Conflict of Interest Disclosure in Off-Label Oncology Clinical Trials.

Conflict of interest disclosure in off-label oncology clinical trials.

Filed under: Drug and Alcohol Rehabilitation

J Oncol Pract. 2012 Sep; 8(5): 298-302
Irwin B, Hirsch BR, Samsa GP, Abernethy AP

We sought to determine the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements for studies of anticancer targeted therapies conducted in the off-label prescribing setting.As a part of a federally funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to compendia published in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and presence of COI and funding disclosure statements.Among the 69 included studies, prevalence of COI and funding disclosures was low, at 33% and 58% respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high-impact-factor journals (P < .001), large study sample size (P = .001), enrollment exclusively in the United States (P = .04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (P = .03).Disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anticancer targeted therapies was low and did not increase substantially over time. HubMed – drug


Hypericum perforatum extract therapy for chickens experimentally infected with infectious bursal disease virus and its influence on immunity.

Filed under: Drug and Alcohol Rehabilitation

Can J Vet Res. 2012 Jul; 76(3): 180-5
Shang R, He C, Chen J, Pu X, Liu Y, Hua L, Wang L, Liang J

Hypericum perforatum extract (HPE) has been proved a drug effective to many viral diseases. The purpose of this paper was to investigate the therapeutic efficacy and immuno-enhancement of HPE for chickens which were already challenged with infectious bursal disease virus (IBDV BC-6/85). Chickens infected with IBDV were treated with HPE for 5 consecutive days, the observation of immune organ indexes and pathological changes index, determination of IFN-? and detection of IBDV with RT-PCR were employed to assess in vivo whether or not HPE had the certain therapeutic efficacy on infectious bursal disease (IBD), and if HPE was able to improve the immunologic function. The results showed that 1330 and 667.9 mg/kg body weight (BW) per day of HPE had significant therapeutic efficacy and improvement immunologic functions for chickens infected experimentally with IBDV.
HubMed – drug


Sorrell v. IMS Health Inc.: Data Mining of Pharmacy Records and Drug Marketing as Free Speech.

Filed under: Drug and Alcohol Rehabilitation

Public Health Rep. 2013 Jan; 128(1): 64-6
Cartwright-Smith L, Lopez N

HubMed – drug


Transdermal delivery of adipocyte-derived stem cells using a fractional ablative laser.

Filed under: Drug and Alcohol Rehabilitation

Aesthet Surg J. 2013 Jan 1; 33(1): 109-16
Oni G, Lequeux C, Cho MJ, Zhang D, Lazcano E, Brown SA, Kenkel JM

Background: Chronic wound healing problems can pose a significant clinical challenge. Transdermal delivery of adipose-derived stem cells (ADSC) may be a possible solution to healing these recalcitrant, debilitating wounds. Pretreatment of the skin with a fractionated laser has already been shown to assist transdermal drug delivery both in vitro and in vivo and may be an ideal approach to facilitating delivery of ADSC to the target tissue. Objectives: The authors investigate in a porcine model whether ADSC can be delivered transdermally following pretreatment with a fractional laser. Methods: After ethics approval was obtained, the abdomens of 2 adult female domestic pigs were pretreated with an erbium:YAG fractionated ablative laser. Following laser treatment, 20 × 10(6) bromodeoxyuridine (BrdU)-labeled ADSC were applied topically to the first animal for 4 hours. The same number of BrdU-labeled ADSC was applied to the second animal for 48 hours. The animals were euthanized at the end of their respective treatment periods, and the BrdU-labeled ADSC were counted after tissue harvest. Results: At 4 hours, an average of 2.40 × 10(6) cells, or 12.0% of the total cells applied, were found in the tissue. At 48 hours, an average of 1.1 × 10(6) cells, or 5.5% of the total cells applied, were seen. Conclusions: This pilot study demonstrates that ADSC can be delivered transdermally through skin that has been pretreated with a laser. Potential future applications of this approach might include wound-healing or aesthetic indications. Further studies need to be conducted to determine the optimal number of ADSC to use in this approach, the best methods of application, and the effect of transdermally delivered ADSC on wound healing.
HubMed – drug


Solubility-based genetic screen identifies RING finger protein 126 as an E3 ligase for activation-induced cytidine deaminase.

Filed under: Drug and Alcohol Rehabilitation

Proc Natl Acad Sci U S A. 2012 Dec 31;
Delker RK, Zhou Y, Strikoudis A, Stebbins CE, Papavasiliou FN

Protein-protein interactions are typically identified by either biochemical purification coupled to mass spectrometry or genetic approaches exemplified by the yeast two-hybrid assay; however, neither assay works well for the identification of cofactors for poorly soluble proteins. Solubility of a poorly soluble protein is thought to increase upon cofactor binding, possibly by masking otherwise exposed hydrophobic domains. We have exploited this notion to develop a high-throughput genetic screen to identify interacting partners of an insoluble protein fused to chloramphenicol acetyltransferase by monitoring the survival of bacteria in the presence of a drug. In addition to presenting proof-of-principle experiments, we apply this screen to activation-induced cytidine deaminase (AID), a poorly soluble protein that is essential for antibody diversification. We identify a unique cofactor, RING finger protein 126 (RNF126), verify its interaction by traditional techniques, and show that it has functional consequences as RNF126 is able to ubiquitylate AID. Our results underpin the value of this screening technique and suggest a unique form of AID regulation involving RNF126 and ubiquitylation.
HubMed – drug


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