Tuesday, September 25, 2007

Who is the beast? The merger of medical journals and ghostwriters

With publication last week of a strange article about the Gillberg affair by the British Medical Journal (BMJ), the dumbing-down is increasingly obvious (read the article and the responses - or at least those which were allowed). The upshot of this BMJ commissioned piece is that researchers faced with questions over the integrity of their data analysis should simply destroy that data. Great advice! News today adds to the concerns. The BMJ have apparently (yet again) declined to publish a paper (about ghostwriting and data misrepresentation of Paxil study 329) involving one of their advertisers (GSK) because "they feel they don't have the resources for the legal work required to check it all". That seems to have become a regular excuse.

I thought I would relate a trivial personal BMJ incident.

On 12 November 2006 I submitted a response to an excellent BMJ article by Adriane Fugh-Berman entitled Doctors must not be lapdogs to drug firms. The point here is not to discuss my response, but the irony of what happened next. Remember that the integrity crisis that brought this blog into existence involved the small matter of "who stands behind the word" in science.

My letter as submitted (and which also appears in the BMJ online weblog ) was as follows.

Letter as submitted

12 November 2006
Aubrey Blumsohn,
Consultant, Sheffield Teaching Hospitals, S5 7AU

Of course Adriane Fugh-Berman is correct that we need to bite something tender and to get out of that lap. But we are fighting the wrong beast. The beast is not the pharmaceutical industry - it is ourselves.

Pharmaceutical companies sell products under the banner of science. But their only raison d'ĂȘtre is to make money. Industry has to balance genuine hypothesis testing and transparency against commercial interests and the financial consequences of dishonesty. This is not in itself a criticism - it is a simple fact.

It is also of course true that the industry provides products which are often beneficial to our patients. It is equally evident that many actions of industry have not resulted in benefit, and have instead caused harm. More importantly, we are often completely unable to assess the degree of harm, because information is hidden by gag clauses, the threat of litigation, and cozy commercial arrangements between the regulators and industry (1,2).

We, as doctors, have created the atmosphere which has allowed companies to malfunction. We have allowed industry to subvert the rules of science (3). We have watched quietly as governments and academics have colluded with industry to hide information critical to our patients. We have remained silent as our medical schools have churned out graduates who have no knowledge of the dilemmas and scandals of medicine. We have allowed many of our medical journals to become corrupted and timid. We have remained silent as the General Medical Council and other bodies charged with maintaining integrity have taken action against doctors for raising questions of integrity, while ignoring serious concerns brought to their attention (4). We have failed to support our colleagues who have raised concerns.

The soft parts that need biting may well be our own.

Aubrey Blumsohn

1) Godlee F. (2006) Can We Tame the Monster? "Drug companies should not be allowed to evaluate their own products." BMJ 2006;333 http://www.bmj.com/cgi/content/full/333/7558/0-f

2) Healy D (2006). Did regulators fail over selective serotonin reuptake inhibitors? BMJ 333: 92-95.

3) Blumsohn A. (2006)Authorship, ghost-science, access to data and control of the pharmaceutical scientific literature: who stands behind the word? American Association for the Advancement of Science, Professional Ethics Report Vol XIX (3) http://www.aaas.org/spp/sfrl/per/per46.pdf

4) Wilmshurst P. (2006) The General Medical Council - a Personal View. Cardiology News Oct/Nov 2006 14-15 http://www.pinpointmedical.com/uploads/pdfs/57A.pdf

Competing interests: Involved in a dispute with Procter and Gamble Pharmaceuticals over hiding of research data and research Integrity. http://www.slate.com/id/2133061/

The letter as published in the print version of the BMJ (BMJ VOLUME 333 25 NOVEMBER 2006 page 1121) is below. It is apparently signed by me as if written by me. However I did not write it. Two critical sentences had been removed, and it is therefore not the letter I wrote. Although this is apparently trivial, I found it irritating and inappropriate. This was particularly so, in view of the BMJ's (successful) efforts at the time to remove an article by Peter Wilmshurst related to those two sentences (again based on a legal threat). It is not up to a journal to decide whether my edited writing still says what they think I want it to say. Perhaps medical journals don't understand the fundamentals. I wonder how often this happens? Does it matter?

  1. The graphic is from the excellent cult comic V for Vendetta
  2. Someone at the BMJ decided to highlight (in bold red) every instance of the word "scientology" in the online BMJ article about the Gillberg affair adding to the embarrassing new "Hello magazine" style of the BMJ. This was later removed.
    Scientologists are certainly interesting creatures and their malign influence on scientific debate is worthy of discussion. However, the fact that scientologists are also interested in the Gillberg affair is a distraction. The comment by Keenan seems appropriate:
    "The [BMJ article] devotes almost a page to demonstrating that the Scientologists advocate strong criticism of Gillberg's work. So what? The Nazis advocated vigorous outdoor exercise. Does this mean that vigorous outdoor exercise is bad? Gornall's argumentation here is not logical, it is rhetorical."
  3. I have a watered-down letter in the next BMJ, but at least the watering-down was handled properly this time.
Get your act together BMJ. You might start by having a debate about your principles and the difference between a medical journal and the Sun newspaper. You might also allow some proper discussion (by proper discussants and involved individuals) about the principles underying the events you are so studiously ignoring.

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Monday, September 24, 2007

Power silences scrutiny

bullyingThis isn't to do with science or the pharmaceutical industry. However it is directly related. It is about the way in which the powerful avoid illumination of their dealings.

Arsenal Football Club's newest shareholder, the Uzbek minerals billionaire Alisher Usmanov complained about a blog posting by Craig Murray. Usmanov ranks 278th on the listings of world billionaires at $2.6 billion. Murray is a former British ambassador to Uzbekistan. Over the past few hours Murray's ISP pulled the plug on his blog, also killing sites of several other customers (including MP and London mayoral candidate Boris Johnson). There appear to have been emails to Arsenal Football Club fan sites threatening libel action. Whoever suggested blogging was dull?

The Google-cache of Murray's blog is here. As it happens I thought it an irrational embarrassment, but such is the nature of ex ambassadors.

For recent discussion see:

Uzbek billionaire Usmanov censors critic and many UK MPs' blogs
Craig Murray, Boris Johnson and Arsenal's Uzkek billionaire
Alisher Usmanov: Unspeakable
Usmanov allegations
Perhaps He Is Confused As To Which Country He Is In?
This is what pissed off that fat fellow, Mr Alisher Usmanov
Bloggers for Craig Murray
Alisher Usmanov: A big, fat bully
craig murray muzzled, bloggers rally
Alisher Usmanov - porkey Russian oligarch(post 2
Bloggers and freedom of speech v Alisher Usmanov
Alisher Usmanov Did Not Use His noodle
Uzbek billionaire silences bloggers

The very powerful and the very stupid have one thing in common.
Instead of altering their views to fit the facts, they alter the facts to fit their views...
Doctor Who

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Tuesday, September 11, 2007

CME Quiz

Mental Floss has a CME quiz.

Try to match 10 popular drugs with their warning labels.

Sample warnings:

  1. Babies born to mothers who have taken [this drug] in the latter half of pregnancy have reported complications, including difficulties with breathing, turning blue, floppiness, stiffness, irritability or constant crying.
  2. Vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green. Also, "An erection that won't go away".
  3. Some patients tried to end their own lives. And some people have ended their own lives.

Test yourself here.

Hat tip Boing Boing.

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Saturday, September 01, 2007

Gottlieb pronounces on pharmaceutical research integrity

Roy poses has a thoughtful piece about the recurrent ramblings of Dr Scott Gottlieb (medical doctor, apologist in chief for creative commercial pharmaceutical science, and columnist for the Wall Street Journal).

Gottlieb just wrote an opinion piece in the WSJ in which he expressed the opinion that government funded researchers must somehow be forced to provide their raw data to the pharmaceutical industry ---- just so industry can check the honesty of what those researchers are doing.

All I can say is that sounds very interesting Dr Gottlieb. I fully agree - of course science should be transparent. Science that cannot be scrutinized is not science at all.

Perhaps Gottlieb will join us in a campaign to get GSK to place "their" Seroxat data in the public domain (that's raw data we're talking about), to get P&G to do the same with their Actonel data from Sheffield, and to get Lilly to put out all the raw numbers from the Zyprexa studies.

The list is endless.

That would be fun Dr Gottlieb. Doctors might actually be able to make prescribing decisions based on complete and non-combobulated numbers instead of the far more interesting company version of events.

The free market may be able to operate at last, and industry might be able to start selling their products under the banner of science. I'll send along a copy of the petition for you to sign immediately Dr Gottlieb. I see a new world dawning.

And by the way Gottlieb is resident fellow at the American Enterprise Institute. He was made Deputy Commissioner of the FDA (2005 to 2007) despite being described in the press as "a Wall Street insider, promoting hot biotech stocks to investors", and having "consulted for, and written positively about, a major matchmaking firm that links doctors with Wall Street investors, the Gerson Lehrman Group", an advisor to Novartis and with host of other conflicts of interest, none of which are declared. He is even a medical doctor, or did I forget to mention that.

For another excellent commentary see http://www.scienceblogs.com/denialism/ by Mark Hoofnagle.

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