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

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”.

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 19^th 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.

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.  A  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 4^th  –  (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 19^th 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 25^th 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 21^st 1980. Prescriptions for Propoxyphene, Rank Among Top 200 most Prescribed Drugs.  All is about DXP and Eli Lilly. 

We want to change focus on the present opioid epidemic: Propoxyphene ( DXP) was on the US market more than 40 years before Oxycodone, Hydrocodone and Fentanyl were available - which were at sales 1996 and 1999

After a number of years – uncertain how many – there is an opioid epidemic in the United States and in recent years, the total numbers of deaths caused by different opiate preparations, have risen sharply since many years and the number of fatal poisoning is almost unimaginable.

Drug overdoses killed 63,632 Americans in 2016. (On Aug 15^th 2018, New York Times informed that the number of fatalities during the year 2017 is around 72,000 persons. Nearly two-thirds of these ODs (66%) involved a prescriptions or illicit opioid according to CDC – Centers for Disease Control Prevention http://Bit.ly/2uWnWtF

It is very difficult to say when this opioid epidemic was begun, but it is considered by most reviewers that the substances Oxycodone, Hydrocodone and Fentanyl underlie the worst opiate epidemic ever in US history.

The total umbers of deadly poisons now exceed more than 70,000 persons - since 2017 - and although some attempts have been made to stop this opioid epidemic, some researchers estimate that in the next ten years as many as half a million persons can be poisoned to death.

Currently, it is primarily considered the cause of death for men under the age of 50 to be just opiate related deaths. And for the second consecutive year, the American average age for men has fallen because of this

.

We wrote two doctoral theses about DXP and we have studied the substance for more than 25 years

For the last 25 years, we have studied one opioid that has been banned in the United States since 2010, namely Dextro-(Propoxyphene) DXP, brands in US were Darvon and Darvocet. One of the most important results of our two doctoral theses – presented in 2000 and 2001 – was that in 1992-1999 about 200 persons per year were poisoned to death due to DXP preparation in Sweden.

DXP was synthesized in 1953 by the drug company Eli Lilly and was approved to the US market 1957. The drug was immediately high appreciated and for many years Eli Lilly´s greatest medical success.

We have since the year 2003 cooperated with INCB (The International Narcotic Control Board) in Vienna and thanks to them we were able to present consumption figures of DXP since 1980. There are no official figures for the years 1957 – 1979 on the consumption of DXP. During the years 1957 -1979 we have estimated these consumption figures as well

Thanks to these data and the consumption data of the drugs Oxycodone, Hydrocodone and Fentanyl, it shows that DXP was on the US market more than 40 years before the other three preparations were available.

Consumption data in next text; Consumption of six “Principal Narcotic Drugs” from 1956 - 2016 (Main source Nabil Katkhouda, INCB, 2012 - 2019).

From these facts, we conclude that DXP would be a more serious cause that the other three drugs for the opiate crisis today – and many years to come – pervades the America society.

“The Opioid Epidemic” became “ The Propoxyphene-Epidemic” that later became “The Heroin-Fentanyl Epidemic

Consumption of the six Principal Narcotic Drugs from 1956 - 2016 (Main source INCB, 2012 - 2019). These drugs are: Codeine, Oxycodone, Hydrocodone, Methadone, Fentanyl and Propoxyphene (DXP) http://bit.ly/2YnXYfv

We want to change focus on the present opioid epidemic: Propoxyphene (DXP) was on the US market more than 40 years before Oxycodone, Hydrocodone amd Fentannyl were available - which were at sales 1996 and 1999.   http://bit.ly/2Y48NI5

We have studied the painkilling substance Propoxyphene (Darvon and Darvocet) for more than 25 years, some of our results:  http://bit.ly/2ZbqCBH

FDA is a highly part of the opioid epidemic: Ther are involved in the FDA decisions from 1957 - 2016 for both DXP, Oxycodone, Hydrocodone and Fentanyl.  http://bit.ly/2YrCxhp

FDA 1. (FDA Docket 2006:0090) http://bit.ly/2TRxBAQ  FDA-commissioner Dr von Eisenbach was informed about our data already in Sept. 2006 - four years before Darvon-DXP was banned in the US - Nov.2010.  http://bit.ly/2JUhHzc

FDA 2. The following persons have been FDA commissioners during some years - when Propoxyphene, Fentanyl. Methadone, Oxycodone and Hydrocodone were approved.  http://bit.ly/2Mh3z4Q

FDA 3. Search for a new analgesic drug - Eli Lilly found on after four hundred and fifty  (450) compounds  http://bit.ly/2Ol0IKO

FDA 4. When FDA approved  a drug - the usually doesn´t accept a laboratory report - I do hope so - as the did with ELi Lilly, April 25th 1953. That´s how Propoxyphene was approved http://bit.ly/2MdFCv7

 FDA 5. The FDA does not care about outside researchers, they listen most tom their own employees, who more often are MDs than PhDs. Just saying  http://bit.ly/2LJ11wC 

The Legal section: Eli Lilly - Lawyers - Plaintiffs and as Federal Judge http://bit.ly/30WuXca 

How MHRA ( Medicines & Healtcare Regulatory Agency) in the UK acted befored deciding how to do wíth DXP, that is, obtaining a scientific basis for its decisions - FDA didn´t  http://bit.ly/30TpXFp

Hearing about DXP in the US congress - we have read the report from 1980  http://bit.ly/2YpcMyp

Dear Friends. I have sent you som tweets tha last days. Thea are quite new, I have published lots of data in my MasterClass report. Do you want to know more???   http://bit.ly/2xSr3Ex 

Why were there no trials about DXP in US? No damages to no victims. Vague data in DXP in the US did not work in the courtrooms. Forensic facts - as in Sweden - could have given completely different results in the court. http://bit.ly/2MiIA1e

Three waves caused the opioid epidemic - but our waves are different than  others. We think DXP was the main problem  http://bit.ly/2Gz4Dxg 

It is real people that are poisoned to death - they´re not just numbers - they have mothers and dads, brothers and friends.  http://bit.ly/2MgzUIU

The Jonasson Factor, I have found out a method to estimate the numbers fo fatalities die to DXP - if you have figures on the consumption of DXP - which i have and have had in many years  http://bit.ly/32QGsnm 

Florida Department of Law Enforcement - Drugs identified in Deceased persons by Florida Medical Examiner, year 2001- 2012 http://bit.ly/2YjAJXZ 

Los Angeles County Departmant of Coroner Annual Report. Prescription Drug Categories (Drugs by Classification) years 2003 - 2010   http://bit.ly/32LPFgG

I got in contact with the director for CDC in US, Dr Tom Frieden, about Propoxyphene  http://bit.ly/32PZ8nb