lördag 29 mars 2014

Local, National TV in Sweden and Russian TV about our reserach on Darvon & Darvocet.


Our CV http://bit.ly/1mB4LxE

523 000 persons in the world could have been poisoned to death due to Propoxyphene during 1985- 2011

We present here three reports on television about our research on the analgesic ( Dextro ) - Propoxyphene ( Darvon and Darvocet )

The first element was shown in local television in Sweden - http://bit.ly/1m8Aoe4   - the second in both the local TV and national TV in Sweden http://bit.ly/1dRhO5d The third element was sent to a Russian documentary programs in the television channel Channel One before this "Public Russian Television ( ORT)" http://bit.ly/1mwY7Yh


The entire Russian documents breaker - whose name was "Death on Prescription " - is here http://bit.ly/1fxEIPq


This is what was said in the Russian Show:

( We'll get into the program after 30 seconds )

What do we really do in the program?

We got an email from All who works on the production company Indigo ;

Dear Ulf and Birgitta

Hope you are well ! So I have translated your party of the movie . Please see it below . I hope it is understandable )

Ulf : It entered the market in 1957. In the middle of sixties it was the most popular and widespread of medicine That time . But alreadycreated in the beginning of sixties They knew that it was a dangerous medicine .

Voice-over : This married couple are the scientists in medicine . They were first who gave the alarm When found out That thou sands of people die annually after taking inoffensive painkiller produced by the company Lilly.

Birgitta : We started our investigation , we found those people . It Became serious for us after we had read 1600 files and found out about all that tragic deaths . And then there was a struggle against the pharmacological companies and agencies .

Voice-over : The struggle Which took years and Which was Accompanied by works of thou sands victims considers Ulf Jonasson . But the company Eli Lilly didn `t want to stop selling the profitable medicine . Meanwhile During The 17 -year struggle of the scientists Became the collectors of the typical horrific stories with a terrible end .

Birgitta : For example, there was a guy who found Several pills in a cupboard at a party . He mixed them with beer . In the morning he wanted to eat cereals . So he sat down to watch a sports television program with a plate of cereals and died . His mother entered the room and found him dead .

Voice-over : Inspite of the prohibition of the medicine in Sweden the company Eli Lilly Continues to produce and sell the painkiller Which contains dextropropoxyphene .

Birgitta : This medicine is still used in the USA and in many other parts of the world . It is being sold in the quantity of 70 to 80,000 kilograms a year in the U.S. . It kills 5-6000 people a year .

Voice-over : The medicine is being with drawn from circulation in Europe but it is still used in Russia . Partially the reason is in our system of clinical trials . In Russia They don `t carry out a blood test on a person perished . So if a bad medicine was the cause of the death nobody will know . And the most important Is that in Russia the clinical trials are being Conducted by the same company .

Documentary program shown in Channel One in Russia usually have 15-20 million viewers.

torsdag 27 mars 2014

Some minutes about us and Propoxyphene in Russian TV





http://www.youtube.com/watch?v=0IImEfCUF18&feature=youtu.be

(We get into the program after 30 seconds)

What do we really do in the program?

We got an email from Alla who works on the production company Indigo;

Dear Ulf and Birgitta,

Hope you are well! So I have translated your part of the film. Please see it below. I hope it is understandable )

Ulf: It entered the market in 1957. In the middle of sixties it was the most popular and widespread medicine of that time. But already in the beginning of sixties they knew that it was a dangerous medicine.

Voice-over: This married couple are the scientists in medicine. They were first who gave the alarm when found out that thousands of people die annually after taking inoffensive pain killer produced by the company Lilly.

Birgitta: We started our investigation, we found those people. It became serious for us after we had read 1600 files and found out about all that tragic deaths. And then there was a struggle against the pharmacological companies and agencies.

Voice-over: The struggle which took years and which was accompanied by tens of thousands victims considers Ulf Jonasson. But the company Eli Lilly didn`t want to stop selling the profitable medicine. Meanwhile during the 17-year of struggle the scientists became the collectors of the typical horrific stories with a terrible end. 

Birgitta: For example, there was a guy who found several pills in a cupboard at a party. He mixed them with beer. In the morning he wanted to eat cereals. So he sat down to watch a sport tv program with a plate of cereals and died. His mother entered the room and found him dead.

Voice-over: Inspite of the prohibition of the medicine in Sweden the company Eli Lilly continues to produce and sell the pain killer which contains dextropropoxyphene.

Birgitta: This medicine is still used in the USA and in many other parts of the world. It is being sold in the quantity of 70-80 000 kilograms a year in US. It kills 5-6 000 people a year.

Voice-over: The medicine is being withdrawn from circulation in Europe but it is still used in Russia. Partially the reason is in our system of clinical trials. In Russia they don`t carry out a blood test on a perished person. So if a bad medicine was the cause of the death nobody will know. And the most important is that in Russia the clinical trials are being conducted by the same company. 

onsdag 26 mars 2014

Some minutes about us and Propoxyphene in Russian TV.......



http://www.youtube.com/watch?v=0IImEfCUF18&feature=youtu.be


(We get into the program after 30 seconds)

What do we really do in the program?

We got an email from Alla who works on the production company Indigo;

Dear Ulf and Birgitta,

Hope you are well! So I have translated your part of the film. Please see it below. I hope it is understandable )

Ulf: It entered the market in 1957. In the middle of sixties it was the most popular and widespread medicine of that time. But already in the beginning of sixties they knew that it was a dangerous medicine.

Voice-over: This married couple are the scientists in medicine. They were first who gave the alarm when found out that thousands of people die annually after taking inoffensive pain killer produced by the company Lilly.

Birgitta: We started our investigation, we found those people. It became serious for us after we had read 1600 files and found out about all that tragic deaths. And then there was a struggle against the pharmacological companies and agencies.

Voice-over: The struggle which took years and which was accompanied by tens of thousands victims considers Ulf Jonasson. But the company Eli Lilly didn`t want to stop selling the profitable medicine. Meanwhile during the 17-year of struggle the scientists became the collectors of the typical horrific stories with a terrible end.

Birgitta: For example, there was a guy who found several pills in a cupboard at a party. He mixed them with beer. In the morning he wanted to eat cereals. So he sat down to watch a sport tv program with a plate of cereals and died. His mother entered the room and found him dead.

Voice-over: Inspite of the prohibition of the medicine in Sweden the company Eli Lilly continues to produce and sell the pain killer which contains dextropropoxyphene.

Birgitta: This medicine is still used in the USA and in many other parts of the world. It is being sold in the quantity of 70-80 000 kilograms a year in US. It kills 5-6 000 people a year.

Voice-over: The medicine is being withdrawn from circulation in Europe but it is still used in Russia. Partially the reason is in our system of clinical trials. In Russia they don`t carry out a blood test on a perished person. So if a bad medicine was the cause of the death nobody will know. And the most important is that in Russia the clinical trials are being conducted by the same company which


onsdag 19 mars 2014

The consumption of the banned painkillers Darvon&Darvocet increased in the US with 145% from 2011-2012.

The consumption of the banned painkiller Darvon/Darvocet ( Propoxyphene ) increased 145 % from year 2011 to 2012, in spite that the substance was banned in the US Nov 19th 2010.

The consumption for 2011 was 5 227 kg and 2012 it was 12 841 kg according to INCB in Vienna. (The International Narcotics Control Board, an organization under WHO). The figures are to be found here:  http://bit.ly/1ggNqS4 - page 189 (“Consumption of the principal narcotic drugs and calculated consumption of buprenorphine et al – among these drugs are Dextropropoxyphene”).

During the year 1982 – 2010 (29 years) the consumption in the US was 2 153 387 kg, an average of 74 255 kg per year. We estimated the number of fatalities in US during these years to be 178 000, figures I first presented at my press-conference at the National Press Club in Washington DC in September 2013. http://bit.ly/1dECImR

Consumption of Propoxyphene in the US during 2008 – 2012.

2008                    68 694 kg
2009                    76 033
2010                    44 376
2011                      5 227
2012                    12 841

The substance (Dextro) Propoxyphene was banned in US nov 19th 2010. The consumption of the drug this year in US was 44 376 kg. During the year 2011 the consumption declined – due to the banning – to 5 227 kg. We can assume that there have been some prescriptions on license.

But it is really astonishing that the drug was consumed in such amount as in  2012. It is well known in US that there have been lots of protests against the banning of the substance Propoxyphene – the two most popular brand-names were Darvon & Darvon. There are some real reasons that the drug was banned – it has killed people in the US during more than 50 years, from 1957 to 2010.

Hundreds of lawyers are working on the cases

Since the banning 2010 hundreds of lawyers - http://1.usa.gov/1l3G1wO  - have been working to prepare hundreds of trials http://1.usa.gov/1nDIksi 

Most of the trails are supposed to be in East Kentucky under the federal Judge Danny C Reeves. http://1.usa.gov/1mIQZE1 - but Judge Johnnie B Rawlinson at the United States Court of Appeal for the ninth Circuit will also be involved in the coming trials.

We assume that the licensed prescriptions will cause some problems for the involved lawyers as well for the judge. I have got to know that FDA will react on the above mentioned fact. Tomorrow – March 10th – FDA will publish a notice in The Federal Register about the banning of Propoxyphene Products.

PS.
In our research from Sweden during the years 1992-2002 we found that "for the consumption of every 12 kg" - one person was poisoned to death in our country. If we use these figures we are able to estimate the numbers of fatalities in the US during 2012 is estimated to be around 1 000 persons when the consumption was 12 841 kg.


A prohibited drug should be a prohibited drug.

måndag 10 mars 2014

FDA opens (Docket No. FDA-2014-N-0198) Monday March 10th - “Withdrawal of Approval of 8 new Drug Applications and 46 Abbreviated New Drugs for Propoxyphene Products”

Today - March 10th - (FDA (Food and Drug Administration) - will publish a notice in Federal Register http://1.usa.gov/1n7WmSH

At this link http://1.usa.gov/1h4LRIp you will find the whole letter published by FDA.

I quote the following text from the letter written b y FDA;  

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 8 new drug  applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.

Propoxyphene is an opioid pain relief medication marketed under brand names such as Darvon and Darvocet. 

In 1957, FDA approved NDAs 010996 and 010997 for propoxyphene hydrochloride (HCl), alone and in combination with other active ingredients, both of which are currently held by Xanodyne Pharmaceuticals, Inc. (Xanodyne).

In 2010, after receiving new clinical data showing that when propoxyphene is taken at therapeutic doses, the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, and other information including new epidemiological data, FDA concluded that the risks of propoxyphene outweigh its benefits as a pain reliever. In separate telephone conversations on November 18, 2010, FDA asked Xanodyne and the holders of marketed generic propoxyphene drug products to permit FDA to withdraw approval of their applications and to waive their opportunity for a hearing. 

In a separate notice published elsewhere in this issue of the Federal Register, FDA notifies other holders of ANDAs for pain medications containing propoxyphene  if they wish to challenge the Agency’s proposal to withdraw approval of their applications.

Xanodyne and manufacturers of generic propoxyphene products identified in table 1 have written to FDA asking the Agency to withdraw approval of their applications for propoxyphene- containing products and have waived their opportunity for a hearing. Some products approved under the applications identified in table 1 were discontinued in the past, before FDA’s November 2010 determination that the risks of propoxyphene outweigh its benefits. Not included in table 1 are NDAs and ANDAs for which Federal Register notices were previously published announcing withdrawal of approval.”

Propoxyphene banned Nov 19th 2010

It is well-known that the substance Propoxyphene (Darvon & Darvocet)– was banned Nov 19th 2010. The day before - Nov 18thFDA was in telephone-contact with Xanodyne and the holders of marketing generic propoxyphene drug products to permit FDA to withdraw approval of their opportunity for hearing.

There have been some question-marks around the banning of the substance Propoxyphene.

There are many questions about how this ban has been handled. Although there are more than three years and three months after the ban came into force has not yet the federal judge Danny C Reeves decided how it will be with future trials.

At a meeting on Monday, January 7 of this year, Judge Reeves met a couple of the court appointed attorneys - who represented the more than 100 attorneys who are expected to participate in future trials. Two of these were Richard W Shulte from Dayton , Ohio, and Matthew J. Herring from Edmond, Oklahoma.

Still, Judge Reeves have not officially reported any decision from this meeting - even though it is now eight weeks since the meeting took place.

As I recently wrote in another post in my blog, I reported that the consumption of the prohibited drugs Darvon and Darvocet has increased by 145% from 2011 to 2012 from 5227 kg to 12.841 kg .
Surely you can understand that some relatively few people - for a short time - can have access to the drug in the license.

But when a drug is banned by its toxicity should such a ban be upheld.



Another issue that should be addressed is the note that the FDA will publish today, we have written about in this blog post. One guess is that the FDA believes that the parties involved - both the court that the lawyers representing both sides in the coming trials - have difficulty agreeing on the trials will be conducted. A question like this cannot be delayed as long as you completely because of legal wrangling.

söndag 9 mars 2014

The consumption of the banned painkillers Darvon&Darvocet increased in the US with 145% from 2011-2012.

The consumption of the banned painkiller Darvon/Darvocet ( Propoxyphene ) increased 145 % from year 2011 to 2012, in spite that the substance was banned in the US Nov 19th 2010.

The consumption for 2011 was 5 227 kg and 2012 it was 12 841 kg according to INCB in Vienna. (The International Narcotics Control Board, an organization under WHO). The figures are to be found here:  http://bit.ly/1ggNqS4 - page 189 (“Consumption of the principal narcotic drugs and calculated consumption of buprenorphine et al – among these drugs are Dextropropoxyphene”).

During the year 1982 – 2010 (29 years) the consumption in the US was 2 153 387 kg, an average of 74 255 kg per year. We estimated the number of fatalities in US during these years to be 178 000, figures I first presented at my press-conference at the National Press Club in Washington DC in September 2013. http://bit.ly/1dECImR

Consumption of Propoxyphene in the US during 2008 – 2012.

2008                    68 694 kg
2009                    76 033
2010                    44 376
2011                      5 227
2012                    12 841

The substance (Dextro) Propoxyphene was banned in US nov 19th 2010. The consumption of the drug this year in US was 44 376 kg. During the year 2011 the consumption declined – due to the banning – to 5 227 kg. We can assume that there have been some prescriptions on license.

But it is really astonishing that the drug was consumed in such amount as in  2012. It is well known in US that there have been lots of protests against the banning of the substance Propoxyphene – the two most popular brand-names were Darvon & Darvon. There are some real reasons that the drug was banned – it has killed people in the US during more than 50 years, from 1957 to 2010.

Hundreds of lawyers are working on the cases

Since the banning 2010 hundreds of lawyers - http://1.usa.gov/1qiHq3h - have been working to prepare hundreds of trials http://1.usa.gov/1fb1j7W

Most of the trails are supposed to be in East Kentucky under the federal Judge Danny C Reeves. http://1.usa.gov/1mIQZE1 - but Judge Johnnie B Rawlinson at the United States Court of Appeal for the ninth Circuit will also be involved in the coming trials.

We assume that the licensed prescriptions will cause some problems for the involved lawyers as well for the judge. I have got to know that FDA will react on the above mentioned fact. Tomorrow – March 10th – FDA will publish a notice in The Federal Register about the banning of Propoxyphene Products.

PS.
In our research from Sweden during the years 1992-2002 we found that "for the consumption of every 12 kg" - one person was poisoned to death in our country. If we use these figures we are able to estimate the numbers of fatalities in the US during 2012 is estimated to be around 1 000 persons when the consumption was 12 841 kg.


A prohibited drug should be a prohibited drug.

lördag 8 mars 2014

A Deadly Mix: Opioids and ‘Benzos

National Pain Report. 

March 7th, 2014 


Prescriptions for benzodiazepines have soared in the past decade, causing an alarming rise in overdose deaths when the tranquilizers are taken with opioid painkillers, according to a new study by Stanford researchers.
Benzodiazepine medication such as Xanax, Klonopin and Ativan  — also known as “benzos” – are used primarily to treat anxiety, mood disorders and insomnia. But they are being prescribed at greater rates than ever before and addicts are using them to enhance their highs.
Actor Philip Seymour Hoffman, who died last month from a drug overdose, had heroin, cocaine, benzodiazepines and amphetamines in his system, according to the New York medical examiner.
Researchers say the prescribing of benzodiazepines grew by 12.5% a year between 2002 and 2009. Patients being prescribed opioids were 4.2 more likely to also have simultaneous prescriptions of benzodiazepine. In fact, joint prescriptions of benzodiazepines and opioids increased by 12% a year.
Drug PoisoningThe combination turned up in nearly a third of the 16,651 overdose deaths in 2010 involving opioid painkillers, according to data from the U.S. Centers for Disease Control and Prevention.
“More research is needed to elucidate the reason behind the increase in benzodiazepine prescription, and a national effort is needed to highlight the danger of co-prescription of benzodiazepines and opioids,” said principal investigator Sean Mackey, MD, director of the Stanford Systems Neuroscience and Pain Lab.
Many pain patients are on an opioid/benzodiazepine regimen that can last for years.
“They are prominent fellow travelers with opioids,” Len Paulozzi, MD, a medical epidemiologist with the CDC told MedPage Today.“The problem is, people get on them and they stay on them forever.”
“As a complex, emotional experience, pain often is accompanied by significant alterations of mood, in particular anxiety,” said study co-author Ming-Chih Kao, MD, a clinical assistant professor at Stanford University Medical Center.
Kao says benzodiazepines are good medications to treat anxiety, but when taken with opioids there is a greater risk of depressing the central nervous system, which can lead to respiratory failure and death.
He called for better coordination between prescribers of opioids, who are often primary care physicians or pain specialists, with prescribers of benzodiazepines, who are often psychiatrists.
“The increased prescribing of benzos is directly related to the increased prescribing of opioids,” said Percy Menzies, president of Assisted Recovery Centers of America, in an email to National Pain Report.
Opioid addicts will often compartmentalize their symptoms, obtaining prescriptions for opioids from one doctor and prescriptions for benzos from other doctors. When patients test positive for benzos, they will admit that they need to benzos for their ‘panic’ attacks.”
Menzies says short-acting benzodiazepines, such as Xanax, Klonopin, and Ativan, have an abuse potential of their own.
“The relatively short ‘high’ is often used to mitigate the anxiety of withdrawal from opioids. Opioid addicts have attempted to combine the high from the opioids and the benzodiazepines, especially through IV use.”
The Stanford study was presented this week at the annual meeting of the American Academy of Pain Medicine.

måndag 3 mars 2014

Shame on You Eli Lilly (2) – Why is there no research in US about the fatal consequences caused by Darvon & Darvocet?


Not one single researcher in the world – except us – has made any reasonable estimates on how many fatalities the substance Propoxyphene (Darvon & Darvocet) – have caused during the years the drug was available in US from 1957 – 2010.

I think the main reason for that is that these potential researchers do not have any knowledge of how they should do. At least nobody else has presented good data about fatalities during the last 20 years - not before that either.

Hereby I share some interesting links with these people that are interested in our findings. We have data both from the US and from Europe

1.Data from The National Board of Forensic Medicine (Sweden) http://bit.ly/piOQAs

2.Data from INCB - (International Narcotic Control Board, in Vienna, Austria – consumption figures about DXP during the years 1982- 2010. http://bit.ly/SFIIop

3.Data from DrugTopics, we used data from Top 200 Generic Drug by Prescriptions from the years 2000 – 2000 in US - about Propoxyphene. http://bit.ly/19f5w8H

4.Data from Florida Department of Law Enforcement (FDLE) in Florida. We used data from Drug identified in Deceased Persons by Florida Medical Examines. (US) http://bit.ly/1dUEXDA

5.Data from Los Angeles County Department Coroner Annual Report 2009 – 2010 (US) http://bit.ly/1e9RtDW and http://bit.ly/1jMRzBe

Can anyone tell me why American researchers haven´t done anything to get and analyze these data?

If they did, they would have gotten an idea of the numbers of fatalities the substance Propoxyphene caused the American Society and the rest of the world during the years 1957 – 2010. (There are still fatalities in the US because some people got the drug on license – and the drug kills even then, you know. Some people could also have old pills still at home.

Why didn´t the American society do anything? Some people somewhere must have been aware of the terrible impact the drug led to – hundreds of thousands fatalities just in the US.

PS
In my next blog I will show you some data about how many fatalities Propoxyphene could have causes during the 53 years it was available in US.