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”. 
.
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






söndag 25 augusti 2019

Early in the 1970s there were warnings from FDA about the risk of DXP toxicity in US. Report of fatalities due to DXP led to an information campaign 1978-1980 - but Eli Lilly didn´t do what FDA had expected


In 2001 - after our dissertations 2000 and 2001 - we published the following book in English. Fatalities due to use or misuse of pain-killers, written by Birgitta Jonasson and Ulf Jonasson in collaboration with the National Board of Forensic Medicine in Sweden, RMV-report 2001:1. We have scanned the book in one of my blogs – http://bit.ly/34051yX at my blog http://jonassonulf.blogspot.com .

The year 1999 we wrote “Dödsfall genom bruk och missbruk av värktabletter” RMV Rapport 1999:1, the Swedish version

In chapter 3 - International experiences and measures taken we present different countries and how their story of (Dextro) (Propoxyphene) DXP has been. These countries are USA, UK, Denmark, Norway, Sweden and Australia
.
There are a several articles that are of greatest interest, for example:

·        DXP – field of application and toxicity
·        International experiences and measures taken
·        Dependence of DXP
·        Summary, discussion and conclusion

DXP in the United States

Early in the 1970s warnings about the risk of DXP toxicity and about the potentiating action of alcohol on the DXP effect were issued in the USA on the bases of clinical reports (37). It was concluded that physicians should be alerted to the potential deleterious effects of indiscriminate use and abuse of DXP - and should warn their patients not to drink alcohol when taking DXP. It was recommended that physicians should observe extreme caution when prescribing DXP to young people.

In extensive surveys it was found that the number of deaths involving DXP was increasing each year, and at a faster rate than the total drug deaths. Deaths attributed to suicide, as well as those judged to be accidental deaths and undetermined deaths had increased (35, 38-40). DXP, according to these studies, did not appear to be a paediatric problem. 

Nor did the deceased persons belong to the illegal drug abuse population or have any particular propensity for the use of heroin or narcotics. Rather they constituted a particular medical population of those who misuse prescription drugs and alcohol. Almost all of them received a wide range of prescription drugs, particularly tranquillisers, which they often misused by self-medication, multiple drug ingestion, and combining alcohol with their medication.

Information campaign in 1978-80 due to DXP

The reports of fatalities due to DXP led to an information campaign in 1978-80 undertaken by the US Food and Drug Administration (FDA) and the drug’s manufacturer through mailed warnings, face-to-face education of prescribers, press- releases, and labelling changes. The goal was to reduce simultaneous use of DXP and alcohol or other CNS depressants, to reduce the prescription of refills, and to get physicians to stop prescribing DXP for patients at risk of abuse and misuse.

Trends in prescribing and deaths related to DXP overdose before and after this campaign were analysed by Soumerai and collaborators (14). They found that a pre-existing downward trend of about 8% per year continued during the warnings, but halted after them. The no-refill recommendations had no effect on the refill rates. They also noted that the overdose death per DXP prescription had remained about constant since 1979, and considered that stronger, more sustained regulatory or educational measures had to be implemented to achieve any sharper reductions in the misuse of the drug. 

Further, they suggested that the wide extent of DXP use is mainly due to its overall popularity in relation to competitive products, probably largely on account of effective marketing activities. One example of these activities is described in their report:


As FDA had no ongoing physician education programme of its own, it requested that the manufacturer of DXP should revise the drug labelling and conduct both a mailed and a person-to-person educational campaign. Eli Lilly and Company sent a mailed warning message to 145,000 physicians, but when it came to the face-to-face education an investigation conducted by an FDA official showed that Eli Lilly did not fulfil this commitment. It was only in less than 10% of the "face-to-face educational occasions" that the detailers conveyed suitable information on the new warnings; while over 75% of the detailers left free samples of DXP products on those particular occasions. 

The FDA official quoted several verbatim messages from Lilly detailers recorded by physicians. “Darvon and Lilly won FDA battle”, “Safe in spite of Nader report”, “OK by the Drug Commission”, “Few if any side effects”.

onsdag 21 augusti 2019

Tweet 1. How the hell could the US authorities refuse to accept that Darvon& Darvocet (DXP) have a major responsibility for the worst opiate epidemic of all time?


When somebody talks or writes about the ongoing opioid-epidemic they usually say that the epidemic started mid or late 1990. I have heard this in many years now – but I cannot agree with all of those who says that the epidemic started in mid or late 1990s.


My truth looks different, and it is simply because my wife and I have been studying another opioid – namely (Dextro)(Propoxyphene (DXP) - trademarks in the US, mainly Darvon and Darvocet - more than 25 years and we wrote and defended two doctoral dissertations ( 2000 and 2001)

When people - representatives of all kinds of government agencies and not least journalists - repeatedly write/say that the epidemic began in the mid or late 1990s and you completely avoid showing a source for this claim - you could call this behavior FAKE NEWS.

Now I will not do this - I am not that kind of man - but I want to help authorities and journalists with that task. Many years in research and many years in investigating journalism (PhD in Public Health and BS in journalism) have taught me to be very careful about facts and I will therefore share my knowledge with those who want to know the truth.

My data comes from INCB - The International Narcotic Control Board in Vienna - a group operating under WHO. In my first table I show what year a number of preparations were notes by INCB in term of consumption of some substances that we are interested in.

In 1996 the following preparations - Codeine, Methadone and Fentanyl - were noted at INCB for consumption on the US medicine market and 1999 both Oxycodone and Hydrocodone were on sale in the US. But “everybody” in US has forgotten to talk about the painkiller Propoxyphene (DXP) that came out on the US market already 1957 and it seems that “everybody” - except me - remember that DXP was banned in US in Nov 2010.

DXP was on the market more than 40 years before the other opioids. Around 165 000 persons could have died. The consumption of DXP were around 1 985 000 kg.

It would be decent that those using the term "mid or late 90s" - also counting the substance DXP - that have been on the US market for more than 40 years before the other opiates entered the US market.

I simply cannot understand why it would be so difficult for Americans to remember that DXP came out on the market already 1957. I repeat the substance was banned in 2010 - from one day to another - a ruthless act by the FDA. It took many years before FDA banned DXP, and when they this they did it from one day to another. In UK, Sweden and EU the authorities gave the DXP users many months to change drug, they phased out the drug in a decent way.

They should be ashamed of this behavior, lots of people then turned to heroin - and many, many died from ODs.

Hundreds of thousands of DXP user were out of the DXP pills after Nov 19th 2010 and many started to use heroin, that was cheap and easy to get.  During the years 1957 – 2016 – 3 099 944 kg was consumed in the USA. When we analyze this figure and use The Jonasson Factor, we can estimate the number of fatal seizures to approximately 258 000 persons during these years, a figure completely unknown to the American public

Some of the consumption data  about DXP during the years I used  this link http://bit.ly/2GklK7P there is our main source: Narcotic Drugs - Technical Report  and at present there is data as far back as 2001 (the years 1996-2000) and on that page there is data from http://bit.ly/305Ock2

On the mentioned INCB pages you will find data on all drugs from 2001 to 2017. We have cooperated with INCB since 2003 and we got DXP data from them back to 1980, the first year DXP was noted.

We estimated DXP from 1957 – 1979, thanks to our new The Jonasson Factor, see other pages in my MasterClass report.

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.

FDA is a highly part of the opioid epidemic; They are involved in FDA decisions from 1957 - 2016 for both DXP, Oxycodone, Hydrocodone and Fentanyl.


FDA 1      

FDA Docket 2006-0090 http://bit.ly/2TRxBAQ, FDA commissioner Dr  von Eisenback was informed about our data already in Sept 2006 – four years before Darvon-DXP was banned in USA in Nov 19th 2010.

FDA 2     

The following persons have been FDA commissioners during some years when Propoxyphene, Fentanyl, Methadone, Oxycodone and Hydrocodone were accepted. http://bit.ly/2MqWyis

FDA 3  
      
Search for a new analgesic – Eli Lilly found one after four hundred and fifty (450 compounds.

FDA 4        

When FDA approves a drug, they usually don´t accept a laboratory report as they did with Eli Lilly, April 25th 1953. That´s how Propoxyphene was approved.

FDA 5.     

The FDA doesn´t care about outside researchers, they listen more to their own employees, who more often are MDs than PhDs. Just saying
.

FDA 6 + The Legal Section

Why were there no trials about DXP in US? No damages to thousands of victims? Vague forensic data - in the FDA article - does not work in the court. Forensic facts - as in Sweden - would have given completely different results in the court for the plaintiffs.


FDA 7 + The Legal Section, 

Hearing about DXP in the US Congress, Propoxyphene – Oversight, May 21st 1980. Prescriptions for Propoxyphene, Rank Among Top 200 most Prescribed Drugs.  All is about DXP and Eli Lilly