756
practitioners is, from the facts, totally illogical. He is not comparing like with like, since patients who attend the dental surgeon regularly may go for a very good reason-because they need fillings. It is incredible to say that regular attenders have had more teeth filled than irregular attenders have had teeth decayed-and to deduce that this can result only from a tendency to overtreat. Might not some non-attenders have decided that, with no symptoms, they have no need for a visit? Is it not possible that, in the absence of symptoms, decay may not exist? It is like saying that cars which have been taken to garages have had more repairs than those which have not, and, for those which have not been taken, there is evidence that less repairs are necessary. What of the psychological advantages of dental examinations and consultation from the earliest possible age? Is it not good to give children confidence by familiarising them with the dental surgeon before any treatment is necessary? What about the value of preventive dentistry? If overprescription does exist, may it not be as a result of other factors, such as a method of remuneration which seems to place a premium on quantity rather than quality? There is evidence to suggest that the dental state of the nation is poor. How can this be the result of overprescription? Is Dr Sheiham suggesting that the dental practitioners are doing more harm than good? Is he saying that the present conditions of service are totally inadequate and need revision? Is he saying that practitioners are acting unethically and, if so, what proof has he? Has Dr Sheiham never been to a dental practice and been given permission to study the records of patients’ treatment? Is he not aware of the possibility-nay, the probability-that conscientious practitioners make such notes as: "early enamel caries, no treatment required at present, see patient again in four months, oral hygiene instruction given"? Or perhaps: "grossly carious teeth and appalling oral hygiene, conservative work not advised at this stage, oral hygiene instruction given, see patient again in two months, will consider conservative work only when oral hygiene improves"? Dr Sheiham should perhaps attempt to eliminate the doubts he has manufactured. Cleveland House, 30 New Road, Chippenham, Wiltshire SN15 1HP
N. J. KNOTT
Round the World West Germany AN OVERABUNDANCE OF DRUGS
AT the end of last year, there were about 2400 pharmaceutical firms in West Germany; and about 30 000 different proprietary and other drugs were registered at the Federal Health Office. Registration of a new drug requires some examination of its safety but not of its efficacy. A new drug law, which will come into force on Jan. 1, 1978, declares that new drugs can be put on the market only when both their safety and their efficacy have been proved. All older drugs must also be examined in the same way, but a stay of judgment of 12-15 years has been granted. Meanwhile, how are doctors being influenced in what they prescribe? Even if the figure of 30 000 drugs includes thousands which have practically no turnover, there are between 8000 and 10 000 which are on the official list of the pharmaceutical industry (the Red List) or will be included shortly and which are on sale. Three-quarters of them are combinations of two, three, or more substances. Perhaps doctors have seen them used during their training or tried them in practice, or read of them in the journals, or heard about them in postgraduate courses. But information on the newer ones comes mostly from intensive promotion by the pharmaceutical in-
dustry.
There are about a dozen medical weeklies or fortnightlies in West Germany which have, after every two pages of text, two or four pages of advertisements in colour. In addition there are a number of journals edited by regional medical associations, by local medical representative bodies, or by lay health-insurance organisations, and about 500 medical or part-medical periodicals, which usually have little scientific content, and what they have is of modest value. They are mostly "giveaways", with many advertisements, without which they could not exist. Some of them have to increase the number of editorial pages by including non-medical material, such as articles on motoring or foreign travel, in order to have enough editorial pages between which advertisements can be slotted. Thus, doctors can hardly avoid the influence of these advertisements, cleverly designed by the many flourishing advertising agencies. Doctors are also visited by the manufacturers’ representatives, who will be given legal standing by the new drug law, since they will be expected to collect and report undesirable sideeffects. Many doctors are uneasy about an element of untruth in some advertisements which stress the advantages of a product and play down its disadvantages. Moreover, even big firms seem to have no qualms about telling half-truths or keeping quiet about serious side-effects. The most striking excesses (for example, claims that cyanocobalamin counters fatigue in schoolchildren or recommendations for chloramphenicol in minor infections) have not been repeated recently. But chloramphenicol is still marketed by one firm in combination with guaiacol, theophylline, papaverine, and three vitamins, with a hint that it might be useful in bronchitis and bronchospasm. Another firm is marketing a combination of several B vitamins for use as an analgesic; and this firm is not the only one selling multi-vitamin preparations for this purpose. The doctor is not helped by the fact that journals carrying advertisements hardly ever publish criticisms of such blandishments. The leaders of the German medical profession have, so far, done little to counter this attempt to manipulate doctors’ prescribing habits. Prof. R. Aschenbrenner, President of Arzneimittelkommission der deutschen Arzteschaft, has, however, warned that there are grave dangers in the way the practice of medicine is being influenced in West Germany. Unfortunately, his committee, not being a statutory body, has little influence. But if his warnings are not heeded, there will be more new drugs, more ineffectual drug combinations, and more misleading information, as drug firms continue to market preparations which are only modifications of a successful drug recently launched by a competitor.
United States THE LONG ARM OF BUREAUCRACY
DESPITE all campaign promises, the federal Government continues to expand inexorably, and the present Administration has already proposed several new departments, including a Consumer Protection Agency. But the U.S. public is becoming increasingly impatient, and the day of reckoning is rapidly approaching. Until the last few years, most Government agencies seem to confine themselves to major problems that affected the whole country. Thus the Department of Agriculture limited its activities to national matters such as agriculture subsidies, irrigation, and soil erosion, and in this capacity was regarded by most farmers as an ally and a source of help in time of need. However, the last few years have seen the birth of a series of small administrations and agencies, including the Occupational Safety and Health Administration (O.S.H.A.), the Mining Enforcement Safety Administration, and the National Institute of Occupational Safety and Health. The raison d’etre of these newcomers sometimes appears to be the harassment of small businesses and private citizens. In their zeal, many of these agencies seem to have lost all perspective, and have far exceeded the mandate of Congress and the people. There are now around twelve pages of regulations governing the construction of ladders which are to be sold on the market.
757 and the latest lawn-mowers have so many safety devices attached that they are almost too heavy to push. This year’s model electric mower can only be pushed forward, since O.S.H.A. has insisted on fitting a device that prevents the operator from pulling the machine backwards. Instead, a gadget has been installed that makes it impossible to turn the mower around except by slowly navigating it through a great semi-circle-a journey which almost invariably leads to the electric extension cord either slipping under the machine and becoming entangled in the blades, or else becoming wrapped around the limbs and neck of the operator. Nonetheless, O.S.H.A. underestimated the ingenuity of the average householder, and most have managed to dismantle every safety device within hours of purchase, thereby leaving a strippeddown version which is some 15 to 20 pounds lighter and much easier to use. O.S.H.A. has also contrived to attract a fair share of odium through its continued persecution of the owner of a small factory in the Far West. When the Government bureaucrats inspected the workshop of the factory (where fewer than ten people work), they found it to be without blemish, but the O.S.H.A. officials then demanded entrance to the owner’s home in order to look inside his refrigerator, where two of the workers kept their pre-packaged lunch and where one or two agents used in the manufacturing process were stored. On being denied entrance they brought a suit against the owner and over the past two years have conducted a continuing vendetta against him. The owner of the factory took the matter to court and fortunately O.S.H.A. was rebuffed. But the owner has spent several thousand dollars in legal fees with no hope of recovering the cost from the Government. This sort of petty harassment is becoming more frequent and the trouble lies, not so much with the hierarchy and directors of the various Government agencies, but with the lesser officials, many of whom seem to have emerged straight from Franz Kafka’s The Trial. RUMPUS ON RIVER POLLUTION
SOME time late last year the F.M.C. Corporation was found have inadvertently discharged excessive quantities of carbon tetrachloride into the Kanawha River at Charleston, West Virginia. Immediate steps were taken by the company to prevent a recurrence of this episode. The Kanawha is a tributary of the Ohio and some 300 miles downstream, the city of Cincinnati draws its water-supply from the larger river. Information concerning the spill hit the national press, and some reports asserted that carbon tetrachloride was a potent carcinogen; not unnaturally, there was a huge public outcry. But F.M.C:, having first sought expert advice and having been assured that the practice was safe, continued to discharge into the Kanawha effluents containing small quantities of carbon tetrachloride. The Environmental Protection Agency (E.P.A.) became involved, and although at first stating that the continued discharge of small quantities of carbon tetrachloride was harmless, it then did an about-face, and brought an action against the F.M.C. Corporation to forbid the discharge of any carbon tetrachloride into the river. The company warned that they would have to close the plant if this order was put into effect, but the E.P.A. sought an injunction against F.M.C., and a hearing is currently taking place before the U.S. District Court. The E.P.A. called as an expert witness an environmentalist from the Midwest, who testified that carbon tetrachloride was a potent carcinogen and that all those downstream had a greatly increased risk of developing cancer as a result of the discharges. This testimony conflicted with the opinion of most other experts, and certainly does not seem to fit in with the fact that carbon tetrachloride has been used in Britain and elsewhere as a dry-cleaning agent for many years. In any event, the furor seems somewhat inappropriate, since for years dozens of small towns in Pennsylvania, Ohio, and West Virginia have been pouring raw sewage into the Ohio and its tributaries, the upper reaches of which are likely to filter through a few glomeruli but undergo little else in the way of purification. to
i
j
!
Letters
to
the Editor
MORTALITY IN WOMEN ON ORAL CONTRACEPTIVES
SIR,-We would like to comment on the research results from the Royal College of General Practitioners and Professor Vessey and his colleagues published in this issue. Whilst much requires to be clarified through further retrospective and longterm prospective studies certain recommendations can be made in the light of present information. It has been shown in the R.C.G.P. study population that oral-contraceptive users compared with non-users have an increased risk of 1 per 5000 per year of dying from cardiovascular disease. The risk is concentrated, however, in women over the age of 35 years, especially if they smoke cigarettes and have used oral contraceptives continuously for 5 years or more. This relationship to duration of use requires confirmation. These observations will permit clinicians to identify women at special risk more accurately than before. There is no evidence to suggest that the risk for most women under the age of 35 years is great enough to warrant any change in clinical practice unless the well-known additional risk factors for cardiovascular disease are present. The division of the data at age 35 is arbitrary and it would be prudent to assume that there is a gradually increasing risk at an earlier age. These considerations are the basis for our recommendations: Women under 30 Years of Age We have no evidence to justify recommending any change of oral-contraceptive practice. It would be wise to emphasise the general advantage of stopping smoking. Women Aged 30-35 Years Because we have to assume a gradually increasing risk up to 35 years of age, we suggest that some women over 30 years ought to reconsider their use of oral contraceptives. We believe that women in this age-group who have used oral contraceptives continuously for more than 5 years and who are cigarette smokers should come into this category. If they would stop smoking it would probably be reasonable for them to continue the pill. If not it might be wiser for them to change to another method. Women over 35 Years There may well be circumstances where women over the age of 35 years would accept the additional risks involved and would wish to continue oral contraceptives. However, in general it would be wise for all oral-contraceptive users over 35 years of age to reconsider their method of contraception. Older women who smoke and/or have used oral contraceptives continuously for more than 5 years may well have extra risks which they and their doctor will wish to consider when weighing the balance of advantage and disadvantage. It appears that the pill takes several years to affect the cardiovascular system. There is therefore, no advantage in making any sudden change, and it would be reasonable for most women to consult their doctor as they come to the end of their current supplies of oral contraceptives. In no case should patients stop the pill without having adopted a satisfactory alternative method of contraception.
Type ofPill We are unable to determine from present evidence whether oral contraceptives containing lower doses of oestrogen confer any advantage over those containing 50 g. E. V. KUENSSBERG, Royal College of General Practitioners,
President
Royal College of Obstetricians and Gynæcologists
JOHN DEWHURST, President
practitioners is, from the facts, totally illogical. He is not comparing like with like, since patients who attend the dental surgeon regularly may go for a very good reason-because they need fillings. It is incredible to say that regular attenders have had more teeth filled than irregular attenders have had teeth decayed-and to deduce that this can result only from a tendency to overtreat. Might not some non-attenders have decided that, with no symptoms, they have no need for a visit? Is it not possible that, in the absence of symptoms, decay may not exist? It is like saying that cars which have been taken to garages have had more repairs than those which have not, and, for those which have not been taken, there is evidence that less repairs are necessary. What of the psychological advantages of dental examinations and consultation from the earliest possible age? Is it not good to give children confidence by familiarising them with the dental surgeon before any treatment is necessary? What about the value of preventive dentistry? If overprescription does exist, may it not be as a result of other factors, such as a method of remuneration which seems to place a premium on quantity rather than quality? There is evidence to suggest that the dental state of the nation is poor. How can this be the result of overprescription? Is Dr Sheiham suggesting that the dental practitioners are doing more harm than good? Is he saying that the present conditions of service are totally inadequate and need revision? Is he saying that practitioners are acting unethically and, if so, what proof has he? Has Dr Sheiham never been to a dental practice and been given permission to study the records of patients’ treatment? Is he not aware of the possibility-nay, the probability-that conscientious practitioners make such notes as: "early enamel caries, no treatment required at present, see patient again in four months, oral hygiene instruction given"? Or perhaps: "grossly carious teeth and appalling oral hygiene, conservative work not advised at this stage, oral hygiene instruction given, see patient again in two months, will consider conservative work only when oral hygiene improves"? Dr Sheiham should perhaps attempt to eliminate the doubts he has manufactured. Cleveland House, 30 New Road, Chippenham, Wiltshire SN15 1HP
N. J. KNOTT
Round the World West Germany AN OVERABUNDANCE OF DRUGS
AT the end of last year, there were about 2400 pharmaceutical firms in West Germany; and about 30 000 different proprietary and other drugs were registered at the Federal Health Office. Registration of a new drug requires some examination of its safety but not of its efficacy. A new drug law, which will come into force on Jan. 1, 1978, declares that new drugs can be put on the market only when both their safety and their efficacy have been proved. All older drugs must also be examined in the same way, but a stay of judgment of 12-15 years has been granted. Meanwhile, how are doctors being influenced in what they prescribe? Even if the figure of 30 000 drugs includes thousands which have practically no turnover, there are between 8000 and 10 000 which are on the official list of the pharmaceutical industry (the Red List) or will be included shortly and which are on sale. Three-quarters of them are combinations of two, three, or more substances. Perhaps doctors have seen them used during their training or tried them in practice, or read of them in the journals, or heard about them in postgraduate courses. But information on the newer ones comes mostly from intensive promotion by the pharmaceutical in-
dustry.
There are about a dozen medical weeklies or fortnightlies in West Germany which have, after every two pages of text, two or four pages of advertisements in colour. In addition there are a number of journals edited by regional medical associations, by local medical representative bodies, or by lay health-insurance organisations, and about 500 medical or part-medical periodicals, which usually have little scientific content, and what they have is of modest value. They are mostly "giveaways", with many advertisements, without which they could not exist. Some of them have to increase the number of editorial pages by including non-medical material, such as articles on motoring or foreign travel, in order to have enough editorial pages between which advertisements can be slotted. Thus, doctors can hardly avoid the influence of these advertisements, cleverly designed by the many flourishing advertising agencies. Doctors are also visited by the manufacturers’ representatives, who will be given legal standing by the new drug law, since they will be expected to collect and report undesirable sideeffects. Many doctors are uneasy about an element of untruth in some advertisements which stress the advantages of a product and play down its disadvantages. Moreover, even big firms seem to have no qualms about telling half-truths or keeping quiet about serious side-effects. The most striking excesses (for example, claims that cyanocobalamin counters fatigue in schoolchildren or recommendations for chloramphenicol in minor infections) have not been repeated recently. But chloramphenicol is still marketed by one firm in combination with guaiacol, theophylline, papaverine, and three vitamins, with a hint that it might be useful in bronchitis and bronchospasm. Another firm is marketing a combination of several B vitamins for use as an analgesic; and this firm is not the only one selling multi-vitamin preparations for this purpose. The doctor is not helped by the fact that journals carrying advertisements hardly ever publish criticisms of such blandishments. The leaders of the German medical profession have, so far, done little to counter this attempt to manipulate doctors’ prescribing habits. Prof. R. Aschenbrenner, President of Arzneimittelkommission der deutschen Arzteschaft, has, however, warned that there are grave dangers in the way the practice of medicine is being influenced in West Germany. Unfortunately, his committee, not being a statutory body, has little influence. But if his warnings are not heeded, there will be more new drugs, more ineffectual drug combinations, and more misleading information, as drug firms continue to market preparations which are only modifications of a successful drug recently launched by a competitor.
United States THE LONG ARM OF BUREAUCRACY
DESPITE all campaign promises, the federal Government continues to expand inexorably, and the present Administration has already proposed several new departments, including a Consumer Protection Agency. But the U.S. public is becoming increasingly impatient, and the day of reckoning is rapidly approaching. Until the last few years, most Government agencies seem to confine themselves to major problems that affected the whole country. Thus the Department of Agriculture limited its activities to national matters such as agriculture subsidies, irrigation, and soil erosion, and in this capacity was regarded by most farmers as an ally and a source of help in time of need. However, the last few years have seen the birth of a series of small administrations and agencies, including the Occupational Safety and Health Administration (O.S.H.A.), the Mining Enforcement Safety Administration, and the National Institute of Occupational Safety and Health. The raison d’etre of these newcomers sometimes appears to be the harassment of small businesses and private citizens. In their zeal, many of these agencies seem to have lost all perspective, and have far exceeded the mandate of Congress and the people. There are now around twelve pages of regulations governing the construction of ladders which are to be sold on the market.
757 and the latest lawn-mowers have so many safety devices attached that they are almost too heavy to push. This year’s model electric mower can only be pushed forward, since O.S.H.A. has insisted on fitting a device that prevents the operator from pulling the machine backwards. Instead, a gadget has been installed that makes it impossible to turn the mower around except by slowly navigating it through a great semi-circle-a journey which almost invariably leads to the electric extension cord either slipping under the machine and becoming entangled in the blades, or else becoming wrapped around the limbs and neck of the operator. Nonetheless, O.S.H.A. underestimated the ingenuity of the average householder, and most have managed to dismantle every safety device within hours of purchase, thereby leaving a strippeddown version which is some 15 to 20 pounds lighter and much easier to use. O.S.H.A. has also contrived to attract a fair share of odium through its continued persecution of the owner of a small factory in the Far West. When the Government bureaucrats inspected the workshop of the factory (where fewer than ten people work), they found it to be without blemish, but the O.S.H.A. officials then demanded entrance to the owner’s home in order to look inside his refrigerator, where two of the workers kept their pre-packaged lunch and where one or two agents used in the manufacturing process were stored. On being denied entrance they brought a suit against the owner and over the past two years have conducted a continuing vendetta against him. The owner of the factory took the matter to court and fortunately O.S.H.A. was rebuffed. But the owner has spent several thousand dollars in legal fees with no hope of recovering the cost from the Government. This sort of petty harassment is becoming more frequent and the trouble lies, not so much with the hierarchy and directors of the various Government agencies, but with the lesser officials, many of whom seem to have emerged straight from Franz Kafka’s The Trial. RUMPUS ON RIVER POLLUTION
SOME time late last year the F.M.C. Corporation was found have inadvertently discharged excessive quantities of carbon tetrachloride into the Kanawha River at Charleston, West Virginia. Immediate steps were taken by the company to prevent a recurrence of this episode. The Kanawha is a tributary of the Ohio and some 300 miles downstream, the city of Cincinnati draws its water-supply from the larger river. Information concerning the spill hit the national press, and some reports asserted that carbon tetrachloride was a potent carcinogen; not unnaturally, there was a huge public outcry. But F.M.C:, having first sought expert advice and having been assured that the practice was safe, continued to discharge into the Kanawha effluents containing small quantities of carbon tetrachloride. The Environmental Protection Agency (E.P.A.) became involved, and although at first stating that the continued discharge of small quantities of carbon tetrachloride was harmless, it then did an about-face, and brought an action against the F.M.C. Corporation to forbid the discharge of any carbon tetrachloride into the river. The company warned that they would have to close the plant if this order was put into effect, but the E.P.A. sought an injunction against F.M.C., and a hearing is currently taking place before the U.S. District Court. The E.P.A. called as an expert witness an environmentalist from the Midwest, who testified that carbon tetrachloride was a potent carcinogen and that all those downstream had a greatly increased risk of developing cancer as a result of the discharges. This testimony conflicted with the opinion of most other experts, and certainly does not seem to fit in with the fact that carbon tetrachloride has been used in Britain and elsewhere as a dry-cleaning agent for many years. In any event, the furor seems somewhat inappropriate, since for years dozens of small towns in Pennsylvania, Ohio, and West Virginia have been pouring raw sewage into the Ohio and its tributaries, the upper reaches of which are likely to filter through a few glomeruli but undergo little else in the way of purification. to
i
j
!
Letters
to
the Editor
MORTALITY IN WOMEN ON ORAL CONTRACEPTIVES
SIR,-We would like to comment on the research results from the Royal College of General Practitioners and Professor Vessey and his colleagues published in this issue. Whilst much requires to be clarified through further retrospective and longterm prospective studies certain recommendations can be made in the light of present information. It has been shown in the R.C.G.P. study population that oral-contraceptive users compared with non-users have an increased risk of 1 per 5000 per year of dying from cardiovascular disease. The risk is concentrated, however, in women over the age of 35 years, especially if they smoke cigarettes and have used oral contraceptives continuously for 5 years or more. This relationship to duration of use requires confirmation. These observations will permit clinicians to identify women at special risk more accurately than before. There is no evidence to suggest that the risk for most women under the age of 35 years is great enough to warrant any change in clinical practice unless the well-known additional risk factors for cardiovascular disease are present. The division of the data at age 35 is arbitrary and it would be prudent to assume that there is a gradually increasing risk at an earlier age. These considerations are the basis for our recommendations: Women under 30 Years of Age We have no evidence to justify recommending any change of oral-contraceptive practice. It would be wise to emphasise the general advantage of stopping smoking. Women Aged 30-35 Years Because we have to assume a gradually increasing risk up to 35 years of age, we suggest that some women over 30 years ought to reconsider their use of oral contraceptives. We believe that women in this age-group who have used oral contraceptives continuously for more than 5 years and who are cigarette smokers should come into this category. If they would stop smoking it would probably be reasonable for them to continue the pill. If not it might be wiser for them to change to another method. Women over 35 Years There may well be circumstances where women over the age of 35 years would accept the additional risks involved and would wish to continue oral contraceptives. However, in general it would be wise for all oral-contraceptive users over 35 years of age to reconsider their method of contraception. Older women who smoke and/or have used oral contraceptives continuously for more than 5 years may well have extra risks which they and their doctor will wish to consider when weighing the balance of advantage and disadvantage. It appears that the pill takes several years to affect the cardiovascular system. There is therefore, no advantage in making any sudden change, and it would be reasonable for most women to consult their doctor as they come to the end of their current supplies of oral contraceptives. In no case should patients stop the pill without having adopted a satisfactory alternative method of contraception.
Type ofPill We are unable to determine from present evidence whether oral contraceptives containing lower doses of oestrogen confer any advantage over those containing 50 g. E. V. KUENSSBERG, Royal College of General Practitioners,
President
Royal College of Obstetricians and Gynæcologists
JOHN DEWHURST, President
