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

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 19^th 2010 FDA informed that Propoxyphene was banned. If you gave a prescription at the Pharmaceutical company on the 18^th you didn´t get any drugs on Saturday 20^th

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

The opioid crisis should now be called "The Heroin & Fentanyl Crisis". Fentanyl up 1300 % and Heroin up 650 % over the last ten years. Soon millions of deaths.

IMPT message to the White House:

It seems that the White House believes the reports saying that the prescription of opioids have decline - that is partly true but instead the overdoses raised by Heroine and Fentanyl have raise quite a lot. Heroin up 650 % and Fentanyl up 1300 %. During the year 2017 there were 47 600 fatalities due to opioids.

The overdoses caused by Heroin and Fentanyl increased immeasurably much – thus, mortality has also done so.

A couple of examples during the year 2007 were the number of ODs 18 516 and the Fentanyl accounted for 2 213 persons = 12 % and Heroin for 2 399, cases, which represented 13%. Totally Heroine and Fentanyl was 25 % of the total numbers of the 18 516 fatalities.

Some figures for the year 2017 are: Fentanyl is 59,8 % and Heroine is 32,5% av the total of 92,3 % That means that the prescription of legal drugs are only 7,7%. These figures are remarkable.

If you compare these two years you find that the use of Fentanyl has risen almost 1300 % - from 2 213 ODs to 28 466 – 2017. The use of Heroin has increased 650 % - from 2 399 ODs to 15 482 ODs. The total increase for both Fentanyl and Heroine is around 260 %.

These figures are completely unimaginable an there are no signs that the lethal poisonings will decrease.