A gold-plated scandal hits the bonus bank

I thought this was quite funny, in an "oh, dear: please don't tell me that we've made the assumption that because these guys have got lots of money that they're in any way decent, or honest, or representative of any kind of admirable human characteristic" -sort of a way...

A gold-plated scandal hits the bonus bank

Anyway, time (and the quality of legal advocates involved), will determine whether or not GS is as crooked as it looks, right now.

Scientific Misconduct Blog: Dean Edward J Wing and integrity at Brown Medical School

I've a certain interest in this story - I posted about it, when I was writing about the Great Genius Who Is Professor Marty Keller. Aubrey seems to have decided to press the issue - and good for him. Brown never did bother to respond, when I sent them an advance copy of Ghost in the Machine. I imagine that they were busy with other things. Sweeping. And rugs, I should think.

Scientific Misconduct Blog: Dean Edward J Wing and integrity at Brown Medical School

Recording: British Paxil Users Meet With Brit FDA

Furious Seasons has posted the audio recording of the recent meeting between representatives of the Nine Elms Massive and patient advocates. I've made a couple of comments on there, if you're interested (and even if you're not interested, I've still made a couple of comments), but the upshot is that the Establishment has decided to defend its position - there is no attempt being made to address the issues with the industry that several commentators and patient advocates have raised. It seems to be about justifying the status quo, when the status quo is shit.

I listened to the recording for 36 minutes, and I was so disgusted with the whole fucking thing that I refused to expose myself to it, any further. It sounded very much like a PR exercize, nothing more. If the MHRA was really listening, it would be including its biggest (or at least most vocal), critics in the discussion and it would be addressing the issues that they raise, instead of justifying the machinations of the system, which, in their totality, I argue achieve precisely the opposite of what it is argued is being achieved.

What is being done to address the way in which companies have complete control over the trial of drugs, statistical analysis and writing of papers? What is being done to establish regulatory rules and guidelines, which fill the gaps left by legislation? Will the UK regulator address the question of its apparently flimsy assessment process - for example, why does it accept those dodgy academic papers as valid evidence of safety and efficacy, when there is evidence that this business of "information laundering" renders academia unreliable, to say the least?

Oh, it's all bollox - the halfwits don't want to change a damn thing, because it's not in their interests to change anything, and because they don't know how.

Matt

Clinical trials and drug promotion: Selective reporting of study 329

A paper by Jureidini, McHenry and Mansfield on the subject of Protocol 329. Dr Jureidini, you may remember, was one of the original critics of the paper that the Great Genius Who Is Professor Martin Keller "wrote," back in 2001. The paper is available on Healthy Skepticism, but has attracted attention from Fidders and Clinical Psych, the latter making the particularly pertinent observation that the various statistical shennanigans that took place in order to turn, quite magically, Paxil from a pile of kak into a pile of kak with a bow on top is anything but an isolated incident (although, I find that all magic is based on sleight of hand).

I'm not a statistician, and so I don't fully understand the nature of the argument, although I do understand that changing what one claims to have been looking for, after one has the results in front of one, probably isn't very scientific. No, to quote the Great Genius Who Is Professor Martin Keller, "I'm better with words"! And I'm still struck by the need that James McCafferty (the Paxil Phase 4 project manager, and a SKB employee), perceived to tell Sally Laden (the ghostwriter) that she oughtn't to be making grand claims as to safety, when she was also documenting lots of adverse events.

McCafferty and Rosemary Oakes, a senior statistician at SKB, who worked on the project, got their names on the paper, when it was published. Call me old-fashioned, but I should have thought that having the Company run the trial, crunch the numbers, and then write the paper, informing people of what the numbers meant, before using that paper as an adjunct to a marketing authorization application (and have the regulator accept said paper as valuable evidence), is probably open to abuse. What? Oh, yeah: it was abused, but I should state for legal reasons that it is only my opinion that this was abused. As such, it is merely my opinion that I cannot conceive of a more flagrant fraud.

Matt

More opaque than an opaque thing... Part VI

I just thought I'd let Johnson know what the position was...


Dear Mr Johnson,

I'm reasonably confident that you're not going to do anything about this, but I have to prove that you're not going to do anything, don't I? I can't just say that, can I?

Shame on you: people are having to put up with incompetent performance and fraudulent marketing because people like you are protecting interests that do not deserve to be protected. Pharmaceuticals are not appropriate for the treatment of mental health issues (and they're probably not much good for anything else, either). The Chemical Imbalance theory, the very pillar on which all these shite drugs are balanced, is bollox. And you know it, as does the FDA, even if the MHRA hasn't acknowledged it, yet.

Best regards

Matthew Holford

More opaque than an opaque thing... Part IV

I thought I might as well go through all the hoops and mail the Head of the absurdly-named Intelligence and Enforcement Unit, at the MHRA. This to Michael Deats, copied to Woods, Breckenridge, Vara, Johnson and the CPS:


Dear Mr Deats,

I am currently engaged in a discussion with Professors Woods and Breckenridge and the CPS (please see below) on a question over the application of Regulation 50 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).

Would it be your position, as Head of the Intelligence and Enforcement Unit at the MHRA, that where trials have been carried out on a drug, and those trials have produced negative results, and that there are also trials of that same drug that have yielded results that are interpreted as positive, and it is subsequently only the positive results that are submitted in support of a marketing authorization application, that the presentation of only the positive data (owing to the suppression of the negative data) amounts to the provision of "false or misleading" information, under Regulation 50?

Best regards

Matthew Holford

Corruption: it's a big problem in Namibia (and elsewhere)

Apparently, Namibia has a Zero Tolerance for Corruption campaign, which you have to be impressed by, seeing as there doesn't appear to be the slightest concern in the western democracies that this might be an issue:

http://www.anticorruption.info/corr_def_alt.htm

Apparently, if you're a public official, if you're in doubt as to the nature of your actions, you should ask yourself a) “Are my actions legal?”; b) “Am I being fair and honest?”; c) “How will it look in the newspaper?”; and d) “Would I like my child, my mother or my friends to know what I have done?”

They've certainly nailed the key issues, to be sure. There are even a series of definitions of corruption, from a variety of sources, just so that one knows what it is, when one sees it, I suppose. This is a taster:

In broad terms, corruption is the abuse of public office for private gain. It encompasses unilateral abuses by government officials such as embezzlement and nepotism, as well as abuses linking public and private actors such as bribery, extortion, influence peddling, and fraud [my emphasis]. Corruption arises in both political and bureaucratic offices and can be petty or grand, organized or unorganized. Though corruption often facilitates criminal activities such as drug trafficking, money laundering, and prostitution, it is not restricted to these activities. For purposes of understanding the problem and devising remedies, it is important to keep crime and corruption analytically distinct.
Handbook on fighting corruption, the Centre for Democracy and Governance

Thank goodness we don't have to concern ourselves about this kind of thing in the UK, because the definition, above, clearly clearly doesn't apply to any Politically Exposed Person (PEP) that I know of. Can you imagine if this sort of thing was going on in the pharmaceutical sector? It'd be a nightmare, wouldn't it?

Matt

More opaque than an opaque thing... Part III

I'm a bit disappointed with the feedback I'm getting from the MHRA, just now, so I thought I'd try a different angle. This was sent to Breckenridge and Woods, copied to Johnson, Vara and the CPS:


Dear Professors Breckenridge and Woods,

My apologies, I should have copied you in on this, earlier. There appears to be a consensus amongst the (disinterested) scientific community that the withholding of data on drugs is unscientific. I would argue that it is unlawful, although I am interested to understand whether that view is shared by the Establishment.

Either way, the practice of suppressing negative data has contributed significantly to the Seroxat farce, in all its ignominy. To date, the MHRA has done nothing to ensure that that does not happen again. I would hold that that is incompetence of the highest order, and I can only imagine that it is not doing anything, because it is not in the interests of the Worshipful Company to do anything. That is corruption, if it be true. Are you corrupt, gentlemen?

Best regards

Matthew Holford

*************************



Dear Sir or Madam,

I am currently engaged in a discussion with the MHRA, concerning the application of the Medicines for Human Use (Clinical Trials) Regulations 2004 (please see below). It appears that the MHRA is unable to provide an opinion, for whatever reason that it might have.

Is the CPS positioned such that it may provide definitive guidance as to the nature of conduct that would constitute a contravention of Regulation 50?

Best regards

Matthew Holford

********************************

The letter of the Law (but what of the spirit?)

In the light of the previous post, I thought it might be worth reminding everybody just how excoriating (if one was paying attention) some of the commentary of the Health Select Committee's report into the influence of the pharmaceutical industry was. It's a riveting read, if you're into that sort of thing...

The Report is available at http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf, if any readers feel inclined to trawl through the 100+ pages for themselves. Pertinent extracts, in support of my last post, follow:


282. The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry, the main exception being Prof Woods, who became chief executive of the MHRA in 2004. Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it. Dr Herxheimer stated:

…when the agency was hived off from the Department of Health…the culture became confirmed that the industry is the client and the client must be looked after: quick service, good service, easy contact, etcetera - so it is a closed community in a sense.

283. Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process. The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate [my emphasis]. 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.

284. Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; it should be earned rather than presupposed. The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable, as Sir Iain Chalmers [co-conveners of the James Lind Alliance] commented:

Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

285. Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem: the December 2004 report of the CSM’s Expert Working Group (EWG) into the safety of SSRI antidepressants. The Group’s main findings pointed to lack of evidence of risk (rather than risk itself) not least because a number of essential studies had never been performed...

That Hare definition of psychopathy in full...

Is this somebody you know?

"...the most devastating features of psychopathy are a callous disregard for the rights of others and a propensity for predatory and violent behaviors. Without remorse, psychopaths charm and exploit others for their own gain. They lack empathy and a sense of responsibility, and they manipulate, lie and con others with no regard for anyone's feelings."

Read on: http://www.crimelibrary.com/criminal_mind/psychology/robert_hare/3.html

Just in case you were wondering about Dr Hare's credentials, he co-wrote DSM-IV.

Matt

Re: FOIA 07/040

I just thought I'd put the previous two posts into context:

Sent: 01 February 2007 01:53
To: MHRA Information Centre
Subject: Panorama: Secrets of the Drugs Trials

Dear Sir or Madam,

I note from the BBC's reportage that the MHRA initiated criminal proceedings against GSK, presumably with respect to its (GSK's) claims and misrepresentations about its anti-depression drug, Seroxat (Paxil, in the US):

http://news.bbc.co.uk/1/hi/health/6308871.stm

I note that this case is some three years old, and wondered what, if any, progress had been made? For what it's worth, the allegations have caused consternation, anger and resentment amongst the "depressed community", if commentary on the internet forums that I post on are anything to go by. If you were able to disclose the status of the investigation, I imagine it would be a benefit to a lot of people to know that this matter is being taken very seriously indeed by those in a position to regulate the drugs industry, and to punish those who take advantage of the desperation of people, who have little choice but to take drugs owing to the paucity of alternatives offered, generally-speaking.

Please note, for your information, that I have discussed this matter (in the context of corporate manslaughter/gross negligence manslaughter) with my local police force, and it is currently logged as an incident.


MHRA Reply

Sent: 21 February 2007 15:19
To: @hotmail.co.uk
Cc: MHRA Information Centre
Subject: RE: FOI 07/040 - FW: Panorama: Secrets of the Drugs Trials

Dear

Thank you for your e-mail of 1st February concerning reports of an MHRA investigation into GSK with respect to claims and misrepresentations concerning its anti-depression drug, Seroxat.

MHRA has considered your request under the provisions of the Freedom of Information Act 2005 and I am pleased to be able to provide the following response. The MHRA has a duty to protect public health and takes seriously any report of a suspected breaches of medicines regulations.

The MHRA investigation into GlaxoSmithKline and its alleged failure to supply pharmacovigilance information to the MHRA relating to the paediatric use of Seroxat (paroxetine) commenced on 1st October 2003. The investigation is still in progress and will continue until the relevant lines of enquiries have been concluded. No decision has yet been made on whether or not to prosecute GSK.

I hope this clarifies the position.