tisdag 10 september 2019

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 19th 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 15th 2001 - and the process to ban took some more years. This whole process started May 11th 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


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


onsdag 4 september 2019

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.

onsdag 28 augusti 2019

President Xi Jinping in China acts long term, Trump raises tariffs and taxes and loses EVERYTHING against Xi Jinping – Trump is a big looser – as always


Trump does not have a chance against Xi Jinping in the Fentanyl war.

China will never forget the two opium wars they lost in the 1800s – they won´t lose the current, third war. Today the fight is about Fentanyl, the fight applies to the opioid Fentanyl, which is fully absorbed into the US from China.


Today's reality:

It is mainly two opiates - Heroin and Fentanyl - that it the greatest threat, ie killing most. The shrinkage of legal opiates has decreased somewhat, but the illicit drugs - Heroin and Fentanyl - have increased tremendously. The Heroin comes mainly from Mexico and Fentanyl from China.

-        IMPT message to the White House. The opioid crisis should be called “The Heroin and Fentanyl crisis”. Fentanyl is up 1 300% and lots of people will die. http://bit.ly/2YFT2mo

President Trump has talked with the Chinese President Xi Jinping about the many so called illegal factories in China that make Fentanyl and Trump tells the people that XI Jinping has promised him to stop the smuggling of Fentanyl. Nobody believes that.

Historical background

Even today, Chinese school children learn about the “Century of Humiliation”. The end of this period was 1949 with reunification of China under Mao. While Americans are routinely assured they are exceptional and the greatest country on earth by their politicians, Chinese school teach student that their country was humiliated by greedy and technological superior Western imperialists.

The first Opium War occurred in 1839 and extended to 1942. This war was between China and Britain and it was the English who went out of it all.

The background to this war was briefly that the new royal governor of Guangdong, Lin Zexhu, had the destruction of 20 000 chests of opium at the end of the 1839 trading season and set strict rules for trade in Canton for the coming season. This decision completely opposed the English and the war was a fact.

The second opium war between the years 1856 -1860. During this war the English had with them Emperor Napoleon III on his side, who saw an opportunity to expand his influence in China.

Background. Starting in the mid-1700s, British vegan trading opium grown in India in exchange for silver from Chinese merchants. Opium – an addictive drug today is refined into heroin - was illegal in England, but was used in Chinese traditional medicine.





The history of these two opium wars is both very complicated and profound for Chinese society. Consequences of the two wars were that the ancient Qing Dynasty - with its more than 2,000 years of history - collapsed and made the Chinese realize that the country must modernize and industrialize.

These two opium wars the Chinese have never forgotten, and it would be important than in that day for the country's leadership to mark towards the west. Thus, the two wars were for Englishmen and Frenchmen, who were to represent the Western values. Today, the US has now that role.




tisdag 27 augusti 2019

Propoxyphene could have caused around 680 000 lives in the world, around 165 000 in US - but the authorities don´t admit that


The CDC (Centers of Disease Control and Prevention)  in the US recently informed that in the years 1999-2017, more than 702 000 people have died from overdoses. We have recently provided data showing that during the 40 years that preceded a number of opiates "laid the foundation for" the now-ongoing opioid epidemic. http://bit.ly/2HuAsrn


During these 40 years, approximately 1 985 000 kg of Propoxyphene (DXP) (INCB data) were consumed and according to our forensic calculations - according to The Jonasson Factor - approximately 165 000 people were poisoned to death.

DXP was on the US market from 1957 to 2010 - when the substance was stopped in the US. A smaller number of kg has been licensed to certain patients thereafter, which is why we expect the years 1957-2016 (60 years)

During the 60 years that DXP was on the US market, - according to INCB and our agile data - 3 099 944 kg was consumed, which is estimated to have required approximately 285 000 fatalities
Worldwide, 8 171 033 kg of DXP was consumed between the years 1957-2016 (60 years), which has required about 680 000 people.

PS. You may have heard that of the six opiates that were previously on the ground, there is one substance - I repeat: a single substance - which has been judged to have been so dangerous and required so many deaths in the world that this drug was stopped. Can you guess which ????


You can read at this link how we worked on this major problem and how we succeeded in our work http://bit.ly/2Lf6Orh

In what ways did we influence authorities in different countries when the painkilling substance Propoxyphene (DXP) was banned in US and other countries?

Sweden: In May 11th 2001 - I published an article in the largest Swedish newspaper Expressen with the headline: “The Medical Product Agency (MPA) offers 200 lives every year” It was one debate article that basically covered a whole page, four columns.  “Every year around 200 persons die due to the painkiller Distalgesic and Paraflex Comp”. 
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In UK: The MHRA in UK (Medicines & Healthcar products Regulatory Agency) in UK gave Professor Keith Hawton, University of Oxford Centre for Suicide Research and his group the task of submitting assist that would be intended as a recommendation for how authorities would act in stopping Dextropoxyphene or not.”

In the European Union. After my dissertation June 20th 2001 – I took a driving license six months later – and I found out that I kind of have some time over. Then I decided to join the local politics in our hometown Uppsala for the liberal party. I worked in a social council in the municipality. I was very lucky to get two mentors, Erik Ullenhag he was 2002 elected to   Member of the Parliament. Later he became a member of the government for four years. After he left the government when he became ambassador to Jordan http://bit.ly/2ITzIOk

Thanks to Erik Ullenhag we got to know a student friend to him – also a lawyer – Christian Juliusson and was the chief of staff to a member of the EU-parliament in Brüssel -  Marit Paulsen http://bit.ly/2k65lX0  Marit was a well-known Swedish politician. She raised our research about Dextropropoxyphene I the European Parliament “The dangers of DXP (Dextropropoxphene)  http://bit.ly/saZz4y . We visited Brüssel and the Parliament that day she presented the DXP question to the parliament. It was really exciting moment when she entered

In US – together with Public Citizen. Our contacts with Public Citizen - and primary Larry Sasich, Pharm Dr – went very well. I visited Larry twice, and once he followed me when I was going to meet David J Dorsey. Public Citizen had worked in many years to try to stop DXP in USA. Larry Sasich was a well-known researcher in the American Society. He was one of the founders to Public Citizen, the other one was Ralph Nader. http://bit.ly/2IuHmiZ and Sidney M Wolfe http://bit.ly/2IAhkus

Letter one from Public Citizen to FDA about banning Darvon, 2006 (We are co-signers of the letter
http://bit.ly/1j0nnTh February 28, 2006. Sidney M. Wolfe, M.D. Director - Dan Suzman, Research Assoate - Public Citizen’s Health Research Group - Ulf Jonasson, DrPH - Nordic School of Public Health,
Gothenburg, Sweden, Birgitta Jonasson, PhD, Department of Forensic Medicine, University of Uppsala,Sweden

Letter two from Public Citizen to FDA about banning Darvon, 2009 (We are co-signers of the letter
http://bit.ly/1pMLWpq August 6, 2009  - Sidney M. Wolfe, M.D.- Director, Health Research Group at
Public Citizen - Steven Karch M.D., Forensic Toxicologist, Author of Pathology of Drug Abuse – Donald
Kennedy, Ph.D President Emeritus, Stanford University, Former Commissioner, FDA former Editor-in
Chief, Science Magazine - Jerry Avorn, M.D., Professor, Harvard Medical School, Director of Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital Ulf Jonasson, Doctor of Public Health, Nordic School of Public Health, Gothenburg, Sweden, Brigitta Jonasson, Ph.D., Department of Forensic Medicine, University of Uppsala, Sweden, D.N. Bateman,M.D. Professor of Clinical Toxicology, Royal Infirmary of Edinburgh, Scotland  
 .
One day I got a very important mail:

On June 26th 2009 I got a mail from Gunnar Alvan, he used to be General Director for the MPA in Sweden during the years 1999-2008. He has also been Professor in clinical pharmacology and medical director at Huddinge Hospital. He wrote:

Dear Ulf,

I recently visited a pharmacological congress and meet with a reputed British clinical pharmacology. He was satisfied and fascinated by the fact that dextro disappeared as a result of purposeful opioid formation, but not really aware of your and your wife's central role in this and that you even had it as a thesis hypothesis.

I realized he would write something on the subject and I think it would be nice if he could get your dissertations or other relevant information. His name is Nick Bateman nick. Bateman@luht.scot.nhs.uk     

Postal address is Poisons Information Bureau, Royal Infirmary of Edinburgh, Edinburgh EH 16 4SA.

Regards Gunnar

The two authors - Bateman DN, Sandilands EA - wrote in Journal Clinical Toxicology Volume 47, 2009-Issue 8   


-         There was also an active campaign in Sweden where there was concern about underdetection of associated deaths (6). A decision not to renew a 5-year marketing license extension had been taken in Spring 2004 and in autumn 2005 dextropropoxyphene became unavailable following a campaign that focused on its toxicity in overdose (7). Sweden thus lead Europe on this issue."

We have shown that propoxyphene (DXP) existed for more than 40 years before the other opiates. 1,985,000 kg of DXP was consumed and approximately 165,000 died from overdoses. The drug authorities ignored our data, as did the media


I now want to tell you how, for several years, the authorities and journalists in the United States have said and written about the so-called opioid crisis - which they also call the worst ever in the country's history. I should not be long-winded in any way, I should be as simple and straightforward as it is only possible, I should be so straightforward if it just goes so that the youngest child understands what I say and mean.

Three painkillers - Codeine, Methadone and Fentanyl - were introduced on the US market in 1996.

Two years later - ie in 1999 - two more so-called opiates became available on the market, these preparations were Oxycodone and Hydrocodone.

After a few years, "all" US authorities and "all" journalists - who were somehow interested in these painkillers - announced that the country was now suffering the worst opioid epidemic the country had ever seen.

The first table showing the ravages of the epidemic began in 1999 and it grew over the years and was updated annually.

If you look at my first table you will see that in 1996 there are three drugs - Codeine, Methadone and Fentanyl. In 1999, two new painkillers were added - Oxycodone and Hydrocodone.

When you study my second table you see that a brand new preparation namely Propoxyphene (DXP) is emerging. You also see that DXP was available for more than 40 years BEFORE the other opiates began to be used. DXP came our on the US market 1957 and was banned 2010, mainly thanks to us.

I can tell you that for some more than 40 years, 1,985,000 kg of DXP was consumed and we estimate that about 165,000 people died from DXP overdoses.

I have been in contact and cooperated with INCB (The International Narcotics Board) in Vienne since 2003. These data relate to the consumption of all kinds of drugs and their data on DXP I have combined with the forensic data we have produced and presented in 6 - 7 scientific articles and two dissertations. You can see that our data is fairly well documented.

Finally, I want to ask you, who do you believe in, the authorities or us? When did the real epidemic- “The propoxyphene Epidemic” started??

I think you, dear leader, are smarter than the authorities