- Email: [email protected]
IDENTIFYING THE MEDICAL CONSULTANTS OF PHARMACEUTICAL COMPANIES
197 3 Sensitised sheep erythrocytes (75 µl) are added to the serum dilu25 u.lB and the mixture is incubated at 37°Cfor 1 h. All dilutions in the HI test are made in HEPES buffer, pH 6-2, supdnMnted with divalent cations and sodium chloride, but gelatin is titrated. () ?2 is added to the buffer when the :M
haemagglutinin
HI can be performed in this way because four units of the hxmaggiutinin do not cause clumping of erythrocytes; they become adhesive. Antibody abolishes this adhesiveness. Moreover, four HA units is too low an antigen dose to sentisise for indirect (passive) hxmagglutination. The new method has been used for six months in the routine and assessment of immunity status, The standard HI after kaolin absorption (also using sheep erythrocytes) and an indirect (passive) haemagglutination JHA) (’Rubacell’, Abbott) have been done in parallel. BVhen conflicting results were obtained the examination was supplemented by radial haemolysis in gel (Orion Diagnostics) and in some cases by flotation centrifugation. 1323 sera have been examined. The new HI method was slightly less sensitive than the standard method and HIG. This was of no importance in the diagnosis of rubella infection. Both HI methods permitted the detection of a significant titre rise with 75 paired sera from patients with fresh rubella. The number of false-positive reactions, of special importance for immunity screening, was 8 (0.6%) with both HI methods (6 of the sera gave a false-positive reaction with both methods, titre 10 or 20). The frequency of false-negative reactions was almost the same for both methods, about 1%. In fresh rubella the new method became positive a few days earlier than with the standard method and HIG because kaolin removes most of the IgM and HIG does not detect IgM. Some false-negative reactions were due to an IHA caused by an impurity in the hxmagglutination reaction. Studies are in progress to adapt the method to human erythrocytes and to purify the hxmagglutinin preparation. Department of Microbiology, Virology Section,
Jiagnosis of rubella infection
Gade Institute, University of Bergen, N-5016 Haukeland Sykehus,
Bergen, Norway
GUNNAR HAUKENES
TOBACCO ADVERTISING
who has a legitimate need for this information. A possible bias in the consultant’s opinion can then be allowed for, so enhancing the value of the opinion. This is especially important in small countries where the number of experts is limited, making it inevitable that their opinions will be widely sought. We suggest that consultants whose opinion is asked on any subject related to drugs, or indeed medical equipment, should spontaneously disclose any relationship they may have with a commercial company. To help this to become established practice they should be asked routinely about the existence of such relationships. to anyone
Division of Clinical Pharmacology and Toxicology, Central Laboratory, Ullevål, Oslo 1, Norway
P. K. M. LUNDE
Departments of Medicine and Pharmacology, Charing Cross Hospital Medical School, London W6 8RF
A. HERXHEIMER
PERITONEAL DIALYSIS FOR RENAL FAILURE
SIR,-Dr Oreopoulos and his colleagues (April 28,
p. 926) widespread adoption in Toronto of peritoneal dialysis (PD) in general, and continuous ambulatory peritoneal dialysis (CAPD) in particular. Our impression is that Oreopoulos’s results,’ like those of Tenckhoff,2 are not generally reproducible ; survival for years on chronic peritoneal dialysis (CPD) is still considered exceptional, and this is one reason why this technique has not spread more widely (it is used in only 1.3% of urxmic patients in Europe3 and in only 2-2% in the U.S.A.4). Peritoneal dialysis has many advantages; however, before it is put forward as a treatment, not just for patients for whom haemodialysis (HD) is impracticable or risky, but also as an alternative to the more usual therapies for uraemia such as HD and/or transplantation, one important factor must be evaluated-namely, the average duration of treatment, not indicated in Oreopoulos’ letter or in other reports.’,6 Statistical data on survival of patients on CPD, such as those for patients on HD supplied by the European Dialysis and Transplantation As-
describe the
sociation are not available.
SIR,-Your Parliamentary Correspondent (June 30, p.
SUMMARY OF EXPERIENCE WITH PERITONEAL DIALYSIS IN
1415) discusses controls on tobacco advertising. Perhaps he (and you) would care to note, should you return to the subject: fa) that compliance with the present rules (not "guidelines") on cigarette advertising is mandatory, not voluntary; (b) that these rules are part of a tripartite agreement between the Government, the tobacco industry, and the Advertising Standards Authority; and (c) that the present enforcement system, which involves the pre-clearance of all cigarette advertisements, is independently administered by this Authority to the
VARESE, 1973-78
satisfaction of the Government. Advertising Standards Authority, 2-16 Torrington Place, London WC1E 7HN
PETER THOMSON, Director-general
IDENTIFYING THE MEDICAL CONSULTANTS OF PHARMACEUTICAL COMPANIES
StR,-Pharmaceutical companies need outside medical advice on their plans and activities. Many companies obtain such outside advice, regularly or ad hoc, from clinicians or scientists. These arrangements are entirely appropriate but in some cases lead to conflicts of interest. For example, a consultant’s opinion may be sought by a drug regulatory body, a iocal or regional formulary committee, or the editor of a medical journal, all of whom expect a truly independent opinion. In most cases the consultant’s integrity will ensure that his opinion is as independent as he can consciously make it. Never, his commitment to a company should be made known
We have experience of 24 patients (see table) chosen for a CPD programme from 178 patients treated for acute or chronic renal failure during the past 7 years at our centre. The average age is 56 (higher than for patients on HD, which is 1. Oreopoulos DG. Clin Nephrol 1978; 9: 165. 2. Tenckhoff H. Nephron 1974; 12: 420. 3. Combined Report on Regular Dialysis and Transplantation in Europe. Proc EDTA 1977, vol. VIII. 4. Friedman EA, Delano BG, Butt KMH. N Eng J Med 1978; 298: 368. 5. Panel Conference. Peritoneal dialysis update. Trans Am Soc Artif Intern 6.
Organs 1978; 24: 774. Oreopoulos DG, Robson M, Faller B, Ogilvie R, Rapoport A, Clin Nephrol 1979; 11: 125.
de Veber GA.
haemagglutinin
HI can be performed in this way because four units of the hxmaggiutinin do not cause clumping of erythrocytes; they become adhesive. Antibody abolishes this adhesiveness. Moreover, four HA units is too low an antigen dose to sentisise for indirect (passive) hxmagglutination. The new method has been used for six months in the routine and assessment of immunity status, The standard HI after kaolin absorption (also using sheep erythrocytes) and an indirect (passive) haemagglutination JHA) (’Rubacell’, Abbott) have been done in parallel. BVhen conflicting results were obtained the examination was supplemented by radial haemolysis in gel (Orion Diagnostics) and in some cases by flotation centrifugation. 1323 sera have been examined. The new HI method was slightly less sensitive than the standard method and HIG. This was of no importance in the diagnosis of rubella infection. Both HI methods permitted the detection of a significant titre rise with 75 paired sera from patients with fresh rubella. The number of false-positive reactions, of special importance for immunity screening, was 8 (0.6%) with both HI methods (6 of the sera gave a false-positive reaction with both methods, titre 10 or 20). The frequency of false-negative reactions was almost the same for both methods, about 1%. In fresh rubella the new method became positive a few days earlier than with the standard method and HIG because kaolin removes most of the IgM and HIG does not detect IgM. Some false-negative reactions were due to an IHA caused by an impurity in the hxmagglutination reaction. Studies are in progress to adapt the method to human erythrocytes and to purify the hxmagglutinin preparation. Department of Microbiology, Virology Section,
Jiagnosis of rubella infection
Gade Institute, University of Bergen, N-5016 Haukeland Sykehus,
Bergen, Norway
GUNNAR HAUKENES
TOBACCO ADVERTISING
who has a legitimate need for this information. A possible bias in the consultant’s opinion can then be allowed for, so enhancing the value of the opinion. This is especially important in small countries where the number of experts is limited, making it inevitable that their opinions will be widely sought. We suggest that consultants whose opinion is asked on any subject related to drugs, or indeed medical equipment, should spontaneously disclose any relationship they may have with a commercial company. To help this to become established practice they should be asked routinely about the existence of such relationships. to anyone
Division of Clinical Pharmacology and Toxicology, Central Laboratory, Ullevål, Oslo 1, Norway
P. K. M. LUNDE
Departments of Medicine and Pharmacology, Charing Cross Hospital Medical School, London W6 8RF
A. HERXHEIMER
PERITONEAL DIALYSIS FOR RENAL FAILURE
SIR,-Dr Oreopoulos and his colleagues (April 28,
p. 926) widespread adoption in Toronto of peritoneal dialysis (PD) in general, and continuous ambulatory peritoneal dialysis (CAPD) in particular. Our impression is that Oreopoulos’s results,’ like those of Tenckhoff,2 are not generally reproducible ; survival for years on chronic peritoneal dialysis (CPD) is still considered exceptional, and this is one reason why this technique has not spread more widely (it is used in only 1.3% of urxmic patients in Europe3 and in only 2-2% in the U.S.A.4). Peritoneal dialysis has many advantages; however, before it is put forward as a treatment, not just for patients for whom haemodialysis (HD) is impracticable or risky, but also as an alternative to the more usual therapies for uraemia such as HD and/or transplantation, one important factor must be evaluated-namely, the average duration of treatment, not indicated in Oreopoulos’ letter or in other reports.’,6 Statistical data on survival of patients on CPD, such as those for patients on HD supplied by the European Dialysis and Transplantation As-
describe the
sociation are not available.
SIR,-Your Parliamentary Correspondent (June 30, p.
SUMMARY OF EXPERIENCE WITH PERITONEAL DIALYSIS IN
1415) discusses controls on tobacco advertising. Perhaps he (and you) would care to note, should you return to the subject: fa) that compliance with the present rules (not "guidelines") on cigarette advertising is mandatory, not voluntary; (b) that these rules are part of a tripartite agreement between the Government, the tobacco industry, and the Advertising Standards Authority; and (c) that the present enforcement system, which involves the pre-clearance of all cigarette advertisements, is independently administered by this Authority to the
VARESE, 1973-78
satisfaction of the Government. Advertising Standards Authority, 2-16 Torrington Place, London WC1E 7HN
PETER THOMSON, Director-general
IDENTIFYING THE MEDICAL CONSULTANTS OF PHARMACEUTICAL COMPANIES
StR,-Pharmaceutical companies need outside medical advice on their plans and activities. Many companies obtain such outside advice, regularly or ad hoc, from clinicians or scientists. These arrangements are entirely appropriate but in some cases lead to conflicts of interest. For example, a consultant’s opinion may be sought by a drug regulatory body, a iocal or regional formulary committee, or the editor of a medical journal, all of whom expect a truly independent opinion. In most cases the consultant’s integrity will ensure that his opinion is as independent as he can consciously make it. Never, his commitment to a company should be made known
We have experience of 24 patients (see table) chosen for a CPD programme from 178 patients treated for acute or chronic renal failure during the past 7 years at our centre. The average age is 56 (higher than for patients on HD, which is 1. Oreopoulos DG. Clin Nephrol 1978; 9: 165. 2. Tenckhoff H. Nephron 1974; 12: 420. 3. Combined Report on Regular Dialysis and Transplantation in Europe. Proc EDTA 1977, vol. VIII. 4. Friedman EA, Delano BG, Butt KMH. N Eng J Med 1978; 298: 368. 5. Panel Conference. Peritoneal dialysis update. Trans Am Soc Artif Intern 6.
Organs 1978; 24: 774. Oreopoulos DG, Robson M, Faller B, Ogilvie R, Rapoport A, Clin Nephrol 1979; 11: 125.
de Veber GA.