Ethics in Pharma: in Search of Tales from the Front

Many would dismiss "ethical pharmaceuticals" as an oxymoron. We're planning to do a survey of readers---an anonymous survey, of course---to see how ethical pharma manufacturing people are in their work-a-day lives.  This survey will deal with non-sales and marketing situations, in engineering, QA/QC, manufacturing, drug development, process development, plant operations and maintenance. Have you ever been in a situation where you had to make a choice between doing what was right and doing what was expedient? Please write in and tell us, anonymously, and describe that situation generically.  We'll take these situations and turn them into a survey to ask our readers "what would you do?" Then we'll publish the results.  Here's our first contributed example.  Can you please share others?  I was the package development chemist in charge of testing compatibility between drugs and packages. We had a problem with a new over-the-counter spray product. Within each package in a warehouse full of product, the liquid had turned from gold to pink, and a precipitate had formed, blocking the spray nozzles. A component in the gaskets of the spraying device was causing the problem (it was present in a concentration that was legal, but still higher than the original formula called for).  I "failed" the materials. My director wanted me to say it was safe since the material in the gaskets was "safe." I refused and told him to pass them on his own signature or do a tox screen on the product. He backed down and destroyed the batch, delaying commercial introduction of the product by three months.
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  • <p>Information found in the ISMP Medication Safety Alert!® Community/Ambulatory Care Edition stems from error reports submitted voluntarily by practitioners and consumers to the ISMP Medication Errors Reporting Program and the FDA MedWatch program.-<a href="">Guy Riordan</a></p>


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