Zantac Lawsuit


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

Saturday, September 12, 2015

GlaxoSmithKline 329 - Risky Business









It's no secret that British pharmaceutical giant, GlaxoSmithKline, have been involved in some rather unsavory shenanigans of late. Bribery and corruption seem to be two words that people associate with Glaxo, and rightly so. With an admittance of guilt and a record $3 billion fine in the US it came as no surprise that the cancer had spread across to China, where, once again, Glaxo agreed to plead guilty and pay out $489 million. They are currently under the investigation by the UK Serious Fraud Office for yet more allegations of bribery and corruption. They also go to trial in the UK within the next 12 months where they will defend allegations that Paxil (known as Seroxat in the UK) caused severe withdrawal issues and dependency in a number of people who were prescribed it.

The above cases already settled may be the cost of running a business and, after the dust settled, Glaxo (including their shareholders) shrugged their shoulders and put it all behind them.

Buried deep in the the record-breaking US settlement was the fact that Glaxo had made millions, if not billions, through the sale of Paxil. They illegally promoted its use in children and adolescents. Because this settlement centred around the illegal promotion of a number of Glaxo's products and also how they bribed doctors to prescribe more of their products, there really hasn't been much of a backlash from the public.

All that is about to change and it all centres around Glaxo putting profit ahead of the safety of children and adolescents. The spotlight will, once again, fall on Glaxo hiding important safety information from healthcare professionals and the public, safety information that put a vulnerable population at risk and, arguably, resulted in children and adolescents self-harming, suffering withdrawal and completing suicide.

The fact that Glaxo hid this information from all and sundry shouldn't really be the issue here. The general public need to look through that, after all, it's just part of running a business to hide negativity away from prying eyes.

What we, the public, should be outraged about is Glaxo execs, senior management and reps (to an extent) put children and adolescents at risk by keeping the truth from both them and their doctors.

Glaxo have, in essence, erected a fence around a playground. They have told the children that it's perfectly okay to touch the fence (even though the fence has electricity running through it)

Glaxo have also reassured the parents of these children in the playground.

In teenagers, Glaxo have offered news of a new rollercoaster, it's the best rollercoaster in the world and, more importantly, it is perfectly safe to ride (even though there is a number of cracks in the structure and missing wheels on the carts)

Those selling the tickets to ride the Glaxo rollercoaster are blissfully unaware because they have been informed by world renowned structural engineers that the rollercoaster is safe. Little do they know that these same structural engineers haven't even inspected the rollercoaster. Little do they know that Glaxo have merely told these engineers that their rollercoaster is safe and they should sign off the relevant paperwork that supports this claim.

The above comparisons relate to Glaxo's infamous 329 study that has, for many years, hid the facts of the electrical fence and the unsafe rollercoaster.

Here we have a company who have raked in billions of dollars on Paxil alone. Any harm that has come to children and adolescents has been met with denial from Glaxo. Indeed, adults climbing that same fence and riding that same rollercoaster are, apparently, not at risk either.

I digress.

This is not about adults, it's about children and teenagers. It's about a pharmaceutical company who, for whatever reason, decided one day to put them at risk by giving a drug the all clear when they knew that the drug could, potentially, end the lives of those children and teenagers.

To support the safety and efficacy of this drug, they hired world renowned pediatric psychiatrists, pretty much in the same way they hired those structural rollercoaster engineers) - with such an endorsement they knew (despite the risk to the kids) that they would make a huge profit.

Who thinks like that these days? A psychopath perhaps?

No doubt, when the reanalysis of Study 329 is published soon, Glaxo will cite that it was all part of an era and they aren't like that anymore. There will be no apology and, more importantly (for Glaxo) the electric fence and rollercoaster will remain in place, the fence still with electricity running through it, the rollercoaster still with cracks in its structure and carts missing wheels. Those that regulate the structural engineers of both the fence and rollercoaster will, as usual, do nothing.

That's some legacy for Glaxo, 329 authors (by proxy) and Medicine regulators.

The 329 website can be found here and will be updated once the reanalysis has been published in the British Medical Journal later this month.


Bob Fiddaman.











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