What Is a Scientifically Recognized Medication?
By: Gerhard Kienle, M.D.
This article is reprinted from Complementary Medicine, Compendium III
For those concerned with complementary or alternative medicine today, this article by Dr. Kienle rings with a familiar tone. Many have become aware that the concept of "scientifically proven" is now used by third party carriers, insurance companies to decide on reimburseability. It is the "science" that decides. Dr. Kienle tells us something that more are becoming aware of and this is that the "science" is no science. Dr. Kienle's investigations point to the unscientificness of the dogmatized label "science". He does not reject science, on the contrary asks that it be respected and used with integrity. Science is being used as dogmatically to make judgments of remunerability. Cited is that the term "scientific" can decide remunerability when harm is produced by a medication or "unscientific" can decide unremunerability when there has been a positive therapeutic response.
The misuse of "science" is well presented. The need is to make economic decisions on the basis of the ill persons need. The judgment of a positive result should not be a dogmatic decision, but one of scientific insight. This insight is a highly complex process as it slowly becoming evident.
Complementary Medicine\ Compendium III
What Is a Scientifically Recognized Medication?
It can be shown by means of practical examples that the concept of the scientifically (generally) recognized medication is not used to single out senseless or medically indefensible medications. Rather, it is misused to decide scientific arguments on an economic or legal level. One should therefore renounce this concept and focus decisively on whether or not a therapeutic result is to be attained with a medication. The author, who recently took a stand on proof of effectiveness in medicinal law in the "Journal for Political Rights," 1976, p. 64, is the director of the Institute for Clinical Pharmacology at the Public(ally useful) Cooperative Hospital in Herdecke-
I. Science and Quackery
In his contribution to the "position of medical science" as a legal concept(1) Kriele pointed to the problem of the scientific recognition of a medication in the example of the litigation around the cancer medication S. It was a question of payment for this medication, which had been refused by the insurance carrier, even though an undisputed and medically investigated cure of a woman with a bad case of cancer existed. The mistletoe preparation in question is certainly recognized by the Drug Commission of the German Medical Association and likewise by the German Federal Republic Secretary of the Interior, but not by the state of North Rhine-Westphalia. Certain insurances pay for the medication whereas several other health insurance-companies do not. At an international symposium in Vienna, a whole day was devoted to the mistletoe treatment of carcinomas, whereas the German Cancer Research Center has a negative attitude for no immediate scientific reason. The Swiss Intercantonal Control Point for Medicine declined further registration of the cancer medication X, but in a contrary judgment the appeal commission admitted it again.
The situation could not be more confusing. However, this is characteristic of the cognitional situation which underlies the concept of a "scientifically (generally) recognized medication". The purpose of such a formulation might well be protection against quackery. No one would object if medications advertised with fantastic ballyhoo with no basis in concrete medical experience were excluded from compensatory payments. The concept of scientifically accepted medications would be a useful instrument in the defense against the misuse of medicine, if it were not itself misused for scientific power purposes.
The history of medicine, especially of the last two centuries, is characterized by a plethora of methods, theoretical opinions and dogmas. Up till now, medicine has not developed any independent theory of method, cognitional theory (or expressed more generally) theory of science. This state of affairs, for example, made the physiologist and medical historian Rothschuh doubt that medicine is a science at all. Elsewhere in the search for scientific criteria, one tried to rely on the extra-medical disciplines. For a long time the positivistic method of natural science was held to be the standard for the scientific method of medical argumentation. In recent years, however, knowledge of the limitation of natural scientific medical statements has prevailed. The methodology of clinical statistics developed from criticism of natural scientific medicine. It is concerned with the application of a deductively developed theoretical science and a special kind of randomization to medicine. As a consequence of this theory, Hill and others developed the so-called controlled clinical experiment. The questions of a medical proof was now supposed to be decided within this theoretical science, but the chasm between theoretical and empirical science proved to be increasingly unbridgeable. The deeper reason for the conflict of opinions lies in the absence of a commonly connected cognitional theoretical or methodological foundation. From the most various starting points, hypotheses, working concepts, methods and schools arose which finally had to prove themselves with therapeutic successes. The relatively high standing of our medicine depends on the possibility of the free competition of methods and standpoints so that the same concept yesterday could be a sectarian outsider method, today the official scholastic opinion, and a relapse tomorrow into long since overcome, outmoded viewpoints. In the battle between what helps and does not help the patient, what is better should be able to assert itself. Social orders which hinder free spiritual competition also clearly show stagnation of independent medical development. Mixed into the unbiased competition for the benefit of the patient, on the other hand, is the scientific claim of dogmatic viewpoints to sole authority. The expression "school medicine" or "official medicine" always indicates that one line of thought has succeeded in making itself into some kind of state authority. Such concepts can often be group psychological adaptation phenomena or general trend phenomena, without it necessarily being the case that they are based on a scientific content which could stand up to criticism. A form of dogmatic argument in the defense of the scientific claim to sole authority is the attachment of quackery or even of malpractice to the measures of other therapeutic methods. The effort to outmaneuver contrary world conceptions, scientific or therapeutic lines of thought by discrimination or even penalization makes it more difficult for jurisdiction to distinguish actual quackery and really irresponsible malpractices from justifiable differences of opinion.
II. Unclear Conceptual Language
The concept of scientifically (generally) recognized medications should make it possible to distinguish between deviating views and real quackery. In what follows we will investigate by means of examples whether this is possible, or whether these concepts are misused in practice. In the assistance regulations of the German Federal Republic (GFR), it says in No. 4, 1: "The GFR Secretary of the Interior may not deny the possibility of assistance to applications for an investigation or to treatment for a method that is not generally, scientifically recognized." To my question as to what is meant by a scientifically generally accepted medication, I received the following information from the GFR Department of Youth, Family and Health in a letter dated 6-4-74:
"According to No.4, 1 of the assistance to applications for an investigation or to treatments given by a not scientifically generally acceptable method. To judge questions arising in this connection the government of the GFR employs the advice of the relevant medical scientific professional societies. The Medication Commission of the GMA may also be heard before a decision. For more information, please apply to the Insurance Control Board of the GFR." The GFR Insurance Control board had the following to say on 7-22-74: "The concept of scientifically not generally recognized medications is a legal concept which cannot be generally defined and which is to be delimited by jurisdiction in particular cases. Depending on the case this will require consultation with medical, pharmacological or chemical specialists. The medical literature should certainly be decisive for general scientific recognition. If only isolated objections to a particular medication exist there, then this by itself would not yet oppose its general recognition. The exclusion clause would therefore be used with care."
At the recommendation of the GFR Department of Youth, Family and Health, the GFR Department of the Interior published the advice in the official paper of the GFR Secretary of Telecommunications and the Post Office that the blood crystallization test is not a scientifically recognized method of healing. To my further inquiry to the GFR Dept. of Youth, Family and Health as to whose information this recommendation was based on, I received the reply that in the interest of an unhindered flow of information the names of the societies and scientists I wanted could not in principle be revealed. This kind of secret information is apparently not an isolated case. In the administrative court proceedings referred to by Kriele, a representative of the National Payment Bureau could give no information about how the determination was made that a medication is not scientifically recognized. In this respect the information of the GFR Dept. of Youth, Family and Health is comprehensible and representative. It certainly arouses the suspicion that persons or institutions are chosen as experts according to the answer one wants. However, the determination of scientific recognition is thereby withdrawn from scientific control.
In a judgment about non-payment for a particular medication the Regional Court in Darmstadt referred to the Medication Commission of the GMA: "According to information from the Medication Commission of the GMA., these preparations are prescribed and administered by a narrow circle of physicians. Therefore they cannot be viewed as scientifically recognized in the sense of the payment conditions of the defendant." Thereupon, I inquired of the GFR Medication Commission what they meant by "narrow": "Is it a matter of an absolute number, a percentage number, or how is the expression defined? For example, is hand surgery not a scientifically recognized method, because hand surgeons represent at best 2% of all surgeons, or is rheumasurgery a not recognized method because it is neither taught nor advocated in German university clinics, and because there are very few surgeons who practice rheumasurgery?"
I received the following reply in 1975: "Since it is to be expected that in the course of the proceedings the court will require the Medical Commission to take an advisory position I would like to avoid making a comment about the basis for judgment of the Superior Court so as not to anticipate this statement,"
The GFR Medication Commission had in 1974 expressed itself about the concept of "scientifically (generally) recognized" as follows: "For the law giver and the courts the designation 'scientifically recognized' clearly means a statement about the therapeutic value of medications ... Because of known difficulties in evaluating publications about the therapeutic value of medications the Medication Commission of the GMA has published guidelines which you can find in pamphlet No. 36 of the German Medical journal. That the concept 'scientifically recognized' is of course a changing one was expressly emphasized in the first as well as in the draft for the 2nd German Medication Law. In Section 21 M(edication) L(aw) it says that the particular medication must be sufficiently and carefully tested 'in accordance with the respective state of scientific knowledge.' Also in the preliminary memorandum of the official advisor's draft of 12-12-73 an insured scientific cognitional material is mentioned and explained in Section 22 to the effect that the respective state of scientific knowledge must be taken into account in testing".
III. "The State of Scientific Knowledge" in Practice
By means of several examples I examined to what extent the criteria of "sufficiently and carefully tested in accordance with the respective state of scientific knowledge" is really decisive for scientific recognition in practice:
1. Acupuncture: The scientific advisory board of the Federal Medical Chamber in its session of 10-28-57 determined. "that acupuncture can not be regarded as a scientifically recognized method of treatment since the physicians using acupuncture have not yet succeeded in furnishing a proof for the correctness of this method." In a circular of 8-20-70 the Federal Department of the Interior made it known that "Expenditures for the treatment with acupuncture can be reimbursed .... These methods of curative treatment previously widely known only in Asia (Japan, China, etc.) have also taken hold ever more in recent years in Europe and America, especially as a therapy for joints and nerves." Nevertheless, in the meantime, the cognitional situation for acupuncture had not changed significantly -aside from undisputed reports of its success.
2. Phenolisatin: Phenolisatin is a chemical that is added to many laxatives and whose harmful effects on the liver has been irrefutably shown in many publications. A comprehensive survey of the recent literature permits one to say that the administration of laxatives containing phenolisatin is no longer defensible on account of the danger to one's health. The consumption of laxatives containing phenolisatin was warned against in the most varied scientific journals. One can therefore proceed or, the assumption that that kind of medication can no longer be considered "scientifically generally recognized". Nevertheless, inquiries could not discover a private insurance company which excludes this laxative from reimbursement. The Private Insurance Companies Union could also give me no other information. The same state of affairs was discovered for several frequently used medications whose therapeutic usefulness is, for example, decisively questioned in the "Medication Letter". Therefore they are at least not "generally scientifically recognized". According to information from the Central Health Insurance Company, which refused payment for medications of particular healing methods, these medications are unhesitatingly reimbursed.
3. Homeopathy: It is a characteristic of world ideological views that one uses a double standard. I asked various authors, who had made statements in scientific journals that the effectiveness of homeopathy is not yet proven, to give their opinion on the most important publications concerning the effectiveness of homeopathic medications, and to produce proofs of effectiveness for at least one of the medications administered by them. None of the scientists asked knew the homeopathic literature and none could present a proof of effectiveness of even one of the medications administered by them.
4. Cellular Therapy: The following case is also characteristic: On 10-17-74 the Federal Department of Youth Family and Health asked the German Children's Medicine Society for an opinion as to whether cellular therapy for mongolism is scientifically and generally recognized. The publications under discussion were those of F. Schmid, who established the effectiveness of this therapy with intensive investigations. Among other things, on the basis of skull measurements he could prove a normalization of skull size through cellular treatment, The opinions of five experts which were published in the German Children's Medicine Journal disagree with those of Schmid, The chief expert took no position on Schmid's scientific reasons at all but claimed a proof by means of a controlled clinical doubleblind experiment.
Thereupon I wrote him: "The No. 2 and 3 interpretations in F. Schmid's paper are intuitively convincing. I don't understand what you wanted to accomplish with a double-blind experiment. I just can't imagine that the skull volume index of a child could be affected by a placebo. I would only like to ask you to send me copies of publications from your house which have equivalent methodical requirements to the ones you're demanding of Schmid." The reply ran as follows! "I cannot furnish you with copies of the kind you want since on the whole we only deal sparingly with medication tests, and if so then only with easily provable criteria (blood mirror for antibiotics, circulation parameters, years of survival in leukemia, etc.)". Up till now a similar parameter in the treatment of Down's syndrome is unavailable.
The chief expert was unable to take a position on Schmid's investigations from a methodical standpoint, or to present his own publications of controlled clinical experiments. Instead of an exposition criticizing the method, a kind of proof was demanded whose realization could not be demonstrated in his own domain. One can only draw the conclusion from the expert's opinion that the concept of cellular therapy for mongolism does not fit into the leading scientific line of thought of the executive committee of the German Children's Medicine Society, and that it does not deem it necessary to deal scientifically with Schmid's results. Thus, the judgment of the state of affairs becomes dependent on ones own theoretical position.
5. Silybin: As a further example, consider the case of silybin, which is an active agent in Milk thistle, and is used for liver dysfunctions. Meyer-Burg questioned the effectiveness of silybin preparations and classifies them as a placebo, or as pseudo-preparations. The criticism of Creutzfeldt was in the some vein. We then checked all obtainable publications on silybin and other preparations with the same or similar indications. Study of these works revealed the extreme difficulty in carrying out definitive controlled clinical experiments. Here, from a methodological standpoint, silybin investigations came out better on the whole than the other investigations.
I therefore questioned Meyer-Burg whether one could test a liver medication at all. On 4-10-74 he wrote me: "I think that there's no real difference in our views. I also don't know of a reasonable experimental method to clinically test so called liver-protecting preparations. I'm also not sure whether we should bother about this question at the moment."
Creutzfeldt could also not give me a proof of effectiveness for the unobjectionable liver treatment he uses. My query to the Medication Commission of the GMA on 3-4-75, in which I asked for an indication about methodologically and ethically unobjectionable controlled experiments for liver treatments, has till now, in spite of many reminders, remained unanswered.
The well-known liver specialist Wildhirt, to whom I explained the methodological difficulties, wrote me on 8-12-75: "An exact proof of effectiveness is not only (even though particularly) hardly capable of being carried out for liver preparations, but will also not be performable in the future with our present means and methods. However, to deduce the negative conclusion of ineffectiveness, or unproven effectiveness from this, is in my opinion absolutely inadmissible. One must not leave medical empiricism and its extensive experience out of account here, even though one must of course admit that here the door is opened for a partially uncritical judgment." The problem in judging liver medications is thereby aptly characterized.
The critics who "shoot up" a particular preparation can certainly rightfully assert that the effectiveness of this preparation is not sufficiently proven. In this, however, they conceal that this proof exists just as little for other methods, and also that they know of no method for arriving at this proof. With the reproach of the unfurnished proof of effectiveness, and with the way one selects information, one practices deliberate deception or abuse.
6. Antibiotics: Let us also demonstrate the practical difficulties in judging medications using antibiotics as an example. No one seriously questions that antibiotics represent a beneficial extension of therapeutic possibilities. This is really "scientifically generally recognized". Nevertheless, there are no controlled clinical experiments for the proof of effectiveness of antibiotics in illness needy of treatment. One explains the lack of these investigations by saying that for scientific reasons one surely cannot leave the patients in the control group untreated. This objection is rightfully made. In addition, the methodological difficulties are so great that the hygienist Neumann has flatly disclaimed that one can make any kind of statement about an antibiotic by means of a controlled clinical experiment. Our knowledge is based on medical empiricism and on the judgment of success in particular cases. These judgments are certainly to the point. In practice decisions about the applicability of antibiotics are made on the basis of in vitro data, ideas based on analogy, and uncontrolled medical observations. Thus, there are no proofs of effectiveness in serious illness needy of treatment but only standpoints about which indications make treatment with antibiotics meaningful. Should one therefore exclude antibiotics from indemnification? This would completely contradict the purpose of health insurance. But why does one require "proofs" for particular medications while for others medical judgments of success are considered to be sufficient? For the clinical methodologist there is no difference between the necessity of proof for the effectiveness of antibiotic treatments and, for example, homeopathic ones. If in particular cases one is able to successfully treat a life-threatening organ mycosis with the aid of an antimycotic, then this treatment is" scientifically recognized," whereas the same success with a cancer medication for an incurable cancer patient is not "scientifically recognized", because the two treatments correspond to different scientific standpoints. For example, there are pathologists who would rather withdraw their own histological diagnoses than recognize a success for a treatment that does not correspond to their scientific conviction.
IV. Conventional Medicine's Claim to Sole Representation?
The attempt to make scientific theory into a superior criteria is reflected in many ways. I asked the German Health Insurance Company: "Do you also view the costs of a medication with which successful treatments have been carried out as not obligatorily reimbursable?" To this I received the reply: "If scientific recognition has thus far been denied to a medication, then the contractual exclusion of payment still holds in a particular case even if a successful treatment was achieved." According to the interpretation of the German Health Insurance Company, scientific recognition has priority over healing. It thus concurs with the interpretation of the Regional Payment Bureau of North Rhine-Westphalia for which the cure of a patient is only then an obligatorily reimbursable event if the therapeutic measures correspond to a particular viewpoint. With this, scientific dogma is elevated to a higher protected interest than are the patient's life and health.
This kind of scientific dogma which disregards experience in its finding of judgments has found entry into jurisdictions, as the following decision of the Federal Social Court (FSC) shows: "The Social Court (SC) could only decide the question (considered by it to be legally relevant) of whether electron neural therapy is a scientifically recognized therapy on the basis of expert opinions of representatives of `school medicine'. Whether a court--that has to decide a scientific case to whose resolution it lacks its own expert information, which therefore it can only decide with the aid of expert witnesses--may also listen to representatives of scientifically not-recognized theories and evaluate their views, need not be examined here. In any case, a court does not overstep the boundaries of judicial respect for evidence, and also does not fail in its duty to clarify issues if to arrive at a judgment it only calls on generally recognized specialists and depends solely on their expertise. Whereas, in addition, the plaintiff alleges that only the healing methods administered in the private clinic succeeded with her and that the SC should therefore have pursued the question about the effectiveness of this method, relying on the judgment of Dr. X (the treating physician), and in addition should have called in other experts, she objects to the legal view of the SC in this matter. The latter considers the supposed effectiveness of an unrecognized method of treatment to be insufficient to derive a reimbursement obligation to the defendant therefrom." The plaintiff was cured of an unspecified illness with a particular method of healing after a cure had not occurred by the application of other methods. This state of affairs is disputed neither by the SC nor the FSC. The SC only listened to experts with an adverse standpoint; like the FSC, it identified itself in a scientific case with a particular medical view by ignoring the facts of the case ("because what may not be can not be"), Therewith both courts violate Section 5 III C(onstitutional) L(aw), The courts cannot even claim to support the majority view. According to three comprehensive polls by Ritter, scientifically not generally recognized methods of healing are used by a total of 70% of the domiciled physicians. Only a minority of domiciled physicians represent the standpoint that only "scientifically recognized methods of healing should be used” and identify themselves with "school medicine's" claim to sole representation. Both courts stand in contradiction to not only the actual medical circumstances but also to previous jurisdiction. Thus the Bremen Supreme Court decided that "General Findings of collective science do not exist for some therapies, but only findings which are opposed by other scientific views." For a proof of effectiveness it is therefore sufficient if one can refer to medical experts who have confirmed the effects claimed even though others dispute or doubt them. The preferential treatment for "generally recognized methods" or of "majority-use forms of therapy" by courts, insurance companies, etc., not only violates constitutional law, it also indirectly breeds political health monstrosities. Thus, for example, the uncritical administration of antibiotics in mild and slightly serious infectious diseases is presently the "majority method". American authors estimate the frequency of wrong administration of antibiotics to be about 70-90%. Antibiotic abuses lead to the development of resistant germs and to so-called nosocoial infections, i.e., a change in the constitution of germs occurs so that uncontrollable infections appear in hospitals which can only be checked by a radical curb in the use of antibiotics. In the U.S. about 7% of the patients admitted to hospitals become ill of a hospital infection, and the latter is the cause of death in 6% of the patients who die there. All the experts agree that this abuse must be reduced as fast as possible, but they do not have a generally recognized alternative, because to date every other treatment would be a disputed "minority method". In view of the uncertainty in the indemnification of other forms of therapy, or even of malpractice suits, physicians think that they have to go along with the "majority view" by treating every infection with antibiotics. However, if the abuse of antibiotics is not rigorously curbed soon, it is to be feared that in the near future there will be uncontrollable epidemics or ones which can only be controlled with difficulty.
In the treatment of rheumatic disease the alleviation of pain is a difficult problem because, with prolonged use, all scientifically recognized medications have sizeable side effects. Recently, success has sometimes been achieved in reducing pain, or even eliminating pain, with preparations of "devil's claw" (Herpagophytum), a South African medicinal plant, so that one can avoid harmful analgesics. If health insurance (e.g., the United Health Insurance Company) refuses to indemnify this medicine, it forces the patient to subject himself to a more harmful treatment. Such action is health-politically irresponsible and boycotts physicians' efforts to curb the use of pain killers and illness from side effects. Government, courts and insurance companies are engaged in active health politics with their scientific dogmatism, namely against the patient's interests.
V. Beyond Dogmatics: The Interest of the Patient
With the question under which presuppositions one can consider a medication to be scientifically recognized, the ground of reality on which the physician must move is usually abandoned. When forming theories one must not forget the main thing: namely, that it is a question of the patient who is ill and is looking for help. As a rule he is quite indifferent to whether the help succeeds in a scientifically recognized or not recognized form, as long as it succeeds. By agreeing to treat the patient, the physician obligates himself to cure him in the best possible manner. In this he should pay no attention to scientific questions because by doing so he might endanger the success of the treatment. His duty to enlighten the patient can surely only consist in informing him about the possible usefulness of various methods of treatment and the risk involved. It is not in the interests of the patient if the selection occurs one-sidedly from dogmatic points of view. If, for example, a patient is suffering from very painful trigeminus neuralgia, then from "conventional medicine's" point of view treatment with fuming medications and surgical intervention are available. Both methods are burdened with a high quota of failure and side effects. However, the patient has a right to know that there a neural therapeutic treatments, for example, with at least equivalent rates of success and with no side effects. The physician is obliged to inform himself about all methods of treatment, even if he does not use them himself. As a rule, the patient will not be influenced by what the majority view is but by the usefulness to be expected and also by his confidence in the various therapeutic methods. One should not deprive him of this right. Only a dogmatist can support the view that it would be better for a cure not to occur than to have it result from "scientifically unrecognized" presuppositions. This, however, cannot be the purpose of health insurance protection, no matter of what kind. The ill person does not insure himself for the case that he will be helped on the condition that particular scientific theories are recognized, but for the case of illness as such.
The sameness of similarity of arguments and formulations of private health insurance companies makes one suspect a conspiracy. One should investigate and see whether there is not an illegal monopoly there. One should also check whether the Federal Insurance Bureau has fulfilled its inspection duties and whether it might not be obligated to take action in accordance with Art. 5 III CL. Also there is a question whether the health insurance companies are not committing a grave offense to the principles of honesty and good faith. Thus, the insured is in a quandary. The determination of non-indemnification for scientifically unrecognized medications leads to legal uncertainty. Since objective criteria or other maxims for scientific recognition do not exist, neither the insured nor the physician treating him can predict which medication will be repaid. The insured can also not avoid the issue with another insurance. If he does not want to do without insurance altogether, he has to subject himself to the one-sided abuse of this concept. As a result of his economic inferiority and the long duration of civil or administrative law suits, the insured is also legally inferior.
In practice, the instrument of scientifically not generally accepted medications is not used to single out meaningless or medically indefensible medicaments. Laxatives containing phenolisatin would otherwise have been on the index for a long time, and a dispute would long since have broken out about many coronary dilators, vitamin preparations, so-called lipid sinkers and psycho-pharmaceuticals. However, precisely these medications represent a considerable cost factor. Instead of this, the concept is abused to decide scientific disputes on an economic or legal level. According to Art. 5 III CL, it does not belong to the tasks of an administrative body or a court to identify itself with a particular medical method, or to bring about the preference of a particular medical method or view, against the sometimes vital interests of the patient. It is also not in the province of a health insurance company to practice scientific politics. The health insurance company, of whatever kind it may be, must enable the patient to obtain the best treatment that is economically possible, without regard to medical disputes about methods.
In order to end the predominantly abused application of protection against abuse, the concept of “scientifically (generally) recognized medications" should no longer be used. Instead of this, one should adhere to the formulation of the new medication law. According to this, a medication should be excluded from indemnification if it is certain that no therapeutic success can be achieved with it. Only in this way can the insured, or the one entitled to compensation, be placed in a position of legal security.