Newsletter - July 9, 2015
Unblinded Studies are Biased Even if the Researchers are Well-Intentioned
Despite a well-known and scientifically accepted practice of using blinded studies to support a claim, it is still not uncommon for well-intentioned researchers to conduct open-label studies leading to highly biased results. In an article published in the PLOS journal by three Australian researchers, a review of 960 peer-reviewed articles in 5 different animal behavior journals found that only 6.3% of the studies involved blinded study design. Even in clinical research, a sample of 234 meta-analyses of clinical trials showed that about one-third of the meta-analyses did not contain any double-blind studies. Read more..
FDA Expects Drug Manufacturers to Intimate 6 Months in Advance of an Upcoming Drug Shortage
Starting 1st of September this year (2015), FDA will require all manufacturers of drugs or biological products including manufacturers of blood or blood components for transfusion to notify FDA electronically of a permanent or temporary discontinuation in the manufacturing of their product that is likely to lead to a significant disruption in supply of that product in the US. In the recent past, several long- or even short-term disruption in drug supplies lead to huge public outcry. In some cases, treatments for life-threatening diseases were not available such as the case of cancer drug Doxil, leading to many patients either scrambling to find alternate therapies that were not as effective or forgo treatment altogether leading to worsening of the disease. Read More...
US FDA and Interpol Seize 21 Million Fake Medicines Worth $81 Million in One Week of Joint Operation
Every year regulatory agencies from all over the world jointly conduct an international week of action, called Operation Pangea, to go after online pharmacies selling counterfeit and illicit medicines and post their results publicly to create awareness about the dangers of buying medicines from internet pharmacies. This operation is coordinated by INTERPOL which brings together customs, health regulators, national police and the private sector from countries around the world. Operation Pangea targets the three principal components of illegal web pharmacies – the Internet Service Provider (ISP), payment systems and the delivery service. The annual week-long operation which was launched with participants from 10 countries in 2008, has risen is stature with 115 countries and 236 agencies participating in the 8th Operation Pangea from 9-16 June 2015. Read More...
Unblinded Studies are Biased Even if the Researchers are Well-Intentioned
Despite a well-known and scientifically accepted practice of using blinded studies to support a claim, it is still not uncommon for well-intentioned researchers to conduct open-label studies leading to highly biased results. In an article published in the PLOS journal by three Australian researchers, a review of 960 peer-reviewed articles in 5 different animal behavior journals found that only 6.3% of the studies involved blinded study design. Even in clinical research, a sample of 234 meta-analyses of clinical trials showed that about one-third of the meta-analyses did not contain any double-blind studies. Read more..
FDA Expects Drug Manufacturers to Intimate 6 Months in Advance of an Upcoming Drug Shortage
Starting 1st of September this year (2015), FDA will require all manufacturers of drugs or biological products including manufacturers of blood or blood components for transfusion to notify FDA electronically of a permanent or temporary discontinuation in the manufacturing of their product that is likely to lead to a significant disruption in supply of that product in the US. In the recent past, several long- or even short-term disruption in drug supplies lead to huge public outcry. In some cases, treatments for life-threatening diseases were not available such as the case of cancer drug Doxil, leading to many patients either scrambling to find alternate therapies that were not as effective or forgo treatment altogether leading to worsening of the disease. Read More...
US FDA and Interpol Seize 21 Million Fake Medicines Worth $81 Million in One Week of Joint Operation
Every year regulatory agencies from all over the world jointly conduct an international week of action, called Operation Pangea, to go after online pharmacies selling counterfeit and illicit medicines and post their results publicly to create awareness about the dangers of buying medicines from internet pharmacies. This operation is coordinated by INTERPOL which brings together customs, health regulators, national police and the private sector from countries around the world. Operation Pangea targets the three principal components of illegal web pharmacies – the Internet Service Provider (ISP), payment systems and the delivery service. The annual week-long operation which was launched with participants from 10 countries in 2008, has risen is stature with 115 countries and 236 agencies participating in the 8th Operation Pangea from 9-16 June 2015. Read More...
