Five GlaxoSmithKline execs who ignored GMP violations still at GSK

[size=+2] David Pulman, Janice Whitaker, Peter Savin, Diane Sevigny, and Jonathan Box [/size]

[size=1.5]Five GlaxoSmithKline executives who allegedly ignored Eckard believed to be still at company

Whistleblower's detailed memorandum said to have been ignored by five named senior directors [/size]


Simon Goodley
guardian.co.uk, Thursday 28 October 2010 21.20 BST
Article history

GlaxoSmithKline's headquarters in London. Photograph: Sang Tan/AP
Five of the six senior GlaxoSmithKline executives cited by a whistleblower as part of a cover-up of contamination problems at the group's Puerto Rico factory are understood to still be employed by the pharmaceuticals company.

Cheryl Eckard, who was sacked by the company as a quality control manager in 2003 after repeatedly raising her concerns with a series of GSK executives, received a $96m (£61m) reward this week as part of a $750m criminal and civil settlement between US regulators and the company.

Her evidence stated that she believed company executives refused to acknowledge the gravity of the production violations – which included the wrong strength of pills being shipped – because it would delay the approval of two new drugs by the US Food and Drug Administration.

The court documents allege that Eckard, who had recommended the factory be shut until the issues were resolved, communicated the quality violations at the plant in Cidra to David Pulman, president of global manufacturing and supply; Janice Whitaker, senior vice president of global quality; Peter Savin, vice president of global quality assurance; Diane Sevigny, director of global quality assurance, risk management and compliance; and Jonathan Box, vice president of manufacturing and supply for North America.

All five executives are believed to be still working for the London-listed company, while Pulman is also a member of the company's 18-strong corporate executive team, which includes chief executive Andrew Witty.

The whistleblower's evidence states: "Eckard now believes that Whitaker, Pulman and other GSK executives were unwilling to acknowledge the gravity of the violations at the Cidra plant and to take the action that Eckard had recommended in part because the FDA had indicated that it would not consider approvals for [GSK drugs] Avandamet and Factive until [a previous FDA warning was] resolved."

It further outlines how "on or about April 2, 2003, Eckard delivered to GSK senior managers Box, Savin, Whitaker and Sevigny … a non-routine detailed memorandum on Current Compliance Risks for Manufacturing and Supply of Drug Products at Cidra … She did not receive any response to her memorandum from any of the managers."

Eckard also states that she told Sevigny "that she would not participate in a cover-up … and would not take part in any further meetings with the FDA about the Cidra plant … During this period and thereafter, Eckard and Sevigny were in frequent and increasing conflict about GSK's management of the quality and compliance problems at Cidra."

After 10 months of repeatedly alerting a string of GSK executives to the problems, Eckard was sacked in 2003. In July of that year, she telephoned JP Garnier, GSK's then chief executive, who declined to take the call. Eckard then reported the company to the FDA in August 2003.

A spokesman for GSK declined to discuss the five executives or confirm that they still worked for the company. She said: "I think it is also important to reiterate our commitment to patient safety and compliance with cGMP [current Good Manufacturing Practice], which has been demonstrated by the fact that we have not received an FDA warning letter at any plant since the Cidra facility was cited in July 2002."

The company has pleaded guilty to five breaches of quality standards, including those relating to certain lots of Kytril – an anti-nausea drug used for cancer patients – being released when "the manufacturing processes and laboratory testing were insufficient to assure the medicine was of the quality and purity required" and certain lots of diabetes treatment Avandamet being released before the company was sure the drug "was of the strength, identity, quality and purity required".

The company says that, aside from those five specific breaches, it "denies all other government allegations and the allegations by Ms Eckard".

 

China will make Cidra look like boy scouts. JB, this falls into the category of "careful what you ask for".

New release test for API: "Total Melamine". Let's get our specs set right here boys!

 

Is JB next on the target list?

JB's initial response to the Cidra mess (back when it was unraveling a few years ago) was to implement an extraodinary amount of "governance" systems in PreClinical Development, primarily the DFM (designed for morons, aka, GMS) initiative. DFM was aimed at a fully understanding our products and processes.

JB's goal was that GSK's going to know AS MUCH as possible about products and processes.

Fascinating how within a few years we have nearly abandoned DFM in favor of Differentiated Developability (DD or Don't Do). Which really means GSK aren't going to know anything about its products that isn't absolutely essential to producing the next CTM batch.

In other words, JB's current approach is that GSK will know AS LITTLE as possible about its products and processes before GSK knows it can make money off of them.

I'm not sure the FDA would approve of that - in light of the FDA's past allegations that GSK failed to demonstrate that it was developing robust drug products.

I think FDA needs to follow-up on whether GSK is complying with the promises it made as part of the descent decree regarding improving our drug development process.

In my humble opinion, while GMS caused the GMP problems in Cidra, JB's organization may very well have some liability for apparently breaching GSK's obligations in the consent decree where GSK committed to improving its product understanding, not reducing it.

Who knows, maybe JB will be targeted for PCD's apparent failure to comply with consent decree regarding developing robust products.

But I'm not a lawyer, what do I know.

Well, what I do know, is that with all of the on-going legal actions against GSK, it is certain that some legal flunkies from the DOJ and/or FDA are reading these forums looking for clues to guide their investigations.

Happy reading Feddies!

 

JB going to jail? Absurd. (But we can dream...)

Is the consent decree posted anywhere?

The DD approach doesn't violate the consent decree. Almost all DD compounds will fail, therefore not knowing much about the robustness of the formulation/process is irrelevant.

The real trick will be when a DD compound approaches success.

How fast can we generate the necessary information to have confidence in what is actually launched? That will be the real challenge of DD.

But as long as most DD compounds die, there is no PCD liability.

On the other hand, I've heard recent rumblings about taking one of these supposedly 'simple' formulations/process for DD compounds all the way to market, and then coming up with a commercially robust product after regulatory approval. If I've heard correctly, it sounds like we may be moving the DD end-point from Proof Of Concept, to first regulatory approval. To me, that sounds like a questionable practice that may not be in keeping with consent decree. But all of that is gross speculation. We haven't had a DD compound get that far yet so we don't know how much info we would actually have at time of submission. Anyway, the whole DD initiative is about customisation of the development process based on particulars of each compound. So pointless to speculate if a DD project would satisfy the consent decree or no.

JB in jail? Just a fantasy.

 

Taking a 'simple' formulation to market with very limited information should be OK too.

The concept is that the formulation/process is so simple that you don't NEED a lot of information.

 

do you know whats really easy?

CONTRACTING OUT a simple formulation

If all you are doing is putting powder in a bottle or powder in capsule no reason on earth why that cant be contracted out

 

And, why is it again that there are so many people still "needed" in PD?

 

"because no contract lab can do it as well as we can" is what i keep hearing

PD: a bunch of whining self-centered Prima Donnas

 

Utter nonsense. I've heard that so many times, and it's rubbish for most routine needs.

 

What also appears to have been missed by most, is who was in charge of the formulation development while Paxil CR tablets were splitting etc. Our good friend JB. He knew there were issues.

 

clinical trials in India

I am a journalist looking for individuals in India who have been harmed in clinical trials or families who have lost loved ones.

Please e-mail me at sgambard@earthlink.net.

All responses are confidential.

 

What about the local management? Are they still active in industry? Adalberto Ramirez, Gloria Martinez, Jeff Williams, and others.