Open Medicine EU

I was irritated recently when I went to a presentation here in Brussels of a survey on off-label prescribing by the Irish Patients Association (IPA). I don’t blame the IPA for this – they presented a perfectly valid study, but I felt the meeting overall was serving another purpose or agenda.

The survey, and the meeting, were sponsored by Novartis.

Off-label prescribing is the prescribing of a medicine for an indication or purpose other than the purpose for which it has been officially authorised. Off-label prescribing is common, particularly for psychiatric drugs, for some cancers and for medicines for children. Few would want a complete ban on off-label prescribing but it must be approached with caution.

The IPA surveyed 150 patient groups across the EU. Most (66%) felt that patients do not always know they are being prescribed off-label, and some (12%) said that patients are never told. For most groups (69%), off-label prescribing was acceptable and indeed important sometimes, but 90% said that patients have a right to informed consent in these cases. Information to patients about side effects was also seen as essential, as was better monitoring by regulators of off-label use.

There was another intervention at the meeting, from EAASM or the European Alliance for Access to Safe Medicines in the form of a report on three examples of off-label prescribing. EAASM seems to get its money from pharmaceutical companies. It is not on the EU Transparency Register, although I think it should be.

The first example was of Avastin, which is often prescribed for a type of age-related blindness instead of the more expensive authorised product. According to the EAASM brochure, between 2007 and 2009 “..newspapers reported clusters of adverse reactions..” I studied the report references and the EAASM website and I did not find any convincing arguments against prescribing this medicine – “newspaper reports” don’t count in this context. Now I don’t know whether this medicine should be prescribed off label or not, but I do know that there are independent experts who approve off-label use in this case, under certain conditions. A number of studies seem to support their view but, as I say, I don’t know.

The other two case studies seemed more clear-cut – the use of disinfectants for pre-op skin cleansing that are not approved for this purpose, and the re-use of medical devices designed for single use. Again, I don’t know if these practices are always wrong but they do seem dubious at first sight.

Unlike these three cases, most off-label prescribing is happily tolerated by the industry – it may amount up to 40% of total revenue for some medicines. Companies may not promote off-label use but they have many ways of encouraging it without running afoul of the law, for example by selective funding of projects and key opinion leaders.

Sometimes the law is broken. Many deaths followed the off-label prescribing of anti-psychotics for dementia in the US. In this and other cases, companies have paid fines and settlements amounting in all to billions of dollars in recent years. In 2010, Novartis agreed to pay $425 million in criminal and civil fines for promoting off-label use. According to the New York Times of 30 September 2010, Novartis “joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the last few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million; and Forest Laboratories, $313 million. Pfizer, Lilly, Allergan and Forest pleaded guilty to crimes in the cases.”

(More recently, Glaxo was reported as moving towards a settlement of some $3 billion with the US Government.)

It seemed odd to me, therefore, and I said so, that a meeting devoted to off-label use focussed only on three cases where the industry opposed such use. In focusing on a few selective, and unrepresentative, examples the meeting ignored the “elephant in the room” and steered away from any real analysis of off-label prescribing. END

Author :