Pharma, Big Pharma (2)

 Government, Big Pharma, and The People. A Century of Dis-Ease

A book to read, with this Table of Contents:

Dedication
Acknowledgements
Preface
Chapter One – Introductions
Health
Woman as a Biological and Social Entity
A Different Paradigm
Health Care and Rights
Drugs and Their Role in Society
Drug Policy
Big Pharma
Drug-Related Problems
The People
What’s Ahead
Conclusion
Chapter Two – The Four "P’s"
Introduction
Marketing as an Actualizing Process
The Marketing Mix/The Four "P’s"
Government and the Four "P’s"
Conclusion
Chapter Three – Investigators and Investigations
Introduction
The Hearings
The Grand Inquisitor
Gaylord Nelson – Son of Torquemada
The Fountain Hearings
Senator Kennedy Joins the Fray
Small Business Problems – Dingell
Drug Efficacy Problems – Fountain
Moss on Drug Abuse
Fountain Redux
Congressman Rogers on Transition
Senator Humphrey and the Literature
A Newcomer – Congressman Van Deerlin
Senator Fountain – "One More Time"
Senator Kennedy Returns
FDA Under the Microscope Again
Kennedy – Not Too Tranquil
Gore on Pharmaceutical R & D
Senator Fountain Again
Claude Pepper for the Old Folks
Zomax in the Spotlight
A Pryor Engatement
The Task Force on Prescription Drugs
Research Findings and Recommendations
Conclusion
Chapter Four – Legislators and Legislation
Introduction
Laws and Policy
Bills and Sponsors
The Process
Conclusion
Chapter Five – Regulators and Regulations
Introduction
The Food and Drug Administration
Other Regulators and Regulations
Federal Trade Commission
Federal Communications Commission
Drug Enforcement Administration
Centers for Medicare and Medicaid Services
Patents and Trademarks
State Regulations
Drug Names
Conclusion
Chapter Six – Non-Government Influence
Introduction
Self-Regulation
Third Parties – Managed Care Controls
Formularies and Prescription Limitations
Lawyers
Advocates and Adversaries
Mail Order Pharmacy
Pharmacy Benefit Managers and Outcomes Management
Conclusion
Chapter Seven – The People and Their Drugs
Introduction
The People as Patients
Health Belief Model
Case – Health Belief Model
Attitudes and Evaluation of Drugs
The Sickness Career
The Sick Role
The Sick Role in Acute and Chronic Illness
Compliance with Medication Regimens
Other Influences on Medication Use
What to Do
Death or Maybe Not
Conclusion
Chapter Eight – Response of Big Pharma
Introduction
Response to Government
Big Pharma Speaks
Response of Big Pharma to the People
Some Ideas for Big Pharma
PMA Monographs
Statesmanship
Conclusion
Chapter Nine – Little Pharma and Friends
Introduction
Generic Pharma – Not So Little
Big Bio
What is Special about Specialty Drugs?
Little Boutiques
Back to the Future – Compounding Pharmacists
Friends
Conclusion
Chapter Ten – Greedy Big Pharma
Introduction
Two Parts of Greedy
AARP and Greedy Big Pharma
Congress and Greedy Big Pharma
Risk vs. Reward
Greedy Big Tech
Conclusion
Chapter Eleven – Whence the Drugs?
Introduction
Origins of Drugs
Drug Product Development
Marketing in the Last Century
Invention, Discovery, Development
Curiosities and Surprises
Recommended Reading
Conclusion
Chapter Twelve – Drugs of the Future
Introduction
But Seriously
Drugs in an Aging Society
Future Drugs for the Aged
Lifestyle Drugs
Conclusion
Chapter Thirteen – The Non-Prescription Products Market-Dr. W. Steven Pray
Introduction
Patent Medicines
Laws That Regulated Non-Prescription Products
FDA’s Review of O-T-C Products
The Prescription to O-T-C Switch
A Third Class of Drugs
Quackery – Lacking Proof of Efficacy
Quackery – New Names Confer False Respectability
Conclusion
Chapter Fourteen – Issues and Studies in Pharmacoeconomics
Introduction
The Emergence of Pharmacoeconomic Research
The Cost of Illness
Quality of Life Assessment
The Economics of Non-Compliance
Economic Epidemiology
Conclusion
Chapter Fifteen – On Drug Prices – Dr. E. M. "Mick" Kolassa
Pricing: The Forgotten "P"
The Growing Importance of Pharmaceutical Prices
Prices, Politics and Problems
Pricing Terminology
What is a Pharmaceutical Price?
Price Decision Making
The Value of Pharmaceuticals
The Future of Pharmaceutical Pricing
Chapter Sixteen – Summary, Ruminations and Apologia
Introduction
Ruminations
Trends
What If’s
Apologia

Pharma, Big Pharma

 White Market Drugs. BIG PHARMA AND THE HIDDEN HISTORY OF ADDICTION IN AMERICA

A book to understand the contribution to addiction over a century.

By showing how the twenty-first-century opioid crisis is only the most recent in a long history of similar crises of addiction to pharmaceuticals, Herzberg forces us to rethink our most basic ideas about drug policy and addiction itself—ideas that have been failing us catastrophically for over a century.

This is the outline:

Introduction
The First Crisis
1 Drug wars and white markets
2 “Legitimate addicts” in the first drug war
3 Preventing blockbuster opioids
The Second Crisis
4 Opioids out, barbiturates in
5 A new crisis and a new response
6 White markets, under control
The Third Crisis
7 White market apocalypse
Conclusion: Learning from the past
Appendix: White market sales and overdose rates, 1870–2015

Human genome 20 years later

Complicated legacies: The human genome at 20

On genome and precision medicine:

Debates about precision medicine (PM), which uses genetic information to target interventions, commonly focus on whether we can “afford” PM (17), but focusing only on affordability, not also value, risks rejecting technologies that might make health care more efficient. Affordability is a question of whether we can pay for an intervention given its impact on budgets, whereas value can be measured by the health outcomes achieved per dollar spent for an intervention. Ideally, a PM intervention both saves money and improves outcomes; however, most health care interventions produce better outcomes at higher cost, and PM is no exception. By better distinguishing affordability and value, and by considering how we can address both, we can further the agenda of achieving affordable and valuable PM.

The literature has generally not shown that PM is unaffordable or of low value; however, it has also not shown that PM is a panacea for reducing health care expenditures or always results in high-value care (17). Understanding PM affordability and value requires evidence on total costs and outcomes as well as potential cost offsets, but these data are difficult to capture because costs often occur up front while beneficial outcomes accrue over time (18). Also, PM could result in substantial downstream implications because of follow-up interventions, not only for patients but also for family members who may have inherited the same genetic condition. Emerging PM tests could be used for screening large populations and could include genome sequencing of all newborns, liquid biopsy testing to screen for cancers in routine primary care visits, and predictive testing for Alzheimer's disease in adults. These interventions may provide large benefits, but they are likely to require large up-front expenditures.

 

 

Post COVID-19

 Post Corona. From Crisis to Opportunity

Amazon (not the rainforest)

 Now that Jeff Bezos anounces that he is to step aside as CEO, a summary in one figure:

The history, in one book:

Clinical utility of genetic testing for breast cancer

 Breast Cancer Risk Genes — Association Analysis in More than 113,000 Women

Genetic testing for breast cancer susceptibility is widely used, but for many genes, evidence of an association with breast cancer is weak, underlying risk estimates are imprecise, and reliable subtype-specific risk estimates are lacking.

However,

 We found strong evidence of an association with breast cancer risk (Bayesian false-discovery probability, <0.05) for protein-truncating variants in 9 genes, with a P value of less than 0.0001 for 5 genes (ATM, BRCA1, BRCA2, CHEK2, and PALB2) and a P value of less than 0.05 for the other 4 genes (BARD1, RAD51C, RAD51D, and TP53).

  None of the other 25 genes in the panel had a Bayesian false-discovery probability of less than 0.10. Of note, 19 genes had an upper limit of the 95% confidence interval of the odds ratio of less than 2.0, with 2.0 representing a proposed threshold for “pathogenic, moderate risk alleles”9; we therefore conclude that these genes are not informative for the prediction of breast cancer risk. We confirmed that missense variants in BRCA1, BRCA2, and TP53 that would be classified as pathogenic according to clinical guidelines are indeed associated with clinically significant risks. We also found that rare missense variants in CHEK2 overall, as well as variants in specific domains in ATM, are associated with moderate risk.

The summary:

 Variants in 8 genes — BRCA1, BRCA2, PALB2, BARD1, RAD51C, RAD51D, ATM, and CHEK2 — had a significant association with breast cancer risk.

 

Insights from Biotech on COVID-19

 Biotechnology in the Time of COVID-19

Our journey is far from over. In my mind, it is our responsibility as an industry, as a company, and as global citizens to help ensure a pandemic of this magnitude never happens again. I’ve worked in infectious diseases for my entire career—and I’ve been exposed to the disruption, the health crises, and the economic fallout they create. It is up to all of us to bring forward solutions. I hope you will join the many companies, worldwide health agencies, and nongovernmental organizations that are answering the call. Together, we can all use our skills to help serve people in this remarkably urgent time of need.

Great words by Stephane Bancel, CEO of Moderna 

Laboratory medicine as a data science (2)

 Recent evolutions of machine learning applications in clinical laboratory medicine

You'll find an interesting review about laboratory medicina and machine learning in this article, with applicatons to chemical chemistry, hematology and microbiology.

There has been a recent rise in various ML applications in the field of clinical laboratory medicine. Despite the potential of ML to ameliorate the efficiency of laboratory processes and optimize diagnostic workflows, translation into routine practice is still slow-going. There is a need to raise more awareness about the vast ML landscape among laboratory professionals. Educational programs dealing with theoretical ML concepts as well as their associated challenges and opportunities could stimulate wider acceptance and exploitation in the clinical laboratory. It is important to realize that ML will not  immediately function as a surrogate of the laboratory professional’s neural networks, but will rather act as a valuable supportive tool with the capability of increasing the odds on optimal outcomes for patients accessing health care.

 Margaret Huntington Boehner

The risk in a funambulist society

 The Great Risk Shift. The New Economic Insecurity and the Decline of the American Dream

Behavioral economics of markets

 The Community of Advantage. A Behavioural Economist's Defence of the Market

The threat of populism is among us

 The Populist Temptation: Economic Grievance and Political Reaction in the Modern Era

Antitrust

 The Antitrust Paradigm. Restoring a Competitive Economy

A plea for public patents on COVID prevention and treatment

 Funding of Pharmaceutical Innovation During and After the COVID-19 Pandemic

Extensive public investments also are being made in therapeutics. The 2 most prominent monoclonal antibodies (by Regeneron and Lilly) have come to market with substantial governmental support for product commercialization. Both products derive from therapeutic research platforms established with governmental support before the COVID-19 pandemic, but product commercialization and manufacturing received major additional investments in 2020. Separately, the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics program has committed $1.5 billion to supporting development of diagnostic tests related to COVID-19. The specifics of the federal contracts largely remain confidential.

Why do they remain confidential? 

The lesson of the COVID-19 experience is that, when innovation in the life sciences is imperative, the traditional reliance on pharmaceutical industry prices and profits is jettisoned in favor of governmental grants and procurement. Sustained public funding for product development and commercialization will permit the sustained financing of innovation, a renewed attention to major public health needs, and the global position of the US pharmaceutical industry.

If there is public funding, why there aren't public patents? 

Technology assessment effectiveness

 Does the use of health technology assessment have an impact on the utilisation of health care resources? Evidence from two European countries

And the answer is YES.

This study suggests that medicine utilisation does respond to the positive recommendations of HTA bodies.However, if HTA capacity is organised primarily regionally, considerable effort may be required in coordination, to ensure consistent and rigorous assessments and adequate implementation of HTA findings.