WHO/HIV/2015.39 © World Health Organization 2015
World Health Organization
Global Hepatitis Programme Guideline development for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B
Management of conflicts of interest
Page | 1
WHO/HIV/2015.39 © World Health Organization 2015
Conflicts of interest were managed as follows: 1. All experts who participated in the process were required to complete the WHO Declaration of Interest (DOI) form before they commenced their work for WHO, and to promptly notify WHO if any change in the disclosed information occurred during the course of this work. The completed DOI forms were reviewed by the WHO Secretariat with a view to managing disclosed interests in the field of viral hepatitis. 2. At the meeting of the Guidelines Development Group in June 2014, a set of slides was projected to all meeting participants, which indicated each expert’s disclosure of his/her declared interests. Hence, the GDG was aware of any existing interests among its members. 3. All declarations of interest were reviewed by the WHO Secretariat. It was decided that all experts could participate in the process but their interests should be disclosed in the guideline. 4. All relevant declared interests are summarized below.
Definition of potential financial conflict of interest At the meeting of the Guidelines Development Group, the Secretariat of the WHO Global Hepatitis Programme considered predominant funding from a single company whose drug was being considered for use in the treatment of HBV (e.g. tenofovir by Gilead Sciences). The interest declared as stated by two Guidelines Development Group members (Tables 1 and 2), Lewis Robert and Anna Lok, posed a potential conflict of interest. However, in the case of Robert Lewis, the funding was for a community based screening project, and unrelated to treatment, and the amount received by Anna Lok from Gilead was less than US$ 30 000 and equivalent to that from other companies. The Secretariat therefore concluded that these experts should not excluded from actively taking part in formulating the recommendations during the meeting. For the peer review group (Tables 3 and 4), the WHO secretariat was satisfied that there had been a transparent declaration of interests and no case necessitated exclusion from the review process. Table 1. Members of the Guideline Development Group who declared no potential conflicts of interest Last Name Aghokeng Block Khatib Khwairakpam Leung Andrieux- Meyer Ocama Qureshi Strauss Sulaiman First Name Avelin F Joan Ahmed Giten Nancy Isabelle Ponsiano Huma Edna Ali Institution Virology Laboratory CREMER/IMPM/IRD (Cameroon) Hepatitis B Foundation (USA) Ministry of Health (Tanzania) TREAT Asia/amFAR (Thailand) ASIAHEP Hong Kong Limited (Hong Kong) Médecins Sans Frontières (Switzerland) Makerere College of Health Sciences (Uganda) Pakistan Medical Research Council (Pakistan) School of Medicine, University of São Paulo (Brazil) University of Indonesia-Faculty of Medicine (Indonesia)
Page | 1
WHO/HIV/2015.39 © World Health Organization 2015
Table 2. Members of the Guideline Development Group who declared potential conflicts of interest Last name Abraham First Name Priya Institution Christian Medical College & Hospital (India) Hospital Edgardo Rebagliati (Peru) Nature of interest Drug resistance project funded by Indian Council of Medical Research Consulting (Gilead, BMS, MSD, Bayer Schering, Pharma) HCV research (Merck Sharp) Amount of income US$ 53 944.782
Davalos Moscol
Milagros
US$ 8 000.00
US$ 3 000.00
El-Sayed
Manal Hamdy Charles
Faculty of Medicine, Travel to conferences (MSD, Roche) Ain Shams University (Egypt) World Hepatitis Alliance (UK) Yonsei University (South Korea) WHA receives funding from 8 competing pharma companies involved in HCV drugs Investigator of clinical trial of HBV antiviral (Gilead, Ildong Pharma); The Korean Association for the Study of the Liver (KASL) support travel Consulting (BMS, MSD, Novartis, Roche) US$ 1 000.00–2 000.00 once a year in the past 4 years US$ 5 000.00
Gore
Han
Kwang Hyub
Jia
Jidong
Beijing Friendship Hospital Capital Medical University (China) Hôpital SaintAntoine, SorbonneUniversités (France)
Lacombe
Karine
Advisory boards (Gilead, BMS)
Research grants (Gilead)
US$ 15 000.00
Lesi
Olufunmilayo University of Lagos and Lagos University Teaching Hospital (Nigeria) Anna
Conference travel (Roche, Gilead), flight and hotel (one-time events)
Lok
University of Michigan Consultlant, research grants (Gilead, and American GSK, Merck, Roche, BMS, Gilead) Association for the Study of Liver Diseases (USA) Alaska Native Tribal Health Consortium (USA) Mayo Clinic (USA) Consultation, funding to Liver Disease Program (payment sent to Alaska Native Tribal Health Consortium) Consulting, research grants and speaking honorarium Consultancy on clinical trials in HBV infected patients (BMS)
US$ 100 000.00
McMahon
Brian
US$ <5 000.00
Roberts
Lewis
US$ 197 000.00 (161 494.80 from Gilead)
Thursz
Mark
Imperial College Faculty of Medicine (UK)
€1500.00
Page | 1
WHO/HIV/2015.39 © World Health Organization 2015 Honorarium for speaking at industry sponsored symposia (BMS) Yurdaydin Cihan University of Ankara Medical School (Turkey) Advisory board member (Gilead, Merck, Janssen) Speaker’s bureau (Gilead, Roche, Merck) BMS (research unit)
€2 500.00 €4 000.00 €4500.00 €30 0000.00
Page | 1
WHO/HIV/2015.39 © World Health Organization 2015 Table 3. Members of the Peer Review Group who declared no potential conflicts of interest Name Serge Eholié Samuel So Nikoloz Chkhartishvili Mihai Voiculescu Karen Kyuregyan Jude Byrne Gilles Wandeler Adele Benzaken Aaron Harris Geoff Beckett Shaffiq Essajee George Siberry Institution Unit of Infectious and Tropical Diseases,Treichville University Teaching Hospital, Abidjan (Côte d’Ivoire) Asian Liver Center, Stanford University (USA) Infectious Diseases, AIDS and Clinical Immunology Research Center, (Georgia) Fundeni Clinical Institute (Romania) Chumakov Institute of Poliomyelitis and Viral Encephalitides (Russia) International Network of People who Use Drugs (INPUD) Department of Infectious Diseases, University Hospital Bern (Switzerland) Ministry of Health (Brazil) Centers for Disease Control and Prevention (USA) Centers for Disease Control and Prevention (USA) Clinton Health Access Initiative (USA) National Institutes of Health (USA)
Table 4. Members of the peer review group who declared potential conflicts of interest Name Vincente Soriano Institution IdiPAZ-La Paz University Hospital & Autonomous University, Madrid (Spain) Nature of interest Research support by Gilead and BMS on Drug resistance and safety profile for tenofovir and entecavir Research support for clinical trials on HBV, including provision of free PEGinterferon; by Merck, BMS, Novartis and Gilead Sciences Amount Undisclosed
Seng Gee Lim
National University of Singapore (Singapore)
Mark Sonderup
David Muljono
University of Cape Town and Groote Schuur Hospital (South Africa) Eijkman Institute for Molecular Biology, (Indonesia)
Travel support by Roche to attend liver meeting Support for research reagents (for research unit given by Indonesian Ministry for Research and Technology); funding to research unit for operational cost of professorship by the Indonesian Academy of Sciences and the Royal Netherlands Academy of Arts and Sciences Consulting, research support, and travel by Flamel, Janssen, Roche, and BMS
Provision of free PEG-interferon for 248 patients for 1 year US$ 250 000; Provision of free drug supply of tenofovir for 132 patients for 2 years US$ 350 000 US$ 4 000.00
US$ 20 000.00 for research reagents, €12 000 for operational cost of professorship
Christian Trepo
INSERM - UCBLYON1 (France)
Undisclosed
Page | 1