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SEMINARS 2022

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SEMINARS 2022

Who discovers medicines and what clinical benefit do they deliver to patients?

24.02.2022 

Leeza Osipenko, PhD
Pharmaceutical innovation: where does it come from? How much does academia contribute compared to industry? What do the medicines entering the market offer to patients in terms of clinical benefit? We look at the decade of medicines’ launched in the French market (2008-2018). Most of these medicines entered other EU and North American markets at the same time. We compare these medicines in terms of additional clinical benefit and their origin (academia/industry). We also investigate differences between combination and non-combination products, and how medicines’ origin and their clinical benefit rank by therapeutic category.

Video | Slides

 

Prescrire: a critical eye on new drugs

10.03.2022 

Pierre Chirac
How many new drugs offer an advantage and how many bring nothing new? Very few sources in the world can answer this question. Prescrire has done that since 1981. Run by a non-profit organisation, Prescrire has been fully financed by its subscribers (26,000 in 2022) since 1993. The 150 editors (mostly medical doctors and pharmacists) have no conflict of interest with industry, and work collectively following an original multistep process. A “critical eye on new drugs”, Prescrire has almost never been sued by companies and never lost the cases. Prescrire is also very much involved in policy advocacy at the European level, challenging the European institutions (Commission, Council, Parliament and European Medicines Agency) to better serve the needs of patients and health professionals. This talk is about explaining Prescrire: the reason for its existence, people behind it, operations, main achievements, and limitations.

Video | Slides

Institutionalizing systematic priority setting in LMIC

24.03.2022 

Javier Guzman, MD
Low- and middle-income countries (LMICs) have pledged to achieve universal health coverage (UHC) as part of their commitment to attain the Sustainable Development Goals. During this journey, some LMICs have decided to institutionalize systematic priority setting and have used health technology assessment to determine what services should be available under UHC, to whom should they be made available, and what (if any) user charges or other arrangements should be attached to services that are not considered priorities given budget constraints. This webinar will go through some lessons learned in this process and will highlight some successes and failures that can help countries interested in deepening or pursuing this journey going forward.

Video | Slides

Value, benefit, and time: finding our way again in cancer care

07.04.2022

Christopher Booth, MD
Therapeutic advances have transformed the outcomes of some cancers. However, there is growing recognition that many new cancer medicines are associated with small benefits. These newer medicines have staggering economic implications; this needs to be reconciled with the fact that there are patients in all health systems who lack access to core cancer treatments with large benefits. This lecture will explore themes of value, access, magnitude of benefit, and time toxicity in modern oncology and offer thoughts on how we can improve the delivery of cancer care.

Video

Patient power in pricing disputes

05.05.2022 

Diarmaid McDonald
Patients and patient groups are playing an increasingly prominent role in decision making at many steps of the drug development and rollout process. Their role has been particularly high profile in debates around NICE appraisals of highly priced medicines, as they attempt to influence the outcome of a process that determines whether or not they can access a potentially life-changing drug on the NHS. Just Treatment, a patient-led campaign group, has attempted to intervene in these disputes in a way that generates scrutiny of the wider causes of the problem, and builds pressure for systemic reform of government and pharmaceutical industry behaviour. What has the historic role of patients in these disputes been, how is that role evolving, and what does the future hold?

For this talk Diarmaid will be joined by a patient leader who has participated in their campaign work, and has been directly affected by the consequences of high medicine prices.

Video | Slides

Government support for Cancer Research & Drug Development in the US

19.05.2022

Elad Sharon, MD, MPH
The discussion will focus on the National Cancer Institute’s Cancer Therapy Evaluation Program.  The mission of the Cancer Therapy Evaluation Program (CTEP) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects.  This will serve as an example of the United States government’s involvement in promoting cancer research and developing novel therapies, in collaboration with industry and academia.

Video | Slides

Predictive validity in drug discovery

16.06.2022

Jack Scannell, PhD
Successful drug discovery is like finding oases of safety and efficacy in chemical and biological deserts. Disease models, and other decision tools used in drug R&D, point towards oases when they score therapeutic candidates in a way that correlates with clinical utility in humans. Otherwise, they generally lead in the wrong direction. This line of thought can be quantified using the idea of ‘predictive validity,’ or the correlation coefficient between the output of a disease model and clinical utility across therapeutic candidates. History and decision theory both suggest that predictive validity is under-managed in drug R&D, not least because it is so hard to measure before projects succeed or fail later in the process. This talk explains the influence of predictive validity on R&D productivity and discusses methods to evaluate and improve it.

16.06.2022 Predictive validity in drug discovery: what it is, why it matters and how to improve it
   Video | Slides | Transcript

Transformative Innovation Policy

07.07.2022

Governments have increasingly turned to innovation policy as a route to address deeply embedded and systemic societal challenges. This is most evident in relation to global climate change but is also visible in stubborn health challenges such as cancer. This turn to transformative innovation is seen by some as a new era of missions echoing the 1960s ‘moonshot’ programme. Others suggest that we need a radically different focus on system wide transitions which embrace a mix of social and technological innovations. This seminar introduces these different concepts of innovation and how policy needs to change in order to fulfil transformative aspirations. Illustrations will be given from the areas of climate change and cancer.

Key publications for seminar
Transformative innovation policy: Addressing variety in an emerging policy paradigm Research Policy 48 880-894 (with Gijs Diercks, Henrik Larsen) (2019) Transformative innovation policy to meet the challenge of climate change. Sociotechnical networks aligned with consumption/end-use as a new public arena for the transition to a low carbon society/green economy Technology Analysis & Strategic Management Vol. 24, No. 4, April 2012, 331–343 (2012)
 
07.07.2022     Transformative Innovation Policy
  Video | Slides | Transcript

Pathological Consensus

14.07.2022

“To me, the thing is extremely interesting, that men, perfectly honest, enthusiastic over their work, can so completely fool themselves.” I. Langmuir
In 1953 Langmuir described pathological science as “the science of things that aren't so.” In those days discovery was often made by precise instrument-based measurements. An undetected error in those measurements could lead to many years of wasted research studying a false or improperly defined phenomenon. In the 1980s critical care science replaced precise measurements by instruments with measurements defined by consensus (called “criteria”) comprised of guessed thresholds. Generally, these consensus-based measurements were unknowingly erroneous, producing a state of “pathologic consensus” rendering an output analogous to pathological science but on a worldwide scale. This has caused over three decades of failed randomized controlled trials, representing perhaps the greatest, well intentioned, waste of research resources in modern times.
In this talk we will examine the origin and history of pathologic consensus and describe the campaign, over the past decade, to bring an end to this failed methodology.
 Additional reading:

Video | Slides | Transcript

IP and access to health technologies

22.09.2022

Jaume Vidal
The COVID-19 pandemic demonstrated that the tensions between intellectual property (IP) rights and access to life-saving technologies remain well after the Doha Declaration. Despite the hefty words and good intentions of governments in the Global North, misuse and abuse of patent-based exclusive rights and other IP protection measures hinder access to innovation and greatly limit policy space for governments in the time of need.

As the discussions and debate around the TRIPS waiver for COVID-related health goods have shown, there is a new political appetite among governments in the Global South governments to revisit some of the main tenets of global IP protection framework to ensure that tech transfer and greater access to innovation are effectively fulfilled. Despite the disappointing result of the 18-month effort by over 50 governments, with the support of civil society and academy, the issue is back in the agenda and specific steps need to be taken in the short term to bring necessary change to fruition. This talk looks at the background and context of the IP and public health balance and identifies possible actions for the short, mid and long term to make sure that, in the next pandemic, artificial scarcity of health technologies does not leave anyone behind.

22.09.2022     IP and access to health technologies
  Video | Slides | Transcript

Lessons from NICE

06.10.2022

Sir Andrew Dillon
NICE was never a counsel of perfection. It was always - and still is - a work in progress. Its development was never fast enough for many and for some, not always in the right direction. Its heart was always in the right place, though and it did its best to learn from its mistakes, as well as from the advice it received from its friends and critics (it’s possible to be both, of course). This talk is just one take on what was learned along the way, during NICE’s first two decades, by someone who saw it happen and survived.

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Alternative medicine: research and integrity

20.10.2022

Edzard Ernst, MD, Ph.D

Alternative medicine is a vast and controversial subject. Research into alternative medicine has substantially increased during recent years. Yet, important questions remain unanswered. One reason for this phenomenon might be the often-lamentable lack of research integrity that seems to plague alternative medicine.

Video | Slides | Transcript

The waste in futile oncology drug development

10.11.2022 5pm

John Hickman, Valerie Jentzsch, Jack Scannell, Leeza Osipenko

A reported attrition rate of >90% for the development of oncology drugs results in a
substantial waste of resources and disappointment for all parties involved,
particularly patients. This talk presents our research where we aimed to estimate the
costs of the 183 clinical trials of 16 agents targeted to the insulin growth factor 1
receptor (IGF1R), none of which exhibited activity permitting approval for clinical use.
This is the first attempt to quantify drug development cost focussing on a specific
target.

The wind that shook the Sugary Willows

17.11.2022  5pm BST
 

Homeopathy is an alternative medicine, invented by Hanneman in 1796. If the original homeopaths were pioneers, enforcing "hygieno-dietetiques" recommendations alongside the ludicrous dilution and "like cures like theories", modern homeopathy is now a SCAM, So Called Alternative medicine, in E. Ernst's words. In France, since 1984, homeopathy was reimbursed by Social Security. Since then, the homeopathy industry has thrived, with Boiron and other Big Sugar industries sponsoring Homeopaths unions, lifelong learning foundations, and even medical faculties like in Lyon and Strasbourg. Homeopathy was there to stay, diluted or not. OR was it?

In 2018, a small ragtag bunch of healthcare professionals joined on Twitter to write and publish in the Figaro Santé an op-ed asking institutions like the Ordre des Médecins and Healthcare and Education ministers to stop funding treatments not based on evidence. Unions of homeopaths across France, in anger, threatened to sue one author after another until excuses were made, in a move Don Corleone would approve.

What was supposed to be a "Fire and forget" op-ed became a national debate across the media, with even the Big Sugar lobby pitching in with the campaign "Mon Homeo Mon Choix '' and political figures like Xavier Bertrand endorsing the granules. The authors of the op-ed decided to create the No Fakemed Collective in response.
This... is their story since.

Video | Slides | Transcript

Which medicines should be used in cancer care?

01.12.2022 5pm BST

Nathan I Cherny MBBS, FRACP, FRCP
How good are oncology drugs? Which ones should be used and which ones should not? Who should decide and how? ESMO (European Society for Medical Oncology) Magnitude of Clinical Benefit Scale
(MCBS) is a tool for assisting in prioritization of medicines in cancer care. This talk by Professor Cherny presents an overview of ESMO-MCBS and its multiple uses in public policy, the clinic and research
design.
More information about the tool: https://www.esmo.org/guidelines/esmo-mcbs

Video | Slides | Transcript.

Busting 2 zombie trials in a post-covid world

15.12.2022 5pm.

Florian Naudet, MD, PhD

For long, fraud in biomedical research was seen as an infrequent problem. It is no longer the case. While rare frauds in the past often involved falsification of data by isolated centers within a study, today fraud can involve entirely invented trials, the so-called ‘Zombie trials’. Zombie trials are “randomised controlled trials that appear to be false and those where the data lack credibility so blatantly that they can be called ‘Zombies’". In this talk I will describe two zombie trials about Artemisia tea infusions effectiveness including one in Malaria. I will then provide an overview of the problem with numerous other examples.

Video | Slides | Transcript

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