Alessandro Liberato was suffering from multiple myeloma and trying to decide whether to go through the trauma – for the second time – of a bone marrow transplant.
“There were four [clinical] trials that might have answered my questions, but I was forced to make my decision without knowing the results because, although the trials had been completed, they had not been published,” he said.
But Alessandro’s predicament isn’t unique. Millions of patients like Liberato and their doctors are avoidably in the dark. Amazingly, fully half of all clinical trials are unpublished.
“As a result, the effects of most medicines are effectively unknown,” says Dr. Ben Goldacre, who has studied the problem of why clinical trials often go unpublished.
Health systems and taxpayers pay dearly for this lack of access to information. For example, in 2009, governments around the world, concerned about a flu epidemic, stockpiled the drug Tamiflu, which is made by the Swiss company Roche. The UK government alone spent £500m on Tamiflu purchases.
But then a Japanese researcher noticed that of the ten studies of whether Tamiflu works, eight of them had never been published. After a long fight, enough data about those missing trials were released to show that Tamiflu does not reduce hospitalisations and may not reduce deaths.
The problem of unpublished trials
It’s not just a random half of clinical trials that aren’t published. Overwhelmingly, it’s the trials that reveal unwanted outcomes that remain unpublished. This means that the available literature that doctors use to determine a treatment’s efficacy might seem that some interventions work— when in fact they’re not effective, or worse, dangerous. Studies funded by pharmaceutical companies – which have a strong incentive to show that their products work – are four times as likely to be withheld as independent studies; and studies with negative findings tend to take a year longer to publish than do those with positive findings.
Like a bad joke about politics, the medical industry and others for years have denied that the problem of selective publication exists. Then they conceded that it goes on but denied that it’s a problem. Then they said that it’s a problem but can’t be fixed. Then they claim that it is already fixed.
AllTrials and the campaign to eliminate publication bias
This problem has the potential to be fixed by the AllTrials campaign, which calls for the publication of the results of all trials. In just two years and on barely any budget, AllTrials has convinced GlaxoSmithKlein, Johnson & Johnson, and Bristol Myers Squib to publish all their trials. AllTrials has changed laws in Europe so that future drug trials must be publicly registered in advance and results reported within a year of the trial’s completion. The campaign has also gotten the world’s largest medical publishing company, Elsevier, and various major journals, to agree to publishing only on trials that were properly reported. Finally, to date, AllTrials has gained support from 84,293 individuals and 562 organisations—including hundreds of medical professional bodies and patient groups.
AllTrials currently has more pharmaceutical companies asking for support in releasing their ‘back catalogues’ than it can cope with. And the campaign has pension funds calling to ask how they can pressure companies in which they own a stake into releasing their unpublished reports.
Why AllTrials has the potential for high impact outcomes
My framework for analysing charities is this:
impact = importance x idea x implementation
The importance of AllTrials’s work is huge. Unlike almost anything else you’ll ever see, solving this publication bias problem will benefit literally all people everywhere, forever.
AllTrial’s idea (approach/intervention) is a supremely sensible two-pronged approach. First, it fosters compliance in the way future trials are conducted through regulation of current trials, such that you can’t get approval for a new trial if you’ve not published the results of your previous ones. This approach has been adopted in the UK and Europe, and the UK regulator has made it a priority to persuade its counterparts elsewhere to adopt it too. Second, AllTrials seeks to make the results of past trials publicly accessible, by getting shareholders to pressure companies into opening up their data-vaults, and providing practical help to do so.
And despite the odds, the implementation of this approach is effective, as witnessed by the successful results of AllTrials’s campaign.
Plus, AllTrials’s solution is cheap. Medical research to ‘discover new cures’ costs about $240 billion each year. By stark contrast, making all this information public only costs about $1 million a year—and might enable a lot more discoveries.
How publication bias hurts the global poor
Why is the AllTrials campaign relevant to the world’s poorest people? Most obviously, non-publication affects the effectiveness of medicines bought and prescribed to help cure and alleviate the debilitating illnesses of those who live in the developing world.
But additionally, researchers have used these formerly unpublished results to understand the side effects of medical treatment of diseases that are still prevalent in many parts of the world. For example, in an initiative funded by the Gates Foundation and FIDEC (Fighting Infectious Diseases in Emerging Countries), a Belgium clinical trial company called P95 has requested access to data from a GSK trial of a rotovirus vaccine that was conducted on 63,000 children and infants in Latin America. The project seeks to examine newly-available information about the drug’s side effects data with two main aims: First, the project seeks to predict and better prepare future healthcare needs in countries after vaccines are rolled out. (How many children likely to be affected by side effects? What kind of care are they going to need?) The project's second goal is to design better trials in the future--ones that will reduce side effects and improve monitoring of the children enrolled in trials.
The data that will prove most useful to saving and improving lives in less developed countries lurk in those unpublished trials. Digging them out and making them public could be one of the most cost-effective health interventions for them that we’ll see.
You can donate to support AllTrial's campaign at Just Giving
Caroline Fiennes will be delivering City Philanthropy's half-day workshop DonorWISE*: An Introduction to Effective Philanthropy on September 27. Click here to find out more and book your place.
Caroline Fiennes is the director of Giving Evidence, and author of It Ain't What You Give, It's The Way That You Give It, a guide to effective charitable donations. Buy it discounted from www.giving-evidence.com/book