transcervical endometrial resection but also in transurethral prostatectomv. P N RAO
University Hospital of South Manchester, Manchester M20 8LR
2 3 4
5 6
Bauimann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcersical resection of endometrium. Br M edJ 1990;300:304-5. (3 Februarv.) Madsen PO, Kuni H, Naber KG. Various methods of determining irrigating fluid absorption during transurethral resection of prostate. Urol Res 1973;1:70-8. Sittclair JF, Hutchison A, Baraza R, Telfer ABM. Absorption of 5% glycine after percutaneous ultrasonic lithotripsy for renal stone disease. BrMedj 1985;291:691-2. Schultz RE, Hanno PM, Wein AJ, Lesin RM, Pollack HM, Arsdalen KNV. Percutaneous ultrasonic lithotripsy: choice of irrigant.J Urol 1983;130:858-60. Rao PN. Fluid absorption during urological endoscopy. Br J Urol 1987;60:93-9. Hahn R, M joberg M. Immediate detection of irrigant absorption during transurethral prostatectomy: case report. Can JAnaesth 1989;36:86-8.
SIR,-Dr Ralf Baumann and colleagues describe changes in haematological and biochemical variables in patients before, during, and after transcervical endometrial resection with a urological resectoscope.t These changes correlated with the volume of irrigating fluid absorbed. Glycine solution is commonly used as a medium in operative endoscopy and Dr Baumann and colleagues used 1-5% glycine, which is claimed to be the simplest and safest' medium and
non-haemolysing.' We measured the osmolality of 1-5% glycine with a Roebling micro-osmometer that was calibrated to 0 and 300 mmol/kg. A total of 34 samples from five batches were measured. The osmolality was found to vary between 186 and 200 mmolUkg with the exception of one sample from a batch of 15, which had an osmolality of 39 mmolUkg. Interbatch difference in osmolality was 5 mmol/kg and intrabatch variation was 14 mmolUkg. A physiologically isotonic solution would have an osmolality in the range 280-300 mmolUkg. Therefore, 1 5% glycine is considerably hypotonic and not nearly isotonic.4 We suggest that greater consideration should be given to the choice of irrigating fluid for endometrial resection and similar procedures. J WIENER L GREGORY University Hospital of Wales, Cardiff CF4 4XN I Baumann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcervical resection of endometrium. BrMledj 1990;300:304-5. (3 February.) 2 Chisholm GD, Fair WR. Scientific foundation of-urology. Chicago: Oxford and Year Book Medical Publishers, 1990. 3 Nesbit RM, Glickman SI. The use of glycine solution as an irrigating medium during transurethral resection. 7 Urol 1948;59: 1212-6. 4 Rao PN. Fluid absorption during urological endoscopy.
Brj Urol 1987;60:93-9.
Promotion by the British pharmaceutical industry SIR, -As pharmaceutical physicians in a company that has not been mentioned in complaints to the Association of the British Pharmaceutical Industry (ABPI) we were interested in the paper by Drs Andrew Herxheimer and Joe Collier on promotion by the British pharmaceutical industry. ' Breach of the ABPI code or the Medicines Act cannot be condoned under any circumstances. We find it difficult, however, to interpret the data in the paper and do not understand how the authors reached their conclusions. We cannot tell whether a large or small proportion of all the promotional materials in the United Kingdom are in breach of the act and whether the ABPI has been diligent in detecting 100 breaches per year or whether the problem is much more widespread. How wide is
BMJ VOLUME 300
17 MARCH 1990
the ABPI's spontaneous audit? Numerators have been identified, but not denominators. The paper contains unproved assumptions such as "we estimate in round numbers that 600 breaches were detected in six years" and "it is assumed that the incidence of breaches did not change between 1972 and 1988." Such methods for deriving conclusions would not usually pass scientific peer review. An independent audit for comparison with these data would help to investigate whether the ABPI code is being enforced more vigorously than the Medicines Act. We do not know of any data to support the hearsay quote of a Food and Drug Administration official that "the vast majority of promotional materials submitted for consideration to the FDA are false or misleading in some respect" or that the administration takes regulatory action in 5% of cases. The interpretation of this statement requires a definition of the conditions under which the materials are submitted: Were they complaints or routine audit? How can we tell whether the system in the United Kingdom is better or worse than that in the United States? There are no data in this paper that suggest that a different type of regulation would be more effective. In particular, the general public and members of the health professions may not be qualified to judge whether materials are misleading. Independent specialists in the field may be the best judges. This paper will probably be widely cited, but it is hard to interpret without suitable comparative groups. A W FOX J E GAIT
Norwich Eaton Pharmaceuticals, PO Box 191, Norwich, New York 13815, United States 1 Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. Br MedJ 1990;300:307-1 1. (3 February.)
SIR,-In their analysis of self regulation of the promotion of prescription medicines by the British pharmaceutical industry Drs Andrew Herxheimer and Joe Collier on numerous occasions refer to the breaches of the Association of the British Pharmaceutical Industry code by Organon.' In table III they list Organon as having made misleading claims or comparisons on five occasions while in the bar chart Organon is shown as having breached the code on 32 occasions. What the authors signally failed to point out is that Organon Laboratories does not market Norcuron, which accounts for the vast majority of the breaches referred to in the article. This product belongs to the entirely independently managed company, Organon Teknika. Therefore the reference to Organon is misleading. This error is all the more regrettable as the authors note that the subsidiaries of Glaxo have been consolidated. B J BOATFIELD
Organon Laboratories,
Cambridge CB4 4FL Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BrMedJ 1990;300:307-11. (3 Februarv.)
AUTHORS' REPLY, - Drs A W Fox and J E Gait say that they do not understand how we reached our conclusions but do not say which conclusions they mean. Our study is essentially descriptive and based on published information that anyone can check. We also cannot tell what proportion of the promotional materials in the United Kingdom breaches the ABPI code or the Medicines Act and therefore could make no statement about the diligence of the ABPI. If they want to know how wide the ABPI's "spontaneous audit" is then they must ask the ABPI, not us.
Our estimate that around 600 breaches were detected in six years derives from the data we gave: 379 breaches were detected by the committee and 158 or more by the secretariat, totalling 537. To this must be added an undisclosed number detected by the ABPI medical consultant. We did not assume that the incidence did not change: we wrote "if it is assumed that . the incidence of breaches did not change," and in the next sentence indeed suggested that this assumption may not be justified. Drs Fox and Gait mistrust the statement by the Food and Drug Administration official that we quoted, but he was talking about his full time professional work. We do not know of any data to suggest that he was wrong. We sympathise with Mr B J Boatfield's irritation at being unwittingly lumped together with his sibling at Organon Teknika, which shares his address. We thank him for putting us right. ANDREW HERXHEIMER
Charing Cross and Westminster Medical School, London W6 8RF
JOE COLLIER St George's Hospital Medical School, London SW 17 ORE
Node negative breast cancer SIR,-In their editorial Drs S M O'Reilly and M A Richards addressed the question of adjuvant treatment in patients with node negative breast cancer. How often, though, does the clinician have information as to the state of the axillary nodes? We examined all of the patients with primary breast cancer who presented over two years in Hillingdon Health District. From January 1985 to December 1986 there were 199 new patients. In all, 111 of them underwent a conservative surgical procedure (not mastectomy), but an axillary nodal staging procedure was carried out in only 30 patients. We suspect that this finding is not exceptional and is probably representative of practice in most health districts aside from specialist centres. Thus in practice the oncologist has often to make a decision regarding adjuvant treatment without the benefit of information about the state of the axillary nodes. M D LESLIE E J MAHER
Department of Radiotherapy and Oncology, Mount Vernon Hospital, Middlesex HA6 2RN 1 O'Reilly SM, Richards MA. Node negative breast cancer. BrMtfedJ7 1990;300:346-8. (10 February.)
Open access gastroscopy SIR,-Mr G H Hutchinson is to be congratulated on his foresight in offering open access gastroscopy at Halton District General Hospital' when others have clearly felt this to be unrewarding. He and the other authors of the audit paper on open access gastroscopy tended, however, to judge the success
of the technique by the number of positive results -a criterion by which others have judged similar results to be less worth while. It is about time that hospital specialists looked a little further than positive or negative results in assessing the worth of their services. Do we chastise general practitioners for referring patients for a lengthy outpatient appointment when nothing abnormal is found? General practitioners have to diagnose and treat people with symptoms that are sufficiently severe to warrant several general practitioner consultations. Whatever the patient's age the result will be of some value to the general practitioner. Indeed a negative result in a 60 year old patient may be of more value than a positive result in a 20 year old. This-is not to condone the indiscriminate
749
University Hospital of South Manchester, Manchester M20 8LR
2 3 4
5 6
Bauimann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcersical resection of endometrium. Br M edJ 1990;300:304-5. (3 Februarv.) Madsen PO, Kuni H, Naber KG. Various methods of determining irrigating fluid absorption during transurethral resection of prostate. Urol Res 1973;1:70-8. Sittclair JF, Hutchison A, Baraza R, Telfer ABM. Absorption of 5% glycine after percutaneous ultrasonic lithotripsy for renal stone disease. BrMedj 1985;291:691-2. Schultz RE, Hanno PM, Wein AJ, Lesin RM, Pollack HM, Arsdalen KNV. Percutaneous ultrasonic lithotripsy: choice of irrigant.J Urol 1983;130:858-60. Rao PN. Fluid absorption during urological endoscopy. Br J Urol 1987;60:93-9. Hahn R, M joberg M. Immediate detection of irrigant absorption during transurethral prostatectomy: case report. Can JAnaesth 1989;36:86-8.
SIR,-Dr Ralf Baumann and colleagues describe changes in haematological and biochemical variables in patients before, during, and after transcervical endometrial resection with a urological resectoscope.t These changes correlated with the volume of irrigating fluid absorbed. Glycine solution is commonly used as a medium in operative endoscopy and Dr Baumann and colleagues used 1-5% glycine, which is claimed to be the simplest and safest' medium and
non-haemolysing.' We measured the osmolality of 1-5% glycine with a Roebling micro-osmometer that was calibrated to 0 and 300 mmol/kg. A total of 34 samples from five batches were measured. The osmolality was found to vary between 186 and 200 mmolUkg with the exception of one sample from a batch of 15, which had an osmolality of 39 mmolUkg. Interbatch difference in osmolality was 5 mmol/kg and intrabatch variation was 14 mmolUkg. A physiologically isotonic solution would have an osmolality in the range 280-300 mmolUkg. Therefore, 1 5% glycine is considerably hypotonic and not nearly isotonic.4 We suggest that greater consideration should be given to the choice of irrigating fluid for endometrial resection and similar procedures. J WIENER L GREGORY University Hospital of Wales, Cardiff CF4 4XN I Baumann R, Magos AL, Kay JDS, Turnbull AC. Absorption of glycine irrigating solution during transcervical resection of endometrium. BrMledj 1990;300:304-5. (3 February.) 2 Chisholm GD, Fair WR. Scientific foundation of-urology. Chicago: Oxford and Year Book Medical Publishers, 1990. 3 Nesbit RM, Glickman SI. The use of glycine solution as an irrigating medium during transurethral resection. 7 Urol 1948;59: 1212-6. 4 Rao PN. Fluid absorption during urological endoscopy.
Brj Urol 1987;60:93-9.
Promotion by the British pharmaceutical industry SIR, -As pharmaceutical physicians in a company that has not been mentioned in complaints to the Association of the British Pharmaceutical Industry (ABPI) we were interested in the paper by Drs Andrew Herxheimer and Joe Collier on promotion by the British pharmaceutical industry. ' Breach of the ABPI code or the Medicines Act cannot be condoned under any circumstances. We find it difficult, however, to interpret the data in the paper and do not understand how the authors reached their conclusions. We cannot tell whether a large or small proportion of all the promotional materials in the United Kingdom are in breach of the act and whether the ABPI has been diligent in detecting 100 breaches per year or whether the problem is much more widespread. How wide is
BMJ VOLUME 300
17 MARCH 1990
the ABPI's spontaneous audit? Numerators have been identified, but not denominators. The paper contains unproved assumptions such as "we estimate in round numbers that 600 breaches were detected in six years" and "it is assumed that the incidence of breaches did not change between 1972 and 1988." Such methods for deriving conclusions would not usually pass scientific peer review. An independent audit for comparison with these data would help to investigate whether the ABPI code is being enforced more vigorously than the Medicines Act. We do not know of any data to support the hearsay quote of a Food and Drug Administration official that "the vast majority of promotional materials submitted for consideration to the FDA are false or misleading in some respect" or that the administration takes regulatory action in 5% of cases. The interpretation of this statement requires a definition of the conditions under which the materials are submitted: Were they complaints or routine audit? How can we tell whether the system in the United Kingdom is better or worse than that in the United States? There are no data in this paper that suggest that a different type of regulation would be more effective. In particular, the general public and members of the health professions may not be qualified to judge whether materials are misleading. Independent specialists in the field may be the best judges. This paper will probably be widely cited, but it is hard to interpret without suitable comparative groups. A W FOX J E GAIT
Norwich Eaton Pharmaceuticals, PO Box 191, Norwich, New York 13815, United States 1 Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. Br MedJ 1990;300:307-1 1. (3 February.)
SIR,-In their analysis of self regulation of the promotion of prescription medicines by the British pharmaceutical industry Drs Andrew Herxheimer and Joe Collier on numerous occasions refer to the breaches of the Association of the British Pharmaceutical Industry code by Organon.' In table III they list Organon as having made misleading claims or comparisons on five occasions while in the bar chart Organon is shown as having breached the code on 32 occasions. What the authors signally failed to point out is that Organon Laboratories does not market Norcuron, which accounts for the vast majority of the breaches referred to in the article. This product belongs to the entirely independently managed company, Organon Teknika. Therefore the reference to Organon is misleading. This error is all the more regrettable as the authors note that the subsidiaries of Glaxo have been consolidated. B J BOATFIELD
Organon Laboratories,
Cambridge CB4 4FL Herxheimer A, Collier J. Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation. BrMedJ 1990;300:307-11. (3 Februarv.)
AUTHORS' REPLY, - Drs A W Fox and J E Gait say that they do not understand how we reached our conclusions but do not say which conclusions they mean. Our study is essentially descriptive and based on published information that anyone can check. We also cannot tell what proportion of the promotional materials in the United Kingdom breaches the ABPI code or the Medicines Act and therefore could make no statement about the diligence of the ABPI. If they want to know how wide the ABPI's "spontaneous audit" is then they must ask the ABPI, not us.
Our estimate that around 600 breaches were detected in six years derives from the data we gave: 379 breaches were detected by the committee and 158 or more by the secretariat, totalling 537. To this must be added an undisclosed number detected by the ABPI medical consultant. We did not assume that the incidence did not change: we wrote "if it is assumed that . the incidence of breaches did not change," and in the next sentence indeed suggested that this assumption may not be justified. Drs Fox and Gait mistrust the statement by the Food and Drug Administration official that we quoted, but he was talking about his full time professional work. We do not know of any data to suggest that he was wrong. We sympathise with Mr B J Boatfield's irritation at being unwittingly lumped together with his sibling at Organon Teknika, which shares his address. We thank him for putting us right. ANDREW HERXHEIMER
Charing Cross and Westminster Medical School, London W6 8RF
JOE COLLIER St George's Hospital Medical School, London SW 17 ORE
Node negative breast cancer SIR,-In their editorial Drs S M O'Reilly and M A Richards addressed the question of adjuvant treatment in patients with node negative breast cancer. How often, though, does the clinician have information as to the state of the axillary nodes? We examined all of the patients with primary breast cancer who presented over two years in Hillingdon Health District. From January 1985 to December 1986 there were 199 new patients. In all, 111 of them underwent a conservative surgical procedure (not mastectomy), but an axillary nodal staging procedure was carried out in only 30 patients. We suspect that this finding is not exceptional and is probably representative of practice in most health districts aside from specialist centres. Thus in practice the oncologist has often to make a decision regarding adjuvant treatment without the benefit of information about the state of the axillary nodes. M D LESLIE E J MAHER
Department of Radiotherapy and Oncology, Mount Vernon Hospital, Middlesex HA6 2RN 1 O'Reilly SM, Richards MA. Node negative breast cancer. BrMtfedJ7 1990;300:346-8. (10 February.)
Open access gastroscopy SIR,-Mr G H Hutchinson is to be congratulated on his foresight in offering open access gastroscopy at Halton District General Hospital' when others have clearly felt this to be unrewarding. He and the other authors of the audit paper on open access gastroscopy tended, however, to judge the success
of the technique by the number of positive results -a criterion by which others have judged similar results to be less worth while. It is about time that hospital specialists looked a little further than positive or negative results in assessing the worth of their services. Do we chastise general practitioners for referring patients for a lengthy outpatient appointment when nothing abnormal is found? General practitioners have to diagnose and treat people with symptoms that are sufficiently severe to warrant several general practitioner consultations. Whatever the patient's age the result will be of some value to the general practitioner. Indeed a negative result in a 60 year old patient may be of more value than a positive result in a 20 year old. This-is not to condone the indiscriminate
749
