Phase I Evaluation of Intravenous Ascorbic Acid in Combination with Gemcitabine and Erlotinib in Patients with Metastatic Pancreatic Cancer

Preclinical data support further investigation of ascorbic acid in pancreatic cancer. There are currently insufficient safety data in human subjects, particularly when ascorbic acid is combined with chemotherapy.14 subjects with metastatic stage IV pancreatic cancer were recruited to receive an eight week cycle of intravenous ascorbic acid (three infusions per week), using a dose escalation design, along with standard treatment of gemcitabine and erlotinib. Of 14 recruited subjects enrolled, nine completed the study (three in each dosage tier). There were fifteen non-serious adverse events and eight serious adverse events, all likely related to progression of disease or treatment with gemcitabine or erlotinib. Applying RECIST 1.0 criteria, seven of the nine subjects had stable disease while the other two had progressive disease.These initial safety data do not reveal increased toxicity with the addition of ascorbic acid to gemcitabine and erlotinib in pancreatic cancer patients. This, combined with the observed response to treatment, suggests the need for a phase II study of longer duration.Clinicaltrials.gov NCT00954525

Vitamin C: Intravenous Use by Complementary and Alternative Medicine Practitioners and Adverse Effects

Background: Anecdotal information and case reports suggest that intravenously administered vitamin C is used by Complementary and Alternate Medicine (CAM) practitioners. The scale of such use in the U.S. and associated side effects are unknown. Methods and Findings: We surveyed attendees at annual CAM Conferences in 2006 and 2008, and determined sales of intravenous vitamin C by major U.S. manufacturers/distributors. We also queried practitioners for side effects, compiled published cases, and analyzed FDA’s Adverse Events Database. Of 199 survey respondents (out of 550), 172 practitioners administered IV vitamin C to 11,233 patients in 2006 and 8876 patients in 2008. Average dose was 28 grams every 4 days, with 22 total treatments per patient. Estimated yearly doses used (as 25g/50ml vials) were 318,539 in 2006 and 354,647 in 2008. Manufacturers ’ yearly sales were 750,000 and 855,000 vials, respectively. Common reasons for treatment included infection, cancer, and fatigue. Of 9,328 patients for whom data is available, 101 had side effects, mostly minor, including lethargy/fatigue in 59 patients, change in mental status in 21 patients and vein irritation/phlebitis in 6 patients. Publications documented serious adverse events, including 2 deaths in patients known to be at risk for IV vitamin C. Due to confounding causes, the FDA Adverse Events Database was uninformative. Total numbers of patients treated in the US with high dose vitamin C cannot be accurately estimated from this study

Providing competency-based family medicine residency training in substance abuse in the new millennium: a model curriculum

<p>Abstract</p> <p>Background</p> <p>This article, developed for the Betty Ford Institute Consensus Conference on Graduate Medical Education (December, 2008), presents a model curriculum for Family Medicine residency training in substance abuse.</p> <p>Methods</p> <p>The authors reviewed reports of past Family Medicine curriculum development efforts, previously-identified barriers to education in high risk substance use, approaches to overcoming these barriers, and current training guidelines of the Accreditation Council for Graduate Medical Education (ACGME) and their Family Medicine Residency Review Committee. A proposed eight-module curriculum was developed, based on substance abuse competencies defined by Project MAINSTREAM and linked to core competencies defined by the ACGME. The curriculum provides basic training in high risk substance use to all residents, while also addressing current training challenges presented by U.S. work hour regulations, increasing international diversity of Family Medicine resident trainees, and emerging new primary care practice models.</p> <p>Results</p> <p>This paper offers a core curriculum, focused on screening, brief intervention and referral to treatment, which can be adapted by residency programs to meet their individual needs. The curriculum encourages direct observation of residents to ensure that core skills are learned and trains residents with several "new skills" that will expand the basket of substance abuse services they will be equipped to provide as they enter practice.</p> <p>Conclusions</p> <p>Broad-based implementation of a comprehensive Family Medicine residency curriculum should increase the ability of family physicians to provide basic substance abuse services in a primary care context. Such efforts should be coupled with faculty development initiatives which ensure that sufficient trained faculty are available to teach these concepts and with efforts by major Family Medicine organizations to implement and enforce residency requirements for substance abuse training.</p