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Dr. David Healy

Psychiatrist. Psychopharmacologist. Scientist. Author.

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AbbVie: Sharing The Yellow Stuff

September 30, 2013 5 Comments

Editorial Note:  This is the second part of our effort to “translate” Neal Parker’s recent presentation in Bruxelles. The first half is here Neal Parker Avoiding Adverse Events. Reading the first half and Neal Parker’s original transcript – available here – will give lots more material for the Caption Competition below.

The least dramatic moment in Mr Parker’s talk laying out Pharma’s position on access to clinical trial data came came early on when he put up a “busy” slide and talked about AbbVie being committed to sharing the Blue Stuff but wanting to limit access to the Yellow Stuff. We don’t have a copy of the slide to show.

The most intensely dramatic moment came toward the end when he was questioned by Flaminia Macchia. The entire video is in Trade Wars we have known and loved: AbbVie v China. The interaction with Ms Macchia is from 48.00 – 50.40. Some of the intensity of the drama of the exchanges lay in the body language – which the photo here can only hint at. This body language makes the entire sequence close to untranslatable but we’ve taken a stab. Translating is never about getting things word for word right – its more about attempting to capture what this speaking act was all about.

Neal Parker and Flaminia Macchia

Flaminia Macchia

Hello I’m Flaminia Macchia, European Public Affairs at Eurordis, which is the European Organisation for Rare Diseases.

Neal Parker

Eurordis have been the most helpful ever patient group for us. They have done so much to get regulators and politicians onside by playing the patient confidentiality card. As a result people like me have usually been able to come to meetings like this and appear to be occupying the middle ground when it comes to transparency.

But you’re wearing Yellow today – almost like a scene from Breaking Bad. I hope we’re not talking about some chemical change here.

Flaminia

Maybe it is.  Maybe I’m going to be like Papa Francisco, who looked like a diehard conservative until they made a mistake and made him Pope – no?

I’m really trying to understand what you’re saying. It’s difficult but…can you give an example of an adverse event that would be commercially confidential, so commercially confidential not to have to be shared with the patients?

Neal

I cannot come up with an example of an adverse event that we would not share. Because AbbVie is going to Share all of its Yellow Stuff under appropriate conditions that maintain the public health.

Personally from Abbvie’s perspective I cannot imagine any circumstance where my company would not release voluntarily adverse event information that was relevant to one of our products on the market. That’s just not the way we do business.

Flaminia

But this has happened in the past, in the history, no?

Neal

I don’t know what you’re talking about…the specific examples. I seem to remember something about thalidomide – but hey that was last millennium.

Flaminia

What about New York States action against GSK for Fraud that led on to a $3Billion fine last year?

Neal

I can only speak for AbbVie here.

Flaminia

What about 2008 when FDA asked Abbott about reports of Histoplasmosis on Humira – that FDA now had 16 cases reported to it. Turned out that Abbott unbeknownst to FDA had 32 cases?

Neal

That was Abbott – We’re now AbbVie – who knows what went on in a completely different company.

Flaminia

What about the $1.6 Billion fine paid last year to the Federal and nearly all state governments apparently because of illegal marketing of Depakote – something about giving it in nursing homes to elderly patients with dementia? (See press coverage).

Neal

That case went back years and it was about marketing.

Flaminia

Can you distinguish between marketing and hiding adverse events?

Neal

Of course.  Besides when we settle these lawsuits, it’s usually without admission of guilt. It’s just more convenient all round to draw a line under things.

Flaminia

Same answer when it comes to the recent Senate investigation of Abbott about Stents – how much was that $30 million or something?

Neal

Even more so – Abbott now make Devices while we do Drugs.

Flaminia

What about the bit where an Abbott official is supposed to have said that local connections or the “Philly mob” should intervene to silence Baltimore Sun columnist Jay Hancock for his coverage of the way the company went about marketing Stents.

The phrase I seem to remember was “someone needs to take this writer outside and kick his ass!” Sounds like a scene from Breaking Bad to me.

Neal

Listen – there will always be someone in an organization who uses colorful language – I bet there is even someone in the Vatican who says things like this about critics from time to time.

Flaminia

You don’t think it means anything?

Neal

Not as much as you seem to think.

Flaminia

What about the reports just two weeks ago about fines against Abbott last week in China for price fixing and anti-competitive practices.

Neal

Flaminia you weren’t listening very well earlier. This is why we’re here. There is a Trade War going on and the Chinese are trying to make life awkward because we are trying to make it difficult for them to knock off cheap versions of our drugs. Eurordis are key to the good guys winning – so get onside.

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Reader Interactions

Comments

  1. Ken Spriggs says

    October 1, 2013 at 12:47 pm

    I would love to know more about the cases of Histoplasmosis and Humira. Is there a reference to Flaminia’s comments?

    And wouldn’t it be great if physicians took into account the culpability of the drug manufacturers when writing prescriptions?

    Reply
  2. annie says

    October 1, 2013 at 1:55 pm

    Body image from Neil Parker – grubby with pencil = our company is successful as long as we tell people our company is successful, that is all that matters.
    Pendantico Plc

    Love the dress, Flaminia, and your face, has the same expression as my face. I can see right through you Meesta Parkaaaa…….

    Yellow peril meets grubby grey, pencils at the ready…………………….

    Reply
  3. annie says

    October 2, 2013 at 1:39 pm

    GSK Website
    Sharing our Research:

    We are committed to reporting the results of clinical research that evaluates our medicines and vaccines, irrespective of whether the outcomes are perceived to be positive or negative. In addition, we are being more open with our expertise, know-how and intellectual property around research into neglected tropical diseases.

    Let’s look at this statement from the UK’s flagship pharmaceutical company.

    Positive words: committed, reporting, results, evaluation, positive, open, expertise, know-how, intellectual.

    How would you have phrased this statement?

    irrespective that the outcomes…..are perceived to be positive or negative
    we are being…..more open with our expertise, know how and intellectual property

    Intellectual is not a word I would use about dodgy clinical trials.
    Intellectual is usually reserved for intellectuals.
    For GSK to be intellectual is somewhat divorced from reality…do they write for the intelligentsia or do they write on little white folded up bits of paper, tucked inside a box.

    If you worked for GSK, could you have written a better statement of transparency and if, so, what would you have said?

    The competition winner will receive a conversation with Sir Andrew Witty.

    Reply
  4. annie says

    October 5, 2013 at 1:15 am

    Now the cops are shooting anyone stoned, dead, on an anti-depressant, in front of The White House, in front of the President of the USA.
    Did you see it Obama? Did you see ‘cops meet anti-depressant and go in for the kill’.
    Only in America……………………..?
    Will doctors wear hi-viz jackets for their safety when the day of judgement comes….will GSK turn up at appgita to listen to politics of health or are his politics of health, mere politics, not health………perhaps, his friend, at the MHRA, will accompany him……are we now talking about the White Stuff, the right stuff.

    Reply

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