Applications for Research Concerning Fetal or Placental Tissue and Expected Institutional Review Board Responses.

Proposals for research concerning fetal and/or placental tissue may be refused institutional review board (IRB) review, effectively preventing the research from occurring. We conducted an anonymous electronic survey of IRB chairs to determine their assessment of the likely response to research projects using fetal/placental tissue obtained from various procedures. We found that proposals concerning tissue obtained from diagnostic procedures or miscarriage were anticipated to be considered at most institutions. Tissue obtained after abortion was likely to be refused consideration by more than 25% of respondents. Additional consultation during review was anticipated for up to 30% of scenarios. Responses for fetal and placental tissue were similar. The most frequently anticipated reason for refusal was institutional policy.

Factors related to colonization with Oxalobacter formigenes in U.S. adults.

GOALS: To elucidate the determinants of Oxalobacter formigenes colonization in humans. BACKGROUND: O. formigenes is a gram-negative anaerobic bacterium that colonizes the colon of a substantial proportion of the normal population and metabolizes dietary and endogenous oxalate. The bacterium has been associated with a large reduction in the odds of recurrent calcium oxalate kidney stones. Subjects were 240 healthy individuals from Massachusetts and North Carolina. O. formigenes was detected by culture of fecal swabs. Information on factors of interest was obtained by telephone interviews and self-administered questionnaires. STUDY RESULTS: The overall prevalence of O. formigenes was 38%. Use of specific antibiotics previously thought to affect the bacterium was significantly related to colonization, with prevalences of 17%, 27%, and 36%, for those who had used these drugs <1, 1-5, and >5 years ago, compared with 55% in nonusers. There were no significant associations with demographic factors, nutrient intake, or medical history, although the prevalence appeared to increase somewhat with increasing oxalate consumption. CONCLUSIONS: Some antibiotics markedly affect colonization with O. formigenes. Although no other factor was identified as having a material influence on the prevalence of the bacterium, there is much to learn about how an individual acquires the organism and which factors affect persistence of colonization.

Statin and NSAID use and prostate cancer risk.

PURPOSE: Some studies have reported reduced risks of advanced, but not early, prostate cancer among statin users, and one study found a reduced risk only among statin users who had also used non-steroidal anti-inflammatory drugs (NSAIDs). We have previously reported no association between statin use and prostate cancer in our hospital-based Case Control Surveillance Study. The purpose of the present analyses was to update the findings by cancer stage and to evaluate the joint use of statins and NSAIDs. METHODS: Cases were 1367 men with prostate cancer and controls were 2007 men with diagnoses unrelated to statin or NSAID use. We used multivariable logistic regression analyses to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for statin use compared with no use, and joint use of statin and NSAIDs compared with use of neither. RESULTS: The odds ratio among regular statin users was 1.1 (95%CI 0.9-1.5), and odds ratios were similar among early and late stage cancers. The odds ratio among joint statin and NSAID users was 1.1 (95%CI 0.7-1.6). CONCLUSION: The present results do not support a protective effect of statin use, or statin and NSAID use, on the risk of advanced prostate cancer.

Prevalence and characteristics of opioid use in the US adult population.

This report describes the prevalence of opioid use in the US adult population, overall and in subgroups, the characteristics of opioid use, and concomitant medication use among opioid users. Data were obtained from the Slone Survey, a population-based random-digit dialing survey. One household member was randomly selected to answer a series of questions regarding all medications taken during the previous week. There were 19,150 subjects aged > or = 18 interviewed from 1998 to 2006. Opioids were used 'regularly' ( > or = 5 days per week for > or = 4 weeks) by 2.0%; an additional 2.9% used opioids less frequently. Regular opioid use increased with age, decreased with education level, and was more common in females and in non-Hispanic whites. The prevalence of regular opioid use increased over time and was highest in the South Central region. Nearly one-fifth of regular users had been taking opioids for > or = 5 years. Concomitant use of > or = 10 non-opioid medications was reported by 21% of regular opioid users compared to 4.5% of subjects who did not use opioids. Regular opioid users were more likely to use stool softeners/laxatives (9% vs. 2%), proton pump inhibitors (25% vs. 8%), and antidepressants (35% vs. 10%). From this nationally-representative telephone survey, we estimate that over 4.3 million US adults are taking opioids regularly in any given week. Information on the prevalence and characteristics of use is important as opioids are one of the most widely prescribed classes of drugs in the US.

Use of herbal/natural supplements according to racial/ethnic group.

OBJECTIVES: The aim of this paper was to determine similarities and differences in the use of herbal/natural supplements among various racial/ethnic groups. DESIGN: A random-digit dial (RDD) telephone survey of medication use during the week before the interview was used. SETTINGS/LOCATION: Households in the 48 contiguous United States comprised our study. SUBJECTS: One (1) subject was selected by a random procedure from each contacted household, including interviews conducted from 1998 through September 2004. There were 13,436 subjects at least 18 years of age, including 10,372 non-Hispanic whites, 1174 African Americans, 1109 Hispanics, 335 Asian/Pacific Islanders, and 446 others. OUTCOME MEASURES: Use of any herbal/natural product during the prior week served as outcome measures. Prevalence of use was weighted according to household size; for comparisons among the three largest groups, estimates were also adjusted for age, gender, and education. RESULTS: The overall prevalence was lowest in African Americans (9.5%; 95% confidence interval [CI], 7.8%-11%), intermediate in Hispanics (12%; 10%-14%), and highest in non-Hispanic whites (19%; 18%-20%). Use was higher among women and generally higher for subjects 45-64 years of age, regardless of race/ethnicity; use increased with increasing years of education. The most commonly taken individual herbal/natural substances were similar among the groups. Hispanics used the largest number of products. Distribution of product type differed somewhat, with Hispanics taking more monopreparations and herbal mixtures than the other groups, and herbal mixture use particularly uncommon among African Americans. Use between 1998 and 2004 increased slightly for non-Hispanic whites, increased then declined for African Americans, and did not change for Hispanics. CONCLUSIONS: Based on nationally representative U.S. data, these results provide a comparative picture of contemporary use of herbal/natural supplements in the largest racial/ethnic groups in the United States. The prevalence of use was lowest among African Americans, with a possible decline in recent years, whereas Hispanics take the greatest number of products.

Use of postmenopausal hormone therapy since the Women's Health Initiative findings.

PURPOSE: To assess how use of postmenopausal hormone therapy (PHT) has changed since the Women's Health Initiative (WHI) trial was halted early due to an excess risk of stroke and other adverse outcomes. To estimate whether use of alternative drugs to treat menopausal symptoms (e.g., selective serotonin reuptake inhibitors [SSRIs], soy) has increased. METHODS: Women were interviewed in the Slone Survey, a random-digit-dial (RDD) survey of current medication use in a representative national sample. Information was obtained on PHT including dose, route, and reason for use, and on use of alternative drugs to treat menopausal symptoms. There were 3853 women aged >or=50 years, interviewed from 1/2001 to 6/2004. RESULTS: The average weekly prevalence of PHT declined 57%, from 28% in the first half of 2002 to 12% in the first half of 2004. Use declined for conjugated estrogens (CE) and for other estrogens, taken either alone or with progestin. The decrease exceeded 50% in most strata of age, race, education, and region. The proportion of PHT users taking 0.3 mg CE did not change. Comparing prevalence in 2004 with prevalence in 2002, there was no material increase in use of black cohosh (2.0% in 2004) or soy (2.0%) and use of SSRIs was somewhat lower (8.9%). CONCLUSIONS: These population-based usage data demonstrate a large decline in PHT use among women of postmenopausal age. The proportion of CE users taking lower doses has not increased. On a population basis, millions fewer women are using PHT in 2004 than before the WHI results were published, but there has been no appreciable increase in use of alternative therapies for menopausal symptoms over the same period.

The risk of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with nonsteroidal antiinflammatory drugs: a multinational perspective.

OBJECTIVE: To quantify the risk of the severe cutaneous adverse reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) associated with use of nonsteroidal antiinflammatory drugs (NSAID). METHODS: Three large data sources were analyzed: an international case-control study on severe cutaneous reactions (SCAR Study), a population based registry in Germany, and the US Food and Drug Administration (FDA) spontaneous reporting system. RESULTS: In the international case-control study, the oxicams were associated with the greatest increase in risk of SJS and TEN (relative risk 34, 95% confidence interval 11-105). When the risk for only recently initiated use was compared to that for longterm use of these agents (> 8 weeks), the relative risk of SJS and TEN associated with oxicams was significantly increased (p < 0.05). German data registry confirm these findings. The incidence of spontaneous US reports of SJS and TEN (per 1,000,000 visits with a prescription) for diflusinal, sulindac, oxaprozin, and etodolac were not significantly lower than that of piroxicam (p > 0.05, all comparisons). CONCLUSION: Although the absolute risks of SJS and TEN associated with NSAID use are low, these risks should be considered in monitoring patients who recently began therapy. In 3 independent databases, oxicams have higher risk of SJS and TEN than other NSAID widely used on the 2 continents. The FDA spontaneous reporting systems suggest some NSAID not widely used in Europe may have risks comparable to the oxicams.