Development of an innovative method for the evaluation of fungal contamination of surfaces

The objective of this technical report is to compare the ability to capture fungal spores through samples performed with three different methods: Rodac contact plates, cotton pad and a pad prepared with a dusting cloth (DC pads) selected from those available on the market. The tests were conducted using a suspension of Aspergillus niger conidia equal to 0.5 MacFarland diluted 1/30, 1/40, 1/50, 1/100. With each of these dilutions 3 sterile tiles of stainless steel were contaminated, each divided into 16 small squares, in the center of which 0.1 ml of the dilution chosen was placed and left to dry (for a total of 12 sheets). In addition, we have used other 6 tiles to repeat the experience with dilutions 1/40 and 1/50. A total of 288 squared surfaces were contaminated: 96 of these were sampled with Rodac contact plates, 96 with cotton pads and 96 with DC and then inseminated in Petri plates. Sabouraud dextrose agar was used as culture medium for the first 12 plates, while, for the other 6 plates Sabouraud dextrose agar added with lecithin and polysorbate 80 was used. All plates were incubated at 37 degrees for 18 hours. To estimate the differences among the sampling methods and the dilutions tested, multiple linear regression was used. The analysis showed that the number of colonies harvested at dilution 1/40 is 13% higher (P = 0.09) than the number harvested at dilution 1/50 and the number of colonies harvested at dilution 1/30 is 6% higher than dilution 1/50 (P = 0.52). With regard to the comparison between the number of colonies harvested with Rodac contact plates, with cotton pads and DC pads, regression analysis shows that cotton pads harvest a number of fungal cfu 5 times higher than those detected with Rodac plates, while DC pads harvest a number of fungal ufc 6 times higher than those detected with Rodac plates (P < 0.00005). These results, although preliminary, indicate that DC pads are a sensitive and simple approach for the environmental control of fungal contamination

Can I Tell You the Truth? A Comparative Perspective on Regulating Off-Label Scientific and Medical Information

American pharmaceutical manufacturers are under siege. Even casual observers of this sector recognize the severe challenges to the prevailing business model: declining research productivity; heightened regulatory focus on safety and comparative outcomes with a correspondingly low number of new product approvals; decreasing market capitalization of mature companies; increasing product liability claims; evolving price restraints in the face of increasing managed care market power; and the looming uncertainty of the effects of federal health care reform. But, in fact, the single greatest threat to the pharmaceutical industry may be the policy environment within the United States, which is restricting the ability of companies to speak truthfully with physicians about their products. During the past decade drug companies have endured intrusive government investigations of their business practices, particularly with respect to the marketing and promotion of their products. Firms face extraordinary civil and criminal liability if they discuss or otherwise attempt to influence prescribing other than for the indications approved by the U.S. Food and Drug Administration (FDA). There are now well more than one hundred ongoing civil and criminal investigations involving the U.S. Department of Justice (DOJ) and units of the U.S. Department of Health and Human Services (HHS), as well as associated investigations run by state attorneys general. Billions of dollars in civil and criminal penalties have been paid to date for alleged wrongdoing, and many billions more surely will be paid in the coming years, on top of the costs of the investigations themselves and the potential further liability that may stem from related private class actions brought by plaintiffs\u27 counsel. The concomitant media and political scrutiny has irreparably harmed the reputation of the industry. If the history of Western civilization may be seen as one long battle pitting order against freedom, the government\u27s effort to curtail off-label speech might be dismissed as a minor skirmish on the outskirts of town. However, this issue is anything but minor in policy terms. The eventual outcome will have significant implications for the practice of medicine, the development of new drugs, and the public health

Kingsfield Meditates

John Jay Osborn explores the effect of meditation on the famed Professor Kingsfield from his novel, The Paper Chase

Kingsfield Meditates

John Jay Osborn explores the effect of meditation on the famed Professor Kingsfield from his novel, The Paper Chase