Science and Technology CommitteeWritten evidence submitted by Glyn Moody

1. My name is Glyn Moody, and I am a journalist who has been writing about technology for over 30 years. More recently, I have been exploring the advantages of openness—notably open source (such as GNU/Linux), open content (Wikipedia, for example), and open data. My perspective is therefore from an open data, rather than a clinical viewpoint. I have no interests to declare.

2. In general, open data brings a number of benefits. It automatically increases transparency, it allows data to be used in new ways, and can also generate new economic activity. I believe that all of these are possible if clinical trials information were made available as open data.

3. Of these, transparency is perhaps the most important, because in this case it will save many lives and much money. Given the exhaustive treatment of this issue by Ben Goldacre in his book “Bad Pharma”, referred to on the Inquiry’s home page, I won’t repeat details here. I would, however, like to mention the particularly egregious case of Roche’s Tamiflu. As the Committee will know, this has provoked a letter from a group of MPs to the Public Accounts Committee to request action on hidden trials and Tamiflu.

4. This paragraph captures their—and my—concerns: “There are failings at every level, from ethics committees which allow trials to proceed without insisting on data being published, to organisations like the National Institute for Clinical Excellence and the European Medicines Agency which do not insist on receiving all the evidence—and then making it available to all interested medical researchers—before granting regulatory approval for drugs, appliances and implants. Sharing information can be a very powerful way to protect patients, because then ‘many eyes’ can be brought to bear on what are often complex questions. Problems with Rosiglitazone, Tamiflu, Vioxx, and many devices were spotted by the global community of independent academics, rather than by individual countries’ regulators acting behind closed doors.

Most manufacturers claim they release data. However, unless they publish relevant data in a form accessible to UK regulators and researchers, it may be useless or incomplete.”

5. In the light of this widespread lack of transparency, I would therefore like to urge that the UK require drug companies to make available the full clinical study reports as well as the raw data (but only in an anonymised form, of course).

6. The benefits would be many. As well allowing external experts such as the Cochrane Collaboration to examine the data, and to combine it with information from elsewhere to produce statistically significant results, making the data available would allow many other uses, including commercial ones that would produce further benefits for healthcare in this country, as well as boosting its leading position in the open data world thanks to the Open Data Institute.

7. There is no justification for not providing this information. It is based on research carried out with public volunteers, who have placed themselves and their health at the disposition of drug companies in the expectation that the greatest benefit for society would result. Withholding the anonymised data is a betrayal of that trust, and is motivated by purely selfish reasons on the part of the pharmaceutical industry, which we now know has much to hide about the medicines we have been taking. The recent scandals involving high-profile players demonstrates that the current system does not work; instead we must have real transparency in the form of clinical trials information released as open data.

February 2013

Prepared 16th September 2013