In this second part of 'Aropax Hell' we touch on the behind the scenes documentation and "The" memo - "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine" - that exposed GSK's intention to place the money before the box - as it were. A concerted plan to educate sales rep's from wavering under the strain of humane thoughts was launched.

We touch on Study 329 which produced the very data GSK decided to hide. Self harm, highly addictive and non-efficacy: things look bad for paroxetine. Problems continue to unfold and GSK released studies "showing suicide, hostility, etc". It's clear that the jury verdict [original document] holding GSK 80% liable for the murder-suicide case of Donald Schell was reported widely and led to the BBC Panorama investigation - which actually continues in court today [timeline]. The argument over addiction or discontinuation semantics proceeds splendidly with the courts eventually catching on to the shortfalls of addiction definitions.

BBC Panorama: Secrets of the Drugs Trials - can't see embed? Pop in here.

Struggles with paroxetine are complicated. We can see a gradual "chronology of admission" as GSK confirms dangers effect all ages and quietly reveal it's a major risk during pregnancy. At last after more time - and possibly energy - than earning a PhD, GSK admit what we wanted: paroxetine is an absolute tragedy regardless of age, and can induce suicid ideation in at risk adults.. Thankfully, the FDA agree.

Ultimately, Eliot Spitzer lodged a class action [original PDF] on behalf of New York residents deceived by GSK. The FDA succeeded in agitating for close reviews of paroxetines trials: the famous and detailed Article 31. This episode includes  more out-takes of Dr. Alistair Benbow lying heroically as authours drag his name through mud [2]. GSK itself continually releases token "warnings" and basks in the credit-for-responsibility spotlight.

Our TGA is silent, yet vocal on Straterra - the type of medication one leap up from SSRI's targeting norepinephrine also. Read the documentation, find your own answers. Never use paroxetine - but it is your choice.

This Episode has an Extended News section focusing on the god-bothering moralists distress over those bastions of evil, debauchery and altered consciousness. No, not the pub - The Medically Supervised Injecting Centre. But, this isn't relevant?

Piers Akerman who is a writer for The Daily Telegraph" - Sydneys sister to Melbournes Pulp and Print Court wrote this hysterical gem. Piers, foolishly quotes the misinformative trickery of Drug Free Australia and Dr. Stuart Reece in his hilarious leap from the window sill of journalistic integrity. Kicking off with supportive waffle for The Independent in UK, which raised sales splendidly by "apologising" for a brilliant and much needed call to end prohibition of cannabis a decade ago, Piers races ahead of the Biblical rants of Stuart Reece [last episodes winner] by on-publishing a sentence containing "estimated", "could have" and - my personal favourite - "if" as fact. The tripod holding the sign "run away" snares Piers in one stupefying intellectual thrust. Go Piers!

The Kings Cross Medically Supervised Injecting Centre - Uniting Church report here on why it took the decision - is a world class facility, and recognised as such. The British government is considering such a trial because of this very success. A strict review found the Kings Cross pilot study was a success, other key findings supported Harm Reduction and recommendations were made to commence the same in the UK. Incredibly, in 2007, Australia still has Victorian obsessions with the behaviour of others - as witnessed by the tripe we pay to read, and the fact this "room" is a pilot study.

Whilst an accepted and respected legislative bill gives weight to the need of such facilities. It's up for review this year - hence the efforts of Drug Free Australia to sell it's hysteria. Family and Friends For Drug Law Reform, in March 2007, demolished DFA's so called "report". National experts never question its value. This approach has been repeated by numerous independent bodies. Germany has dozens of these facilities, as they are vital to the public health landscape. Canadas Insite is often attacked with the same non-logic: 'addicts aren't worth the cost of government small change'. Insite also, succeeds in its mission. References abound. Critics write fictional opinion pieces - not science. European Report on "Drug Consumption Rooms" - 97 page PDF.

A full reply to Akermans piece - for which he is yet to apologise to his readers and the health community - from Dr. Ingrid van Beek, the Centres director, on May 3, 2007 is as follows:

Mr Akerman cites Drug Free Australias "review of the statistics" of the first 18 months operation until October 2002, of the Medically Supervised Injecting Centre (MSIC) in Kings Cross, as evidence that it has "failed" (DT 3/5/07) despite a range of health professionals respectfully pointing out the various flaws in its extrapolations over the past several years.

The irrefutable statistics are that in the 6 years the MSIC has now been operating, around 400,000 injecting episodes have occurred in this clinical facility instead of public parks, back alleys and public toilets etc improving public amenity; more than 2,000 drug overdose cases have been successfully treated undoubtedly saving lives and drug users have been referred to treatment and other relevant services on more than 6,000 occasions. Meanwhile the number of drugs users in the Kings Cross area has decreased 40%, the number of ambulance callouts to overdoses has decreased 86% and drug-related crime has decreased 30 - 40%. These facts perhaps explain why 80% of local residents living in the area over these past 6 years support the MSIC.

Please also note that the MSIC is funded by the confiscated proceeds of crime and not tax payer revenue and that I am employed by the Area Health Service and not the Medical Faculty of the University of NSW, which employs the MSIC's evaluation team.

Dr Ingrid van Beek

Medical Director, MSIC.

All articles specific to Aropax/Paroxetine are here

All articles specific to Injecting Facilities are here

Music thanks to Garageband.com

All welcome,

Gags.

Aropax is skillfully marketed and has destroyed lives [Product Information] - all with our TGA's cautious blessing. As addictive as Injecting Ice, data are there for all to see, never ending and absolutely unambiguous. BBC and GSK battle over how to battle. It's over Four Years since Four Corners screened "Hazards of the Happy Pill".

In this Two Part review of GSK's fraudulent activity Firesnake looks at the "pillars of evidence" as it were, surrounding a fairly useless drug, the obscene logic of the business mind and a close examination of sensational cases. Can Paroxetine really be said to have been 80% of the cause motivating Donald Schell to kill? We pick over what we have as evidence and in Part 2, reach the only conclusion possible - jury verdicts aside.

Whilst it's easy to embellish with an accusatory tone, simply presenting the data allows for readers to remain within their own "emotive space". The mature view holds that these issues certainly occur and we can learn from them. It's a case of big business management, investment, expected outcome and the pressure of competition in manufacturing pharmaceuticals. It's also a case of vulnerable people being ignored, ill people being made more ill, tragedy and deception. It also raises concerns over present regulation. And yes - government apathy.

Part One ranges broadly casting a net over what we can encapsulate. Part Two, will examine specifics, health choices and offer advice.

Paroxetine has been marketed as "non-addictive". Whilst the withdrawal form paroxetine is now recognised and Canada has insisted on removal of the "non-addictive" label from packaging, GSK argue semantics. The definition of addiction originally trotted out some decades ago never included drugs like SSRI's. Excluding psychological components such as compulsive behaviours like gambling, overeating, etc the physiological aspect is;

1. Withdrawal symptoms in the absence of the drug such that normal functioning is difficult if not impossible. Symptoms are specific to the type of drug.
2. Physical dependence. This gets immediately murky for SSRI's because tolerance is a component of dependence. It even stands seperate from "addiction" because addiction per se includes behavioural changes [drug seeking, spending, apathy] and a complex psycho-social aspect].
3. Tolerance. SSRI's don't induce tolerance. Tolerance is part of dependence so it can be argued SSRI's don't come close to the accepted definition.

Yet we had a medication that presented withdrawal symptoms in it's absence and these symptoms cease in it's presence. People were unable to function without it. This made management of depression difficult as symptoms conflicted, and paroxetine has proven to be powerfully addictive. One must be slowly weaned from paroxetine. This severely limits the opportunity depressives have to assess various SSRI and NSSRI meds. [1], [2], [3], [4] [5], [6]. GSK has gone to some lengths to fight what have become known as "Withdrawal Lawsuits". Canada succeeded in having GSK release a statement regarding prescription to teens and children.

There is enough concern over paroxetine withdrawal for data specific to it to get an airing in many areas - and the data are helpful. But the nuts and bolts are this: One of the world's foremost experts in SSRI neurophysiology is Dr. David Healy. He has published a 5 page PDF on halting SSRI medication. However, there are conflicts of interest relating to Dr. Healy's employers, his research findings and his perceived bioethical stance [2]. However, Healy has been a key player in exposing GSK, and in the case of Donald Schell.

The "Problem" with paroxetine isn't it's status as the most addictive SSRI and the most difficult to withdraw from. It was the fact that paroxetine had been shown to be non-efficacious in treating depression, led to suicidal ideation and acts in healthy subjects of all ages, led to anxiety in depressed and healthy subjects, may well lead to suicide in children and teens and should not be released.

By then however, GSK had invested billions. The "target" demographic was 25 million in the UK alone, as proudly boasted to UK Labour MP, Paul Flynn. They had invested and budgeted on paroxetines success. Lilly [formerly Eli Lilly] were racing ahead on the success of Prozac. As will be plain in the documents below, the company tried to suppress data and present a favourable outcome, fraudulently. It was considered "commercially unacceptable to include a statement efficacy had not been demonstrated" [original memo here]. [Definition of "Efficacy"].

GSK tried to stop sales reps from divulging the accurate information to potential prescribers - thereby puttng the public at immediate risk. This fact was published in the journal of The Canadian Medical Association. But it was the paying of compensation to the family of Donald Schell, after a jury ruled GSK liable [2] [Jury Verdict original], that was a turning point. This decision brought closer inspection to the safety of SSRI's in general and GSK specifically, due the public awareness of executive deception.

The BBC Panorama investigation shook the U.K. It was a regular discussion point in Parliament and the Labour member for Newport West, Hon. Paul Flynn, delivered a condenming speech on Feb. 23rd 2004. Concern for children's health was plain in later discussion. Indeed, some of Flynn's claims as specific to paroxetine are well documented in the treatment of depression by other means and even all other means; Eg - suicide risk does increase in the early stages of recovery from depression and this has long been recognised. Reasons postulated range from a renewed energy enabling the depressed person to suicide on a "bad day", an as yet not understood "stage" of recovery [ie; recovery may not be steady but a rise and fall process and we should be treating for this] or simply a clearer mind and renewed sense of identity actually play a role in the person rationalising suicide as a non-selfish "correct" choice.
The speech may rankle the scientist in me, but it did draw much needed attention toward this billion dollar industry. Other SSRI meds received scrutiny. This, along with the ever increasing noise from The Seroxat Users Group who continue to produce up to date media releases, led to scrutiny around the world. [Info' PDF: Happy Pills that make you go Mad].

Ultimately, parents in the USA began a class action. New York Attorney General, Eliot Spitzer acted firmly on their behalf [original court lodgement]. This also had the effect of re-igniting the debate of a "trials registry" to record all trial data from the outset. Prior to the merger with SmithKline Beecham in 1998, GlaxoWellcome was considering such a registry.

And data continue to emerge in various forums around the world, giving a fragmented chronology of events at a time we need to seriously assess just what to attribute to paroxetine, SSRI's, illness per se and Poor Science. For this is a fact: whilst paroxetine was released and marketed in an unacceptable fashion, it was marketed and widely prescribed. For better or worse, planet Earth has become a living laboratory. Whilst much attention is given to the re-examination of GSK's data regarding paroxetine, many patients choose to remain on this particular SSRI. That choice must [at present] remain.

Part Two also expands on the documentation that damns paroxetine, acknowledges the work of Citizen Investigators, looks present tensions and offers advice on alternative treatment/s.

In News we touch upon a 3 part offering from health writer Ray Moynihan on the dangerous and unregulated use of Naltrexone Implants [not oral naltrexone] by two Christian Fundamentalists. Used to stop the effect of illicit drugs, these implants carry risks. Severe risks if relapse occurs.

Our Minister for Morality Hon. Father Abbott, has given this risk his blessing - and our money. This issue itself, deserves an episode.

Whilst methadone is evidence based and effective and naltrexone isn't, a christian fundamentalist mag erroneously and negligently reported on Reece's "vindication" and the value of Naltrexone implants over the failure of methadone. A crusador against porn, free thought and Harm Minimisation - Australias official D&A policy, Firesnake must conclude it is Sin, not Suffering Reece seeks to "cure".

Any refusal to answer a perfectly legitimate question on our communities health, by a theocrat profitting from his personal moral crusade on our ill, is indeed a Clear and Present Danger to Critical Thought. Congratulations Dr. Reece!

All documents mentioned in both episodes are here.

Music thanks to Garageband.com.

Gags.