Central institutional ethics committee needed to facilitate timely review of multicenter clinical trials.

A multicenter trial in India undergoes review by Institutional Ethics Committees (IECs) of all participating institutions. The failure to obtain approval even from a single institution's IEC creates a situation of inequitable access to clinical trials. The dichotomy in decisions of different IECs is attributed to lack of standardization and accountability in their functioning. The registration of IECs with Central Drugs Standard Control Organization notwithstanding, the current model of IEC review has failed to ensure uniformity in IEC decisions in multicenter trials. Alternative models that allow central review of multicenter clinical trials should be explored.

5HT3 antagonists for prophylaxis of postoperative nausea and vomiting in breast surgery: a meta-analysis.

BACKGROUND: Postoperative nausea and vomiting (PONV) are distressing adverse events following breast cancer surgery with an incidence of up to 80%. 5HT 3 antagonists are commonly employed as drugs of first choice for PONV although there is no clear evidence favoring one pharmacological approach over another. AIMS: The objective of this meta-analysis is to compare the efficacy of 5HT 3 antagonists against all non-5HT 3 antagonism-based pharmacological approaches as a preemptive strategy for PONV in women undergoing breast surgery. DESIGN: Meta-analysis of Randomized Controlled Trials. MATERIALS AND METHODS: Literature search was conducted through PUBMED, reference lists, and Cochrane Central Register of Controlled Trials till June 2010 to identify eligible studies. Trials comparing 5-HT 3 antagonists with placebo or active controls for prophylaxis against PONV in women undergoing breast surgery were included. Two reviewers extracted the data independently. Methodological quality of each trial was assessed using Jadad score. RESULTS: Nineteen trials were included. All trials were of good methodological quality (Jadad score >3). 5HT 3 antagonists were found superior to placebo [Odds ratio (OR)=0.18 (0.13-0.26)] or active controls [OR=0.65 (0.47-0.91)] in the prevention of PONV. 5HT 3 antagonists were also superior to placebo in preventing nausea alone [OR=0.51 (0.34-0.76)], vomiting [OR=0.31 (0.20-0.47)] and the use of rescue antiemetics [OR=0.18 (0.11-0.28)]. No significant difference was observed in the use of rescue antiemetics as compared to active controls [0.59 (0.19 to 1.86)]. CONCLUSION: 5HT 3 antagonists are superior to other pharmacological interventions for the prevention of PONV in patients undergoing breast surgery under general anesthesia.

Development of botanical principles for clinical use in cancer: where are we lacking?

Development of drugs from plant sources (botanicals) for the treatment of cancer has not been successful in India, despite a plethora of medicinal plants and an equal number of experiments demonstrating anti-cancer activity of plant principles in vitro. There are several pitfalls in our approach to botanical drug development. Foremost is the lack of industry-academia collaborations in this field. Research goals in Indian academic institutions are generally short-term and mostly aimed at fulfilling the minimum requirements of a doctoral/MD or MPharm thesis. Secondly, quality assurance of herbal formulations is difficult to achieve and good manufacturing practices are expensive to implement. This could introduce bias during the biological evaluation of botanicals. A systematic approach covering a wide range of investigations including but not limited to mechanistic studies, potential herb-drug interactions, pharmacokinetics and bioavailability could help in the optimization of herbal formulations in the preclinical stage of development before they can be considered for clinical trials. Government initiatives such as Ayurveda, Unani, Siddha and Homeopathic have encouraged research in these areas, but are insufficient to promote focused and aggressive evaluation of potential herbs. Particular emphasis should be given to clinical pharmacokinetics, drug interactions and clinical trials in specific cancers for the evaluation of dosage, safety, efficacy and concomitant use with chemotherapy. Only such policies can result in meaningful evaluation of botanicals for cancer therapy.

Positron emission tomography / computerized tomography evaluation of primary Hodgkin's disease of liver.

Occurrence of primary Hodgkin's lymphoma (PHL) of the liver is extremely rare. We report on a case of a 60-year-old male who presented with liver mass and B-symptomatology. Hepatoma or hepatic metastasis from a gastrointestinal primary was initially suspected. Tumor markers like AFP, CEA, Total PSA, and CA-19.9 were within normal limits. Positron Emission Tomography / Computerized Tomography (PET/CT) revealed a large hepatic lesion and a nodal mass in the porta hepatis. A liver biopsy was consistent with Hodgkin's lymphoma. There was complete regression of the hepatic lesion and evidence of shrinkage of the nodal mass following four cycles of chemotherapy. 18F Fluro -de-oxy Glucose (FDG) PET / CT in this case helped in establishing a primary hepatic lymphoma by demonstrating the absence of pathologically hypermetabolic foci in any other nodes or organs. PET / CT scan is a useful adjunct to conventional imaging and histopathology, not only to establish the initial diagnosis, but also to monitor treatment response in PHL.

Toward better quality of anticancer generics in India.

Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.