Dr Accuses GSK of Breaking Their Corporate Integrity Agreement

In July 2012 GlaxoSmithKline entered into a Corporate Integrity Agreement (CIA) that obligated them to collect and report on payments and transfers of value to US physicians and US healthcare organizations.

The Corporate Integrity Agreement signed by GSK with the Office of the Inspector General for the Department of Health and Human Services in June 2012 also requires the them to disclose payments and transfers of value to US physicians.

Two years on and what do we have?

A post published on metabolism.com on September 22, 2014 by Dr. S. Brown is accusing Glaxo of going back on their word, thus breaking the Corporate Integrity Agreement.

According to the author, GSK have released a list of 168 physician lecturers, specifically trained to promote their new diabetes product, Tanzeum. 

Albiglutide, which is marketed as Tanzeum, was approved by the FDA earlier this year, can be used as a stand-alone therapy or in combination with other Type 2 diabetes therapies, including insulin and metformin. FDA says albiglutide shouldn't be used to treat people who have Type 1 diabetes.

Okay, so the pledge, according to a 2013 article in the New York Times, would be completed worldwide by 2016.

In the NYT article Glaxo chief Andrew Witty said...

“We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

The 2013 NYT article also states that "Glaxo will continue to pay doctors consulting fees for market research because Mr. Witty said it was necessary for the company to gain insight from doctors about their products, but he said that activity would be limited in scope."

Are we to assume that Glaxo are not actually breaking any agreement (yet) because they have penciled in a 2016 target?

It seems to be a half-assed way to achieve a target of compliance by GSK, or are we to assume that , as Brown suggests, "using doctors to promote their products was just too successful a tactic to give up"?

Brown's post, "Glaxo-SmithKline Reneges on Pledge to End Paid Physician Promoters" offers no evidence or the list of the 168 physician lecturers targeted by GSK.

If true, let's hope that those paid physicians and Glaxo will stick to the guidance of the FDA and not promote Tanzeum for other off-label uses.

A pig just flew past my window.

Bob Fiddaman.

The Glaxo Corporate Integrity Agreement - "Patient First Program"

Glaxo's Deirdre Connolly. "The edge in her voice became very noticeable after that question asking if there would be changes to Patient First."

CafePharma is a wonderful place to hang out.

For those that don't know, CafePharma is a forum designed for pharmaceutical reps to discuss all things pharma. The GlaxoSmithKline forum is a hot bed for potential whistleblowers. Lots of disgruntled ex-employees of Glaxo seem to come under fire if they say anything negative about GSK. Those firing the abuse are reps that currently work for GSK.

A thread caught my attention earlier, it was something I just had to save to PDF as I think, at some point, it may get pulled.

The thread, entitled, "Dierdre's Call", (sp) discusses recent events at GlaxoSmithKline, something the public don't ever get to read about.

First off, the back story...

After Glaxo were found guilty last year of a whole host of violations they had to enter into a corporate integrity agreement with the Office of Inspector General (OIG) of the United States and the Department of Health and Human Services (HHS)

Part of this agreement was to enter into a "Patient First Program". The program was implemented and agreed upon by GSK to ensure that "it will not provide financial reward (through compensation, including incentive compensation or otherwise)"

Seems a tad ironic considering the latest news from China.

Anyway... it appears that GSK's Deirdre Connolly is the subject of debate regarding a phone seminar with Glaxo reps. The topic of conversation was the Patient First program.

Apparently Connolly "lost it" when asked "if assessments and sims (simulations) were still the most effective way to assess reps?"

One poster writes, "The edge in her voice became very noticeable after that question asking if there would be changes to Patient First."

Another interesting comment comes in the shape of , "Total disdain for her teammates is what I heard in her voice. Perhaps she knows the field can't stand her beloved program of test taking and simulations but she is so hard headed that her attitude is its her way or the highway. Either way the call was further verification of the crap hole direction we have been led into. Steve Sons and HR play a big role in all this too - they have never sold a dose/script of anything yet they can tell everyone else how it is done - right."

Comically, and I just love this, a poster then adds, "Please keep us updated on Patient First China Edition."

The CafePharma thread, as usual, turns into a playground school fight with words such as 'retard' and  'moron' being thrown around. And these are the people employed by GlaxoSmithKline!

I wrote about Connolly back in July.

In an interview with the New York Times Connolly describes how both she and Witty shared coffee [how romantic] after she had read an article about him.

Soon after that meeting Connolly joined forces with Witty.

She told the NYT, "Our company is facing a changing health care market that demands higher-quality care, lower costs and better outcomes. As part of rethinking and redesigning our commercial model in the United States, we have revamped our procedures for training, evaluating and compensating our 5,000 sales people.

"This was under way when, last year, the company paid $3 billion in fines to the federal government because it had earlier promoted some antidepressants for unapproved uses and failed to report the status of studies about our diabetes drug. We are committed to ensuring that this never happens again."

I think whoever came up with the name "Patient First" program either has a perverse sense of humour or is just plain ignorant of Glaxo's history regarding patients.

If Glaxo CEO Andrew Witty refuses to meet with disgruntled patients to discuss their horrific withdrawal experiences on Seroxat (Paxil) then what hope does Deirdre Connolly have trying to sell the Patient First program to Glaxo reps!

I'm just loving the Andrew Witty era at GlaxoSmithKline.

Bob Fiddaman