Tag Archives: Rare Disease

Information to Patients Debate 2010 – as if the Internet was still a walled garden

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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 Information in local language is often not available at all, outdated or just too technical.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