Will you include new uses for established medicines?

01 January 1970 2 2K Report

A potentially very important use of off-label prescribing is a new use of an existing medicine, and zolpidem for brain damage is a particularly clear example. See this web page:

https://sites.google.com/site/zolpidemtherapy/updated-scientific-summary

We think that 5-10% of patients with traumatic, hypoxic or stroke injuries respond. When they do so the effect on quality of life is so great that doctors should be using it if they truly want to do the best for their patients. Examples are return of consciousness, limb function, cognitive ability and speech when patients have aphasia. Many doctors are afraid to use it, not realising that it is very safe as well as inexpensive. Their reasons are fear of being thought irresponsible for using an off label treatment. I would hope that your project goers some way toward preventing this attitude. Andy Sutton MD(London UK)

Narcyz Ghinea

Dear Andy

Thanks for your message. I did not investigate zolpidem as part of this project, but did look at misoprostol for post-partum haemorrhage. An old drug registered for gastric ulcers but commonly used off-label in gynaecology and obstetrics.

I was also a co-author of an article that investigates the Ethics of Drug Labels and Generic Medicines (https://ses.library.usyd.edu.au//bitstream/2123/12938/2/the-ethics-around-drug-label-PP-2015.pdf). This article summarises how labels for off-patent medicines can in fact be misleading and provide poor guidance - we used methotrexate for rheumatoid arthritis as an example.

The conclusion I have reached as a consequence of this project is that there are more fundamental concerns relevant to prescribing than whether or not the medicine is on or off-label. Putting too much emphasis on the "label", particularly for old established medicines as you say, can be counter-productive. Especially since there is usually little commercial incentive to seek new indications for cheap off-patent medicines.

This is not to deny the fact that "labels" are an important mechanism of control over the market and drug sponsor activities. However I think we need to be more critical about exactly what it is we are trying to achieve.

I am planning to write further on this, but my initial views are published in the discussion of Challenges to the Validity of Using Medicine Labels to Categorize Clinical Behavior (http://onlinelibrary.wiley.com/doi/10.1111/jep.12673/abstract).

Thanks for letting me know about zolpidem. I will be sure to look into this case.

Best

Narcyz

Andrew Sutton

Many thanks for your answer Narcyz. I fully agree with your aims and, like you wonder if we should reform labelling, particularly when off patent.as in your 2015 paper. Judging by your recent article, I rather think your physicians in Australia are more independent minded that many of ours here in the UK.

I have an imminent review paper on zolpidem in the journal Brain Injury and if you would like a copy let me know. It has been proof read but they haven't yet given me a date. Best might be via email where I am [email protected]

Cheers

Andy

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