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.

Treatment of diarrheal dehydration.

PIP: In a paper on fluid therapy of rehydration, the rehydration fluid advocated by Speretto et al, N/2 saline, is approximately 60% of the tonicity of their children's plasma with respect to sodium. Thus, their data show a weight gain over a 3-hour reparation period of about 60% of the fluid administered. Administering a half normal solution leaves a severely dehydrated child still dehydrated. In addition, the potassium deficits are exacerbated and acidosis is only slowly corrected. The author of this letter recommends for rapid rehydration, the use of a balanced solution with a range of electrolyte content (in mEq/liter) as follows: Na, 100 to 130; K, 10 to 15; HCO3, 20 to 30. Children should take oral fluids and food within a few hours after rehydration. A 2nd paper on fluid therapy of rehydration by Nichols and Soriano contains practical, conceptual, physiological and historical fallacies. The practical fallacy is their theoretical critique of an approach that is already successful, and documented worldwide. The conceptual fallacy is their argument for individualized therapy and management based on average stool electrolyte concentration. The physiologic fallacy is their assumption that less sodium content (30 mEq/liter), is safer than more sodium content (90 mEq/liter), while the historical fallacy is their objection of the nutritional inadequacy of oral rehydration fluids.^ieng

The treatment of acute diarrhea in children. An historical and physiological perspective.

This review examines the historical, physiological, clinical, and epidemiological evidence to support a method of therapy for children's diarrhea that may be recommended for general acceptance. The understanding and use of fluid and nutritional therapy of acute diarrhea in childhood have progressed over the years to a point where acute mortality can be reduced to nearly zero. At the same time, the ill effects on electrolyte balance and nutrition may be reduced to a minimum. Through use of an oral glucose electrolyte solution with a carefully designed composition, physiologically correct treatment may now be so simplified and inexpensive as to be readily available to the remote, under-served areas of the world where most of the morbidity exists; and be useful as well to more sophisticated settings. The method of therapy recommended in this paper has several important departures from traditional teaching. It advocates rapid restoration of extracellular fluid with a polyelectrolyte solution containing sodium, base and potassium; use of an oral glucose electrolyte solution for repletion of those not in shock and for maintenance; use of a single oral glucose electrolyte solution for all age groups, regardless of diagnosis, and quite early feeding with tolerated foods. Sodium loads given are generally higher than advocated by standard pediatric teaching. The origins of that teaching and support for the newer approach come from a detailed analysis of current knowledge in the epidemiological, clinical, and physiological aspects of diarrheal illness.

Oral glucose-electrolyte therapy for diarrhea: a means to maintain or improve nutrition?

PIP: Since over half of the children aged 5 years and under in the developing world suffer from mild-moderate malnutrition, means of correcting nutrition deficiencies are essential. In the case of the child with diarrhea, malnutrition is exacerbated by a number of disease-related factors including anorexia, cultural or medical withdrawal of food, and purgation. It was discovered, in a study among Apache children, that early and rapid replacemtnt of volume loss and correction of electrolyte imbalance using glucose-electrolyte solutions administered orally can restore physical well-being and appetite to children suffering from acute diarrhea, and hence enhance these children's nutritional status. The solution recommended contained, in millimolar concentrations per liter: sodium, 81; potassium, 18; choride, 71; HC03, 28; and glucose, 139. A field trial of oral therapy for acute diarrhea in children is called for tod etermine the extent of effects on nutrition and mortality, as well as to indicate some of the cultural and logistical problems which remain to be solved.^ieng

The current status of oral therapy in the treatment of acute diarrheal illness.

PIP: Diarrheal diseases are a primary cause of morbidity and mortality in the developing countries. This is a literature review and evaluation of the new form of oral therapy, surveying field and clinical studies which have been performed. The etiology and effects of diarrheal diseases are discussed. Oral fluid therapy aims at preventing and treating dehydration and facilitating continued dietary intake, not in terminating the diarrhea. The composition of the widely used fluid therapy solution is explained; there are presently some differences of opinion regarding the optimal composition of the solution. Clinical experience with the therapy in hospitals, clinics, and relatively unsupervised home use is cited. This simple, inexpensive therapy seems to be effective for a wide variety of diarrheal diseases and for people in all age groups. The greatest current controversy regarding oral therapy is whether it should be widely used as a home remedy. Further study will be necessary to measure its effectiveness on a home-use basis.^ieng

Oral rehydration therapy for diarrhea in children--a basic primer.

PIP: This article reviews current knowledge on oral rehydration therapy (ORT) for diarrhea in children. The World Health Organization (WHO) has formulated an ORT solution suitable for most cases of diarrhea, regardless of etiology or patient's age. At least 65 separate studies in 21 countries have documented successful use of ORT (largely the WHO formulation). Although it is popularly believed that food intake should be minimized during diarrhea to rest the bowel, fasting impairs the absorption of glucose, salt, water, amino acids, and the activity of disaccharidases. However, even children with intractable diarrhea gain weight and have less diarrhea on diets that are predigested but not hypertonic. Locally available food, such as rice and rice water, and breast milk can be tolerated by children with diarrhea. ORT can play a positive role in reducing anorexia and promoting food intake by restoring appetite. ORT must be delivered through a community-based distribution program to reach the majority of people in developing countries. The minimum elements for such a program are the chemicals, a means to measure them, a container, a source of potable water, education of deliverers and family, and managerial surveillance. Medical backup for ORT failures and evaluation of outcomes are also desirable features. Although ORT packets can be produced for US8 cents, they are not always available to remote areas, leading some to advocate use of table salt and household sugar solutions. The problems of delivery of ORT to those most in need mirror more general problems in health care delivery in developing countries. Nonetheless, in comparison with many curative and preventive health care measures, ORT has an exceptionally high cost-benefit ratio.^ieng

Attempted prevention of diarrheal disease in Apache children with a non-absorbable broad-spectrum antimicrobial.

A double-blind study was conducted to test the prophylactic effect of a non-absorbable broad-spectrum antimicrobial (oral colistin sulfate) against acute diarrhea in Apache children. Children 1 to 6 months old had over twice the morbidity from diarrhea if assigned to the antimicrobial group as compared to placebo, while the toddler group (7-30 months) taking the antimicrobial had somewhat less diarrhea. Enteropathogenic E. coli were significantly more often isolated from the antimicrobial group (but only in well children). No special effect on the children's growth by the antimicrobial was discerned.

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.

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.

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.