Pathways to independence: towards producing and using trustworthy evidence
BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6576 (Published 03 December 2019) Cite this as: BMJ 2019;367:l6576Commercial influence in health: from transparency to independence
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Dear Editor
Moynihan and colleagues are investigating pathways for the production and the use of trustworthy evidence free from financial conflicts of interest in medical research, education and practice. Corporate influence on the policy and decision-making process needs more scrutiny.
1. Public funding of medicines agencies is crucial for their independence
According to the announced European Medicines Agency (EMA) budget for 2020, around 86% derives from fees and charges from industry, 14% from the European Union’s contribution for public health issues and less than 1% from other sources (1). The European Commission Inception Impact Assessment on the revision of the EMA fee system cites similar figures: 90.2% of the Agency’s total budget funded by fees from pharmaceutical companies and around 9.6% by EU/EEA budget contributions (2). As for the U.S. FDA’s human drug regulatory activities, industry user fees provide 65% of the funding (3).
Industry fees undermine the independence of drug regulatory agencies
Fees for services make drug regulatory agencies dependent on funding from the industry that they are supposed to regulate. This is an obvious conflict of interest. Health authorities have a responsibility to act objectively and in the public interest, without being swayed by the business concerns of companies who are seeking product approval or who are “regular clients” within the framework of post-marketing follow-up.
For the sake of independence, and to carry out its public health mission, the EMA needs to be weaned off its fee-for-service relationship with pharmaceutical companies and funded through public funding from the European Union. The upcoming revision of the EMA fee system represents a great opportunity for exploring options of adequate public funding and to make steps towards greater independence (4).
The principle of the independence of European Medicines Agency must be safeguarded, to ensure that the business interests of pharmaceutical companies do not override public health interests.
2. Eliminate industry capture of medicine agencies and authorities
Scientific advice
Situations exposing EMA staff and experts to the risk of institutional capture that could compromise their impartiality and objectivity should be avoided. Repeated contact between pharmaceutical companies and EMA representatives long before submission of a marketing authorisation application can lead to institutional capture and the potential for corporate influence that goes against the public interest.
As stated in EMA’s annual report for 2018, “EMA and its scientific committees and groups of experts from the EU national competent authorities are fostering early interaction and dialogue with developers to facilitate the development process, and help companies to collect adequate data and comply with regulatory standards” (5). Due to the large increase in companies’ requests for pre-submission scientific advice from medicines agencies (and Health Technology Assessment bodies) there are growing concerns that this practice might exert control from an early stage over everyone involved in the assessment of marketing authorisation applications at both national and European levels.
In follow-up of a strategic inquiry, the European Ombudsman came up with suggestions for improvement in July 2019 (6). The Ombudsman called for “a separation between those responsible for providing scientific advice …and those subsequently involved in evaluating a marketing authorisation application for the same medicine”. The Ombudsman also suggested that EMA attach “to the EPAR a detailed log of all relevant pre-submission activities, including the names of the experts involved”.
There is little transparency over the content of requests for pre-submission scientific advice and the answers provided. The publication of this information would greatly facilitate independent research on the provision of scientific advice and evaluation of its impact. Currently, only pharmaceutical companies and EMA itself are in a position to evaluate the impact of early scientific advice, yet patients and health professionals are directly affected. Access to the questions raised would help clarify pharmaceutical companies’ needs and concerns when designing clinical research programmes. For the sake of scientific rigour, impartiality and neutrality, EMA should make its scientific and procedural requirements clearer in guidelines on clinical research being publicly available. This would be a useful step towards information sharing and greater transparency. It would also help to improve existing guidelines by specifying or clarifying exactly what assessors need from clinical research.
Influence on policy regulation
EMA's many close contacts with the pharmaceutical industry have an impact on policy regulation. The proposed objectives/recommendations outlined in the recent consultation paper on regulatory science were mainly driven by industry, science or technology, with little focus on clear regulatory merits and responsibilities. There is a continuous trend towards early interactions between companies and EMA, such as scientific advice, flexibilities and faster marketing authorisations with a shift from pre-marketing approval evidence-collection towards an unclear post-approval assessment (7).
Transparency, robust and independent assessments of medicines free from vested interests and full access to clinical data should be a priority for the benefit of patients, healthcare professionals and the public in general.
References:
(1) https://www.ema.europa.eu/en/about-us/how-we-work/governance-documents/f...
(2) https://ec.europa.eu/health/human-use/legal-framework/ema_impact-assessm...
(3) https://www.fda.gov/media/131874/download
(4) https://english.prescrire.org/en/79/207/46302/6187/5953/SubReportDetails...
(5) https://www.ema.europa.eu/en/documents/annual-report/2018-annual-report-... (see p. 44)
(6) https://www.ombudsman.europa.eu/en/decision/en/116683
(7) https://english.prescrire.org/en/79/207/46302/6127/5953/SubReportDetails...
Competing interests: No competing interests
Dear Editor
The BMJ’s initiative to focus on the commercial influence on scientific research and medical practice is both welcome, and to those of us of us fighting to against interests that damage patients and consumers, long overdue. Health Action International (HAI) is grateful for the opportunity to contribute to this important discussion.
Since its inception, HAI has always concerned itself with the influence pharmaceutical companies have on medical professionals’ prescribing and treatment habits. The evidence is clear - exposure to information from pharmaceutical companies does not lead to net improvements in prescribing but has been shown to negatively affect prescribing and professional behaviour.1
We are far from alone in our concern about pharmaceutical marketing, as this BMJ effort has highlighted. However, not enough is being done to tackle harmful marketing practices and more attention must be given to the commercial influences targeting medical students and healthcare professionals in training.
We know that healthcare professionals encounter promotional materials during their studies, yet most medical students do not obtain adequate education on how to critically respond to pharmaceutical promotion. 85.2% of medical students surveyed in France (n=2,101) reported feeling inadequately educated about conflicts of interest arising from interactions with the pharmaceutical industry.1
Medical students are the future of the healthcare systems on which we rely. But they are often left with little understanding of the impact commercial influence has, and will continue to have, on them throughout their studies and when they begin prescribing medicine in medical practice. A recent study has shown how little contact with students is needed to impact their behaviour: the US study of 280,000 doctors found an association between accepting even just one sponsored meal and higher prescribing of sponsors’ medicines, with additional or costlier meals associated with even higher prescribing.2 Engaging first-hand with medical students, time and again we have heard concerns about medical schools’ inaction when it comes to educating students about the impact of even the most (seemingly) innocuous pharmaceutical promotion.
By giving medical students the tools to critically evaluate the information provided by pharmaceutical companies, and to assess each treatment option thoroughly and objectively, we are supporting ethical clinical practice, and patient-, rather than pharmaceutical company-led healthcare.
HAI has fought to counter the influence of pharmaceutical promotion with a series of tools for medical students, from our recently re-modelled Fact or Fiction guide, workshops at European universities (more to come in 2020), to our ongoing webinar series on the subject which reaches as far afield as Nigeria and Australia. Meanwhile, in France, the National Association of French Medical Students (ANEMF), La Troupe du RIRE and Formindep continue to work tirelessly to put this issue on the map, and with great success: most notably seen in the adoption of calls for conflict of interest proposals being taken up by the national body representing Deans of National Educational Institutions. The student led activism of Universities Allied for Essential Medicines (UAEM) chapters across Europe is another great asset to the efforts to change the way faculties approach marketing on their campuses.
Student mobilisation has been instrumental to putting the issue of conflict of interest on the agenda, and by continuing to work with partners and student groups like these, we can expand our reach in 2020. But without concerted action to regulate pharmaceutical promotion, or to embed tools like the those we have developed into medical curricula, the spectre of undue influence will shape medical systems across Europe for years to come.
References:
1. Health Action International, Fact or Fiction: What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union, available: https://haiweb.org/wp-content/uploads/2016/10/Fact-or-Fiction-1.pdf
2. BMJ 2019;367:l6576, available: https://www.bmj.com/content/367/bmj.l6576
Competing interests: No competing interests
Dear Editor
Independent information does exist, but deserves more attention and visibility
Moynihan and colleagues are investigating pathways for the production and the use of trustworthy evidence free from financial conflicts of interest in medical research, education and practice. It appears worthwhile to point out that independent sources of information do exist, and many are members of the International Society of Drug Bulletins (1-2).
La revue Prescrire is one of these independent drug bulletins. Since 1981, it has been living proof that the provision of independent, trustworthy information and continuing education free from commercial ties is feasible (3). Prescrire has made the choice of independence from drug and device companies, as well as from government, a cornerstone of its editorial and business model. Prescrire is a non-profit organisation that is wholly financed by subscriptions and receives no revenue from advertising or grants. The principle of independence is anchored in Article 1 of the organisation’s bylaws: "To work, in all independence, in favour of quality healthcare, first and foremost in the interest of patients (...)." Prescrire’s texts are produced by members of the in-house editorial team, all of whom are free from conflicts of interest (4).
Editorial choices are guided solely by the content’s usefulness to healthcare professionals in daily contact with patients. Prescrire publishes independent, comparative, systematic reviews of new products (including their packaging), e.g. new active substances, new indications and new pharmaceutical forms. It closely monitors adverse drug effects, medication errors, market withdrawals and product shortages. It also provides information on therapeutic strategies and on the regulatory environment for health products, particularly at the EU level. It addresses corporate capture and conflicts of interest at all levels of the health sector, including in peer-reviewed journals.
For its reviews of new medicines and indications, Prescrire has put in place a unique system that rates the therapeutic advantage of a new drug or a new clinical use (5). This system identifies products representing true advances or those which are no better than existing treatments. It provides clear warnings about the products which should never have been authorised, due to uncertainty over their harms or benefits, or because they are clearly dangerous. The rating system considers not only the inherent value of each product in terms of its harm-benefit balance, but also its advantages and disadvantages relative to the best therapeutic options available in Europe. The system is built upon 7 ratings ranging from “Bravo” (major therapeutic advance) to “Not acceptable”. In 2019, 11 of the 108 (10%) new drugs analysed in Prescrire constituted a notable therapeutic advance, 61 (56%) were rated “Nothing new”, 14 (13%) were deemed “Not acceptable” and 9 (8%) got a “Judgement reserved” (6). In addition, the packaging of 173 drugs was examined, and in 34 cases was judged dangerous (7).
Independent information on drugs and therapeutic strategies free from commercial ties does exist. Greater attention and visibility for these sources of information would produce a positive impact on patient safety, independent medical education and patient-centred care.
@Prescrire
1. https://www.isdbweb.org
2. https://www.who.int/bulletin/volumes/91/6/13-122762/en/
3. https://english.prescrire.org/en/82/169/0/0/About.aspx
4. https://english.prescrire.org/en/82/173/0/0/About.aspx
5. https://english.prescrire.org/en/115/1782/53780/5532/ReportDetails.aspx
6. Prescrire Rédaction « L’année 2019 du médicament, en bref » Rev Prescrire 2020 ;40(436) :146-147
7. Prescrire Rédaction « Le Palmarès 2019 du conditionnement » Rev Prescrire 2020 ;40(436) :86-87 & https://www.prescrire.org/fr/3/31/58307/0/NewsDetails.aspx
Competing interests: No competing interests
Dear Editor,
Legal action can also be used as strong leverage for change, by raising awareness and opening debate.
In France, we have deployed this legal initiative several times : we appealed to the Conseil d’Etat (the Supreme Court for Administrative Jurisdiction) to rule against two clinical guidelines issued by the Haute Autorité de Santé (National Health Authority). In both cases the internal rules for disclosing and managing links of interests had been ignored by the Authority, and we had concerns about the scientific validity of the resulting guidelines which departed from the state of science at the time. Both guidelines (Alzheimer's, T2 diabetes mellitus) were cancelled by Conseil d'Etat. (1)
In the wake of this judgement, another 6 guidelines were withdrawn voluntarily by the Authority, on the same grounds.
Other appeals we made and won resulted in the publication of decrees required to enforce the national regulation on disclosure and management of interests in the healthcare sector and administration.
Our most recent legal action in 2018 is of a new type: criminal justice. In collaboration with Anticor, an anti-corruption organisation, we sued Haute Autorité de Santé experts for failure to disclose their direct interests with the marketers of medicines involved in the clinical guidelines they were drafting (2).
(1) French guidelines are withdrawn after court finds potential bias among authors - BMJ2011;342:d4007
(2) https://formindep.fr/mauvaises-pratiques-des-recommandations-de-la-has/
Competing interests: No competing interests
Dear Editor,
The Drug Commission of the German Medical Association (DCGMA) is the scientific expert committee for drug-related matters of the German Medical Association. It consists of 40 full members and approximately 121 associate members from all areas of medicine and pharmacy. The DCGMA is financed by the German Medical Association (BÄK) and the National Association of Statutory Health Insurance Physicians (KBV). All members work voluntarily for the DCGMA.
The main tasks of the commission include:
• providing the medical profession with various and up-to-date information on rational drug therapy and drug safety
• making available expert opinion for medical science and practice as an authorised organisation for the early benefit assessment of pharmaceuticals pursuant to the Social Code (SGB V)
• reporting, documentation and assessment of adverse drug reactions.
Carrying out these tasks, the independence of its members is of utmost importance for the DCGMA. Since 2002 all full and associate members as well as the academic staff of the central office have to declare their conflicts of interest (COI) resulting from financial ties to pharmaceutical and medical device companies to the chairman. The declarations of DCGMA-members were initially confidential. Since 2014, however, they have been publicly available on the DCGMA-homepage and also include the amount of payments and non-financial COI (1). This transparency is voluntarily created by all members. It is not self-evident and of particular importance, as COI in Germany are not made transparent in public registers on the basis of a legal obligation. The DCGMA has also worked straightforwardly to reduce COI of their members. This has been implemented by the obligation of new members with no financial ties to pharmaceutical and medical device companies as well as having substantial expertise. In addition, the DCGMA has discussed in depth the risk of bias from COI on the organisation’s recommendations. This approach has resulted in a consequent reduction of financial ties of members of the DCGMA to pharmaceutical companies, as shown by a number of 18 of 37 (49 %) members with financial ties for lectures and advisory boards in 2010-2013 as compared to 7 of 38 (18 %) in 2017.
The DCGMA has furthermore worked hard to increase awareness of all physicians in Germany on COI and its potential undue influences on medical decisions and recommendations as well as medical education. For instance, revised rules for dealing with COI were established in 2012. Two years later, a panel of experts was set up with the aim to promote the independence of physicians by developing and disseminating strategies for the avoidance and handling of COI. In 2016, rules for independent medical training courses were introduced, accompanied by an evaluation form. In addition to these activities, the DCGMA participates continuously in the public debate on COI by publishing statements, in which, for example, an obligatory transparency of COI for Germany is demanded. Also, the DCGMA has published results of its research as to the influence of COI on drug studies (2, 3) and clinical practice guidelines (4, 5). Members of the DCGMA have also released a book about COI in medicine, which can be regarded as one of the standard works on this topic in Germany (6).
In summary, the DCGMA as an important expert committee for rational drug therapy in Germany has adopted strong rules for transparency of COI and has continuously reduced COI of their members. This will most likely improve the quality of its recommendations as valued by the independent HTA-Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG), the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) and physicians throughout the country.
References:
1. https://www.akdae.de/Kommission/Organisation/Mitglieder/index.html
2. Schott, G; Pachl, H; Limbach, U; Gundert-Remy, U; Ludwig, W; Lieb, K. Dtsch Arztebl Int 2010; 107(16): 279-85. DOI: 10.3238/arztebl.2010.0279
3. Schott, G; Pachl, H; Limbach, U; Gundert-Remy, U; Lieb, K; Ludwig, W. Dtsch Arztebl Int 2010; 107(17): 295-301. DOI: 10.3238/arztebl.2010.0295
4. Schott, G; Dünnweber, C; Mühlbauer, B; Niebling, W; Pachl, H; Ludwig, W. Dtsch Arztebl Int 2013; 110(35-36): 575-83. DOI: 10.3238/arztebl.2013.0575
5. Schott, G; Lieb, K; König, J; Mühlbauer, B; Niebling, W; Pachl, H; Schmutz, S; Ludwig, W. Dtsch Arztebl Int 2015; 112: 445-51. DOI: 10.3238/arztebl.2015.0445
6. Lieb, K; Klemperer, D; Kölbel, R; Ludwig, W. (editors) Interessenkonflikte, Korruption und Compliance im Gesundheitswesen. Medizinisch Wissenschaftliche Verlagsgesellschaft, Berlin 2018.
Competing interests: No competing interests
I completely agree with the points and issues raised. I am a consultant breast radiologist working in the NHS for the last 9 years. The NHS prides itself in being one of the few medical institutions in the world free from any financial incentives to the healthcare providers directly from the patients. Having worked in other medical settings, I know this system works well for the patient and doctors alike, keeping the public trust in doctors high.
To uphold NHS principles, it is crucial to obtain trustworthy medical evidence free from commercial and sponsor bias. For that to be possible, direct industry sponsored research to test new equipment and drugs should be stopped with separation of those who make products (with clear financial gains) and those who evaluate it. Often the medical stalwarts involved in industry-sponsored research are the same persons who are actively involved in contributing to key guidelines as ‘experts’ by speaking in national and international meetings. I can speak that from personal experience as recently I was asked to help in an industry sponsored research to test a new equipment, in which the data was completely held by the industry and the chief investigator had significant contribution to decision making which effects protocols throughout the country. I refused to take part. I also know from personal experience that all ‘breast screening’ guidelines in this country are made by people who work in the screening set up with clear gains from screening to continue, even though resources are scarce and are taken away from genuine symptomatic women who wait for weeks to be seen by a breast radiologist. There is never a healthy debate about the pros and cons of screening healthy women for breast cancer in national meetings. We are in an age of over diagnosis, over treatment and turning healthy people into patients.
There are few steps that could be taken. Firstly, there should be a strict universal policy to have a clear display of conflict of interests before any presentations/ published materials with key findings, especially those that could influence public and medical opinion. Secondly, experts involved in drafting guidelines on a particular topic should not have financial or non-financial gains from the outcome of those guidelines. Thirdly, industries interested in testing new equipment/drugs should contribute to a public body, from where there should be blinded allocation to a research team for an non-biased testing of these new equipment/ drugs. There should be no direct contact between industry and healthcare providers.
Competing interests: No competing interests
Dear Editor,
On behalf of Formindep, a French non-profit organisation aiming at better formation and information in health, especially regarding conflicts of interests and misleading influences from the commercial sector, we wanted to thank the BMJ for this call to action for more independence, and the different suggestions gathered in this text that we fully support.
We would suggest completing the chapter on education, here focused on continuous medical education, with initiatives in medical schools and teaching hospitals:
1) Implementation of strong conflicts of interests policies in medical schools and teaching hospitals
The toolbox developed as early as 2002 by the Just Medicine (fka Pharmfree) campaign of the American Medical Students Association (AMSA) could be adapted and used in other countries.
The annual scorecard of medical schools started in 2007 in the USA with great results (1). Progress was made possible by the media pressure exerted by this ranking, as well as the AMSA students’ commitment, highly involved in their local medical schools.
So far, this ranking has been replicated in Australia in 2011 (2) and Canada in 2013 (3) , but for a unique edition, without much support of the local medical students representatives, so in both countries the initiative did not reach the impact observed in the US. It has also been conducted in France (4) and Germany (5), always on the AMSA model. In France, the adapted score card and the campaign were an initiative of Formindep (the French No Free Lunch group) which gained the support of the national medical students association (ANEMF). In Germany the initiative came from the students themselves. In both countries this exercise will be done over the years. The first score card for all Belgian medical schools should be published in January 2020, and similar projects are ongoing in Italy and Spain. It is also worth noting that the International Federation of Medical Students Association and the European Medical Students Association expressed publicly their support to the implementation of strong conflic of interests (CoI) policies, among other changes in medical education (6-7).
In November 2017, the French Deans’ Conference of Medicine published a 14 pages Code of ethics presenting its proposals on scientific integrity and the management of conflicts of interest (CoI). This code is in our view one of the most advanced CoI policies for medical schools, our association translated it in English to help share it more easily (8).
As medical education is done for a large part in teaching hospitals, Formindep drafted a dedicated scorecard and ranked the French major teaching hospitals for the first time this year. AMSA again inspired this scorecard, although the outcome of the US initiative is unclear. The paper was published in November 2019 (9) and gained national and local coverage. However, unlike Deans, hospital administrations have not yet responded with either statement or action.
2) Use of the AMSA Pharmfree Curriculum (or equivalent) in medical schools.
AMSA also developed a global Pharmfree curriculum (10) defining the competences to be taught, the calendar, the faculty, the pedagogy. This is in our view the most complete instance of a medical students training about this issue. For French speakers, Formindep translated it also in French (11). The French Dean's code of Ethics explicitly endorsed it.
3) Teaching resources
Teaching material is readily available. The World Health Organisation (WHO) and Health Action International (HAI) published in 2009 a manual, still useful : Understanding and responding to pharmaceutical promotion, currently available in English (12) and French (13). A powerpoint presentation of the manual is available online (14).
HAI published in 2016 a shorter update of this manual, under a creative common license, with a part centred on the European Union regulation Fact or Fiction: What Healthcare Professionals Need to Know about Pharmaceutical Marketing in the European Union (15). HAI published also two free online webinars on the issue (16).
There must be instances of such teachng sessions in English and other languages. For French speakers, the most advanced course is Facripp (Formation on the critical analysis of pharmaceutical promotion), a 14 hour course given to General Practice residents in Bordeaux medical school, based on the WHO/HAI Manual, and the AMSA Pharmfree Curriculum. Facripp has now been integrated in other medical schools curricula (Brest, Paris V, Poitiers).
A shorter e-learning training has been developed so that it could be used for medical and pharmacy students, residents of other specialities. The faculty leading this program are willing to share all the resources they are using for this course (contact : Marco Romero – General Practice Department – Bordeaux medical School – marcodanielromero@gmail.com
Facripp Video presentation https://www.youtube.com/watch?v=0VvERSOchmA).
1. https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-016-0725-y
2. Mason PR, Tattersall MHN, Conflicts of interest: a review of institutional policy in Australian medical schools. MJA, 2011, 194: 121–125
3. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0068633
4. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0168258
5. https://www.biorxiv.org/content/10.1101/809723v1
6. https://ifmsa.org/wp-content/uploads/2019/09/AM19-Integrity-and-transpar...
7. https://emsa-europe.eu/wp-content/uploads/2019/05/Policy-Statement-Confl...
8. http://formindep.fr/wp-content/uploads/2017/11/Charte-Faculte%C3%ACs-Ver...
9. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0224193
10. https://www.amsa.org/wp-content/uploads/2015/03/ModelPharmFreeCurriculum...
11. https://formindep.fr/wp-content/uploads/2016/07/Curriculum-AMSA-VF1.pdf
12. https://haiweb.org/wp-content/uploads/2015/05/Pharma-Promotion-Guide-Eng...
13. https://www.has-sante.fr/upload/docs/application/pdf/2013-04/comprendre_...
14. https://haiweb.org/wp-content/uploads/2016/11/Understanding-and-Respondi...
15. https://haiweb.org/wp-content/uploads/2016/10/Fact-or-Fiction-1.pdf
16. https://haiweb.org/what-we-do/pharmaceutical-marketing/understanding-pha...
Competing interests: No competing interests
Dear Editor,
The BMJ issue on commercial interests in health in very timely.
Last week 43 organisations including patients, consumers, doctors, payers, HTAs and public interest organisations, wrote to the European Commission to express their views on the “European Partnership for innovative health (Horizon Europe programme) – 2021 - 2027” (https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2019-49...).
Under the future Partnership between the European Commission and the healthcare sector industries, a considerable amount of public funds will be allocated to health research and innovation projects. Strong stewardship by the Commission, from inception to implementation, is crucial to ensure that this large investment serves the public interest.
Numerous evaluations of the previous health partnership, the Innovative Medicines Initiative (IMI), have criticised the lack of inclusivity in the choice of research priorities, the governance structures and the dominance of large industry players, and have warned that scientific advisory groups have “no significant influence” on shaping the agenda. The European Commission should be seeking to reform the next partnership to ensure health authorities, academics, public health professionals and civil society organisations are robustly engaged in agenda setting, rather than taking a step backwards and entrenching the dominance of commercial interests.
A lack of transparency around funding, beneficiaries, governance, data and results, as well as a lack of alignment between industry’s research priorities and the public interest, has resulted in questionable output for public healthcare systems and the use of public money.
The signatories call on the European Commission to safeguard that the public interest is at the core of the future European Partnership on Innovative Health by ensuring:
1. Priority Setting driven by public health needs
2. Transparent, balanced and inclusive governance structures
3. Public return on public investment and ensuring equitable access to publicly funded R&I
4. Full transparency on R&I investments
5. Open science
6. Sensitive health policy issues to be discussed in inclusive multi-stakeholder platforms with strong stewardship from public authorities
Read the full letter and more details about the proposal here: https://medicinesalliance.eu/wp-content/uploads/2019/12/Letter-future-He...
Competing interests: No competing interests
Dear Editor,
We would like to congratulate the authors for gathering evidence on the risks due to lack of independence in research and development into health care. We represent the European Organisation for Research and Treatment of Cancer (EORTC) a not for profit cancer clinical research organization with primary mission to improve survival and quality of life of cancer patients. EORTC runs independent multidisciplinary clinical research activities optimizing therapeutic strategies, and contributes to pushing forward the standards of care.
EORTC would like to further emphasize issues related to independent clinical research. Through the publication of an EU Manifesto developed with the EU parliament and supported by many organizations, EORTC is alerting on the challenges which are met to deliver independent knowledge and therapeutic progress based on clinically relevant end-points which matter for the patients and health care providers. The poor external validity of regulatory datasets in hyper selected patient populations and concluding based on surrogate end-points often leads to unconfirmed innovation. Ill-developed agents reaching healthcare systems create confusion on how best to use treatments when their costs are over estimated. Questions such as optimal duration of immuno-oncology agents remain undocumented leading potentially to over treatment with very expensive agents. At the same time the commercial sector is disincentivized to pursue research in the post marketing phase while many questions do remain such as documentation of clinically meaningful end-points, optimal duration, exact dose, optimal targeted population due to lack of appropriate biomarker and assays clinical validation and utility, combinations etc…as well as addressing rare tumor types.
Absence of support by the commercial sector, insufficient public funding and expensive drugs impact on the capacity of non commercial sponsors to optimally deliver datasets which have the potential to inform health care systems. EORTC is therefore calling for revisiting the process of drug development into health care systems, re-engineering a structural balance between commercial and non -commercial clinical research. Possible routes are to identify early on in the development of new agents, clinically relevant questions which will inform health care, and empower non commercial organizations to deliver independent evidence how to integrate new agents in existing strategies based on clinically relevant end-points but also potentially to de-escalate or decommission irrelevant and duplicative treatments. Another possible route, is to identify first clinical needs and mandate research to meet such needs. The 2 routes are not mutually exclusive and require a re-organisation of the respective roles of stakeholders in the continuum of drug development into health care systems. The latter potentially stimulates true innovation avoiding multiplicity of me-too agents, often purely developed for a manufacturer to develop own pipeline combinations.
Unless pathways of development into HTA and access are substantially revisited, we remain with drug centered, not patient centered, systems. At the time when Europe is setting up a cancer mission, it would be critical that it focuses on such needs. It could establish models to be implemented in other fields of medicine. It would optimize the use of public money for a patient and citizen oriented mission.
Competing interests: No competing interests
Re: Pathways to independence: towards producing and using trustworthy evidence
Dear colleague Ray Moynihan,
I fully adhere to the efforts of your team exploring pathways to build an evidence base for healthcare that is free of commercial influences. It is a critical dilemma; financial support of research by industry is vital for advancing medical care, but it is crucial that the researcher’s judgments remain independent to eliminate commercial bias.
The problem is due to the direct financial relationship between both sides that have different ethics. We need to think about a funding system of biomedical research that allows indirect support by pharmaceutical and device companies through a world-financial intermediary agency. This could be a kind of world “bank”, funded by governments and pharmaceutical companies. Submitted research proposals would be reviewed and eventually approved to be funded through this bank. The companies that are shareholders will have the right to purchase patents through this bank.
This idea requires more discussion and details, including legislators and policy makers, in order to be translated into a concrete initiative. The aim is to create a “double-blind” funding system of biomedical research that maintains the support of industry and preserves the researcher’s integrity and independence. Moreover, this global funding system may eventually help researchers from all the world to have a best access to research funds. This could be a source of the pluralism of ideas and innovation.
Biomedical research and industry influence: some jasmine thoughts
Bouzidi R, Kooli M. Orthopedics. 2011 Dec;34(12):932-3. Doi: 10.3928/01477447-20111021-01. PubMed PMID: 22147211.
Competing interests: No competing interests