Thursday, 29 October 2015

Take two - PoliticalSpeak: Off-patent Drugs Bill - 6th November

Here's the email I sent Chuka Umunna on 18 Oct: 


Dear Mr Umunna

I am contacting you about the drug re-purposing Bill to ask for your support to see it become Law. I believe it comes before the house on November 6. I attach some documents setting out the case for the Bill and please excuse me if you are already familiar with the arguments.

Breakthroughs in research have meant that several existing drugs have been found to be effective in treating conditions other than the ones they were originally made and patented for. They are referred to as “off patent” drugs. Repurposing these could have potentially huge benefits for many people suffering from conditions like multiple sclerosis (MS) and Cancer. They can be supplied at low cost by Generic Drug companies. The annual treatment for a patient may be less than £1,000 versus over 20x the cost for patented alternatives if in fact they exist. The savings would be of great benefit to patients, the NHS and the taxpayer, and could lead to treatment for many people whose treatment is denied by NICE on the grounds of cost.

However, drugs need to be licensed and approved for their new uses in order to be made available and there is little commercial incentive for pharmaceutical companies, who normally sponsor this process, to do so for off patent treatments. This is largely because prices generally fall a great deal once the patent has expired. There is no mechanism in place to enable licensing of drugs for uses other than their original purpose. Even if a doctor can refer to strong evidence in support of prescribing an off-patent drug to a patient, they would likely be put off by the potential personal liability they may face in doing so. 

There are thus political, legal and commercial barriers in place to prescribing off patent drugs. The Bill seeks to overcome these barriers by obliging the Government to act in the public interest through the process of the Medicines and Healthcare Regulatory Agency (MHRA) to license and approve off-patent, repurposed drugs for use on the NHS. 

The Bill is strongly supported by medical charities and specialists in the NHS, including myself - I am a Reader in Clinical Neurology at Queen Mary University of London & Consultant Neurologist at Barts Health NHS Trust.  As a clinical academic with an interest in MS, I know that early effective treatment of people with MS is key for a beneficial long term outcome.  I therefore have a particular interest in the re-purposing of Cladribine, a drug licensed in the UK for patients with hairy cell leukaemia.  There is evidence from phase III trials that Cladribine is highly effective and safe for people with MS.  The annual cost of Cladribine treatment in MS would be under £1,000 compared to licensed drugs of lesser efficacy that cost 20x or more.  I would be very happy to expand on this example further if you are interested and have the time; just call me on my mobile xxx.

For now, I do hope you are able to support the Bill. Please let me know if there is anything further I can do to promote it.

With best wishes

Sincerely Yours,
Klaus Schmierer


I'll keep watching out for comments by my MP, over and above his auto-reply...

17 comments:

  1. Barts-MS should not be promoting off-label prescribing; it defeats the whole point of the regulatory process, which has taken decades to develop and is in place for a specific reason to make sure a drug is both effective and safe. The fact that both the FDA and EMA said no to cladribine tells you that there are issues with the drug.

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  2. To the Anons above - if you have progressive MS and feel your body disengaging from your brain and failing year on year, you may be very happy to take some risk in trying to help retain the integrity of your CNS. Particularly if a drug has already been used for another purpose and shown to have a good safety record.

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  3. We absolutely appreciate due regulatory process. However, these processes are made by humans, who as members of organisations also have specific interests when it comes to licensing. People with diseases and their health carers want effective, safe and convenient drugs, the NHS the best possible care for a finite amount of money, industry & shareholders as much revenue as possible, and the government is wearing two hats (promoting industry & funding the NHS). As made clear on this blog and by others, regulation plays has an important role, however it is also fair that we question its dependence on an industry it is meant to regulate.

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    1. I suggest that you check the legal implications of off-label prescribing. I would be surprised if the NHS or your medical insurance policy will cover you if a patient develops a serious adverse event as a result of being treated with cladribine.

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    2. No-one is talking about off-label prescribing here. We want drugs like cladribine to be repurposed and approved for MS before it is prescribed. The fact that Movectro is apparently being reactivated by Merck-Serono suggests that safety concerns have been addressed but of course it follows that it would cost far mare than cladrbine.

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    3. AnonymousThursday, October 29, 2015 3:21:00 p.m.
      Thanks for reminding me of the potential legal implications, though I'm surprised to read these comments now that for well over one year the off-label prescription list has been in the upper left corner. Mitoxantrone, for example, isn't licesned for MS in the UK, and we keep prescribing it in exceptional cases. I am aware Cladribine is a 'scary' drug, however not because of its biological effects. I wonder is your advice rather a threat in camouflage?

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    4. In addition to mitoxantrone most of the symptomatic treatments we use in MS are prescribed off-label. If we shied away from prescribing off-label drugs we would be doing our patients a disservice. All we are trying to do is help people with MS; trying to make their lives and the lives of their families better.

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    5. " I wonder is your advice rather a threat in camouflage?"

      I was thinking the same thing ;-)

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    6. Exactly, I don't think it "was a council" of someone truly with RRMS or even has MS, that want to use a really effective treatment and so spend a lot of time without disease activity, taking a life as close to normal, and are accessible to all treatments... And knowing drugs cheaper and really effective for treatment of RRMS their own pharmaceutical industry and other research centers will focus for better understanding and for really effective treatments for these foramas ... I totally agree with your email DRK and I am vibrating positively to you get success for indeed who wins with all this we are MSers ...

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    7. Dear Anon 1:59 & 3:21

      Based on studies with rituximab and supported by the recent orecluzimab trial it is clear that people with primary progressive MS with active disease will show some benefit.

      At barts the neuros have been giving people with PPMS an option for rituximab treatment as there is nothing licenced for this group of people. The hospital trust eventually stopped paying for their requests to use rituximab, and so it would mean the MSer had to pay for their prescription or they get nothing. Cladribine is a very effective B cell depletor and was an option used.

      Would you rather our neuros did nothing? Surely if you do you cannot be an MSer or an MSer with any compassion for your fellow humans

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    8. It is almost universally authorised for medical practitioners to prescribe off-labels. Regulatory processes were primarily developed for pharmaceutical companies to regulate market access and communication. Indications relate to what has the drug been developed for (as in R&D), associated output from the available data. It is of course information used by practitioners and it's always better to have as much data as possible when chosing a treatment but unfortunately it's not always the case.
      However, as mentioned, drug repurposing is not the same discussion and all this initiative is to have it regulated.

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  4. just call me on my mobile xxx.

    Is that Kiss Kiss DrK? :-)

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  5. Things in the land are different than here in the colonies (USA). You all are fighting to get early DMT treatment for example. Over here having now been to numerous MS functions over the past year I have yet to here one Neurologist or Med. Professional say, "Wait to get on a DMT" if diagnosed with MS. In fact, even if one cant afford them the "system" almost always will find a way.

    The moral of corporate money .vs. health is a lengthy debate.

    If the medical insurance system in the UK cannot afford to get people with MS adequate treatment due to expense of currently approved disease modifying therapies then at the VERY least the humane thing to do is provide individuals affordable access to medications re-purposed that do have an impact on disease progression. Its just a "no brainer". Pharma is not going to loose money as their solutions are not being purchased to go into the bodies of patients. On the other side of the coin the national insurer system wins because the people enduring MS are going to have slowed progression and better quality of life hopefully. Perhaps as well it will encourage pharma to medicate your legislators so both parties come to real solutions for real people rather than leaving their constituents whom by the way elected them, pay their salaries a bit more respect towards quality of life. Not a single patient asked for MS. These people did ask to be elected.

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  6. Look at this: http://www.nationalmssociety.org/About-the-Society/News/Congress-Nears-Budget-Deal-That-Benefits-People-wi

    Then look where you folks are at.

    The US system of.... hmmm... everything? Makes what is simple complex. What is complex infinitely more complex and what is infinitely complex leave for the next guy.

    If we the nation that runs into the same walls we built scant years back can make things work surely a nation whos population is less than California & NY combined can make it happen.

    We are a nation very fond of dain bramage when individuals such as Commander Trump can make a serious run for one of the most powerful positions in the world. Yet, we still manage get things done whilst the media tells us smoking is bad for us albeit blowing cartons of propaganda smoke up our posteriors resulting in real brain damage to what are physically undamaged brains.

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    1. Yes a "No Can Do" attitude by the men in grey over here in contrast to "Just do it" across the pond.

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  7. The MS Society's page makes it really easy to contact your MP and takes a minute max. I've completed it as have my friends and family who live in different areas. I so hope enough MPs attend.

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