Thursday, 15 February 2018

Crowd-funding: Listeriosis Prevention Pack

We, Barts-MS, and the NHS needs your help to try and prevent Listeriosis after alemtuzumab treatment. We are raising money to produce a Listeriosis Prevention Pack. 


Barts-MS Listeria Prevention Pack Prototype


Barts MS Listeriosis Prevention Pack

We need to raise £7,000 which will be used to manufacture a large number of listeriosis prevention packs. The packs contain a food choice and hygiene manual, food stickers, fridge magnet, wallet card and thermometer. This pack, which has been designed by the Barts-MS advisory group, will engage both people with MS and healthcare professionals to take a pro-active approach to listeria prevention.

Why a listeria pack?

Currently, all we have is a single advice sheet with only basic information. We hope that we can fully prevent any unnecessary infections and enable patients, their family and friends to dramatically reduce the risk of infection.

The Barts MS team have developed the information in the pack with a cross-disciplinary team involving a listeriosis expert, people with MS, designers and healthcare professionals who will deliver it.


Why do we still need a pack? 

The reported incidence of Listeriosis post-alemtuzumab is reported as being 0.25%. In other words, 1 person in every 400 people treated with alemtuzumab gets Listeriosis. We are aware of at least one person who died as a result of this complication. 

What are we doing about it?

One solution is to provide prophylactic antibiotics. We use a drug called cotrimoxazole, a broad-spectrum antibiotic. The problem with this drug is that some people can't  take it because they are allergic to the drug and others refuse because they are really worried about the effects of broad-spectrum antibiotics have on their microbiome. The microbiome refers to the trillions of bacteria that live in and on our bodies. 

An excellent, and currently best-selling, book 'The Diet Myth: The Real Science Behind What We Eat', by Professor Tim Spector, details the impact of broad-spectrum antibiotics on our health. As a result of this book, I have had two patients turn down the option of Listeria antibiotic prophylaxis as part of our Alemtuzumab treatment protocol. One said: 'No thank you; I don't want my microbiome bazooka-ed'. I seem to recall this term being used in the book. We, therefore, have to also rely on diet to prevent Listeriosis a potentially life-threatening complication of alemtuzumab treatment. 

We have therefore designed a Barts MS Listeriosis Prevention Pack and now need £7,000 for a manufacturing run. These packs will be distributed to all patients prior to alemtuzumab treatment; please note these packs are not only for Barts Health patients; we plan to distribute them to other centres if they want them. 

If you would like to support this programme you can make a donation via our Barts Health crowdfunding site

Thank you.

ABN Guidance on preventing Listerial Infection



Some background reading

Evans & Redmond. Older Adult Consumer Knowledge, Attitudes, and Self-Reported Storage Practices of Ready-to-Eat Food Products and Risks Associated with Listeriosis. J Food Prot. 2016 Feb;79(2):263-72. doi: 10.4315/0362-028X.JFP-15-312.

Consumer implementation of recommended food safety practices, specifically relating to time and temperature control of ready-to-eat (RTE) food products associated with listeriosis are crucial. This is particularly the case for at-risk consumers such as older adults, given the increased listeriosis incidence reported internationally among adults aged ≥60 years. However, data detailing older adults' cognitive risk factors associated with listeriosis are lacking. Combining data about knowledge, self-reported practices, and attitudes can achieve a cumulative multilayered in-depth understanding of consumer food safety behavior and cognition. This study aims to ascertain older adults' cognition and behavior in relation to domestic food handling and storage practices that may increase the risks associated with L. monocytogenes. Older adults (≥60 years) (n = 100) participated in an interview and questionnaire to determine knowledge, self-reported practices, and attitudes toward recommended practices. Although the majority (79%) had positive attitudes toward refrigeration, 84% were unaware of recommended temperatures (5°C) and 65% self-reported "never" checking their refrigerator temperature. Although most (72%) knew that "use-by" dates indicate food safety and 62% reported "always" taking note, neutral attitudes were held, with 67% believing it was safe to eat food beyond use-by dates and 57% reporting doing so. Attitudes toward consuming foods within the recommended 2 days of opening were neutral, with 55% aware of recommendations and , 84% reporting that they consume RTE foods beyond recommendations. Although knowledgeable of some key practices, older adults self-reported potentially unsafe practices when storing RTE foods at home, which may increase risks associated with L. monocytogenes. This study has determined that older adults' food safety cognition may affect their behaviors; understanding consumer food safety cognition is essential for developing targeted food safety education.

34 comments:

  1. Great idea. Why aren't Genzyme funding this project? Surely, it is in their interests to get this pack to each patient in the country being treated with alemtuzumab?

    ReplyDelete
  2. We wanted this initiative to be independent of Pharma. Anything funded by Pharma is often treated with cynicism including information packs.

    However, there is nothing stopping Genzyme donating via the website.

    ReplyDelete
  3. In 2016 Sanofi (Genzyme's parent company) made a profit of Euro 4.6 billion. At the start of every presentation slide deck Prof G lists out all the pharma companies he has provided consultancy to. I find it pretty distasteful that people with MS (high levels of unemployment) are being asked to contribute to this project. Preventing this serious infection should not fall to the recipients of this drug.

    ReplyDelete
    Replies
    1. I agree, but Barts Health NHS Trust has a predicted deficit of close to £50M this year.

      https://www.cqc.org.uk/provider/R1H/reports

      I agree it is scandalous that Sanofi-Genzyme are not paying for the manufacturing costs. This can only benefit patients.

      Delete
    2. "Net sales of Lemtrada® amounted to €425 million (+79% CER), including €233 million in the United States and €151 million in Europe, mainly in Germany and the United Kingdom"


      Compensation of the Chief Executive Officer, Olivier Brandicourt (ceo of Sanofi,Genzyme)

      $ 9,660,113 millions(2016)=26 466 $ per day
      $ 16,760,008millions(2015)=45 917 $ per day

      Should a call him to contribute :):)

      Obrigado

      Delete
  4. Some context. Sanofi-Genzyme don't think this is necessary. Listeriosis is in the Summary of Product Characteristics hence it is up to us to sort out. The antibiotic prophylaxis protocol was lead by the ABN and not Sanofi-Genzyme. Either we ignore the problem or we do something about it. We are trying to do something about it.

    ReplyDelete
  5. Will there also be an online or downloadable version of the manual?

    ReplyDelete
    Replies
    1. Good idea. We will put a instructions for a DIY version. We have put some basic information on-line already.

      http://www.clinicspeak.com/listeriosis/

      Delete
  6. Genzyme should learn from Biogen; their STRATIFY-JCV assay is free. No NHS cap in hand to build a derisking programme for PML on natalizumab. I hope the senior Genzyme executives feel suitably chastised. Maybe you should ask Biogen for a donation? ;-)

    ReplyDelete
  7. I suspect that your pack will not be necessary once you start offering ocrelizumab as an alternative treatment option? Why take the risk of Listeriosis and the other complications of Lemtrada when you don't have to?

    ReplyDelete
    Replies
    1. Ocrelizumab is not an induction, and we do not have long term datas about efficacy and safety (chronic Bcell depletion). Alem has the best atrophy rates and potential cure for most of MSer. (Ocr is not pregnancy-friend, Alem is!)

      Delete
    2. Genzyme are still hiding the real alemtuzumab brain atrophy data. We need to know what the results are for those with NEDA vs. non-NEDA. The non-NEDA patients have reversal of pseudoatrophy, i.e. their brains swell again which will make the brain atrophy data look better that it really is.

      I have been asking for the NEDA vs. non-NEDA brain atrophy data for 4 years now. Nothing coming. I suspect the non-NEDA brain atrophy results will be non better than the other high efficacy DMTs.

      Delete
  8. Are you not reinventing the wheel?

    ReplyDelete
    Replies
    1. Yes, and no. All the information we used came from the field of oncology. All we have done is repackaged it in a form that pwMS understand and like.

      Delete
  9. Thanks for sharing such a valuable information .

    ReplyDelete
    Replies
    1. Agree with Vani.
      Thanks to this site I'm aware of all the different risks post Alem. Now have them listed on my mobile in the Medical ID section - 17 different conditions, at the last count! Only 3 or 4 of which have been flagged up by hospital from where I received my treatment.
      Anything that'll help keep PwMS informed and potentially safe, whatever the source and funding is a big bonus!

      Delete
  10. Prof G, I'd prefer you use your brainpower on some scientific research e.g. pinning down the cause of MS. Tube map, information packs, Brain Health Matters stuff, and an ever increasing selection of presentations are no substitute for real scientific research / breakthroughs. I hear on the grapevine that Cambridge will soon be publishing research showing a very low conversion rate to SPMS for those who have had Alemtuzumab. Their work seems to address what MSers really want - long term remission and the possibility of not hitting the SPMS stage.

    ReplyDelete
    Replies
    1. I suspect you would have a different opinion if it was your partner, sibling, daughter, son or friend who was now resting in peace having died of listeria meningitis post-alemtuzumab.

      Service developments and de-risking DMTs in very important for pwMS and the field in general.

      Delete
    2. Cambridge have already published on their SPMS conversion rates; they are low (~5%).

      Tuohy O, Costelloe L, Hill-Cawthorne G, Bjornson I, Harding K, Robertson N,May K, Button T, Azzopardi L, Kousin-Ezewu O, Fahey MT, Jones J, Compston DA, Coles A. Alemtuzumab treatment of multiple sclerosis: long-term safety and efficacy. J Neurol Neurosurg Psychiatry. 2015 Feb;86(2):208-15.

      Delete
    3. Maybe Cambridge will publish their CAM-THY Trial data soon.
      Is bad news being hidden. The ACTRIMS presentation suggests it could have gone the wrong way, but did it?

      Delete
    4. Let's hope they do as we should get a citation, as we suggested there was a problem with the initial idea:-),

      However, based on the ACTRIMS abstract there was a problem with the methodology too, as the mouse and monkey data was not replicated in humans. Rather than boost thymic output, it was inhibited. This issue was sort of confirmed by work published in 2014, where keratinocyte growth factor had no influence on thymic output. It didn't boost it as planned.

      Delete
  11. The NHS is the biggest recipient of charitable donations in the country. It is embarrassing that we need charitable initiatives to support care that should be paid for by the NHS.

    The real story here is the fact that your hospital has no resources to pay for these packs. We need to ask our politicians what they are doing about it?

    ReplyDelete
    Replies
    1. Yep, the most underfunded healthcare system in the rich-world. Its mantra is 'Do More with Less' and ask as the public for donations to prop it up. We need a properly funded healthcare system.

      Delete
  12. It is now mentioned in the European label that Alemtuzumab induces neutralizing antibodies that can stop it working...

    Should it be up to us to design an assay to test this?

    ReplyDelete
  13. Nice idea, I dont understand how the involvement of Genzyme in such an initiation would be a bad thing though. It's kind of their duty and it would improve the drug's profile, which brings chills to many patients. However, the hot potato is how to make Alemtuzumab safer about secondary autoimm. and there I would happily donate.

    Anyway, 7,000 is a very small amount and I am sure you will make it. Online could go worldwide too.

    ReplyDelete
  14. I note not many people have donated money to your campaign? I think you need to reposition this as anti-Pharma campaign, i.e. we don't want Pharma money corrupting our neurologists or our NHS. The idea that Pharma should always pay for things like this preposterous. We need to keep our NHS clean; clean from covert corruption.

    ReplyDelete
    Replies
    1. Very good point. I will have to think about this issue before commenting in detail. But you are correct we have let the NHS become to dependent on Pharma support; this is a particular problem for MS.

      Delete
  15. Listeria can survive in the freezer (but not grow), is this discussed in the manual?
    Frozen vegetables might not be that safe if cooked in the microwave as the heat is uneven.

    ReplyDelete
  16. Sanofi have about 110,000 staff.

    https://en.wikipedia.org/wiki/Sanofi

    If everyone staff member donated 7p you would raise the money in a blink.

    ReplyDelete
  17. Good idea and I will contribute to the Crowdfund. But what I'd really like to see is a collection of practical strategies for managing the diet in your day-to-day life. Post R1 I learned a lot from online forums, but also developed my own approaches to fit the diet into my life. For instance, I bought Milton sterilising fluid to wash fruit, veg, herbs etc. I washed everything before it went in the fridge, storing it in labelled freezer bags. When cooking, I kept antibacterial wipes on hand to easily clean my fingers, knife, chopping board etc. I bought plastic chopping boards that can go in the dishwasher, with separate ones for different foods. The biggest challenge with the diet is getting organised. You can't just grab a sandwich on the go so, apart from the question of what you can/can't eat, practical tips on how to get organised would be a really useful addition.

    ReplyDelete
    Replies
    1. Re:'But what I'd really like to see is a collection of practical strategies for managing the diet in your day-to-day life.'

      Good idea. I now have one of those chilled lunch bags, to take my lunch outside the home.

      I wash my salad and vegetables in cold salty water in a bowl, then rise. I have recently read that adding vinegar to the water, then adding the salt to the water kills off even more, easy and affordable.

      Delete
  18. BBC news today: A third person has died in Australia after eating melon contaminated with listeria bacteria.

    The elderly, pregnant, and infants are being warned to avoid melon which has already been sliced.

    The 15 diagnosed with the infection had all consumed rockmelon, also known as cantaloupe, before falling ill.
    http://www.bbc.co.uk/news/world-australia-43269136

    ReplyDelete
  19. Funded! Wonderful news.

    ReplyDelete

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