Portmeirion Village in North Wales provided the backdrop for a 1960s Cult Classic series, The Prisoner, starring Patrick McGoohan. McGoohan was ‘Number Six’. At its core was the Prisoner’s unwillingness to be a number.
We are all on our way to being imprisoned by our numbers if the drug companies, rebranded as “Life Sciences”, get their way. In Europe Big Pharma is straining to extract Big Data from of all of us. Their vision of the future is having unfettered access to all our health-data.
There will be no escape for the unvaccinated; no rest for those with high cholesterol or at risk of sarcopenia, the muscle wasting we all get as we age. Where our doctors once knew us as people, we will be known instead by a number, a risk score, and other data. The Health Police will call us in for our flu jab and to tell us we will be deregistered from the clinic if we don’t get our cholesterol level down. We may lose health insurance on the basis of untreated ‘pre-diabetes’. Those of us who comply will rattle – not from our chains but from our pills. Polypharmacy R Us.
The Quest for Big Data
Computerisation of medical data has been slowly developing over the past 50 years. There are good sides to this – better disease and prescription drug coding. Overcoming the problem of doctors’ illegible handwriting.
Sharing computerised essential health data makes some sense within a single country like the UK or across a large private health service company like Kaiser Permanente.
You could argue it might help with cross-border sharing of data – so that for instance doctors treating a Finn becoming ill in Greece can access their health record. But these are uncommon events, which these days are easily managed by phone or email.
But Europe is where the problems come into focus. Some of Europe’s problems are explained in this video by a gloomy Ioana-Maria Gligor, Digital Health Unit Head at the European Commission.
Brexit was caused by Brits resistance to Free Movement of Labor, which is a central tenet of the EU. But the EU in turn has led the world in clamping down on Free Movement of Data. It put in place the General Data Protection Regulation (GDPR). Companies from Google through to the Life Science outfits hate GDPR.
Industry will have the opportunity to make use of the Health Data Access Bodies, after they have been granted a permit for access to data. Only the data necessary for that specific research would be put at their disposal, without revealing individual’s identity, and it can only be accessible in the secure processing environment for the duration of their project.
In the context of healthcare, the European Health Data Space (EHDS) only supports the access of health professionals to the data of their patients. The view was that Industry will not have access to such data. Paradise.
Trouble in the Garden
This has set up a clash between the EU and the Life Science guys. Watching the LiScis maneuver is like watching the Snake tempt Adam (Given that Lilith was written out of the original story – who knows what happened).
On the Seventh Day God, Satan or Someone created TEHDAS – Towards the European Health Data Space.
TEHDAS is advised by EFPIA (European Federation of Pharmaceutical Industries and Associations).
“TEHDAS helps EU member states and the European Commission to develop and promote concepts for the secondary use of health data to benefit public health and health research and innovation in Europe. Our goal is that in the future European citizens, communities and companies will benefit from secure and seamless access to health data regardless of where it is stored.”
Then there is The European Institute for Innovation through Health Data, i~HD was created in 2016 as the sustainable result of the IMI (Innovative Medicines Initiatives) -EFPIA sponsored project Electronic Health Records for Clinical Research (EHR4CR) and a number of other European R&D projects supported by the European Commission. Its members include industry giants like A-Z, Novartis and ICON – who ran what everyone else calls the Pfizer vacccine trial. They already issue their own certificates of GDPR compliance.
The IMI/EFPIA Health Outcomes Observatory project (H2O)
“brings together the public and private sectors to create an unprecedented, standardised data governance and infrastructure system across Europe to incorporate patients’ experiences and preferences in decisions affecting their individual health care and those of the entire patient community”.
This H2O video explains that we need Data as much as we need Water and how patient organizations, universities and pharmaceutical companies are joining together to design the healthcare of the future.
World Economic Forum
Bert meets Bill at the most recent World Economic Forum (WEF) in Davos. Two weeks before this photograph was taken the BFG had tested positive for COVID. I wonder how the conversation with Albert went. Albert has since had two doses of COVID
The WEF is a bete noire for many. It has intimate links to the World Health Organization (WHO) – the body whose guidelines tell investigators not to attribute an adverse event to a vaccine in a clinical trial. Looking at WEF and WHO pronouncements, many worried about a World Government taking shape. Two years ago WEF produced ‘Sharing Sensitive Health Data in a Federated Data Consortium Model’, which claims:
In the current era of the Fourth Industrial Revolution, data is our most valuable resource – more valuable than oil.
The ICON (Pfizer) trial data were written up and published online in the New England Journal of Misinformation within four weeks of the trial ending. As things stand, Albert in his book MoonShot regards this as too slow. With A.I. we will soon have authoritative articles published online the day after the trial ends – without any clinical or regulatory oversight.
This is where Pharma has a spot of bother. A large majority of citizens are content for their anonymised health data to be used in research by universities for the good of mankind. However, many draw the line at their data being used by commercial companies. According to a survey 93% of patients do not trust advice from pharmaceutical companies about their medication.
Arthur M Sackler – the guy who bought Purdue Pharma and gave it to his slightly slower brothers – is a great candidate for the Svengali of twentieth century health services. AMS created IMS in the 1950s. IMS later called IMS Health pioneered the quest for Big Data. The mission was to get the data on what drugs every doctor was using and not using into company hands. Once it took off, Sales Reps visiting doctors armed with this information knew more about what the doctor was doing than s/he knew herself.
IMS was rebranded to IQVIA some years ago when it also got into the clinical trial business getting the data According to IQVIA, secondary data can help Pharma:
Understand the current standard of care
Identify unmet medical needs or existing treatment obstacles
Trace disease progression, diagnosis, and treatment trends
Assess the safety and efficacy of existing treatment interventions
Support protocol design and feasibility to optimize studies from primary data
Identify the best sites and most appropriate patients for studies from primary data
Conduct safety surveillance and signal detection
Demonstrate cost of illness and Healthcare Resource Utilization (HCRU)
Collect evidence for negotiating optimal pricing, reimbursement, and coverage
Forecast and track brand performance
Support targeted campaigns, inform messaging, and hone market strategy
IQVIA is the largest global healthcare data vendor in the world.
Data Saves Lives
Data Saves Lives is:
“a multi-stakeholder initiative with the aim of raising wider patient and public awareness about the importance of health data, improving understanding of how it is used and establishing a trusted environment for multi-stakeholder dialogue about responsible use and good practices across Europe”.
It is led by the industry dominated European Patients’ Forum (EPF) and the European Institute for Innovation through Health Data (i~HD)
“the only independent organization that brings together regulatory authorities from across the globe in an international Council of Regulators.”
Data Saves Lives helpfully produces a toolkit to help patient groups spread the word about data sharing. In other words, Pharma-backed DSL helps patient groups help Pharma – as outlined in Remind your Sister to Get Vaccinated.
Although not in Europe, Britain’s National Health Service has its own version of Data Saves Lives – called Data Saves Lives. Everyone in Britain knows that their data is going online – making it possible to access your records through an App.
As outlined in comments on recent posts, many doctors are resisting this – but not because of their concerns about our privacy. It’s far more a case of them not wanting us to see what they have written about us. This of course makes it irresistible for us to insist on transparency – and hand over our data to people even less interested in oiur welfare than the local family doctor.
Ben Goldacre appears heavily involved in mobilizing health data in the UK for broader noble purposes – just as he was with AllTrials – a pharmaceutical company initiative aimed at blocking access to data from company studies while giving the appearance of supporting responsible access.
There is also the Ethical Medicines Industry Group – EMIG – which has echoes of Sense about Science and AllTrials. EMIG is keen to contribute to British efforts to build back better after COVID – by ensuring we are all on the same cooperative page. This has all the features of what Naomi Klein calls Disaster Capitalism. You’d never guess it from the website.
What could possibly be the problem with an avowedly ethical body?
To Be Continued next week with the appropriately title Sovereign Individual.