With this small report I
am trying to illustrate which difficulties the practicians of medical science
are meeting in large parts of the population. I have myself gained a certain
reputation throughout the country and above its borders as a specialist
in the treatment of certain malignant diseases. I am mentioning this in
all modesty, just in order to permit the reader to understand my background.
Our department is continuously occupied with the development or, shall
we better say, the application of new drugs for the complicated treatment
of that disease. Thereby, we have gained confidence from the pharmaceutical
industry which is a precaution for their investment of large sums in the
clinical test of new substances.
Unfortunately, these
diseases are still often resulting in sad outcomes, which is the justification
for a continued research. For that reason, I am not only occupied with
patients but also with their relatives, who have rarely grasped our dilemma.
In this sense the visit of Mrs. Birthe Kragh (names altered by the author)
must be seen:
“I am sorry to disturb
you with some questions, Prof. Jensen, but my husband, Troels Kragh, was
one of your patients for a longer time, until he died three weeks ago.
There are some uncertainties which disturb me.”
“Of course I remember
your husband and if I can assist you in any way, I should be delghted to
do so,” I answered.
“I am referring to
the treatment he received here. It appears as if it did not influence the
progress of his disease in any way.”
“What that is concerned,
there are two things you must remember,” I explained. “Cancer is still
a disease many people are dying from; it is thus difficult to predict the
course of a disease with and without treatment. Possibly, it would have
proceeded more aggressively in your husband’s case, had he not received
any drugs.”
“I can hardly imagine
it could have proceeded any faster,” Mrs. Kragh replied. “The diagnose
was set less than six months before his decay.”
You may understand
that I do not want to discuss these matters with lay-people. Nevertheless,
she continued:
“At first, I was positively
surprised so well he tolerated the drugs. I have seen other patients here
in the department getting nauseated and weak for many days after a cycle.
Troels did not react to the infusions at all.”
“Yes, this impression
was what you could get initially,” I said, hoping soon to get it over.
“Troels mentioned
that he participated in a clinical study.”
So that was the problem.
It is a daily challenge to inform the patients and it may take several
hours in a single case, and then you may occasionally start from the beginning
with the relatives. Therefore, on with the standard reply: “As practically
all the patients here, your husband participated in a study with the purpose
to develop drugs for further treatment of his condition. He was fully informed
of the consequences of that and he signed the standard paper for informed
consent.”
That was obviously
also known to Mrs. Kragh, since she proceeded: “I have read his copy of
that ‘informed consent’ and, indeed, that is the reason for my coming.
It states that it is unknown weather the new drug offers any advantages
and it is thus necessary to compare it with an inert substance, so-called
placebo. Therefore, there should be no certain advantages connected to
being allocated to one therary or placebo.”
When she even used
our arguments, I could only confirm it.
“But then I have also
read in our not quite new ‘Family Doctor’s Manual’ that there already exist
some drugs which could influence this condition,” she continued. “If my
husband received placebo, he was certainly in a worse position than if
he had not participated in any study and just received what has been effective
for years.”
Now it almost sounded
as a complaint so I was forced to inform Mrs. Kragh that the new testsubstance,
ZPX, presumably was better than the old treatment, as evaluated according
to animal experiments and the first singular experiences from its use in
humans.”
“Strange,” she summarized
with an insulted female logic, “just before you told me that ZPX was not
necessarily better than placebo and now I hear that it should be even better
than the existant therapy.”
I should have stopped
the discussion there, simply referring to her husband’s signed consent;
instead, I patiently tried to inform her about modern research technology:
“Both are right. We do not know if ZPX is better than placebo and, simultaneously,
we have some justified hopes that it is better than the previous therapy
which, by the way, has not quite fulfilled the expectations we had for
it previously.”
“Then I do not understand
why you do not compare the two active drugs with another.”
I was now forced to
explain her something about statistics and the importance of sample-sizes
for yielding any clear result of the study. If the two treatments offers
a rather similar result, enormously many patients are required for offering
a clear statement that the new therapy is at all of any significance. This
is not economically feasible, already sponsoring a placebo-based study
is very expensive to the manufacturer of ZPX.
“Just what I thought,”
she cried explosively, “it is just a matter of money. It may be expensive
for the firm, but they are not investing it for our behalf. And because
of that, poor Troels had to swallow chalk tablets and die so soon.”
“Why do you think
that he received placebo? The study will proceed for another year and only
then can we break the code and see, who got verum therapy, the real stuff.”
“I am certain that
Troels was receiving placebo. No effect, no adverse effects either, except
for not getting any valuable therapy. Had he only never let himself persuade
to participate in this study.”
“I am sorry, Mrs.
Kragh, but I am somewhat vulnerable to criticism of our aim for improving
therapy. This study has been approved by the hospital’s ethical commission
in which, among others, Pastor Jepsen, whom you probably know from the
television, is taken part. As physicians, we are obliged to search continuously
for new therapies and not blindly utilizing doubtful methods, which may
appear traditionally sound but are void of any qualified, controlled study.
It is in a justified confidense to the decision of the ethical commission
that your husban has signed …”
“… his own death penalty,”
Mrs. Kragh interrupted.
“I understand your
bitterness but research in this country demands use of double-blind studies,
as I have just described, and for the reasons given, it is only posible
to investigate towards placebo.”
“I have read that
the ‘Helsinki Declaration’ has prohibited such studies when there was already
some active treatment which worked,” she continued.
“Fortunately, the
Amerikan ’Food and Drug Administration,’ FDA, managed to stop this initiative,
or it would have meant the end of medical science.”
“I don’t mind if the
Americans want to play research rabbits, if they are so obsessed in doing
so, but what has that to do with Denmark?”
“Science is international,
and we Danes are internationally reknown for our research,” I proudly announced.
“Besides, if only the Americans would perform science, then only their
industry might profit from it. We would simply be forced only to adobt
their results.”
“But isn’t the manufacturor
of ZXP an American company?”
“Nowadays, all big
firms are multinational.”
Mrs. Kragh reflected
my last statements for a while and muttered, “so is research, it appears.”
Then she raised and said loudly, “one of my friend claimed that there are
also other principles. In fact, if you were forced to search for them,
other techniques would be developed or are already available. With the
distribution of computers in medicine, you could be in possession of much
larger comparison material from the daily therapy.” She hesitated for a
while, recognizing that such a speech was pointless towards me. Then she
continued “I understand that you feel in the American way that what you
call research must be permitted under all circumstances, while it is unethical
not to perform any research. Conversely, I should prefer that unethical
research is forbidden, then you’ll see that it is still possible to find
something else. Anyhow, all these considerations do not bring back my poor
Troels. I must thank you for having taken the time for me. You did not
manage to convince me of your arguments. I shall make my efforts for making
it more difficult for you to motivate your patients for participating in
your studies in the future, whatever profitable they may be to the industry.”
I had wasted enough
time on this conversation. At least, this women was not one of those who
threatened with any claims at court. By the way, here in Denmark, she would
not have had any success with such claims, which would just have been tiresome
to both of us and expensive to her. Fortunately, this was a solemn skeptician.
In most other cases, I succeed to convince the relatives of the importance
of Danish medical science which has gained considerable recognition in
international relation.
Translated
from Danish: ‘Forskningsofret’ by the author.
Inserted
November 9, 2003
The
names of Birte and Troels Kragh was taken from the story ‘Dysthanasia.’