The roots of good governance (3)

 High Performance Boards: Improving and Energizing your Governance

Contents:

Part I: The Four Pillars of Board Effectiveness 1

Joanne Marker and Board Service 3

Chapter 1 The Four Pillars of Board Effectiveness 9

The First Pillar: People Quality, Focus, and Dedication 11

The Second Pillar: Information Architecture 14

The Third Pillar: Structures and Processes 15

The Fourth Pillar: Group Dynamics and Board Culture 17

Chapter 2 Governance Challenges around the World 20

Scientific Lessons from Natural Selection 22

What is Transformational Leadership? 23

Should We Trust Leaders? 24

The Governance DNA 26

Chapter 3 The Successful Director: Values and Character 28

Duty of Care 30

Duty of Loyalty 32

Integrity: A Key Characteristic of Board Directors 32

Chapter 4 The First Pillar: People Quality, Focus, and Dedication 35

Quality 35

Focus 38

Dedication 41

Chapter 5 The Second Pillar: Information Architecture 45

How Complete is Your Information? 46

Chapter 6 Board Structures and Processes 50

Processes 51

Committee Structure 52

Board Secretary 53

Lead Director or Vice Chair 55

Chapter 7 Group Dynamics and Board Culture 56

Understanding Group Dynamics 57

Coalitions Within a Board Are Inevitable – and they Feed into Politics 60

Boards Fall into Traps 63

Drawing Strength from the Board’s Potential 66

Developing Self-Awareness 67

Board Culture 69

Part II: Board Failures and Challenges 77

Chapter 8 Four Areas of Board Failure 79

Chapter 9 Risks and Ensuring the Right Board Risk-Philosophy 82

Chapter 10 A Board Member’s Practical Guide to Risk Thinking 85

The Physical Health Check: Technical Risks 86

The Mental Health Check: Behaviours 89

The Strategic Risk Check 93

The Governance Risk Check 94

Chapter 11 Elements of Advanced Risk Techniques for Board Members: From Quants to Cyber 97

The Why and How of Quantitative Risk Assessment for Boards 98

Integration of Risks 101

The Outcome of Risk Assessment 102

Cyber Risk 104

Chapter 12 Crisis Management 107

Crisis as a Turning Point 110

There is Work to Be Done In Peaceful Times 111

Communication Principles 111

Another Powerful Weapon: Gathering Information 113

A Crisis Will Shed Light On Boardroom Fissures 115

Procedure vs. Authenticity 117

Communicate Your Way to Rebuilding Trust 118

Chapter 13 The Four Tiers of Conflicts of Interest 120

Tier-I Conflicts: Individual Directors vs. Company 122

Tier-II Conflicts: Directors vs. Stakeholders 124

Tier-III Conflicts: Stakeholders vs. Other Stakeholders 131

Conflicts of Interest within a Group of Stakeholders 135

Tier-IV Conflicts: Company vs. Society 136

Chapter 14 High-Level Fraud and Active Board Oversight 141

Why Does High-Level Fraud Happen? 143

Injustice 147

Lax Oversight 148

Problematic Culture 149

Financial Illiteracy 151

How to Create an Effective Oversight Environment 152

Preventing Injustice: Broaden the Notion of Conflict of Interest 152

Preventing Lax Oversight: Build Appropriate Frameworks 153

Preventing Toxic Behaviours: Create a Positive Culture 156

Strengthen Board Oversight Expertise with Special Focus on Legal, Compliance, Risk, Fraud, and Financial Reporting 159

Tools For Anti-Fraud Activities: Assessment, Prevention, Detection, and Investigation 160

Assessment 161

Prevention 161

Detection 161

Investigation 162

Part III: Board Best Practices 165

Chapter 15 The Board as a Strategic Asset 167

Five Definitions of Strategy 168

Clarifying the Board’s Role 171

Taking Context into the Mapping Process 174

The Impact of Context on Strategic Views and Roles of the Board 175

The Board’s Ultimate Strategic Significance 176

Chapter 16 A Primer on Finance Essentials for Directors 177

Reading Financial Reports 178

Understanding Ratios to Analyse Operating Strategies 179

Interpreting Between the Lines of Financial Statements 181

How to Identify Red Flags in Financial Statements 182

Implementing Desired Capital Structure 184

Understanding Valuation Fundamentals 185

Making Better M&A Decisions 187

Overseeing Risk 189

Joanne Marker and Board Values at Comfre 193

Chapter 17 Board Leadership and Values 197

Quality Boards Live and Breathe Integrity 198

Which and Whose Values? 199

Board Values vs. Organisational Values 202

Family Values in Business 203

Chapter 18 The Intricacies of Subsidiary/Holding Governance 204

Structures 206

Culture 208

Chapter 19 Fostering Entrepreneurship from the Board 210

‘Best Practice’ Governance vs. Entrepreneurship 211

Boards Should Actively Encourage Entrepreneurship 212

Chapter 20 The Board’s Oversight Framework for M&As 217

Creating a Deal-Making Mindset 218

Seeing the Bigger Picture 220

Staging Deals with Maximum Precision 220

Integration 225

Confronting Litigation Involving M&As 226

Joanne Marker Confronts Failing Board Culture 229

Chapter 21 The Chair–CEO Relationship 233

The Role of the Chair 233

Chairs are Increasingly Active 237

Chair–CEO Dynamics – the Hallmarks of a Productive Relationship 238

Tests of the Chair–CEO Relationship 240

The Ideal Attributes of a Chair 242

Chapter 22 The Board–Management Relationship 244

Supervision 244

Support 246

Blurring the Board–Management Relationship 247

Writing Governance Codes is Easier Than Changing Behaviours 248

Chapter 23 Effective Diversity 251

Diversity is Good . . . But Why; and When? 251

Diversity as a Considered Choice 252

Gender 253

Culture 255

Personality 256

Age 257

Social Background 259

We Have Embraced Diversity . . . Now What? 260

The Chair’s Role in Building and Nurturing Diversity 262

Chapter 24 The Talent Pipeline 265

The Board’s Responsibility for Talent Management 265

The New Talent Dynamic: Culture, Values, Community 268

Chapter 25 Boards and Social Media 272

JP Morgan’s Failed Foray into Twitter Q&A 273

Why Boards Should Understand Social Media 274

What Boards Should Do 276

Chapter 26 Boards and Investors 279

The Move toward Increasing Shareholder Engagement 281

Chapter 27 Managing Stakeholders 283

Shareholders vs. Stakeholders: A Definition 284

How to Identify a Company’s Key Stakeholders 285

The Board Can Be Instrumental in Shaping the CEO–Stakeholders Conversation 285

Anticipating Stakeholders’ Influence and Impact 286

Chapter 28 Stewardship from the Board 289

Building Upon a Rich Cross-Disciplinary Legacy of Thought 291

Psychological, Organisational, and Cultural Influences on Stewardship 291

Steward Leaders Build on their Unique Strengths to Drive Stewardship 292

Steward Leaders Deliver Long-Lasting, Meaningful, and Inclusive Impact 293

Becoming a Steward Leader: What it Takes 295

Stewardship Risks 297

Boards Are Key to Fostering Stewardship 297

Conclusion 299

Wellbeing as a top priority

Wellbeing. Alternative Policy Perspectives

Open access book by Tim Besley et al.

Why not focus directly on increasing measured human happiness? Why not try to improve people’s overall quality of life, as it is subjectively seen by citizens themselves?

Contents:

 Introduction: Making Wellbeing Policies Effective

Timothy Besley & Irene Bucelli

Wellbeing as the Goal of Policy

Richard Layard

Accounting for Consequences and Claims in Policy

Paul Dolan

Weighing the Costs and Benefits of Public Policy: On the Dangers of Single Metric Accounting

Johanna Thoma

Wellbeing in Public Policy: Contributions Based on Sen’s Capability Approach

Paul Anand

Incorporating Wellbeing and Mental Health Research to Improve Pandemic Response

Michael Daly & Liam Delaney

COVID-19 and Mental Health and Wellbeing Research: Informing Targeted, Integrated, and Long-Term Responses to Health Emergencies

Annette Bauer

Health, Wellbeing, and Democratic Citizenship: A Review and Research Agenda

Christopher J. Anderson et al.

Health and Disability Gaps in Political Engagement: A Short Review

Mikko Mattila

The decline of pharma R&D productivity (2)

Science needs to move beyond luck if it is to design better drugs for the brain

The Economist:

Between 2011 and 2020 the likelihood of a drug in psychiatry being approved by the Food and Drug Administration was 7.3%. In neurology it was 5.9%. (The industry average is 7.9%.) As well as being less likely to succeed in trials (see chart), neurology drugs also take much longer, on average, to develop, further decreasing their appeal

According to the Global Burden of Disease project 12 mental-health disorders affect about 970m people. Their prevalence has increased by 48% since 1990 as the population has grown. With more than one in ten people on the planet affected, it is a global problem, although what data are available suggest it is more marked in Western countries (see map).

Pharma, big pharma (8)

 Drug Truths: Dispelling the Myths About Pharma R & D

This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.

TABLE OF CONTENTS

PART I A MATTER OF THE HEART 1

CHAPTER 1 CHOLESTEROL DRUGS ARE UNNECESSARY 3

CHAPTER 2 INDUSTRY IS MORE INTERESTED IN "ME-TOO" DRUGS THAN IN INNOVATION 13

CHAPTER 3 IT TAKES INDUSTRY TOO LONG TO DISCOVER NEW DRUGS 23

PART II THE ROLE OF PHARMACEUTICAL R&D IN HEALTH CARE 39

CHAPTER 4 DRUGS ARE DISCOVERED BY ACADEMIA 41

CHAPTER 5 NEW MEDICINES ADD COSTS BUT LITTLE BENEFIT 50

CHAPTER 6 BIG PHARMA HAS FAILED AND SHOULD LEARN FROM BIOTECH SUCCESS 59

PART III THE PROFIT MOTIVE 69

CHAPTER 7 THE INDUSTRY INVENTS DISEASES 71

CHAPTER 8 NEW DRUGS ARE LESS SAFE THAN TRADITIONAL MEDICINES 79

CHAPTER 9 INDUSTRY SPENDS MORE ON ADVERTISING THAN ON R&D 91

CHAPTER 10 INDUSTRY DOES NOT CARE ABOUT DISEASES OF THE DEVELOPING WORLD 100

PART IV THE FUTURE 109

CHAPTER 11 BIG PHARMA'S DAY HAS PASSED 111

CHAPTER 12 FINAL REFLECTIONS 122

Aquí teniu un resum detallat del llibre "Drug Truths: Dispelling the Myths About Pharma R&D" de John L. LaMattina.

El llibre, escrit per John L. LaMattina, Ph.D., i publicat per John Wiley & Sons, Inc. el 2009 (amb copyright del 2008), té com a objectiu dissipar els mites sobre la R&D farmacèutica. Intenta respondre preguntes com quin valor aporten els nous medicaments a la societat, d'on provenen, quina innovació aporta la "Big Pharma" i com s'avaluen els riscos i beneficis dels medicaments. El llibre busca oferir un relat intern del procés de descobriment de fàrmacs a la indústria, destacant els costos de les percepcions errònies, els alts riscos (econòmics i científics), els èxits en el llançament de nous compostos que salven vides i la decepció quan fallen. LaMattina espera que el llibre ampliï les perspectives dels lectors sobre la importància de la feina en R&D farmacèutica.

El llibre s'estructura en quatre parts principals:

• PART I: Qüestió del cor
• PART II: El paper de la R&D farmacèutica en l'atenció sanitària
• PART III: El motiu del lucre
• PART IV: El futur

Part I: Qüestió del cor Aquesta part se centra en les contribucions de la R&D farmacèutica respecte al colesterol i les malalties cardíaques. S'esmenta la hipòtesi científica intrigant que la infecció per Chlamydia pneumoniae podria tenir un paper en el desenvolupament de malalties de les artèries coronàries, tot i que estudis posteriors no van confirmar el benefici dels antibiòtics per a la prevenció secundària d'esdeveniments cardíacs.

• Capítol 1: Els medicaments per al colesterol són innecessaris Aquest capítol refuta la idea que els medicaments per al colesterol no són necessaris. Es descriu l'estudi LRC-CPPT, que va demostrar per primera vegada que la reducció del colesterol total i LDL amb colestiramina tenia un impacte directe en la reducció de malalties cardíaques. Es relata la descoberta de la compactina per Akira Endo, un inhibidor de l'enzim HMG-CoA reductasa, que va obrir la via a les estatines. Es discuteix l'assaig ENHANCE amb Vytorin (ezetimibe més simvastatina) en pacients amb hipercolesterolèmia familiar heterozigòtica (HeFH), que va mostrar una major reducció del colesterol LDL amb la combinació però cap diferència en l'aterosclerosi de l'artèria caròtida després de 2 anys, malgrat la reducció del LDL. Aquest resultat va generar especulació i articles de premsa que qüestionaven el valor dels medicaments per al colesterol. El llibre conclou que els medicaments per al colesterol són necessaris per reduir les malalties cardiovasculars.

• Capítol 2: La indústria està més interessada en fàrmacs "jo també" que en la innovació Aquest capítol explora el mite dels fàrmacs "me-too" o de seguiment. Un anàlisi va identificar 72 noves classes terapèutiques i 235 fàrmacs de seguiment aprovats als EUA entre 1960 i 2003. El llibre utilitza la història de Lipitor com a exemple d'un fàrmac de seguiment (la cinquena estatina al mercat) que va resultar ser molt important. Es detalla com Pfizer, malgrat un pressupost de R&D modest als anys 80, va invertir en recerca cardiovascular, inicialment centrada en la hipertensió, que va portar a Norvasc i Cardura. Quan van desenvolupar atorvastatin (Lipitor), es va demostrar que tenia una capacitat de reducció del LDL especialment alta. Es destaca la importància dels estudis de Fase 4 (post-aprovació), que sovint van més enllà dels requisits de la FDA per demostrar plenament el valor d'un medicament. Els estudis de Fase 4 amb Lipitor, com TNT, CARDS i ASCOT-LLA, que van implicar desenes de milers de pacients i una inversió de més de 800 milions de dòlars per part de Pfizer, van canviar la pràctica mèdica, demostrant els beneficis de la reducció intensiva del LDL en diverses poblacions (malalts coronaris estables, diabètics tipus 2, pacients hipertensos amb colesterol moderat). Es suggereix que Lipitor pot tenir efectes pleiotròpics addicionals a la simple reducció de lípids. La història de Lipitor il·lustra que un fàrmac de seguiment pot ser molt important.

• Capítol 3: La indústria triga massa temps a descobrir nous fàrmacs Aquest capítol aborda la percepció que el procés de descoberta de fàrmacs és massa lent. Es descriu breument el procés que culmina en la presentació d'una New Drug Application (NDA) a les agències reguladores, que conté una gran quantitat d'informació i sovint requereix aclariments o estudis addicionals. El capítol aprofundeix en la història del desenvolupament de torcetrapib, un inhibidor de la proteïna de transferència d'èsters de colesterol (CETP), basat en la hipòtesi que l'augment del colesterol HDL podria ser anti-aterogènic. El projecte va començar el 1991 a Pfizer i va ser extremadament desafiant trobar un petit molècula capaç d'inhibir aquesta gran proteïna. Es van tamisar centenars de milers de molècules i sintetitzar moltes altres, sense èxit inicialment. Un canvi simple (dissoldre compostos en oli d'oliva) va permetre provar-los en animals i demostrar augments sense precedents del colesterol HDL. El desenvolupament d'una formulació viable per a ús clínic va ser un repte important, resolt amb la tècnica de dispersió assecada per aspersió (SDD), una novetat en la indústria en aquell moment. Els primers estudis en humans (Fase 1/2) van mostrar efectes profunds sobre els perfils lipídics, augmentant el HDL i reduint el LDL. L'interès en torcetrapib va ser alt, sent vist com potencialment revolucionari. El programa de Fase 3 de torcetrapib/atorvastatin (T/A) va ser el més car mai realitzat a Pfizer i potser a tota la indústria, amb un cost esperat de 800 milions de dòlars. Malgrat els resultats positius sobre els lípids, la FDA requeria estudis d'esdeveniments cardiovasculars a llarg termini (estudis d'outcome), ja que el HDL no era un marcador subrogat establert per a malalties cardíaques de la mateixa manera que el LDL. El programa de Fase 3 incloïa estudis d'imatge (ecografia carotídia i IVUS coronària) i un estudi massiu de morbiditat i mortalitat, ILLUMINATE, amb més de 15.000 pacients seguits durant una mitjana de 4,5 anys. No obstant això, el novembre de 2006, l'assaig ILLUMINATE es va terminar prematurament perquè un consell de monitorització de dades (DSMB) va observar un desequilibri en la mortalitat per totes les causes, més alta en el grup T/A. Aquesta història demostra que el descobriment i desenvolupament de nous medicaments és un procés llarg i costós (centenars de milions de dòlars) que pot ser frustrant i decebedor, fins i tot en etapes avançades.

Part II: El paper de la R&D farmacèutica en l'atenció sanitària Aquesta part explora la relació entre la recerca acadèmica i la indústria farmacèutica.

• Capítol 4: Els medicaments són descoberts per l'acadèmia El capítol distingeix el paper de la recerca bàsica realitzada principalment a l'acadèmia i finançada per organismes com el NIH, del paper de la indústria en la descoberta i desenvolupament de nous medicaments. Es presenta l'exemple de Xalatan, un medicament per al glaucoma. La recerca bàsica finançada pel NIH realitzada pel professor Laszlo Bito a la Universitat de Columbia va identificar el potencial de les prostaglandines en dosis baixes per reduir la pressió intraocular. No obstant això, va ser Pharmacia qui va dur a terme el "dur treball del procés de desenvolupament de fàrmacs", incloent la cerca de compostos específics, proves en animals i humans (seguretat i eficàcia), presentació de dades als reguladors i, finalment, l'introducció del producte després de 12 anys i centenars de milions de dòlars. S'il·lustra una col·laboració exitosa acadèmia-indústria amb la història del descobriment d'un inhibidor de la JAK-3 (CP-690,550) per a malalties autoimmunes. La recerca sobre la cadena gamma del receptor d'interleucina 2 (IL-2Rγ) i la mutació JAK3 es va dur a terme a l'acadèmia (NIH, St. Jude Children's Research Hospital, Hospital Infantil de Boston, etc.). Aquesta recerca va proporcionar la base teòrica per desenvolupar un inhibidor de JAK-3. Pfizer va desenvolupar el compost CP-690,550 i va col·laborar amb grups acadèmics (com l'equip del Dr. Dominic Borie a Stanford) per provar-lo en models animals rigorosos de trasplantament de ronyó. CP-690,550 (posteriorment anomenat tofacitinib) es va mostrar prometedor també per a la psoriasi i l'artritis reumatoide.

• Capítol 5: Els nous medicaments afegeixen costos però poc benefici Aquest capítol s'oposa a la noció que els nous medicaments només augmenten els costos sense gaire benefici. Presenta exemples que demostren el valor de l'accés als medicaments:

  • Limitar la cobertura de medicaments per a pacients amb malalties mentals cròniques (esquizofrènia) a Medicaid va augmentar l'ús de serveis d'atenció de salut mental aguts i els costos per al govern, a més d'augmentar el patiment dels pacients.
  • El Projecte Asheville, que va oferir accés gratuït a medicaments receptats i serveis de gestió de cures per a diabètics, va demostrar que la provisió d'atenció integral per a aquests pacients va reduir els costos generals alhora que millorava la seva salut.
  • La introducció de la teràpia antiretroviral altament activa (HAART) per al VIH va conduir a una disminució espectacular dels costos d'hospitalització i un augment significatiu de l'esperança de vida per als pacients infectats pel VIH als EUA [105, esmentat a la llista de referències]. També es detalla el desenvolupament de vareniclina (Chantix/Champix) com a ajut per deixar de fumar. Va ser aprovat amb estatus de revisió prioritària per la FDA en 6 mesos. El llibre assenyala que la seguretat d'un medicament es monitoritza al llarg de tota la seva vida i que, tot i que els efectes secundaris rars poden aparèixer després que milions de pacients hagin estat tractats, el sistema funciona per comunicar aquests riscos.

• Capítol 6: La Big Pharma ha fracassat i hauria d'aprendre de l'èxit de la biotecnologia Aquest capítol aborda el mite que les grans farmacèutiques han fracassat en innovació en comparació amb les empreses de biotecnologia. Utilitza la història del descobriment de Selzentry (maraviroc) per al VIH a Pfizer com a exemple d'èxit industrial. El fàrmac actua bloquejant el receptor CCR-5, imitant una mutació genètica coneguda per conferir resistència al VIH. Els estudis clínics de Fase 2 van mostrar una reducció significativa de la càrrega viral en pacients. S'inclou un relat personal d'un biòleg de Pfizer que destaca l'impacte emocional i motivador de veure pacients beneficiar-se dels nous tractaments per al VIH. El llibre reconeix que hi ha un desig d'accelerar l'aprovació de medicaments importants, però les exigències de dades de seguretat per a les NDAs són més altes que mai, el que implica estudis més grans i llargs, i per tant més temps i cost. Això no significa que la revisió sigui menys rigorosa.

Part III: El motiu del lucre Aquesta part examina diverses crítiques relacionades amb els motius econòmics de la indústria.

• Capítol 8: Els nous fàrmacs són menys segurs que les medicines tradicionals El capítol refuta la idea que els medicaments nous són intrínsecament més arriscats que els tradicionals o els de venda lliure (OTC). Es citen exemples dels perills de l'ús indegut de medicaments OTC, com els productes per a la tos i el refredat en nens petits. Es destaca que l'acetaminofèn i l'aspirina, medicaments OTC comuns, poden causar reaccions tòxiques greus, incloent sagnat intern en el cas de l'aspirina, que probablement impediria el seu desenvolupament si es descobrissin avui. Es presenta la història del desenvolupament dels inhibidors selectius de la COX-2, com Celebrex, que es van buscar com a alternatives més segures als AINEs tradicionals, lliures de la toxicitat gastrointestinal. Searle va invertir molt en aquest programa. La NDA de Celebrex va ser particularment extensa, incloent dades de gairebé 15.000 pacients, molt més que les NDAs d'AINEs anteriors. Celebrex també va ser estudiat per a la prevenció del càncer de còlon en pacients amb poliposi adenomatosa familiar (FAP). No obstant això, després de la retirada voluntària de Vioxx per part de Merck a causa d'un augment del risc cardiovascular (esdeveniments trombòtics), estudis amb Celebrex en dosis altes per a la prevenció del càncer també van mostrar un augment del risc cardiovascular. Una reunió d'un comitè assessor de la FDA va concloure que el risc cardiovascular podria ser un efecte de classe per a tots els AINEs, tant selectius de COX-2 com tradicionals en dosis de recepta. Com a resultat, es van afegir advertències de "caixa negra" a les etiquetes de Celebrex i de tots els AINEs tradicionals per al risc cardiovascular. La història conclou amb relats personals sobre l'impacte positiu de Celebrex en pacients, malgrat els riscos.

• Capítol 9: La indústria gasta més en publicitat que en R&D Aquest capítol compara la despesa promocional amb la inversió en R&D. També discuteix la publicitat directa al consumidor (DTC) de medicaments receptats, assenyalant que la FDA revisa aquesta publicitat per assegurar que no sigui enganyosa. S'utilitza l'exemple del sildenafil, originalment investigat per a la hipertensió, que va resultar efectiu per a la disfunció erèctil (Venut com Viagra). Un estudi posterior va demostrar que el sildenafil també era efectiu per a la hipertensió arterial pulmonar (PAH), millorant la capacitat d'exercici i la funció, i es ven amb un nom i format diferents (Revatio) per evitar confusions. Això il·lustra com la recerca pot portar a noves aplicacions inesperades.

• Capítol 10: La indústria no es preocupa per les malalties del món en desenvolupament El capítol refuta el mite que la indústria farmacèutica ignora les malalties que afecten els països en desenvolupament. Es destaca que les empreses comparteixen experiència i donen medicaments. L'exemple principal és el treball de Merck per erradicar l'oncocercosi (ceguesa dels rius), mitjançant la donació de Mectizan (ivermectin) a tots els que el necessiten des de 1987. Un altre exemple és el desenvolupament de Zithromax (azithromycin) per Pfizer. Tot i que les proves inicials no van ser totalment concloents, la persistència d'un científic i la demostració de l'eficàcia oral van salvar el projecte. Zithromax s'ha utilitzat en programes massius de tractament per erradicar el tracoma, la principal causa de ceguesa infecciosa evitable, amb una dosi única anual. Es mostra l'eficàcia de dues dosis anuals en un estudi de Tanzània. Aquests exemples demostren el compromís de la indústria amb les malalties del món en desenvolupament.

Part IV: El futur Aquesta part contempla el futur de la indústria i la R&D.

• Capítol 11: El dia de la Big Pharma ha passat Aquest capítol aborda la idea que les grans farmacèutiques ja no són innovadores. Es discuteix la recerca en nous fàrmacs per al càncer, incloent les teràpies dirigides i la immunoteràpia. Es mencionen exemples com els inhibidors de l'angiogènesi (Avastin, Sutent), que bloquegen el subministrament de sang als tumors. Es destaca la recerca en immunoteràpia, com el bloqueig de CTLA-4 amb anticossos (tremelimumab, ipilimumab), dissenyats per reactivar el sistema immunitari contra les cèl·lules tumorals. Es presenta un exemple d'un pacient amb melanoma metastàtic que va respondre bé al tremelimumab. S'assenyala que la immunoteràpia per al càncer encara és en etapes inicials, però hi ha resultats prometedors. El llibre també assenyala que la disminució de noves sol·licituds de fàrmacs (NDAs) en els últims anys es deu, en part, a l'augment de les exigències de dades de seguretat per part dels reguladors, cosa que allarga els estudis de Fase 3.

• Capítol 12: Reflexions finals El capítol final reflexiona sobre els repetits fracassos en la recerca de fàrmacs (més del 90% dels compostos que entren en desenvolupament no són aprovats) i què motiva els científics. Un científic pot passar una carrera sencera sense descobrir un nou medicament. S'inclou un commovedor correu electrònic d'un col·lega de Pfizer el pare del qual es va beneficiar d'un assaig clínic amb tremelimumab per al melanoma, destacant l'impacte personal de la feina i la importància de recordar que "el pacient està esperant". Aquesta perspectiva ajuda a entendre la motivació darrere dels desafiaments de la R&D farmacèutica.

En conjunt, el llibre "Drug Truths" utilitza nombrosos exemples i històries detallades del procés de R&D, sovint extretes de l'experiència de l'autor a Pfizer, per desmuntar les percepcions públiques negatives sobre la indústria farmacèutica i il·lustrar la complexitat, el cost, els riscos i, finalment, el valor i l'impacte humà de la descoberta de nous medicaments.

The world is fat (2)

 Can the Obesity Crisis Be Reversed?

From conclusions: 

Ending the obesity epidemic will take both individual and collective action. Neither alone is sufficient. Individuals try to lose weight and keep it off, but the system is working against them. The route to population-wide weight loss will not be through trendy, unsustainable diets. It will be through widespread, appropriate, personalized, and comprehensive approaches.

The first action we all must take, no matter our size, is to educate ourselves about obesity—and you’ve been doing that by reading this book. People need to understand the structural, environmental, and genetic components of obesity. They need to see the ways in which systemic factors contribute to weight gain. The idea that obesity is a choice or a matter of willpower has been thoroughly disproved. The unfortunate fact that many people still believe this actively harms efforts to reduce obesity rates.

The government should first seek to change the public perception of obesity. Obesity is largely a result of structural forces, not just individual actions. A shared awareness of its origins could foster greater support for interventions that allow people to make healthier choices.

People and institutions need to work together to make healthy foods more accessible, affordable, appetizing, and convenient than unhealthy foods. Reversing the obesity crisis will require environments that promote physical activity and social movements that encourage people to get more exercise. We need to devote more resources to preventive efforts for all ages to improve our health.

To reverse the obesity crisis, we will need an all-hands-on-deck approach. Pharmacological advances, surgery, and other treatments should complement new policies, societal practices, and population-wide interventions that promote healthier diets and decrease food consumption. Improving the nation’s health may require implementing policies perceived as restricting personal freedoms that have long been granted to industries and individuals. But these policies will be essential to keeping the population healthy.

For individuals, the goal should be to reach and maintain your optimum weight, meaning the weight at which your body the optimal physical and mental health. 

Outline of free ebook:

INTRODUCTION: Struggling with Obesity

CHAPTER 1: How Do People Gain Excess Weight?

CHAPTER 2: Why Are People Getting Heavier?

CHAPTER 3: What Are the Consequences of Obesity?

CHAPTER 4: What Are the Best Ways to Lose Weight?

CHAPTER 5: How to Reverse the Obesity Crisis

Mental health challenges

 Fitter Minds, Fitter Jobs

From Awareness to Change in Integrated Mental Health, Skills and Work Policies

1 What does a mental health-in-all-policies approach look like? 

2 What are current social and labour market outcomes for persons with mental health conditions? 

3 How far have we come in implementing integrated mental health, skills and work policies?

4 What are the implications and lessons of the COVID-19 pandemic for integrated mental health, skills and work policy?

A timely OECD report 5 years after the approval of the Recommendation on Integrated Mental Health, Skills and Work Policy. Unfortunately many countries still have to apply them...

Reordering our society is possible

 What We Owe Each Other.A New Social Contract for a Better Society

A thought -provoking book. Chapter 5 is devoted to Health:

Being healthy is the most important determinant of our wellbeing. Physical and mental health (subjective well-being as it is called in the academic research) rank at the top of every major study of happiness across the world. Ultimately, this is why every society aspires to provide health care for its population. And because the costs of providing health care are reduced when a large population pools its resources, and because a healthy labour force is also good for the economy, the social contract in every society includes health care in some form or another.

The great issues:

• Defining a Minimum for Universal Health Care
•  How Should Health Care Be Provided?
• Health Spending Is Only Going Up
• A More Digital Future for Health
• Individual and Social Responsibilities – Where Is the Balance?

The message:

We owe each other more. A more generous and inclusive social contract would recognise our interdependencies, provide minimum protections to all, share some risks collectively and ask everyone to contribute as much as they can for as long as they can. This is not about increasing the welfare state, but about investing in people and building a new system of risk sharing to increase overall well-being. Change will come inevitably because the forces of technology, demography and environmental pressures will drive it. The question is whether we prepare for that change or continue to allow our societies to be buffeted by these powerful forces, as we have in recent decades. This book lays out the challenges we face and provides a menu of alternatives for a better social contract around families, education, health, work, old age and between the generations. It is not a blueprint, but it provides a direction of travel that is economically feasible. Nor is it a fixed menu – countries may choose to  implement some elements and not others depending on their values and preferences.

Improving mental health

 A New Benchmark for Mental Health Systems

From the OECD Mental health performance framework: 

Our fragile world

 Death, Grief and Loss in the Context of COVID-19

Outline of the book:

Introduction: Capturing the beginning of a long journey of loss, trauma and grief Panagiotis Pentaris

PART 1: Reconsidering Death and Grief in Covid-19

Chapter 1. Familiarity with death

Chapter 2: Grief in the COVID-19 pandemic

Chapter 3: Apocalypse now: COVID-19 and the crisis of meaning

Chapter 4: Physically distant but socially connected: Streaming funerals, memorials and ritual design during COVID-19

Chapter 5: Social death in 2020: Covid-19, which lives matter and which deaths count?

PART 2: Institutional Care and Covid-19

Chapter 6: End-of-life decision-making in the context of a pandemic

Chapter 7: NHS Values, Ritual, Religion, and Covid-19 Death

Chapter 8: Non-COVID-19 related dying and death during the pandemic

Chapter 9: Covid-19 and care home deaths and harms: A case study from the UK

Chapter 10: Impact of Covid-19 on mental health and associated losses

Chapter 11: Assisted dying and Covid-19

PART 3: Impact of COVID-19 in Context

Chapter 12: Losing touch? Older people and COVID-19

Chapter 13: Between cultural necrophilia and African American activism: life and loss in the age of COVID

Chapter 14: The biopolitics and stigma of the HIV and Covid-19 Pandemics

Chapter 15: Suicide in the context of the COVID-19 pandemic

Chapter 16: Death and dying during the COVD-19 pandemic: The Indian context

Health behaviors and behavior change

 Behavioral Economics and Public Health

Health behaviors and practices constitute the foundation of good physical and mental health. The leading contributors to the global burden of disease include tobacco smoking, low-quality diets, alcohol abuse, physical inactivity, and obesity. Accordingly, encouraging people to adopt—and maintain—healthy behaviors is a major objective of public health. 

Today I recommend this book and this is what you'll find inside:

Chapter 1: An Introduction to Behavioral Economics and Public Health. Christina A. Roberto and Ichiro Kawachi

Chapter 2: Intertemporal Choices for Health. Justin S. White and William H. Dow

Chapter 3: Maintenance of Healthy Behaviors: Forming and Changing Habits. Dennis Rünger and Wendy Wood

Chapter 4: Emotions and Health Decision-Making: Extending the Appraisal Tendency Framework to Improve Health and Health Care. Rebecca Ferrer, William Klein, Jennifer Lerner, Valerie Reyna, and Dacher Keltner

Chapter 5: Social Norms, Beliefs, and Health. Brent McFerran

Chapter 6: Communicating for action: the importance of memorability and actionability. Jason Riis and Rebecca K. Ratner

Chapter 7:Nudging Individuals Toward Healthier Food Choices with the 4Ps Framework for Behavior Change. Zoë Chance, Ravi Dhar, Michelle Hatzis, and Kim Huskey

Chapter 8: Incentivizing Health Behaviors. Kristina Lewis and Jason Block

Chapter 9: Slim By Design: Moving from Can't to CAN.Brian Wansink

Chapter 10: Applying Behavioural Economics in a Health Policy Context: Dispatches from the front lines. Michael Sanders and Michael Hallsworth

Chapter 11: From Choice Architecture to Policy Infrastructure: Multi-Level Theory and the Political Economy of Health Behaviors. Frederick J. Zimmerman

Mobile medicine transformation

THE TRANSFORMATIVE POWER OF MOBILE MEDICINE, Leveraging Innovation, SeizingOpportunities, and Overcoming Obstacles of mHealth

Eleven topics in a book reflecting current mhealth:

1. Innovations in mHealth Part 1

2. Innovations in mHealth, Part 2

3. Exploring the Strengths and Weaknesses of Mobile Apps

4. Mobile Apps Critique: Heart disease and hypertension

5. Mobile Apps Critique: Diabetes and asthma

6. Mobile Apps Critique: Mental health/Depression

7. Reinventing clinical decision support: Is there a role for mobile technology?

8. Telemedicine: Opportunities and Challenges

9. Patient Engagement must be our Top Priority

10. Security and privacy concerns

11. Designing the ideal mobile medical app

Why are we waiting? (5)

Waiting Times for Health Services. Next in Line

Long waiting times for health services is an important policy issue in most OECD countries. Reducing the time that people have to wait to get a consultation with a general practitioner, or a diagnostic test or treatment, can go a long way in improving patient experience and avoiding possible deterioration in their health. Governments in many countries have taken various measures to reduce waiting times, often supported by additional funding, with mixed success. This report looks at how waiting times for elective treatment, which is usually the longest wait, have stalled over the past decade in many countries, and have started to rise again in some others. It also analyses the differences in how long people have to wait to get a consultation with general practitioners or specialists across countries. The report reviews a range of policies that countries have used to tackle waiting times for different services, including elective surgery and primary care consultations, but also cancer care and mental health services, with a focus on identifying the most successful ones.

Just a few words. For citizens, this is the hottest topic in our health system. And policymakers are neglecting it, while some citizens are voting with their feed...only those that can.

Bowery men waiting for bread in bread line, New York City, Bain Collection

Behavioral response to the virus

Using Behavioural Science to Help Fight the Coronavirus

Main topics of the paper:

(1) Evidence on handwashing shows that education and information are not enough. Placing hand sanitisers and colourful signage in central locations (e.g. directly beyond doors, canteen entrances, the middle of entrance halls and lift lobbies) increases use substantially. All organisations and public buildings could adopt this cheap and effective practice.

(2) By contrast, we lack direct evidence on reducing face touching. Articulating new norms of acceptable behaviour (as for sneezing and coughing) and keeping tissues within arm’s reach could help.

(3) Isolation is likely to cause some distress and mental health problems, requiring additional services. Preparedness, through activating social networks, making concrete isolation plans, and becoming familiar with the process, helps. These supports are
important, as some people may try to avoid necessary isolation.

(4) Public-spirited behaviour is most likely when there is clear and frequent communication, strong group identity, and social disapproval for those who don’t comply. This has implications for language, leadership and day-to-day social interaction.

(5) Authorities often overestimate the risk of panic, but undesirable behaviours to watch out for are panic buying of key supplies. Communicating the social unacceptability of both could be part of a collective strategy.  

(6) Evidence links crisis communication to behaviour change. As well as speed, honesty and credibility, effective communication involves empathy and promoting useful individual actions and decisions. Using multiple platforms and tailoring message to
subgroups are beneficial too.

(7) Risk perceptions are easily biased. Highlighting single cases or using emotive language will increase bias. Risk is probably best communicated through numbers, with ranges to describe uncertainty, emphasizing that numbers in the middle are more likely. Stating a maximum, e.g. “up to X thousand”, will bias public perception. 

Climate change and health

Enviromedics: The Impact of Climate Change on Human Health

These are tough times for the relationship between mankind and the planet. Therefore, this is a good reason to know better the relationship between climate change and health. In this book you'll find the details on each topic.
These are the key issues:

Part I. Climate Change Cascade
2 Climate Change 101: A Primer
3 Heat Waves and Heat Stress
4 Extreme Weather
5 Vector-Borne Diseases
6 Mental Health
Part II. Clear and Present Pathogens
7 Air Degradation
8 Water Security
9 Food Security
10 Allergens
11 Harmful Algal Blooms 

 Many of these modern sources of environmental hazards share a common feature—they derive from human activity as much as or more than from nonhuman sources. Radiation exists in nature, but its concentrated forms on Earth are created by humans. Industries produce the goods that support modern life, while they spin off by-products that can harm the environment and humans. We celebrate the productivity of modern agriculture, but if the runoff of pesticides and antibiotics pollutes the water supply and encourages antimicrobial resistance, we pay a higher price than we realize for food.

Balancing this tradeoff is complicated by the fact that the individuals and interests who typically stand to benefit from a polluting activity are not the same as the ones who will suffer the adverse health and other consequences.

Global externalities and how to fix them. This is one of the greatest challenges nowadays.

Wellbeing economics: a prescription letter

A SPENDING REVIEW TO INCREASE WELLBEING
An open letter to the Chancellor

UK has setup an All-Party Parliamentary Group on Wellbeing Economics. That's great!. If there is one thing that should be on the public agenda is wellbeing. However, after reading the last report it's a little bit disappointing. The have decided 6 priorities to take into account in the spending review according to its importance on wellbeing.

1. Health: Scaling up treatment of mental illness
2. Education: Tackling children’s wellbeing in schools 
3. Further Education: A proper start to working life
4. Social care and community services: Investing in social support networks
5. Work: Better wellbeing leads to better productivity
6. Other priority areas

Not so easy...as they say, It's just a letter...

At a glance

Health at a Glance: Europe 2018

Every two years OECD publishes this report for the European Union on the state of health. The new one has an interesting thematic chapter on mental health. It says:

According to the latest IHME estimates, more than one in six people across EU countries (17.3%) had a mental health problem in 2016  – that is, nearly 84 million people.
The most common mental disorder across EU countries is anxiety disorder, with an estimated 25 million people (or 5.4% of the population) living with anxiety disorders, followed by depressive disorders, which affect over 21 million people (or 4.5% of the
population).An estimated 11 million people across EU countries (2.4%) have drug and alcohol use disorders. Severe mental illnesses such as bipolar disorders affect almost 5 million people (1.0% of the population), while schizophrenic disorders affect another estimated 1.5 million people (0.3%).

And the second thematic chapter is about health expenditure: Strategies to reduce wasteful spending: Turning the lens to hospitals and pharmaceuticals. It says:

For hospitals, reducing or eliminating unnecessary investigations and procedures, many of which expose patients to unnecessary risks without the prospect of clinical benefit, is an obvious target for direct intervention. Expanding the use of day surgery can also be instigated at hospital level. However minimising avoidable admissions, particularly for ambulatory care-sensitive conditions, reducing unnecessary length of stay, and improving discharge processes require broader perspectives. Enhanced primary care services, expanded postacute care facilities, post-discharge care coordination, and in home care services all require health system reforms that cannot be initiated by hospitals  alone.

For pharmaceuticals, creating and supporting competitive markets and promoting the uptake of generics and biosimilars can generate substantial savings. That said, reducing waste does not necessarily mean spending less; it may equally be achieved by gaining better value for money from existing expenditure. Both supply and demand side levers offer scope for better value. Using health technology assessment to inform selection, pricing and procurement of new medicines facilitates an understanding of the true opportunity costs of therapies and helps avoid the displacement of high value interventions with ones of lesser value.

This is not new. We have already heard the same for years. Therefore, current inertia is supported by strong incentives that prevent change (either in policy or management). This is the key challenge.

Mental health: the problem and what can be done

THRIVE: How Better Mental Health Care Transforms Lives and Saves Money

I have to recognise it. Mental health is a difficult issue, and all the efforts to decrease its impact on individual and social welfare are not enough by now. The book by Layard and Clark is a useful reference. I had to read it since long time. It says:

Mental illness is the great hidden problem in our societies, so most people are amazed when they hear the scale of it. In the Western world today one in six of all adults suffers from depression or a crippling anxiety disorder. Roughly a third of households currently include someone who is mentally ill.

I don't know the exact figure, but I agree with the statement.

Mental illness is not just a problem for those it affects directly. It also imposes huge costs on the rest of society. So the case for tackling the problem is not just humanitarian—it is also a matter of plain economics. Mental health problems diminish work, increase crime, and make additional demands on physical health care.

So, what is the cost? The answer is huge. Layard and Clark provide some figures. And in the second part of the book, they review the alternative approaches to the issue. A highly recommended book by one of the greatest economists of our time.

PS Great Tribute to Uwe Reinhardt in NYT by Paul Krugman.

Healthcare Quality Lessons

Caring for Quality in Health

An OECD report provides the lessons on caring for quality, quite general but of interest to dive into each one:

Lesson 1. High-performing health care systems offer primary care as a specialist service
that provides comprehensive care to patients with complex needs
Lesson 2. Patient-centred care requires more effective primary and secondary prevention
in primary care
Lesson 3. High-quality mental health care systems require strong health information systems
and mental health training in primary care
Lesson 4. New models of shared care are required to promote co-ordination across health
and social care systems
Lesson 5. A strong patient voice is a priority to keep health care systems focussed
on quality when financial pressures are acute
Lesson 6. Measuring what matters to people delivers the outcomes that patients expect
Lesson 7. Health literacy helps drive high-value care
Lesson 8. Continuous professional development and evolving practice maximise
the contribution of health professionals
Lesson 9. High-performing health care systems have strong information infrastructures
that are linked to quality-improvement tools
Lesson 10. Linking patient data is a pre-requisite for improving quality across pathways
of care
Lesson 11. External evaluation of health care organisation needs to be fed into continuous
quality-improvement cycles
Lesson 12. Improving patient safety requires greater effort to collect, analyse and learn
from adverse events 

It is like a check list, have you done your homework?

Searching for a book to read

Manel Castro

A prescription for “high-need, high-cost” patients

David Blumenthal presented at the recent  OECD health conference the Commonwealth Fund report: Designing a High-Performing Health Care System for Patients with Complex Needs: Ten Recommendations for Policymakers
These are the recommendations:

1. Make care coordination a high priority for patients with complex needs
2. Identify patients at greatest need of proactive, coordinated care
3. Train more primary care physicians and geriatricians
4. Improve communication between providers, e.g. integrated clinical records
5. Engage patients in decisions about their care
6. Provide better support for carers
7. Redesign funding mechanisms for patients with complex needs
8. Integrate health and social care, and physical and mental healthcare
9. Engage clinicians in change, train and support clinical leaders
10.Learn from experience; scale up successful projects

Once again, the issue is not about what, but about how, according to the specific setting. This is the reason why change implies modify incentives and coordination mechanisms. This is the hardest part, with cost and benefits uneven distributed over time and people. And this is the reason why recommendations fail so often in its implementation.

At Tate Britain, righ now, David Hockney

Common challenges and responses to improve healthcare quality

Caring for quality in health: Lessons learnt from 15 reviews of health care quality

Towards actionable international comparisons of health system performance:expert revision of the OECD framework and quality indicators

Key messages from the last OECD report on quality:

Systemic changes on where and how health care is delivered will optimise both quality and efficiency
Lesson 1: High-performing health care systems offer primary care as a specialist service that provides comprehensive care to patients with complex needs
Lesson 2: Patient-centred care requires more effective primary and secondary prevention in primary care.
Lesson 3: High-quality mental health care systems require strong health information systems and mental health training in primary care
Lesson 4: New models of shared care are required to promote co-ordination across health and social care systems

Health care systems need to engage patients as active players in improving health care, while modernising the role of health professionals
Lesson 5: A strong patient voice is a priority to keep health care systems focussed on quality when financial pressures are acute
Lesson 6: Measuring what matters to people delivers the outcomes that patients expect
Lesson 7: Health literacy helps drive high-value care
Lesson 8: Continuous professional development and evolving practice maximise the contribution of health professionals

Health care systems need to better employ transparency and incentives as key quality-improvement tools
Lesson 9: High-performing health care systems have strong information infrastructures that are linked to quality-improvement tools
Lesson 10: Linking patient data is a pre-requisite for improving quality across pathways of care
Lesson 11: External evaluation of health care organisation needs to be fed into continuous quality-improvement cycles
Lesson 12: Improving patient safety requires greater effort to collect, analyse and learn from adverse events

It may sound as a dejà-vu, and the difficult part is how, not what to do to improve quality. However if you want to read an article on health care quality comparisons, check this one. Comparing quality is crucial because we are used to compare expenditure without a detailed knowledge of quality achievement. We'll have to follow next reports on the issue.