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THE MOSS REPORTS Newsletter (09/20/03)

 

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com

Newsletter #100 09/20/03

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DOES TRAVELING FOR TREATMENT INCREASE SURVIVAL?

 

 

There was a surprising study in this week's issue of

the Journal of the National Cancer Institute.

Researchers at Massachusetts General Hospital studied

the impact that traveling for treatment had on

survival, specifically the survival of 110 cancer

patients who were being treated in Chicago over a

7-year period. They showed that patients who traveled

to receive cancer treatment survived longer than those

who were treated within 15 miles of their home.

 

 

It was previously known that patients who traveled for

treatment tended to survive longer. This phenomenon had

even been given a name- " referral bias " or " distance

bias. " One easy explanation for referral bias in

general is that patients who can afford to travel are

able to receive more sophisticated and effective

treatment. But that explanation clearly didn't hold

true in this case.

 

 

What is truly surprising about the current study is

that all of the patients had the same diagnosis, took

part in the same Phase II clinical trial, and received

the same or comparable treatments. (They all had

regionally advanced squamous cell carcinomas of the

head and neck region and all received a particular

combination of chemotherapy and radiation.) Yet those

who came from a distance did better-in fact MUCH

better-than those who happened to live near the

treatment center. Those who traveled more than 15 miles

for treatment astonishingly had just one-third the risk

of death of those who lived closer to the treatment

center! Similar results were observed for

progression-free survival, another key measure of

response to treatment.

 

 

Other more predictable factors that influenced survival

were age, race, family income, smoking history, and

tumor stage. But " after adjusting for the previously

mentioned variables…the hazard of death decreased by

3.2% with each 10 miles the patients traveled for

treatment, " Dr. Elizabeth Lamont and her colleagues at

the Massachusetts General Hospital Cancer Center,

Boston, explained.

 

 

" Our study formally documents something clinical

researchers in oncology have long appreciated, " Dr.

Lamont commented. " That is, on average, those patients

who are able and willing to 1) research therapeutic

options (or have agents who will do so for them) and 2)

find and expend the resources necessary to then receive

those therapies seem to fare better than those patients

who end up at the closest place for care, even if their

disease and treatments are apparently the same. "

 

 

What makes this finding so provocative is that although

the patients all received the same treatment, clearly

they must have differed significantly in some

as-yet-unidentified psychological or sociological way.

 

 

I have frequently observed this phenomenon, which (as

Dr. Lamont has shown) is independent of the patients'

economic status. My belief is that patients who

carefully and deliberately select a treatment, and then

travel to receive it, obtain a psychological lift by

exercising their medical freedom of choice. They

probably feel more optimistic about their disease and

the possibility of cure. I believe that an indefinable

" will to live " can influence survival. Perhaps that is

the difficult-to-measure phenomenon that these

scientists are now bumping up against.

 

 

I also believe that such self-directed patients are

more likely to use adjunctive complementary and

alternative measures than are the average patients. Dr.

Lamont and her colleagues should question these

patients on their use of antioxidants, herbs,

meditation, etc. before, during and after receiving

radiation and chemotherapy. The judicious use of such

approaches might help explain their dramatically better

survival.

 

 

People have traveled for cancer treatment for a very

long time. In the 19th and early 20th century this

became something of a mania. I have a century-old book

that attempts to explain the impact of climate on

disease and describes literally hundreds of health

resorts and mineral springs in Europe alone (Cohen

1901). Germans still frequent their spas in great

numbers.

 

 

To view a picture of the spa at Baden-Baden, Germany

click or go to:

http://www.cancerdecisions.com/images/baden-bad.jpg

 

 

Nowadays, there are scores of clinics, many of which

are located in spa towns, that cater to international

patients, including those with cancer. There are also

an increasing number of similar facilities in the

United States and elsewhere. Many cancer patients

travel long distances to be treated at these places. I

am sure that the very act of traveling to receive a new

treatment has an uplifting effect on many patients. But

making a good treatment decision under present

circumstances is not easy. Some clinics do offer

promising treatments that are not readily available in

one's home territory. Yet others, sad to say, are

thinly veiled rip-offs. They may even cause harm and

shorten survival. Sometimes it is difficult for even

experienced investigators to tell the difference

between the two.

 

 

 

Dangers of Phase II Trials

 

 

The Lamont study also provides extremely important

lessons about the evaluation of new cancer treatments,

in particular the danger of allowing the Food and Drug

Administration (FDA) to use Phase II trials as the

basis for new drug approval. " If the studies they

considered had been restricted to distant patients, "

wrote Duke University biostatistician Stephen L.

George, in an accompanying editorial, " the overall

results would have been impressively positive.

Conversely, had they been restricted to local patients,

the results would have been discouragingly negative. "

 

 

Thus, selection bias, which is a distortion introduced

during the enrollment process of clinical trials, " can

seriously damage the external validity of trials. "

Simply put, says Dr. George, " patients enrolled in

clinical trials often bear little resemblance to the

larger population of patients to which we wish to

generalize the results because of the complicated

processes by which patients are identified and

recruited for clinical trials. " Yet many new cancer

drugs are given accelerated approval on the basis of

just such Phase II trials. And oftentimes the yardstick

used to evaluate success is not whether the drug in

question extends life but simply whether or not it

temporarily shrinks tumors. As I showed in my book,

Questioning Chemotherapy, tumor shrinkage, which

oncologists call a 'response', is not a reliable

predictor of improvement or overall survival.

 

 

Anyone interested in the thorny question of how the FDA

has given a green light to ineffective treatments

(which Dr. George calls " toxic placebos " ) should

consult these two important articles. They are instant

classics in the field of oncology.

 

 

I will be discussing this subject further in next

week's newsletter.

 

 

The Moss Reports

 

 

I made my first visit to a foreign cancer clinic in

1976, when I took time off from a scientific meeting in

Anaheim, California, to visit a Tijuana cancer clinic.

I became convinced at that time that some important

work was going on in some of these foreign clinics and

that (despite incessant warnings about " false hope " )

most patients who sought treatment at such clinics felt

positive about the overall experience. I still believe

this to be true.

 

 

However, dubious establishments still flourish, and one

of the purposes of the Moss Reports is to help our

clients identify and avoid the useless or even

dangerous places, and to assist them in focusing their

choices on those practitioners and treatments that are

credible and reliable. We offer written reports on

several hundred separate cancer diagnoses as well as

individualized research and phone consultations. Please

go to our website, www.cancerdecisions.com, or call

800-980-1234 (from outside the US call 814-238-3367)

for further information. We would be happy to put our

several decades of experience at your service.

 

 

 

--Ralph W. Moss, PhD

 

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References:

 

 

Cohen SS. A System of Physiologic Therapeutics.

Philadelphia: Blakiston's, 1901.

 

George, S. L. (2003). Selection bias, phase II trials, and

the FDA accelerated approval process. J Natl Cancer Inst 95:

1351-1352

 

Lamont EB, Hayreh D, Pickett KE, et al. Is patient travel

distance associated with survival on phase II clinical

trials in oncology? J Natl Cancer Inst 2003; 95:

1370-1375. At:

http://jncicancerspectrum.oupjournals.org/cgi/content/abstract/jnci;95/18/1370

 

Moss, Ralph W. Questioning Chemotherapy. State College:

Equinox Press, 2000. To order go to:

http://ralphmoss.com/html/books.shtml

 

Pogge RC. The toxic placebo, I: side and toxic effects

reported during the administration of placebo medicine. Med

Times. 1963,91:14.

 

Press coverage of Lamont article:

http://www.medscape.com/viewarticle/461673

 

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IMPORTANT DISCLAIMER

 

 

The news and other items in this newsletter are

intended for informational purposes only. Nothing in

this newsletter is intended to be a substitute for

professional medical advice.

 

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