Zantac Lawsuit

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

Tuesday, July 10, 2012

GlaxoSmithKline: The Andrew Witty "Era"

GSK's Andrew Witty. What was his role in 1997/98?

First off let's take a look at Andrew Witty's statement that came on the back of his company pleading guilty to violations over a number of its drugs.

“Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.

“We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.
 “In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management. 
 “We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.”
All seems 'sweet' until we delve deep into Andrew Witty's tenure at Glaxo Wellcome and GlaxoSmithKline.

Glaxo's PR Department must have been hard at work these past few months or so. Searching for Witty's previous roles at the company have been exhausting. His bio page on the GlaxoSmithKline page doesn't really tell us anything about him at all, particularly between the years of 1997 and 1998 when he was head of the Glaxo Wellcome marketing team. One would think that winning an award for his marketing achievements during this period would sit proudly on any person's bio or CV...not Andrew Witty's though. Maybe it's a past that he would rather forget about or maybe his recent statement [above] would seem utterly ridiculous given that he himself was part of the problem [era]

1997/98 is a period of time where Witty was heavily involved in marketing although there are very few articles left on the internet that show this.

Glaxo Wellcome'sVP-General Manager of Marketing Andrew Witty, as he was known between 1997/98, worked very closely with prescription drug ads on TV. This is known as DTC or Direct to Consumer advertising.

In August 1997 the US Food and Drug Administration [FDA] relaxed its rules on DTC, it basically meant that the FDA were giving carte blanche to the pharmaceutical industry whereby they could promote their products in TV ads without giving detailed medical information on the indications, potential side effects, or proper use. [1]

Witty was quick to pounce. Why wouldn't he? DTC is lucrative for the pharmaceutical industry, well, it is in America and New Zealand as these are the only two countries that allow TV ads for prescription medication.

Witty added more products in 1997 with Glaxo's new anti-smoking pill Zyban, [buproprion] which got an estimated $55 million in support (the brand is even got TV teaser ads prior to its launch)

For those who don't know, Zyban is also in fact Wellbutrin which is an antidepressant that Glaxo marketed off-label for a whole host of reasons that it was never indicated for. See back story here and it will show you how Glaxo hired a famous radio personality to promote Wellbutrin for  increasing someone's orgasmic potential.

If we use the generic name, buproprion, rather than the brand names it gets slightly easier to follow.

You see bupropion is used to treat major depressive disorder and seasonal affective disorder and it is also used to help people stop smoking by reducing cravings and other withdrawal effects.

So, in 1997, Witty pushed Zyban, Wellbutrin, call it what you will, onto the TV screens and into the homes of millions of Americans. He was in actual fact pushing an antidepressant onto an unsuspecting public.

Here's a Zyban ad from 1997, this is one that Witty would have been behind as Glaxo Wellcome'sVP-General Manager of Marketing. What I find remarkable about this ad is that they do not distinguish the two brand names as being practically the same. The only warning they off is, "Don't take Zyban if you are taking Wellbutrin" - Surely it would have been morally ethical to tell the consumer, "If you take Zyban and Wellbutrin together you will actually be overdosing on the active ingredient, bupropion." But hey, why would a pharmaceutical company, like Glaxo, wish to inform its consumers that a drug that could help you quit smoking was  really an antidepressant?

Of course Glaxo got around this by altering the molecule structure. Change a molecule here and there and it can give you a whole new brand name with an even bigger target audience, case in point being Celexa and Lexapro, Forest pharmaceuticals blockbuster antidepressants, they are pretty much the same, save for a bit of laboratory tweaking.

So, with Witty's marketing strategy he and his team launched Zyban.

Are we to believe that Witty had no input to the sales team? Remember his statement at the top of this post?

"Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made."


A number of other drugs mentioned in the whistleblower suit seem to have fallen on deaf ears in the mainstream media. Lotronex,[alosetron] a drug made by Glaxo Wellcome that was on the US market for nine months, during which time it netted them an estimated $56 million. 

Why was it taken off the market?

According to Wikipedia alosetron was withdrawn in 2000 following the association of alosetron with serious life-threatening gastrointestinal adverse effects. The cumulative incidence of ischaemic colitis was 2 in 1000, while serious complications arising from constipation (obstruction, perforation, impaction, toxic megacolon, secondary colonic ischaemia, death) was 1 in 1000. 

This from The Lancet [2]

By July, 2000, concerns about the balance of risk and benefit were being voiced.3 Between February and June that year, seven patients had developed serious complications of constipation, three of whom required surgery. Eight further cases of ischaemic colitis were reported. The FDA had an opportunity then to take stock of its earlier decision. The clinical data confirmed the substantial and potentially life-threatening risks hinted at during pre-approval review. But instead of withdrawing Lotronex and calling for more evidence, the FDA issued a medication guide designed to warn patients of escalating risks, while keeping the drug on the market.
This decision was to prove fatal. On Nov 28, GlaxoWellcome withdrew Lotronex from the market after the deaths of five patients taking the drug. There had been 49 cases of ischaemic colitis and 21 of severe constipation, including instances of obstructed and ruptured bowel. In addition to the deaths, 34 patients had required admission to hospital and ten needed surgery. A letter from Janet Woodcock, director of CDER, declared that the "FDA is committed to working with pharmaceutical sponsors to facilitate the development and availability of treatment options for patients with IBS". There was no word of sorrow or regret for the families of those who had died.

Strangely it was reintroduced to the market in 2002, although it carried warnings that were not put in place during the nine months it was previously on the market.

Although it can be said that Andrew Witty was not head of marketing during the Lotronex debacle he was, however, still Vice President - General Manager of Marketing of Glaxo Wellcome when their drug Raxar was pulled to task regarding violations of its marketing. Raxar wasn't mentioned in the whistleblower suit but it's worth mentioning because Witty was in charge of marketing during this specific time.

In 1997, Barbara Thompson, Assistant Director, Advertising Policy, FDA, wrote to Glaxo Wellcome. She told them that, after reviewing the Raxar press release it was found to be in violation [Fig 1]

Fig 1
Raxar was withdrawn from the market in 1999 for causing Prolonged QT interval.

Witty would have been in charge during the advertising faux pas and quite possibly would have been behind the press release slated for violations by Barbara Thompson [above.]

Records filed with the U.S. Food and Drug Administration (FDA) showed that Raxar was cited as a suspect in the reported deaths of 13 patients. [3]

Imitrex, a migraine product that was mentioned in the whistleblowwer suit, was approved by the FDA in 1992. Documents from the lawsuit showed how Glaxo had pushed Imitrex for mild headaches and for use in children even though it was not indicated for both.

Here's an Imitrex ad from the 1990's, it's not known if Andrew Witty was head of marketing during this particular TV ad.

Here's Glaxo's 'self test' they created with the National Headache Foundation.

Lamictal, [lamotrigine] yet another drug mentioned in the lawsuit, was FDA approved in 1994. Once again,  I think it safe to assume that any promotional push via the marketing team would have come from Witty, at least during the 1997/98 campaign.

During the promotional push for Lamictal, after Witty had moved on from his role of marketing, Glaxo hired speakers to 'big up' the drug. Documents from the whistleblower suit show 7 pages of paid speakers, many of which were child neurologists. 

In 2010 the FDA issued a warning that Lamictal use can cause aseptic meningitis, an illness characterized by serous inflammation of the linings of the brain.

Maybe Witty should come clean or maybe documents will one day surface that shows how he, as head of marketing, pushed the off-label promoting of drugs that he was in charge of. I'm sure there are lots of internal emails that haven't made the public domain... yet.

Are we really expected to believe that Andrew Witty is whiter than white and he never knew what was going on or, indeed, he never once promoted the use of drugs in people or illnesses that they were never indicated for?

I'm surprised no journalist has asked him these questions. I'd just love him to go on record and state that he has never promoted the use of any drug for off-label use either personally or by proxy to the 9,000 or so pharmaceutical reps Glaxo once had, a figure that has almost halved over the years. Nonetheless, there's approximately 9,000 potential whistleblowers who would know whether or not Andrew Witty is the shining knight in armour who has been left to stifle the stench of JP Garnier, Glaxo's former CEO.

The violations, which amount to a humongous lump of excrement, cannot all be left at the feet of Witty's predecessor, JP Garnier. Witty, himself, has to take some blame on a personal level. 

I've yet to see him do this.

Special thanks to the Truthman for digging out the 1997 article from The Advertising Age.

[1] Do Ads Really Drive Pharmaceuticai Sales? By Steven Findlay

[2] Lotronex and the FDA: A Fatal Erosion of Integrity - Volume 357, Number 9268, 19 May 2001
[3] RAXAR: Warning on Label Omits Deaths - LA Times, Fri, 02 Sep 2005

Back Stories:

GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint

Advair Launch 2001: GSK's “Myth of Mild” Campaign


Please contact me if you would like a guest post considered for publication on my blog.