Comment Blog 7 November, 2018

Transparency can help the NHS save money and improve patient care. Here’s how.

Last week, the Science and Technology Committee of the House of Commons issued a clarion call for transparency in medical research. Noting that around half of all clinical trials still fail to report their results in violation of existing disclosure rules, the Committee warned that this “presents risks to human health”, and called on the government to “introduce a system of sanctions to drive improvements in clinical trials transparency”.

The example of Tamiflu illustrates how the widespread failure to report trial results runs counter to the interests of patients and taxpayers alike. In 2009 alone, the NHS spent £424 million – half a percent of its entire annual budget – on stockpiling the drug, amassing enough of the pills to treat four out of five people in the country. All evidence available at the time suggested that Tamiflu was a safe and effective treatment for influenza. However, the results of eight clinical trials of the drug had remained unpublished. After a struggle lasting several years, scientists managed to get hold of the hidden data from those trials. After assessing the full evidence on the drug, they concluded that Tamiflu was not fit for purpose.

Alarmingly, even after this high profile debacle, the problem of hidden and distorted evidence in medicine has not been fixed. Oxford University researchers recently discovered that 3,673 drug trials violate European Union guidelines requiring their results to be posted on a public database. Around half of these trials have not reported their results anywhere else either, meaning that the results of over 1,800 trials conducted in Europe remain completely hidden from patients, doctors and the medical research community. (The true number is likely to be far higher, as the researchers excluded over 3,000 trials with inconsistent data from their study.) A total of 1,639 clinical trials run by UK universities have failed to post their results on databases. In addition, many pharmaceutical companies and even NHS Trusts have left trials unreported.

Clinical trials whose findings remain hidden make no contribution to medical understanding or public health. Imagine you are testing a new drug, hoping to find a cure. Your trial shows that the drug does not work. You may think that the results are uninteresting, but unless you publish them, chances are that other scientists will explore the same dead end again, wasting public money and putting patients at risk. Worldwide, an estimated $85 billion in medical research funding goes to waste every year due to non-publication of results.

The Science and Technology Committee has proposed two excellent solutions to this problem.

First, the Health Research Authority should routinely track every single trial conducted in the UK to check whether it publishes its results. As the Health Research Authority already holds documentation on every single clinical trial approved in the UK, this would not impose additional red tape on researchers. The cost of running such a national audit programme would be no more than £2.4 million – less than the cost of running a single large trial. In the Committee’s words, “this is a small price to pay compared with the sums of money involved in policy decisions that draw on clinical trials evidence.”

Second, the government should give the Health Research Authority the power to impose fines on companies and universities that fail to report results. (A similar rule is already in place in the United States.) Health advocates are likely to welcome this transparency blueprint, but it is too early to celebrate. After all, the very same Committee released a similar report in 2013, but most of its recommendations were subsequently ignored, leaving the problem unresolved.

Eight hidden Tamiflu trials alone cost the British taxpayer £424 million. Today, the results of hundreds of trials conducted in the UK remain completely unreported. Against a backdrop of growing pressure on the NHS, which last year spent an estimated £17.4 billion on medicines in England alone, opacity as usual is no longer a viable option. This is a problem that can, and must, be fixed.

The ball is now in the court of the government, which has two months to respond to the Committee’s recommendations. The Committee correctly noted that “clinical trials transparency is as much a question of political will as it is a technical issue.” Political decision-makers cannot allow to let this issue slip off their radar again.

This blog was co-written by Dr Till Bruckner, Founder of TranspariMED, a Bristol-based initiative that works to end evidence distortion in medicine and Rachel Cooper, Director of Transparency International Health Initiative.