The World Health Organisation was established in 1945 to provide leadership on global health matters. According to its Director General Dr Margaret Chan, it is “quietly protecting the health of every person on this planet, every day.”
On 25 October 2013, WHO issued a press release promoting guidelines produced by the Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium.
The consortium’s stated purpose is “to improve [drug] safety reporting by better incorporating the perspective of the patient” with the aim of the guidance produced “to ensure that the patient ‘voice’ and perspective feed appropriately into collection of safety data.”
The WHO website proudly describes its Patients for Patient Safety programme (PFPS) as being designed to ensure that the perspective of patients and families shapes the important work of the programme and the global patient safety movement.
At the policymaking level, consumer participation can be marginalized, with the assumption that consumers are unable to appreciate the complexity of healthcare. Such an approach fails to take into account that many consumers offer the richest resource of information related to patient safety as witnesses to every detail of systems failures from the beginning to end
Given this statement, and the fact that medication safety is a core element of the PFPS programme, I expected strong patient involvement in the PROSPER Consortium and this expectation was shored up by the WHO press release which advised that patients had indeed been represented.
Interested to know what input patients had in a project that is all about incorporating patient experiences of adverse drug reactions, I scanned the list of Consortium members.
Two from pharmaceutical consulting company, Pope Woodhead and Associates Ltd, two from PatientsLikeMe, a company that sells patient data to pharmaceutical companies, and one each from WHO, pharmaceutical company AbbVie, the University of Namur, the University of Texas and Duke University.
No patient groups, or even patient advocates, amongst the guidelines writers at all. Perhaps patients were involved as consultants or advisers to the project.
In their acknowledgements, the Consortium extend thanks to the following people who contributed to PROSPER meetings and discussions
European Federation of Neurological Associations
European Brain Council
University of Oxford
Of the 23 people who participated in meetings and discussions on the guidelines, two appeared to represent patient advocacy groups – the European Brain Council (EBC) and the European Federation of Neurological Associations (EFNA.) Having not a clue who these organisations are, I did a bit of research and discovered that the EBC is an umbrella group which has two patient advocate members – EFNA and GAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe.)
No one who takes an interest in the fields of psychiatry and pharmacovigilance is unaware of the fact that many patient advocacy groups are pharma funded and therefore lack the independence required to properly advocate for patients. Similarly no one is unaware of the research showing clearly that pharma funding has a significant impact on the conclusions and outcomes of research and guideline development. So a bit more detective work was required to discover whether these organisations had any ties to pharmaceutical companies. Not surprisingly, five minutes research showed that EFNA and GAMIAN, are both pharma funded.
According to the EFNA website, the organisation’s funding “arises from a small number of sources, including the pharmaceutical and medical device industries.”
GAMIAN-Europe whose objectives are listed as advocacy, information and education, anti-stigma and discrimination, patients’ rights, co-operation, partnerships and capacity building, received all their sponsorship in 2012 from Janssen, GSK, Pfizer, Lundbeck, Lilly and Bristol-Myers Squibb.
The WHO press release states that
The modern model of medicine is one of partnership and joint decision-making with the voice of the patient playing a decisive role at every stage;
Not every stage though clearly. There was no independent patient voice in the development of these guidelines, only patient voices paid for by the pharmaceutical industry.
But what of organisation PatientsLikeMe (PLM), with 65,000 members recording their conditions and responses to treatment, surely they provide a patient voice?
PatientsLikeMe promotes itself as a website where people can chart their health over time and contribute to research that advances medicine, share their experience, give and get support, compare treatments, symptoms and experiences with others like them and take control of their health. If you click on the small print at the bottom of the page however, the company under the heading How We Make Money advises
We take the information patients like you share about your experience with the disease and sell it to our partners (i.e., companies that are developing or selling products to patients). These products may include drugs, devices, equipment, insurance, and medical services.
Their partners include many of the drug companies involved in the development of the PROSPER guidelines.
The New York Times profiled this company recently and reported that
For corporate clients, the site [also] functions as a sophisticated data-mining tool that allows them to better pinpoint consumers and to develop new or improved drugs. 
According to the article, the site provides corporate clients with analysis of members’ conversations, broken down by age, sex, disease progression and treatments, so pharmaceutical companies can “learn not only what’s being said about your brand, but by whom.” PLM also allows drug companies to conduct market research “on 25 to 50 of the most active users on the site — typically those who post messages often and have emerged as opinion leaders — who consent to participate.” It quotes the site as saying that this research allows drug makers to “refine their marketing efforts based on the effect of the program “on patient dialogues across the entire community.”8
Other benefits to pharmaceutical companies of partnership with PLM, according to the New York Times, include the creation of an environment in which patients promote treatments to other patients, without the involvement of doctors.
There’s a thread currently on the site where members are complaining about not having made informed consent to their data being sold to drug companies. Some comments from the thread are below
I do not want someone profiting from the absolutely misery my loved ones (family and friend) and I have been through ..
I know our data and all was used for research purposes, I had no idea it was being SOLD to the highest bidder ..
that explains it .. all those emails about “don’t forget to update your treatments’ .. it wasn’t because PLM cares about me .. it was because they care about their data and clients ..
I heard about users here being harrassed directly by researchers and Im very very very very pissed with it. You know what? We are doing something good giving data to improve therapies, but come and think, we should gather and make more demands to med industries. to get better responses, to get off market the ones which are really bad to health, to make the ones we take cheaper.
Agreed. If I can help find a cure, good. But I have to wonder… if the revenue from selling data is that much more than the revenue that advertising would raise, then whoever is buying this data must think it’s really valuable. Why do they consider our data so valuable? They wouldn’t pay so much for it if they didn’t expect a greater return from it. I had no idea there was such big bucks going on here…
There was NO MEETING OF THE MINDS WHEN I SIGNED MY (CONTRACT) AGREEMENT. Therefore, there is no contract/agreement. I was mentally ill at the time (as you were aware). And therefore, was unable to fully understand the “risk.”
first of all .. I don’t buy the research crap .. PLM doesn’t seem to be associated with a hospital or a psychiatric facility for it to be able to be doing research .. and I mean ACTUAL research .. collecting statistics .. contacting vendors for various drugs/meds .. and selling them patient information .. is not research .. it’s just collecting stats .. I’m not saying PLM hasn’t be useful .. it sure has .. and it will continue to be .. I just feel there should be an option where you’re allowed to opt-in for the “we’re going to sell every piece of personal information we have on you and make us some money!” bit .. how do we know where the information goes? .. do people bid for it? .. I mean what is it used for? .. don’t you have be like an actual doctor to really figure out side-effects and report that back to pharma firms? .. I may be complaining of an headache, but PLM doesn’t know if it’s because of my meds or the fact that I bashed my head against the wall or whatever .. I can’t believe I’ve been here for two-three years .. and I didn’t know the information was being SOLD! .. this web-site is monetizing on my misery .. research/development is one thing .. but all of their data is up for sale, it seems .. PLM’s beginning to sound like one of those “oh take a survey and we’ll paypal you 2 cents” sort of emails .. I’m sure they make a lot more ..
The response on the thread from PLM?
In regards to selling your data, we have a larger view that your data is being used to better understand mental illness, informing making better products, understanding which patients respond better to which interventions, and overall a very useful source of information for both patients and researchers.
The data component of the site is a big part of the value for individual patients as well as the nature of the discussion. Data-driven discussions are a much better starting point for helping improve one’s own care. We also know that many patients are using this as a tool to improve the interaction and value they receive from their physicians.
The PROPSER consortium and guidance development were funded by two companies, Pope Woodhead and Associates, Ltd. and PatientsLikeMe. Pope Woodhead is an agency that provides advice to pharmaceutical companies in getting their drugs to market and uses PLM data to assist pharmaceutical companies to obtain regulatory approval. Their focus is clear in their advice to these companies that “Patient-reported outcomes and spontaneous adverse drug reaction reports will eventually be a pricing and reimbursement influencer in the future.”
In directly promoting PLM to pharmaceutical companies, Pope Woodhead advise that the use of PLM data confers certain advantages and opportunities for industry, regulators and payers including
a) Patient access: One of the more obvious benefits of such a web-based platform is that patients can be recruited to clinical trials or selected post-approval studies at a fraction of the cost and time compared to traditional means
b) Adherence and persistence: Engaging with and properly educating patients through a one-stop, controllable web-based PRO/ADR reporting platform will lead to better adherence and persistence on therapy, influencing treatment outcomes and data quality directly.
c) Patient monitoring: Before patients are enrolled in either a clinical trial or for a post-approval study, it is possible to monitor their adherence, persistence and medical indicators, ensuring a best fit for a trial or study.
d) Safety data: High quality data generation will lead to additional and more cost-effective Phase IV/post-approval insights, particularly in the field of subjective diseases, or, where tests (blood pressure, body temperature, glucose level) can be collected by the patient at home
In the disclosure statement for the PROSPER guidelines, the consortium members who are employees of Pope Woodhead and PatientsLikeMe declare conflicts of interest related to their employment, the holding of stock grants received, and having provided consultancy to multiple global pharmaceutical companies.
The PROSPER guidelines quite clearly promote the commercial interests of Pope Woodhead and PLM with the gathering of patient data such as that collected by PLM being embedded in the guidelines.
The PROSPER guidelines are a paid-for pitch by two commercial companies to have the data they collect from patients included in the regulatory framework for drug approvals and so increase its utility to pharmaceutical companies and therefore its profitability.
That would be fine, if the WHO hadn’t dressed them up as something completely different – objective, evidence-based, patient-centric guidelines.
Throughout the report, patients are mere providers of data, not partners in developing guidelines to ensure that data informs patient safety. Their involvement is nowhere near an active voice for patients in decision making around the appropriate use of their adverse event data. Reading the guidelines it is clear that a patient perspective is missing from the issues raised and resolutions reached.
It is nothing short of betrayal for the global agency responsible for protecting and promoting the health of the citizens of the world to participate and promote guidelines that state
Patient-centeredness and patient safety are emerging as core elements of any responsive health system. As patients become more activated in their health and healthcare, they support the maxim of ‘‘Nothing about me, without me’’ and expect others involved in their care to engage in shared decision making, so that what matters to the patient is always included
and yet to exclude any independent patient voice in the development of guidelines on patient reporting of outcomes.
NATASHA SINGER When Patients Meet Online, Are There Side Effects? New York Times Published: May 29, 2010