Bad Pharma: Why is data being removed from public scrutiny?

Lack of transparency concerning the Association of the British Pharmaceutical Industry's Disclosure Database

INTRODUCTION

Alongside the pharmaceutical industry’s power to change lives for the better, the industry has almost unmatched scope to cause serious harm to the health not only of individuals, but in some cases of whole generations, if not the entire nation. Full transparency over the promotional payments made by pharma companies – for example to clinicians, politicians, media, charitable, academic or trade organisations – is therefore critical to understanding how the industry influences those whose personal and public health decisions can affect both the commercial success of a manufacturer and the health of every consumer.  

Indeed, for that reason alone, it would not be unreasonable to expect there to be a fully searchable register of such payments so that members of the public could freely explore and understand whether particular individuals or organisations recommending, promoting or prescribing certain drugs or health products have any financial connections to the relevant manufacturers.  One might go further to expect that, if manufacturers have nothing to hide from their consumers, they should be willing to provide full transparency of the nature and extent of their financial influence over third parties — after all, transparency not only helps to reveal bad behaviour, it nurtures public trust and confidence.

As Dr Alan Black, a retired pharmaceutical physician with 30 years’ experience in the pharmaceutical industry explains in this guest article, the reality is rather different.

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ARTICLE BY DR. ALAN BLACK

Though far from perfect, the starting point for pharma industry financial disclosures in the UK is the ABPI Disclosure UK Database (Disclosure UK) — a useful tool for those wishing to understand the extent of the pharmaceutical industry’s spending in the UK. Introduced by the industry’s trade association, the ABPI, in 2016 as part of a Europe-wide initiative, it provides information about cash payments and other transfers of value to certain categories of UK individuals and organisations. Information about donations, grants, event sponsorships, fees for services, and some types of research funding, are contained within it.

The role of the ABPI Disclosure UK Database

The Association of the British Pharmaceutical Industry (the ABPI) is the trade association for British pharmaceutical companies and the subsidiaries of foreign pharmaceutical companies based in the UK.  Membership is voluntary (but most pharma companies are members) and adherence to its Code of Practice (the ABPI Code) is mandatory for all members.  Since 2016, the ABPI Code has required all payments to Healthcare Professionals (HCPs) and Healthcare Organisations (HCOs) by pharmaceutical companies to be publicly declared on the Disclosure UK database.  

This includes not only cash but also benefits-in-kind such as rail tickets, diagnostic equipment, provision of marketing support or of admin support to conferences and so on.  Since 2016 the number of pharma companies declaring such transfers of value has increased greatly, as have the amounts being declared. But we are still far from the level of transparency required for the public to have confidence that we are seeing the full picture.  

For instance, if a healthcare professional refuses their consent for a payment or transfer of value to be attributed to them in the Disclosure UK Database, then it is lumped in as an aggregated amount along with all other payments and transfers to non-consenting professionals by the relevant pharma company – hardly transparent.  In 2022, 21% of HCPs refused consent to disclosure of their names alongside payments received. To give just one other example of translucency in the database, payments made to individual journalists are not yet required to be specifically disclosed; pharma companies need only disclose the aggregate amount paid to all journalists in a given year.  

So the Disclosure UK Database is far from the finished article, and certainly not yet a paragon of transparency.

Weight-loss scandal

An example of why it is so important for the public to be able to access this data is the recent scandal involving Novo Nordisk. The scandal arose from a complaint in 2021 about the misuse by Novo Nordisk of a large-scale promotional campaign in the UK to increase sales of its weight-loss drug Saxenda.  It was found that Novo Nordisk knowingly disguised the promotional campaign as a training programme, paying for marketing of the drug and offering inducements to HCPs to use the drug.

When a complaint about this sales push masquerading as training was made to the ABPI, because the history of inducements and payments to individuals by Novo Nordisk could be traced, it ultimately resulted in the expulsion of Novo Nordisk from the ABPI, the resignation of the Novo Nordisk UK Managing Director as President of the ABPI, and the Royal College of Physicians cutting all financial ties with Novo Nordisk. The scandal has also led to additional investigations of Novo Nordisk by the UK’s medicines regulator, the MHRA.

Subsequently, Novo Nordisk’s promotion of another new weight loss drug Wegovy was investigated by journalists at the Observer and reported in two articles in the paper earlier this year.  Using the ABPI database, the journalists were able to determine the extent of the historical spending by Novo Nordisk with influential UK individuals and organisations in the field of obesity over a number of years during a key period in the lifecycle of the drug.  As a result, NICE has now decided to examine the process by which Wegovy was approved for NHS use, saying that:

“Following concerns raised by the Observer, we are reviewing the declarations of interests from organisations and experts who provided advice to our committee that undertook the appraisal of semaglutide [Wegovy].”

It was crucial to the Novo Nordisk case that the investigative journalists were able to trace back through a number of years of payments by the company. Although in the case of Wegovy there are currently no suggestions that any rules have been broken, it is fortuitous for the Observer journalists that the Saxenda complaint and their subsequent Wegovy investigation happened when they did.  Had the journalists’ investigation been delayed more than a couple of years it appears that, following an important policy interpretation by the ABPI, many of the useful data that had been accessible for their investigation would have become unavailable – indeed removed from the public domain, and thus from scrutiny, forever.

Transparency has become time-limited

A few weeks ago while carrying out some routine periodic research I spotted that entries in the ABPI’s Disclosure UK database for 2019 had been removed from the database.  When I queried the removal of data the ABPI explained it by writing in response:

“The ABPI Code of Practice requires data to be published for three years. After that time it is deleted from Disclosure UK and all back-end servers.

However, the Code also require companies to keep records of their transfers of value for up to 5 years, so you could contact individual companies for historical info if required”.

The realisation that simple access to all the collated industry transparency data prior to 2020 is now denied to the UK public was concerning, and not mitigated in the slightest by the suggestion that individual manufacturer companies could in principle be contacted. For the project I was working on, tracking the spending relating to the particular recipient organisations in which I was interested would have involved contacting every single pharma company in the UK to request information about their detailed spend with each one of these organisations: a resource-intensive exercise for me, with no guarantee that any such requests would receive positive responses from the pharma manufacturers.  

Equally concerning however, is the ABPI’s misrepresentation of their own Code of Practice  in order to justify its decision to remove these data from public scrutiny. 

“The information disclosed must remain in the public domain for at least three years from the time of first disclosure”, is what Clause 31.2 of the ABPI’s Code actually says (emphasis added).

So, 3 years is the minimum period required for disclosure, not the maximum as implied by the ABPI in their apparently defensive response to my query. The ABPI is plainly free to leave these data in the public domain for longer than 3 years if it chooses to do so, but it has chosen not to do so. 

When I pointed this out and asked why the ABPI had made this decision, I was presented with a series of vague responses comprising a mixture of spin and inaccuracy as attempts to justify this new policy. Statements such as: 

“I was referring to the requirements of the Europe-wide EFPIA* Code, which are that all disclosure data is published for three years, and held by companies for five years. It is from the EFPIA Code that the requirements within the ABPI are originally drawn – although I don’t have a record of why the publication and retention periods for this data were set as three and five years by EFPIA. However, it is desirable to have the same structures at the UK and EU level as many of the firms operating in the UK and subject to the ABPI code may only have a minimal footprint or resources in the UK itself. Most operate on a European-wide or global basis, so it is helpful to have consistent data gathering, reporting and processing requirements across markets if at all possible. This reduces costs, complexity, and the chance of reporting errors.”

*The EFPIA is the European Federation of Pharmaceutical Industry Associations, of which the ABPI is a member.

It’s all very well trying to pass the buck to our European cousins with their European rules, but what Section 22.01 of the EFPIA Code of Practice actually says is:

“[I]nformation disclosed must be required to remain in the public domain for a minimum of 3 years after the time such information is first disclosed”.

So, in fact, exactly the same as the ABPI’s Code: 3 years is the minimum period required for disclosure by the EFPIA, not the maximum. In light of which, the ABPI’s protestations begin to look increasingly self-serving.

Protection of privacy is a transparently self-serving charade

In a further attempt to distance itself from its own decision to time-restrict access to the disclosed data, yet at the same time to portray its decision as a defence of personal privacy, the ABPI also told me that: 

“There is a general ongoing global debate about what data it is reasonable to hold on people and for how long. We operate on the principle that we should’t be holding people’s data for longer than necessary”

No reasonable person could really disagree with the principle that personal data should not be held for longer than necessary – indeed this has become a central principle of data protection law the world over now. However, there are a couple of important aspects of this principle which I think are worthy of expansion with regard to the ABPI’s Disclosure UK database:

1. This principle is surely most tenable when it relates to the personal information of private individuals.  However, this does not apply to the vast majority of data contained within the Disclosure UK database because:

• firstly they relate to financial information about payments to organisations and individual HCPs that deliver, or have influence over the delivery of, healthcare for the British people. Many, or even the majority, of recipients are concurrently in receipt of public funds (originating from taxes and National Insurance contributions) so this is not really the personal information of private individuals. And…

• the Disclosure UK database should not include any sensitive personal data such as home addresses or other personal contact details.

Surely it is not too much to ask that if publicly funded individuals or organisations, working in healthcare, want to receive funding from private pharmaceutical companies which may at the same time be providing goods and services to them or to their employers, then they should be prepared fully to disclose that additional funding and to have that disclosure remain publicly available for an extended period of time.  It can be argued whether or not this data should be available for perpetuity, but it should certainly be available for longer than 3 years. Which brings me onto a second aspect of the ABPI’s stated operating principle.

2. “... for longer than necessary”:

• An obvious question here is what exactly does ‘necessary’ mean in this context? Aside from recent notable Covid-19 vaccine exceptions, the pharmaceutical industry usually works within famously prolonged timescales. The time taken for a medicine to pass through discovery and preclinical phases, through the various clinical development phases, through regulatory submission and approval, into marketing planning, health technology submission and approval and eventually into several years of active marketing itself, can be many years, even decades. During all of these phases of a medicine’s lifecycle, there will be almost constant interaction of pharmaceutical companies with external experts, organisations and institutions.  In this context, time-limited transparency is not genuine transparency at all (especially when the time limit is set at such a short period as 3 years).  

• If the pharmaceutical industry truly aspires to give faithful transparency over the way it interacts with healthcare professionals and organisations then – as evidenced by the Novo Nordisk case – it must allow journalists, academics, and the public to access information and data which will not just allow them to identify individual payments, but also, if necessary, to track patterns of payments over the entire lifecycle of a medicine.  This will be extremely difficult, even impossible, if these data are not collated over an appropriately lengthy period, in a single source which is freely accessible to all.

What’s the point of partial transparency?

The introduction of the Disclosure UK database in 2016 was an important step forward in improving transparency in this famously complex industry, as were its various enhancements over the past 7 years.  The move away from a purely voluntary approach to more mandatory disclosures for pharma companies and recipients, and the broadening of disclosures to include pharma payments to journalists, influencers and patient organisations, are also to be welcomed.  

However, if this important information is only going to remain in the public domain for a brief period and then disappear forever, its utility is going to be vastly diluted and the extent of the true commitment of the ABPI and its members to genuine transparency must be in doubt. 

After all, if collaboration between the pharmaceutical industry, healthcare organisations and healthcare professionals is something to be celebrated, as the ABPI have often asserted, then what is there for the ABPI, or the recipients of their members’ generosity, to be afraid of? Surely disclosure beyond the limited 3 years permitted by the ABPI is something they should feel able to welcome.

Indeed, there is a strong case to be made that the current disclosure rules do not go nearly far enough: consider the fact that, as of today, it is near impossible to find out what, if anything, pharmaceutical companies paid, for example, to newspapers and broadcast media during the pandemic.

One piece of information obtained from my recent correspondence with the ABPI that I did find useful was the fact that, in response to the 2020 Cumberlege Report, the Department of Health is looking at introducing mandatory disclosure of pharmaceutical payments, and apparently intends to run a consultation on this topic.  If this led to a broadening of the scope of the disclosure standards to include payments made to any organisation, including the press and broadcast media, this would be a further significant step in the right direction, and if such a consultation does eventually happen then those of us striving for greater transparency in this industry must contribute to make our voices heard.

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Broken Custodians runs occasional articles from guest writers. The author of this article is Dr Alan Black, a retired pharmaceutical physician with 30 years’ of experience in the pharmaceutical industry.