Newsletter - September 24, 2015
CEO Jailed for Life in Food Contamination Case
In one of the more severe sentences ever in history for food safety violations, the CEO of the peanut butter company accused of selling salmonella contaminate peanut butter products was given a 28 year sentence for this event. His partner in the company, who is also his brother, was sentenced to 20 years while their quality assurance manager was given 5 years. This ends the 7 years saga of this foodborne disease outbreak that led to 9 death and 714 infections across 46 states and one of the largest food recalls in American history since peanut butter is a component of multiple popular snacks. Read More
One Bad Apple! Not Really. Price Gauging Puts Practice on Front Page
Lots of times, we don’t know what right or wrong is, and lots of times we do. No one takes responsibility for anything anymore. We foster, we obfuscate, and we rationalize. “Everybody does it”, that’s what we say. So we come to occupy a moral safe house, where everyone’s to blame so no one’s guilty. By now, you must have heard about one Martin Shkreli, the CEO of Turin Pharma that raised the price of a life-saving drugs used mostly by AIDS patients from $13.50 to $750 per pill. This 5000% price hike was not justified by any additional clinical or non-clinical work, manufacturing change, or marketing expenses, but by the fact that... Read More
Doctor’s Role in Clinical Trial Quality Likely Takes Center Stage with the New FDA Commissioner
This week President Obama announced the appointment of Dr. Robert Califf at the new Commissioner of the FDA. This was no surprise; Dr. Califf had already been acting as the FDA Commissioner since his hiring by FDA earlier this year. Dr. Califf’s major achievement before coming to FDA was creation of Clinical Research Institute at Duke University, which along with FDA launched the Clinical Trial Transformation Initiative (CTTI). Dr. Califf also is one of the first FDA Commissioners to come to the Agency with extensive and close relations with the drug industry. Read More
CEO Jailed for Life in Food Contamination Case
In one of the more severe sentences ever in history for food safety violations, the CEO of the peanut butter company accused of selling salmonella contaminate peanut butter products was given a 28 year sentence for this event. His partner in the company, who is also his brother, was sentenced to 20 years while their quality assurance manager was given 5 years. This ends the 7 years saga of this foodborne disease outbreak that led to 9 death and 714 infections across 46 states and one of the largest food recalls in American history since peanut butter is a component of multiple popular snacks. Read More
One Bad Apple! Not Really. Price Gauging Puts Practice on Front Page
Lots of times, we don’t know what right or wrong is, and lots of times we do. No one takes responsibility for anything anymore. We foster, we obfuscate, and we rationalize. “Everybody does it”, that’s what we say. So we come to occupy a moral safe house, where everyone’s to blame so no one’s guilty. By now, you must have heard about one Martin Shkreli, the CEO of Turin Pharma that raised the price of a life-saving drugs used mostly by AIDS patients from $13.50 to $750 per pill. This 5000% price hike was not justified by any additional clinical or non-clinical work, manufacturing change, or marketing expenses, but by the fact that... Read More
Doctor’s Role in Clinical Trial Quality Likely Takes Center Stage with the New FDA Commissioner
This week President Obama announced the appointment of Dr. Robert Califf at the new Commissioner of the FDA. This was no surprise; Dr. Califf had already been acting as the FDA Commissioner since his hiring by FDA earlier this year. Dr. Califf’s major achievement before coming to FDA was creation of Clinical Research Institute at Duke University, which along with FDA launched the Clinical Trial Transformation Initiative (CTTI). Dr. Califf also is one of the first FDA Commissioners to come to the Agency with extensive and close relations with the drug industry. Read More
