(so called) Bad Science

[Guest guest]

Boy oh boy, every worm from under a rock has shown up this last week -

Deer, India Knight & now old Ben Goldacre.

I doubt that I ever thought of wielding an axe, but now that its been

suggested............

show me quality published research on the safety of MMR vax with placebo

controlled, extended-time-period trials.

Sheri

http://www.guardian.co.uk/life/badscience/story/0,,1794440,00.html

Bad Science

Academics are as guilty as the media when it comes to publication bias

Ben Goldacre

Saturday June 10, 2006

The Guardian

When I am finally assassinated by an axe-wielding electrosensitive

homeopathic anti-vaccine campaigner - and that day surely cannot be far off

now - I should like to be remembered, primarily, for my childishness and

immaturity. Occasionally, however, I like to write about serious issues. And

I don't just mean the increase in mumps cases from 94 people in 1996 to

43,322 in 2005. No.

One thing we cover regularly in Bad Science is the way that only certain

stories get media coverage. Scares about mercury fillings get double page

spreads and Panorama documentaries; the follow-up research, suggesting they

are safe, is ignored. Unpublished research on the dangers of MMR gets

multiple headlines; published research suggesting it is safe somehow gets

missed. This all seems quite normal to us now.

Strangely, the very same thing happens in the academic scientific

literature, and you catch us right in the middle of doing almost nothing

about it. Publication bias is the phenomenon where positive trials are more

likely to get published than negative ones, and it can happen for a huge

number of reasons, sinister and otherwise.

Major academic journals aren't falling over themselves to publish studies

about new drugs that don't work. Likewise, researchers get round to writing

up ground-breaking discoveries before diligently documenting the bland,

negative findings, which sometimes sit forever in that third drawer down in

the filing cabinet in the corridor that nobody uses any more. But it gets

worse. If you do a trial for a drug company, they might - rarely - resort to

the crude tactic of simply making you sit on negative results which they

don't like, and over the past few years there have been numerous systematic

reviews showing that studies funded by the pharmaceutical industry are

several times more likely to show favourable results than studies funded by

independent sources. Most of this discrepancy will be down to cunning study

design - asking the right questions for your drug - but some will be owing

to Pinochet-style disappearings of unfavourable data.

And of course, just like in the mainstream media, profitable news can be

puffed and inflated. Trials are often spread across many locations, so if

the results are good, companies can publish different results, from

different centres, at different times, in different journals. Suddenly there

are lots of positive papers about their drug. Then, sometimes, results from

different centres can be combined in different permutations, so the data

from a single trial could get published in two different studies, twice

over: more good news!

This kind of tomfoolery is hard to spot unless you are looking for it, and

if you look hard you find more surprises. An elegant paper reviewing studies

of the drug Ondansetron showed not just that patients were double and treble

counted; more than that, when this double counting was removed from the

data, the apparent efficacy of the drug went down. Apparently the patients

who did better were more likely to be double counted. Interesting.

The first paper describing these shenanigans was in 1959. That's 15 years

before I was born. And there is a very simple and widely accepted solution:

a compulsory international trials register. Give every trial a number, so

that double counting is too embarrassingly obvious to bother with, so that

trials can't go missing in action, so that researchers can make sure they

don't needlessly duplicate, and much more. It's not a wildly popular idea

with drug companies.

Meanwhile the system is such a mess that almost nobody knows exactly what it

is. The US has its own register, but only for US trials, and specifically

not for clinical trials in the developing world (I leave you to imagine why

companies might do their trials in Africa). The EU has a sort of register,

but most people aren't allowed to look at it, for some reason. The Medical

Research Council has its own. Some companies have their own. Some research

charities do too. The best register is probably Current Controlled Trials,

and that's a completely voluntary one set up by some academics a few years

ago. I have a modest prize for the person with the longest list of different

clinical trial registers.

And why is this news? Because people have been calling for a compulsory

register for 20 years, and this month, after years of consulting, the World

Health Organisation proudly announced a voluntary code, and a directory of

other people's directories of clinical trials. If it's beyond the wit of

humankind to make a compulsory register for all published trials, then we

truly are lame.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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