Claiming for global regulation of genome editing (2)

HUMAN GENOME EDITING:RECOMMENDATIONS

 Last July the WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing released its recommendations. This is a crucial document that all governments should take into account and develop its specific regulation. Time is running out

The Committee produced a series of recommendations in nine discrete areas: 1. Leadership by the WHO and its Director-General; 2. International collaboration for effective governance and oversight; 3. Human genome editing registries; 4. International research and medical travel; 5. Illegal, unregistered, unethical or unsafe research and other activities; 6. Intellectual property; 7. Education, engagement and empowerment; 8. Ethical values and principles for use by WHO and 9. Review of the recommendations.

PS: https://theconversation.com/who-guidelines-on-human-genome-editing-why-countries-need-to-follow-them-164895

Business as usual is unacceptable in a pandemic

 What are the obligations of pharmaceutical companies in a global health emergency?

Timely article by Ezequiel Emanuel et al. in The Lancet:

Pharmaceutical companies have special obligations in this emergency, which follow from their indispensable capacity to help to end the pandemic by developing, manufacturing, and distributing COVID-19 vaccines. However, the capacity to help alone does not fully specify companies’  obligations. Additionally, market-based arrangements, with patents, marketing exclusivity, and confidentiality clauses, give pharmaceutical companies the freedom to choose what treatments to research and develop, how to price and distribute their products, and whom to furnish with products through bilateral agreements.9 Indeed, companies need not produce vaccines or infectious disease therapies at all. Patents and exclusivity, alongside the absence of price controls or requirements for technology transfer, also permit companies to charge higher prices than they otherwise could.  Governments adopt intellectual property rights, limited pricing regulations (ie, each country has its own pricing, with no one countrycontrolling the pricing, at most being able to set limits on the prices that can be charged), trade agreements, and other limited  interventions (eg, manufacturing, inspections of facilities, etc) in the hope of incentivising the development, manufacturing, and distribution of socially valuable products. Everyone—including pharmaceutical companies— agrees that business as usual is unacceptable in a pandemic.

 Ethical obligations:

Misguided proposals

 Consideration Of Value-Based Pricing For Treatments And Vaccines Is Important, Even In The COVID-19 Pandemic

Prices send signals about consumer preferences and thus stimulate producers to make more of what people want. Pricing in a pandemic is complicated and fraught. The policy puzzle involves balancing lower prices to ensure access to essential medications, vaccines, and tests against the need for adequate revenue streams to provide manufacturers with incentives to make the substantial, risky investments needed to develop products in the first place. We review alternative pricing strategies (cost recovery models, monetary prizes, and advance market commitments) for coronavirus disease 2019 (COVID-19) drugs, vaccines, and diagnostics. 

All these stuff on consumer preferences is useless under a pandemic. We are all at risk, and this systemic risk has to be solved "systemically", by the government. It is not an issue of individual preferences. Forget value based in systemic risk events. Forget this misguided article. 

Sorolla 1903

The right to healthcare access

 Population Health and Human Rights

From NEJM article:

The study of population health encompasses two main objects of analysis: the health conditions affecting a population (the frequency, distribution, and determinants of diseases and risk factors) and the organized social response to those conditions, particularly the way in which that response is articulated in the health system, including the principles and rules that determine who has access to which services and at what cost to whom. These services include both clinical and public health interventions. Since the 19th century, national health systems have sought to provide health services to an increasing proportion of the population, using four eligibility principles: purchasing power, poverty, socially defined priority, and social rights. Reliance on purchasing power means that access is  determined by ability to pay, with governments limiting their role to basic regulation. Because this principle excludes many people, governments have historically intervened to expand access, either through public assistance programs covering families with incomes below a predetermined level or through social insurance schemes for prioritized groups (e.g., the armed forces, industrial workers, civil servants, or older adults). All these eligibility principles result in only  partial coverage, but the ideal of universality has influenced public policy in most countries, though the design and performance of health systems vary widely.

Theranos on trial

 Podcast: 'The Dropout: Elizabeth Holmes on Trial'

ABC News' #1 podcast is back with new episodes, available on Tuesdays.

Money. Romance. Tragedy. Deception. The story of Elizabeth Holmes and Theranos is an unbelievable tale of ambition and fame gone terribly wrong.

You'll find it in Spotify every week

 

Health expenditure after COVID

Right now we know the impact of COVID on health expenditure and the rise has been of 18%, the largest increase ever. We spent 1.786€ per capita in 2020 , 271€ more than in 2019 (1.515€). 

Public expenditure on health by catalan government was 13.392M€ in 2020 (provisional data), while in 2019 11.531M€ . We spent 48€ per capita on PCR tests in 2020. 

Until June 30 2021, the Health Department has executed an amount of € 5.918M, lower than in 2020 by € 257.8 million. We will have to wait for the end of the pandemic to have the final estimates of expenditure.

And now, what's next? Is this only a shock or it will remain consolidated for the future?. Place bets.

Bureaucratic darkness

 Sludge. What Stops Us from Getting Things Done and What to Do about It

The economic impact of covid pandemic

 Shutdown. HOW COVID SHOOK THE WORLD'S ECONOMY

A conversation with David Cutler

Edward Glaeser and David Cutler on the Health and Wealth of Cities

Highly recommended:

 

on David Cutler in Econsalut

Creating conditions for population health

 Population Health Science: Fulfilling the Mission of Public Health

Great article. Selected statements:

In 1988, an Institute of Medicine commission defined the mission of public health as “assuring the conditions in which people can be healthy.” Yet much of public health continues to focus not on the conditions in which people can be healthy but rather on individual health.

Several forces have combined to push public health away from its historical mission.

First, science has been increasingly narrowly construed as the business of conducting randomized controlled trials (RCTs). The emphasis on RCTs took hold in the field of medicine as a useful antidote to expert opinion about the effectiveness and appropriateness of care. The resulting turn to evidence-based medicine has the potential—as yet only partially realized—to improve the quality of medical education and clinical care.3-6 However, to say that RCTs can lead to an evidence base that improves clinical care is not to say that RCTs are the only avenue to improving health. This point seems to have been lost on prominent gatekeepers of science. 

A second factor pushing public health away from its mission of assuring the conditions in which people can be healthy are the limits of our theoretical models. Public health can be proud of a long tradition of interdisciplinary collaboration, with economic, sociological, psychological, and other theoretical currents enriching the flow of public health research. But theoretical developments have often remained anchored in their home fields without ever creating a coherent theoretical base within public health. Within public health, our two methodological subfields—epidemiology and biostatistics—are empirical, not theoretical, fields.

Population health science starts with its own theoretical commitments: that the health and health equity of a population are different from and determined differently than the health of individuals. This is a point that was made long ago by Virchow and Durkheim and repeatedly since.19-21 While individual health may be determined by health behaviors or toxic exposures, progress on population health requires understanding why those behaviors and exposures happen. Population health science is invested in the population causes of incidence and not only the individual causes of susceptibility.

Population health science requires scientists from different disciplinary backgrounds to combine their knowledge and expertise to answer questions that individual disciplines alone cannot. It requires syncretic practice focused not on individual health, but on the mean and variation—the health equity—of outcomes in a population.

Creating the conditions for health is difficult work: far more difficult, for example, than admonishing people to act more healthfully. It is more difficult for medical delivery systems to take responsibility for keeping people healthy than to treat them when ill. It is more difficult to engage in politics with scientific integrity than to avoid political controversy altogether. And it is more difficult to think critically about the theoretical basis of what causes health in populations than to conduct randomized trials of clinical interventions.

 Henry Cartier-Bresson 1969

Global health impact labeling

 Global Health Impact. Extending Access to Essential Medicines

From the last chapter:

Beyond Global Health Impact Labeling, Licensing, and Investment: Advancing Public Health

The book began by making the case for a human right to health and to access essential medicines, in particular. It defended the right against recent critics. The second section explained the Global Health Impact initiatives. The final section made the case for consuming things with Global Health Impact and similar ethical labels and considered empirical evidence that can support such initiatives.
More precisely, the first chapter suggested that everyone should have an enforceable legal human right to health that includes a right to access essential medicines to treat diseases like malaria, tuberculosis (TB), and HIV/  AIDS because it protects individuals’ ability to live minimally good lives. It sketched an account of the minimally good life that has some advantages over the main alternative. It argued that a basic minimum of health supports,
and may even partly constitute, such lives. Moreover, it argued that the right (partly because it generates a derivative right to access essential medicines) protects this basic minimum. So, the first chapter concluded that everyone should have an enforceable legal human right to health.
The second chapter argued that the human right to health can help claimants, advocates, and duty bearers find ways to fulfill everyone’s claims. Even if this right cannot provide guidance for distributing scarce resources, the chapter argued that we should not reject it; the human right to health provides hope that can foster the virtue I call creative resolve. The right inspires a fundamental commitment to finding creative solutions to apparently
tragic dilemmas; it gives claimants, advocates, and duty bearers a response to apparent tragedy in motivating them to search for ways to avoid it.

The third chapter presented some creative new ways to use data on global health to address the access to medicines problem. It suggested utilizing information about medicines’ global health consequences to create incentives for positive change. More precisely, it claimed that having something like the Global Health Impact index provides a mechanism for incentivizing pharmaceutical companies and other organizations to extend access to essential drugs and technologies around the world. It opens the door to fruitful social activism including ethical labeling, fair licensing, lobbying insurance companies to include Global Health Impact products in their formularies, and so forth.

The fourth chapter made the moral case for supporting a Global Health Impact labeling initiative, in particular. It argued that (1) pharmaceutical companies violate rights and (2) do not do enough to address the access to medicines issue, so (3) if the initiative helps rectify these problems, people should generally purchase goods from Global Health Impact– certified companies. A similar argument might support many other ethical consumption initiatives as well.

The fifth chapter defended the new perspective on how consumers should think about their basic economic powers supporting the book’s argument for purchasing Global Health Impact– labeled goods. It defended positive change consumption: Under just institutions, people can consume what they want as long as they respect the institutions’ rules. Absent such institutions, significant moral constraints on consumption exist. Against recent critics, it argued that consumers can aim at democratic change but need not always do so.  emocratic constraints may prevent truly positive change; but, at the same time, democracy is important for bringing about such change. Although people can promote democracy, they can also promote other positive processes and outcomes.

This book’s final chapter considered how examining the prospects for Global Health Impact initiatives might expand traditional philosophical inquiry’s domain. It presented a proposal for testing consumers’ willingness to make decisions based on a Global Health Impact label. The basic idea is to put a Global Health Impact label on a few over- the- counter products and to collect data on changes in consumers’ willingness to purchase these products compared to otherwise similar products from sales.

The dark side of biomedical research

 Error and Fraud. The Dark Side of Biomedical Research

The Theranos scam whistleblower

 Thicker Than Water

From the hero whistleblower of the infamous Theranos scam, Thicker than Water is a look at never-before-revealed details behind closed doors at the company, revealing a cautionary tale of corporate bullying, gaslighting, ego, and wealth run amok in Silicon Valley.

Tyler Shultz had been in the workforce for less than a year when he emailed Elizabeth Holmes, his employer and the CEO and founder of Theranos, with concerns that the company’s lab practices were faulty, ignored quality control, and were potentially dangerous to patients. The COO fired back with a dismissive and insulting email, to which Tyler replied: "Consider this my two weeks’ notice."

From there, his life spun out of control at the hand of Elizabeth, her team of high-powered lawyers, and the patriarch of Tyler’s own family, George Shultz—one of America’s most prominent statesmen, who sat among the top of the Theranos Board of Directors. And yet, Tyler forged on. To protect his own conscience, the honor and reputation of his grandfather, and the health of patients worldwide.

Thicker than Water is Tyler’s as-told-to story—a harrowing and heartbreaking roller coaster of biomedical drama, family intrigue, and redemption—that will ultimately make you feel as though you are at a dinner party, seated next to a brilliant friend with one hell of a story. 

NHS as a health system

 The NHS. The Story So Far