- Email: [email protected]
MEDICINE AND THE DRUG INDUSTRY IN GERMANY
743 out in his own department. Our friend is a shy man, and stands somewhat in awe of his adopted Professor, in whom many years of agriculture have rnatured an already
Initially, therefore, ourfriend viewed his translation with some misgiving, and he was comfortably reassured to observe, standing in the entrance hall of the department, a fine brindled cow of about 2llx hands, entirely composed of some plastic material, and bearing on its face an expression of disinterested benevolence. For a few days the matter went little further, and beyond nodding to the animal as he passed, our friend made no effort to ripen the acquaintance. One afternoon, however, as he conversed uneasily in the hall with his formidable host, a chance glint of sunlight revealed that the dorsal portion of the cow, including the tail, was detachable. Our friend’s knowledge of cows is undeniably sketchy, and it came to him that his horizon would be considerably enlarged could he but remove the detachable portion and investigate what lay within. Clearly, however, the moment was inopportune, and the next day he was at pains to choose a time when nobody was about. The catch was a little stiff, and our friend was injudicious enough to give it a smart tug. With a resounding clatter the cow overbalanced and fell to the floor, retaining its benevolent expression but scattering plastic viscera in all directions. On all sides doors opened inquiringly, and our friend found himself surrounded by a crowd of interested and helpful agriculturalists. Nothing was ever said, our friend tells us, but the cow has now been moved to the Professor’s room, and he feels that the agriculturalists are watching him. hearty personality.
*
*
*
I am not sure what to think of those clever chaps in the World Influenza Centre who have been watching A/Asia/57 creeping up on us over the past few months. Their reports have been followed so closely by the newspapers that at any moment I have been expecting to see a rash of black arrows on maps, like an enemy’s wartime troop movements. All this intelligence has been too much for the more frail section of the local populace. They have had headache, backache, andBthe rest, retired to bed, sent neighbours round to the phone : "’ Mrs. R- thinks she’s got theAsian,’ Doctor." Those who really do have it seem almost pleased that they are genuine and not hypochondriacal. I’ve had a subacute prodrome myself for the past three weeks, and can’t decide whether to treat with tab. codein. co. or phenobarbitone. Now the white arrows of the Ministry’s counter attack Do you want an injection in are beginning to appear. three weeks’ time, to be repeated one month later, against a virus which you first contacted three weeks ago ? Please sign on the dotted line. *
*
*
Our visitor from Scotland was greatly taken with an item on the menu : Poached Fresh B.C. Spring Salmon He told the waitress that in Scotland you wouldn’t expect to see it stated on the menu that the salmon had
been poached. Lines
*
*
*
the Select Committee’s proposal that medical students be required to satisfy their examiners that they have a sound knowledge of the financial side of the National Health Service on
before being
allowed to qualify. Now what is the cost of
an
aspirin, boy,
with a Codeine Co ? And what do you pay
Compared
For a whole-plate X-ray Of a colon that simply won’t go ? How high is the price Of a large lump of ice For cooling an ’Oxygenaire ’ ?P If a doctor’s away, Does he go on half-pay, Or his Registrar give him a share ? If you really don’t know, Then you’re certainly slow, And something, I fear, of a dunce, I sincerely advise That this work you revise, Before you come back in six months.
Letters
to
the Editor
CHRISTMAS GIFTS FUND APPEAL SIR,—I am writing this appeal in the interim period between the resignation of Lord Webb-Johnson and the assumption of office by Sir Henry Tidy, our newly
elected
president. Although we are now able to give far larger grants than in the past, it is difficult for your readers to realise what extraordinary joy and happiness the Christmas Gift brings to our beneficiaries. I appeal most earnestly to all members of the medical profession to help to bring Christmas cheer into the homes of many of our less fortunate doctors. Please send your contributions marked " Christmas Gifts " to the Secretary, Royal Medical’ Benevolent Fund, 1, Balliol House, Manor Fields, Putney, London, S.W.15. R. M. HANDFIELD-JONES Chairman of the Committee of Management, Royal Medical Benevolent Fund.
MEDICINE AND THE DRUG INDUSTRY IN GERMANY as we suspect, your correspondent’s article1 written after a short tour of the Federal Republic, it is understandable that he was not fully familiar with the facts, and was unable to judge the German pharmaceutical markets accurately. In any case, we believe that we owe both your readers and the subject itself some clarification of the position. It is not true that the " red list " only " sometimes " gives both thecomposition and the indications for the proprietary products it lists. Both the composition and field of application of each individual product have always been given. The latest (1957) edition of the list gives for most of the products not only the qualitative composition but also the content of medically active ingredients. In this way the publishers, the " Trade Association," give every doctor precise information about the nature and content of the products he prescribes. In this connection, who can compel a doctor to prescribe remedies whose formula or scientific basis are unknown to him? It is not true to say that in Western Germany over 500 small firms account for about 85% of the trade, whilst the remaining 15% of trade is done by the 30 largest firms. It would be interesting to know how your correspondent obtained these figures. It can be definitely stated that the well-known large or middle-size firms account for more than 50% of German pharmaceutical trade. It is also wrong to say that mixtures of drugs have been " quite arbitrarily selected "-that is to say, marketed without previous research. Compound pharmaceuticals scientifically designed and practically tested are becoming increasingly important in Germany, as in Great Britain.2 Their usefulness, particularly in ambulant practice, was emphasised recently by a qualified speaker at the " Heubnertag in Karlsruhe. There may indeed be certain abuses in this field, but this does not reflect upon the German pharmaceutical industry as a whole. The Trade Association, however, is doing its best to bring about improvements in this respect. Its
SIR,—If,
was
,
"
statute " The
provides
that :
members
of
the
Federation
have
the
primary
obligation :
special care in manufacturing and testing their products, (b) only to market novelties in combination, action or indication after adequate pharmacological and clinical
(a)
to take
trials, 1. 2.
Lancet, 1956, ii, 1304. Herxheimer, H., Whittet, T. D., Wilson, A. Lancet, 1954, ii, 42.
744
(c)
to make known to all
physicians and other medically persons, details of combination, active ingredients and mode of action of their products, to avoid untrue, ambiguous or misleading statements in advertising and otherwise to refrain from unethical methods in competition. qualified
(d)
is
certainly time-consuming and expensive. Testing But it is out of the question to say that such tests are probably not carried out by more than 20 firms, although the scientific resources of individual concerns naturally vary according to their financial capacity. Besides the well-known large and medium-sized firms, there are many smaller concerns who, in their own laboratories, or in cooperation with university institutes, apply the same high standards to the development, manufacture, and sale of their products. It cannot be denied that advertising by the pharmaceutical industry has increased in recent years. One of the reasons for this is that new knowledge resulting from the increased tempo of medical research has led to development of more new products. To attract the attention of the busiest doctors, increased effort has to be made to keep them adequately informed. Another important influence on the volume of advertising is the existence of fierce competition in the German pharmaceutical market, in which foreign pharmaceutical companies also play a significant part, aided by liberal trade regulations. Nevertheless, if a doctor obtains, from the information sent to him daily, only two or three ideas of value to a patient, and whose application may perhaps save a life, then this alone is sufficient justification for the volume of such information. It is true that the West German pharmaceutical manufacturers sometimes come in for criticism by the scientists, a fate which they share with pharmaceutical producers abroad. The late Prof. W. Heubner, a senior German pharmacologist, criticised drug therapy during the last German Therapy Congress in September, 1956. It is, however, untrue that " neither the medical press nor the industry took much notice." On the contrary, representatives of the industry, both during the discussions at the congress and later in the medical press, discussed the arguments put forward in the lectures. Certainly in Western Germany there are many medical journals. As there exist both good and bad products, so there are both good and bad journals. The general standard of the German technical press is, however, represented by those publications whose editorial staffs have a due sense of responsibility to the medical world and hence to the whole community. Furthermore, the medical journals are not exclusively or even predominantly concerned with therapeutics but deal with broader aspects of medical science for the better information of theoretical and practical physicians. Therefore, it is not a fact that material is used which " even first-class editing cannot transform into something valuable." Neither is it true that descriptions of new drug combinations fail to give all the constituents or their exact On the contrary, no new medicament is amounts. secret, either in part or as a whole ; all published results of tests can be critically checked by any observer ; and, as in the " red list," the details of the combination are indicated. Finally, it must be pointed out that a wide range of medical journals ensures that even apparently unimportant therapeutic advances receive serious scientific discussion at every stage. Every scientific article has the same ultimate purpose as advertising by post and in the press-namely, keeping the physician’s therapeutic knowledge up to date. The importance of this matter was emphasised by the chairman of the Senat fur arztliche Fortbildung at the 57th German Medical Congress in 1953 in the following words : "
In order that all shall share in new scientific knowledge and in new methods of healing, these must not be confined
to a small privileged group, but should be made available without delay to every physician, even in the most remote
village. to
The
patient
cannot wait for
grow’up bringing with
it
medical generation of new discoveries from
a new
knowledge
the universities."
The pharmaceutical industry of the Federal Republic is determined fully to support this fundamental aspect of the campaign against illness. BUNDESVERBAND DER PHARMAZEUTISCHEN INDUSTRIE. ESTIMATION OF PLASMA-PROTHROMBIN SIR,—In your leader last week you state: " Owren has elaborated the one-stage technique by adding excess of factors v and vii ; this seems of doubtful value since for control of anticoagulant treatment any depression of factor viii needs to be included in the estimation." It should be noted that Owren has never recommended this method for the control of anticoagulant therapy. In the method which he does recommend, the prothrombin and proconvertin (p and p) method, an optimum amount of fibrinogen and factor v are added to a diluted plasma system. This method is gaining increasing favour throughout the world and there is no doubt that it is superior to the unmodified one-stage test for the control of anticoagulant therapy. The reasons for its superiority are : that the test measures the combined deficiency of factor vii and prothrombin, that random variations are less than with the unmodified test, that the results are reasonably reproducible from one batch of reagents to another, and that the method records values in the near normal range. This last attribute may seem of little value, but the increased sensitivity emphasises trends into and out of the therapeutic range and facilitates the early choice of a balancing dose. The Radcliffe Infirmary, Oxford.
SrR,,-I would like to
ROSEMARY BIGGS.
correct a serious error in your article last week. You state that Owren has elaborated the one-stage technique by adding excess of factor v and factor vn. This, of course, is not so, as it would be impossible to control anticoagulant therapyif factor vn was added. In fact, in Owren’s technique it is only factor v that is added. In our anticoagulant unit here we have over the last eighteen months compared the value of Quick’s, Owren’s, and Ware’s modification of Owren’s technique in the control of anticoagulant therapy. In all, more than 2000 blood samples were tested and there appeared to be no doubt that Owren’s technique (with minor modifications) proved definitely superior to the other methods for the control of anticoagulant therapy for inpatients. The value of Owren’s technique as compared with Quick’s method for outpatient long-term therapy is still under investigation. It is hoped to publish the results of this investigation in detail in the near future. There is no doubt, as I have stressed for many years, that the basic essential for the proper control of anticoagulant therapy is a reliable thromboplastin. I feel sure that part of the value of Owren’s technique is that he prepares a reliable thromboplastin with constant reproducible activity by a saline extraction of human brain. Owren states that an acetone-dried extract does not give constant reproducible activity, as does a saline extract. This is entirely in keeping with what 1 have advocated for many years, and I have always considered it entirely unnecessary to use an acetone-dried extract, as a saline extract gives more constant and reproducible results. A saline extraction of human brain is, moreover, much simpler to prepare than an acetone-dried brain extract, and it keeps absolutely stable for an indefinite period when stored at -20°C.
leading
Initially, therefore, ourfriend viewed his translation with some misgiving, and he was comfortably reassured to observe, standing in the entrance hall of the department, a fine brindled cow of about 2llx hands, entirely composed of some plastic material, and bearing on its face an expression of disinterested benevolence. For a few days the matter went little further, and beyond nodding to the animal as he passed, our friend made no effort to ripen the acquaintance. One afternoon, however, as he conversed uneasily in the hall with his formidable host, a chance glint of sunlight revealed that the dorsal portion of the cow, including the tail, was detachable. Our friend’s knowledge of cows is undeniably sketchy, and it came to him that his horizon would be considerably enlarged could he but remove the detachable portion and investigate what lay within. Clearly, however, the moment was inopportune, and the next day he was at pains to choose a time when nobody was about. The catch was a little stiff, and our friend was injudicious enough to give it a smart tug. With a resounding clatter the cow overbalanced and fell to the floor, retaining its benevolent expression but scattering plastic viscera in all directions. On all sides doors opened inquiringly, and our friend found himself surrounded by a crowd of interested and helpful agriculturalists. Nothing was ever said, our friend tells us, but the cow has now been moved to the Professor’s room, and he feels that the agriculturalists are watching him. hearty personality.
*
*
*
I am not sure what to think of those clever chaps in the World Influenza Centre who have been watching A/Asia/57 creeping up on us over the past few months. Their reports have been followed so closely by the newspapers that at any moment I have been expecting to see a rash of black arrows on maps, like an enemy’s wartime troop movements. All this intelligence has been too much for the more frail section of the local populace. They have had headache, backache, andBthe rest, retired to bed, sent neighbours round to the phone : "’ Mrs. R- thinks she’s got theAsian,’ Doctor." Those who really do have it seem almost pleased that they are genuine and not hypochondriacal. I’ve had a subacute prodrome myself for the past three weeks, and can’t decide whether to treat with tab. codein. co. or phenobarbitone. Now the white arrows of the Ministry’s counter attack Do you want an injection in are beginning to appear. three weeks’ time, to be repeated one month later, against a virus which you first contacted three weeks ago ? Please sign on the dotted line. *
*
*
Our visitor from Scotland was greatly taken with an item on the menu : Poached Fresh B.C. Spring Salmon He told the waitress that in Scotland you wouldn’t expect to see it stated on the menu that the salmon had
been poached. Lines
*
*
*
the Select Committee’s proposal that medical students be required to satisfy their examiners that they have a sound knowledge of the financial side of the National Health Service on
before being
allowed to qualify. Now what is the cost of
an
aspirin, boy,
with a Codeine Co ? And what do you pay
Compared
For a whole-plate X-ray Of a colon that simply won’t go ? How high is the price Of a large lump of ice For cooling an ’Oxygenaire ’ ?P If a doctor’s away, Does he go on half-pay, Or his Registrar give him a share ? If you really don’t know, Then you’re certainly slow, And something, I fear, of a dunce, I sincerely advise That this work you revise, Before you come back in six months.
Letters
to
the Editor
CHRISTMAS GIFTS FUND APPEAL SIR,—I am writing this appeal in the interim period between the resignation of Lord Webb-Johnson and the assumption of office by Sir Henry Tidy, our newly
elected
president. Although we are now able to give far larger grants than in the past, it is difficult for your readers to realise what extraordinary joy and happiness the Christmas Gift brings to our beneficiaries. I appeal most earnestly to all members of the medical profession to help to bring Christmas cheer into the homes of many of our less fortunate doctors. Please send your contributions marked " Christmas Gifts " to the Secretary, Royal Medical’ Benevolent Fund, 1, Balliol House, Manor Fields, Putney, London, S.W.15. R. M. HANDFIELD-JONES Chairman of the Committee of Management, Royal Medical Benevolent Fund.
MEDICINE AND THE DRUG INDUSTRY IN GERMANY as we suspect, your correspondent’s article1 written after a short tour of the Federal Republic, it is understandable that he was not fully familiar with the facts, and was unable to judge the German pharmaceutical markets accurately. In any case, we believe that we owe both your readers and the subject itself some clarification of the position. It is not true that the " red list " only " sometimes " gives both thecomposition and the indications for the proprietary products it lists. Both the composition and field of application of each individual product have always been given. The latest (1957) edition of the list gives for most of the products not only the qualitative composition but also the content of medically active ingredients. In this way the publishers, the " Trade Association," give every doctor precise information about the nature and content of the products he prescribes. In this connection, who can compel a doctor to prescribe remedies whose formula or scientific basis are unknown to him? It is not true to say that in Western Germany over 500 small firms account for about 85% of the trade, whilst the remaining 15% of trade is done by the 30 largest firms. It would be interesting to know how your correspondent obtained these figures. It can be definitely stated that the well-known large or middle-size firms account for more than 50% of German pharmaceutical trade. It is also wrong to say that mixtures of drugs have been " quite arbitrarily selected "-that is to say, marketed without previous research. Compound pharmaceuticals scientifically designed and practically tested are becoming increasingly important in Germany, as in Great Britain.2 Their usefulness, particularly in ambulant practice, was emphasised recently by a qualified speaker at the " Heubnertag in Karlsruhe. There may indeed be certain abuses in this field, but this does not reflect upon the German pharmaceutical industry as a whole. The Trade Association, however, is doing its best to bring about improvements in this respect. Its
SIR,—If,
was
,
"
statute " The
provides
that :
members
of
the
Federation
have
the
primary
obligation :
special care in manufacturing and testing their products, (b) only to market novelties in combination, action or indication after adequate pharmacological and clinical
(a)
to take
trials, 1. 2.
Lancet, 1956, ii, 1304. Herxheimer, H., Whittet, T. D., Wilson, A. Lancet, 1954, ii, 42.
744
(c)
to make known to all
physicians and other medically persons, details of combination, active ingredients and mode of action of their products, to avoid untrue, ambiguous or misleading statements in advertising and otherwise to refrain from unethical methods in competition. qualified
(d)
is
certainly time-consuming and expensive. Testing But it is out of the question to say that such tests are probably not carried out by more than 20 firms, although the scientific resources of individual concerns naturally vary according to their financial capacity. Besides the well-known large and medium-sized firms, there are many smaller concerns who, in their own laboratories, or in cooperation with university institutes, apply the same high standards to the development, manufacture, and sale of their products. It cannot be denied that advertising by the pharmaceutical industry has increased in recent years. One of the reasons for this is that new knowledge resulting from the increased tempo of medical research has led to development of more new products. To attract the attention of the busiest doctors, increased effort has to be made to keep them adequately informed. Another important influence on the volume of advertising is the existence of fierce competition in the German pharmaceutical market, in which foreign pharmaceutical companies also play a significant part, aided by liberal trade regulations. Nevertheless, if a doctor obtains, from the information sent to him daily, only two or three ideas of value to a patient, and whose application may perhaps save a life, then this alone is sufficient justification for the volume of such information. It is true that the West German pharmaceutical manufacturers sometimes come in for criticism by the scientists, a fate which they share with pharmaceutical producers abroad. The late Prof. W. Heubner, a senior German pharmacologist, criticised drug therapy during the last German Therapy Congress in September, 1956. It is, however, untrue that " neither the medical press nor the industry took much notice." On the contrary, representatives of the industry, both during the discussions at the congress and later in the medical press, discussed the arguments put forward in the lectures. Certainly in Western Germany there are many medical journals. As there exist both good and bad products, so there are both good and bad journals. The general standard of the German technical press is, however, represented by those publications whose editorial staffs have a due sense of responsibility to the medical world and hence to the whole community. Furthermore, the medical journals are not exclusively or even predominantly concerned with therapeutics but deal with broader aspects of medical science for the better information of theoretical and practical physicians. Therefore, it is not a fact that material is used which " even first-class editing cannot transform into something valuable." Neither is it true that descriptions of new drug combinations fail to give all the constituents or their exact On the contrary, no new medicament is amounts. secret, either in part or as a whole ; all published results of tests can be critically checked by any observer ; and, as in the " red list," the details of the combination are indicated. Finally, it must be pointed out that a wide range of medical journals ensures that even apparently unimportant therapeutic advances receive serious scientific discussion at every stage. Every scientific article has the same ultimate purpose as advertising by post and in the press-namely, keeping the physician’s therapeutic knowledge up to date. The importance of this matter was emphasised by the chairman of the Senat fur arztliche Fortbildung at the 57th German Medical Congress in 1953 in the following words : "
In order that all shall share in new scientific knowledge and in new methods of healing, these must not be confined
to a small privileged group, but should be made available without delay to every physician, even in the most remote
village. to
The
patient
cannot wait for
grow’up bringing with
it
medical generation of new discoveries from
a new
knowledge
the universities."
The pharmaceutical industry of the Federal Republic is determined fully to support this fundamental aspect of the campaign against illness. BUNDESVERBAND DER PHARMAZEUTISCHEN INDUSTRIE. ESTIMATION OF PLASMA-PROTHROMBIN SIR,—In your leader last week you state: " Owren has elaborated the one-stage technique by adding excess of factors v and vii ; this seems of doubtful value since for control of anticoagulant treatment any depression of factor viii needs to be included in the estimation." It should be noted that Owren has never recommended this method for the control of anticoagulant therapy. In the method which he does recommend, the prothrombin and proconvertin (p and p) method, an optimum amount of fibrinogen and factor v are added to a diluted plasma system. This method is gaining increasing favour throughout the world and there is no doubt that it is superior to the unmodified one-stage test for the control of anticoagulant therapy. The reasons for its superiority are : that the test measures the combined deficiency of factor vii and prothrombin, that random variations are less than with the unmodified test, that the results are reasonably reproducible from one batch of reagents to another, and that the method records values in the near normal range. This last attribute may seem of little value, but the increased sensitivity emphasises trends into and out of the therapeutic range and facilitates the early choice of a balancing dose. The Radcliffe Infirmary, Oxford.
SrR,,-I would like to
ROSEMARY BIGGS.
correct a serious error in your article last week. You state that Owren has elaborated the one-stage technique by adding excess of factor v and factor vn. This, of course, is not so, as it would be impossible to control anticoagulant therapyif factor vn was added. In fact, in Owren’s technique it is only factor v that is added. In our anticoagulant unit here we have over the last eighteen months compared the value of Quick’s, Owren’s, and Ware’s modification of Owren’s technique in the control of anticoagulant therapy. In all, more than 2000 blood samples were tested and there appeared to be no doubt that Owren’s technique (with minor modifications) proved definitely superior to the other methods for the control of anticoagulant therapy for inpatients. The value of Owren’s technique as compared with Quick’s method for outpatient long-term therapy is still under investigation. It is hoped to publish the results of this investigation in detail in the near future. There is no doubt, as I have stressed for many years, that the basic essential for the proper control of anticoagulant therapy is a reliable thromboplastin. I feel sure that part of the value of Owren’s technique is that he prepares a reliable thromboplastin with constant reproducible activity by a saline extraction of human brain. Owren states that an acetone-dried extract does not give constant reproducible activity, as does a saline extract. This is entirely in keeping with what 1 have advocated for many years, and I have always considered it entirely unnecessary to use an acetone-dried extract, as a saline extract gives more constant and reproducible results. A saline extraction of human brain is, moreover, much simpler to prepare than an acetone-dried brain extract, and it keeps absolutely stable for an indefinite period when stored at -20°C.
leading