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From: oliver@unc.UUCP (Bill Oliver)
Newsgroups: net.med,net.women
Subject: Re: Breast Cancer Treatment.
Message-ID: <602@unc.UUCP>
Date: Mon, 15-Jul-85 21:53:56 EDT
Article-I.D.: unc.602
Posted: Mon Jul 15 21:53:56 1985
Date-Received: Tue, 16-Jul-85 08:38:53 EDT
References: <1765@aecom.UUCP> 
Reply-To: oliver@unc.UUCP (Bill Oliver)
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Organization: CS Dept., U. of N. Carolina at Chapel Hill
Lines: 124
Xref: pepe net.med:614 net.women:3011
Summary: 

In article  sophie@mnetor.UUCP (Sophie Quigley) writes:
>
>*randomly* assigned (!?!) outch!!!  Did the patients know that their
>treatment was decided *randomly* ?  Whatever happened to the hypocratic
>oath?  couldn't they do this on monkeys or something?  I don't know
>what other people think, but this sounds like wonderful grounds for
>malpractise suits.
>
>Could you please tell us where this kind of thing is going on so that I
>can make sure never to go there if I get breast cancer?
>-- 
>Sophie Quigley
>{allegra|decvax|ihnp4|linus|watmath}!utzoo!mnetor!sophie

I think this needs a little explanation.  The methods by which
an experimental protocol is put into practice and how patients
are placed into treatment groups are very carefully thought out
and the potential benefit and risk to the patient is examined.

Generally speaking, patients are not put on therapeutic protocols
which have not been evaluated in detailed animal studies
or profoundly good epidemiological evidence.
Following the animal studies, the experimental protocol is then
brought before a board, usually consisting of physicians, clergy,
government and advocate representatives, and frequently ethicists
(here it is called the Human Experimentation Committee).  The board
then evaluates the possible benefit and risk to the patients involved
with the protocol.  For instance, in the protocol above, none of
the therapies mentioned were considered bad therapies, and in fact,
there were no good criteria for desiring one above the other for
breast cancer as presented in the article, i.e. without regard
to histologic type (there are some good arguments against the way 
the protocol is presented in the NEJM,
but that is not germaine here).

If you were to go to a private practice surgeon, the type of 
therapy you would receive would depend largely
on his individual background (what they did back at the mecca where he was
trained, what articles he had read recently, what he decided to try
because of a recent symposium, what he had been successful with in the
past, etc.), and not on a proven best therapy - because any one of a number
of different therapies are accepted as equally valid.  In medicine, 
there is frequently not a single best way of doing something.

Thus, the patient has little to lose by being in the protocol.  
The surgeon firmly believes that a lumpectomy is as good as a 
modified radical, and would not suggest the trials unless both 
he and the board felt there was good evidence. If, in fact, a distinction
in outcome bacomes quickly and dramatically apparent, the physician
is ethically bound to discontinue the protocol, as has occasionally
happened in the past.

Once the protocol is accepted as ethical and of scientific worth, 
the patients are inevitably
given a detailed description of the protocol (unless the description
itself may affect the outcome as in some psychiatric trials, or
unless the educational status of the patient precludes a 
detailed description - in any
case a valid if not detailed description is made).  The patient
then decides whether or not to become part of the protocol.


In the case of the above protocol, the patients had the choice of
demanding a therapy of their choice, or of being a part of the study.
Believe it or not, a large number of patients are quite willing
to aid in advancing medical knowledge.  I have been involved in
a number of treatment protocols, and have uniformly been impressed
with the generally intelligent, open, and agreeable attitude of 
most patients.  Physicians in tertiary care facilities generally
don`t have to sneak anything by a patient because most patients
have pretty good heads on their shoulders.  If they don`t, then
they will probably not be compliant and would screw up the 
protocol if they were placed on it.  What you really don`t want is
a sullen, suspicious, or dishonest patient on a protocol -
you have no idea where you stand, they frequently do unusually 
poorly no matter how hard you try, and then they sue. As far as being
assigned randomly goes, if you use a bias of any sort then the
experiment is compromised.  Even self-choice
would leave a bias.  I suspect that younger, healthier women would
tend to opt for more cosmetically pleasing surgery and would 
bias the population.  I don`t know however, I am drawing from my
experience with offering men the option of castration for therapy
in prostatic carcinoma.  The older the men were, the less they
resisted the idea.


I am presently involved with a study of Ewing`s sarcoma, a bone tumor
of children.  The tumor is rare, and it would be virtually impossible
to figure out a way to treat it without a large number of hospitals
pooling their cases and using strict protocols to be able to compare
treatment methods. As the years have passed, fairly startling 
conclusions have been drawn about treatment of the disease - many
of which may well save young patients the pain and terrific 
discomfort which sometimes accompanies aggressive surgical and
chemotherapy - therapies which, while discomforting, are increasingly
bringing about cures when the correct patient population is identified.

As each year passes, more tumors are going the way of Hodgkin`s 
disease - from 95% mortality to 85% survival (these number are +/-
about 10%. I am not near my references now and am quoting from 
my head - a notoriously bad place from which to dredge numbers).
 

As an aside, the same committee must review 
all experiments which use human tissue from any source.  It is impossible,
for instance to do a casual prospective study of biopsy, autopsy, or
surgical tissues which does not use procedures which would have been
performed anyway (in other words, you can make a microscopic slide 
of the tissue and look at it for some experimental reason only if 
you were making the slide for some bona fide therapeutic purpose) 
without first going through the committee - the bane of the agressive
young resident.

This is not to say, of course, that poor protocols have not existed;
they are, however, by far the exception in terms of patient rights and
not the rule.  They also tend to be rather old.  Every time I hear
someone berate experimental protocols because of weird things done to
prisoners in the 20s - 40s, I must point out that this was some time
ago.  Experimental medicine, like all society, is not the same in the 
80s as it was in the 40s.

Bill Oliver

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