May Fools’ Day

Following the long-standing tradition, dating back at least to Chaucer, of playing practical jokes on May 1, The Scientist clearly thought it would be a good idea to show the outside world that science doesn’t always have to be stuffy and picked the appropriate day to demonstrate the point (http://the-scientist.com/2012/05/01/data-diving/).

May Fools’ Day Joke

Sadly, the joke has gone unnoticed, which defeats the point. Practical jokes of this type need to be celebrated. Hopefully this belated recognition will bring some comfort to the author and editors, and encourage them to continue bringing this important tradition into an arena that desperately needs it.

To celebrate May 1, the journal ran an article called Data Diving, ostensibly on a subject that is at the heart of healthcare debates today – access to clinical trial data. In the presence of full and unfettered access, scientific data will supposedly sing out clear and true (Chant clear – they might have said in Chaucer’s day). Without access, companies can claim their trials show whatever the company wants them to show. Without access, companies get to charge whatever they want for their products.

From Tamiflu to Public Citizen

Data Diving opens with the struggles of Peter Doshi, Tom Jefferson and colleagues to get access to the data on Roche’s Tamiflu. Several articles have appeared over the last 3 years mainly in the BMJ outlining what has now become a saga (see Pharmageddon). This story has recently been told by Doshi and Jefferson in a wonderful Op-Ed in the New York Times, outlining the billions of dollars lack of access has cost (see http://www.nytimes.com/2012/04/11/opinion/drug-data-shouldnt-be-secret.html?_r=1 ).

The Tamiflu saga is one bookend to The Scientist’s May Fool’s Day joke. The other is the use of Sidney Wolfe of Public Citizen, Elizabeth Loder  of the BMJ, and other distinguished activists on this issue.  These are names whose invocation leads all right thinking folk to agree with whatever is being said – in this case that pharmaceutical companies are leading the way toward the sunny uplands of an academic Arcadia.

Step Forward Robert Gibbons – Modest Hero 

The centerpiece of Data Diving, the joke, features the work of Robert Gibbons, who has supposedly had unfettered access to patient level data from the trials of Lilly’s Prozac and Wyeth’s Effexor (see Coincidence a fine thing). Just as Doshi and Jefferson’s access overturned a myth – that Tamiflu has a significant clinical effect, so also Gibbons’ access to the “data” seemingly has overturned myths. In this case, those pesky myths that antidepressants don’t really work and especially that they cause suicide. It was, it turns out, lack of access to the data in the first place that led us to these mistaken beliefs. Companies don’t engage in conspiracies, we are being told, they are masters of the cock-up, and if given a choice of feet to shoot themselves in will opt for both feet. It needs independent academics like Robert Gibbons to  wade in and put a stop to their self-injurious behavior.

The give away that this is a May Fool’s Day joke is that very few articles in recent years in the psychiatric or any other literature  have received such withering critique as the Gibbons’ articles to which The Scientist refers – see for example the sequence from April 14 to 16 by boringoldman. The journal’s fact checkers would never have missed this, and by picking such an egregious piece are clearly letting us in on the joke.

an anatomy of a deceit 1…    introduction

an anatomy of a deceit 2…    the fog comes on little cat feet

an anatomy of a deceit 3…    readin’ and writin’ and ‘rithmetic

an anatomy of a deceit 4…    the letter

an anatomy of a deceit 5…    the purloined letter

an anatomy of a deceit 6…    anticipated and forestalled          

High parody 

There is high parody here in that of course Gibbons didn’t have access to anything the original authors of the Prozac papers didn’t already have access to, in that the original authors were all company people with presumably even fuller access than Gibbons was later given. Gibbons has also managed to avoid incorporating or otherwise handling data in the public domain that could be readily accessed anyway that show incontrovertibly that Prozac and Effexor can not only trigger suicide but that on balance the harms outweigh any benefits. By ignoring relevant accessible data in favor of data no-one else has access to, there is here an almost complete inversion of the standard access to data argument.

In the new spirit of openness and perhaps to continue the joke, The Scientist might consider asking Dr Gibbons to make his data fully available on the journal’s website. Or Dr Gibbons could be invited to chair an interview panel to recruit academics to whom companies would be prepared to make data available in the manner Lilly and Wyeth have done in this case.

Hey guys, get with it..

There may be an unexpected sequel to this joke. A scandal brewing over the Gibbons’ articles – some unreconstructed academics it seems just don’t “get it”. Not only are Gibbons’ data inaccessible they complain but it seems criticism of the Gibbons’ paper is out of bounds. The Archives of General Psychiatry has steadfastly refused to publish letters from a number of groups pointing out the lethal flaws in Gibbons papers.

Perhaps these critics should relax a little – it’s not as though much is at stake with data as old as these trials dating back in some cases to the 1980s – and entertain the possibility that following the lead of The Scientist, the Archives’ steadfastness may be a case of trying to draw the story out to have something ready for May 1 2013. If all journals were to follow suit, May 1 could rapidly become the day most academics gear their year around.

What has the Great Scriptwriter in the Sky in store next?

May Fool’s Day appears to have arisen out of a misreading of Chaucer. The tradition of practical jokes stemmed from his tale of how, even though he knew trusting foxes was not a good idea, the vain cock Chanticleer was tricked by a fox. Chaucer gave Chanticleer a second chance – let’s hope the great Scriptwriter in the Sky has written in a reprieve for the rest of us.


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Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

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Comments

  1. I recently encountered a document from the European Medicines Agency that has me still trying to understand just what is believed can be achieved and how. I have to wonder what government functionary wrote this material and anyone read it objectively. Perhaps it was meant as a joke?
    Among some staggeringly uninformed statements are the following:
    “New pharmacovigilance legislation adopted in the European Union (EU) in December
    2010 will promote and protect public health and save potentially thousands of lives each
    year by:
    • strengthening the European system for monitoring the safety and use of medicines;
    • clarifying and simplifying tasks for the parties involved;
    • improving decision-making procedures and reducing administrative costs;
    • strengthening communication and transparency on the safety of medicines.

    No medicine is inherently safe, and all can potentially have harmful side effects, known as
    adverse drug reactions (ADRs). Currently, some 197,000 people in the European Union (EU) die
    each year as a result of ADRs. It is estimated that these measures could save up to approximately 5,000 lives, while providing savings to society of some €2.5 billion, per year in the EU.”
    Are we concerned about the remaining 192,000 deaths?
    “Phased implementation from July 2012 As a result of budget and resource restrictions, implementing the new pharmacovigilance legislation, which requires a major revision of existing activities and/or the creation of new ones by pharmaceutical companies, national regulatory authorities and the European
    Medicines Agency, will be done in a step-wise approach over the coming years.”
    So, this Utopia will come about at some point in the future, as yet undetermined, while hundreds of thousands continue to die needlessly. Right. And yes, Virginia, there is a Santa Claus.

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  1. [...] In the midst of the Industrial Revolution, the factories around cities like Sheffield were belching out so much smoke that the sun was blocked out and children famously developed rickets. The factories of industrial post-modernism are also belching out vast amounts of smoke and people are developing diseases from pediatric bipolar disorder to osteopenia as a result that will only clear when the smoke clears. These factories also contain a production line that turns out “North Koreans”, whose job it is to defend the system (see We’re all North Koreans now). They have a department whose brief it is to work out new initiatives such as the colonization of May Fool’s Day (see May Fools’ Day). [...]

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