- Email: [email protected]
Traffic safety and sports utility vehicles
Correspondence
[email protected] Second Department of Therapy, Semipalatinsk State Medical Academy, Semipalatinsk, Kazakhstan (AA, LK); *Division of Public Health (NT, KA) and Department of Molecular Medicine (SY), Nagasaki University Graduate School of Biomedical Sciences, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; and Department of Protection of the Human Environment, World Health Organization, Geneva, Switzerland (SY) 1
2
Haggarty P, McCallum H, Andrews K, et al. Effect of B vitamins and genetics on success of in-vitro fertilisation: prospective cohort study. Lancet 2006; 367: 1513–19. Akilzhanova A, Takamura N, Zhaojia Y, Aoyagi K, Karazhanova L, Yamashita S. Kazakhstan: a folate deficient area? Eur J Clin Nutr (in press).
DVT and pulmonary embolism after acute infection At first glance, this study by Liam Smeeth and colleagues (April 1, p 1075)1 was impressive, making use of a database comprising “more than 20 million person-years of observation from 220 general practices”. The method used was laid out in an earlier paper on adverse events from vaccines.2 The authors of that paper reported on both the relative incidence and attributable risk associated with the vaccine. We were surprised that Smeeth and colleagues chose to report only the incidence risk ratio, despite apparently having data on unexposed cases (used in adjustment for the effects of age) which would give access to attributable risk rates. Surely this was a missed opportunity. A doubling of relative risk might mislead the unwary reader into considering thromboprophylaxis after any lower respiratory tract or urinary tract infection. This would be appropriate if, for example, the risk doubles from 10 in 100 to 20 in 100, but would not make clinical sense if, for example, the risk increased from one in a million to two in a million. Perhaps the existing data set would allow this aspect to be investigated? www.thelancet.com Vol 368 July 15, 2006
We declare that we have no conflict of interest.
*Vera Neumann, Rory J O’Connor, Bipin B Bhakta, Alan Tennant [email protected] Department of Rehabilitation Medicine, Academic Unit of Musculoskeletal Disease, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9NZ, UK 1
2
Smeeth L, Cook C, Thomas S, Hall AJ, Hubbard R, Vallance P. Risk of deep vein thrombosis and pulmonary embolism after acute infection in a community setting. Lancet 2006; 367: 1075–79. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 228–35.
Authors’ reply We used a computerised research database of clinical records. Because of the case-only design of our study, the first step was to extract the records of cases of venous thromboembolism only. We then used these records to assess the association between diagnosed infections and subsequent thrombembolic events. We do not have data on the total number or rate of infections occurring in the whole population—only among our included cases. In the 1995 paper by Farrington and colleagues,1 the investigators had data on the total catchment population from which the cases arose, and also on the total number of vaccines given. Reliably estimating vaccine exposure in a population is much easier than estimating levels of infectious exposure. Farrington and colleagues were therefore able to estimate the population attributable risk. It is possible, from our data, to calculate an approximate attributable risk during specific risk periods after infection. This is the proportion of venous thromboembolic events occurring within a particular period after an infection that is attributable to the infection. For example, of the deep vein thromboses that occurred in the 2-week period after a diagnosed systemic respiratory tract infection, the proportion of exposed cases that could be attributed to the infection
during the 2-week period is given by: 1–(1/incidence ratio), which is about 50%. However, this is only applicable to infections presenting to and diagnosed by general practitioners. In addition, we applied very strict case definition criteria to ensure our cases were likely to be true incident cases for whom we could be reasonably confident about the date of event. In doing so, we undoubtedly will have excluded many genuine cases. Thus some caution is required in the interpretation of this figure. We declare that we have no conflict of interest.
*Liam Smeeth, Claire Cook, Sara Thomas, Andrew J Hall, Paddy Farrington [email protected] *Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK (LS, CC, ST, AJH); and Division of Statistics, Open University. Milton Keynes, UK (PF) 1
Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 567–69.
Traffic safety and sports utility vehicles The Review by Shanthi Ameratunga and colleagues (May 6, p 1533)1 is an excellent contribution to the global traffic safety literature. However, it lacks discussion on sports utility vehicles (SUVs). The increasing threat posed by SUVs to other road users is likely to reverse some of the hard-earned improvements that have been made in road safety over the past decades.2 The chief determinants of the degree of severity of injuries in motor vehicle collisions are the vehicle’s size and weight. It has been estimated that the changing composition of the car fleet (a greater proportion of both small cars and SUVs) increased the number of road fatalities by 1% between 2001 and 2002 in the UK.3 Studies from the USA4 and United Arab Emirates5 reported that increased numbers of SUVs and pick-up trucks
We do not have the rights to reproduce this image on the web.
201
Science Photo Library
Ainur Akilzhanova, *Noboru Takamura, Kiyoshi Aoyagi, Ludmila Karazhanova, Shunichi Yamashita
Correspondence
See Viewpoint page 247
were associated with more pedestrian deaths and a higher pedestrian injury severity score.4 With increasingly compelling evidence on the mortality and morbidity of pedestrians involved in these crashes, the car industry cannot deny the burden of action that is required on their part to design vehicles that will minimise the effect of traffic crashes on pedestrians, cyclists, and the occupants of other cars. We declare that we have no conflict of interest.
*Ediriweera Desapriya, Ian Pike, Sayed Subzwari [email protected] Department of Pediatrics, Faculty of Medicine, BC Injury Research and Prevention Unit, Centre for Community Child Health Research, University of British Columbia, Vancouver, British Columbia V6H 3V4, Canada 1
2 3
4
5
Ameratunga S, Hijar M, Norton R. Road-traffic injuries: confronting disparities to address a global-health problem. Lancet 2006; 367: 1533–40. Simms C, O’Neill D. Sports utility vehicles and older pedestrians. BMJ 2005; 331: 787–88. Broughton J. Car occupant and motor-cyclist deaths, 1994–2002: TRL Report 629. Crowthorne: Transport Research Laboratory, 2005. Ballesteros MF, Dischinger PC, Langenberg P. Pedestrian injuries and vehicle type in Maryland, 1995–1999. Accid Anal Prev 2004; 36: 73–81. Bener A, Ghaffar A, Azab A, Kutty MS, Toth F, Lovasz G. The impact of four-wheel drives on traffic disability and deaths compared to passenger cars. J Coll Physicians Surg Pakistan 2006; 16: 257–60.
Funding of patients’ groups Cancerbackup exists to provide information, understanding, and support to all those affected by cancer and in so doing is categorically not influenced by pharmaceutical companies (July 1, p 2).1 Cancerbackup raised more than £4 million last year, of which only £371 410 (8·9% of our overall funding) came from the pharmaceutical industry. Therefore to infer that Cancerbackup is an example of a charity that “would not exist without funding from the pharmaceutical industry” is misleading and untrue. 202
When the results of the trastuzumab (Herceptin) trials on HER2-positive women with earlystage breast cancer were released in 2005, they were widely considered by leading clinicians around the world as exceptional. A drug that can halve the rate of breast cancer recurrence is remarkable. No other treatment has ever had as big an effect on breast cancer recurrence. As a charity providing up-to-date, accurate information, Cancerbackup details all new cancer treatments, such as trastuzumab, and always includes potential side-effects. We form our opinion on new treatments through a systematic process of consulting with our board of clinical specialist advisers. Pharmaceutical companies play no part in this. We are proud of our role in advocating access to new cancer drugs. Cancerbackup’s “Dossier of delay”2 has been influential in speeding up the rate at which drugs are assessed by the UK’s National Institute for Health and Clinical Excellence, for example. Cancerbackup is leading the way in being entirely transparent about its relationship with pharmaceutical companies. Prominently published on Cancerbackup’s website are guidelines as to how and why we work with the industry, and a full list of the 23 pharmaceutical companies that provide any funds to the charity, stating exactly how much they donate. We are not obliged to do this; we choose to, and are now considering how we can further clarify the ethical relationship we have with the industry. I declare that I have no conflict of interest.
Maurice Slevin [email protected] Chairman, Cancerbackup, 3 Bath Place, Rivington Street, London EC2A 3JR, UK 1 2
Department of Error Attaran A, Barnes KI, Bate R, et al. The World Bank: false financial and statistical accounts and medical malpractice in malaria treatment. Lancet 2006; 368: 247–52—In this Viewpoint (July 15), the y-axis labels on figures 1 and 2 should have been ×103 (not ×106). The conflict of interest statement should have included: AA has received payments for advising Novartis, and travel and accommodation costs from the Roll Back Malaria Partnership, which includes the World Bank. KIB has received travel and accommodation costs for advising Novartis and Roche. RB has received a travel grant from Novartis, and his institute receives some funding from pharmaceutical companies. FB is a member of the WHO Technical Advisory Group on artemether/ lumefantrine. Ud’A has received travel and daily costs for being on the data and safety monitoring board of a GlaxoSmithKline (GSK) malaria vaccine study; is the principal investigator for a trial funded by the Medicine for Malaria Venture (MMV) with an artemisinin-combination therapy made by Sigma-Tau; is negotiating with Sanofi and GSK about study drugs for a malaria trial supported by the European & Developing Countries Clinical Trials Partnership (EDTCP); is involved in a trial of artemisinin-combination therapy sponsored by Novartis and supported by MMV; and has received artesunate for a Sanofi study. CIF has received travel and accommodation costs from Novartis, and some malaria study drugs from Holleypharm and Sanofi for trials funded by the East African Network for Monitoring Antimalarial Treatment (EANMAT). TKM has received travel and accommodation costs from Novartis and GSK, was on a product development team for malarone/proguanil, has done clinical trials supported by the Gates Malaria Partnership with drugs supplied by Norvatis via WHO, Sanofi, and GSK, and, while chair of EANMAT, the Network did malaria trials with drugs supplied by WHO. CHS has a joint NIH grant (AI 46065) with Jacobus Pharmaceutical. AT sits on the WHO’s LapDap development team as a consultant and receives expenses from WHO, received travel and accommodation costs to attend meetings from Novartis and Pfizer, co-ordinates in Africa a malaria study funded by MMV, and is vice-president of EANMAT. J-PVang has received payments for attending meetings with Novartis, is involved in a trial of artemisinin-combination therapy supported by MMV and EDTCP, and received drugs for malaria studies from Mepha, Novartis, and Ipcalabs. WMW has received a daily payment for meetings with Novartis, and travel and accommodation costs from GSK for meetings of their development team for an artemisinin-combination therapy.
The Lancet. Funding of patients’ groups. Lancet 2006; 368: 2. CancerBACUP. Dossier of delay. http://www. cancerbackup.org.uk/News/Press/Pressreleasess tatements/2005/84975716/ NICEdossierMay05.doc (accessed July 4, 2006).
www.thelancet.com Vol 368 July 15, 2006
[email protected] Second Department of Therapy, Semipalatinsk State Medical Academy, Semipalatinsk, Kazakhstan (AA, LK); *Division of Public Health (NT, KA) and Department of Molecular Medicine (SY), Nagasaki University Graduate School of Biomedical Sciences, 1-12-4 Sakamoto, Nagasaki 852-8523, Japan; and Department of Protection of the Human Environment, World Health Organization, Geneva, Switzerland (SY) 1
2
Haggarty P, McCallum H, Andrews K, et al. Effect of B vitamins and genetics on success of in-vitro fertilisation: prospective cohort study. Lancet 2006; 367: 1513–19. Akilzhanova A, Takamura N, Zhaojia Y, Aoyagi K, Karazhanova L, Yamashita S. Kazakhstan: a folate deficient area? Eur J Clin Nutr (in press).
DVT and pulmonary embolism after acute infection At first glance, this study by Liam Smeeth and colleagues (April 1, p 1075)1 was impressive, making use of a database comprising “more than 20 million person-years of observation from 220 general practices”. The method used was laid out in an earlier paper on adverse events from vaccines.2 The authors of that paper reported on both the relative incidence and attributable risk associated with the vaccine. We were surprised that Smeeth and colleagues chose to report only the incidence risk ratio, despite apparently having data on unexposed cases (used in adjustment for the effects of age) which would give access to attributable risk rates. Surely this was a missed opportunity. A doubling of relative risk might mislead the unwary reader into considering thromboprophylaxis after any lower respiratory tract or urinary tract infection. This would be appropriate if, for example, the risk doubles from 10 in 100 to 20 in 100, but would not make clinical sense if, for example, the risk increased from one in a million to two in a million. Perhaps the existing data set would allow this aspect to be investigated? www.thelancet.com Vol 368 July 15, 2006
We declare that we have no conflict of interest.
*Vera Neumann, Rory J O’Connor, Bipin B Bhakta, Alan Tennant [email protected] Department of Rehabilitation Medicine, Academic Unit of Musculoskeletal Disease, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9NZ, UK 1
2
Smeeth L, Cook C, Thomas S, Hall AJ, Hubbard R, Vallance P. Risk of deep vein thrombosis and pulmonary embolism after acute infection in a community setting. Lancet 2006; 367: 1075–79. Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 228–35.
Authors’ reply We used a computerised research database of clinical records. Because of the case-only design of our study, the first step was to extract the records of cases of venous thromboembolism only. We then used these records to assess the association between diagnosed infections and subsequent thrombembolic events. We do not have data on the total number or rate of infections occurring in the whole population—only among our included cases. In the 1995 paper by Farrington and colleagues,1 the investigators had data on the total catchment population from which the cases arose, and also on the total number of vaccines given. Reliably estimating vaccine exposure in a population is much easier than estimating levels of infectious exposure. Farrington and colleagues were therefore able to estimate the population attributable risk. It is possible, from our data, to calculate an approximate attributable risk during specific risk periods after infection. This is the proportion of venous thromboembolic events occurring within a particular period after an infection that is attributable to the infection. For example, of the deep vein thromboses that occurred in the 2-week period after a diagnosed systemic respiratory tract infection, the proportion of exposed cases that could be attributed to the infection
during the 2-week period is given by: 1–(1/incidence ratio), which is about 50%. However, this is only applicable to infections presenting to and diagnosed by general practitioners. In addition, we applied very strict case definition criteria to ensure our cases were likely to be true incident cases for whom we could be reasonably confident about the date of event. In doing so, we undoubtedly will have excluded many genuine cases. Thus some caution is required in the interpretation of this figure. We declare that we have no conflict of interest.
*Liam Smeeth, Claire Cook, Sara Thomas, Andrew J Hall, Paddy Farrington [email protected] *Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK (LS, CC, ST, AJH); and Division of Statistics, Open University. Milton Keynes, UK (PF) 1
Farrington P, Pugh S, Colville A, et al. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 1995; 345: 567–69.
Traffic safety and sports utility vehicles The Review by Shanthi Ameratunga and colleagues (May 6, p 1533)1 is an excellent contribution to the global traffic safety literature. However, it lacks discussion on sports utility vehicles (SUVs). The increasing threat posed by SUVs to other road users is likely to reverse some of the hard-earned improvements that have been made in road safety over the past decades.2 The chief determinants of the degree of severity of injuries in motor vehicle collisions are the vehicle’s size and weight. It has been estimated that the changing composition of the car fleet (a greater proportion of both small cars and SUVs) increased the number of road fatalities by 1% between 2001 and 2002 in the UK.3 Studies from the USA4 and United Arab Emirates5 reported that increased numbers of SUVs and pick-up trucks
We do not have the rights to reproduce this image on the web.
201
Science Photo Library
Ainur Akilzhanova, *Noboru Takamura, Kiyoshi Aoyagi, Ludmila Karazhanova, Shunichi Yamashita
Correspondence
See Viewpoint page 247
were associated with more pedestrian deaths and a higher pedestrian injury severity score.4 With increasingly compelling evidence on the mortality and morbidity of pedestrians involved in these crashes, the car industry cannot deny the burden of action that is required on their part to design vehicles that will minimise the effect of traffic crashes on pedestrians, cyclists, and the occupants of other cars. We declare that we have no conflict of interest.
*Ediriweera Desapriya, Ian Pike, Sayed Subzwari [email protected] Department of Pediatrics, Faculty of Medicine, BC Injury Research and Prevention Unit, Centre for Community Child Health Research, University of British Columbia, Vancouver, British Columbia V6H 3V4, Canada 1
2 3
4
5
Ameratunga S, Hijar M, Norton R. Road-traffic injuries: confronting disparities to address a global-health problem. Lancet 2006; 367: 1533–40. Simms C, O’Neill D. Sports utility vehicles and older pedestrians. BMJ 2005; 331: 787–88. Broughton J. Car occupant and motor-cyclist deaths, 1994–2002: TRL Report 629. Crowthorne: Transport Research Laboratory, 2005. Ballesteros MF, Dischinger PC, Langenberg P. Pedestrian injuries and vehicle type in Maryland, 1995–1999. Accid Anal Prev 2004; 36: 73–81. Bener A, Ghaffar A, Azab A, Kutty MS, Toth F, Lovasz G. The impact of four-wheel drives on traffic disability and deaths compared to passenger cars. J Coll Physicians Surg Pakistan 2006; 16: 257–60.
Funding of patients’ groups Cancerbackup exists to provide information, understanding, and support to all those affected by cancer and in so doing is categorically not influenced by pharmaceutical companies (July 1, p 2).1 Cancerbackup raised more than £4 million last year, of which only £371 410 (8·9% of our overall funding) came from the pharmaceutical industry. Therefore to infer that Cancerbackup is an example of a charity that “would not exist without funding from the pharmaceutical industry” is misleading and untrue. 202
When the results of the trastuzumab (Herceptin) trials on HER2-positive women with earlystage breast cancer were released in 2005, they were widely considered by leading clinicians around the world as exceptional. A drug that can halve the rate of breast cancer recurrence is remarkable. No other treatment has ever had as big an effect on breast cancer recurrence. As a charity providing up-to-date, accurate information, Cancerbackup details all new cancer treatments, such as trastuzumab, and always includes potential side-effects. We form our opinion on new treatments through a systematic process of consulting with our board of clinical specialist advisers. Pharmaceutical companies play no part in this. We are proud of our role in advocating access to new cancer drugs. Cancerbackup’s “Dossier of delay”2 has been influential in speeding up the rate at which drugs are assessed by the UK’s National Institute for Health and Clinical Excellence, for example. Cancerbackup is leading the way in being entirely transparent about its relationship with pharmaceutical companies. Prominently published on Cancerbackup’s website are guidelines as to how and why we work with the industry, and a full list of the 23 pharmaceutical companies that provide any funds to the charity, stating exactly how much they donate. We are not obliged to do this; we choose to, and are now considering how we can further clarify the ethical relationship we have with the industry. I declare that I have no conflict of interest.
Maurice Slevin [email protected] Chairman, Cancerbackup, 3 Bath Place, Rivington Street, London EC2A 3JR, UK 1 2
Department of Error Attaran A, Barnes KI, Bate R, et al. The World Bank: false financial and statistical accounts and medical malpractice in malaria treatment. Lancet 2006; 368: 247–52—In this Viewpoint (July 15), the y-axis labels on figures 1 and 2 should have been ×103 (not ×106). The conflict of interest statement should have included: AA has received payments for advising Novartis, and travel and accommodation costs from the Roll Back Malaria Partnership, which includes the World Bank. KIB has received travel and accommodation costs for advising Novartis and Roche. RB has received a travel grant from Novartis, and his institute receives some funding from pharmaceutical companies. FB is a member of the WHO Technical Advisory Group on artemether/ lumefantrine. Ud’A has received travel and daily costs for being on the data and safety monitoring board of a GlaxoSmithKline (GSK) malaria vaccine study; is the principal investigator for a trial funded by the Medicine for Malaria Venture (MMV) with an artemisinin-combination therapy made by Sigma-Tau; is negotiating with Sanofi and GSK about study drugs for a malaria trial supported by the European & Developing Countries Clinical Trials Partnership (EDTCP); is involved in a trial of artemisinin-combination therapy sponsored by Novartis and supported by MMV; and has received artesunate for a Sanofi study. CIF has received travel and accommodation costs from Novartis, and some malaria study drugs from Holleypharm and Sanofi for trials funded by the East African Network for Monitoring Antimalarial Treatment (EANMAT). TKM has received travel and accommodation costs from Novartis and GSK, was on a product development team for malarone/proguanil, has done clinical trials supported by the Gates Malaria Partnership with drugs supplied by Norvatis via WHO, Sanofi, and GSK, and, while chair of EANMAT, the Network did malaria trials with drugs supplied by WHO. CHS has a joint NIH grant (AI 46065) with Jacobus Pharmaceutical. AT sits on the WHO’s LapDap development team as a consultant and receives expenses from WHO, received travel and accommodation costs to attend meetings from Novartis and Pfizer, co-ordinates in Africa a malaria study funded by MMV, and is vice-president of EANMAT. J-PVang has received payments for attending meetings with Novartis, is involved in a trial of artemisinin-combination therapy supported by MMV and EDTCP, and received drugs for malaria studies from Mepha, Novartis, and Ipcalabs. WMW has received a daily payment for meetings with Novartis, and travel and accommodation costs from GSK for meetings of their development team for an artemisinin-combination therapy.
The Lancet. Funding of patients’ groups. Lancet 2006; 368: 2. CancerBACUP. Dossier of delay. http://www. cancerbackup.org.uk/News/Press/Pressreleasess tatements/2005/84975716/ NICEdossierMay05.doc (accessed July 4, 2006).
www.thelancet.com Vol 368 July 15, 2006