måndag 19 augusti 2019

The following persons have been FDA Commissioners during some years - when Propoxyphene, Fentanyl, Methadone, Oxycodone and Hydrocodone were apprtoved




Georg P. Larric - Aug 12, 1954 - Dec 27,1965 - Propoxyphene - 1957.

Donald Kennedy - April 13, 1957 - Mar 15, 1973 - He later changed his opinion.

David A Kessler  - Nov 8, 1990 - Febr 28, 1997 - Fentanyl and Methadone -99  He later change his mind.

Jane E. Henney  - Jan 17,1999 – Jan 19, - 2001 - Oxycodone + Hydrocodone -1999.

Andrew von Eisenbach Dec 13,2006 – Jan 20, 2009 - He didn´t answer my letter in  FDA  Docket

Margret Hamburg  May 22, 2009 – April 1, 15 - She was responsible for the decision to ban  DXP from one day to another.                                                                                                                        
There have been some discussions during the years about the responsibility the regulatory authority has for medicines and their approval.   very simple answer on that question - it is the FDA that has this extremely important mission and full responsibility.

There have been numbers of decisions made by the FDA during the years, that proved to be very unfortunate and which had consequences that we could never have dreamed of.

The six above-mentioned persons have for some years been the highest head of the federal authority FDA (= U.S Food and Drug Administration) which is a Food and Pharmaceutical authority and they are called commissioners.

Under these six persons' respective management, the various opioids were taken up, mainly for approval.

Tips to investigating reporters in the DC area

One person who should undergo a more thorough control is undoubtedly Margret Hamburg, who was head of the organization for over six years, including when DXP was stopped and banned by the FDA in the United States. I suggest an investigative journalist - in the DC area - to immerse himself in the FDA archive for a few days when I believe that there can be both important and very exciting things to find.

During the years there have been many tries – for example by Public Citizen – to draw attention, for example, to the painkiller (Dextro) Propoxyphene (DXP) and the consequences of the extremely large consumption associated with the substance. (You will find some data about the consumption figures in another article in this Master Class paper).

I also propose a second item for investigating; the first applies to the years 1955-1957 ie the time of application for permission to use propoxyphene. What emerged about Eli Lilly's application is under all criticism. As I mentioned in this report, the article that is referred to is merely a laboratory report under no circumstances can be regarded as a serious scientific article, which of course is exposed to referee assessments.

I did the same thing when we were investigating the acceptance for DXP in Sweden. We lived in the University town of Uppsala where Läkemedelsverket (The Medical Product Agency) (MPA) had their head quarter.

I learned a great deal about formalities when a drug is to be assessed for and new market, and here Sweden showed a very good work on the part of the authority, especially in comparison with the FDAs work on the same product.

LATEST NEWS;

Today – July 4th    (Happy United States Independence Day) I read the following article about former FDA commissioners “ Trust issues deepen as yet another FDA commissioners joins the pharmaceutical industry” http://bit.ly/2XmUUzB

Nine of the of the last ten FDA commissioners – from four decades – have gone to the Big Pharma after working for the FDA.

In my Master Class report – as you are reading now - I have written several articles about the FDA and how some of their commissioners have been acting both in terms of DXP and some of today's most sold - and some of the most smuggled preparations - which in recent years caused hundreds of fatalities.

Besides the above mentioned article, I can also recommend one article from Aspen Institute Health, Medicine and Society: Seven former FDA commissioners: FDA should be an independent Federal Agency http://bit.ly/30h3bad

The terms of the seven FDA Commissioners who reached consensus on the recommendations presented here:  

1) Robert Califf, MD (2016 -17), 
2) Margaret Hamburg, MD (2009 -15) , 
3) Andrew von Eschenbach, MD (2006-09), 
4) Mark McClellan, MD, PhD (2002-04), 
5) Jane Henney, MD (1999-2001), 
6) David A. Kessler, MD, JD (1990 - 97) ,
7) Frank Young, MD, PhD (1984-89).



I have the feeling that these seven people - all of whom had the well-paid and prestigious service of the Commissioner - then take a new, more well-paid job within Big Pharma does not feel decent. I have a hard time trusting such a person. but it can also be because I live and work in a completely different context, where the boundaries between work in the public sector and the private business sector, such as Big Pharma, are supposed to be hopefully is clearer.

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