The Association of the British Pharmaceutical Industry (ABPI) is calling for NICE to reform the way it assesses treatments for its guidelines, echoing the views I’ve read on social media from health professionals, academics and frustrated patients with long-term conditions such as M.E., fibromyalgia and vitamin B12 deficiency, amongst many others.
In an opinion piece in the Pharmaceutical Journal, the Acting CEO of ABPI, Alison Clough, acknowledges that NICE performs well in some areas but says that it also stifles innovation, which is causing the UK to lose its place as the global leader in pharmaceutical innovation. This has the knock-on effect of new drugs not reaching patients in desperate need of treatments.
Clough states that several vital cancer drugs and medicines for rare diseases have not been approved for use in the UK and that the way NICE approves treatments needs urgent reform so that guidelines keep up with the fast pace of research.
The “one-size-fits-all” approach of NICE is criticised, along with its failure to update guidelines quickly enough when the evidence base for treatments is built upon. The ABPI would like to see treatments approved at an earlier stage so that patients have quicker access to novel treatments, updated with clinical evidence as it comes to light. For the processes involved in licensing in the UK, read How long does it take a new drug discovery to be licensed in the UK?
An aside before I carry on…
- I know we don’t like the term CFS/ME but this is what the guideline is called at the moment, so I have to refer to it as that.
- Many people seem to think that in calling something a treatment we mean a cure but it is really defined as “medical care given to a patient for an illness or injury”.
Clough’s criticisms are also applicable to CG53, the NICE guideline for CFS/ME, which was published way back in 2007. In February 2014, it was reviewed but NICE decided not to update it and moved it to the “static” list. This means the guideline won’t be reviewed again for another 5 years instead of updating it as the evidence-base for M.E. treatments evolves with published research findings. The reasons given for guidelines being moved to the static list are
“at that time no major ongoing studies/research was identified as due to be published in the near future (that is within the next 3-5 years)”
Thanks to the M.E. charities and the M.E. Twitter bringing our attention to all the research going on, I think it would be fair to say that this assumption was incorrect.
Here’s a link that carries out a search query for M.E. and CFS. Clicking the link runs a PubMed query and a bar chart on the right hand side on the results page under “Results by year”, shows how many papers have been published each year. There has been so much research coming out recently into bio-markers for possible use in blood tests and potential drug targets and drug candidates, such as rituximab and we’re only just over 1 year into the 5 years we’ll have had to wait for another review.
I think this shows that the decision to shelve CG53 has stifled innovation in M.E. treatments and diagnostics. There would be no benefit in drug companies developing new drugs or repositioning existing ones when they will never be approved for use or recommended in the NICE guideline. This is possibly why research has had to rely on donations to the ME charities and crowdfunding campaigns.
Evidence from 8 years ago wouldn’t have been acceptable in coursework during my degree – if I used anything more than 3 years old I was told to check that the evidence is still up to date and provide a more recent reference – so why is this acceptable in the evidence-based treatment of patients? It surely wouldn’t be for other physical illnesses.
It’s a problem generally with having guidelines. They try to standardise care but can stop doctors trying other treatments and not reviewing often enough causes problems. They were supposed to just be “guidelines” but have gradually come to be seen as compulsory.
My point is that we’re not the only people annoyed by the NICE guidelines. If big pharma is also unhappy, with their influence – money talks, something is likely to happen to improve the situation.
So, do you agree with the ABPI? What barriers do you see for the advancement of treatment of M.E. in the UK?
Feel free to leave your thoughts in the comment section below but there’s also an opportunity for UK patients to have our say in a government review, which I’ve written about with a links to it in the article, Patients invited to engage in government review to speed up use of new treatments and tests. Although the review is about all illnesses in general I think it’s an opportunity not to miss.
1 Clough A. NICE’s assessment process is stifling pharmaceutical innovation. Pharmaceutical Journal. 2015. http://www.pharmaceutical-journal.com/opinion/comment/nices-assessment-process-is-stifling-pharmaceutical-innovation/20068953.article (accessed 16 Jul 2015).
2 Oxforddictionaries.com. treatment – definition of treatment in English from the Oxford dictionary. 2015. http://www.oxforddictionaries.com/definition/english/treatment (accessed 16 Jul 2015).
3 NHS England. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) | Guidance and guidelines | NICE. NICE.org.uk. 2007. https://www.nice.org.uk/guidance/cg53 (accessed 16 Jul 2015).
4 NHS England. Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) | Guidance and guidelines | NICE. NICE.org.uk. 2015. https://www.nice.org.uk/guidance/cg53/resources/list-of-static-clinical-guidelines (accessed 17 Jul 2015).