Blanket disapproval of all unlicensed indications is wrong
BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d7726 (Published 29 November 2011) Cite this as: BMJ 2011;343:d7726
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Professor Evans is incorrect in assuming that “Kyle and the GMC” disapprove of all use of unlicensed medication.(1) I certainly do not; it would be impossible to practice ophthalmology safely if one were confined to use of licensed products only. As far as I am aware the GMC do not object to this either.
The point at issue is whether unlicensed drugs should be used when a licensed alternative is available.
I have previously expressed my views on this (2), which are not what Evans implies either.
The thrust of my letter was that, given the clearly expressed views of the GMC, to ask clinicians to go against that is simply bullying.
However, the problem with the use of unlicensed products for some clinicians, is not only that it contravenes GMC guidance; to their view, it does not square with evidence based practice, and thus it is ethically challenging. Such views also need to be respected.
Graham Kyle
Grahamkyle33@gmail.com
1. Evans SJ. Blanket disapproval of all unlicensed indications is wrong. BMJ 2011;343:d7726
2. D Wong, G Kyle. Some ethical considerations for the “off-label” use of drugs such as Avastin. 2006;90:1218-1219
Competing interests: I have received remuneration for lectures given on this topic by various pharmaceutical companies, including Novartis
Re: Blanket disapproval of all unlicensed indications is wrong
I have read the recent series of letters regarding the use of
bevacizumab in place of ranibizumab in wet macular degeneration. I
agree with Mr Kyle and his interpretation of the GMC prescribing
guidance on this issue. There are currently no data that suggest
bevacizumab better suits a patients needs that ranibizumab. Indeed
there is some information that ranibizumab is more effective (1) and
that bevacizumab is not as safe (2,3).
I disagree with the cost saving that was proposed by Mr Jackson
(4) and refer to a recent article (5) in which
I have calculated the differential cost of using the two agents.
Taking into account the increased frequency of dosing of bevacizumab needed in the ‘prn’ group (1), the ranibizumab reimbursement scheme and the lifetime of a
patient, bevacizumab can be more expensive for the NHS to
administer. The calculations do not include the cost of
treatment of additional surgical complications (given the increased
frequency of dosing), nor the cost of managing the systemic
complications, nor the distinct possibility of financial settlement
where patients have had such complications from the use of bevacizumab.
With the current state of knowledge about these two agents, there is no clinical argument for the use of the unlicensed bevacizumab nor a robust financial one.
Nigel Davies
nigel.davies@chelwest.nhs.uk
(1) CATT research group: Martin DF, Maguire MG et al Ranibizumab and
bevacizumab for neovascular age-related macular degeneration. N Eng J
Med 364 (20): 1987-908
(2) Curtis LH, Hammill BG Schulman KA Cousins SW. Risks of mortaliy,
myocardial infarction, bleeding and stroke associated with therapies
for age-related macular degeneration. Arch Ophthalmol 2010; 128(10)
1273-9
(3) Gower E, Cassard S, Chu L et al. Adverse event rates following
intravitreal injection of avastin or lucentis for treating age-related
macular degeneration. ARVO 2011 Abstract 6644
(4) Jackson T, Kirkpatrick L Cost comparison of ranibizumab and
bevacizumab BMJ 2011;343:d5058
(5) Davies N Comparison of bevacizumab and ranibizumab in wet AMD. Eye
News 18(4) 17-18.
Competing interests: I was sponsored by Novartis to attend the ARVO meeting in 2009.