ABSTRACT
<p><b>OBJECTIVE</b>Exposure to polychlorinated biphenyls (PCBs) is considered to have culminated between 1950 and 1970 in Japan, and exposure through diet, the major exposure route, has decreased significantly over the last 10 years. The primary goal of the present study was to investigate the long-term trends and congener profiles of serum and dietary levels of PCBs using historical samples.</p><p><b>METHODS</b>Using banked samples collected in 1980, 1995, and 2003 surveys, we determined the daily intakes and serum concentrations of 13 PCB congeners (#74, #99, #118, #138, #146, #153, #156, #163, #164, #170, #180, #182, and #187) in women.</p><p><b>RESULTS</b>The total daily PCB intake [ng/day, geometric mean (geometric standard deviation)] decreased significantly from 523 (2.5) in 1980 to 63 (3.2) in 2003. The serum total PCB level (ng/g lipid) in women <40 years of age decreased significantly from 185 (1.8) in 1980 to 68 (1.8) in 2003. In contrast, the level in women >50 years of age increased significantly from 125 (1.7) in 1980 to 242 (1.7) in 2003. Specifically, the serum concentrations of hexa (#138, #146, #153, #156, #163, and #164) and hepta (#170, #180, #182, and #187) congeners increased significantly. A comparison of the serum PCB levels of women born from 1940 to 1953 revealed that their serum total PCB level was significantly higher in the 2003 survey [242 (1.7), n = 9] than in the 1995 [128 (2.0), n = 17] surveys. This increase in the total PCB level was attributable to increases in the hepta congener groups.</p><p><b>CONCLUSION</b>Present results suggest a decreased rate of elimination of hepta congeners with aging in females, rather than a birth-generation phenomenon.</p>
ABSTRACT
Although the two regulatory bodies, Pharmaceutical and Medical Devices Agency (PMDA) and Ministry of Health, Labour & Welfare (MHLW) cooperate in pharmacovigilance in Japan, presence of clinicians in the two bodies is surprisingly limited with only about twenty medical doctors compared more than 300 in CDER/CBER. The lack of doctors in PMDA, resulting from several factors including low social status and hard work, make them to review drugs and devices in which they are not expertised at all. For example, a paediatric cardiologist is obliged to review a drug for overactive bladder because no urologist is available for drug review in PMDA. Such a case would make the reviewer guilty of professional negligence. These critical issues make a PMDA reviewer rather dangerous than unexciting job. On the other hand, most Japanese doctors, heavily dependent on PMDA and pharmaceutical companies for drug information, would not commit in the drug review or pharmacovigilance. To make Japanese doctors more committed in pharmacovigilance, there are several measures to be implemented. First, better benefit, i.e. income, working hours, holidays. Second, escape clause for the reviewers. Third, more doctors to the Office of Safety rather than the Offices of New Drug. People outside PMDA can also contribute to pharmacovigilance with better media literacy and better understanding of PMDA.