There is a big debate going on in the pharmaceutical industry at the moment and it’s a ‘big data’ debate. The topic of the moment is transparency: clinical trial data transparency, regulator transparency, and transparency from marketers.
In the UK, the debate has been turbo-charged by the publication of Ben Goldacre’s book, Bad Pharma. Whilst many may have issues with some of the detail (it’s hardly a book title for the industry to embrace) the over-arching messages in Bad Pharma are hard to disagree with: missing data is potentially detrimental to the wellbeing of patients and society.
At the heart of the transparency debate is missing trial data. A definitive figure is hard to come by, but everybody agrees that the published literature only represents a fraction of the clinical studies undergone by currently used medicines. What’s more, there is a gathering consensus amongst both medical bodies and industry alike that previously unpublished and unavailable trial data should be made public. Initiatives like the “ALLTrials” campaign aim to ensure that all Clinical Study Reports (CSRs) for all trials on all drugs currently on the market should be made publically available. Also, that all future trials should be publically registered and results made available within a year of completion. This is not something that industry seems to disagree with: GSK have signed up to AllTrials and in a recent Pharma Times debate 69% of the (industry-dominated) audience agreed that “all results from all trials for all treatments currently in use must be publicly available”, whilst ABPI’s chief executive Stephen Whitehead was at pains to emphasise that: “we agree that summary clinical trials should be made available for both new and existing medicine”
Of course transparency of this sort results in data- lots of data. Pharma industry personnel need to track down and disseminate all of this historical data. Then there is the issue of patient confidentiality. Many CSRs would need redacting to a certain extent, where patients could be uniquely identified from information contained within. There is some disagreement over the workload all of this ‘big data processing’ entails.
The focus for the transparency debate in the marketing arena has been on doctor payments. In June of this year EFPIA (The European Federation of Pharmaceutical Industries and Associations) issued its code on disclosures of ‘transfers of value’ …. to HCPs. All payments to doctors and healthcare organisations for the year 2015 onwards- from the sponsorship of travel to conferences to consultancy services- needs to be publically declared on a company’s website (or on a central platform such as an industry body website) by June of the following year. In the UK, ABPI was swift to propose a 2014 up-date to its own code of practice to reflect the EFPIA code: previously UK companies had only to disclose “the total amount paid in a calendar year to all of the consultants who have provided services…..the names of the consultants need not be disclosed.” Individual names will now also need to be published.
The US has opted for legislation rather than self-regulation on this matter, with the passing of the Physician Payment Sunshine Act. From the 1st August 2013 all Pharma companies, as well as medical device and other manufacturers, will have to report all payments made to named physicians, dentists, poietrists etc. on an annual basis. Failure to submit payments will result in fines for companies of up to $1million.
Pharma industry transparency has to be a good thing for patients, and industry too. As ABPI head, Whitehead, has pointed out, it is part of a wider trend in UK society today. From MP’s expenses, press intrusion and government lobbying through to the publications of performance data for surgeons, transparency often benefits society as a whole and the industry should embrace it. The question remains: what will be done with all of that data?