers. .
(Ideally there should also be a lot of "best cases" in proportion to the number of people being
treated, as spontaneous remissions are bound to be responsible for some).
If you read the minutes of the NCCAM at http://nccam.nci.nih.gov/about/advisory/capcam/minutes/ you
will see how much difficulty there is in getting an adequate best case series out of even well-
established clinics like those offering ImmunoAugementative Therapy (Burton).
The Gerson clinic, which treats about five hundred patients yearly, admitted this --- "The genesis
of this inquiry occurred during a landmark study by the U.S. Congressional Office of Technology
Assessment [Ref 2] to which one of us
(G.H.) was an advisor. In its report, OTA put forward a protocol for best-case reviews based on the
premise that, no matter how many patients failed, as few as 10 or 12 cases with objective
evidence of tumor response would be enough to propel an investigation by the National Cancer
Institute (NCI).
Because we had proposed the original best-case review protocol to OTA, we were eager to construct a
best-case review. However, we found OTA's (and later NCI's) protocol to have a serious shortcoming
when used retrospectively: its focus on only tumor regression. Adequate documentation of tumor
regression is unlikely to be collected in most alternative medical practices."
This is from their paper ----- Hildenbrand GLG, Hildenbrand C, Bradford K, Cavin SW. 5-year survival
rates of melanoma patients treated by diet therapy after the manner of Gerson: a retrospective
review. Altern Ther Health Med 1995-09;1(4):29-37
So after treating thousands upon thousands of patients, and advertising with hundreds of
testimonials, The Gerson clinic is unable to satisfy a request for 10-12 best cases??. Yet they
felt able to chase up the results for 153 of their patients with melanoma for this poorly
conceived study?
So I still have to ask: "How do they know it works?". It is time the alternative cancer clinics and
practitioners were forced to lift their game. They are not short of funds, and excuses are wearing
very thin in the present favourable climate.
Peter Moran
--
records tend to be bad
Ms. Holloran questioned the need for best case series. Dr. Nahin said that
RAND was hired to try to provide the type of data that CAPCAM providers have
said they need. If RAND can't get it, it may not be attainable. Dr. Coulter
talked about the time involved, and the need to pick the programs in which
this is attainable. Dr. Tripathy talked about needing to find a fairly
cohesive group of patients. Dr. Coulter stated that their statistician asked
for the same thing, and he agreed it's a problem. Dr. Hawkins posed the
rhetorical question: what are we trying to learn from a best case series? He
explained that CAPCAM needs finished studies to see if they are worth
pursuing further, although none of these studies will be definitive, since
only the best case examples will be used. But he said that trying to put
statistical conclusions on this type of data would slow the process. Dr.
Coulter agreed, saying that they just need good, promising cases that are
documented. Dr. Hufford asked about prospective analysis studies, as they
might be a way to get systematic data if best case study fails. Dr. Nahin
added that they might make a good second phase after best case study. Dr.
Moss explained that historically, one group of patients claimed something
was a cure; and on the other side, fraud was claimed. The best case study is
used to determine whether anything is there before running a clinical trial.
The goal is to find plausibility only. Mr. Williams noted that patients are
quite anxious to find out if anything is there.