Enforcement of codes governing pharmaceutical promotion: What happens when companies breach advertising guidelines?

Some or all of the promotional activities of pharmaceutical companies are typically governed through self-regulatory codes administered by industry associations. However, the conflicts between the commercial objectives and the ethical and scientific goals of promotion can potentially lead to serious weaknesses in the way in which these codes are enforced. This paper focuses on 5 critical aspects involved in the enforcement of codes governing pharmaceutical promotion: mechanisms for recognizing violations, composition of monitoring committees, sanctions for code violations, the quantity and quality of information in reports issued about complaints and code violations, and the circulation these reports receive. The Code of Marketing Practices of the Pharmaceutical Manufacturers Association of Canada (PMAC) has serious weaknesses in all of these areas. Although the Pharmaceutical Advertising Advisory Board''s Code of Advertising Acceptance avoids many of the deficiencies of the PMAC code, it, too, has weaknesses. Proposals for strengthening the enforcement of both codes are offered.     

Behavioural medicine in health promotion

Behavioural medicine is a rapidly developing interdisciplinary field that integrates the physiological and psychosocial aspects of human behaviour and applies them to prevention. In the early stage of chronic non-infectious illnesses of great epidemiological significance the most important risk factors are the reversible psychophysiological regulation disturbances. According to the behavioural medicine model depressive symptomatology, hopelessness, anxiety, non-adaptive ways of coping, dysfunctional attitudes are common risk factors in the background of self-destructive behavioural disturbances, such as smoking, alcohol and drug abuse and suicidal behaviour. The basic link between physiological and psychological phenomena is the decision making process, the cognitive appraisal, evaluation of the given situation, which is very subjective and depends on the socialization process. The modern civilised way of life continuously creates situations in which we experience loss of control, and therefore the psychological and physiological balance can only be obtained with great difficulty. Especially under conditions of sudden cultural and socioeconomic transition strengthening adaptive ways of coping and preventing emotional disturbances are fundamental in health promotion.     

Phage display in pharmaceutical biotechnology

Over the past year, methods for the construction of M13 phage-display libraries have been significantly improved and new display formats have been developed. Phage-displayed peptide libraries have been used to isolate specific ligands for numerous protein targets. New phage antibody libraries have further expanded the practical applications of the technology and phage cDNA libraries have proven useful in defining natural binding interactions. In addition, phage-display methods have been developed for the rapid determination of binding energetics at protein-protein interfaces.     

Helix promotion in polypeptides by polyols

The helix content of [L -Lys(Me₃)]_n · ClO₄, and [L -Lys(Me₃)⁵⁰, L -Ala⁵⁰]_n · ClO₄ in water is markedly increased by the presence of sucrose and glycerol. For [L -Lys(Me₃)]_n · ClO₄ the ellipticity at 222 nm changes from +2 × 10³ deg cm² dmole^?1 in water to ?44 × 10³ in 50% glycerol. Sucrose does not promote helix formation in melittin at pH 7.2, but glycerol does. At pH 5.5 sucrose and, more so, glycerol, induce helix in melittin. Glycerol induces some helix in methylated melittin, but less than in melittin. The results are discussed in relation to excluded volume effects, ΔG of transfer of peptide and hydrophobic groups from water to mixed solvents, electrostatic effects, and preferential hydration. © 1993 John Wiley & Sons, Inc.     

Vegan diet in physiological health promotion

We have performed a number of studies including dietary interventions and cross-sectional studies on subjects consuming uncooked vegan food called living food (LF) and clarified the changes in several parameters related to health risk factors. LF consists of germinated seeds, cereals, sprouts, vegetables, fruits, berries and nuts. Some items are fermented and contain a lot of lactobacilli. The diet is rich in fiber. It has very little sodium, and it contains no cholesterol. Food items like berries and wheat grass juice are rich in antioxidants such as carotenoids and flavonoids. The subjects eating living food show increased levels of carotenoids and vitamins C and E and lowered cholesterol concentration in their sera. Urinary excretion of sodium is only a fraction of the omnivorous controls. Also urinary output of phenol and p-cresol is lowered as are several fecal enzyme levels which are considered harmful. The rheumatoid arthritis patients eating the LF diet reported amelioration of their pain, swelling of joints and morning stiffness which all got worse after finishing LF diet. The composite indices of objective measures showed also improvement of the rheumatoid arthritis patients during the intervention. The fibromyalgic subjects eating LF lost weight compared to their omnivorous controls. The results on their joint stiffness and pain (visual analogue scale), on their quality of sleep, on health assessment questionnaire and on general health questionnaire all improved. It appears that the adoption of vegan diet exemplified by the living food leads to a lessening of several health risk factors to cardiovascular diseases and cancer. Rheumatoid patients subjectively benefited from the vegan diet which was also seen in serum parameters and fecal analyses.     

Co-composting of pharmaceutical wastes in soil

AIMS: Soils at a commercial facility had become contaminated with the pharmaceutical chemical residues, Probenecid and Methaqualone, and required remediation. METHODS AND RESULTS: Soil composting was investigated as an alternative to incineration for treatment. In laboratory trials, a factorial experimental design was used to evaluate organic matter amendment type and concentration, and incubation temperature. In pilot scale trials, Probenecid was reduced from 5100 mg kg(-1) to < 10 mg kg(-1) within 20 weeks in mesophilic treatments. An 8 tonne pilot scale treatment confirmed that thermophilic composting was effective under field conditions. In the full-scale treatment, 180 tonnes of soil were composted. Initial concentrations of the major contaminants in the full-scale compost treatment were 1160 mg kg(-1) and 210 mg kg(-1), for Probenecid and Methaqualone, respectively. Probenecid concentration reached the target level of 100 mg kg(-1) in 6 weeks, and removal of Methaqualone to < 100 mg kg(-1) was achieved after 14 weeks. CONCLUSION: Co-composting was effective in reducing soil concentrations of Probenecid and Methaqualone residues to acceptable values. SIGNIFICANCE AND IMPACT OF THE STUDY: Co-composting is a technology that has application in the remediation of pharmaceutical contaminants in soil.