US Attorney General Eric Holder and the Revolving Door

Covington - DOJ - Covington

I'm not really into American politics, not really into British politics either, I'd sooner read knitting patterns as politics, in general, bores me rigid.

That's not to say that every now and again something pops up that is of interest. None more so than the recent news surrounding US Attorney General, Eric Holder.

Holder was part of the legal team for the Department of Justice (DOJ) - the same team that fined GlaxoSmithKline a staggering $3 billion for promoting its best-selling antidepressants (Paxil and Wellbutrin) for unapproved uses and failing to report safety data about its top diabetes drug, Avandia.

Bizarrely, Holder had previously worked for the law firm, Covington, who specialize in representing (defending) pharmaceutical companies in litigation.

It was quite a turnaround. One minute Holder is defending pharmaceutical companies, the next, he's prosecuting them.

Strange then that, after just 6 years with the DOJ, he should return to Covington as a partner.

So, what input, if any at all, did Holder have regarding the negotiations of the $3 billion settlement figure, and, more importantly, could the original figure, said to be a lot more than $3 billion, have been whittled down by Holder? Furthermore, who was exactly behind the Wellbutrin promotion, was it, as some sources suggest, the current CEO of Glaxo, Andrew Witty, who, at the time of the illegal promotion, was Vice President General Manager of Marketing for Glaxo?

I'm just throwing the question out there because this revolving door between Covington and the DOJ seems, to me at least, to be bordering on being incestuous.

News of Holder's double u-turn came via Melayna Lokosky who has wrote a quite brilliant blog post where she raises many questions regarding Holder's latest "unethical move."

Her blog can be read, in full, here.

Lokosky also tweets about it via her Twitter account, here.


One to keep an eye on.


Bob Fiddaman.

Plus ça change, plus c'est la même chose for GSK

I found getting my head around today's Bloomberg article, Glaxo Paid Doctors $15 Million Before Promised End to Fees, pretty difficult.

Admittedly, when it comes to figures or counting backwards I'm no Stephen Hawkin - so, I had to sit with this for a while to try and fathom out just what Glaxo were playing at here.

In 2013, Glaxo chief, Andrew Witty, announced that it was implementing a new global marketing strategy to transform the way it sells and markets drugs to both doctors and patients.

GSK, in 2013, said...

• They would be stopping direct payments to physicians who speak about the Company’s drugs, or diseases treated by its drugs, to other doctors and healthcare professionals who write or influence prescriptions and ending payments for doctors to attend medical conferences.

The new strategy, according to Andrew Witty, would be implemented globally by 2016.

Back-slaps all around for Witty. What a thoroughly nice chap for showing some ethics. So you would think, right?

What the company statement failed to mention was that this new initiative was actually required as part of a corporate integrity agreement Glaxo made with the US Justice Department.

So, what have Glaxo done to implement this 'new strategy' then?

Well, according to Bloomberg, it would seem that it's been business as usual for Glaxo.

Bloomberg write...

GlaxoSmithKline Plc paid U.S. doctors about $15 million in 2014 to promote and learn about its products, showing little change from the previous year... 

The total includes consulting and speaking fees, as well as meals and travel for thousands of doctors. The largest consulting payment $195,000 went to Joseph Goldstein, a professor of biomedical research at the University of Texas Southwestern Medical Center, (above) according to Glaxo’s figures.

Bloomberg kindly throw a link up to GSK's website, http://fortherecord.payments.us.gsk.com/ - another website to show how transparent they supposedly are, another attempt at showing the new GSK.

Bizarrely, the Bloomberg link to Glaxo's page returns a 404 Error code. So, what ever was available, isn't now.

So, I guess we are just left with the Bloomberg article.

In 2014, Thomas Yunger, a pulmonologist in Dayton, Ohio, (above) was the highest-paid speaker for Glaxo, with $75,450 in speaking fees and $10,853 for consulting, travel, food and beverage. Yunger couldn’t be reached for comment, and Goldstein declined to comment.

Now, I guess technically Glaxo haven't gone back on their promise, they did say that this practice of not paying doctors would be implemented globally by 2016 so, I guess, it remains to be seen if they keep to their word. It does, however, seem a kind of half-arsed way to go about evolving down that ethical route, don't you think?

Make claims you are going to stop being naughty but continue being naughty until the official deadline day of naughtiness comes into view.

Mommy and Johnny at the Supermarket.

Mom: Johnny, put that ice cream back, I don't have enough money to pay for it.

Johnny: But I want it and I'm going to take it.

Mom: If you take it you will be grounded for a week!

**Johnny takes ice cream, looks at his mom and bites into it**

Mom: Right, you are grounded for one week.

**Johnny then steals more ice cream**

Hey, who can blame Johnny? When he gets back from the supermarket he's going to be grounded for a week so why not take more - the punishment will remain the same.

Isn't this exactly what GlaxoSmithKline are currently doing?

Can you imagine, for one minute, if you or I were ordered by a Judge to stop our thieving or face the consequences and, in response to his request we told him that we would stop in three years time?

Would you or I be allowed this luxury?

So, it would appear that Andrew Witty's statement to shareholders in December 2013 was nothing more than a token gesture. Yes, we've been naughty and we will stop that naughtiness soon... but before we do let's just have one more stab at naughtiness.

Naughty, naughty Glaxo.

Take a look at the figures again for 2014. $15 million to promote and learn about its products. including consulting and speaking fees, meals and travel for thousands of doctors. This coming after a company statement in late 2013 stating that they were implementing changes!

Will Johnny refrain from stealing ice cream in 2016? 

I doubt it.

Plus ça change, plus c'est la même chose.

Bob Fiddaman.

**Thanks to The Truthman for the tip.**

Hey Glaxo, Guess Who's Been Talking?

GSK Whistleblower Blair Hamrick & Bob Fiddaman

I started writing this blog back in 2006. I had some issues with the antidepressant drug manufactured and marketed by British pharmaceutical giant GlaxoSmithKline. I also had some issues with the way drugs were regulated in this country by the British drug regulator, the MHRA.

Eight years on and I have learned so much about GlaxoSmithKline... I learned more about them yesterday evening as I sat down to dinner with Blair Hamrick, one of the whistleblowers who blew the lid on Glaxo's fraud in the US, a blow which, after 11 years of legal wrangle, Glaxo settled for a record breaking $3 billion.

Blair is a very brave soul for going up against the company that he once worked for. His life is now back on track after Glaxo sacked him then muddied the waters so he couldn't get a job elsewhere in the pharmaceutical field. Yes, he was paid handsomely for his bravery and is now living a life that most could only dream of. 

Despite the publicity, fame and riches Blair is one of the most down to earth people you could ever wish to meet, a trait that became evident when he just couldn't bring himself to promote the antidepressant Wellbutrin off-label to doctor's.

Wellbutrin is an antidepressant and indicated to treat adults that are depressed. Blair, whilst working for GSK, was prompted by senior management to promote it off-label to doctors for treating children. He just couldn't bring himself to do that. One of the side effects of Wellbutrin is seizures and Blair envisaged kids going into seizure. "It was wrong, it wasn't indicated for kids and I just couldn't bring myself to tell doctor's it was okay for kids to take," Blair told me over a glass of wine in the plush settings of one of Westminster's finest hotels in London. "They also tried to market it as the happy-horny-skinny pill because they had learned through post marketing that patients taking it for depression were losing weight and reporting high sex drives." [increased libido] Wellbutrin was not indicated for this but the Glaxo marketing team came up with the "happy-horny-skinny pill" line so reps could convince doctors to prescribe it to patients who were overweight and also those who were experiencing a low sex drive [decreased libido]

Blair also spoke about the doctors who were paid by GlaxoSmithKline, a staggering 48,000 doctors were paid speaker fees, attendance fees and given lavish gifts, all in an attempt to get them to prescribe more of Glaxo's drugs.

"We'd pay doctor's between $2-4000 to give a talk to other doctor's.

"6 or 7 doctors would be invited out for dinner, sometimes with their spouses in tow, they'd be wined and dined and then the speaker would talk about the wonders of drug a or b, of course these were off-label "wonders" - that's how Glaxo rolled.

"Our marketing team would send them a slide-show and a carefully scripted narrative so they could convince other doctor's that it was okay to prescribe a number of drugs off-label.

"Some doctor's, whose basic annual salary was around $150,000, could give 2 or 3 talks in a week, giving them a potential to earn up to an extra $12,000 per week.

"I was also given luxury private box tickets for sporting events, these would be given to doctors as a 'thank-you' or incentive to prescribe more and more of Glaxo's drugs."

Glaxo, at some point during these wanton violations, caught wind that their off-label promotion had been leaked and reps were told to be careful what they added to their call-notes.

Call-notes are what pharmaceutical reps use to familiarize themselves with a doctor.

"The way it worked was that a doctor would be visited by a rep who would  then add notes to a hand-held device.

"It was useful because we knew what these doctor's liked, be it a particular football, baseball team or if he had a sweet tooth - on the next visit we would bring in a small token of gesture, be it tickets to the game or sweet tasting delicacies - it was just a way to keep them prescribing more drugs."

Blair recalled a meeting where reps were told to be careful what they wrote in the call-notes, the crux of the meeting was basically to tell reps to "write right", in other words write down the legal stuff and not the violations.

I asked Blair about Glaxo's recent announcement that they are going to be more transparent.

"The whole transparency thing wasn't a conscious decision by Glaxo, their hand was forced, it was all part of the settlement - it makes me laugh when I now read how they are claiming to offer up the results of their clinical trials, they were told that's what they had to do as part of the agreement they entered into with the Department of Justice."

Regular readers of this blog will note the tagline I use, "It's perverse when GSK claim that they are going to be more transparent when they do not offer transparency when writing about their transparency."

I could have listened and talked to Blair all night, alas I had a train to catch back home, a train that I almost missed due to losing track of the time.

Blair Hamrick, along with the other whistleblowers in this particular case, should be applauded for their efforts. It's no coincidence that Glaxo are now being investigated for the same type of violations in other countries. 

Blair blew the whistle and it almost took the roof off GSK, for that he deserves a future of happiness. His conscience not to promote a drug that could cause kids to have seizures was frowned upon by senior management at GSK - what kind of human being could promote a drug that could be potentially harmful to children, moreover, what type of human being could sanction such a promotion?

On a side note, I wasn't just in London yesterday to meet Blair. Earlier on I met with a film-maker who is in the process of making a documentary about antidepressants. The film-maker also dined with myself, Blair and his partner. More about the documentary in a future post.

I now have something to tell my grandchildren.

I once had dinner with Blair.

Bob Fiddaman

Glaxo's Murky Transparency Claim

Glaxo head, Andrew Witty, is in the news - this time he's bigging-up his company for being transparent.

Many of the mainstream press are carrying the story, "All Hail Sir Andrew". Critics are viewing this by asking their own questions, one such critic being Mickey Nardo, who, by his own admission, is one boring old man with time on his hands.

Mickey, a retired psychiatrist, raises some good points in a post here, he writes:

I don’t want to join the voices that find something wrong not matter what changes are made. So long as pharmaceutical manufacturers remain private business enterprises, we can expect the to act like other businesses in a capitalistic society. But at a time like this when GSK is making a change in policy towards something that needs fixing as badly as this does, I think it behooves us to go over it with a fine tooth comb to make sure it conforms to the needed change rather than represents another attempt at deceit. With GSK, we’ve earned the right to use that word [deceit] freely. I’ve already mentioned the issue of "panel of experts" as a potential conduit for deceit. But there’s something else.

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

The Department of Justice website has uploaded video excerpts of GlaxoSmithKline's promotional push of Advair to its reps. The video excerpts, from Las Vegas, even show former Glaxo head, JP Garnier, get in on the act, relaying the message, “...it would be criminal to not put an asthmatic patient on Advair”. It's hard to know who or where this message originated from as 'JP', it seems, is quoting someone else.

Hmm, nice use of the word 'criminal', JP.

GSK's Advair is used to prevent asthma attacks, and to treat chronic obstructive pulmonary disease [COPD] and the recent whistleblower suit, that GSK plead guilty to and paid a record $3 billion in fines, shows how they aggressively marketed it with promotional 'get togethers' as shown in the video  excerpts [below]

The whistleblower filings in the US Courts also name senior managers at GlaxoSmithKline for aggressively urging sales of Advair for forms of asthma that it was not indicated for, such as mild intermittent attacks, such as the senior manager telling the audience in the video, "The clinical data that supports Advair, you know you gotta just ask the simple question...what patient with asthma is not appropriate for Advair?" [Video around the 2 minute mark] whilst another tells the audience, "...there are people in this room who are going to make an ungodly amount of money selling Advair."


According to documents Glaxo even launched a “Myth of Mild” asthma campaign, its sole purpose, it seems, to target sufferers of mild asthma, even though Advair was not indicated for patients who suffered with mild asthma.


All Glaxo reps needed to do was to tell the doctors prescribing it. 



Documents also reveal that in 2004 Chris Viehbacher, former head of US pharmaceuticals at GSK, told investors at a meeting in London, “The real opportunity for us with Advair is that we can now convince physicians that there is no such thing as mild or severe asthma.” 


Amazing isn't it? And there was me thinking that pharmaceutical companies invented illnesses, not dismissed them!


Viehbacher is now Chief Executive Officer at Sanofi.


GSK's CEO, Andrew Witty, said in a statement about the record payout that “Today brings to resolution difficult, long-standing matters for (Glaxo). Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of (Glaxo), I want to express our regret and reiterate that we have learnt from the mistakes that were made,” 


A different era?

In actual fact, and what the mainstream press seem to be missing here, is that Andrew Witty was the Vice President and General Manager of Marketing of Glaxo Wellcome Inc. [GlaxoWellcome and SmithKline Beecham merged in 2000 to become GlaxoSmithKline.] Some of his responsibilities included, strategy development, marketing execution and new product positioning. Witty and his team were awarded a Medical Marketing Association [MMA] award [Medical Marketer of the Year] in 1998. He also worked in the Company’s International New Products groups, both in the Respiratory and HIV/Infectious disease fields.

Two words - Marketing and Respiratory. Alarm bells anyone?


In a perverse twist of fate during Witty's rise to success he was actually a sales representative for the respiratory business!

I'm just left wondering if, whilst a rep for Glaxo, Witty offered incentives to doctors... or if he actually thought that was morally wrong. If he did then any talk of era's at GSK must land at his feet and the buck-passing blame game must stop.

Apart from Paxil [Seroxat] and Advair, GSK also violated the promotional terms of  Imitrex, Valtrex,  Lotronex and Lamictal.

GSK's corporate tagline is, "GlaxoSmithKline helps people to do more, feel better and live longer."

Can someone please hand me a vomit bag!

Related:

GSK - The Company With Great Ethics

GlaxoSmithKline - Pinsky, Bradshaw and Promises

GlaxoSmithKline's Perverse Olympic Games

Glaxo's Qui Tam Paxil Complaint




Fid

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