Intimidation: a standard tactic?

I couldn't help but have a chuckle to myself, this morning. I'm a longtime fan of Elvis Costello, and Watching the Detectives is a wonderful track, but given recent events, it was an uncannily timed post.

It seems that Bob Fiddaman has incurred the wrath of the Great, Powerful and Excellent GSK, and has, incidentally, injured the fragile sensibilities of Ali B, in the process. You should have a read, for yourself:

GSK Lawyers target Seroxat campaigner Bob Fiddaman

GSK's got form in the intimidation stakes, of course, as I pointed out to the Ministry of Truth, in a recent post. Anyway, I suppose I ought quickly to apologize to GSK and Ali B, et al, if I have inadvertently suggested that they are a bunch of lying, scheming scumbags, at any point, during the past year, on this blog. They are, of course, not lying, scheming scumbags, but fine upstanding members of the corporate community, with only the good of Mankind in their thoughts. I just wanted to make that absolutely clear.

Related links:
Addleshaw and Goddard email request form - feel free to make enquiries of GSK's conduct, via its lawyers!

Genius: there's no other word for it - Part VII

Genius: there's no other word for it - Part VI

Abuse of Trust - Part VI

I'm not sure what prompted this: boredom, I suppose. To Breckenridge, copied to the Ministry of Truth and Vara. Blind copied to lots of people:


Dear Professor Sir Alasdair (that's "D-A-I-R") Breckenridge,

"The MHRA Chairman [that'd be you] suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based."
Source: The Influence of the Pharmaceutical Industry para 283

Did the HSC surmise correctly? If so, then I would suggest that this is not sensible. The cases of Avandia, Seroxat, Vioxx, Seroquel, Risperdal and Zyprexa (and, no doubt, many other drugs), would bear me out. There appears, then, to be ample evidence that the Worshipful Company of Apothecaries is not to be trusted. Why do you continue to trust it, Professor?

What I'm saying, in essence, is that the Worshipful Company appears to be only too well aware that it's opinion of its own drugs is going to be taken at face value, with little or no scrutiny from the body that is charged with that responsibility. As such, the temptation to take liberties is one that the Worshipful Company is unable to resist, apparently. This would be fine, if everybody understood that to be the position - we just wouldn't take the snake oil remedies on offer. However, the Worshipful Company (and at this point I include the MHRA), presents itself as the very paradigm of truth and scientific rigour. But it's not, is it? The upshot of this model is that inefficacious and dangerous drugs may find their way onto the market in spades. And you're pretending that everything's OK, by the look of things.

So, why aren't you (ie, you personally, and the MHRA), doing anything to tighten up the system, to prevent the fraudulent use of KOLs, dubious marketing techniques, intimidation of whistleblowers, suppression of adverse event data, etc, etc? It's your job, remember? Or do you not regard this as part of your remit, in which case you should let us know?

Best regards


Matthew Holford

Fluoxetine - Part II

God, I'm bored. The MHRA's mail is in bold, as usual:


Dear Sir or Madam,

I have had the opportunity to scan the excellent and informative documents that you linked. I am particularly interested in the second of these:

Making Regulatory Decisions about Medicines and Medical Devices

and most particularly Section C., paras 1/2:

1 Does the product work and offer useful clinical benefit if used in its specified way? [my emphasis - was this rider included by a scientist, or a lawyer?]

Is there robust evidence that the product will do what the company says it will do?

2 What impact will the product have, or is it having, on both the quality and length of life in those patients who are treated with it or on whose behalf it is used?

Are you able to expand, at all? I think that these questions, in combination, essentially ask the same question that I put to you, initially - ie, "what is the benefit of fluoxetine?". So, perhaps you could detail what "robust" evidence amounts to, and what evidence would be sufficiently robust, such that it demonstrates that which is claimed of a drug? I am particularly interested, in this context, on the question of "quality of life," alluded to in para 2 - presumably the "impact" spoken of is intended to refer to a positive/beneficial impact? In which case, what "robust" evidence would demonstrate the same beneficial impact claimed of a given drug by the manufacturer?

Please feel free to use fluoxetine as a case study, when answering these questions - I imagine that this would assist my understanding.

Best regards

Matthew Hoford

***********************************
Subject: FW: FOI 08/064 - FW: Fluoxetine
Date: Wed, 19 Mar 2008 12:06:56 +0000
From: info@mhra.gsi.gov.uk
To: [redacted]@hotmail.co.uk


Dear Mr Holford,

Thank you for your recent enquiry to the MHRA.

Please find attached a response to your enquiry.

Please contact us again if you need further assistance with this, or any other queries.

Kind Regards,

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

Attachment:
Thank you for your e-mail dated 18 February, 2008, concerning fluoxetine. In particular, you wish to conduct you own risk:benefit analysis using the MHRA’s methodology. You will not be surprised to know that the risk:benefit analysis does not consist of a magic formula. We do however outline our approach to weighing up risks and benefits for medicines in a document on our website called "Medicines and Medical Devices Regulation: What you need to know http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf, particularly in the box entitled "When is a product acceptably safe?" on page 2). There is further detail in another document on our website titled "Making Regulatory Decisions about Medicines and Medical Devices"

http://www.mhra.gov.uk/home/groups/comms-sp/documents/websiteresources/con2030689.pdf

These documents should give you some insight into the way we make decisions and the factors and considerations that go into the risk:benefit analysis.

You have also asked us to explain the benefit of fluoxetine, this information can be obtained from the Summary of the Product Characteristics for fluoxetine which you can access through the Electronic Medicines Compendium (http://www.medicines.org.uk/searchresult.aspx?search=fluoxetine)

I hope the above information is helpful and answers your query.

Genius: there's no other word for it - Part V

I saw the Finns in London a few years back, when they were on the Everyone is Here tour, and they sang this. I think it's my favourite song.

Genius: there's no other word for it - Part IV

Monty Burns and Avandia Renegade-gate‏

Given the MHRA's recent decision not to pursue GSK, I thought I'd stick the boot in - this one's been simmering just beneath the surface for a while, so it's not shy on invective. This to the Ministry of Truth, copied to Vara, Johnson and the White House, blind copied to lots of people:


Dear Sir or Madam,

I am keen that nobody should misunderstand the moniker that I have given to Garnier: one is a shady bastard, who lives in his own private fantasy world, where he may do anything that takes his fancy and avoid the consequences, and the other is a cartoon character. I'm going to quote the Senate Finance Committee's report into the intimidation of Dr John Buse at you, at every possible opportunity:

"GSK’s behavior since these allegations [came] to light has been less than stellar. Instead of acknowledging the misdeed to investors, apologizing to patients, and pledging to change corporate behavior, GSK launched a public relations campaign of denial. Specifically, GSK sent out a press release titled “GSK Response to US Senate Committee on Finance” which stated that the allegations raised by the Committee were “absolutely false.” Further, CEO Jean-Pierre Garnier denied having any knowledge of the alleged intimidation of Dr. Buse in an interview that ran in July in The Philadelphia Enquirer."

Ouch - not many fans on Senate Finance Committee, then, I guess? "Instead of... apologizing to patients, and pledging to change corporate behaviour... GSK launched a public relations campaign of denial..."? Hmmm, there's something about that, that I can't quite put my finger on...

And later we discover that Monty was lying about his knowledge of the incident (what other extremely important matters does he lie about, I wonder?), or if he wasn't lying, then I'd be delighted to have him reconcile for me his claim in The Philadelphia Enquirer, as against the following excerpt:

"In response to [a] series of emails, Dr. Tachi Yamada, GSK’s head of research at the time, wrote in an email that he had discussed Dr. Buse with GSK’s CEO Dr. Jean-Pierre Garnier as well as David Stout, a senior GSK executive. Dr. Garnier and Mr. Stout are copied on the email. Specifically, Dr. Yamada’s email reads: In any case, I plan to speak to Fred Sparling, his former chairman as soon as possible. I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well planned offensive on behalf of Avandia…"
(Source: The Intimidation of Dr. John Buse and the Diabetes Drug Avandia - it's a super read, I really do recommend it)

"Setting him straight as to the facts."? I'll bet Yamada's "facts" barely qualify as opinions. How do these fuckwits get their PhDs? Do they buy them out of the back of Private Eye, or something?

So, the lesson we take from this is that when Monty and his ilk feel that the reputation of their snake oil remedies is under threat, they wheel out the well-oiled intimidation machine and pretend that they are exercizing their legal right. Monty, Yamada, Stout: what a bunch of crooked cunts they would have to be to either actively engage in this type of activity, or to give it their tacit approval by remaining silent while it played out (by which I mean that they would have to be devoid of any admirable human characteristics). Sadly, I'll bet they're not the only ones. In fact, I know they're not, because it's "just business, nothing personal" isn't it? Intimidation = business? I'll remember that - it's another of your unspoken rules, isn't it?

Ah, isn't it great to have opinions? They're the last refuge of free speech, you know.

Best regards


Matthew Holford

PS It's a side issue, given that I just wanted to establish my contempt for Monty, but the Committee report asserts that many lives would have been saved, had GSK not sought to suppress Dr Buse's concerns. Just something to think about.

Genius: there's no other word for it - Part III

Genius: there's no other word for it - Part II

Unfortunately, the embedding code for the official video to The Scientist is no longer available on YouTube, but here's a live version, instead:

I've been tagged!

Actually, I was tagged a while back, but wasn't paying attention!

This is the deal:

1. Pick up the nearest book (of at least 123 pages).

2. Open the book to page 123.

3. Find the fifth sentence.

4. Post the next three sentences.

5. Tag five people.


It's a bit dry, but the nearest book was Rolando Gaete's "Human Rights and the Limits of Critical Reason":

Eichmann's self transcends these properties and as a human being his worth is similar to that of Florence Nightingale. Eichmann, the Nazi mass murderer, is not equal to or of equal worth to Saint Francis because their fundamental choices were very different.

Extravagant as this view sounds, it is at the centre of modern humanism and modern jurisprudence.

I'm going to tag Aubrey, Fidders, Philip Dawdey, Janice and the Anonymous Mr Admin, at Seroxat Secrets!

Matt

Genius: there's no other word for it