måndag 9 september 2019

Tre former FDA commissioners – Larrick, von Eisenbach and Hamburg – bears a huge responsibility for their approval propoxyphene in different phases


There are three former FDA commissioner - Georg P. Larrick (1954 – 1965), Andrew von Eisenbach (2006 - 2009) and Margret Hamburg (2009-2015) – that were in charge in FDA  when some – as it shown out – difficult and problematic decisions on the painkiller (Dextro) Propoxyphene (DXP) was taken, decisions that proved very unhappy.

Georg P. Larrick became commissioner 1954 and 1957 FDA approved the request from Eli Lilly – the manufacturer of Propoxyphene – to accept the substance Propoxyphene.  During my research years I have read a large number of scientific articles, I have also seen how applications to the FDA and other pharmaceutical authorities should look like for a product's approval, but I have never seen such a common request as the current one. It is simply a laboratory report rather than a correct scientific report before an approval.   Eli Lilly was incredibly irresponsible to get a coveted drug - which for many years to come was the premiere's Golden Calf. Shame on you Eli Lilly, shame on you. And during the next 50 years Eli Lilly did not behave better.

Dr Andrew von Eisenbach was commissioner in December 2006, and the same year FDA released a (FDA docket 2006-0090) and we became a part of that Docket. This docket consisted of posts from more than 20 people or institutions. Thus, at such a Docket, the so-called public and others - for example we - were welcomed with posts. A Docket is a meeting place between the FDA and the people who want to tell about their impressions on a current topic.

The title of Docket 2006P-0090 was: Immediately begin the phased removal from the market of Propoxyphene (Darvon) and all propoxyphene containing product. We addressed a letter to commissioner von Eisenbach and we were naive to believe that he would answer our letter as we have been promised. See the letter http://bit.ly/2HzA8Jo

von Eisenbach got our data 2006 – and he never answered us - and it took FDA four more years before they banned DXP and during these years lots of persons died.

Margret Hamburg was the commissioner during some interesting years. Public Citizen, a consumer group that we have had contact with since early 2000. This group sent two letters to FDA where we – also became co-signers of these letters, but nothing happened. We presented our research data for Margret Hamburg, and I also visited the FDA office. Margret Hamburg didn´t want to meet us, but I met a couple of persons on a lower level, so FDA really did know about us. Two letter from Public Citizen (  http://bit.ly/1j0nnTh and http://bit.ly/1pMLWpq )

But suddenly, from one day to another – from Friday November 19th 2010 FDA informed that Propoxyphene was banned. If you gave a prescription at the Pharmaceutical company on the 18th you didn´t get any drugs on Saturday 20th

Thousands and thousands of persons were suddenly out of their Darvon or Darvocet pills, and lots of people became desperate and went out on the streets to get Heroin. That day you could buy heroine where-ever you went. And the price was extremely cheap from the beginning – but it increased very soon. http://bit.ly/2Gz4Dxg and the disaster continues


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