It’s hard to imagine a restaurant without a menu, a sheet where the fare is listed, where the ingredients are explained, and limitations are clearly labelled (“not for people with gluten intolerance,” for example). How would we know what to order without a menu? But when it comes to selecting documents on the safety and effectiveness of drugs, there has been no menu.
On 24 November 2014, the European Medicines Agency (EMA) released a new “Guide on access to unpublished documents.”
The guide follows in the steps of several other policy documents, charting the revolution from a closed shop to what is probably the most liberal experiment in regulatory data sharing on the planet.
The six page guide is written clearly, as you would expect from a document for “anyone” interested. The guide tells you how to apply for documents held by the EMA as part of the process of central pharmaceutical regulation. We learn that English is almost certainly the language of the released documents, but you can apply in any language of the European Union. Other sections tell you what will happen to your request, and what options you have in the event that your request is turned down or not answered in time.
Readers of the guide are warned that the release of large and complex documents may take place in batches over a long time. This certainly has been our experience and presents a serious problem for independent researchers who work on deadlines. We applied for clinical study reports from trials of a global public health intervention, and we’ve yet to see more than 10% of the text six months after the ball got rolling. The EMA tells us that the documents are in preparation, but so far there’s little meat.
Gone, it seems, are the good old days of data request. On 10 January 2011, we requested around 20 clinical study reports on Tamiflu. By the end of May, the EMA had sent us 25 000 pages of unredacted text. One presumes that the EMA’s workload has exploded since those early days. But is this the case? We await increased transparency on the to-ing and fro-ing with the marketing authorisation holders, to understand more precisely what happens as one waits. Where are the delays occurring? How can the system become more efficient?
As we await answers to these questions, we think it’s time to address an equally serious problem: the lack of a menu.
While we applaud the EMA’s efforts to provide a guide that makes requesting documents easier, we are concerned that the guide does not tell us what’s on the menu at the EMA restaurant. For hungry people this is a bit of a problem, but even more so for the restaurateur.
If I am very hungry and a little fussy, I’ll say, “Bring me anything that can fill my stomach!” But if I don’t like what I get, I’ll say, “Not this, I cannot eat this! Bring me something I can eat . . . ” and this sort of thing will go on until by trial and error my dinner will be to my liking. If restaurants were run like this they’d go bust, as the waiters and chef would spend all their time trying to guess what I want, and I’d end up paying for one dinner anyway. Even worse is the contention that you can just apply with the name of a compound, and if you have no further clue but are generally interested in the topic, the EMA will advise you on which documents—according to the EMA—are the right ones for you.
So let’s have a list of holdings by marketing authorisation application, with the dates and types of documents held included. And while you are at it, please explain what’s in each document in plain language so that “everyone” can order the right dish.
Tom Jefferson, reviewer, Cochrane Acute Respiratory Infections Group, 00187, Roma, Italy.
Peter Doshi, assistant professor, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Competing interests: TJ and PD were co-recipients of a UK National Institute for Health Research grant (HTA – 10/80/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children—http://www.nets.nihr.ac.uk/projects/hta/108001).
In addition:
TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to oseltamivir phosphate; Tamiflu [Roche] and in a labour case on influenza vaccines in healthcare workers in Canada. In 1997-99 TJ acted as consultant for Roche, in 2001-2 for GSK, and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral, which did not get approval from the Food and Drug Administration). TJ was a consultant for IMS Health in 2013, and in 2014 was retained as a scientific adviser to a legal team acting on the drug Tamiflu (oseltamivir, Roche).
PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. Dr Doshi is also an associate editor at The BMJ.