I just got word that we got funding from an external to buy 400 copies of Bad Pharma to use as instruction material in our redesigned course on academic and scientific education. The book touches upon the role of the pharmaceutical industry in the design, execution, presentation and dissemination of results of clinical trials. The author, Ben Goldacre, identifies several problems and brings forth several solutions. But are these all correct?
We will use this basic question as the basis for a complete symposium on this topic: are the problems identified by Goldacre the real problems, or just cherry picked examples from the past? And are the solutions that he provides real solution that could work? And can we think of any other way to improve the care of our patients in the future?
I had this idea a long time ago when i first read this book. It touches upon a matter that is discussed in the old version of this course for a couple of years. Even more so: during this course students are asked to grade the quality of trials and the subsequent reference to this publication. The results show that the quality is often low, even in high impact journals, and that the references do not always justify the claims made in medical advertisements. These results have been published in several publications and are even cited in the book.
It was quite a hassle to get a ‘normal’ book into the curriculum of our medical center. Most people liked the idea of reading a book and organising a symposium, but a lot of people told me that it was impossible to do so. A “normal” book could not be placed on the mandatory reading list, and just buying electronic or hard copy versions is just way to expensive. luckily, with help from the Walaeus Library of the LUMC and prof FMH we were able to obtain external funding. And no, its not funded by ‘big pharma’, but a small fund that subsidises small but nice projects that make the world a bit smarter.
So I got an email from the folks from alltrials.net on their progress. I explained the initiative in an earlier post in which I also told that I as well as the Dutch Epidemiological Society (VVE) signed the petition. So did it help? Just read the following section from their email.
You, and 40,000 other people around the world, have signed the AllTrials petition. We are on the threshold of significant change, but we now urgently need help from all of you to make this a reality.
Your support has already persuaded hundreds of organisations to commit to the aim of getting all clinical trials registered and their results reported. These include regulators and faculties. GSK, one of the biggest drug companies in the world, has signed up and others are considering it. Some of these groups are now starting discussions about the practical ways to stop trial results being withheld.
So far we’ve created a ripple, and got some important commitments. We have empowered individuals in large organisations to speak up, and it has changed the mainstream opposition on this issue. In doing so, we have also challenged those who try to pretend that the problem doesn’t exist, or who falsely claim that it has already been fixed.
But this is only the start if you ask the alltrials.net folks: they want to push on with three goals:
- One million signatures on the petition.
- More international organisations signed up.
- £40,000 so we can keep going.
I can only agree: consider signing (if you haven’t done so already)!
Ben Goldacre, known from the bestseller Bad Science (book and blog) has a new book, Bad Pharma. Goldacre is always fun to read: science, both the method as the social phenomenon, explained for non-scientist while still interesting for scientist. The same goes for his new title Bad Pharma, where he explains what is right and wrong in the field of clinical trials needed to determine what treatment is best given. Before I am going to review the complete book, perhaps this TED talk will explain it all:
Basically, his point is that for good answers to questions on what treatment is best to save lives, it is pivotal that all the results of all trials are published. This sounds a bit old, since there are databases in which trials should be registered. However, only registering the existence of a trial is not enough: all data should become known to the public. This sounds familiar: this standpoint is off course the same standpoint of the AllTrials.net petition, which is initiated by a.o. Ben Goldacre. For more on AllTrials.net, please see a previous post.
While reading the book of Goldacre it started reading about reasearch done in the Netherlands, where 250 students were looking into the adverts for medication: they checked their quality (was the science OK?) and correct use (does it support the claim?) of the trials in major journals and found that half was of good quality and only half supported the claim. And the nice thing about this research? It was executed at our department as part of one of our undergraduate courses! All students scored trials and a couple of students were also engaged in the analyses/writing/submission process. The paper from this research, cited by Goldacre, is available from the website of the Netherlands Journal of Medicine. (pdf, open access) An earlier paper with the same concept but focussed on rheumatoid arthritis medication is also published, also open acces. (pdf)
The Dutch Epidemiological Society decided to support the AllTrials petition to get “all trials registered | all results public”. Why this is important? A look at their website tells us:
Thousands of clinical trials have not reported their results; some have not even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated.
All trials past and present should be registered, and the full methods and the results reported. We call on governments, regulators and research bodies to implement measures to achieve this.
I also signed the petition. have you? Visit www.alltrials.net and sign!