GSK Whistleblower Documents Released

Longtime friend and fellow activist, "The Truthman", is taking the bull by the horns on his excellent blog, GSK: Licence To Kill.

Today sees Truthman release just one of many documents pertaining to allegations made by Thomas Reilly who was sacked by GSK after bringing to their attention a staggering number of compliance issues. It seems to be a standard tactic for GSK to sack employees who bring compliance issues to their attention. Hamrick, Thorpe, Kumar are past whistleblowers of GSK who all met the same fate when making complaints to senior staff at GSK. In fact, I've yet to see anyone kept on by GSK who has made a complaint about their compliance procedures.

According to the documents, released via Pacer earlier today, Reilly claims that GSK's entire global manufacturing business has been running on defective IT systems putting their products at high risk of contamination. These products may include, but are not limited to, over-the-counter cold & flu remedies, sports drinks, dietary supplements, tubes of toothpaste. Also, prescription drugs manufactured by GSK, including their antidepressants Seroxat (Paxil) and Wellbutrin (bupropion). Many other products manufactured by GSK could also be at risk of contamination. For a breakdown of GSK products, visit here (last updated in 2013)

It's basically CIDRA on a global scale!

I'm not up to scratch with Reilly's allegations so here's Truthman to explain what has been alleged.

The Most Scandalous Case In Pharma: GSK’s Manufacturing Cover Up Puts Millions At Risk Of Harm.


Bob Fiddaman

Health Canada Refusing to Release Glaxo's Dirty Secret

The Canadian medicine's regulator, Health Canada, are reportedly sitting on information pertaining to a recent FDA  inspection of a GlaxoSmithKline plant in Québec, Canada.

In a letter to John Glavas Site Director, Quebec Operations GSK Biologicals, North America, the FDA raised concerns that related to bacterial contamination problems that were ongoing and may date back to 2011. Moreover, the FDA raised concerns about the purified water system at the plant.

The FDA also noted that since 2011 a total of 60 lots of vaccine from the plant have been rejected due to endotoxin levels that are over a pre-specified limit. Endotoxins are created by bacteria.

Glaxo manufactures roughly half of Canada’s seasonal flu vaccine order and has the country’s pandemic flu vaccine contract.

Health Canada carried out its own inspection of the plant but, according to The Toronto Star, are refusing to release its findings,

“Health Canada seems to be prioritizing what the companies claim is confidential business information over patient safety and that really isn't acceptable,” said Dr. Joel Lexchin, a health policy professor at York University and drug safety expert.

Health Canada refused to release the eight-page report in an emailed response. The agency said the inspection found no “critical risks” and the factory was given a “compliant” rating, but that it documented problems with contamination levels.

Great line, “Health Canada seems to be prioritizing what the companies claim is confidential business information"

So, if there is information that could be potentially damaging Glaxo scream, "Hey that's confidential business information".

Back in April  the FDA sent GlaxoSmithKline a warning letter listing a series of violations regarding one of their plants in Ireland. The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

A month later the Brazilian drug regulatory agency, ANVISA, sent Glaxo a warning letter stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues. As a result, the sale of Paxil was temporarily suspended.

Furthermore, in 2010 Glaxo were fined $750 million for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico. Violations that included...

• Antidepressants containing different dosage strengths.
• Heart medication containing different strengths.
• A diabetes medication with a defect.
• A children's ointment that was contaminated with a microorganism associated with bacteranemia, urinary tract infections, meningitis, wound infection, and peritonitis.
• And a injectable drug used to treat nausea and vomiting in patients undergoing chemotherapy that was contaminated with micro-organisms.

Glaxo's mission statement is that they are "are committed to fighting disease by bringing innovative medicines and services to patients throughout the world".

Maybe they should start by reassuring consumers that there are no contaminated medicines leaving their plants!

Bob Fiddaman.

Brazil Suspends Sale of GSK's Paxil (Seroxat)

The National Health Surveillance Agency (ANVISA) have temporarily suspended the sale of GlaxoSmithKline's antidepressant Paxil.

ANVISA are the Brazilian drug regulatory agency who regulate the drugs Brazilian citizens are prescribed.

GlaxoSmithKline sent ANVISA correspondence stating that batches of Paxil may have been manufactured with the use of active ingredient in the presence of residues.

It's unknown where the contaminated batches originated from. The batches recalled are:

SH0040V (manufacture date, June 2013, and expiration date, June 2015),
RK0084V (manufacture date, August 2012, and expiration date, August 2014),
RJ0220V (manufacture date, July 2012, and expiration date, July 2014),
RJ0219V (manufacture date of July 2012, and expiration date, July 2014),
RC0113V (manufacture date, March 2012, and expiration date, March 2014)
RC0113V1 (manufacture date, March 2012, and expiration date March 2014).


Last month GSK Ireland were sent a warning letter from the FDA listing a series of violations regarding the state of their plant in Currabinny, Carrigaline, Cork. Paxil had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

Back in 2010 Glaxo plead guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.


Bob Fiddaman

GSK Unleash Contaminated Antidepressant Into Ireland

On Wednesday I wrote how the FDA had sent GlaxoSmithKline a warning letter listing a series of violations regarding their plant in Ireland.

The plant, located at Currabinny, Carrigaline, Cork, Ireland, had been inspected by FDA officials back in October 2013 and it was found that batches of paroxetine [Known by it's brand names of Paxil, Seroxat and Aropax] had become contaminated with material from Glaxo's waste tank, which contained APIs [Active Pharmaceutical Ingredients], intermediates, and solvents.

According to the FDA's warning letter, Glaxo became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of paroxetine manufactured using the contaminated solvents on April 19, 2013. Glaxo then distributed paroxetine shipments that were potentially contaminated.

RTE News reported on Wednesday that the Irish Medicines Board had confirmed that a number of batches of Seroxat, that were being recalled by GlaxoSmithKline, had been placed on the Irish market.

So, let's get this straight.

Glaxo knew back in 2012 that batches of paroxetine had become contaminated with material from their waste tank but they did nothing?

I'd smell a lawsuit if this were America. Sadly, European law firms don't have the financial clout to go up against the likes of GlaxoSmithKline.

Inspectors from the Irish Medicines Board are now on site "to ensure that the company's investigation into what happened has been thorough."

How reassuring. Glaxo being monitored by an agency that, in 2009, received 27.08 million euro from the pharmaceutical industry.

This must come as a huge embarrassment to Glaxo Chief, Andrew Witty, who last year blamed Glaxo's fraudulent behaviour on an 'era'. This after his company his company plead guilty to violations over a number of its drugs.

This isn't the first time the FDA have had to warn GlaxoSmithKline over contaminated products.

Back in 2010 Glaxo pleaded guilty for failing to meet government standards for their drugs that were being manufactured at their Cidra plant in Puerto Rico.

Here's an interview with Cheryl Eckard, a former employee of GlaxoSmithKline who was fired after raising the Cidra violations with company officials..

In the words of Jim Royle [Royle Family], "Part of an era, my arse."

Bob Fiddaman