The Philip Morris External Research Program: results from the first round of projects.

BACKGROUND: Philip Morris (PM) launched the Philip Morris External Research Program (PMERP) in 2000, two years after the company agreed to the dissolution of two industry-wide, external research programmes: the Council for Tobacco Research (CTR) and the Center for Indoor Air Research (CIAR). Our previous analysis of PMERP's Request for Applications noted that PMERP's structure, while ostensibly concerned with new product development, was remarkably similar to that of CIAR. We also found the majority of designated peer-reviewers had previous ties to the tobacco industry and the research solicitation seemed to invite mitigating evidence concerning cigarettes and constituent risks. We concluded that a prime reason for PMERP's existence was to garner scientific credibility for PM. OBJECTIVE: To examine the grants awarded in the first round of PMERP and subsequent peer-reviewed publications. METHODS: Searches of industry documents available on the internet using PMERP and its variations as initial keywords; searches on Medline for publications from PMERP grantees. RESULTS: Of 153 applications, 61 proposals were funded, 36 of which generated 78 scientific publications. Of these, 65% deal specifically with the tobacco plant or constituents. Over half the researchers listed as PMERP participants had previously received or applied for tobacco funding. One internal document indicated PMERP's objectives included gaining "credibility" and "goodwill", and finding "young scientists". In addition, PM has launched its own and more extensive internal product design research programme. CONCLUSION: PMERP appears to exist less as a conduit for critical scientific inquiry than to fit into a corporate strategy intended to burnish PM's public image.

Corporate social responsibility and the tobacco industry: hope or hype?

Corporate social responsibility (CSR) emerged from a realisation among transnational corporations of the need to account for and redress their adverse impact on society: specifically, on human rights, labour practices, and the environment. Two transnational tobacco companies have recently adopted CSR: Philip Morris, and British American Tobacco. This report explains the origins and theory behind CSR; examines internal company documents from Philip Morris showing the company's deliberations on the matter, and the company's perspective on its own behaviour; and reflects on whether marketing tobacco is antithetical to social responsibility.

Second hand smoke and risk assessment: what was in it for the tobacco industry?

OBJECTIVE: To describe how the tobacco industry attempted to trivialise the health risks of second hand smoke (SHS) by both questioning the science of risk assessment of low dose exposure to other environmental toxins, and by comparing SHS to such substances about which debate might still exist. METHODS: Analysis of tobacco industry documents made public as part of the settlement of litigation in the USA (Minnesota trial and the Master Settlement Agreement) and available on the internet. Search terms included: risk assessment, low dose exposure, and the names of key players and organisations. RESULTS/CONCLUSION: The tobacco industry developed a well coordinated, multi-pronged strategy to create doubt about research on exposure to SHS by trying to link it to the broader discussion of risk assessment of low doses of a number of toxins whose disease burden may still be a matter of scientific debate, thus trying to make SHS their equivalent; and by attempting, through third party organisations and persons, to impugn the agencies using risk assessment to establish SHS as a hazard.

Philip Morris' new scientific initiative: an analysis.

In the fall of 2000, Philip Morris re-initiated an external research grants programme ("Philip Morris External Research Program", or PMERP), the first since the dissolution of the Council for Tobacco Research (CTR) and the Center for Indoor Air Research (CIAR). The ostensible purpose of the programme is to help develop cigarette designs "that might reduce the health risk of smoking". Internal company documents also indicate that Philip Morris urgently seeks to restore its scientific "credibility", as part of a "new openness" in relation to the external community. The structure of the review panel--a cohort of external peer reviewers, a science advisory board, and an internal, anonymous review and approvals committee--is nearly identical to that of the CIAR. The majority of the named reviewers have had previous affiliation with the tobacco industry either as reviewers or grantees, but only a minority have done research directly on tobacco or smoking. The programmatic substance of the PMERP could be interpreted as soliciting exculpatory evidence with respect to smoking and exposure to smoke. We remain sceptical about the scientific integrity of PMERP.

Abraham Lincoln's blue pills. Did our 16th president suffer from mercury poisoning?

It is well known that Abraham Lincoln took a medicine called "blue mass" or "blue pill," commonly prescribed in the 19th century. What is now hardly known is that the main ingredient of blue mass was finely dispersed elemental mercury. As his friends understood, mercury was often prescribed for melancholy or "hypochondriasis," a condition Lincoln famously endured. Mercury in the form of the blue pill is a potential neurotoxin, which we have demonstrated by recreating and testing the recipe. We present the testimony of many of Lincoln's contemporaries to suggest that Lincoln suffered the neurobehavioural consequences of mercury intoxication but, perhaps crucial to history, before the main years of his presidency; he was astute enough to recognize the effects and stop the medication soon after his inauguration.

A field trial of wheat-based oral rehydration solution among Afghan refugee children.

A total of 326 Afghan children aged between 6 months and 5 years with uncomplicated nondysenteric diarrhea for the previous 24 h to 5 days were treated at home by their mothers with either wheat-salt solution (WSS) or World Health Organization recommended glucose-oral rehydration salts (G-ORS). For 7 consecutive days the children were examined in the household and the mothers interviewed to assess the progress, feeding practices, and perception of treatment efficacy. Children treated with WSS recovered significantly earlier; the mean duration on treatment was 4.0 days (SD 1.7 days) on WSS compared to 6.4 days (SD 1.7 days) on G-ORS. By the second day of treatment, significantly more mothers using WSS (56%) reported that their children had formed stools versus 11% of their G-ORS counterparts; the mean stool frequency after 2 days was also significantly reduced; 3 stools day-1 (SD 2.1) on WSS versus 5 (SD 2.9) on G-ORS. The cereal-based solution was not confused with normal food and led to better feeding patterns. By day 2, 74% of the mothers using WSS had resumed their normal feeding frequencies as opposed to 33% of G-ORS mothers. On recovery the WSS group had gained significantly more weight; the WSS group gained 169 g (SD 142 g) while the G-ORS group lost 150 g (SD 174g). This study suggests by subjective and objective measures that WSS could be considered as an effective home fluid for the first-line treatment of diarrhea.

The effect of a national control of diarrheal diseases program on mortality: the case of Egypt.

The National Control of Diarrheal Diseases Project (NCDDP) of Egypt began in 1981, became fully operational nation-wide by 1984, and concluded in 1991. The project was designed as a campaign to lower mortality from diarrheal disease in children under five by at least 25% within five years. The principal strategy employed was to improve case-management of diarrhea through rehydration and better feeding: through assured production and distribution of oral rehydration salts, education of families through mass media and health workers through training programs, and creation of rehydration corners throughout the established primary health care and hospital network. A detailed plan for evaluation and research was designed at the start of the project. By its own terms, the NCDDP appears to have succeeded in improving case management; by several local and national mortality surveys, overall infant and childhood mortality fell by at least one-third with the majority proportion in diarrheal deaths. The declines coincided with the peak of NCDDP activities and results in improved case-management. The detailed analyses of this monograph seek to demonstrate that: (a) the mortality decline and the diarrheal mortality decline in particular were actual events; (b) that case-management improved with plausible sufficiency to account for most of the diarrheal mortality reduction; and (c) that changes in other proximate determinants to lowered mortality, such as host resistance or diarrheal incidence, do not plausibly account for the magnitude of the reductions seen. Data are also presented on general socio-economic changes in the decade of the Project. We conclude that improvements in primary care delivery and the use of mass media would have been facilitating factors to NCDDP efforts, while the overall deterioration of economic status would have tended to reduce the benefits. The monograph details the strengths and weaknesses of the available data, and also makes recommendations for sustained efforts in the control of diarrheal diseases.

Relationship of pesticide spraying to signs and symptoms in Indonesian farmers.

OBJECTIVES: This study assessed correlations between exposure to pesticides and signs and symptoms of pesticide toxicity among Indonesian farmers. METHODS: Detailed observations were recorded of spray frequency and pesticide handling, dermal exposure, and the chemicals used. Symptoms of acute illness were reported by the farmers, and signs of poisoning were observed by the interviewers at the time of spraying or within a few hours after it. RESULTS: The spray practices substantially exposed the farmers to pesticides. Signs and symptoms occurred significantly more often during spraying than during nonspraying seasons. Twenty-one percent of the spray operations resulted in three or more neurobehavioral, respiratory, and intestinal signs or symptoms. The number of spray operations per week, the use of hazardous pesticides, and skin and clothes being wetted with the spray solution were significantly and independently associated with the number of signs and symptoms. A dose-effect relationship was found between the neurobehavioral signs and symptoms and the use of multiple organophosphates. CONCLUSIONS: For farmers in the tropics, fully protective garb is too hot and too costly to maintain; farmers thus accept illness as a necessity. Integrated pest management has previously been demonstrated to reduce pesticide use with no loss of crop yield. The frequency of spraying should be reduced through widespread training in integrated pest management, and also the licensing and sale of the most hazardous pesticides should be regulated.

Diarrhoea and mortality in Menoufia, Egypt.

From 1982 the Ministry of Health of Egypt implemented the National Control of Diarrhoeal Diseases Project (NCDDP) which attempted to improve case management of childhood diarrhoea by making oral rehydration salts (ORS) widely available and used, to improve feeding patterns during diarrhoea, and other measures. National data indicate a high level of success in achieving the targets. However, impact evaluation is hampered by weak national baseline information available prior to NCDDP on case management of diarrhoea and causes of infant and childhood mortality. A study in Menoufia Governorate in 1979-80 obtained such information. Consequently, in 1988 the area was revisited to examine subsequent changes. Findings showed marked improvement in case management of diarrhoea and rapid mortality decline, with diarrhoeal mortality apparently declining somewhat faster than mortality from other causes.

PIP: The Ministry of Health (MOH) of Egypt has done much for more than a decade to control diarrheal disease (CDD). Oral rehydration salts (ORS) have been distributed since 1978, and the National Control of Diarrheal Diseases Project (NCDDP) was launched in 1982. Full CDD measures in place since 1984 have expanded the use of ORS to treat diarrhea, and have resulted in lower levels of infant and child mortality across the country. Impact evaluation is, however, hampered by weak national baseline data. At the national level, information on the cause of death in the vital register is not considered reliable. Second, there is little data on the case management of diarrhea before the initiation of the NCDDP. These issues were addressed in some sample villages in Dakahlia Governorate, where increases in knowledge and the use of ORS between 1980 and 1986 were associated with a decrease in diarrheal mortality. A potentially comparable situation existed in Menoufia Governorate, where the effect of a program of home distribution of ORS on mortality was evaluated in 12 villages in 1979-80. This paper reports findings from a return visit to the villages in 1988 to compare the current treatment of diarrheal diseases and mortality patterns against conditions at baseline. The authors report marked improvement in the case management of diarrhea and rapid mortality decline, with diarrheal mortality apparently declining somewhat faster than mortality from other causes.

Hypernatraemia surveillance during a national diarrhoeal diseases control project in Egypt.

The nationwide introduction of oral rehydration therapy to Egypt has led to improvement in diarrhoea case management and a fall in infant and child mortality. With the wider use of oral rehydration solution (ORS) prepared from packets, the incidence of hypernatraemia (serum sodium greater than 150 mmol/l) in inpatients with dehydration seen at Abu El-Reeche Hospital, Cairo, increased between 1980 and 1984. Systematic surveillance of hypernatraemia in the outpatient rehydration unit began in late 1984, and we report trends in hypernatraemia and analyses of key variables affecting its incidence in dehydrated children. In 1980, 17 of 100 children sampled had hypernatraemia and 2 had severe hypernatraemia (ie, serum sodium greater than 165 mmol/l). The frequency in inpatients peaked at 49% of 222 children in 1984 (19% with severe hypernatraemia). Between 1986 and 1989, at least 1000 dehydrated outpatients were surveyed each year; by 1989 the incidence of hypernatraemia had fallen to around 10% (2% severe hypernatraemia). The rise and decline coincided with increasing use of ORS and then increasing ability of mothers to mix the solution correctly. Hypernatraemia was positively related to the quantity of ORS taken, severity of dehydration, nutritional status, and the cooler season, and negatively related to age and duration of diarrhoea. Explanations for our findings include improved use of ORS and better case-management. Good practice promoted through the mass media has facilitated these changes; if the standard of ORS use is not maintained, there may be a case for reducing the sodium content of ORS.

PIP: The nationwide introduction of oral rehydration therapy in Egypt has led to improvement in diarrhea case management and a drop in infant and child mortality. With the wider use of oral rehydration solution (ORS) prepared from packets, the incidence of hypernatremia (serum sodium 150 mmol/1) in inpatients suffering from dehydration seen at Abu El-Reeche Hospital, Cairo, increased between 1980-84. Systematic surveillance of hypernatremia in the outpatient rehydration unit began in late 1984, and the trends in hypernatremia and analyses of key variables which affect its incidence in dehydrated children are reported. In 1980, 17 of 100 children sampled suffered from hypernatremia and 2 had severe hypernatremia (serum sodium 165 mmol/1). The frequency in inpatients peaked at 49% of 222 children in 1984 (19% with severe hypernatremia). Between 1986-89, at least 1000 dehydrated outpatients were surveyed each year; by 1989, the incidence had fallen to about 10% (2% severe hypernatremia). The rise and decline coincided with increasing use of ORS and then increasing ability of mothers to mix the solution correctly. Hypernatremia was positively related to the quantity of ORS taken, severity of dehydration, nutritional status, and the cooler season; it was negatively related to age and duration of diarrhea. Explanations for these findings include improved use of ORS and better case management. Good practice promoted through the mass media has facilitated these changes. If the standard of ORS use is not maintained, there may be cause to reduce the sodium content of ORs.

After rehydration: what happens to the child?

Three-hundred infants and toddlers with diarrhoea were followed up for 5 days after initial rehydration with oral rehydration solution (ORS). When an average of 300-340 ml per day was given at home (520 ml if the diarrhoea was watery), only two children required re-hospitalization; one other child died whose voluminous losses should not have been treated at home. Fifteen per cent of the children still had watery diarrhoea and vomiting by the fifth day, perhaps as a result of multiple drug therapy. Continued feeding, especially breast milk and cereal grains, should reduce the duration of diarrhoea and vomiting (and perhaps the number of drugs). The amount of time a mother can spend giving ORS ultimately limits the amount a child receives.

Effect of diarrhoeal disease control on infant and childhood mortality in Egypt. Report from the National Control of Diarrheal Diseases Project.

The effect of the National Control of Diarrheal Diseases Project, started in 1983, on infant and childhood mortality in Egypt was assessed by means of national civil registration data, nationwide cluster sample surveys of households, and local area studies. Packets of oral rehydration salts are now widely accessible; oral rehydration therapy is used correctly in most episodes of diarrhoea; most mothers continue to feed infants and children during the child's illness; and most physicians prescribe oral rehydration therapy. These changes in the management of acute diarrhoea are associated with a sharp decrease in mortality from diarrhoea, while death from other causes remains nearly constant.