WHO Prospers? Not Patients.

Five days ago, the World Health Organisation released a report it co-authored on the PROSPER (Patient-Reported Outcome Measures in Safety Event Reporting) Consortium that “strongly promotes the value of including patients’ experiences of health treatment in official safety monitoring processes.” [1]

“What a fine and absolutely outstanding thing!” I thought. “I shall add the WHO to my Christmas Card list forthwith  and in honour of the approaching season, underline it with my  silver glitter pen.”

“Current methods for safety reporting and risk assessment still rely heavily on healthcare professionals (HCPs)” said the PROSPER Consortium, suggesting that  the quantity and quality of safety information could be improved by encouraging “patient-reported outcomes of adverse events which are more patient focused and may have less formal data collection processes that do not rely on input from HCPs”.

“Marvellous!” I thought and resolved to buy the good folk at the WHO a little angel to sit atop their undoubtedly splendid regulatory Christmas tree.

Eagerly scanning the document, I discovered the consortium was led by a Dr Anjan ‘Swapu’ Banerjee. What a dear, sensible man Dr Banerjee is I smiled to myself and pondered how I might engineer to bump into Swapu (of whom I was feeling inordinately fond) beneath the mistletoe and give him a festive little peck on the cheek! With our shared interest in the role of patient reporting in pharmacovigilance, I felt sure we would find much to discuss . . . perhaps on a cycling date through a wildflower dotted meadow.  I tentatively circled the 21^st of December (with the aforementioned glitter pen) for this romantic little foray.

Checking him out on google images (and finding he had that ‘OMG what’s she going to do next, deer-in-the-headlights look’ that most men I’ve been involved with seem to have ) I shifted my gaze to his credentials.

What was this? With a (not so little) cry of dismay, I read that my Swapu had been a  Global Drug Safety Scientist for Roche Pharmaceuticals and had over 12 years’experience in pharmaceutical marketing before moving to Pope Woodhouse, a company that provides consultancy to pharmaceutical companies seeking regulatory approval. Scanning their website, I discovered that the Pope Woodhouse Values included “working in the clients best interest.” And that their clients were the big pharmaceutical companies.

His company’s website advises pharmaceutical companies that

In today’s challenging environment many companies have reduced product pipelines and yet, at the same time, are faced with increased regulatory stringency. It has never been more important to maximise the filing success of products!

Quelle Horreur! Unlucky in love again! And, equally disturbing, unlucky in pharmacovigilance.

How could it be that the WHO would be part of a working group on patient involvement in reporting adverse drug reactions led by someone who publicly states he is commited to working in the best interests of pharmaceutical companies and funded by that person’s company.

Don’t panic! I told myself (opening a window on my advent calendar a full month in advance as an emergency calming measure), remember I told myself soothingly, the report said Dr Banerjee also worked for an organisation with the lovely name Patients Like Me, which must surely be a champion for healthcare consumers. Perhaps the good doctor is undercover at Pope Woodhouse and has now come out as a patient advocate in order to forge a relationship of an intimate nature with an MIA blogger who is somewhat critical of the pharmaceutical industry! (That’s me, for those of you who may be struggling to follow this narrative).

So, having found a lovely little deer with antlers adorned with tinsel behind my advent calendar window, I calmly set about researching Patients Like Me. The group’s website contains forums where people can share information on drug effects and efficacy, drug interactions and other information and provide mutual support. Lovely!

But the path to true love never runs smooth and what’s not so lovely is the section entitled  How Does Patients Like Me Make Money?

And the response

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.  

And the other section they don’t mention in the ‘How Do We Make Money’ section

Iʼd like to recruit some patients for a focus group or survey for a commercial enterprise, who should I contact?

Please send a message to our partnership team with an outline of the patients youʼd like to contact and for what purpose. If you are an agency representing a pharmaceutical or medical device company weʼd also be grateful if you could let us know who the client is. Weʼll then get back to you to discuss whether your request is suitable for our community, pricing structure, and suggestions for the best way to maximize your budget.

So the author of the WHO’s report on patient reporting of adverse drug reactions is paid by  pharmaceutical companies to achieve regulatory approval and sells patient reports of adverse reactions to those companies to assist them with developing their applications.

No wonder the report is full of subtle references to the flaws in patient understanding of adverse reactions and the need not to confuse adverse reactions with symptoms of underlying disorders blah, blah, blah.

The disclosure statement on the PROSPER report reads

The writing group would also like to thank the following who

contributed to PROSPER meetings and the related discussions:

Willem Jan Atsma (Astellas), Laurent Auclert (Sanofi-aventis), Mary

Baker MBE (European Brain Council), James Heywood (Patients-

LikeMe), Steve Hobbiger (GlaxoSmithKline), Ken Hornbuckle

(Lilly), David Jefferys (Eisai), Crispin Jenkinson (University of

Oxford), Stefan Kaehler (Celgene), Paul Knights (Pfizer), David

Lewis (Novartis), Rick Lilley (UCB), Rebecca Noel (Lilly), Niklas

Nore´n (WHO/UMC), Sten Olsson (WHO/UMC), Sonja Pumpluen

(Actelion), Jan Regenstrom (Scientific assessor, EMA), Jamie Robinson

(Roche), Mette Stockner (Novo Nordisk), Dirk Teuwen

(UCB), Sarah Trease (Roche), Spiros Vamvakas (Head of Scientific

Advice, EMA), Steven Wojtanowski (Abbott Laboratories), and

Amanda Worpole (European Federation of Neurological

Associations).

Funding Disclosure The consortium and guidance development

were self-funded by Pope Woodhead and Associates, Ltd. and PatientsLikeMe

_, Inc.

Conflict of Interest Anjan K. Banerjee is employed by, and is a

Director of, Pope Woodhead and Associates and has a conflict of

interest related to holding Pope Woodhead and Associates stock,

employment, and expert testimony, and has provided consultancy to

multiple global pharmaceutical companies. Sally Okun is employed

by PatientsLikeMe_ and has a conflict of interest related to

employment, holding PatientsLikeMe_ stock grants received, and has

provided consultancy to multiple global pharmaceutical companies.

Paul Wicks is employed by PatientsLikeMe_ and has a conflict of

interest related to employment, holding PatientsLikeMe_ stock grants

received, and has provided consultancy to multiple global pharmaceutical

companies. Dr. Smith is employed by AbbVie has a conflict

of interest related to employment, holding AbbVie stocks, expert

testimony, patents and royalties. Dr. Mayall is employed by Pope

Woodhead and Associates and has a conflict of interest related to

employment and has provided consultancy to multiple global pharmaceutical

companies. Drs. Basch, Cleeland, Flamion and Edwards

have no conflicts

If this is the WHO’s idea of increasing consumer voice in pharmacovigilance, I’m one of Santa’s elves (applied, declined). This is very clearly a marketing document for a consultancy firm who plan to increase profits by selling patient message board conversations to pharmaceutical companies. For this to be endorsed by WHO as a ‘patient centred’ approach to pharmacovigilance is appalling.

While this entire experience has been a disappointment to me, I am determined to turn it into a learning opportunity (yes, you will have to call me Polyanna  rather than Mrs Dr Banerjee). I have decided that I will take a leaf from Swapu’s book and for Christmas this year I shall make myself (no, this is not the section on homemade Christmas gifts of which I strongly disapprove) an armaments consultancy company and a blog for victims of civil war. I shall then get the United Nations to ignore the fact that I supply semi-automatic weapons to mercenaries and persuade them to contract me to lead a think tank (no pun intended haha) on the role of victims of terrorism in regulating the licencing and supply of lethal weapons.

Better add the UN to my Christmas Card list. And then go open another window on my advent calendar.