Source - PharmaTimes
My thoughts in blue text
Change pharmacovigilance reporting rules, govt is told
28 October 2008
The law needs to be changed to make it clearer to drugmakers when they should report new information which might influence the evaluation of a medicine’s risks and benefits to the Medicines and Healthcare products Regulatory Agency, the government has been told.
All this time and it needs to be changed NOW? Isn't this a bit like saying, If your house has asbestos then it could pose a danger to your health? Why the delay?
In particular, there is a need for more guidance on what to report within what timeframe, and for further clarity over use of the terms “promptly” and “due diligence,” respondents (mainly manufacturers) have told the public consultation held by the MHRA on the issue.
Here we go again with semantics. Addiction or discontinuation syndrome? Stop beating around the bush and tell it like it is! It is simple, stop confusing the issue because you are confusing the patient! [Maybe that it the goal here?]
The consultation was launched to discover if the current law – The Medicines For Human Use (Marketing Authorisations, etc) Regulations 1994 – needed to be changed, following the MHRA’s report earlier this year of its investigation into whether GlaxoSmithKline had failed to inform it in a timely manner about information which it had on the safety of its antidepressant Seroxat (paroxetine) when used in patients aged under 18.
Consultation? What or whom was there to consult? There is no debate about this, stop wasting time and money and pull your finger out of your ass and stop this negligence, because that's exactly what it is!
Based on the findings of the investigation and legal advice, government prosecutors decided that that there was no realistic prospect of a conviction and that the case should not proceed to criminal prosecution.
This still sticks in my throat. If this crime [because that's what it was] was committed against the government then they would have pulled out all the stops to get convictions. They would have, at the very least, made arrests and interviewed the 'suspects' under caution. The public were let down with this investigation. I know the MHRA's hands were tied but their excuse for making no arrests and not interviewing suspects just does not wash with me. The only reason I can see why no arrests were made was because mud sticks and I see this as the MHRA protecting the criminal rather than the public!
However, the legislation in force at that time was not sufficiently clear or comprehensive as to require companies to inform the regulator of safety information when the drug was being used for, or tested outside, its licensed indications, says the government, in its response to the consultation.
Tell us something we don't know! We [the public] were told this after the MHRA investigation. I'll ask again, why did you waste time and money with this consultation?
There have been several European Union developments since the Seroxat case, including the new clinical trials Directive and legislative changes to clarify the obligation to report, "promptly," relevant safety information arising from clinical trials using products outside their normal conditions of use.
Remind me again, what does "promptly" mean? Just so we are all clear.
The European Commission is also proposing to strengthen the EU system for monitoring the safety of medicines but, given the length of time that this may take, the MHRA has committed to changing UK legislation in the interim to clarify the requirements.
And approx how long will that take? Has it started already? Are new drugs being evaluated with the proposed criteria yet? Have Pharma been told that they must report new information "promptly" yet?
Therefore, the proposed changes to the 1994 Regulations will state explicitly, to ensure there remains “no room for doubt in industry’s and regulators’ minds,” that Marketing Authorisation (MA) holders should report information from both clinical trials outside the licensed indication and arising from third countries and to provide a timescale for reporting, says the government.
Which begs the question why this matter was overlooked in 1994? Who was responsible for this error of judgement, have they been reprimanded?
Points from the consultation
The MHRA’s review of the consultation says that a number of respondents - including the Faculty of Pharmaceutical Medicine (FPM), Wyeth, the British Association of Research Quality Assurance (BARQA), the Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIO) and the mental health charity Mind – expressed concern over the use of the word “promptly.” As a result, it says, the proposed new legislation will use the term “as soon as reasonably practical” instead.
What a joke! So years down the line a pharmaceutical company can once again slip through the loop by claiming "Sorry, but it wasn't reasonably practical to release the information". Good to see that Pharma were at this 'consultation'. Here is something for you all, how about the proposed new legislation states: "...the very second you learn of new information you MUST report it". It ain't rocket science and hey, you may just save a life or two!
The ABPI also felt there should be guidance on what type of information is caught, in which time frames this needs to be reported and when the clock for such reporting starts, while the BARQA said the MHRA’s preparation of the new regulations should provide a clear audit trail of the underlying legislation, so that MA holders “could understand at a glance exactly what is required of them, especially when severely punitive sanctions apply to non-compliance.”
Here's a scenario for you: I'm a scientist and for the past ten years I have been studying washing powder. I have unequivocal evidence that it causes skin cancer, every single brand. Do I sit on this information or do I refer to the 'new legislation' to see whether or not I should report it at a certain time? C'mon, you are playing right into the hands of Pharma here. How would you feel toward me if your child got skin cancer from washing powder and you learned that I knew about this but said nothing because I didn't have to? It's pathetic. You are merely allowing Pharma an extension to manipulate figures so their product does not lose them money... and lets face it, without Pharma's money, the MHRA would not be able to function.
Among other comments: - the BIA called for guidance on the MA holder’s obligations for reporting safety information arising from non-company-sponsored trials; - Flynn Pharma Ltd pointed out that if the same products are marketed by different countries inside and outside the European Economic Area (EEA), UK-based MA holders might not be informed of problems occurring outside the EEA; and - Merck Sharp & Dohme noted that MA holders might not be made aware of the results of clinical trials sponsored by academic investigators which could affect the their product’s risk-benefit balance prior to such trials being made public and that, until they obtained such knowledge, they would be unable to report such results to the regulator. The BIA raised similar concerns, particularly in areas such as oncology, where trials are often designed and conducted by clinicians and academics acting independently from the MA holder.
How about someone from the MHRA contact every single Pharmaceutical company every month and ask: "Anything to report?" - If they say "No" and it is later found out that they did indeed have new information then the MHRA can say that it was lied to. You are really making a mountain out of a mole hill here. It's so simple. Remember how you used to tell your children, "Don't talk to strangers"? How pissed would you be if you learned one of your children had spoken with a stranger and kept it from you? You would warn them of the importance to tell you wouldn't you? Same thing applies here because if you don't get it right this time then you will allow Pharma to make you look even more incompetent than they did over the GSK investigation fiasco.
I'm a patient, I give you the above advice free of charge... and I didn't need a room full of Pharma execs!
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Zantac Lawsuit
Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Friday, October 31, 2008
Thursday, October 30, 2008
HAPPY HALLOWEEN
THE DARK
Don't be afraid as I enter your room
Just let your mind drift like a floating balloon.
I've come to take the remains of the day,
Go deeper little one and let your mind stray.
Dream of the swings over the park,
Hurry now small child for it will soon be dark.
If you wake up you'll have nothing to fear
Just sit up in bed and let your mind clear.
For I am your friend, I mean you no harm,
So don't be afraid, stay cool, stay calm.
Let your eyes wander through my blanket of black
And don't wish me away for I'll always come back.
It's light that is evil as it enters your world,
Ordering you to see things that make your toes curl.
So don't be afraid as your day turns to night
Just remember I'm here to cast out bad light.
© BOB FIDDAMAN
Just let your mind drift like a floating balloon.
I've come to take the remains of the day,
Go deeper little one and let your mind stray.
Dream of the swings over the park,
Hurry now small child for it will soon be dark.
If you wake up you'll have nothing to fear
Just sit up in bed and let your mind clear.
For I am your friend, I mean you no harm,
So don't be afraid, stay cool, stay calm.
Let your eyes wander through my blanket of black
And don't wish me away for I'll always come back.
It's light that is evil as it enters your world,
Ordering you to see things that make your toes curl.
So don't be afraid as your day turns to night
Just remember I'm here to cast out bad light.
© BOB FIDDAMAN
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Wednesday, October 29, 2008
MHRA - A Good Sign
It seems the wheels are in motion regarding the MHRA meeting with SSRi expert David Healy to discuss the withdrawal issues regarding SSRi's. I firmly believe this is a step in the right direction, otherwise I would not have suggested it to Kent Woods when I met with him a few months back.
Strides are also being made to change the advice given for SSRi's in the BNF
I'll post more about this matter as it unfolds.
Strides are also being made to change the advice given for SSRi's in the BNF
I'll post more about this matter as it unfolds.
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Depression blamed on the credit crunch
This from 'this is swansea' brought to you by The Evening Post
I hate to say it, but I told you so back in September with my post Tough Times Ahead. I fear this is the tip of the iceberg as more and more people turn up at their doctors surgery wanting something to take away the pain of losing their job, house, dignity.
----
A LEADING Swansea GP has blamed the credit crunch for the soaring rate of anti- depressants prescriptions across the region.
Ian Millington (pictured), secretary of Morgannwg Local Medical Committee, said he was unsurprised at the prescribing levels because depression went hand-in-hand with poverty and unemployment.
More prescriptions have been handed out for medication including Prozac and Seroxat, during the last year compared to the previous 12 months.
Figures for Swansea Local Health Board alone show a total of 215,248 anti-depressants were dispensed during 2007/08 to around 16,557 patients.
Meanwhile, between 2006/07, around 15,084 patients were prescribed a total of 196,092anti-depressants.
Millington said he believed it was a sign of the times.
But a spokeswoman for Swansea Local Health Board pointed out that the figures were based on monthly, rather than weekly, prescriptions, implying the anti-depressants rates being prescribed could be less.
Dr Millington said: "It is probably a reflection of the stress of life, as we are in a high unemployment area.
"There is not much doubt that depression goes with unemployment and poverty, and the increase is not surprising if that is the case.
"There is evidence in recession that depression goes up.
"It's the reality of what is going on. People end up staying in unhappy jobs because they do not want to move."
Dr Millington said he believed the increase in prescriptions also underlined that the diagnosis of depression had improved.
"Modern anti-depressants work for depression — they do not work for unhappiness or general stress," he added.
"We are making the diagnosis of depression more now, and, most importantly, there is very little option to do anything else as there is not enough cognitive behaviour therapies — the services are there but they are overstretched."
The secretary of Morgannwg Local Medical Committee said it would not be fair to compare the picture in Wales with the rest of the UK, because there was a 14.1 per cent higher prevalence of disease than elsewhere.
In Neath Port Talbot during 2007/08 a total of 139,033 items were dispensed at a cost of £924,692, compared to 126,423 anti-depressants during 2006/07 at a cost of £988,338.
Meanwhile, in Carmarthenshire, a total of 155,053 anti- depressants were prescribed during 2007/08, costing £1,262,651 compared to 147,469 items, totalling £1,426,414, between 2006 and 2007.
Amy Kent, Carmarthenshire Local Health Board's head of prescribing and medicines management, added: "Although the prescribing of antidepressants has increased by a small percentage, costs have actually decreased as prescribers are using more cost effective drugs first choice, in line with National Institute for Clinical Excellence guidance."
I hate to say it, but I told you so back in September with my post Tough Times Ahead. I fear this is the tip of the iceberg as more and more people turn up at their doctors surgery wanting something to take away the pain of losing their job, house, dignity.
----
A LEADING Swansea GP has blamed the credit crunch for the soaring rate of anti- depressants prescriptions across the region.
Ian Millington (pictured), secretary of Morgannwg Local Medical Committee, said he was unsurprised at the prescribing levels because depression went hand-in-hand with poverty and unemployment.
More prescriptions have been handed out for medication including Prozac and Seroxat, during the last year compared to the previous 12 months.
Figures for Swansea Local Health Board alone show a total of 215,248 anti-depressants were dispensed during 2007/08 to around 16,557 patients.
Meanwhile, between 2006/07, around 15,084 patients were prescribed a total of 196,092anti-depressants.
Millington said he believed it was a sign of the times.
But a spokeswoman for Swansea Local Health Board pointed out that the figures were based on monthly, rather than weekly, prescriptions, implying the anti-depressants rates being prescribed could be less.
Dr Millington said: "It is probably a reflection of the stress of life, as we are in a high unemployment area.
"There is not much doubt that depression goes with unemployment and poverty, and the increase is not surprising if that is the case.
"There is evidence in recession that depression goes up.
"It's the reality of what is going on. People end up staying in unhappy jobs because they do not want to move."
Dr Millington said he believed the increase in prescriptions also underlined that the diagnosis of depression had improved.
"Modern anti-depressants work for depression — they do not work for unhappiness or general stress," he added.
"We are making the diagnosis of depression more now, and, most importantly, there is very little option to do anything else as there is not enough cognitive behaviour therapies — the services are there but they are overstretched."
The secretary of Morgannwg Local Medical Committee said it would not be fair to compare the picture in Wales with the rest of the UK, because there was a 14.1 per cent higher prevalence of disease than elsewhere.
In Neath Port Talbot during 2007/08 a total of 139,033 items were dispensed at a cost of £924,692, compared to 126,423 anti-depressants during 2006/07 at a cost of £988,338.
Meanwhile, in Carmarthenshire, a total of 155,053 anti- depressants were prescribed during 2007/08, costing £1,262,651 compared to 147,469 items, totalling £1,426,414, between 2006 and 2007.
Amy Kent, Carmarthenshire Local Health Board's head of prescribing and medicines management, added: "Although the prescribing of antidepressants has increased by a small percentage, costs have actually decreased as prescribers are using more cost effective drugs first choice, in line with National Institute for Clinical Excellence guidance."
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Tuesday, October 28, 2008
SEROXAT FOR SALE DESPITE SERIOUS ADVERSE REACTION REPORTS
Earlier this week it was reported that Acomplia [Rimonabant] had been withdrawn amid concerns over a link to depression.
Acomplia, was hailed as a wonder drug for dieters when approved for sale in the UK in 2006 but the European Medicines Agency said last week that the benefits of Acomplia no longer outweigh its risks and the drug should be suspended throughout the continent.
Fair enough, reading the Adverse Drug Reactions [ADR's] on the MHRA website shows there have been a total number of 818 ADR reports and a total of 7 fatal ADR reports.
In 2003 Brstol Myers Squibb pulled its antidepressant medication Dutonin [Nefazodone] in Europe because of its link to 25 reports of liver failure and 18 deaths.
A look on the MHRA website shows Dutonin with a total of 1,097 ADR reports and a total of 11 fatal ADR reports.
Seroxat [Paroxetine] is still used for depression. Lets look at the figures and compare them to the above two drugs that are no longer available.
The MHRA website shows that there have been a total of 10,339 ADR reports for Seroxat and a total of 166 fatal ADR reports.
So who does the math here? Is it the EMEA or maybe the MHRA, could it even be GlaxoSmithKline?
Here we have a classic example of the benefit clearly NOT outweighing the risk and yet Seroxat slips through the system.
One has to bear in mind that the total number of reports [Yellow Cards] sent to the MHRA are not a true figure of the problems patients have when on these drugs, some circles suggest that the MHRA receive maybe 10% of actual ADR reports. If the 10% figure is true then Seroxat is more problematic than the MHRA would have you or I believe.
Based on the 10%, Seroxat would have had over 100,000 ADR reports. If that is benefit outweighing risk then I'm at a complete loss of what else to do. Even if the MHRA figures were true, why have two drugs, Acomplia and Dutonin, been pulled when they have less ADR reports [far less] than Seroxat?
In fact both Acomplia and Dutonin have less ADR reports than Efexor [Venlafaxine] another antidepressant with 5,064 ADR reports and a total of 145 fatal ADR reports!
145 fatal ADR reports for Efexor, 166 for Seroxat!
Something is drastically wrong here. It's akin to pulling Walkers Crisps from the market when in fact it is Golden Wonder Crisps that has the problem!
Vioxx [Rofecoxib] was even pulled with a total of 4,162 ADR reports and 112 fatal ADR reports.
This is not rocket science, it's basic mathematics but the people in charge of the sums are telling us that there is no SSRi problem and that the benefits far outweigh the risks.
They will be telling us next that 5+5 = 9
Fid
Acomplia, was hailed as a wonder drug for dieters when approved for sale in the UK in 2006 but the European Medicines Agency said last week that the benefits of Acomplia no longer outweigh its risks and the drug should be suspended throughout the continent.
Fair enough, reading the Adverse Drug Reactions [ADR's] on the MHRA website shows there have been a total number of 818 ADR reports and a total of 7 fatal ADR reports.
In 2003 Brstol Myers Squibb pulled its antidepressant medication Dutonin [Nefazodone] in Europe because of its link to 25 reports of liver failure and 18 deaths.
A look on the MHRA website shows Dutonin with a total of 1,097 ADR reports and a total of 11 fatal ADR reports.
Seroxat [Paroxetine] is still used for depression. Lets look at the figures and compare them to the above two drugs that are no longer available.
The MHRA website shows that there have been a total of 10,339 ADR reports for Seroxat and a total of 166 fatal ADR reports.
So who does the math here? Is it the EMEA or maybe the MHRA, could it even be GlaxoSmithKline?
Here we have a classic example of the benefit clearly NOT outweighing the risk and yet Seroxat slips through the system.
One has to bear in mind that the total number of reports [Yellow Cards] sent to the MHRA are not a true figure of the problems patients have when on these drugs, some circles suggest that the MHRA receive maybe 10% of actual ADR reports. If the 10% figure is true then Seroxat is more problematic than the MHRA would have you or I believe.
Based on the 10%, Seroxat would have had over 100,000 ADR reports. If that is benefit outweighing risk then I'm at a complete loss of what else to do. Even if the MHRA figures were true, why have two drugs, Acomplia and Dutonin, been pulled when they have less ADR reports [far less] than Seroxat?
In fact both Acomplia and Dutonin have less ADR reports than Efexor [Venlafaxine] another antidepressant with 5,064 ADR reports and a total of 145 fatal ADR reports!
145 fatal ADR reports for Efexor, 166 for Seroxat!
Something is drastically wrong here. It's akin to pulling Walkers Crisps from the market when in fact it is Golden Wonder Crisps that has the problem!
Vioxx [Rofecoxib] was even pulled with a total of 4,162 ADR reports and 112 fatal ADR reports.
This is not rocket science, it's basic mathematics but the people in charge of the sums are telling us that there is no SSRi problem and that the benefits far outweigh the risks.
They will be telling us next that 5+5 = 9
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Monday, October 27, 2008
MHRA to be in breach of EU law
From the HTA Blog
The European Court of Justice last week judged the UK's MHRA to be in breach of EU law when it rejected Synthon's marketing application for its generic Varox (paroxetine), submitted through the mutual recognition procedure (MRP). This judgement, hailed as a victory for the generics industry, sets the limits for the way member states handle MRP applications and could even lead to new guidance.
The case started in 2000 when Synthon applied for a marketing authorisation for Varox from the Danish Medicines Authority (DKMA) using the abridged procedure. Under this procedure applicants do not have to present results of certain preclinical and clinical trials if they can demonstrate that the medicine is "essentially similar" to the reference product. The Dutch company cited GlaxoSmithKline's Seroxat (paroxetine hydrochloride) as its reference product as both drugs contain the same active moiety - paroxetine. The DKMA found that Varox (paroxetine mesilate) met the condition of essential similarity, and subsequently authorised the product.
Synthon then applied to the MHRA for mutual recognition of the DKMA's marketing authorisation under directive 75/319, article 9. This says that member states should recognise the marketing authorisation granted by the reference member state within 90 days of receiving the application and assessment report, unless there are concerns over risks to public health. However, in January 2001 the MHRA rejected the application on the grounds that Varox and Seroxat contained different salts from the same moiety and were therefore not "essentially similar".
In 2002 the Dutch company applied again for mutual recognition, this time under Article 28 of Directive 2001/83 (which reproduces Article 9 of Directive 75/319). After the MHRA rejected the application on the same grounds, Synthon took its case to the High Court, seeking damages and an annulment of the MHRA's second decision.
Meanwhile, in 2003 the MHRA decided to accept applications claiming an essential similarity between products containing different salts from the same moiety. Varox finally won MHRA approval in 2006 following Synthon's third application in 2005.
However, the company chose to pursue both a declaratory judgement and damages given the implications of the case. The UK court referred key questions to the European Court of Justice. It asked if Directive 2001/83, Article 28 precludes a member state from refusing mutual recognition of marketing authorisations issued by another member state under the abridged application procedure because of concerns over essential similarity. It also asked if failure of a member state to recognise authorisation granted by another state on such grounds constituted a serious breach of community law, therefore making the state liable for damages. To both these questions the court answered yes.
The judgment limits the options open to member states which have received an application under the MR procedure: the authority must either recognise the marketing authorisation granted by the first member state, or initiate arbitration procedures. There is "no scope to adopt a third course of action such as refusing to validate the incoming application for mutual recognition on the basis that the similarity criteria are not fulfilled", said SJ Berwin, the law firm representing Synthon.
"The judgement will affect the way all member state authorities handle the validation aspects of applications received in the MR procedure," the MHRA told Scrip. New guidance on this will be needed from the co-ordination group for mutual recognition and decentralised procedures, the authority added.
The generics industry also stands to benefit from the judgement. "It clarifies the application of the regulatory framework for mutual recognition of generic medicinal products," said Stephen Kon, a partner at SJ Berwin.
The UK High Court is to determine the MHRA's liability for damages when the case returns.
Source & copyright: SCRIP - World Pharmaceutical News - www.scrippharma.com
The European Court of Justice last week judged the UK's MHRA to be in breach of EU law when it rejected Synthon's marketing application for its generic Varox (paroxetine), submitted through the mutual recognition procedure (MRP). This judgement, hailed as a victory for the generics industry, sets the limits for the way member states handle MRP applications and could even lead to new guidance.
The case started in 2000 when Synthon applied for a marketing authorisation for Varox from the Danish Medicines Authority (DKMA) using the abridged procedure. Under this procedure applicants do not have to present results of certain preclinical and clinical trials if they can demonstrate that the medicine is "essentially similar" to the reference product. The Dutch company cited GlaxoSmithKline's Seroxat (paroxetine hydrochloride) as its reference product as both drugs contain the same active moiety - paroxetine. The DKMA found that Varox (paroxetine mesilate) met the condition of essential similarity, and subsequently authorised the product.
Synthon then applied to the MHRA for mutual recognition of the DKMA's marketing authorisation under directive 75/319, article 9. This says that member states should recognise the marketing authorisation granted by the reference member state within 90 days of receiving the application and assessment report, unless there are concerns over risks to public health. However, in January 2001 the MHRA rejected the application on the grounds that Varox and Seroxat contained different salts from the same moiety and were therefore not "essentially similar".
In 2002 the Dutch company applied again for mutual recognition, this time under Article 28 of Directive 2001/83 (which reproduces Article 9 of Directive 75/319). After the MHRA rejected the application on the same grounds, Synthon took its case to the High Court, seeking damages and an annulment of the MHRA's second decision.
Meanwhile, in 2003 the MHRA decided to accept applications claiming an essential similarity between products containing different salts from the same moiety. Varox finally won MHRA approval in 2006 following Synthon's third application in 2005.
However, the company chose to pursue both a declaratory judgement and damages given the implications of the case. The UK court referred key questions to the European Court of Justice. It asked if Directive 2001/83, Article 28 precludes a member state from refusing mutual recognition of marketing authorisations issued by another member state under the abridged application procedure because of concerns over essential similarity. It also asked if failure of a member state to recognise authorisation granted by another state on such grounds constituted a serious breach of community law, therefore making the state liable for damages. To both these questions the court answered yes.
The judgment limits the options open to member states which have received an application under the MR procedure: the authority must either recognise the marketing authorisation granted by the first member state, or initiate arbitration procedures. There is "no scope to adopt a third course of action such as refusing to validate the incoming application for mutual recognition on the basis that the similarity criteria are not fulfilled", said SJ Berwin, the law firm representing Synthon.
"The judgement will affect the way all member state authorities handle the validation aspects of applications received in the MR procedure," the MHRA told Scrip. New guidance on this will be needed from the co-ordination group for mutual recognition and decentralised procedures, the authority added.
The generics industry also stands to benefit from the judgement. "It clarifies the application of the regulatory framework for mutual recognition of generic medicinal products," said Stephen Kon, a partner at SJ Berwin.
The UK High Court is to determine the MHRA's liability for damages when the case returns.
Source & copyright: SCRIP - World Pharmaceutical News - www.scrippharma.com
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Sunday, October 26, 2008
Obesity drug withdrawn over depression link
Source: The Guardian
Sales and prescriptions of a weight-loss drug were suspended yesterday after European health authorities said the benefits no longer outweighed the risks.
The European Medicines Agency said obese people taking Acomplia were roughly twice as likely to develop psychiatric disorders, such as depression, anxiety and aggression, than those taking a placebo. US authorities have refused to allow Acomplia to be marketed in America.
The Medicines and Healthcare products Regulatory Agency (MHRA), which oversees drugs in the UK, said that as a result of the ruling, healthcare professionals would be told not to give any new prescriptions for Acomplia. Patients taking the drug have been told to consult their doctor.
FULL STORY
Yet Seroxat and other SSRi's remain on the market despite the thousands of adverse reactions reported to the MHRA.
This file from the MHRA website recieved no publicity, they released it on the 13th October 2008 - SSRI anti-depressants - withdrawal and side effects (08/319)
There have been 1,425 'reported' reactions of Seroxat, only 156 of these have been reported by patients under the age of 24 which leaves 1,370 reports from patients over the age of 24. Yet the MHRA have banned the use of Seroxat in patients where there are less adverse reactions. How absurd is this?
Remember these are just the 'reported' reactions to Seroxat, there are literally thousands of others that haven't been reported to the MHRA. One only has to visit Paxil Progress to see how many people are suffering at the hands of Seroxat.
I've been accused by members of a mental health forum for concentrating too much on Seroxat, the latest release by the MHRA shows why I write what I do about it. These same people accuse me of having a vested interest in Seroxat because I am part of the Seroxat litigation here in the UK. This blog was created long before I knew I was part of the litigation.
Other 'reports' of SSRi withdrawal from the recent MHRA file are:
Citalopram [Cipramil] - TOTAL 170
Duloxetine [Cymbalta] - TOTAL 55
Escitalopram [Cipralex] - TOTAL 53
Fluvoxamine [Luvox] - TOTAL 161
Fluoxetine [Prozac] - TOTAL 680
Sertraline [Zoloft] - TOTAL 162
Venlafaxine [Efexor] - TOTAL 318
I am 100% certain that these figures for all SSRi drugs are vastly underplayed. However, it seems that Seroxat with 1,425 'reported' adverse reactions more than doubles that of any other SSRi on the market. And people wonder why myself and others create awareness about the dangers of it!
Fid
Sales and prescriptions of a weight-loss drug were suspended yesterday after European health authorities said the benefits no longer outweighed the risks.
The European Medicines Agency said obese people taking Acomplia were roughly twice as likely to develop psychiatric disorders, such as depression, anxiety and aggression, than those taking a placebo. US authorities have refused to allow Acomplia to be marketed in America.
The Medicines and Healthcare products Regulatory Agency (MHRA), which oversees drugs in the UK, said that as a result of the ruling, healthcare professionals would be told not to give any new prescriptions for Acomplia. Patients taking the drug have been told to consult their doctor.
FULL STORY
Yet Seroxat and other SSRi's remain on the market despite the thousands of adverse reactions reported to the MHRA.
This file from the MHRA website recieved no publicity, they released it on the 13th October 2008 - SSRI anti-depressants - withdrawal and side effects (08/319)
There have been 1,425 'reported' reactions of Seroxat, only 156 of these have been reported by patients under the age of 24 which leaves 1,370 reports from patients over the age of 24. Yet the MHRA have banned the use of Seroxat in patients where there are less adverse reactions. How absurd is this?
Remember these are just the 'reported' reactions to Seroxat, there are literally thousands of others that haven't been reported to the MHRA. One only has to visit Paxil Progress to see how many people are suffering at the hands of Seroxat.
I've been accused by members of a mental health forum for concentrating too much on Seroxat, the latest release by the MHRA shows why I write what I do about it. These same people accuse me of having a vested interest in Seroxat because I am part of the Seroxat litigation here in the UK. This blog was created long before I knew I was part of the litigation.
Other 'reports' of SSRi withdrawal from the recent MHRA file are:
Citalopram [Cipramil] - TOTAL 170
Duloxetine [Cymbalta] - TOTAL 55
Escitalopram [Cipralex] - TOTAL 53
Fluvoxamine [Luvox] - TOTAL 161
Fluoxetine [Prozac] - TOTAL 680
Sertraline [Zoloft] - TOTAL 162
Venlafaxine [Efexor] - TOTAL 318
I am 100% certain that these figures for all SSRi drugs are vastly underplayed. However, it seems that Seroxat with 1,425 'reported' adverse reactions more than doubles that of any other SSRi on the market. And people wonder why myself and others create awareness about the dangers of it!
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Thursday, October 23, 2008
ROB ROBINSON - PAXIL ACTIVIST
The following was archived from former Paxil activist, Rob Robinson's website, SSRi Citizen.
Rob Robinson - Founder's Statement
(May 31st, 2004)
It's a beautiful day today: I’m outside on a shady deck, writing, beneath a canopy of trees enveloping me in the reassuring green of a freshly minted spring. Paper-thin leaves, backlit by the sun, flutter like nature’s own confetti in a gentle breeze. Birds are chirping and flitting about.Squirrels, in tune with the spirit of the season, are racing and chasing one another up and down the trunks of the trees. In between spates of writing I purposely stop, letting it all sink in. A quote by naturalist John Muir comes to mind: "The clearest way into the Universe is through a forest wilderness." My reverie is cut short as my thoughts drift back to the memory of a very different kind of wilderness — one which I only recently escaped — the topography of a life bombed into oblivion by a drug called Paxil. Its been almost two years now since I took my last dose of Paxil, but the memory of what I've endured lives on like a monster in my mind. Yet the beauty of this day infuses me with a slowly greening optimism, and the hope that the withdrawal-scorched slopes of my life are still capable of bearing blooms.
Now that I've survived Paxil — and managed to pick up most of the larger pieces of a shattered existence — the question arises: What should I do with the rest of my life?
Most of you probably know the story of Paul Revere; he was the American Revolutionary hero who raced across the countryside warning his fellow citizens: “The British are coming!” Of course, I'm no Paul Revere. (For one thing, I don't own a horse.) But the dangers I feel compelled to warn others of are just as real a threat as the enemy soldiers that prompted Revere to take to the night.
So what's a Paxil victim-turned-activist like me to do? Some of you probably recall consumer rights activist Ralph Nader, who in a book entitled "Unsafe At Any Speed", brought widespread public attention to a dangerous and unsafe car called the "Corvair" back in the 1960's. Sales of the Corvair "crashed and burned" thanks in large part to Nader's efforts.
Mr. Nader's vision, guts and determination to expose the Corvair for what it was — a "hunk of junk" that was "unsafe at any speed" — inspired me in my own mission to expose the damning truth about a dangerous, junk drug called Paxil.
A few months ago I asked myself a critical question: "What would Mr. Nader do if he had been pulverized by Paxil?" My answer to this hypothetical question led to the following actions:
1) Creation (in progress) of a non-profit consumer's advocacy group called "SSRI Citizen".
2) Creation of the slogan "Unsafe At Any Dose".
3) Creation of a web site designed to bolster the efforts of the SSRI Citizen organization.
Of course, the Internet is already home to scores of web sites that strive to warn the public about the dangers of SSRIs — and to their credit they often do a superb job. Regrettably, by the time the public stumbles across one of these sites it is already too late — someone has been mauled by Paxil or one of its feral siblings. Or worse yet, a family member is dead. That's why SSRI Citizen's plan to inform the public about the SSRI public health menace includes reaching out well beyond the confines of cyberspace.
In addition to educating the public about the dangers of these drugs I hope this web site will serve as a rallying point — not only for the thousands and thousands of Paxil victims who have filed suit against GlaxoSmithKline — but all SSRI victims and their families ... past, present and future. There are untold thousands of us "out here" already, and if you are like me you don't want anyone to ever go through what you or your family endured as a result of taking one of these dangerous drugs —especially Paxil. So on behalf of all SSRI victims, and for the safety of the general public, I am calling on each of us to join forces and launch a "consumers' rebellion"(remember the Boston tea party from your high school history days?) against these profit-crazed,out-of-control multi-national drug companies.
This web site will soon share with you many creative (and even fun) ways you can help fight back against these companies ... without expending a lot of time and energy. For example, you can display an “Unsafe At Any Dose” bumper sticker on your car. (It won’t take long for “our" message to get noticed — especially if a million or more vehicles are sporting one, too.) Of course, I don't think the SSRI drug companies are going to be too happy about this ... which will probably make a lot of SSRI victims happy, myself included.
Support this site and our efforts to educate the public: Purchase one of our two-color bumper stickers now by clicking on the bumper sticker of your choice. Note: The actual size of each bumper sticker is 3.5" by 15".
SSRI Citizen's "Unsafe At Any Dose" campaign wouldn't be necessary if the United States Food and Drug Administration had done its job from the outset and warned us about the menace these drugs present. But no thanks to FDA policy shifts that began almost ten years ago drug companies have been given a virtual "green light" to dump drugs into the medicine cabinets of America that are often unsafe and dangerous — but nevertheless obscenely profitable. So what if tens of thousands of people are injured (many killed) as a result of taking an SSRI — that's just the cost of doing business these days. Isn't it, GlaxoSmithKline?
The embodiment of this depraved ideology is perhaps best seen in the person of GSK spokesperson Alastair Benbow who occasionally appears in public claiming (almost mantralike) that Paxil has "helped millions and millions" of people.
Benbow's "numbers logic" is the same monstrous and twisted logic Ford Motor company used at one time to justify its sale of a car called the "Pinto" — even though it had a defect in the gas tank that often caused it to explode in relatively minor crashes. Occupants trapped inside the Pinto were subsequently burned alive. Ford finally fixed the car defect (which is a story unto itself.)
Paxil is a modern day version of the "exploding Pinto" — stuffed into a pill bottle. Unlike the Pinto, however, Paxil cannot be fixed; it is impossible to alter or remove a defective molecule in the drug's composition, thereby rendering it harmless.
And what about the doctors you ask? Why haven't they warned us about these drugs? The reason is simple. Drug companies have (and continue to) withhold disclosure of critical SSRI drug safety information from them as well.
Or the drug companies saturate the medical journals doctors rely on with "ghost written" "scientific" studies — a.k.a. medical "infomercials". See Ghostly Data for an in depth discussion of this subject.
Sometimes the truth, if you can find it, is backstitched into a meticulously woven curtain of confusing "medicalese" printed on parchment paper, and in letters so small you need a magnifying glass to read the text. Not to mention a medical dictionary. So on the rare occasion when your pharmacist provides you with a drug's bona fide "Product Information Leaflet" along with your filled prescription ... good luck. That P.I.L. is about as useful as a sheet of single ply toilet paper. Rest assured, this is no accident. The drug companies want it that way. Take GSK's Paxil P.I.L. Does it advise patients that Paxil (an antidepressant) can actually cause suicidal behavior — even if you're not suicidal or depressed to begin with? No. And that's not just ironic ... it's by God downright scary. It is, in fact, like playing a physician-assisted game of Russian roulette ... with a pill bottle instead of a pistol. Even scarier is the fact that you, the patient, don't know the "game" you're playing — or that there even is a "game". And neither does the doctor.
Paxil is particularly dangerous when starting — or stopping — the drug; especially if withdrawal symptoms occur. Withdrawal symptoms? Hmm. What are the chances of that you might ask. The most recent Paxil P.I.L. I have on hand is one I picked up for inspection from my local pharmacy not long ago and dated January, 2003. Under the heading of "Other Events Observed During the Pre-marketing Evaluation of Paxil" and "Nervous System" you'll find the phrase "withdrawal syndrome." GSK classifies the condition as "rare".
In drug company parlance the word "rare" indicates a condition is observed in less than 1 out of 1,000 people, or .001% of the population observed. Extrapolate from that, and what GSK would have you believe is less than 100 people out of 100,000 experience "withdrawal syndrome". There is a word for that in the English language. The truncated version of it is "B.S."
The truth is Paxil causes severe and protracted withdrawals in vast numbers of people; moreover, it meets the criteria for an addictive drug as defined by the World Health Organization. GSK knows all of this full well, as the world will soon see for itself when the first Paxil withdrawal case goes to trial.
By the way, when I was first prescribed Paxil (for atypical anxiety by a physician after a five minute visit) I read Paxil's P.I.L. word for word about two weeks after starting the drug. It mentioned nothing about addiction or "withdrawal syndrome", among other things. What it did claim, however, was:
1) “Paxil is non-habit forming.”
2) Paxil “may cause mild, usually temporary, side effects in some individuals.”
3) Paxil “has been studied both in short-term and long-term use and is not associated with dependence or addiction.”
In Britain, GSK is now saying that as many as 25% of people that take Paxil will experience withdrawal symptoms. Independent sources suggest the true figure might be as high as 40%. As a result of these earlier "misrepresentations" GSK is now mired (up to its corporate eyeballs) in a legal quagmire fast approaching Biblical proportions. To date, somewhere between six thousand and ten thousand people have filed suit against the company, and as public awareness of the situation expands it is likely many more victims will file suit. For more information visit the following link HERE .
***
We have been been duped by an industry that is doing everything in its power to hide the truth about these drugs from us. Consequently, GSK and other SSRI machinators rake in billions of SSRI dollars every year. And it appears even greater profits are likely on the way.
No longer relegated to treat mere depression, SSRI’s are now used (but not necessarily approved by the FDA — which means little these days) to treat: alcoholism, anxiety, anorexia, bulimia, chronic pain, dysthymia, fibromyglia, "inhibition of platelet activation", insomnia, irritable bowel syndrome, migraines, obesity, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, pre-menstrual dysphoric disorder, "restless legs syndrome", premature ejaculation, senile dementia, social phobia, substance abuse, trichotillomania ... and even the urge to light up a smoke.
The urge to smoke? U.S. patent #6,300,343 assigned to SmithKline Beecham on October 9th, 2001 claims the following:
"It has now been surprisingly discovered that paroxetine has potential therapeutic utility as a medicament for promoting smoking cessation or reduction or preventing relapse smoking. Accordingly, the present invention provides a method for promoting smoking cessation or reduction or preventing relapse smoking, which method comprises administering an effective, non-toxic amount of paroxetine or a pharmaceutically acceptable salt or solvate there of, to human in need thereof.
The present invention also provides the use of paroxetine or a pharmaceutically acceptable salt or solvate thereof in the manufacture of a medicament for use in promoting smoking cessation or reduction or preventing relapse smoking."
"Surprisingly discovered." Why am I not surprised. I have to ask: Is this some sort of depraved SKB (GSK) insider's joke? If you think quitting cigarettes is tough ... just give a severe Paxil withdrawal a go. By about day three or so you'll swear you've died and gone to Hell. And after four or so months into withdrawal (if you're still alive) — you'll know it for sure.
The "smoking" anecdote is emblematic of a market expansion artificially created by a drug industry driven to sniff out every crumb of profit it can scavenge through the sale of SSRIs. Who cares if the pill really works, right? Isn't that so, GSK.
Not surprisingly, there is a push by GSK et al. to expand into the heretofore unexploited pediatric SSRI market. In other words: the business of drugging kids with SSRIs. Once the public has been "sold" on the idea of "medicating" adults on a mass scale with these "safe and effective" drugs ... why not their offspring? After all, they can benefit, too. Right?
Of course, when the subject of kids and SSRIs comes up drug companies never pepper their marketing lexicon with strange phrases like "developmental toxins" and "limb-length discrepancies" and "neonatal withdrawal syndrome" ... all of which are related to the use of SSRIs. SSRI Citizen is preparing to share with you what's been discovered.
Speaking of kids: Can you imagine a drug company testing an SSRI on children — and finding it next to worthless when compared to a placebo — but then going on to claim the drug was effective? And imagine if some of the most famous psychiatrists in the United States signed off on the results. You'd be shocked, wouldn't you. Well guess what. That’s exactly what happened in GlaxoSmithKline study 329 (which was the largest study of its kind ever conducted in the United States.) The world learned about this "misrepresentation" when in February, 2004, a confidential GlaxoSmithKline document was leaked to the British press. Here’s the published
abstract for the study, along with the names of the doctors involved: Click here for published abstract.
Was GSK study 329 a single strand in a vast web of deception, or was it an isolated incident? For the answer read what world renowned SSRI expert David Healy, M.D., says in "Ghostly Data" and draw your own conclusions. While on the subject of Dr. Healy ... I also recommend his book entitled "Let Them Eat Prozac". A review of "Let Them Eat Prozac" is housed at this web site under SSRI Citizen's "Recommended Reading."
Dr. Healy maintains a web site where you can read about a lot more than just "ghostly data". For instance: In 2001, GlaxoSmithKline was sued in federal district court in Cheyenne by the family members of Donald Schell, a Wyoming gentleman who killed his wife, daughter, granddaughter and then himself on February 13, 1998 — after taking Paxil for just two days. Dr. Healy served as an expert witness on behalf of the Schell family. In that trial two critical things happened:
1) The judge rejected GSK's challenge of the validity of the scientific data presented to the jury by the Schell family legal team.
2) The jury concluded Paxil was the "proximate cause" of Mr. Schell's homicidal and suicidal actions.
This outcome was not just a surprising defeat for the drug company giant, but also GSK's first public scourging where Paxil was concerned. Of course, the Schell case only cost GSK several million dollars to resolve — little more than chump change for a multi-national corporation.
But it was like being paddled with a pipe cleaner compared to what's coming. Current litigation brought by thousands and thousands of Paxil withdrawal victims is going to cost GSK billions and billions of dollars; perhaps as many as ten to 20 billion. Or more.
GSK appealed the Schell verdict (in Denver), but then thought better of it and gave up. The settlement GSK made with the Schell family survivors allowed the company to get the bulk of its damning documents back, along with confidentiality statements from the plaintiffs which barred them from releasing further details of the case not already in the public domain. Of course, when GSK first decided to fight the Schell suit, it likely never imagined the depositions of some of its top company executives would be posted on a web site — along with the actual trial transcripts.
As a result, GSK has unwittingly armed the public-at-large (which includes me) with critical ammunition needed to go after the company in a full scale public relations war.
Following my escape from Paxil, de profundis, I've devoted hundreds of hours perusing thousands of Internet links, combing for information like that found at Dr. Healy's web site all in an effort to learn as much as I can about the legally prescribed poison that nearly killed me. Eventually I came around to the question: How in God's name did this heinous toxin "Paxil" manage to escape from a lab ... and into my medicine cabinet? So began another Internet odyssey, and it's been an extraordinary and riveting journey.
This is the first time the dark and secret history of Paxil has ever seen the light of day. What you are about to read is a written distillation of three weeks worth of intensive Internet research completed using a high speed cable modem coupled with a Macintosh "G4" computer. Along the way I received a couple of crucial pieces of information from novelist (and Paxil survivor) Trish Spinelli (author of "Blind Reason") and as well a little help from "lady luck". My travels whisked me through the "Net" (as if it were a 20th century version of "Alice In Wonderland's legendary looking glass") and tumbling head over heels into the hinterlands of cyberspace. Incredibly, it all began when I stumbled across a single record; one buried and forgotten in a United States government database almost 25 years ago. Are you ready?
The History of Paxil (and a whole lot more)
"Penetrating so many secrets we cease to believe in the unknowable. But there it sits nevertheless, calmly licking its chops." — H.L. Mencken
"Ferrosan"
In the 1960's a small Danish company called Ferrosan entered into (according to their web site)
"a successful venture into CNS (Central Nervous System) research, which led to the discovery and launch of the antidepressant Seroxat / Paxil, now owned by GlaxoSmithKline".
Ferrosan is almost always referred to as a Danish company — but in a document issued by the United States Federal Court of Appeals concerning a highly technical and convoluted patent dispute relative to paroxetine (See: SmithKline Beecham Corporation and Beecham Group, P.L.C. v. Apotex Corp., Apotex, Inc., and Torpharm, Inc. ) — Ferrosan is referred to as "a British company." In any event, Ferrosan was a family owned enterprise; the Danish part of the group remained so until 1986 when it was acquired by Novo Industri A/S (now Novo Nordisk A/S). After the acquisition, the CNS (Central Nervous System) research activities, the distribution of prescription medicine, and the veterinary medicine activities were all merged into the corresponding divisions of Novo Industri A/S.]
By the way, the suit just mentioned was resolved on April 23rd, 2004 in favor of Apotex Corp., Apotex, Inc., and Torpharm, Inc.
Leading the research team of Ferrosan was an individual, Dr. Jorgen Buus-Lassen, who supported the theory that the specific enhancement of serotonin might lift a depressive mood. But Dr. Buus-Lassen was not a doctor in the ordinary sense of the word, but rather a "DVM" or "Doctor of Veterinary Medicine". In other words: Buus Lassen is licensed to be an animal doctor. Buus-Lassen received his DVM credentials from the Royal School of Veterinary and Agriculture Science in Copenhagen.
With his associates Buus-Lassen explored approximately 100 compounds before deciding on the one that the world would come to know as "paroxetine" and, ultimately, Paxil in the United States. Buus-Lassen's first paper on paroxetine was published in 1975.
In 1989 Buus-Lassen wrote a piece entitled "Introduction to the development of paroxetine, a novel antidepressant." [Acta psychiatr. scand. (1989) 80: 13.] I found Buus-Lassen's choice of the word "novel" mephistophelean; he uses it to indicate a compound "of a kind not seen before". He sure got that right — because Paxil is the spawn of Hell. God willing, the world will never see another "novel" antidepressant like it.
I arranged to obtain a copy of the Buus-Lassen "intro" with hopes it would provide a "ham hock of history" I could toss into the investigatory stew I was in the process of cooking up. When it arrived, the document turned out to be a terse four paragraphs. Of those, two were single sentences. At the bottom of the page were nine footnotes.
Later, Buus-Lassen would recall during an interview with the "Guardian Unlimited", a British newspaper, that "It (paroxetine) didn't work with all patients. In most studies we could just show that we had about the same efficacy as the older tricyclic antidepressants. We didn't see a better effect."
A better effect? Like ... drug withdrawals sent from Hell? If you'd like to email Buus-Lassen a note you can do so care of: ns@neurosearch.dk. I expect tens (perhaps hundreds) of thousands of you have a word (or two) you'd like to share with Mr. Buus Lassen. (Be sure to mention the SSRI Citizen web site.) My bet is after he's received a few thousand emails a firewall will be installed to screen out incoming "slings and arrows". If so, don't be disappointed ... we'll find another address for him faster than you can pitch a new prescription for Paxil in the closest garbage can. Failing that, there's always "snail mail", and of course the phone.
Ferrosan patented the formula for the "Buus-Lassen compound" in 1977 under U.S. Patent #4,007,196. The patent claims paroxetine and its salts and discloses their antidepressant properties. Ferrosan eventually developed a process to produce the crystalline hydrochloride salt of paroxetine, or paroxetine hydrochloride (PHC).
In 1980, Ferrosan licensed the #4,007,196 patent and its other "PHC-related technology" to SmithKline. SmithKline began manufacturing PHC in its Harlow plant in England.
In March 1985, a chemist in SmithKline’s Worthing, England laboratory, Alan Curzons, created a new crystalline form of PHC while attempting to improve PHC production. Curzons’ test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate), while Ferrosan’s original form was anhydrous PHC (PHC anhydrate). PHC anhydrate comprises crystals of PHC without bound water molecules. PHC hemihydrate comprises PHC crystals with one bound water molecule for every two PHC molecules. PHC hemihydrate proved more stable and thus more easily packaged and preserved.
Further review of the SmithKline samples showed that the Harlow plant had unwittingly made PHC hemihydrate as early as December of 1984.
In May 1985, SmithKline began double-blind clinical tests in the United States to determine the "safety and efficacy" of PHC hemihydrate capsules to treat depression symptoms.
On October 25, 1985 SmithKline filed a patent application in the British Patent Office relating to “crystalline paroxetine hydrochloride, its preparation and its uses as a therapeutic agent.” The British application identified the invention as both the hemihydrate and the anhydrate form of PHC, as well as mixtures that contain a major portion of either form.
On October 23, 1986, SmithKline filed a U.S. application claiming priority to a British application that issued as the #4,721,723 patent in 1988. The ’723 patent does not claim PHC anhydrate and does not claim mixtures of the two PHC forms.
If you would like to take an in-depth look at all of the U.S. patent records as they pertain to Paxil click here.
And while you're there: Who can explain the patent for "Methods and compositions for reducing toxicity of a toxic agent are provided in which a polysaccharide, galactomannan is coadministered with a therapeutic agent in a liquid formulation to a subject to reduce toxicity of the agent for the subject." [Since removed]
Scroll down through this record to where it reads: "Examples of therapeutic agents with toxic side effects that may be administered with galactomannan to reduce their toxicity include the following: Anti-infectives including antibiotics, antivirals and vaccines, antineoplastics, cardiovascular drugs including antiarrythmics, antihypertensives etc., central nervous system drugs including analgesics, anorectics, anticonvulsants, anti-inflammatories and tranquilizers etc. OTICS, Opthalmics, gastrointestinal including anti-ulcer drugs, anticholinergic drugs etc. hormones, respiratory drugs including allergy medications, bronchodilators and decongestants, topical drugs and vitamins and minerals. Particular examples in the above categories are provided by way of illustration. Prilosec (AstraZeneca) described in U.S. Pat. No. 4,255,431 and Prevacid (TAP) described in U.S. Pat. No. 4,628,098; Lipitor (Pfizer) an anti-cholesterol drug described in U.S. Pat. No. 5,273,995. The antihyper-lipidemic agent, Zocor (Merck) U.S. Pat. No. 4,444,784; anti-depressants such as Prozac (Eli Lilly) described in U.S. Pat. No. 4,314,081; and Zoloft (Pfizer) described in U.S. Pat. No. 4,536,518; Paxil (SmithKline Beecham) U.S. Pat. Nos. 3,923,743 and 4,007,196; 4,721,723; antipsychotic agents such as Zyprexa (Eli Lilly) hematinic agents such as Epogen (Amgen), also known as Erythropoietin, and antiinflammatory agents such as Celebrex (Searle).
It seems a bit odd that three of the four antidepressants which are the focus of the SSRI Citizen web site — Prozac, Zoloft and Paxil — are included as specific "examples of therapeutic agents with toxic side effects that may be administered with galactomannan to reduce their toxicity". What happened to FDA approved "safe and effective"? My doctor didn't mention anything about "toxic side effects" when she dashed off my prescription for Paxil. Did yours?
"Have nothing to do with the evil deeds of darkness, but rather expose them." — Ephesians 5:11
"SmithKline Beecham and the Gates Of Hell"
Beecham — patent #4,007,196 licensing in hand from Ferrosan
— after merging with another drug company called SmithKline & French (to become SmithKline Beecham a.k.a. SKB), would eventually become the company responsible for flinging wide the laboratory "gates of hell", thereby allowing the "demon of Paxil" to find its new home in the medicine cabinets of America (and the world.)
Of course, before Paxil could be sold in the United States SKB had to gain approval from the Food And Drug Administration certifying Paxil as " safe and effective". So in the 1980's SKB undertook a series of Paxil human clinical trials. Most interesting (to me as a Paxil survivor) were those conducted in Yugoslavia in the late 1980's. To SKB's dismay the Yugoslavia trials were an unmitigated disaster; the company was having a hell of a time coming up with tests they could present to the FDA proving the drug was safe and effective. Billions of dollars in anticipated profits were imperiled. So what did SKB do? Using a bit of " the devil's math" they "fixed" the studies so Paxil would "wow" the FDA. Which led to the following lawsuit against SKB (now GSK): paxilcomplaint.html
Exiting Yugoslavia (phony studies in hand) SKB submitted Paxil's application to the FDA and through a combination of agency ineptitude, stupidity and insider collusion Paxil was approved by the FDA for sale in the U.S. on October 5th, 1992.
In 1993, SmithKline placed "its" antidepressant drug (with PHC hemihydrate as the active ingredient) on the market under the name Paxil. (For the record: Paxil was actually first sold in the UK, in 1991, under the trade-name "Seroxat", but I'll leave that history for someone else to pick apart.)
What has followed is a mind-boggling swath of human misery (and sometimes death) for God only knows how many people. And its far from over; for that you can thank people like football legend turned-Paxil-pitchman Terry Bradshaw who is now being paid millions of dollars to serve as GSK's "Pied Piper of Paxil"; in effect, luring thousands of unsuspecting new victims over the edge and into depths of the Paxilian abyss. Much more on him later (elsewhere at this web site.)
But the real story of Paxil is only beginning. For reasons still not fully apparent a trademark for Paxil was applied for on March 28th, 1980 with the United States Patent and Trademark Office(under "Goods & Services") as a "hypnotic drug for human use". But not by Ferrosan or Beecham, but instead by the German drug company of Boehringer Ingelheim G.m.b.H. To view this U.S. government database record go to the following web page and click on "Search Trademarks". A new window will appear. Under the "Select The Search Form" click on "New User Form Search (Basic)". As the next page appears type the word "Paxil" in the "Search Term" field. Next, click on the "Submit Query" button. Another page with records set up in a grid format will appear. Scroll down to the record which displays serial number 73255881". Right of that is a registration number: "1170889". Click on the word "Paxil" just right of the registration number, and the full record will be retrieved. Note: The official registration date for the Boehringer Ingelheim trademark is listed as September 29, 1981 and a "termination" date of April 7, 1988.
The existence of this seemingly (at first glance) ordinary record educed an extraordinary question: Did Boehringer Ingelheim enter into a joint venture with Ferrosan in the 1960's whereby Jorgen Buus-Lassen was provided the (approximately) 100 compounds he studied of which one went on to become Paxil?" Ferrosan was a relatively small company, and it is my surmise they did not create the 100 or so compounds Buus-Lassen studied, but rather acquired them "off the shelf" from a much larger company with the resources to make them ... like Boehringer Ingelheim. What followed would have been an agreement whereby Boehringer Ingelheim told Ferrosan if it came up with anything marketable from the compounds they would serve as distributor.
If this is not the case, why did Boehringer Ingelheim and not Ferrosan, or Beecham (later becoming SKB), register Paxil on March 28th, 1980, with the United States Patent and Trademark Office? The only logical (and inescapable) explanation is Ferrosan and Boehringer Ingelheim had a substantial business agreement regarding Paxil. One that apparently went "poof" the very same year Ferrosan licensed SmithKline the #4,007,196 patent and its other "PHC-related technology". This connection spurred me to take a closer look at Boehringer Ingelheim.
But before doing that, there's a bit more yet to that Boehringer Ingelheim trademark registration. Why, I wondered, did Boehringer Ingelheim classify Paxil as a "hypnotic" and not an antidepressant? That was not a random designation. Far from it: One of the two companies, either Ferrosan or Boehringer Ingelheim, had conducted research and studies that suggested this was the best way to, pharmacologically speaking, describe the drug's effect. Where is that data now? In SKB's (now GSK) confidential company files?
This led to another question: Why did SKB begin selling Paxil in the United States as an antidepressant and not a hypnotic? And still another: How was "Paxil the hypnotic" transformed by SKB into "Paxil the antidepressant"? After all, hypnotics are central nervous system (CNS) depressants. (Webster's dictionary defines a hypnotic as "Any agent that produces, or tends to produce, sleep: an opiate; a soporific; a narcotic." One medical dictionary simply defines a hypnotic as a "sleeping-tablet".) Why, you might ask, does it matter?
Perhaps it doesn't. However, it might have been (rigged studies notwithstanding) more difficult to gain FDA approval if SKB had tried to "pitch" Paxil to the agency as a hypnotic. Worse yet, it might have led to Paxil's scheduling by the FDA as a "controlled substance". (Which it should be.) Or maybe it would have been harder to position Paxil in the marketplace to compete with Lilly's multi-billion dollar Prozac profit engine ... which was being sold as an antidepressant. Or maybe all of the above.
Whatever the case, one has to wonder if Paxil is soon destined to end up in the pharmaceutical trash-bin of history ... just like Halcion (another hypnotic) did. If the name of that drug (which was banned in Britain) doesn't jog your memory ... here's a Newsweek magazine article that will.
Other questions that must be asked and which will — one day soon — be answered by SKB (now GSK) include:
*What did the companies involved in the creation and eventual distribution of Paxil know about the drug's propensity to induce addiction and dependency? When did they know?
*About the horrifying and protracted drug withdrawals Paxil can induce? When did they know?
*About Paxil's potential to trigger homicidal or suicidal behavior? When did they know?
*Is it possible the answers going to be found in Boehringer Ingelheim files passed onto Ferrosan?
*Or was it Ferrosan who first discovered the horrifying truth about Paxil? (After Buus-Lassen's mice dosed with paroxetine started chewing their own legs and tails off, or attacking other mice.)
*Or was it SmithKline Beecham?
The world will soon have the answer to these questions (and a whole lot more) when the first Paxil withdrawal lawsuit goes to trial. For now, only the drug companies and the plaintiffs' attorneys know the ultimate answers.
"For our struggle is not against flesh and blood, but against the rulers, against the powers, against the world forces of this darkness, against the spiritual forces of wickedness in the heavenly places." — Ephesians 6:12
"Boehringer Ingelheim: Black Widow At The Center Of The 'SSRI Web'?"
The net effect of the questions I've posed thus far prompted me to begin looking a bit closer at Boehringer Ingelheim. Here's what I discovered: Boehringer Ingelheim is one of the twenty largest drug companies in the world; it has strategic partnerships with many other multi-national pharmaceutical corporations, including SSRI giants GSK and Lilly — as well as a new company called NeuroSearch which is headed up by none other than the "father of Paxil" himself Jorgen Buus-Lassen. Much more on this in a few minutes (read on). Boehringer Ingelheim's web
site
Probing the history of Boehringer Ingelheim, I discovered the company garnered some bad press after it was widely reported it had, under the direction of Richard von Weizsacker, supplied the United States government with large quantities of a highly toxic and dangerous herbicide called dioxin (a.k.a. "Agent Orange") during the Vietnam War. Weizsacker eventually left the company and went on to become president of the Federal Republic of Germany in 1984.
In a 1991 article that appeared in "The Mirror" in Germany, dioxin was described as "the most poisonous chemical in the world". Elsewhere, I have come across estimates that suggest as many as one million Vietnamese died as a result of exposure to dioxin delivered by U.S. war planes. Dioxin is, in short, a weapon of mass destruction.
By the way ... Weizacker's father, Baron Ernst von Weizsacker, served as state secretary in the foreign ministry of the German Republic from 1938-1943; in 1949 he was sentenced at the Nuremberg trials to seven years imprisonment for "crimes against humanity". Specifically, he was convicted for his use of diplomatic pressure to make possible the deportation of Slovakian and Italian Jews to Nazi death camps. His sentence was later commuted to "time served".
In the 1990's, a study published in the journal of the United States National Cancer Institute provided conclusive evidence of a direct relationship between industry and the cancer-causing effects of dioxin. Generally ignored by the mainstream press, the study revealed that many thousands of workers in the U.S. chemical industry died of various cancer-related illnesses as a result of exposure to dioxin. Pooling data from more than 5,000 workers from 12 different factories across the United States, the study found that workers with the highest dioxin exposure had a 60 percent greater risk of dying from cancer than the U.S. national average.
Before reading on would you like to venture a guess as to where dioxin came from?
Dioxin was discovered in Hamburg, Germany in 1954 — at the company of C.H.Boehringer by a scientist named Karl–Heinz Schulz who conducted a series of (depraved) experiments using "76 assorted Boehringer products".
The ultimate parent company of the Boehringer Ingelheim corporation is C.H. Boehringer Sohn. Boehringer Ingelheim GmbH, which is a subsidiary of C. H. Boehringer Sohn, is the central holding company for administrative purposes — the corporate central body which manages and directs the worldwide family of Boehringer Ingelheim companies and which delivers central services to all companies of the corporation.) For a bit more background information click here.
Schulz's sadistic dioxin experiments involved the use of live rabbits. Schulz would rub the ears of a control group of the animals with one of the 76 Boehringer chemicals. A second group of rabbits — housed alongside the control group and in open cages — was not treated with a test chemical. A few days after the first experiment commenced hideous boils appeared on the test rabbits' ears. Incredibly, the untreated rabbits in the cages next to the test rabbits were also affected even though they did not come in direct contact with one of the chemicals; they began dying of liver necrosis (a condition whereby liver tissue practically rots). Schulz concluded the untreated rabbits were inhaling the chemicals applied to the control group rabbits. The one thing that all of the chemicals being tested had in common? They contained varying amounts of dioxin.
Subsequent to his rabbit experiments, Schulz reported to his employer that the compounds containing dioxin were, in his opinion, “too deadly” for any conceivable use. What did Boehringer management make of Schulz's report? They didn't like it, because the company had decided it wanted to unload many of the compounds into the American market — so they hid the test results. Boehringer subsequently sold most of these compounds to Dow Chemical in, according to one source, 1960. One of the compounds sold to Dow Chemical was the isolate dioxin. (Is any of this sounding familiar yet?)
Interestingly enough, a year prior to the sale of the dioxin et al. rights to DOW a representative of the United States Army Chemical Corps traveled to Boehringer to see what he could find out about dioxin's potential use — as a chemical weapon. Based on his report the U.S. military concluded that dioxin was too dangerous to be handled safely — although the U.S. military later discovered dioxin worked wonders when used as a defoliant (sprayed from airplanes) to clear vast tracts of lush vegetation in Vietnam (during the Vietnam war).
Digging further into Boehringer Ingelheim's past I tried to ascertain what, exactly, the company was doing in the 1930's and 1940's when Germany was controlled by the Nazi party. Specifically, what activities did Boehringer Ingelheim engage in during Hitler's reign that would prompt the company — after the collapse of the Third Reich to join the German Forced/Slave Labor Compensation Fund? Does it have anything to do (as reported by the Shoah Project) with Boehringer "Compound 2516" studies ordered by Heinrich Himmler and carried out under the aegis of "Dr." Claus Shilling at the Dachau concentration camp? See for yourself. Go to the "Google" search engine at google and type in: "dachau" "boehringer" "2516". One of the first links that will appear should be one that reads "Shoah Project Dokumentation KZ Dachau"; immediately right of this phrase click on the text that reads "Translate this page". A new page will appear with German text translated into (approximate) English. Scroll down to the bottom of the page to the following passage which reads (verbatim):
Professor Dr. Claus Schilling
A set of experiments with the malaria preparation Boehringer 2516 let accomplish. None of the 1200 chose ever in agreement explained themselves or freieillig announced themselves. For these attempts clergyman were often selected. The prisoners were infected by the injection of the mosquitoes themselves or by injections of Extracten from the Schleimdruesen of the mosquitoes with malaria.
Note: The Shoah Project's main web site can be found HERE
Traveling back to the late 1800's I discovered that C.H. Boehringer & Sohn had "jumped into the cocaine trade" and was involved in the business for several decades ... possibly well into 1940's through World War II. See: "The Rise and Demise of Cocaine" by Paul Gootenberg.
Today, Boehringer Ingelheim is participating in another "war". But this war is, ostensibly, for a noble cause. And potentially a very lucrative one. It is the "war on AIDS". Yet how Boehringer Ingelheim is participating in this war is raising some disturbing questions. For example:
Boehringer Ingelheim is the manufacturer of an experimental AIDS drug called "Viramune"(nevirapine). The drug is being used in "clinical trials" involving infants and children at a place in New York's Washington Heights called the "Incarnation Children's Services" — as well as at Columbia Presbyterian and, in fact, at hundreds of participating hospitals in pediatric AIDS clinics nationwide. Coincidentally, GlaxoSmithKline (formerly SKB) is also participating in these "studies" with two of its drugs: Retrovir (AZT) and Epivir (3TC, lamivudine). Res ipsa loquitur: For further details visit "The House That AIDS Built."
"Cymbalta: Spawn of Boehringer Ingelheim and Eli Lilly"
In November, 2002, Boehringer Ingelheim and Eli Lilly (Prozac's manufacturer) signed a longterm agreement to work together and develop the commercialized use of a compound called duloxetine hydrochloride. Duloxetine, (trademark named "Cymbalta") is currently being developed for the treatment of a condition known as "stress urinary incontinence"... as well as depression. Lilly and its investors are counting on Cymbalta to be its next blockbuster antidepressant seller since Prozac has gone off patent and profits have gone "poof". Approval for Cymbalta by the FDA as "safe and effective" is right around the corner. But is it safe and effective? Read the following Philadelphia Inquirer article entitled "Suicide Of A Human Guinea Pig."
"A Family Reunion of Sorts: Boehringer Ingelheim and Jorgen Buus-Lassen"
Boehringer Ingelheim is also hooked up with Jorgen Buus-Lassen (formerly of Ferrosan, creator of Paxil) who is now head of his own company called NeuroSearch (a Danish biopharmaceutical company listed on the Copenhagen Stock Exchange: NEUS:CO)
For its part Boehringer Ingelheim is investing a total of DKK 680 million in exchange for sales rights to a drug for Alzheimer’s and Parkinson’s disease that NeuroSearch is developing. DKK 170 million is being made available now, with the rest to follow over the coming years. Boehringer Ingelheim is taking on the future development costs of the drug. “It is the most important agreement in NeuroSearch’s history. The cash injection ensures that we can develop the drug for the ever more prevalent Alzheimer’s and Parkinson’s disease and bring it to market” says Buus Lassen.
"All About NeuroSearch"
NeuroSearch was founded in April of 1989 by Buus-Lassen and five fellow researchers (Asger Aamund, Jørgen Drejer, Frank Wätjen, Leif Helth Jensen, Henrik K. Moltke and Peter Wulff) who left Ferrosan and struck out on their own, pledging their homes to get a startup loan. They first opened shop in a cellar at Danochemo (which specializes in laboratory medical equipment) based in Ballerup, Denmark. They obtained private financing in the amount of DKK 29.7 million for start up capital.
Today, the company is still located in Ballerup, Denmark (between the Copenhagen (DK) area and Skania in Sweden) in the so-called "Medicon Valley" (think Silicon Valley) which, as of October, 2002, was home to 26 hospitals and 12 universities with 4,000 researchers and 135,000 students. The area provides over 30,000 jobs in more than 160 biotechnology companies. See:
NeuroSearch's goal is to become an international leader in pharmaceutical research and development, with an intense focus on the central nervous system. The company intends to develop each of its compounds "in-house" to maximize the opportunity for potential profits. In other words: It won't buy bulk compounds "off the shelf" to experiment with — like Ferrosan did in the 1960's. (We won't make that mistake again. Right Mr. Buus-Lassen?)
Typically, NeuroSearch tries to broker agreements with large pharmaceutical companies to "optimize development and/or marketing". At the same time NeuroSearch seeks to preserve commercial rights for its compounds in the Nordic and Baltic countries "with the possibility of expanding these primary markets to larger parts of Europe".
NeuroSearch operates under an "in-house as long as possible followed by collaboration" model based on the following concepts:
1) "Collaborations established during the late clinical phases of a compound's development are generally more profitable than those started during the initial stages".
2) "A gradual increase in NeuroSearch's capabilities in the areas of drug development, manufacturing of compounds on a larger scale for extended clinical trials and, in the long term, sales of marketable products".
NeuroSearch currently has agreements not only with Boehringer Ingelheim and GSK (as noted above) but also Abbott Laboratories, along with partnerships enjoining Pharmexa and Pierre Fabre, and equity interests in eight biotech companies, including Bavarian Nordic A/S, NsGene A/S, and Sophion Bioscience A/S.
NeuroSearch maintains an Internet site HERE
Note: The site is not Macintosh accessible.
For a complete timeline highlighting NeuroSearch's history see:
"The SSRI Ties That Bind: NeuroSearch, Jorgen Buus-Lassen and GlaxoSmithKline"
NeuroSearch's first accord involving GlaxoSmithKline (GSK) came (as noted in the history of the company, see link above) in 1993 with then Glaxo Group Research Ltd.
Ten years later and on December 13th, 2003, NeuroSearch and GlaxoSmithKline (which
remember, now owns the patent for Paxil — first licensed to SKB from Ferrosan the company Buus-Lassen used to work for) announced a landmark five-year research and development alliance. The alliance comprises a number of research programs, including the treatment of purported "diseases of the central nervous system" like depression and anxiety.
NeuroSearch compound NS2710, intended to treat the "disease of anxiety", was originally slated for distribution by pharmaceutical giant Pharmacia & Upjohn; however, "problems" arose during the clinical "Phase II" human trials. Not that the compound wasn't "effective" according to NeuroSearch, but rather some patients experienced sedation or an allergic reaction. In other words NS2710 knocked them out or made them sick. The disclosure of these problems was serious enough that Pharmacia & Upjohn immediately ended the partnership. Perhaps NS2710 has been relegated to "veterinary use only". Or perhaps a variation of it will turn out to be
GSK"s "new Paxil". By the way ... about those pesky-sounding "allergic reactions" — is that a NeuroSearch-GSK euphemism for some sort of nasty "withdrawal syndrome?" Just thought I'd ask (it never hurts).
For the "disease of depression" GSK and NeuroSearch were, until March of 2002, banking on the success of compound NS2389 which was being hyped as a "triple action", or "mixed monoamine re-uptake inhibitor". Recently though, abnormal cell growth observed in experiments on rats and dogs scuttled further development.
You will probably be hearing much more hype about mixed monoamine re-uptake inhibitors (MMRI's for short) in the near future. In a 2002 interview with the Guardian, a British newspaper, Buus-Lassen spoke of early clinical studies that suggest MMRI's work on some patients who do not respond to "serotonin enhancement" alone. "But we still have to learn and see if this is right," he says. "Until we've had a full program, it's still a kind of prediction. We have many pieces, but we don't know why not all patients are being cured. Several pieces we do not understand." "Cured" did he say? As in cured like Paxil "cures" you? Personally I'm not interested in being "cured" by anything that comes out of a Buus-Lassen lab. How about you?
What Buus-Lassen didn't mention in his interview with the Guardian is the fact that an older class of antidepressants, commonly referred to as "tricyclics", also inhibit monoamine re-uptake. And it was SSRIs (Paxil et al.) that were — according to drug company propaganda — a great leap forward over the tricyclics in both safety and efficacy. We now know this is not true. For example: According to Dr. Robert Temple, Associate Director for Medical Policy United States Food and Drug Administration who (on Monday, September 11th, 2000, during the course of a public hearing conducted under cover of the FDA Pediatric Subcommittee of the Anti-Infective
Drugs Advisory Committee) said "....the new antidepressants do not differ in effectiveness from the old antidepressants." So I'm a bit confused: It appears as if GSK and NeuroSearch are simply "recycling" tricyclics — and repackaging them as "new and improved". Triple action, no less! (A toothpaste I buy is also sold as a "triple action" product.)
If you are an drug stocks investor you might be saying "darn!" by now. But not to worry ... GSK-NeuroSearch's NS2359 for the treatment of " Attention Deficit Hyperactivity Disorder", or ADHD, is still alive and kicking. In a number of pre-clinical models, NeuroSearch's scientists claim to have shown NS2359 "improves" the function of the neurotransmitters dopamine, noradrenaline and serotonin. On the basis of these pre-clinical (and clinical Phase I results) NeuroSearch anticipates NS2359 will provide a better "therapeutic effect" in the treatment of patients (mostly children) purported to have ADHD.
NS2359 has been tested in 125 healthy volunteers in five Phase I clinical studies, and is alleged to be "well tolerated". In another study involving 54 volunteers (carried out by Professor K. Wesnes, Cognitive Drug Research Ltd.) it was "proven" NS2359 increases attention and improves the ability to recall verbal information. (Could you repeat that?)
NeuroSearch has now initiated a Phase II study with NS2359 at three clinical centers in the U.S. The study includes 100 adult (so called) " ADHD patients", of which 50 be treated with a half milligram of NS2359 once a day, while the other 50 will receive placebo. The stated goal of the study is to gauge the efficacy of NS2359 in the treatment of ADHD symptoms as well as its "tolerability". The treatment period is eight weeks, and the study is expected to be finalized in 2004. Would anyone care to forecast what the results will be? No? Then I will. I predict the NS2359 trials will be reported as a resounding success.
By the way, NS2359 has also been studied in cocaine addicts in collaboration with the United States National Institute on Drug Abuse. What's next? Pediatric cocaine addicts with ADHD?
"Watching Every Neurosearch-GSK (ADHD) Move: Lilly on the Prowl"
No doubt Lilly is watching this development very carefully, because if NS2359 eventually passes the cursory FDA "sniff test" then its own ADHD drug "Strattera" might have a new competitor to deal with — one backed by GSK's own mega marketing machine.
Strattera, by the way, is a selective nor-epinephrine re-uptake inhibitor (SNRI) — as is another drug targeted by this web site: Effexor. For more company propaganda regarding Strattera visit the Lilly web site where you'll be greeted by three smiling girls leaning on one another's shoulder in a sort of "Norman Rockwell" knock-off pose. (Note: You may have to click "reload" on your browser several times to get the "three girls" image to load.) One presumes they are taking Strattera— and loving it. Or maybe they're just models. In any event: Strattera is approved "by the FDA" for use in children and adolescents, as well as adults.
Adults? Surely by now you've seen Lilly's glitzy 30 second TV Strattera "infomercials" or come across a glossy full-page magazine Strattera ad seeking to educate the public about the "grown up" version of ADHD, Adult "Attention-Deficit Disorder". Visitors stopping by the Strattera web site are provided an " opportunity" to find out if they are "living with ADD" by taking an online
"screening test". According to Lilly, many adults have been living with the condition — but don't recognize it. Why? "Because its symptoms are often mistaken for a stressful life". Lilly suggests: "If you've felt this type of frustration most of your life, you may have Adult ADD; a condition your doctor can help diagnose and treat." And after what — a (typical) five minute visit with a physician — one hounded by a Lilly professional sales rep (a.k.a. "detail man") to prescribe Strattera?
"Back to the NeuroSearch-GSK Hydra"
Before we head too far off on a tangent (albeit one that might lead to yet another equally interesting inquiry) let's revisit that corporate Hydra borne of GSK and NeuroSearch: Under the Mterms of the five-year agreement NeuroSearch will receive some "triple action" funding — a total of EUR 82 million (DKK 610 million) in guaranteed payments from GSK. NeuroSearch will further receive EUR 46.8 million (DKK 348 million), comprising EUR 29.1 million (DKK 217 million) of up-front and research payments, and EUR 17.7 million (DKK 132 million) for 616,000 new NeuroSearch shares to be issued to GSK. The shares correspond to an 8.7% increase of the share capital equal to GSK having a strategic equity interest in NeuroSearch of 8.0% after the capital increase. The purchase price of DKK 214 per share of DKK 20 represents a 30% premium to the average market price over thirty days before the agreement was signed. For new development candidates selected by GSK, the terms of the agreement continue until the patents regarding the selected candidates expires. The agreement may only be terminated by GSK in case of NeuroSearch's insolvency, material breach or in case the controlling interest in NeuroSearch is transferred to a new owner.
Perhaps this deal is, in an oblique manner and after the fact, a way for GSK to say "thank you!" to Buus-Lassen for inventing Paxil which last year earned GSK several billion dollars — just like it has for many years now.
Regarding the GSK-NeuroSearch agreement Dr. Tadataka Yamada, Chairman of Research and Development at GSK, fawned: "Diseases of the central nervous system are particularly debilitating and represent a massive unmet medical need. Combining the skills and resources of GSK and NeuroSearch will accelerate and augment our current efforts to make effective new treatments available to patients as quickly as possible. GSK particularly values the collaborative culture at NeuroSearch, which bodes well for the success of our alliance."
Dr. Yamada, by the way, was one of the top GSK executives deposed in the Donald Schell Paxil homicide/suicide case. (trial exhibits, more depositions and trial transcripts) Here's just a smattering of what Yamada had to say (about drug warning labels) when questioned under oath by Houston attorney Andy Vickery:
Dr. Yamada: ....We also have the pressure to understand that our drugs aren't safe and that every drug — although every drug — every drug has potential complications but the benefits outweigh the risks.
Andy Vickery: And in that context, what is the importance of proper labeling as a means to accommodate these two competing interests? We need to get this drug out there on the one hand to people but the drug might hurt some people. Can that be ameliorated in some degree by proper labeling?
Dr. Yamada: That is the hope. That is the hope. It's not — It's not always been borne out, and so the FDA is rethinking about what they want to do, how they actually control the physician. I mean one of the problems is that — Maybe I'm saying too much here, Chuck. (Note: "Chuck" is GSK's counsel.)
Andy Vickery: I can't ask you what he said yesterday, but I bet one of them was just answer his questions. But I appreciate your helpfulness.
Dr. Yamada: It's like a pack of cigarettes. You see on there Surgeon General's warning.
Andy Vickery: Right.
Dr. Yamada: Nobody pays any attention to it.
Andy Vickery: Right.
And another excerpt from the Yamada deposition:
Andy Vickery: Dr. Yamada, as a physician, clinician, academician who not only practiced medicine but taught other doctors how to practice medicine for many years, would you agree that as a general proposition that if language appears in the warnings section in boldface that it is more likely that doctors will take heed of that information than if it's put back in the postmarketing surveillance section and it's not in boldface?
Dr. Yamada: Well, my experience would be that doctors just don't look at the label, period. Now, it could be because I was in an academic institution and that's what we did. Maybe we felt that we were more up-to-date and therefore we didn't need no label. I don't know, but my experience is that most physicians don't look at the label very carefully. And I'm not certain — I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section, and if you would ask 20 young physicians, I'm not sure they could tell you the difference between those three.
Andy Vickery: Do you know that in the information disseminating process one of the truly important ways that your company communicates both the indications and the side effects of your medications to doctors is through the — I forget what title we were using about the detail men, as I call them, the people that call on doctors?
Dr. Yamada: Yes.
Andy Vickery: That's a very important conduit for information; isn't it?
Dr. Yamada: I believe it is, yes.
Andy Vickery: And do you know that your people are trained, your salespeople that call on doctors are trained to emphasize and reemphasize information that is in the warning section of the labels to doctors for the very reasons that you talk about?
Dr. Yamada: I believe so, but I don't know for a fact.
Andy Vickery: Okay, sir. How are you doing comfort wise?
Dr. Yamada: I'm fine. I'm fine.
Andy Vickery: Any time you want to take a break —
***
It seems fitting to conclude the history of Paxil by closing with Jorgen Buus-Lassen. The "father" of Paxil. In bed (again) with Boehringer Ingelheim. Now head of his own company, NeuroSearch, and joined at the hip with GSK — which owns Paxil. "I am pleased that we were able to conclude this important strategic alliance with GSK as our two companies have had a well-functioning and trustful partnership within depression research for three years. I have a strong expectation that this extended partnership will be a major success for both companies.This agreement is one of the most important milestones in our history and is a major recognition of NeuroSearch's competencies within research and development. The agreement significantly increases the generation of value in NeuroSearch and strengthens our financial resources considerably."
***
Towards the end of my own Paxil withdrawal one of my relatives — horrified by the suffering I was enduring — abruptly stopped taking another allegedly "safe and effective" SSRI called Zoloft. A few days later he took his own life. He had just returned from what was — according to friends in California with whom he had visited — a great time. And within an hour of his death he had an upbeat phone conversation with a business associate. Moreover, he had plans to meet a business partner early the next morning; together they were going look at some promising new property he was interested in acquiring for his real estate development company.
This web site is dedicated in loving memory — to my father— who took his own life a few days after he abruptly stopped taking Zoloft.
If Zoloft had been properly labeled with a suicide risk warning I am certain my father would never have taken Zoloft — and that he would still be alive today. However, in the year before my father's death the FDA joined forces with Pfizer, the manufacturer of Zoloft, by submitting an amicus ('friend of the court') stating that it would not allow Pfizer to place a suicide warning in the label for Zoloft even if Pfizer sought to include one because, to do so — according to FDA attorneys — would "misbrand the drug." It was later learned that the FDA's intervention in the case was the result of a telephone call between the FDA's newly appointed Chief Counsel, Daniel Troy, and Pfizer's national counsel. Mr. Troy worked for Pfizer during the pendency of the case.
Where, and when, is all of this going to end?
Kind Regards,
Robert Wall Robinson
Rob Robinson - Founder's Statement
(May 31st, 2004)
It's a beautiful day today: I’m outside on a shady deck, writing, beneath a canopy of trees enveloping me in the reassuring green of a freshly minted spring. Paper-thin leaves, backlit by the sun, flutter like nature’s own confetti in a gentle breeze. Birds are chirping and flitting about.Squirrels, in tune with the spirit of the season, are racing and chasing one another up and down the trunks of the trees. In between spates of writing I purposely stop, letting it all sink in. A quote by naturalist John Muir comes to mind: "The clearest way into the Universe is through a forest wilderness." My reverie is cut short as my thoughts drift back to the memory of a very different kind of wilderness — one which I only recently escaped — the topography of a life bombed into oblivion by a drug called Paxil. Its been almost two years now since I took my last dose of Paxil, but the memory of what I've endured lives on like a monster in my mind. Yet the beauty of this day infuses me with a slowly greening optimism, and the hope that the withdrawal-scorched slopes of my life are still capable of bearing blooms.
Now that I've survived Paxil — and managed to pick up most of the larger pieces of a shattered existence — the question arises: What should I do with the rest of my life?
Most of you probably know the story of Paul Revere; he was the American Revolutionary hero who raced across the countryside warning his fellow citizens: “The British are coming!” Of course, I'm no Paul Revere. (For one thing, I don't own a horse.) But the dangers I feel compelled to warn others of are just as real a threat as the enemy soldiers that prompted Revere to take to the night.
So what's a Paxil victim-turned-activist like me to do? Some of you probably recall consumer rights activist Ralph Nader, who in a book entitled "Unsafe At Any Speed", brought widespread public attention to a dangerous and unsafe car called the "Corvair" back in the 1960's. Sales of the Corvair "crashed and burned" thanks in large part to Nader's efforts.
Mr. Nader's vision, guts and determination to expose the Corvair for what it was — a "hunk of junk" that was "unsafe at any speed" — inspired me in my own mission to expose the damning truth about a dangerous, junk drug called Paxil.
A few months ago I asked myself a critical question: "What would Mr. Nader do if he had been pulverized by Paxil?" My answer to this hypothetical question led to the following actions:
1) Creation (in progress) of a non-profit consumer's advocacy group called "SSRI Citizen".
2) Creation of the slogan "Unsafe At Any Dose".
3) Creation of a web site designed to bolster the efforts of the SSRI Citizen organization.
Of course, the Internet is already home to scores of web sites that strive to warn the public about the dangers of SSRIs — and to their credit they often do a superb job. Regrettably, by the time the public stumbles across one of these sites it is already too late — someone has been mauled by Paxil or one of its feral siblings. Or worse yet, a family member is dead. That's why SSRI Citizen's plan to inform the public about the SSRI public health menace includes reaching out well beyond the confines of cyberspace.
In addition to educating the public about the dangers of these drugs I hope this web site will serve as a rallying point — not only for the thousands and thousands of Paxil victims who have filed suit against GlaxoSmithKline — but all SSRI victims and their families ... past, present and future. There are untold thousands of us "out here" already, and if you are like me you don't want anyone to ever go through what you or your family endured as a result of taking one of these dangerous drugs —especially Paxil. So on behalf of all SSRI victims, and for the safety of the general public, I am calling on each of us to join forces and launch a "consumers' rebellion"(remember the Boston tea party from your high school history days?) against these profit-crazed,out-of-control multi-national drug companies.
This web site will soon share with you many creative (and even fun) ways you can help fight back against these companies ... without expending a lot of time and energy. For example, you can display an “Unsafe At Any Dose” bumper sticker on your car. (It won’t take long for “our" message to get noticed — especially if a million or more vehicles are sporting one, too.) Of course, I don't think the SSRI drug companies are going to be too happy about this ... which will probably make a lot of SSRI victims happy, myself included.
Support this site and our efforts to educate the public: Purchase one of our two-color bumper stickers now by clicking on the bumper sticker of your choice. Note: The actual size of each bumper sticker is 3.5" by 15".
SSRI Citizen's "Unsafe At Any Dose" campaign wouldn't be necessary if the United States Food and Drug Administration had done its job from the outset and warned us about the menace these drugs present. But no thanks to FDA policy shifts that began almost ten years ago drug companies have been given a virtual "green light" to dump drugs into the medicine cabinets of America that are often unsafe and dangerous — but nevertheless obscenely profitable. So what if tens of thousands of people are injured (many killed) as a result of taking an SSRI — that's just the cost of doing business these days. Isn't it, GlaxoSmithKline?
The embodiment of this depraved ideology is perhaps best seen in the person of GSK spokesperson Alastair Benbow who occasionally appears in public claiming (almost mantralike) that Paxil has "helped millions and millions" of people.
Benbow's "numbers logic" is the same monstrous and twisted logic Ford Motor company used at one time to justify its sale of a car called the "Pinto" — even though it had a defect in the gas tank that often caused it to explode in relatively minor crashes. Occupants trapped inside the Pinto were subsequently burned alive. Ford finally fixed the car defect (which is a story unto itself.)
Paxil is a modern day version of the "exploding Pinto" — stuffed into a pill bottle. Unlike the Pinto, however, Paxil cannot be fixed; it is impossible to alter or remove a defective molecule in the drug's composition, thereby rendering it harmless.
And what about the doctors you ask? Why haven't they warned us about these drugs? The reason is simple. Drug companies have (and continue to) withhold disclosure of critical SSRI drug safety information from them as well.
Or the drug companies saturate the medical journals doctors rely on with "ghost written" "scientific" studies — a.k.a. medical "infomercials". See Ghostly Data for an in depth discussion of this subject.
Sometimes the truth, if you can find it, is backstitched into a meticulously woven curtain of confusing "medicalese" printed on parchment paper, and in letters so small you need a magnifying glass to read the text. Not to mention a medical dictionary. So on the rare occasion when your pharmacist provides you with a drug's bona fide "Product Information Leaflet" along with your filled prescription ... good luck. That P.I.L. is about as useful as a sheet of single ply toilet paper. Rest assured, this is no accident. The drug companies want it that way. Take GSK's Paxil P.I.L. Does it advise patients that Paxil (an antidepressant) can actually cause suicidal behavior — even if you're not suicidal or depressed to begin with? No. And that's not just ironic ... it's by God downright scary. It is, in fact, like playing a physician-assisted game of Russian roulette ... with a pill bottle instead of a pistol. Even scarier is the fact that you, the patient, don't know the "game" you're playing — or that there even is a "game". And neither does the doctor.
Paxil is particularly dangerous when starting — or stopping — the drug; especially if withdrawal symptoms occur. Withdrawal symptoms? Hmm. What are the chances of that you might ask. The most recent Paxil P.I.L. I have on hand is one I picked up for inspection from my local pharmacy not long ago and dated January, 2003. Under the heading of "Other Events Observed During the Pre-marketing Evaluation of Paxil" and "Nervous System" you'll find the phrase "withdrawal syndrome." GSK classifies the condition as "rare".
In drug company parlance the word "rare" indicates a condition is observed in less than 1 out of 1,000 people, or .001% of the population observed. Extrapolate from that, and what GSK would have you believe is less than 100 people out of 100,000 experience "withdrawal syndrome". There is a word for that in the English language. The truncated version of it is "B.S."
The truth is Paxil causes severe and protracted withdrawals in vast numbers of people; moreover, it meets the criteria for an addictive drug as defined by the World Health Organization. GSK knows all of this full well, as the world will soon see for itself when the first Paxil withdrawal case goes to trial.
By the way, when I was first prescribed Paxil (for atypical anxiety by a physician after a five minute visit) I read Paxil's P.I.L. word for word about two weeks after starting the drug. It mentioned nothing about addiction or "withdrawal syndrome", among other things. What it did claim, however, was:
1) “Paxil is non-habit forming.”
2) Paxil “may cause mild, usually temporary, side effects in some individuals.”
3) Paxil “has been studied both in short-term and long-term use and is not associated with dependence or addiction.”
In Britain, GSK is now saying that as many as 25% of people that take Paxil will experience withdrawal symptoms. Independent sources suggest the true figure might be as high as 40%. As a result of these earlier "misrepresentations" GSK is now mired (up to its corporate eyeballs) in a legal quagmire fast approaching Biblical proportions. To date, somewhere between six thousand and ten thousand people have filed suit against the company, and as public awareness of the situation expands it is likely many more victims will file suit. For more information visit the following link HERE .
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We have been been duped by an industry that is doing everything in its power to hide the truth about these drugs from us. Consequently, GSK and other SSRI machinators rake in billions of SSRI dollars every year. And it appears even greater profits are likely on the way.
No longer relegated to treat mere depression, SSRI’s are now used (but not necessarily approved by the FDA — which means little these days) to treat: alcoholism, anxiety, anorexia, bulimia, chronic pain, dysthymia, fibromyglia, "inhibition of platelet activation", insomnia, irritable bowel syndrome, migraines, obesity, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, pre-menstrual dysphoric disorder, "restless legs syndrome", premature ejaculation, senile dementia, social phobia, substance abuse, trichotillomania ... and even the urge to light up a smoke.
The urge to smoke? U.S. patent #6,300,343 assigned to SmithKline Beecham on October 9th, 2001 claims the following:
"It has now been surprisingly discovered that paroxetine has potential therapeutic utility as a medicament for promoting smoking cessation or reduction or preventing relapse smoking. Accordingly, the present invention provides a method for promoting smoking cessation or reduction or preventing relapse smoking, which method comprises administering an effective, non-toxic amount of paroxetine or a pharmaceutically acceptable salt or solvate there of, to human in need thereof.
The present invention also provides the use of paroxetine or a pharmaceutically acceptable salt or solvate thereof in the manufacture of a medicament for use in promoting smoking cessation or reduction or preventing relapse smoking."
"Surprisingly discovered." Why am I not surprised. I have to ask: Is this some sort of depraved SKB (GSK) insider's joke? If you think quitting cigarettes is tough ... just give a severe Paxil withdrawal a go. By about day three or so you'll swear you've died and gone to Hell. And after four or so months into withdrawal (if you're still alive) — you'll know it for sure.
The "smoking" anecdote is emblematic of a market expansion artificially created by a drug industry driven to sniff out every crumb of profit it can scavenge through the sale of SSRIs. Who cares if the pill really works, right? Isn't that so, GSK.
Not surprisingly, there is a push by GSK et al. to expand into the heretofore unexploited pediatric SSRI market. In other words: the business of drugging kids with SSRIs. Once the public has been "sold" on the idea of "medicating" adults on a mass scale with these "safe and effective" drugs ... why not their offspring? After all, they can benefit, too. Right?
Of course, when the subject of kids and SSRIs comes up drug companies never pepper their marketing lexicon with strange phrases like "developmental toxins" and "limb-length discrepancies" and "neonatal withdrawal syndrome" ... all of which are related to the use of SSRIs. SSRI Citizen is preparing to share with you what's been discovered.
Speaking of kids: Can you imagine a drug company testing an SSRI on children — and finding it next to worthless when compared to a placebo — but then going on to claim the drug was effective? And imagine if some of the most famous psychiatrists in the United States signed off on the results. You'd be shocked, wouldn't you. Well guess what. That’s exactly what happened in GlaxoSmithKline study 329 (which was the largest study of its kind ever conducted in the United States.) The world learned about this "misrepresentation" when in February, 2004, a confidential GlaxoSmithKline document was leaked to the British press. Here’s the published
abstract for the study, along with the names of the doctors involved: Click here for published abstract.
Was GSK study 329 a single strand in a vast web of deception, or was it an isolated incident? For the answer read what world renowned SSRI expert David Healy, M.D., says in "Ghostly Data" and draw your own conclusions. While on the subject of Dr. Healy ... I also recommend his book entitled "Let Them Eat Prozac". A review of "Let Them Eat Prozac" is housed at this web site under SSRI Citizen's "Recommended Reading."
Dr. Healy maintains a web site where you can read about a lot more than just "ghostly data". For instance: In 2001, GlaxoSmithKline was sued in federal district court in Cheyenne by the family members of Donald Schell, a Wyoming gentleman who killed his wife, daughter, granddaughter and then himself on February 13, 1998 — after taking Paxil for just two days. Dr. Healy served as an expert witness on behalf of the Schell family. In that trial two critical things happened:
1) The judge rejected GSK's challenge of the validity of the scientific data presented to the jury by the Schell family legal team.
2) The jury concluded Paxil was the "proximate cause" of Mr. Schell's homicidal and suicidal actions.
This outcome was not just a surprising defeat for the drug company giant, but also GSK's first public scourging where Paxil was concerned. Of course, the Schell case only cost GSK several million dollars to resolve — little more than chump change for a multi-national corporation.
But it was like being paddled with a pipe cleaner compared to what's coming. Current litigation brought by thousands and thousands of Paxil withdrawal victims is going to cost GSK billions and billions of dollars; perhaps as many as ten to 20 billion. Or more.
GSK appealed the Schell verdict (in Denver), but then thought better of it and gave up. The settlement GSK made with the Schell family survivors allowed the company to get the bulk of its damning documents back, along with confidentiality statements from the plaintiffs which barred them from releasing further details of the case not already in the public domain. Of course, when GSK first decided to fight the Schell suit, it likely never imagined the depositions of some of its top company executives would be posted on a web site — along with the actual trial transcripts.
As a result, GSK has unwittingly armed the public-at-large (which includes me) with critical ammunition needed to go after the company in a full scale public relations war.
Following my escape from Paxil, de profundis, I've devoted hundreds of hours perusing thousands of Internet links, combing for information like that found at Dr. Healy's web site all in an effort to learn as much as I can about the legally prescribed poison that nearly killed me. Eventually I came around to the question: How in God's name did this heinous toxin "Paxil" manage to escape from a lab ... and into my medicine cabinet? So began another Internet odyssey, and it's been an extraordinary and riveting journey.
This is the first time the dark and secret history of Paxil has ever seen the light of day. What you are about to read is a written distillation of three weeks worth of intensive Internet research completed using a high speed cable modem coupled with a Macintosh "G4" computer. Along the way I received a couple of crucial pieces of information from novelist (and Paxil survivor) Trish Spinelli (author of "Blind Reason") and as well a little help from "lady luck". My travels whisked me through the "Net" (as if it were a 20th century version of "Alice In Wonderland's legendary looking glass") and tumbling head over heels into the hinterlands of cyberspace. Incredibly, it all began when I stumbled across a single record; one buried and forgotten in a United States government database almost 25 years ago. Are you ready?
The History of Paxil (and a whole lot more)
"Penetrating so many secrets we cease to believe in the unknowable. But there it sits nevertheless, calmly licking its chops." — H.L. Mencken
"Ferrosan"
In the 1960's a small Danish company called Ferrosan entered into (according to their web site)
"a successful venture into CNS (Central Nervous System) research, which led to the discovery and launch of the antidepressant Seroxat / Paxil, now owned by GlaxoSmithKline".
Ferrosan is almost always referred to as a Danish company — but in a document issued by the United States Federal Court of Appeals concerning a highly technical and convoluted patent dispute relative to paroxetine (See: SmithKline Beecham Corporation and Beecham Group, P.L.C. v. Apotex Corp., Apotex, Inc., and Torpharm, Inc. ) — Ferrosan is referred to as "a British company." In any event, Ferrosan was a family owned enterprise; the Danish part of the group remained so until 1986 when it was acquired by Novo Industri A/S (now Novo Nordisk A/S). After the acquisition, the CNS (Central Nervous System) research activities, the distribution of prescription medicine, and the veterinary medicine activities were all merged into the corresponding divisions of Novo Industri A/S.]
By the way, the suit just mentioned was resolved on April 23rd, 2004 in favor of Apotex Corp., Apotex, Inc., and Torpharm, Inc.
Leading the research team of Ferrosan was an individual, Dr. Jorgen Buus-Lassen, who supported the theory that the specific enhancement of serotonin might lift a depressive mood. But Dr. Buus-Lassen was not a doctor in the ordinary sense of the word, but rather a "DVM" or "Doctor of Veterinary Medicine". In other words: Buus Lassen is licensed to be an animal doctor. Buus-Lassen received his DVM credentials from the Royal School of Veterinary and Agriculture Science in Copenhagen.
With his associates Buus-Lassen explored approximately 100 compounds before deciding on the one that the world would come to know as "paroxetine" and, ultimately, Paxil in the United States. Buus-Lassen's first paper on paroxetine was published in 1975.
In 1989 Buus-Lassen wrote a piece entitled "Introduction to the development of paroxetine, a novel antidepressant." [Acta psychiatr. scand. (1989) 80: 13.] I found Buus-Lassen's choice of the word "novel" mephistophelean; he uses it to indicate a compound "of a kind not seen before". He sure got that right — because Paxil is the spawn of Hell. God willing, the world will never see another "novel" antidepressant like it.
I arranged to obtain a copy of the Buus-Lassen "intro" with hopes it would provide a "ham hock of history" I could toss into the investigatory stew I was in the process of cooking up. When it arrived, the document turned out to be a terse four paragraphs. Of those, two were single sentences. At the bottom of the page were nine footnotes.
Later, Buus-Lassen would recall during an interview with the "Guardian Unlimited", a British newspaper, that "It (paroxetine) didn't work with all patients. In most studies we could just show that we had about the same efficacy as the older tricyclic antidepressants. We didn't see a better effect."
A better effect? Like ... drug withdrawals sent from Hell? If you'd like to email Buus-Lassen a note you can do so care of: ns@neurosearch.dk. I expect tens (perhaps hundreds) of thousands of you have a word (or two) you'd like to share with Mr. Buus Lassen. (Be sure to mention the SSRI Citizen web site.) My bet is after he's received a few thousand emails a firewall will be installed to screen out incoming "slings and arrows". If so, don't be disappointed ... we'll find another address for him faster than you can pitch a new prescription for Paxil in the closest garbage can. Failing that, there's always "snail mail", and of course the phone.
Ferrosan patented the formula for the "Buus-Lassen compound" in 1977 under U.S. Patent #4,007,196. The patent claims paroxetine and its salts and discloses their antidepressant properties. Ferrosan eventually developed a process to produce the crystalline hydrochloride salt of paroxetine, or paroxetine hydrochloride (PHC).
In 1980, Ferrosan licensed the #4,007,196 patent and its other "PHC-related technology" to SmithKline. SmithKline began manufacturing PHC in its Harlow plant in England.
In March 1985, a chemist in SmithKline’s Worthing, England laboratory, Alan Curzons, created a new crystalline form of PHC while attempting to improve PHC production. Curzons’ test results established that the new product was the hemihydrous form of PHC (PHC hemihydrate), while Ferrosan’s original form was anhydrous PHC (PHC anhydrate). PHC anhydrate comprises crystals of PHC without bound water molecules. PHC hemihydrate comprises PHC crystals with one bound water molecule for every two PHC molecules. PHC hemihydrate proved more stable and thus more easily packaged and preserved.
Further review of the SmithKline samples showed that the Harlow plant had unwittingly made PHC hemihydrate as early as December of 1984.
In May 1985, SmithKline began double-blind clinical tests in the United States to determine the "safety and efficacy" of PHC hemihydrate capsules to treat depression symptoms.
On October 25, 1985 SmithKline filed a patent application in the British Patent Office relating to “crystalline paroxetine hydrochloride, its preparation and its uses as a therapeutic agent.” The British application identified the invention as both the hemihydrate and the anhydrate form of PHC, as well as mixtures that contain a major portion of either form.
On October 23, 1986, SmithKline filed a U.S. application claiming priority to a British application that issued as the #4,721,723 patent in 1988. The ’723 patent does not claim PHC anhydrate and does not claim mixtures of the two PHC forms.
If you would like to take an in-depth look at all of the U.S. patent records as they pertain to Paxil click here.
And while you're there: Who can explain the patent for "Methods and compositions for reducing toxicity of a toxic agent are provided in which a polysaccharide, galactomannan is coadministered with a therapeutic agent in a liquid formulation to a subject to reduce toxicity of the agent for the subject." [Since removed]
Scroll down through this record to where it reads: "Examples of therapeutic agents with toxic side effects that may be administered with galactomannan to reduce their toxicity include the following: Anti-infectives including antibiotics, antivirals and vaccines, antineoplastics, cardiovascular drugs including antiarrythmics, antihypertensives etc., central nervous system drugs including analgesics, anorectics, anticonvulsants, anti-inflammatories and tranquilizers etc. OTICS, Opthalmics, gastrointestinal including anti-ulcer drugs, anticholinergic drugs etc. hormones, respiratory drugs including allergy medications, bronchodilators and decongestants, topical drugs and vitamins and minerals. Particular examples in the above categories are provided by way of illustration. Prilosec (AstraZeneca) described in U.S. Pat. No. 4,255,431 and Prevacid (TAP) described in U.S. Pat. No. 4,628,098; Lipitor (Pfizer) an anti-cholesterol drug described in U.S. Pat. No. 5,273,995. The antihyper-lipidemic agent, Zocor (Merck) U.S. Pat. No. 4,444,784; anti-depressants such as Prozac (Eli Lilly) described in U.S. Pat. No. 4,314,081; and Zoloft (Pfizer) described in U.S. Pat. No. 4,536,518; Paxil (SmithKline Beecham) U.S. Pat. Nos. 3,923,743 and 4,007,196; 4,721,723; antipsychotic agents such as Zyprexa (Eli Lilly) hematinic agents such as Epogen (Amgen), also known as Erythropoietin, and antiinflammatory agents such as Celebrex (Searle).
It seems a bit odd that three of the four antidepressants which are the focus of the SSRI Citizen web site — Prozac, Zoloft and Paxil — are included as specific "examples of therapeutic agents with toxic side effects that may be administered with galactomannan to reduce their toxicity". What happened to FDA approved "safe and effective"? My doctor didn't mention anything about "toxic side effects" when she dashed off my prescription for Paxil. Did yours?
"Have nothing to do with the evil deeds of darkness, but rather expose them." — Ephesians 5:11
"SmithKline Beecham and the Gates Of Hell"
Beecham — patent #4,007,196 licensing in hand from Ferrosan
— after merging with another drug company called SmithKline & French (to become SmithKline Beecham a.k.a. SKB), would eventually become the company responsible for flinging wide the laboratory "gates of hell", thereby allowing the "demon of Paxil" to find its new home in the medicine cabinets of America (and the world.)
Of course, before Paxil could be sold in the United States SKB had to gain approval from the Food And Drug Administration certifying Paxil as " safe and effective". So in the 1980's SKB undertook a series of Paxil human clinical trials. Most interesting (to me as a Paxil survivor) were those conducted in Yugoslavia in the late 1980's. To SKB's dismay the Yugoslavia trials were an unmitigated disaster; the company was having a hell of a time coming up with tests they could present to the FDA proving the drug was safe and effective. Billions of dollars in anticipated profits were imperiled. So what did SKB do? Using a bit of " the devil's math" they "fixed" the studies so Paxil would "wow" the FDA. Which led to the following lawsuit against SKB (now GSK): paxilcomplaint.html
Exiting Yugoslavia (phony studies in hand) SKB submitted Paxil's application to the FDA and through a combination of agency ineptitude, stupidity and insider collusion Paxil was approved by the FDA for sale in the U.S. on October 5th, 1992.
In 1993, SmithKline placed "its" antidepressant drug (with PHC hemihydrate as the active ingredient) on the market under the name Paxil. (For the record: Paxil was actually first sold in the UK, in 1991, under the trade-name "Seroxat", but I'll leave that history for someone else to pick apart.)
What has followed is a mind-boggling swath of human misery (and sometimes death) for God only knows how many people. And its far from over; for that you can thank people like football legend turned-Paxil-pitchman Terry Bradshaw who is now being paid millions of dollars to serve as GSK's "Pied Piper of Paxil"; in effect, luring thousands of unsuspecting new victims over the edge and into depths of the Paxilian abyss. Much more on him later (elsewhere at this web site.)
But the real story of Paxil is only beginning. For reasons still not fully apparent a trademark for Paxil was applied for on March 28th, 1980 with the United States Patent and Trademark Office(under "Goods & Services") as a "hypnotic drug for human use". But not by Ferrosan or Beecham, but instead by the German drug company of Boehringer Ingelheim G.m.b.H. To view this U.S. government database record go to the following web page and click on "Search Trademarks". A new window will appear. Under the "Select The Search Form" click on "New User Form Search (Basic)". As the next page appears type the word "Paxil" in the "Search Term" field. Next, click on the "Submit Query" button. Another page with records set up in a grid format will appear. Scroll down to the record which displays serial number 73255881". Right of that is a registration number: "1170889". Click on the word "Paxil" just right of the registration number, and the full record will be retrieved. Note: The official registration date for the Boehringer Ingelheim trademark is listed as September 29, 1981 and a "termination" date of April 7, 1988.
The existence of this seemingly (at first glance) ordinary record educed an extraordinary question: Did Boehringer Ingelheim enter into a joint venture with Ferrosan in the 1960's whereby Jorgen Buus-Lassen was provided the (approximately) 100 compounds he studied of which one went on to become Paxil?" Ferrosan was a relatively small company, and it is my surmise they did not create the 100 or so compounds Buus-Lassen studied, but rather acquired them "off the shelf" from a much larger company with the resources to make them ... like Boehringer Ingelheim. What followed would have been an agreement whereby Boehringer Ingelheim told Ferrosan if it came up with anything marketable from the compounds they would serve as distributor.
If this is not the case, why did Boehringer Ingelheim and not Ferrosan, or Beecham (later becoming SKB), register Paxil on March 28th, 1980, with the United States Patent and Trademark Office? The only logical (and inescapable) explanation is Ferrosan and Boehringer Ingelheim had a substantial business agreement regarding Paxil. One that apparently went "poof" the very same year Ferrosan licensed SmithKline the #4,007,196 patent and its other "PHC-related technology". This connection spurred me to take a closer look at Boehringer Ingelheim.
But before doing that, there's a bit more yet to that Boehringer Ingelheim trademark registration. Why, I wondered, did Boehringer Ingelheim classify Paxil as a "hypnotic" and not an antidepressant? That was not a random designation. Far from it: One of the two companies, either Ferrosan or Boehringer Ingelheim, had conducted research and studies that suggested this was the best way to, pharmacologically speaking, describe the drug's effect. Where is that data now? In SKB's (now GSK) confidential company files?
This led to another question: Why did SKB begin selling Paxil in the United States as an antidepressant and not a hypnotic? And still another: How was "Paxil the hypnotic" transformed by SKB into "Paxil the antidepressant"? After all, hypnotics are central nervous system (CNS) depressants. (Webster's dictionary defines a hypnotic as "Any agent that produces, or tends to produce, sleep: an opiate; a soporific; a narcotic." One medical dictionary simply defines a hypnotic as a "sleeping-tablet".) Why, you might ask, does it matter?
Perhaps it doesn't. However, it might have been (rigged studies notwithstanding) more difficult to gain FDA approval if SKB had tried to "pitch" Paxil to the agency as a hypnotic. Worse yet, it might have led to Paxil's scheduling by the FDA as a "controlled substance". (Which it should be.) Or maybe it would have been harder to position Paxil in the marketplace to compete with Lilly's multi-billion dollar Prozac profit engine ... which was being sold as an antidepressant. Or maybe all of the above.
Whatever the case, one has to wonder if Paxil is soon destined to end up in the pharmaceutical trash-bin of history ... just like Halcion (another hypnotic) did. If the name of that drug (which was banned in Britain) doesn't jog your memory ... here's a Newsweek magazine article that will.
Other questions that must be asked and which will — one day soon — be answered by SKB (now GSK) include:
*What did the companies involved in the creation and eventual distribution of Paxil know about the drug's propensity to induce addiction and dependency? When did they know?
*About the horrifying and protracted drug withdrawals Paxil can induce? When did they know?
*About Paxil's potential to trigger homicidal or suicidal behavior? When did they know?
*Is it possible the answers going to be found in Boehringer Ingelheim files passed onto Ferrosan?
*Or was it Ferrosan who first discovered the horrifying truth about Paxil? (After Buus-Lassen's mice dosed with paroxetine started chewing their own legs and tails off, or attacking other mice.)
*Or was it SmithKline Beecham?
The world will soon have the answer to these questions (and a whole lot more) when the first Paxil withdrawal lawsuit goes to trial. For now, only the drug companies and the plaintiffs' attorneys know the ultimate answers.
"For our struggle is not against flesh and blood, but against the rulers, against the powers, against the world forces of this darkness, against the spiritual forces of wickedness in the heavenly places." — Ephesians 6:12
"Boehringer Ingelheim: Black Widow At The Center Of The 'SSRI Web'?"
The net effect of the questions I've posed thus far prompted me to begin looking a bit closer at Boehringer Ingelheim. Here's what I discovered: Boehringer Ingelheim is one of the twenty largest drug companies in the world; it has strategic partnerships with many other multi-national pharmaceutical corporations, including SSRI giants GSK and Lilly — as well as a new company called NeuroSearch which is headed up by none other than the "father of Paxil" himself Jorgen Buus-Lassen. Much more on this in a few minutes (read on). Boehringer Ingelheim's web
site
Probing the history of Boehringer Ingelheim, I discovered the company garnered some bad press after it was widely reported it had, under the direction of Richard von Weizsacker, supplied the United States government with large quantities of a highly toxic and dangerous herbicide called dioxin (a.k.a. "Agent Orange") during the Vietnam War. Weizsacker eventually left the company and went on to become president of the Federal Republic of Germany in 1984.
In a 1991 article that appeared in "The Mirror" in Germany, dioxin was described as "the most poisonous chemical in the world". Elsewhere, I have come across estimates that suggest as many as one million Vietnamese died as a result of exposure to dioxin delivered by U.S. war planes. Dioxin is, in short, a weapon of mass destruction.
By the way ... Weizacker's father, Baron Ernst von Weizsacker, served as state secretary in the foreign ministry of the German Republic from 1938-1943; in 1949 he was sentenced at the Nuremberg trials to seven years imprisonment for "crimes against humanity". Specifically, he was convicted for his use of diplomatic pressure to make possible the deportation of Slovakian and Italian Jews to Nazi death camps. His sentence was later commuted to "time served".
In the 1990's, a study published in the journal of the United States National Cancer Institute provided conclusive evidence of a direct relationship between industry and the cancer-causing effects of dioxin. Generally ignored by the mainstream press, the study revealed that many thousands of workers in the U.S. chemical industry died of various cancer-related illnesses as a result of exposure to dioxin. Pooling data from more than 5,000 workers from 12 different factories across the United States, the study found that workers with the highest dioxin exposure had a 60 percent greater risk of dying from cancer than the U.S. national average.
Before reading on would you like to venture a guess as to where dioxin came from?
Dioxin was discovered in Hamburg, Germany in 1954 — at the company of C.H.Boehringer by a scientist named Karl–Heinz Schulz who conducted a series of (depraved) experiments using "76 assorted Boehringer products".
The ultimate parent company of the Boehringer Ingelheim corporation is C.H. Boehringer Sohn. Boehringer Ingelheim GmbH, which is a subsidiary of C. H. Boehringer Sohn, is the central holding company for administrative purposes — the corporate central body which manages and directs the worldwide family of Boehringer Ingelheim companies and which delivers central services to all companies of the corporation.) For a bit more background information click here.
Schulz's sadistic dioxin experiments involved the use of live rabbits. Schulz would rub the ears of a control group of the animals with one of the 76 Boehringer chemicals. A second group of rabbits — housed alongside the control group and in open cages — was not treated with a test chemical. A few days after the first experiment commenced hideous boils appeared on the test rabbits' ears. Incredibly, the untreated rabbits in the cages next to the test rabbits were also affected even though they did not come in direct contact with one of the chemicals; they began dying of liver necrosis (a condition whereby liver tissue practically rots). Schulz concluded the untreated rabbits were inhaling the chemicals applied to the control group rabbits. The one thing that all of the chemicals being tested had in common? They contained varying amounts of dioxin.
Subsequent to his rabbit experiments, Schulz reported to his employer that the compounds containing dioxin were, in his opinion, “too deadly” for any conceivable use. What did Boehringer management make of Schulz's report? They didn't like it, because the company had decided it wanted to unload many of the compounds into the American market — so they hid the test results. Boehringer subsequently sold most of these compounds to Dow Chemical in, according to one source, 1960. One of the compounds sold to Dow Chemical was the isolate dioxin. (Is any of this sounding familiar yet?)
Interestingly enough, a year prior to the sale of the dioxin et al. rights to DOW a representative of the United States Army Chemical Corps traveled to Boehringer to see what he could find out about dioxin's potential use — as a chemical weapon. Based on his report the U.S. military concluded that dioxin was too dangerous to be handled safely — although the U.S. military later discovered dioxin worked wonders when used as a defoliant (sprayed from airplanes) to clear vast tracts of lush vegetation in Vietnam (during the Vietnam war).
Digging further into Boehringer Ingelheim's past I tried to ascertain what, exactly, the company was doing in the 1930's and 1940's when Germany was controlled by the Nazi party. Specifically, what activities did Boehringer Ingelheim engage in during Hitler's reign that would prompt the company — after the collapse of the Third Reich to join the German Forced/Slave Labor Compensation Fund? Does it have anything to do (as reported by the Shoah Project) with Boehringer "Compound 2516" studies ordered by Heinrich Himmler and carried out under the aegis of "Dr." Claus Shilling at the Dachau concentration camp? See for yourself. Go to the "Google" search engine at google and type in: "dachau" "boehringer" "2516". One of the first links that will appear should be one that reads "Shoah Project Dokumentation KZ Dachau"; immediately right of this phrase click on the text that reads "Translate this page". A new page will appear with German text translated into (approximate) English. Scroll down to the bottom of the page to the following passage which reads (verbatim):
Professor Dr. Claus Schilling
A set of experiments with the malaria preparation Boehringer 2516 let accomplish. None of the 1200 chose ever in agreement explained themselves or freieillig announced themselves. For these attempts clergyman were often selected. The prisoners were infected by the injection of the mosquitoes themselves or by injections of Extracten from the Schleimdruesen of the mosquitoes with malaria.
Note: The Shoah Project's main web site can be found HERE
Traveling back to the late 1800's I discovered that C.H. Boehringer & Sohn had "jumped into the cocaine trade" and was involved in the business for several decades ... possibly well into 1940's through World War II. See: "The Rise and Demise of Cocaine" by Paul Gootenberg.
Today, Boehringer Ingelheim is participating in another "war". But this war is, ostensibly, for a noble cause. And potentially a very lucrative one. It is the "war on AIDS". Yet how Boehringer Ingelheim is participating in this war is raising some disturbing questions. For example:
Boehringer Ingelheim is the manufacturer of an experimental AIDS drug called "Viramune"(nevirapine). The drug is being used in "clinical trials" involving infants and children at a place in New York's Washington Heights called the "Incarnation Children's Services" — as well as at Columbia Presbyterian and, in fact, at hundreds of participating hospitals in pediatric AIDS clinics nationwide. Coincidentally, GlaxoSmithKline (formerly SKB) is also participating in these "studies" with two of its drugs: Retrovir (AZT) and Epivir (3TC, lamivudine). Res ipsa loquitur: For further details visit "The House That AIDS Built."
"Cymbalta: Spawn of Boehringer Ingelheim and Eli Lilly"
In November, 2002, Boehringer Ingelheim and Eli Lilly (Prozac's manufacturer) signed a longterm agreement to work together and develop the commercialized use of a compound called duloxetine hydrochloride. Duloxetine, (trademark named "Cymbalta") is currently being developed for the treatment of a condition known as "stress urinary incontinence"... as well as depression. Lilly and its investors are counting on Cymbalta to be its next blockbuster antidepressant seller since Prozac has gone off patent and profits have gone "poof". Approval for Cymbalta by the FDA as "safe and effective" is right around the corner. But is it safe and effective? Read the following Philadelphia Inquirer article entitled "Suicide Of A Human Guinea Pig."
"A Family Reunion of Sorts: Boehringer Ingelheim and Jorgen Buus-Lassen"
Boehringer Ingelheim is also hooked up with Jorgen Buus-Lassen (formerly of Ferrosan, creator of Paxil) who is now head of his own company called NeuroSearch (a Danish biopharmaceutical company listed on the Copenhagen Stock Exchange: NEUS:CO)
For its part Boehringer Ingelheim is investing a total of DKK 680 million in exchange for sales rights to a drug for Alzheimer’s and Parkinson’s disease that NeuroSearch is developing. DKK 170 million is being made available now, with the rest to follow over the coming years. Boehringer Ingelheim is taking on the future development costs of the drug. “It is the most important agreement in NeuroSearch’s history. The cash injection ensures that we can develop the drug for the ever more prevalent Alzheimer’s and Parkinson’s disease and bring it to market” says Buus Lassen.
"All About NeuroSearch"
NeuroSearch was founded in April of 1989 by Buus-Lassen and five fellow researchers (Asger Aamund, Jørgen Drejer, Frank Wätjen, Leif Helth Jensen, Henrik K. Moltke and Peter Wulff) who left Ferrosan and struck out on their own, pledging their homes to get a startup loan. They first opened shop in a cellar at Danochemo (which specializes in laboratory medical equipment) based in Ballerup, Denmark. They obtained private financing in the amount of DKK 29.7 million for start up capital.
Today, the company is still located in Ballerup, Denmark (between the Copenhagen (DK) area and Skania in Sweden) in the so-called "Medicon Valley" (think Silicon Valley) which, as of October, 2002, was home to 26 hospitals and 12 universities with 4,000 researchers and 135,000 students. The area provides over 30,000 jobs in more than 160 biotechnology companies. See:
NeuroSearch's goal is to become an international leader in pharmaceutical research and development, with an intense focus on the central nervous system. The company intends to develop each of its compounds "in-house" to maximize the opportunity for potential profits. In other words: It won't buy bulk compounds "off the shelf" to experiment with — like Ferrosan did in the 1960's. (We won't make that mistake again. Right Mr. Buus-Lassen?)
Typically, NeuroSearch tries to broker agreements with large pharmaceutical companies to "optimize development and/or marketing". At the same time NeuroSearch seeks to preserve commercial rights for its compounds in the Nordic and Baltic countries "with the possibility of expanding these primary markets to larger parts of Europe".
NeuroSearch operates under an "in-house as long as possible followed by collaboration" model based on the following concepts:
1) "Collaborations established during the late clinical phases of a compound's development are generally more profitable than those started during the initial stages".
2) "A gradual increase in NeuroSearch's capabilities in the areas of drug development, manufacturing of compounds on a larger scale for extended clinical trials and, in the long term, sales of marketable products".
NeuroSearch currently has agreements not only with Boehringer Ingelheim and GSK (as noted above) but also Abbott Laboratories, along with partnerships enjoining Pharmexa and Pierre Fabre, and equity interests in eight biotech companies, including Bavarian Nordic A/S, NsGene A/S, and Sophion Bioscience A/S.
NeuroSearch maintains an Internet site HERE
Note: The site is not Macintosh accessible.
For a complete timeline highlighting NeuroSearch's history see:
"The SSRI Ties That Bind: NeuroSearch, Jorgen Buus-Lassen and GlaxoSmithKline"
NeuroSearch's first accord involving GlaxoSmithKline (GSK) came (as noted in the history of the company, see link above) in 1993 with then Glaxo Group Research Ltd.
Ten years later and on December 13th, 2003, NeuroSearch and GlaxoSmithKline (which
remember, now owns the patent for Paxil — first licensed to SKB from Ferrosan the company Buus-Lassen used to work for) announced a landmark five-year research and development alliance. The alliance comprises a number of research programs, including the treatment of purported "diseases of the central nervous system" like depression and anxiety.
NeuroSearch compound NS2710, intended to treat the "disease of anxiety", was originally slated for distribution by pharmaceutical giant Pharmacia & Upjohn; however, "problems" arose during the clinical "Phase II" human trials. Not that the compound wasn't "effective" according to NeuroSearch, but rather some patients experienced sedation or an allergic reaction. In other words NS2710 knocked them out or made them sick. The disclosure of these problems was serious enough that Pharmacia & Upjohn immediately ended the partnership. Perhaps NS2710 has been relegated to "veterinary use only". Or perhaps a variation of it will turn out to be
GSK"s "new Paxil". By the way ... about those pesky-sounding "allergic reactions" — is that a NeuroSearch-GSK euphemism for some sort of nasty "withdrawal syndrome?" Just thought I'd ask (it never hurts).
For the "disease of depression" GSK and NeuroSearch were, until March of 2002, banking on the success of compound NS2389 which was being hyped as a "triple action", or "mixed monoamine re-uptake inhibitor". Recently though, abnormal cell growth observed in experiments on rats and dogs scuttled further development.
You will probably be hearing much more hype about mixed monoamine re-uptake inhibitors (MMRI's for short) in the near future. In a 2002 interview with the Guardian, a British newspaper, Buus-Lassen spoke of early clinical studies that suggest MMRI's work on some patients who do not respond to "serotonin enhancement" alone. "But we still have to learn and see if this is right," he says. "Until we've had a full program, it's still a kind of prediction. We have many pieces, but we don't know why not all patients are being cured. Several pieces we do not understand." "Cured" did he say? As in cured like Paxil "cures" you? Personally I'm not interested in being "cured" by anything that comes out of a Buus-Lassen lab. How about you?
What Buus-Lassen didn't mention in his interview with the Guardian is the fact that an older class of antidepressants, commonly referred to as "tricyclics", also inhibit monoamine re-uptake. And it was SSRIs (Paxil et al.) that were — according to drug company propaganda — a great leap forward over the tricyclics in both safety and efficacy. We now know this is not true. For example: According to Dr. Robert Temple, Associate Director for Medical Policy United States Food and Drug Administration who (on Monday, September 11th, 2000, during the course of a public hearing conducted under cover of the FDA Pediatric Subcommittee of the Anti-Infective
Drugs Advisory Committee) said "....the new antidepressants do not differ in effectiveness from the old antidepressants." So I'm a bit confused: It appears as if GSK and NeuroSearch are simply "recycling" tricyclics — and repackaging them as "new and improved". Triple action, no less! (A toothpaste I buy is also sold as a "triple action" product.)
If you are an drug stocks investor you might be saying "darn!" by now. But not to worry ... GSK-NeuroSearch's NS2359 for the treatment of " Attention Deficit Hyperactivity Disorder", or ADHD, is still alive and kicking. In a number of pre-clinical models, NeuroSearch's scientists claim to have shown NS2359 "improves" the function of the neurotransmitters dopamine, noradrenaline and serotonin. On the basis of these pre-clinical (and clinical Phase I results) NeuroSearch anticipates NS2359 will provide a better "therapeutic effect" in the treatment of patients (mostly children) purported to have ADHD.
NS2359 has been tested in 125 healthy volunteers in five Phase I clinical studies, and is alleged to be "well tolerated". In another study involving 54 volunteers (carried out by Professor K. Wesnes, Cognitive Drug Research Ltd.) it was "proven" NS2359 increases attention and improves the ability to recall verbal information. (Could you repeat that?)
NeuroSearch has now initiated a Phase II study with NS2359 at three clinical centers in the U.S. The study includes 100 adult (so called) " ADHD patients", of which 50 be treated with a half milligram of NS2359 once a day, while the other 50 will receive placebo. The stated goal of the study is to gauge the efficacy of NS2359 in the treatment of ADHD symptoms as well as its "tolerability". The treatment period is eight weeks, and the study is expected to be finalized in 2004. Would anyone care to forecast what the results will be? No? Then I will. I predict the NS2359 trials will be reported as a resounding success.
By the way, NS2359 has also been studied in cocaine addicts in collaboration with the United States National Institute on Drug Abuse. What's next? Pediatric cocaine addicts with ADHD?
"Watching Every Neurosearch-GSK (ADHD) Move: Lilly on the Prowl"
No doubt Lilly is watching this development very carefully, because if NS2359 eventually passes the cursory FDA "sniff test" then its own ADHD drug "Strattera" might have a new competitor to deal with — one backed by GSK's own mega marketing machine.
Strattera, by the way, is a selective nor-epinephrine re-uptake inhibitor (SNRI) — as is another drug targeted by this web site: Effexor. For more company propaganda regarding Strattera visit the Lilly web site where you'll be greeted by three smiling girls leaning on one another's shoulder in a sort of "Norman Rockwell" knock-off pose. (Note: You may have to click "reload" on your browser several times to get the "three girls" image to load.) One presumes they are taking Strattera— and loving it. Or maybe they're just models. In any event: Strattera is approved "by the FDA" for use in children and adolescents, as well as adults.
Adults? Surely by now you've seen Lilly's glitzy 30 second TV Strattera "infomercials" or come across a glossy full-page magazine Strattera ad seeking to educate the public about the "grown up" version of ADHD, Adult "Attention-Deficit Disorder". Visitors stopping by the Strattera web site are provided an " opportunity" to find out if they are "living with ADD" by taking an online
"screening test". According to Lilly, many adults have been living with the condition — but don't recognize it. Why? "Because its symptoms are often mistaken for a stressful life". Lilly suggests: "If you've felt this type of frustration most of your life, you may have Adult ADD; a condition your doctor can help diagnose and treat." And after what — a (typical) five minute visit with a physician — one hounded by a Lilly professional sales rep (a.k.a. "detail man") to prescribe Strattera?
"Back to the NeuroSearch-GSK Hydra"
Before we head too far off on a tangent (albeit one that might lead to yet another equally interesting inquiry) let's revisit that corporate Hydra borne of GSK and NeuroSearch: Under the Mterms of the five-year agreement NeuroSearch will receive some "triple action" funding — a total of EUR 82 million (DKK 610 million) in guaranteed payments from GSK. NeuroSearch will further receive EUR 46.8 million (DKK 348 million), comprising EUR 29.1 million (DKK 217 million) of up-front and research payments, and EUR 17.7 million (DKK 132 million) for 616,000 new NeuroSearch shares to be issued to GSK. The shares correspond to an 8.7% increase of the share capital equal to GSK having a strategic equity interest in NeuroSearch of 8.0% after the capital increase. The purchase price of DKK 214 per share of DKK 20 represents a 30% premium to the average market price over thirty days before the agreement was signed. For new development candidates selected by GSK, the terms of the agreement continue until the patents regarding the selected candidates expires. The agreement may only be terminated by GSK in case of NeuroSearch's insolvency, material breach or in case the controlling interest in NeuroSearch is transferred to a new owner.
Perhaps this deal is, in an oblique manner and after the fact, a way for GSK to say "thank you!" to Buus-Lassen for inventing Paxil which last year earned GSK several billion dollars — just like it has for many years now.
Regarding the GSK-NeuroSearch agreement Dr. Tadataka Yamada, Chairman of Research and Development at GSK, fawned: "Diseases of the central nervous system are particularly debilitating and represent a massive unmet medical need. Combining the skills and resources of GSK and NeuroSearch will accelerate and augment our current efforts to make effective new treatments available to patients as quickly as possible. GSK particularly values the collaborative culture at NeuroSearch, which bodes well for the success of our alliance."
Dr. Yamada, by the way, was one of the top GSK executives deposed in the Donald Schell Paxil homicide/suicide case. (trial exhibits, more depositions and trial transcripts) Here's just a smattering of what Yamada had to say (about drug warning labels) when questioned under oath by Houston attorney Andy Vickery:
Dr. Yamada: ....We also have the pressure to understand that our drugs aren't safe and that every drug — although every drug — every drug has potential complications but the benefits outweigh the risks.
Andy Vickery: And in that context, what is the importance of proper labeling as a means to accommodate these two competing interests? We need to get this drug out there on the one hand to people but the drug might hurt some people. Can that be ameliorated in some degree by proper labeling?
Dr. Yamada: That is the hope. That is the hope. It's not — It's not always been borne out, and so the FDA is rethinking about what they want to do, how they actually control the physician. I mean one of the problems is that — Maybe I'm saying too much here, Chuck. (Note: "Chuck" is GSK's counsel.)
Andy Vickery: I can't ask you what he said yesterday, but I bet one of them was just answer his questions. But I appreciate your helpfulness.
Dr. Yamada: It's like a pack of cigarettes. You see on there Surgeon General's warning.
Andy Vickery: Right.
Dr. Yamada: Nobody pays any attention to it.
Andy Vickery: Right.
And another excerpt from the Yamada deposition:
Andy Vickery: Dr. Yamada, as a physician, clinician, academician who not only practiced medicine but taught other doctors how to practice medicine for many years, would you agree that as a general proposition that if language appears in the warnings section in boldface that it is more likely that doctors will take heed of that information than if it's put back in the postmarketing surveillance section and it's not in boldface?
Dr. Yamada: Well, my experience would be that doctors just don't look at the label, period. Now, it could be because I was in an academic institution and that's what we did. Maybe we felt that we were more up-to-date and therefore we didn't need no label. I don't know, but my experience is that most physicians don't look at the label very carefully. And I'm not certain — I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section, and if you would ask 20 young physicians, I'm not sure they could tell you the difference between those three.
Andy Vickery: Do you know that in the information disseminating process one of the truly important ways that your company communicates both the indications and the side effects of your medications to doctors is through the — I forget what title we were using about the detail men, as I call them, the people that call on doctors?
Dr. Yamada: Yes.
Andy Vickery: That's a very important conduit for information; isn't it?
Dr. Yamada: I believe it is, yes.
Andy Vickery: And do you know that your people are trained, your salespeople that call on doctors are trained to emphasize and reemphasize information that is in the warning section of the labels to doctors for the very reasons that you talk about?
Dr. Yamada: I believe so, but I don't know for a fact.
Andy Vickery: Okay, sir. How are you doing comfort wise?
Dr. Yamada: I'm fine. I'm fine.
Andy Vickery: Any time you want to take a break —
***
It seems fitting to conclude the history of Paxil by closing with Jorgen Buus-Lassen. The "father" of Paxil. In bed (again) with Boehringer Ingelheim. Now head of his own company, NeuroSearch, and joined at the hip with GSK — which owns Paxil. "I am pleased that we were able to conclude this important strategic alliance with GSK as our two companies have had a well-functioning and trustful partnership within depression research for three years. I have a strong expectation that this extended partnership will be a major success for both companies.This agreement is one of the most important milestones in our history and is a major recognition of NeuroSearch's competencies within research and development. The agreement significantly increases the generation of value in NeuroSearch and strengthens our financial resources considerably."
***
Towards the end of my own Paxil withdrawal one of my relatives — horrified by the suffering I was enduring — abruptly stopped taking another allegedly "safe and effective" SSRI called Zoloft. A few days later he took his own life. He had just returned from what was — according to friends in California with whom he had visited — a great time. And within an hour of his death he had an upbeat phone conversation with a business associate. Moreover, he had plans to meet a business partner early the next morning; together they were going look at some promising new property he was interested in acquiring for his real estate development company.
This web site is dedicated in loving memory — to my father— who took his own life a few days after he abruptly stopped taking Zoloft.
If Zoloft had been properly labeled with a suicide risk warning I am certain my father would never have taken Zoloft — and that he would still be alive today. However, in the year before my father's death the FDA joined forces with Pfizer, the manufacturer of Zoloft, by submitting an amicus ('friend of the court') stating that it would not allow Pfizer to place a suicide warning in the label for Zoloft even if Pfizer sought to include one because, to do so — according to FDA attorneys — would "misbrand the drug." It was later learned that the FDA's intervention in the case was the result of a telephone call between the FDA's newly appointed Chief Counsel, Daniel Troy, and Pfizer's national counsel. Mr. Troy worked for Pfizer during the pendency of the case.
Where, and when, is all of this going to end?
Kind Regards,
Robert Wall Robinson
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
Wednesday, October 22, 2008
GP Sales Representative - GlaxoSmithKline
Seems they have vacancies in Australia! Click on the highlighted links
http://www.tannermenzies.com/page/jobs?id=427667
GP Sales Representative - GlaxoSmithKline
Newly Created Roles - Experienced & New Reps
Committed to Your Career Development
Global Market Leading Organisation in the Healthcare Industry
Now is your chance to work for GlaxoSmithKline (GSK), one of the world’s leading pharmaceutical organisations. GSK have an impressive history spanning over 100 years here in Australia with a key mission of improving the quality of human life. An organisation who are truly committed to developing people to achieve their best GSK are now expanding their National Sales team and are seeking both experienced and new Sales Representatives.
A career as a GP Sales Representative will see you putting the goals and visions of the company on the frontline. You’re main responsibilities will include:
Initiating and developing strong relationships with GP’s and pharmacists
Promoting a portfolio of leading prescription medicines
Effective planning and time management of a set territory
GSK are committed to developing their people and provide continuous product and sales training that will allow you to excel in your career. It is essential you are a highly motivated individual who takes pride in developing strong relationships with your customers, who also has the ability to not only educate but influence your customers. The nature of the role of a GP Sales Representative demands you to be organised and happy to work autonomously as you are out on the road. It is also essential to be an exceptional team player who is committed to developing strong working relationships with your peers.
Ideally you will currently be working as a Sales Representative or potentially you are a nurse seeking a new, exciting and challenge career change. A degree in Science or a related area is highly advantageous and recent graduates are encouraged to apply.
The role is challenging and exciting and in return, you will be rewarded with an excellent package including a competitive base salary, performance related bonus, fully maintained company car and full product training.
To enquire further, please contact Nikki Norbury in our Sydney office on 02 8298 3803. When responding, please quote 35-720500. Confidentiality is assured.
Anyone with morals need not apply
http://www.tannermenzies.com/page/jobs?id=427667
GP Sales Representative - GlaxoSmithKline
Newly Created Roles - Experienced & New Reps
Committed to Your Career Development
Global Market Leading Organisation in the Healthcare Industry
Now is your chance to work for GlaxoSmithKline (GSK), one of the world’s leading pharmaceutical organisations. GSK have an impressive history spanning over 100 years here in Australia with a key mission of improving the quality of human life. An organisation who are truly committed to developing people to achieve their best GSK are now expanding their National Sales team and are seeking both experienced and new Sales Representatives.
A career as a GP Sales Representative will see you putting the goals and visions of the company on the frontline. You’re main responsibilities will include:
Initiating and developing strong relationships with GP’s and pharmacists
Promoting a portfolio of leading prescription medicines
Effective planning and time management of a set territory
GSK are committed to developing their people and provide continuous product and sales training that will allow you to excel in your career. It is essential you are a highly motivated individual who takes pride in developing strong relationships with your customers, who also has the ability to not only educate but influence your customers. The nature of the role of a GP Sales Representative demands you to be organised and happy to work autonomously as you are out on the road. It is also essential to be an exceptional team player who is committed to developing strong working relationships with your peers.
Ideally you will currently be working as a Sales Representative or potentially you are a nurse seeking a new, exciting and challenge career change. A degree in Science or a related area is highly advantageous and recent graduates are encouraged to apply.
The role is challenging and exciting and in return, you will be rewarded with an excellent package including a competitive base salary, performance related bonus, fully maintained company car and full product training.
To enquire further, please contact Nikki Norbury in our Sydney office on 02 8298 3803. When responding, please quote 35-720500. Confidentiality is assured.
Anyone with morals need not apply
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
GSK's Horlicks In Hot Water
It seems GSK's Horlicks has landed them in hot water regarding it's claims that it can make children "Taller, Stronger and Sharper", a recent Times article claims.
From The Times:
The advertisement was broadcast on Nepali TV, a Bengali-language satellite channel aimed at the Indian subcontinent but also available to viewers in Britain. The ASA's investigators spotted the advertisement on Nepali TV.
You may remember GSK were bust by two New Zealand School girls last year for claiming that their product, Ribena, "blackcurrants in Ribena have four times the vitamin C of oranges". The students - now 17 - decided in mid-2004 to test the vitamin C levels of their favourite juices, including Ribena, Just Juice and Arano, for a school project. They calculated that each 100ml of Ribena contained about 22mg of vitamin C.
The Commerce Commission said that although blackcurrants had more vitamin C than oranges, the same was not true of Ribena.
So here we are again, this time with Horlicks. As far as I was aware, Horlicks, was a malt drink to help make you sleep at night. Not so, it can now miraculously make you bigger, taller and sharper [though a GSK spokesman points out that... "the version of the product sold in Bangladesh was fortified and its health claims were supported by clinical studies done by the National Institute of Nutrition in India"]
From The Times:
The advertisement was broadcast on Nepali TV, a Bengali-language satellite channel aimed at the Indian subcontinent but also available to viewers in Britain. The ASA's investigators spotted the advertisement on Nepali TV.
You may remember GSK were bust by two New Zealand School girls last year for claiming that their product, Ribena, "blackcurrants in Ribena have four times the vitamin C of oranges". The students - now 17 - decided in mid-2004 to test the vitamin C levels of their favourite juices, including Ribena, Just Juice and Arano, for a school project. They calculated that each 100ml of Ribena contained about 22mg of vitamin C.
The Commerce Commission said that although blackcurrants had more vitamin C than oranges, the same was not true of Ribena.
So here we are again, this time with Horlicks. As far as I was aware, Horlicks, was a malt drink to help make you sleep at night. Not so, it can now miraculously make you bigger, taller and sharper [though a GSK spokesman points out that... "the version of the product sold in Bangladesh was fortified and its health claims were supported by clinical studies done by the National Institute of Nutrition in India"]
So where is the study that makes these outrageous claims?
According to this article from the Hindu Times in 2005, GlaxoSmithKline attributes this claim to a recent study conducted by the Hyderabad-based National Institute of Nutrition and funded by GlaxoSmithKline Consumer Health Care. The institute tested the product among 869 kids from a boarding school, in which half the kids were served Horlicks continuously over a period of 14 months, while the rest were served a normal health drink (the brand name of which was not revealed).
"The kids were served similar food, asked to do similar physical exercises, and the result that emerged from the study established that those kids who were on Horlicks were significantly taller, sharper and stronger," says Shubhajit Sen, General Manager, Marketing (Nutritionals), GlaxoSmithKline Consumer.
I wonder if they also removed vegetables from some of those 829 kids diets just to make Horlicks look like it helped in their growth?
What a complete load of hokum and once again, GSK shows just how they will use children to push a product.
So, Does Horlicks really make kids taller, stronger and sharper?
This very same question was asked on Yahoo Questions & Answers.
Here are some of the answers from a very clued up public:
"Nope, it's all BS. Nothing can do that."
"Tut! Tut! You should not believe in advertisements. Of course you can try it and find it good, relishing and refreshing, you can continue it."
"No it's a fake thing. only the company use this for their advertisement and the rapid sales of their product. its only for publicity."
"Its just to attract the children and their parents to take it home with them and these qualities are natural in every child."
"No way they will never help, the best way to become taller stronger and sharper is to eat lots of vegetables"
Nothing ever ceases to amaze me in just how far the GSK Marketing Team will go to sell one of it's products. What amazes me even more is how they are allowed, time and time again, to get away with it!
Fid
Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal
By Bob Fiddaman
ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING
AVAILABLE FOR DOWNLOAD HERE
PAPERBACK COMING SOON
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