Yesterday I was writing about open access and open data in the context of the EU's Horizon 2020 initiative. Closer to home, I came across a wonderful real-life example of how open data can almost certainly save not just money, but lives.
The data in question concerns clinical trials. These are the indispensable tests that are carried out on drugs before they are approved and dispensed. Obviously, that data has to be as good as it can be, otherwise useless or even dangerous pharmaceutical products may be approved. And as anyone who has read Ben Goldacre's new book "Bad Pharma" well knows, that's precisely what has happened multiple times in the past. Which means that many thousands of people have suffered and probably died as a result.
This has occurred because the clinical data obtained by drug companies in the course of testing is not made fully available for others to inspect and check. Sadly, this is not simply a problem of the bad old days. As a recent editorial from the BMJ (British Medical Journal) makes clear, there are still issues today:
The drug industry does many good things. It produces medicines that can improve health and save lives. It creates jobs and stimulates economic growth. Sadly it does bad things too. Persistently and systematically over decades it has withheld and misreported data from clinical trials. As a result, a whole range of widely used drugs across all fields of medicine have been represented as safer and more effective than they are, endangering people's lives and wasting public money. Such wilful distortion is scientific misconduct. It is not something we can forgive because of the good things drug companies do. As Ben Goldacre says in the introduction to his new book Bad Pharma, "Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale. But that does not allow them to hide data, mislead doctors, and harm patients.
More specifically, the BMJ would like to see data about Roche's Tamiflu:
The BMJ is also intensifying its efforts to help resolve a three year battle to gain access to the full data on oseltamivir (Tamiflu). In 2009 the Cochrane respiratory group, led by Tom Jefferson, was commissioned by the UK government to update its systematic review of neuraminidase inhibitors. Despite a public promise to release "full study reports" (internal company reports) for each trial, each of which can run to thousands of pages, Roche has stonewalled, variously pleading patient or commercial confidentiality, or claiming that sufficient data have already been provided.
In fact the Cochrane group has told the BMJ that about 60% of Roche's data from phase III trials of oseltamivir have never been published. And although the European Medicines Agency (EMA) could have requested these data from Roche, it did not do so. This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base. Indeed the EMA's unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug's adverse effects. What has Roche got to hide?
As for the Cochrane group and its work, there's a good post over on the Open Knowledge Foundation blog (disclaimer: I am on the Foundation's advisory board) that explains how it works, and why they would like the data from Roche about Tamiflu. Here's the basic reason:
[Clinical] Trials are experiments conducted on human beings. Full reporting of their results (anonymized to prevent individuals being identified) should be a right, not a gift. Your doctor should be in possession of all the facts. Think about that next time he prescribes something for you.
As that rightly points out, doctors cannot prescribe the right medicine to us unless they know what those medicines do – or, indeed, if they are safe. Without all the clinical trial data, suitably anonymised, we are forced to accept the word of the manufacturers that everything is fine. Since they have spent large sums of money on developing their drugs, and are naturally keen to sell large quantities of them (as they did to governments around the world at the time of the Swine 'Flu scare), it's just possible that they may not be totally objective on this matter.
That's why pharmaceutical companies must release all the results of their clinical trials as open data, so that independent researchers can check what has been found. There is simply no justification putting financial considerations above the health and lives of patients that trust their doctors to give them safe and effective medicine. Without open data, we can never be sure it is either.