Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Saturday, December 22, 2007

Aropax Hell Part II

It seems the word is spreading throughout Australia.

This is an account taken from the firesnake website, I urge yo to visit, the guy has obviously done his homework when it comes to Paxil 329 study.

I've republished it here in its entirety, hope the author does not mind.

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Yes, Aropax kills. 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 know it's the fourth most addictive drug on the planet. And we pay good money, for a drug that makes well subjects anxious and depressed to the point of suicide, and has no effect upon depression at all.

Justifiably, criminal charges followed. It is plain Paroxetine must be considered carefully. European Paroxetine Q&A here.
Why was it reviewed? What are concerns? What's the evidence?

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.

For those involved on the inside, it's a bizarre ride. Aside from the raft of personality fragmentation even modest struggles with paroxetine induce, it is clear this induces suicide and self sabotage in previously stable or asymptomatic persons. 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 kills without compunction. Thankfully, the FDA agree.

Annoying the FDA is kinda silly and when Eliot Spitzer was given the run around by GSK over paroxetines inefficacy, one imagines his blood boiled. Ultimately, 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.

Firesnake also looks closely at SSRI induced aggression, depression per se, what we know of Donald Schell, his mood swings, prior medication, SSRI blood levels and time needed to observe any effect of any SSRI - no matter how inefficacious. Paroxetine may be a useless SSRI, but an SSRI it is. Did Schell kill and suicide as a direct result of paroxetine? Or, did justice really catch up with GSK due to illegal business practices and appalling ethics, revealed in so much damning documentation? If the latter, legal purists may find this challenging, but none can deny paroxetine was going to kill, did kill thousands of others, destroyed lives, families, careers and if not for dedicated advocates, we may never know. Firesnake considers the only conclusion possible, and reflects upon "justice" - no matter how it comes.

Australians must be proactive. Ethnocentric, we are blind to global dynamics and receive a filtered trickle of data. I myself have brilliant colleagues, who still, in blind error and with no small amount of defensive, guilt-in-hindsight-arrogance, insist paroxetine's safe. Why? They are busy, prone to follow "best practice" over evidence based practices, meet the needs of pestering patients, staff, colleagues, employers, registrars, ethics committees and of course, the drug companies that paid for their beach front property with decades of obscene perks. And let's not forget because the company blurb says so - and to ever admit the reality is to invite litigation.

If your GP, psychiatrist or gym instructor prescribes or recommends Aropax, take your business - and life quality - elsewhere; that person is genuinely mistaken.

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.

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