Being diagnosed with cancer, or experiencing a recurrence, often puts individuals and their families in an emotional roller coaster ride. Moreover, in cancer, treatment decisions often need to be taken within days to avoid further progression of the disease. Taking tough decisions upon life in the downfall is already difficult enough. To make an informed choice between the bad and the ugly, and to enable informed decision making with their medical professional, patients desperately seek for quality information.
Especially in rare cancers, or any rare disease, this is especially challenging because they struggle to find a medical specialist or a patient support group in their home town at all. Often enough, the consultation time with the doctor is too short to clarify all essential questions. Information in local language is often not available at all, outdated or just too technical. Most patients then end up in Google and the likes, or even become virtual US citizens to be able to access websites — if they are lucky to speak English well enough. Whilst the political debate around “information to patients” and “advertising” has been going on for years as if a walled garden would still exist, or could be built, around the Internet health space, European cancer patients continue to suffer from the lack of access to quality information while the alluring bait of miracle healers, counterfeit online pharmacies and door-to-door advertisers continues to be omnipresent.
I believe that empowerment of patients is a pre-requisite for health, and access to high quality health information is fundamental to achieve this. Patients across the European Union regard access to information as a fundamental right, as long as it meets stringent quality principles. Patients, especially those with a rare disease, are particularly isolated and vulnerable without effective access to information.
Patient group representatives actually provide day to day direct support to patients living with a disease. However, being mostly laymen, they are facing similar barriers to access quality information. Patient group representatives should be supported, rather than hindered, in accessing medical information, to ensure their information provided to patients is evidence-based, useful and relevant.
Nobody, not even the industry, is asking for a US-based advertising model for prescription medicines. Informed patients, and especially patient group representatives, require access to quality information from trusted sources. Core quality principles developed e.g. by the EU Pharmaceutical Forum provide a framework that should be strictly adhered to by all information providers, whether official, public or private organisations. However, it is unrealistic to expect that any public body can cope with a prior approval of all information made available for thousands of diseases on the Internet. A mix of self regulation, co-regulation, codes, quality seals, validation and oversight should be instituted, without increasing further bureaucratic delays in providing information to patients.
Any a priori approval mechanism will eventually strengthen the current situation: authorized websites put their scarce resources on where they perceive the strongest needs, namely the most common diseases by incidence and prevalence. Rare disease patients are eventually left behind, as their priority comes last on the editorial budget of a website or magazine. Furthermore, smaller patient organisations just can’t afford to go through series of formal authorization procedures, and don’t have the funds to get legal advice to be protected against potential penalties.
There is common agreement across patient groups that the current ban on Direct to Consumer Advertising should be maintained. Health care professionals, national competent authorities and patient organisations should remain important sources of health information. However, industry may also be a valuable source of non promotional information on medicinal products, provided that quality principles are strictly adhered to, and are subject to appropriately robust control with penalties enforced on violation of these rules.
The situation in Europe on Information to Patients is incoherent, and a comprehensive EU information to patient strategy is urgently needed. Seeing the positions of both both hard-core consumer rights people and laissez-faire pharma, we are all in need to be more nuanced. There are good examples, like the FASS portal in Sweden (http://www.fass.se) which provides information about all prescription medicines in Swedish lay language, including trial results, safety information and packaging information. There are also bad examples, like in Germany where even the formally authorized package leaflet becomes advertising when provided separately from the box of pills, and where even the highly regulated Summary of Product Characteristics is banned from the general public.
The debate needs to be more patient-centric, and needs to focus on real needs of patients rather than drawing a black and white image — as if anyone was asking for naked men dancing in TV spots for a blue pill, or as if patients would choose to take more cancer drugs just because they have access to medical information.
The debate around “Information to Patients” now requires more courage, commitment and real action at EU and Member State level. I think, after 10 years of inconclusive debate and numerous position papers provided by all stakeholders, including representatives from the patient community like the European Cancer Patient Coalition, the current proposal of the EU Commission deserves to come into effect now. We all must acknowledge that the borderline between information and advertising will never be sharp, and there will always be difference in opinion about where it is. For the sake of patients, we need to come to a solution now. Otherwise patients will continue to suffer from the lack of information, suboptimal adherence to therapies, suboptimal outcome and unnecessary suffering, while the promises of wonder healers will continue to dominate search engines due to the absence of quality information across all diseases.
Patient groups have recently called upon the Commission, the Parliament and Member States again to come to a speedy agreement with all stakeholders. Although the whole process has been fragmented, the current EU political momentum on “Information to Patients” is timely and welcome, and must result in tangible progress. We all need to ensure that all patients across the EU, regardless of status, nationality, economic background, language competence, Internet literacy or disease, are able to access the information they need.
Patients and families will still get on a rollercoaster ride when being diagnosed with diseases like cancer, and doctors will surely remain to be the key source of information. However, a coherent and practical Information to Patients strategy on the EU and Member State level will make sure patients are at least empowered to know their options – and participate by taking an informed choice.
Jan Geissler
Director European Cancer Patient Coalition, 20 April 2010
We need reforms that provide more clarity about what information patients need (are allowed to access) in order to play an active part in their treatment. On the one side, these reforms are needed, because technology, esp. social media, is evolving rapidly making “unregulated” information much more accessible to patients. On the other side, patients’ ability and willingness to be an integral part of their treatment has evolved tremendously since the current regulations were put into place.
Unfortunately, the willingness of authorities to tackle this issue has been lacking. They are getting stuck at who should provide this information rather than looking at which information patients need. They are caught up in philosophical discussions of how to separate marketing from health information rather than trusting patients’ ability to make informed choices.
I believe is a ticking time bomb for Europe. What needs to happen, before change will be forced upon the current regulations? Before they become completely outdated, because patients will find and disseminate the information they need regardless of regulations?
I believe it is time to make a genuine and urgent case to the EU authorities to look at patient information in a new frame of mind. EU, please help us determine of what GOOD information looks like for today’s empowered patient. Please help us find it, encourage its translation, endorse visibly so it is the FIRST and easiest thing patients find when embarking on their rollercoaster ride through sickness and uncertainty.
Thank you, Jan for this strong call to action.
Thank you Jan for continuing to raise this issue. You’ve highlighted some really important points about patients and the international nature of the Internet, and also about the challenge of language barriers for those not lucky enough to speak English.
I believe that in the EU we do have the opportunity to solve some of these challenges and come up with a consistent approach on information to patients in this connected ‘Internet nation’.
I have been reading notes and comments about the last few Rare Disease Conferences since the start of 2010. I have mixed feelings about exactly what is the objective of these costly conferences.
Yes, ther is a lamguage problem and it is time consuming to even communicate and understand what the patient representitives are trying to express. I am sure many valuable insights are lost in translation.
The United Nations has one main headquarter and every language is translated and time and money is not wasted.
Maybe a similar type modeled after thr UN could be effective and more goals could be reached.
I also think many patients who are willing to share personal emotional information about their rare disease experiences and are willing to publically speak would be very effective to gaining sponser support and media attention.
I am rare but I want to carry out what my parent’s started and I am willing to do anything in my power to help. I only wonder why I am not invited or sponsered to any of these conferences. Maybe letting new voices like mine and I speak for others who are private concerned rare disease patients as well should be given the chance to make a difference and inspire other patients like me to gain the respect of the medical community and the feneral public.
The problem may be that individual memberstates (and possiblky pharma industry) can have very different guidelines for treatment of certain conditions with the sme product? I refer to products such as hydroxocobalamin being perscribed for Pernicious Anaemia. In some EU Countries the standard treatment guidelines would be once a month IM injection whilst other EU memberstates recommend the same product to be used only once every 3 months. In some EU memberstates hydroxocobalamin is available over the counter at any pharmacy whilst in other EU countries the same product requires a perscription. This irregularety does not help patients.
Patient information should be an inalienable right, particularly as patients are being asked to shoulder a greater burden of the cost of their care. However, rights to information are just one of many other rights patients should be afforded. Last week Active Citizenship Network relaunched its campaign on patients’ rights at the European Parliament in Brussels. Three senior MEPs submitted a written declaration to make April 18 European Patient Rights Day and 375 signatures are needed by July. So the opportunity to get patient information as a right might be getting closer.
What an excellent summary by Jan Geissler; it most definately outlines the situation for my family and those I try to support in a Voluntary capacity. As 2 of my 3 offspring have the genetic, neurological long-term disability ‘Neurofibromatosis Type 1′ I have had to manage the wide ranging and serious/devastating effects of their Nf…major differences between them as well as similarities.
Finding out information was impossible in 1984…improved in 1989 when Gorbachov released medical professionals to guinea pig my daughter for the first leg lengthening op in the West as she has an additional rare orthopaedic form of Nf1 called pseudarthrosis…but still Nf & it’s effects are not well known or written about. I have a pile of medical abstracts about the specific learning disability associated with Nf1 which I had to use for my son’s Statutory Assessment of Special Educational Needs as there was no usable parent friendly alternative in 2003. The test results for Nf1 rarely meet profiles of other conditions, in educational terms for example Dyslexia is now recognised & has specific management strategies; we often do not get the targetted specialist support required.
My son has an additonal diagnosis of High Functioning Autism or Asperger’s Syndrome but he is classic to the many other children & adults I have met with Nf.The link between Autism and Nf was highlighted years ago by Tony Attwood but this fact has not been brought to most families’ attention; this is key to the day to day care of kids & adults with Nf.
Your article refers to cancer and there are strong links with Nf1 in cancer research. The last Nf Association UK meeting I went to (in Birmingham, UK) was very technical led by an American researcher doing mouse trials on tumour triggers. Nf1 is often classed (incorrectly) as a skin disorder because part of the diagnostic criteria include the presence of fibromas (or gristle bumps) and plexiforms (larger squishier lumps) both generally benign (…but not always…), as well as the highly visible ‘Cafe au lait’ marks.
As you say by the time the medical complication arrives both the person affected & the Carer is in the worst state of mind to then try & find out the best or alternative treatments available. I have remote experience of the voracious nature of the malignant tumours and cancers which form part of Neurofibromatosis; a friend’s son had a malignant brain tumour particular to Nf1 and also another parent had a son with malignant bone tumour on his femur…he died before it was properly investigated! As with any malignant tumour, time is very very short once the growths have been identified….that is often hard to do as Nf tumours need a particular type of imaging to show up properly…any delay can be terminal!
As a Mother/ Carer I can only do so much; as the Voluntary Organiser of an Nf Local family Support Group (un funded) I can do a little more (time & my own health allowing); so on behalf of the many people affected can I say “Thank you, Jan Griessler” for keeping patient friendly access to information on the agenda, in EU terms.
best wishes,
Laura billing
I wanted to share writing comments on this blog has helped me motivate myself to expand my advocacy. Patients like me and or their loved ones all need to share their rare disease stories.
It takes courage and strength to “share” personal details about illnesses. It is the “MOST” effective way to help public awareness, research, and funding.
Once a few patients begin to share pertinent information including physical and emotional effects of living with a particular rare disease and advocate for themselves we will see results in all areas.
I have Parry Romberg Syndrome, I am not ashamed of admitting it. Nobody should.
I am scared that my illness is still so unknown and I had two seizures last week that I never experienced before.
What is going to happen to me next????? Nobody knows. I will keep writing and I started to contact government officials in my state, NY.
The conferences should have patient representatives who are dedicated to the cause and serious.
Thank you once again,
Cheryl Rick Klein
What about a patient in developing countries like Indonesia? I have MDS and hardly can find anything about the disease in my language and yes as Mr Jan said, virtually I am US citizen or even EU citizen just to obtain newsletter or any kind information about the disease. I have to take hydrea and thalidomide and they cost a lot of money since those medicine is considered as an orphan drugs in Indonesia