Afleveringen
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Do we have an equitable or equal society? What even do those words mean? And why do we care - what possible impacts could those things have on people and/ or their healthcare outcomes? The answer - A LOT! We start to tackle this in this episode, part 1, with more to follow in part 2! Also, keep your ears peeled for a very brief outing for our favourite shiny rock!
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
Resources -
https://www.aamc.org/news/how-we-fail-black-patients-pain
https://www.ncbi.nlm.nih.gov/pubmed/22239747
https://www.hra.nhs.uk/planning-and-improving-research/best-practice/people-centred-clinical-research/people-centred-clinical-research-infographic/
Books -
Invisible Women - Caroline Criado Perez
Inflamed - Rupa Marya and Raj Patel
Doing Harm - Maya Dusenbery
Divided - Annabel Sowemimo
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In this episode, we’re back in Elyse’s corner, with the marvellous shiny rocks, which today will go unpolished! Instead, we’re talking about direct to consumer advertising for prescription and over the counter drugs - the history of it, and why does it happen in such a limited number of places worldwide?
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
References -
Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, And Implications
Pharma and healthcare industry advertising in the U.S. - statistics & facts
Ad spending in dietary supplements category
How advertisers are building up their cannabis ad budgets
Manufacturer Spending on Direct-to-Consumer Advertising for Pharmaceutical Products
AMA press release Nov 2015
Advertising and the promotion of medicines in the UK
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What is a conflict of interest and why might it be important? In this episode we briefly define what a COI is, and explore some examples around medical research and what the impact may be.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
GMC Guidance - https://www.gmc-uk.org/-/media/gmc-site/ethical-guidance/mdg-2023/identifying-and-managing-conflicts-of-interest-english.pdf
MHRA Board Members receiving payments from Pharma - https://www.theguardian.com/society/2022/apr/17/medical-regulator-faces-questions-over-board-members-links-to-drug-firms
MHRA 2022 COI Report - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1173562/Annual_Compliaince_Report_2022.pdf
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A question that has stood since time immemorial. What DO government regulators do, when it comes to drugs and devices? Hopefully, this episode will give you some answers to that question! Debbie attempts to tell Elyse about Government regulators, but in the process, does forget her own name and how to say thank you successfully.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Welcome back from our summer break! Today, a shorter episode looking at the use of Ozempic/ Wegovy (brand names) - type II diabetes semiglutide drugs, because they’re all over the news media at the moment. Living in the most fatphobic bit of the world and discussing it made us feel not great, which is why the episode is shorter today. We also talk about the ban on puberty blockers in the UK, drawing some interesting parallels between that and Ozempic.
Content Warnings - fatphobia & diet culture, weightloss, death by suicide, transphobia.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
Resources
https://www.theguardian.com/society/article/2024/jun/13/top-doctor-warns-against-using-anti-obesity-drugs-to-get-beach-body-ready
https://www.maintenancephase.com/
https://www.yourfatfriend.com/
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Today, Elyse and Debbie are putting their finger on the pulse of THE NEWS around clinical research, drugs, science, health - as much news as you could want! We’re going to take it in turns and share with each other - and you - 2 stories each that we’ve seen in the news recently. And then at the end, we go on a tangent about racism and imperialism and white supremacy, you know what we’re like by now.
Also, just to let you know, Elyse & I will be taking a summer holiday - which means no new episodes for August. See you in September! Feel free to send in questions or suggestions if you miss us too badly!
Resources
Debbie Story 1 - IBD - https://www.theguardian.com/society/article/2024/jun/05/bowel-disease-hope-researchers-find-biological-pathway
Elyse story 1 - Covid vaccines
https://www.forbes.com/sites/ariannajohnson/2024/05/22/covids-new-flirt-variants-what-to-know-as-experts-fear-summer-surge/?sh=59372a3dd705
https://www.forbes.com/sites/ariannajohnson/2024/06/05/fda-panel-recommends-new-covid-vaccines-for-jn1-lineage-by-fall/
https://www.fda.gov/advisory-committees/advisory-committee-calendar/postponed-vaccines-and-related-biological-products-advisory-committee-may-16-2024-meeting
https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines
Debbie Story 2 - lung cancer
https://www.theguardian.com/society/article/2024/may/31/trial-results-for-new-lung-cancer-drug-are-off-the-charts-say-doctors
https://clinicaltrials.gov/study/NCT03052608
Elyse Story 2 - Hair Relaxers
https://www.nytimes.com/2023/10/16/health/hair-straighteners-black-women-fda.html
https://www.nytimes.com/2024/06/13/magazine/hair-relaxers-cancer-risk.html
https://pubmed.ncbi.nlm.nih.gov/36245087/
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Today’s topic is not a fun one, but is something many of us have experience with - we’re talking about cancer - what causes it, how it works, and how it’s treated. Once we’ve got the science part out of the way, we’ll look at how complex and interesting cancer research is.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
References -
Hank Green’s blog on cancer - https://youtu.be/rCo71uX_pCI?si=0Gv2eEg8J5ZL7s0p
Hank Green’s chemo vlog - https://youtu.be/ceF4GxVkOqA?si=fynv30g5hynlKB58
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In this episode, we’re back in Elyse’s corner, and it has some extremely shiny rocks! Today, we’re talking about temperature and how important it it to the delivery of research and successful medical treatment.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
References -
https://www.cdc.gov/heat-health/hcp/heat-and-medications-guidance-for-clinicians.html
https://www.tandfonline.com/doi/full/10.1080/10903127.2016.1258098
https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
https://www.sciencedirect.com/science/article/pii/S0939641117308731#b0175
https://www.who.int/teams/immunization-vaccines-and-biologicals/essential-programme-on-immunization/supply-chain/controlled-temperature-chain-(ctc)
https://www.sciencedirect.com/science/article/pii/S0264410X14000723
https://www.gpha.org/expired-vaccine-guidance-from-cdc/
https://aspr.hhs.gov/SNS/Pages/default.aspx
https://torontosun.com/news/national/feds-gets-new-covid-vaccines-as-1-5-b-worth-of-shots-expire-are-trashed
https://www.state.gov/covid-19-recovery/vaccine-deliveries/
https://www.who.int/news/item/29-11-2021-joint-statement-on-dose-donations-of-covid-19-vaccines-to-african-countries
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As members of the public how can we influence what is developed? Who is making the decisions about which new medicines and products get researched? That’s the topic for today, and I’m afraid it’s not great news, everyone!
References - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841468/
https://researchsupport.admin.ox.ac.uk/equity-and-inclusivity-in-research-funding
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Getting a clinical trial site (or sites) ready to start is a busy, hectic and high pressure time and the focus of our episode today. What is needed, how the items interlock and overlap, and who is responsible!
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Ever thought about a career in clinical research? In this episode that’s exactly what we’re talking about - what the options are, what you need to know, and what transferable skills you need.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Today, we’re talking about Informed Consent - what it is, how it works, how it's documented and how it is handled for different people. This is a whistle-stop tour covering the main principles and points, but as always we could talk for hours about this topic!
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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In this episode, we’re talking about some issues with treatments. We’re looking at some drugs that have lost or might lose their approvals, or cases where additional measures are put in place for safety reasons.
Here are some resources or references used in the research for this episode -
Crizanlizumab statement. January 2024 » Sickle Cell Society
Crizanlizumab - end of NHS supply » Sickle Cell Society
FDA starts speedy review of Novartis’ sickle cell antibody - PMLiVE
Exa-Cel (Casgevy) Gene Therapy Update » Sickle Cell Society
Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions - GOV.UK (www.gov.uk)
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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In this episode, we’re back in Elyse’s corner, and it has far fewer cobwebs - someone has been dusting! Elyse is going to tell Debbie all about CPR - how it works, how well it works, and we’re going to discover together how it’s possible to do research around something like CPR when the patient is unconscious!
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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We’ve covered a lot of topics so far, so today we’re recapping what we’ve discussed already AND looking at the end of end of a clinical study - from about 10000 feet! We do want to dive in more to some areas in detail, but for now, it’s a sprint through from beginning to end!.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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So it’s been 5 minutes since we talked about Debbie’s favourite topic documentation, so we’re back there to discuss Good Documentation Practice (GDP). What does that mean in real, clinical trial practice, what are some of the rules that need to be followed?
Here is the link to the FDA Warning letter sent to Amazon.com in December 2023 - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023
AND! Debbie finally found the name of the drug that began with a “K” = Ketek, and the fraudulent enrollment https://www.nejm.org/doi/full/10.1056/NEJMp078032#:~:text=The%20study%20was%20completed%20in,complete%20fabrication%20of%20patient%20enrollment.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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How do we ensure (and assure) the quality of every part of the clinical trial process. Why do you even need quality assurance? What sorts of things do auditors or Inspectors find? That’s our topic for today’s episode, so be prepared to hear about what QA is and why it’s important.
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Unlucky for some, but for us we’re delighted - Episode 13 is our long awaited Q&A episode! We throw questions at each other, though honestly Debbie does answer most of them. Huge thanks to everyone who submitted a question - don’t hesitate to send any more you may have to our email address!
Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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In this episode, Debbie explains to Elyse all about phenylephrine and why it’s been in the news (and maybe not as obvious on your pharmacy shelves) in the last 6 months. What research was done when to get this drug onto the market, what the FDA have said recently and what may the next steps be going forwards.
We recommend you check out the FDA website to stay up to date on this issue, if you’re interested, since this episode was recorded a few weeks ago compared to when it is being released - https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine
You can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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Ep 11
In this episode, we’re back in Elyse’s corner, and it’s lovely! Elyse is going to tell Debbie all about Ketamine therapy and how it’s being researched as a potential treatment for major depressive disorder. A content warning for this episode - consider whether this episode is right for you to listen to, as there is discussion on mental health, depression and suicide. Please proceed with caution.
You can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm!
Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
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