Action Plan Transparency Commission

Action PlanTransmission Commission

Mondher Toumi

Jacques Bedoret

• Targetted members

• Rationale for meeting

• Strategy

• Participants

• Organized by

• When

• Comments

Chairman and Vice-chairpersons

Rationale for meeting Strategy Participants Organised by When Comments

G. Bouvenot Understand his philosophy

MTO, Biot, SYGO

Biot Before

Jacques Massol Professor of therapeutics, pragmatic and open. Official objective of meeting = discuss protocol of planned observatory. Speaker in Sciences Po seminar

Get his adhesion Biot, SYGO Biot One month One pre-meeting MTO, SYGO, Biot (outcome) Two meetings FIRST ? open

Claire Lejeune Vice chairwoman. Influential. Could be seen by MTO if desired.

Get : - adhesion - advice

MTO Moore

MTO One month Member Serdolect board

Member Rationale for meeting Strategy Participants Organised by When Comments F. Berthezène Professor of diabetology with background in

cardio. Previously in AMM commission, tough and demanding. Vocal in commissions.

Disarm soft Biot Biot One month

Valérie Bivas Generalist, not very experienced in practice, generally suspicious of industry. Husband was former policy adviser to Barrot.

Disarm soft Biot Biot One month

E. Autret Leca Interest for pharmacovigilance sevrage One month SYGO investigates with Jaillon and Jolie

B. Falissard Methodologist, x Answer his questions

MTO MTO Continuously Trainee working for MTO

M.Molimard Pharmacologist, fundamentalist Action S Moore MTO/ind

MTO Before TR

Michel Petit Known to be unfavourable and stiff, generally unfavourable to industry, contributed heavily to previous negative ruling. Specific channel

- Politic - Sc

Z JABE Before TR JABE tel Z Political message important

JM Vetel Gerontologist. Interested in use of all products in old-old patients. Demanding in terms of clinical demonstration. Was in previous commission

- ? interactions - relais +

SYGO SYGO Before TR

Patrick Wierre Pharmacist, previously in OCT commission, interested in restructuration of pharmaceutical distribution. Member of a pharmacy grouping

Awareness + Biot Biot Before TR

MC Woronoff Lemsi

Hospital pharmacist, one of the few in France believing in health economy, very professional and knowledgeable. Speaker in Sciences Po seminar

Awareness + Biot Biot Before TR

NB : we are evaluating various ways to make it politically more comfortable for Mr. Bouvenot

Member Rationale for meeting Strategy Participants Organised by When Comments A. Cariou Reanimation O. Chosidow Dermato D. Duboc Cardio D. Giullemot Internal metodo C. Jorgensen Rheumato MA Koenig Loiseau Gyneco F. Tremolières Infectologie O. Wong SYGO GP. Will be checked by SYGO in

Trade Union and interaction, Bivas, Flahault

Deputy-members Rationale for meeting Strategy Participants Organised by When Comments JN Fissinger A. Gompel A. Flahault P. Verpillat Indirect N. Danchin D. Pouchain MTO Why (-) vs Hlu F. Courteille AFSSAPS internal reviewer

Rationale for meeting Strategy Participants Organised by When Comments

Brigitte Messan-Murphy

Full briefing on dossier Biot Biot

We are still considering how to approach the non-voting members of the transparency commission representing the various administrations.

Back-up

Name, city of residence and other pertinent

information

Functions and Specialisations

Areas of Interest/Influence/Network

Publications/Education

Professor Elisabeth Autret-Leca

Tours, France Married

Director of the Regional Centre of Pharmacovigilance and Medication

Information of Tours (Centre Régional de Pharmacovigilance et

d'information sur les médicaments de Tours), a part of the University of Tours Hospital.

Director of the Clinical

Investigation Center of Tours (part of the Inserm-Hôpitaux

network)

Head professor, Department of Pharmacology, University of

Tours- François Rabelais

PROFESSOR AUTRET-LECA’S PRIMARY AREA INTEREST IS

PHARMACOVIGILANCE

Member of the editorial board of the journal AFSSAPS Pharmacovigilance

(bulletin Pharmacovigilance de l’ AFSSAPS)

Reviewer for the journal

PRESCRIRE 2002

1981-2003 : Numerous articles

in Pubmed


information




Professor François Berthezene

Lyon, France

Hospital Practitioner, Head of the Department of

Endocrinology and Metabolic Illnesses

and of the Laboratory of Lipid Metabolism Hôpital de l'Antiquaille – Lyon

Professor/Lecturer Claude Bernard University

Lyon , France

Director of a Research group attached to the Federated Institute

of Endocrinology Research (Institut Fédératif de Recherches

en Endocrinologie) Lyon,

France

ENDOCRINOLOGY , METABOLISM, CARDIOLOGY

Member of the Board of Directors and

the Scientific Committee of the Arteriosclerosis Association of France (Société Francaise d'Athérosclérose)

Co-Author of the ANAES 1997 report:

Diagnosis and treatment of arterial hypertension (non-cause) in adults aged

20 to 80.

Supported Marie Comparini (UDF) - candidate for the Chamber of Deputies from metropolitan Lyon (Elected 2002).


information




Dr. Valérie Bivas MD

Resides in the metropolitan Paris area

GP – in private practice

General Practitioner

Worked with Sanofi (adverse effects of

molecules under study)

Worked with the Agence du médicament as inspector of clinical effects

Masters Degree awarded in

1992 by the University of PARIS 5 COCHIN Thesis: Cardiac and

encephalitic side effects of 5-flurouracile and cisplatine

chemotherapy.


information




Professor Gilles Bouvenot

PRESIDENT OF THE TRANSPARENCY COMMISSION

Marseille, France

Hospital Practitioner

University Professor

Head of the Department of

Internal Medicine and Therapeutics of Sainte Marguerite

Hospital in Marseille.

Former Vice-President of the AMM (Commission

d’Autorisation de Mise sur le Marché)

President of prescription approval arm of the agence du médicament.


Therapeutics and Methodology of Clinical Trials

School of Medicine, University of Marseille (where he has worked

since 1991)

1991-98 Professor INSERM Unité 21, Villejuif, France

Member of the Faculty of the University of Paris Sud, Villejuif,

France

Has co-authored works with:

Fagnani CEMKA,

Bourg la Reine, France (1997-98) and

Doctor DidierGUILLEMOT (JAMA 1998)

Co-author of the report “Outpatient prescription and use of antibiotics”

AFSSAPS 1998 (Bouvenot, Guillemot, Pouchain, Tremolieres, Wong et al.)

1968-2003 :

Numerous articles in Pubmed


information




Dr Alain Cariou MD

Paris

Hospital Practitioner – Master

Lecturer

1998-2003 Hôpital Cochin -

Medical Intensive Care Unit and Cochin Institute of Molecular

Genetics

1997 Hôpital Bichat-Claude Bernard - Cardiology

CARDIAC INTENSIVE CARE UNIT

Masters Degree in Medicine

Awarded in 1995 by The University of PARIS 13

Thesis: The influence of gender in the

treatment and prognosis of acute myocardial infarction.


information




Professor Olivier Chosidow MD

Paris -


Hôpital Pitié-Salpêtrière

2002-2003 Department of Dermatology

Hôpital Pitié- Salpetrière, Paris

2001, member of the evaluating committee of medical instruction

at the School of Medicine, Pitié Salpetrière (Jussieu). Paris

1999 Assistant Professor,

Dermatology Hôpital Pitié- Salpétrière, Paris

1994-2002 Internal Medicine,

Hopital Pitié- Salpetrière, Paris

1990-1994 Department of Dermatology

Hôpital Henri Mondor Créteil, France

1989 Department of Clinical Pharmacology, Hôpital de la

Salpetrière, Paris

DERMATOLOGY – INTERNAL

MEDICINE

1986-2003: several articles in

Pubmed

2 books published about Acne and its implications in daily life

and Clinical Cases in Dermatology

Masters Degree in Medicine awarded by the Univeristy of

PARIS 7-BICHAT in 1987 Thesis: Cutaneous sclerodermiforme

manifestations resulting from the chronic reaction of a graft to

its host: an observation of six cases.


information




Frédéric Courteille Non-voting member of the Commission

Reviewer for the National

Commission of Pharmacopoeia

Articles cited in Pubmed.

BARDAT, A., J. BIGUET, E.

CHATENET, AND F. COURTEILLE. 1993.

Moisture measurement: a new method for monitoring freeze-drying cycles. J Parenter.Sci

Technol. 47: 293-299.

FATOME, M., F. COURTEILLE, J. D. LAVAL,

AND V. ROMAN. 1987. Radioprotective activity of ethylcellulose microspheres

containing WR 2721, after oral administration. Int J

Radiat.Biol Relat Stud.Phys Chem Med 52: 21-29.

Name, city of residence and other

pertinent information




Professor Nicolas Danchin

Non-voting Member of the Commission

Paris


Hôpital Européen Georges Pompidou


2001-2003 Department of Cardiology

Hôpital Européen Georges Pompidou 75908 Paris.

1987-2001 University of Nancy-

Brabois Hospital. Department of Cardiology

Vandoeuvre-les-Nancy, France

General Secretary of the French

CARDIOLOGY Association

Member of the CardiaBase Expert Scientific Committee

http://www.cardiabase.com/en/expertise.asp

1980-2003 : articles in Pubmed, including JAMA and

the Lancet


information




Professor Denis Duboc MD, PhD. Age 47

Resides in Paris


Hôpital Cochin


1987-2003 : Attached to the Cardiovascular Unit, Hôpital

Cochin, Paris

1991 INSERM U 153, Paris

1990 Attached to the Cardio-surgery Department, Hopital

Broussais, Paris

1988 INSERM, Unité 13, Hôpital Claude Bernard, Paris

PRINCIPAL AREA OF INTEREST :

CARDIOLOGY AND GENETICS

Member of the Scientific Committee of Orphanet

Member of the EUROMEN (European

Muscle Envelope Neuropathies) Project, an Association of Victims of Muscle

Diseases

1985-2003 : several articles in Pubmed, four of which have

appeared in The Lancet

PhD awarded by the University of Paris 5 - COCHIN in 1984.

Thesis: Ventricular repolarisation anomalies observed during surgery

Name, city of residence and other

pertinent information




Dr Bruno Falissard MD, PhD.

Born 17 October 1961 Resides in Bordeaux, France

Married, 3 children Enjoys Playing the piano, fencing,

running (marathon), wine, role-play games

Personal HomePage

http://perso.wanadoo.fr/bruno.falissard/


Professor of Biostatistics

Senior Psychiatrist, Hôpital Robert Debré, Paris, department of child and

adolescent psychopathology

PSYCHIATRY

BIOSTATISTICS AND METHODOLOGY

1982

Graduate of Ecole Polytechnique, age 21

1989-2003 : numerous articles in

Pubmed

Masters Degree in Medicine (Psychiatry) awarded in 1995 by

the University of Paris 5 -NECKER

PhD. In Biostatistics

Thesis: Interim Analyses in Clinical Trials

Works Published 2001 Measuring Subjectivity in Health : A Methodological and Statistical Approach / Bruno Falissard (Masson)

2001 Introduction to Statistics: A Multimedia course / Bruno Falissard. - Version PC. University Hospital Kremlin Bicêtre : School of Medicine

2001 Statistical methods for measurement of subjective variables in health : 11-13 juin 2001, Paris / Bruno Falissard, Mounir Mesbah, I. Wouter Molenaar (INSERM)

1998 Falissard, B. (1998) Comprendre et utiliser les statistiques dans les sciences de la vie, 2° édition / 3° tirage, Masson, Paris (314 pages).


information




Professor Jean-Noêl Fiessinger

Paris

non-voting Member of the Commission

Hospital Practitioner Univeristy Professor


Vascular Medicine and Arterial Hypertension (Groupe Hospitalier

Broussais Pompidou)

President and Medical coordinator of the Clinical

Investigation Centre (Centre d'Investigation Clinique) of

Broussais Hospital

1990-99 Attached to the Claude-Bernard Centre for Peripheral Vascular

Disease Research Department of Vascular Medicine, Hôpital Broussais, Paris, France

2001-2003

Attached to the Department of Vascular Medicine, Hôpital

Européen Georges Pompidou 75908 Paris, France

VASCULAR MEDICINE

Member of the Scientific Committee of

the journals : Revue du Praticien

and La Revue du Praticien-Médecine Générale

2001 President of an October 2001 AFSSAPS working group on Aortic endoprostheses used in endovascular

treatment of sub-renal abdominal aortic aneurisms

2001 Member of the French Academy of

Medicine (26 June 2001)

1998 Co-founder with Henri Boccalon of the Collège des Enseignants de Médecine

Vasculaire (CEMV)

1974-2003 : numerous articles in Pubmed

Books Published:

Diseases of the Arterial Wall - Camilleri, Jean-Pierre /Berry, Colin L. /Fiessinger, Jean-Noel

Publisher: Springer Verlag Published 1989


information




Professor Antoine Flahault Non-voting Member of the Transparency

Commission

Paris

University Professor – Hospital

Practitioner Tenon Hospital, Paris

Head of the Epidemiology and

Information Sciences Department

Teaching Professor and Researcher in biostatistics,

applied computerised medicine and communication technologies.

Member of the faculty of INSERM since 1988

Director of the Sentinelles

network at Inserm

Director of a affiliated OMS centre studying the electronic

surveillance of patients.

EPIDEMIOLOGY AND BIOSTATISTICS

1988-2003 :

Numerous articles in Pubmed


information




Professor Anne Gompel

Non-voting Member of the Transparency

Commission



Gynaecology and Infertility

Signatory of the petition "Say No to Sexist Advertising! " (NON à la pub

sexiste !") in September 2003

Member of the Committee for the Defence of Medical Gynaecology for

Women’s Health

1998: reviewer for ANAES

1979-2003 :

numerous articles in Pubmed


information




Dr. Didier Guillemot MD

Paris -

Doctor and Researcher

Institut Pasteur and

INSERM 1999-2001 INSERM U258,

Villejuif, France. 1994-1999 INSERM U21,

Villejuif, France. 1992 Attached to the Department of Internal Medicine, University

Hospital Bichat, Paris

Doctoral Lecturer “Epidemiology, Social Sciences and Public Heath” (Epidémiologie Sciences Sociales

et Santé Publique) Institut Pasteur, Paris

INFECTIOUS DISEASES–

EPIDEMIOLOGY



1992-2003: Several articles

cited in Pubmed

Masters Degree in Medicine awarded by the Univeristy of PARIS 5-COCHIN in 1997. Thesis: Interns in Medicine

confronted by AIDS: Perceptions and attitudes in

France, The United States and Canada 10 years after the

beginning of the epidemic of infection by the HIV virus.


information




Professor Christian Jorgensen

Montpellier -

Hospital Practitioner Hôpital Lapeyronie

2001 Attached to the department

of Immuno-rheumatology Hôpital Lapeyronie,

Montpellier

1991-1996 Attached to the department of Immuno-

rheumatology, Centre Gui-de-Chauliac, Montpellier

1988 Attached to the Department

of Rheumatology, Hopital Notre-Dame de Bon

Secours, Paris

IMMUNO-RHUEMATOLOGY

Member of APET UNICE, The National Pedagogic Association for Therapeutic

Instruction.

1988-2003:

some articles in Pubmed

Masters Degree in Medicine awarded by the University of

Montpellier 1 in 1996. Thesis:

Implication of the lymph system associated with mucous

membranes in the immunopathology of

polyarthritic rheumatology


information




Dr. Marie-Agnès Koenig-Loiseau

Resides in the metropolitan Paris area


Hôpital Louis Mourier

GYNAECOLOGY AND OBSTETRICS


information




Pr Claire Le Jeunne

VICE PRESIDENT OF THE TRANSPARENCY COMMISSION

Paris

Existing Member of the previous

Transparency Commission


Hôpital Georges Pompidou-Broussais

University Professor -

Professor and Member of the Executive Board of the School of

Medicine, University of Paris -NECKER

1987-1996 Attached to the

Department of Internal Medicine and Therapeutics

Hôpital Laennec, Paris

2000 Attached to the Center for the treatment of Migraines and

Headache Hôpital Laennec, Paris

2001 Attached to the Department

of Internal Medicine and Therapeutics

Hôpital Européen Georges-Pompidou, Paris

ENDOCRINOLOGY-METABOLISM MIGRAINE and CEPHALIC

ILLNESSES

Member of the Scientific Committee of the journal CONCOURS MEDICAL

Member of APET UNICE, The National Pedagogic Association for Therapeutic

Instruction.

Co-author of the AFSSAPS study: Good Therapeutic Practice: Medications

that induce ovulation June 2003 (Bouvenot, Petit, Le Jeunne,

Tremolieres , Wong et al.)

1984-2003: several articles in Pubmed


information




Professor Jacques Massol

VICE PRESIDENT of the TRANSPARENCY COMMISSION

Besançon, France


University of Besancon Hospital J. Minjoz


2003 Head of the Commission for the Science of Medicine of the Direction Générale de la Santé


Department of Endocrinology and Diabetes, J. Minjoz Hospital,

Besançon, France

1988-1990 Attached to the Department of Pharmacology,

School of Medicine Hospital Pitié-Salpétrière, Paris, France

ENDOCRINOLOGY AND

DIABETES

DGS Direction Générale de la Santé ANDEM National Agency for the

development and evaluation of medicines (Agence Nationale pour le

Développement de l'Évaluation Médicale),

ANAES, National Agency of Health Evaluation and Accreditation (l'agence

nationale d'accréditation et d'évaluation en santé)

AFSSAPS : Agence du Médicament

2002 Member of the Scientific Committee of the 4th International

Conference on Hospital Quality (4èmes Journées Internationales de la Qualité

Hospitalière)

1993 Member of the Association Pédagogique Nationale pour

l'Enseignement de la Thérapeutique (APNET)


Pubmed


information



Publications

Professor Mathieu Molimard MD 41 ans

Bordeaux :



Head of the Pharmacotoxocology Unit and Fundamental

Pharmacology Department of Pharmacology -

Victor Segalen University Bordeaux


Department of Pharmacology University Hospital Pellegrin-Carreire, Bordeaux, France.

1992-1995 Attached to Laboratory of Pharmacology, School of

Medicine, University of Paris West

Paris, France 1990-1994 Attached to the Department of Pulmonary

Diseases, Saint-Louis Hospital, Paris

1993 Attached to the Laboratory of Cordeliers Biomedical Institute

Paris, France

Former Intern - Hôpitaux de Paris

Former Head of Clinic – Pulmonary Diseases

PULMONARY DISEASE

Co-Author with and Colleague of Nicholas MOORE (8 publications)

1990-2003 : several articles in Pubmed

Masters Degree in Medicine awarded in 1990 by the University of Paris 6 -

PITIE SALPETRIERE Thesis: The mechanism of action

of bradykinin on respiratory tract sensitivity


information



Publications

Professor Michel Petit

Rouen, France

Existing Member of the previous Transparency Commission

Director: Schizophrenia Research Group (GRS – Hospital and

University Biomedical Research Group)

Rouvray Hospital Sotteville-lès-Rouen, France

PSYCHIATRY

EVIDENCE BASED MEDICINE

Edouard Zarifian

Co-author of the AFSSAPS study: Good Therapeutic Practice: Medications

that induce ovulation June 2003 (Bouvenot, Petit, Le Jeunne,

Tremolieres , Wong et al.)


Pubmed

Co-Author of the book “Deciding to Treat: Evidence based

Medicine”.


information



Publications

Dr. Denis Pouchain MD

Vincennes, France (a suburb of Paris)

Non-voting Member of the Transparency Commission

General Practitioner in Vincennes

and Lecturer at the University Hospital of Créteil, France

Honorary President of the CNGE : National College of

Teaching General Practitioners

Official representative of France at the European General Practice Research Workshop (EGPRW).

EVIDENCE BASED MEDICINE

Co-Author in October 2001of the PAAIR

report “Outpatient prescription of antibiotics for Respiratory Infections”,

financed in part by GSK.



1998 Member of the Comité d’Orientation de l’Observatoire [

Reviewer of the Study : “Outpatient prescription and use of antidepressors”

July 1998 - Agence du Médicament – Director of Pharmacoeconomic

Information Studies, Observatoire National Member of Committee on prescriptions and

medications

BOOK chapter

Pouchain D, Attali C, Butler J. de, Clément G, Gay B, Molina J, Olombel P, Rouy JL. Principes

de médecine générale. in Médecine Générale : Concepts & Pratiques. Paris Masson 1996:5-

9.

Cited in Pubmed including an article published in L’Encéphale (Alzheimer’s disease & Anxiety) and the British Medical Journal


information



Publications

Dr. François Tremolières MD

Resides in metropolitan Paris

1996-2002 Attached to the Department of Internal Medicine

and Infectious Diseases Hospital Group Francois Quesnay

78200 Mantes-la-Jolie, France

INFECTIOUS DISEASES

Co-author of the AFSSAPS study:

Good Therapeutic Practice: Medications that induce ovulation

June 2003 (Bouvenot, Petit, Le Jeunne, Tremolieres , Wong et al.)



1955-2002 : several articles in

Pubmed

Masters Degree in Medicine awarded in 1956. Thesis:

Use of certain steroid hormones in

cellular and tissue equilibrium.


information



Publications

Dr. Jean-Marie Vetel

Le Mans, France


Full-time Hospital Practitioner

Central Hospital Mans, France

Member of the Scientific

Committee assigned to review article 17 of the Law of July 20,

2001 concerning the treatment of elderly patients that have lost

their autonomy and the individual compensation allocated to these

patients.

GERIATRICS ALZHEIMER’S DISEASE

Member of the Board of Directors of

The Western and Central France Geriatric Society

President of the National Association of

Clinical Geriatrics (SNGC)

Member of SYNERPA,- The National Association for the Creation of Private

Residences for the Elderly

Participating Member in ANAES workshops developing recommendations

for clinical practice and diagnosis of chronic adult renal

Solicited as an Expert for the AFSSAPS report on “Outpatient prescription and use of vasodilators” - September 1999

1978-2000 : several articles in Pubmed


information



Publications

Patrick Wierre

Lille, France

Associate Professor – School of Pharmaceutical Sciences and

Biology University of Lille, France

Community Pharmacist

Reviewer for the journal

PRESCRIRE 2002 Has worked with Madame Thérèse

DUPIN-SPRIET (good friend of MTO)

1 Book : A Manual for

Emergency Care and First Aid for Pharmacies. Patrick Rayet,

Jean-Paul Belon, Patrick Wierre... [et al.].

Paris : Masson, 2000

1 article in “Actualités pharmaceutiques” 2003 -

Number 422 : BPOQuiz C. Garat-Chabrot, T. Dupin-Spriet,

P. Wierre, M. Luyckx


information



Publications

Professor Marie-Christine Woronoff-Lemsi

Besançon


University of Besancon Hospital

Head Lecturer

Director of Hospital Healthcare Assurance University of Besancon

Attached to the Department of

Pharmacy, University of Besancon Hospital

Pharmacist (Medical and Pharcoeconomic)

Assistant Secretary and active member

of the French Association of Clinical Pharmacy

Honorary Member of the CNHIM :

National Hospital Center for Medical Information

Hôpital de Bicêtre

Member of SNPHCU : National Association of Hospital and University

Pharmacists

Worked with Glaxo on a study of Zovirax

2003 Assigned the task of reporting on

the use of medications in French Hospitals by the Minister of Health, M

Mattei

1996-2003 : several articles in

Pubmed

Thesis in Clinical Pharmaceutics 1997

The pharmacoeconomics and pharmacotherapy of human

haematopoietic growth factors.


information



Publications

Dr. Olivier Wong MD

Paris


General Practitioner

Co-author of the AFSSAPS study:

Good Therapeutic Practice: Medications that induce ovulation

June 2003 (Bouvenot, Petit, Le Jeunne, Tremolieres , Wong et al.)



Article in the Lancet;

Negotiating decisions with patients

2 works published in the collection « Que sais-je ? », a

University level review available to and read by the general public

Masters Degree in Medicine awarded by the University of Paris 5 - NECKER in 1992

Thesis: Physical Exercise and its role in the regulation of sugar

levels in diabetic patients. (Exercice physique et regulation de la glycemie chez le diabetique)

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Action Plan Transparency Commission

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