BOOK
How Medicines Are Born: The Imperfect Science Of Drugs
Vozza Lisa | D'incalci Maurizio | Gescher Andreas
(2017)
Additional Information
Book Details
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Contents | xiii | ||
| Foreword — Improving the Culture of Medicine | v | ||
| About the Authors | vii | ||
| Precautions and Warnings before Using this Book | xi | ||
| Chapter 1 To Cure, Heal or Repair | 1 | ||
| Unresolved Medical Problems | 2 | ||
| Drugs which Cure | 2 | ||
| Drugs which Can Heal | 5 | ||
| From Animal Insulin to the Biotechnologically Generated Hormone | 6 | ||
| “Anything but Chemistry!” | 8 | ||
| The Inheritance of the Willow Tree | 9 | ||
| From Aspirin to Baby Aspirin | 10 | ||
| Drugs which Break Up Preformed Blood Clots | 11 | ||
| When Serendipity Leads to New Drugs | 12 | ||
| Drugs Discovered to a Plan | 13 | ||
| Towards Drugs which Can Repair? | 19 | ||
| Chapter 2 Hunting for Drugs | 21 | ||
| The Human Body — Is there an Instruction Manual? | 22 | ||
| The Cell — A Great Chemical Laboratory | 23 | ||
| The Most Common Target of Drugs | 25 | ||
| Catalogues of Genes and Proteins | 25 | ||
| Towards the Molecular Causes of Diseases | 27 | ||
| Is this Target “Druggable”? | 30 | ||
| Screening of Chemicals | 30 | ||
| Biologicals | 33 | ||
| Molecular Targeted Drugs | 36 | ||
| Fashion, Advertisement and some Thoughts | 37 | ||
| How to Overwhelm Barriers against Poisons | 38 | ||
| Poison or Remedy? Depends on the Dose | 39 | ||
| Routes and Formulations | 43 | ||
| And now — Do we Have a New Drug? | 45 | ||
| Chapter 3 Laboratory Studies | 47 | ||
| We Are Not All the Same — And Mostly Do Not Know Why That Is | 47 | ||
| Experiments Using Cells | 48 | ||
| Why Are Experiments in Animals Necessary to Evaluate a Drug? | 50 | ||
| A Model for (Almost) any Disease | 52 | ||
| Toxic or Harmless? | 54 | ||
| How the Organism Modifies a Drug: Pharmacokinetics | 54 | ||
| How the Drug Alters the Organism: Pharmacodynamics | 55 | ||
| The Therapeutic Index | 56 | ||
| Towards the First Tests in Humans: Does the Traffic Light Display Green, Red or Yellow? | 56 | ||
| Chapter 4 First Time in Humans | 59 | ||
| The First Controlled Clinical Trial | 60 | ||
| The Participants | 62 | ||
| Informed Consent | 63 | ||
| Randomised, Controlled, Blinded — Three Fundamental Rules of a Rigorous Clinical Study | 64 | ||
| Placebo and Nocebo Effects | 66 | ||
| The Four Phases of a Clinical Study | 67 | ||
| Phase one | 68 | ||
| The initial dose is small | 71 | ||
| A phase one trial is not necessarily the last resort | 72 | ||
| Towards phase two: Drugs which just make it | 74 | ||
| Phase two | 75 | ||
| Phase three | 76 | ||
| Endpoints | 77 | ||
| Not Inferior Drugs | 78 | ||
| “One Can’t Predict the Weather...” | 79 | ||
| Chapter 5 Only Probabilities, Never Certainties | 81 | ||
| Measurements are Never without Errors | 82 | ||
| Is the Study Sufficiently Powered? | 83 | ||
| Is the Result a False Negative? | 84 | ||
| Is the Result a False Positive? | 85 | ||
| Can We Exclude Chance? | 85 | ||
| Cause and Effect or Correlation? | 86 | ||
| Rare Diseases | 88 | ||
| Extrapolation can be Dangerous! | 89 | ||
| Chapter 6 Approval or Rejection | 91 | ||
| Who Does Approve New Drugs? | 92 | ||
| Stories of Rejections | 94 | ||
| Which Criteria are Important for Drug Approval? | 96 | ||
| Good Practices | 96 | ||
| Has a New Drug Got to Be Innovative? | 97 | ||
| Transparency: Needs to be Improved | 98 | ||
| Unpublished Studies and a Treatment for Depression | 99 | ||
| The Patent — Branded and Generic Drugs | 101 | ||
| Are Generic Drugs Trustworthy? | 101 | ||
| What are Biosimilar Drugs? | 103 | ||
| Shapes and Colours | 104 | ||
| Finally in the Pharmacy! | 105 | ||
| Chapter 7 Vigilance, Revisions, New Indications | 107 | ||
| Pharmacovigilance Can Dig Up Dishonesty | 108 | ||
| Pharmacovigilance Can Improve Therapy | 109 | ||
| Pharmacovigilance Can Discover Resistance | 109 | ||
| Indications Beyond Those in the Patient Information Leaflet | 112 | ||
| Drugs Against Non-existent Diseases | 114 | ||
| Drug Pipelines | 115 | ||
| Chapter 8 Predicting the Drugs of the Future | 119 | ||
| Nanovehicles for Drugs | 120 | ||
| Selecting the Right Patients for the Right Therapy | 122 | ||
| New Indications for Old Drugs | 123 | ||
| Biobanks — Sources of Priceless Treasures | 126 | ||
| Digesting Big Data Sets | 129 | ||
| Simulations and Imaging | 131 | ||
| Drugs Which Repair Rather Than Treat | 131 | ||
| Dreaming of the Molecular Instruments of Tomorrow | 134 | ||
| Who Will Invent the Drugs of Tomorrow? | 135 | ||
| Chapter 9 Not Every Pill is a Proper Drug | 137 | ||
| Imagining a World without Drugs | 139 | ||
| Pills Which Are not Drugs | 140 | ||
| The Odd World of Homoeopathy | 142 | ||
| Be Careful! | 144 | ||
| If You Want to Know More… | 145 | ||
| Books | 145 | ||
| Websites and Articles | 145 | ||
| Myths to be Dispelled | 147 | ||
| 1. A natural substance is less toxic than a chemically synthesised one | 147 | ||
| 2. Each pill is a proper drug | 147 | ||
| 3. Homoeopathic remedies may be less efficacious than traditional drugs but at least they do not cause harm | 148 | ||
| 4. Drug experimentation using animals is a waste of time | 148 | ||
| 5. We know the mechanisms of action of all drugs | 149 | ||
| 6. Drug effects are the same in all persons who take them | 149 | ||
| 7. The human body is like a machine and we know exactly how it functions | 149 | ||
| 8. Molecular targeted drugs are better than traditional drugs | 149 | ||
| 9. Biological drugs are better than chemically synthesised ones | 150 | ||
| 10. Poisons and drugs are different from each other | 150 | ||
| 11. A new drug against a particular disease is always better than an old one | 150 | ||
| 12. Results of studies of new drugs constitute absolute certainties | 151 | ||
| 13. Drug safety is always advantageous for the patient | 151 | ||
| 14. Generic drugs are worse than branded ones | 151 | ||
| 15. Identification of a gene facilitates the understanding of its role in a disease and engenders the discovery of a new drug | 152 | ||
| 16. A tablet is always better than an injection | 152 | ||
| Did You Know That… | 153 | ||
| Many drugs treat, a few cure, almost none repairs | 153 | ||
| Insulin is generated by a genetically modified organism | 153 | ||
| The ancient legacy of the willow tree | 153 | ||
| “Anything but chemistry” | 154 | ||
| Baby aspirin | 154 | ||
| The effects of viagra were discovered by accident | 154 | ||
| Erythropoietin (EPO) is perhaps the best known biological drug | 154 | ||
| In nature, poisons are the norm rather than the exception | 155 | ||
| The first clinical trial | 155 | ||
| Participants in clinical trials are always volunteers | 156 | ||
| The placebo effect | 156 | ||
| The nocebo effect | 157 | ||
| The reality about some novel anticancer drugs | 157 | ||
| Recruitment of volunteers is difficult | 158 | ||
| Many new drug dossiers are more voluminous than an encyclopaedia | 158 | ||
| New drug approval in Europe | 158 | ||
| Thalidomide: disaster and rebirth | 159 | ||
| To what extent are results of clinical studies made public? | 159 | ||
| Do drugs against depression act like a placebo? | 160 | ||
| Individual preferences of medicines | 160 | ||
| Only one in 60,000 experimental drug molecules goes on to obtain regulatory approval | 160 | ||
| Pharmacovigilance can improve therapy | 161 | ||
| Any drug targeted against a microorganism is destined to fail | 161 | ||
| Many drugs are prescribed for off-label indications, for purposes not listed in the information leaflet | 162 | ||
| The medical world pre-anaesthesia was brutal | 162 | ||
| A healthy life style is always better than any pill | 163 | ||
| Index | 165 |