When Propoxyphene was banned some years ago- Amateurishly performed at FDA in US in 2010. At MHRA in UK 2006 - according to the rulebook - great work

On Friday 19^th November 2010 FDA in US banned the painkilling substance (Dextro)Propoxyphene. (DXP) This happened from one day to another – and this was a huge mistake.

In Sweden the first restrictions - when prescribing DXP - was June 15^th 2001 - and the process to ban took some more years. This whole process started May 11^th 2001 when I had a debate article published in the largest tabloid in Sweden Expressen. The headline in the article was (translated into English) “The Medical Product Agency (MPA) offers 200 lives every year. Ever year around 200 persons die due to the painkiller Distalgesic and Paraflex comp. The article covered whole page, four columns and got lots of attention.

UK followed the Swedish example and started their process. We were part of the process in the European Union (EU) and we were a part if that, our rese4rcah was presented in the parliament by the Swedish liberal member of the EU.

As soon as I read FDA news Release http://bit.ly/2G7kmmG of Nov 19th 2010 about the banning of the painkilling substance Propoxyphene – brandmarks Darvon and Darvocet – I was completely convince that the people who would sue Darvon and Darvocet manufactures namely Xanodyne and Eli Lilly - the company that “invented” DXP would not receive any damages whatsoever.

In the report you found, among other things:

-        The FDA sought market withdrawal of Propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.

You cannot express your thoughts in a s mild way as above – not in science. No one will ever be able to proof that deaths of someone loved ones would depend on a risk of potentially serious or even fatal heart rhythm abnormalities. You cannot prove that in any court – you need facts - I also find the following:

-         Propoxyphene causes significant changes to the electrical  activity of the heart.

We wrote the following in one of our scientific articles: “The prevalence of Dextropropoxyphene (DXP) in autopsy blood samples”. Foer Sci Int 1998:96:165 – 142.

-         DXP was found in blood samples 782 (7,5%) of the 23 691 blood samples during the year 1992-1996.

-         The mean blood DXP concentration was 1,62 µg/g. (The DXP level in the blood concentration to therapeutic doses from 0,05 µg/g - 0,75 µg/g). Of the 1 782 cases 60% were men and 40% were female.

-         A significant higher DXP level - 2,36 µg/g - was found in the group aged younger than 50 years compared with the cases older than 50 years of age (was 1,04 µg/g).

-         We also reported the presence of paracetamol, alcohol and sometimes also bensodiazepines .

It is from data like this we were able to present data that are scientific correct. In the FDA report there was no scientific data, just some vague data.

My view is that the FDA did everything they could to get someone to unclear and vague, to write so that no court would get accurate data at all and thus risk plaintiffs winning in hundreds of upcoming lawsuits.

I can well call them that they - the FDA - chose writers who were very much on the side of pharmaceutical companies.

Can we call it bribery? I have no problem with it. After being in the research on drugs for more than 25 years I know that there are a lot of unethical situations.

I suggest that you readers continue to read the rest of my text and see how the English Medicines Agency MHRA and independent researchers from Oxford.

The MHRA in UK (Medicines & Healthcare product Regulatory) gave Professor Keith Hawton (University of Oxford Centre for Suicide Research) the task of submitting assist that would be intended as a recommendation for how authorities would act in stopping Dextropropoxphene or not.

In the article - written by professor Hawtons group -  Co-proxamol and suicide: preventing the continuing toll of overdose deaths QJM: An International Journal of Medicine, Volume 98, Issue 3, March 2005, Pages 159–170,  https://doi.org/10.1093/qjmed/hci026

Some excerpt from the article.

-         Electronic searches of PsycINFO (1872–2003), MEDLINE (1966–2003), EMBASE (1980–2003) and CINAHL (1982–2003) were done, using search terms for co-proxamol, coproxamol, dextropropoxyphene and distalgesic combined with terms for overdose, self poisoning, suicide and attempted suicide. Four hundred and two papers (402) were identified. From these we selected 42 English language papers where the contents of the abstract were relevant to the aims of this review. Twenty additional relevant papers were identified from reference lists.

My comment: In the final article there were 73 articles, and we were writer of six if the (21-26) - a real acknowledgment that our articles are appreciated. In the FDA article, there were none that completely referenced us - which nevertheless presented most of the research in the field in recent years

In a forthcoming article, I will talk about the DXP issue in law

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PS. Because I am a party to the case, I let the readers decide for themselves the authority they feel best - most professionally - MHRA in UK or FDA in US