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.
from Danish: ‘Forskningsofret’ by the author.
Inserted November 9, 2003
The names of Birte and Troels Kragh was taken from the story ‘Dysthanasia.’
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