Posted in Education, FDA, Government Regulations, Medical Costs, Patient Safety, Policy Issues, Technology, U.S. Security, Uncategorized

Is that a Centipede I See in My Capsule?? | MedPage Today

Eban: They knew I was coming. They had let me come in, but I saw a very different world within these plants through whistleblowers. I worked with a lot of whistleblowers who had contacted me — or I had made contact with them — who were showing me documents, showing me photographs, giving me really the sort of gory details of what was happening in these plants and the kinds of crazy decisions that were being made like failing drugs, drugs that had glass particles in them were being approved to be dispensed. Broken down, rusted equipment that was leaving metallic fragments in pills. Those were being dispensed.

Illicit use of ingredients. You can’t just swap ingredients. But they had drugs that were dissolving improperly, so they just haphazardly changed things up to try to get better data to show the FDA. All of this was taking place in a kind of lawless regulatory environment. They’re not afraid of their own regulators. They’re afraid of the FDA, but what they have built is an elaborate system to trick the FDA. Our FDA has all but volunteered to be tricked because we announce our inspections in advance overseas. We give 3 months’ notice. They send in data fabrication teams.

https://www.medpagetoday.com/podcasts/anamnesis/84501

Posted in British National Health Service, Economic Issues, FDA, Health Insurance, Healthcare financing, outcomes, outcomes measurement, Patient Choice, Patient Safety, Policy Issues, Protocols, Quality, Technology, Uncategorized

Should access to life-saving medicines be determined by economic evaluations? | TheHill

“My opportunity finally came. In April 2018, I was one of a few hundred cystic fibrosis patients to dose in a pivotal phase III clinical trial to evaluate a new drug designed to correct CFTR, the dysfunctional protein responsible for CF. The medication, two pills in the morning, and one at night worked almost immediately.

Within a few hours, the viscosity of my usually thick, sticky mucus changed; within a week, the constant cough I had lived with for my entire life nearly vanished, and within a month, my pulmonary function tests skyrocketed. I could finally breathe.

Instead of heading towards end-stage illness, disability income, and an end to my fight with cystic fibrosis, Trikafta, as the drug came to be named, saved my life.

A disturbing trend is washing over the United States, though. Insurers are using economic analyses based on a discriminatory cost-effectiveness metric called Quality-Adjusted Life Years (QALY) as negotiating leverage to limit access to life-changing medications.

A 2018 article in Health Affairs said, “QALY calculations inherently privilege treatments that extend the lives of those who can be restored to perfect health, and disadvantage the many who seek life-extending treatments despite having a disability or chronic condition that is not curable.”

But, QALY is not adequately able to quantify what happened in my own life — my journey from near end-stage illness and no hope for a future to correctly managed CF and entrance into an elite graduate program. Living in a world where I would not have had the chance to dose Trikafta sends a shiver down my spine.

That world, however, has existed in countries where QALY has been used to justify not covering CFTR modulators for people with CF. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) makes QALY calculations to determine which medications are covered by the nation’s National Healthcare Service. In 2016, NICE decided that Orkambi, a previous CFTR modulator iteration, was not cost-effective for its citizens.”

https://thehill.com/opinion/healthcare/477547-should-access-to-life-saving-medicines-be-determined-by-economic

Posted in Economic Issues, Education, Good Stress, Leadership, Medical conditions and illness, Organizational structure, Patient Safety, Philosophy, Policy Issues, Stress, Technology, Uncategorized

The Problem – Center For Humane Technology

The extractive attention economy is tearing apart our shared social fabric.

The companies that created social media and mobile tech have benefited our lives enormously. But even with the best intentions, they are under intense pressure to compete for attention, creating invisible harms for society.

Today’s tech platforms are caught in a race to the bottom of the brain stem to extract human attention. It’s a race we’re all losing.
The result: addiction, social isolation, outrage, misinformation, and political polarization.

These aren’t disconnected issues. They are part of human downgrading.
https://humanetech.com/problem/

Posted in Free Society, Government Regulations, Liberty, Philosophy, Policy Issues, Progressivism, Rule of Law, Science and the Sexes, U.S. Constitution, Uncategorized

Preferred Pronouns or Prison | PragerU

“The State can’t force people to say things they don’t believe.”

Justice Robert Jackson – West Virginia State Board of Education v Barnette (1943)

Source: Preferred Pronouns or Prison | PragerU

Posted in Education, emotional intelligence, Free Society, Philosophy, Stress, Technology, Uncategorized, Unsettled Science

How Would Dostoevsky Have Responded to the Smartphone? | Intellectual Takeout

“The proliferation of digital technology has created an interesting paradox: devices that were designed to connect people have coincided with increasing rates of isolation, with nearly half of Americans reporting feelings of loneliness. Gen Z, the generation that has grown up immersed in a culture of communication technology, has fared the worst.

It turns out that this paradox of isolation and connection is nothing new. Fyodor Dostoevsky observed a similar trend in his own day. In Dostoevsky’s work, Brothers Karamazov, Father Zosima describes the isolation of Russian society in the late 1800s: “We are assured that the world is becoming more and more united, is formed into brotherly communion, by the shortening of distances, by transmitting of thoughts through air.”

Do not believe them, he tells us. According to Dostoevsky, the seeming connectedness of Russia at the time was only a thin veneer covering the reality of a deeply isolated and lonely society. Another character in the book explains:”

[Isolation is] that which is now reigning everywhere, especially in our age… For everyone now strives most of all to separate his person, wishing to experience the fullness of life within himself, and yet what comes of all his efforts is not the fullness of life but full suicide, for instead of the fullness of self-definition, they fall into complete isolation. For all men in our age are separated into units, each seeks seclusion in his own hole, each withdraws from the others, hides himself, and hides what he has, and ends by pushing himself away from people and pushing people away from himself….

Source: How Would Dostoevsky Have Responded to the Smartphone? | Intellectual Takeout

Posted in Economic Issues, Education, emotional intelligence, Entrepreneurs, Income Inequality, Organizational structure, outcomes measurement, Policy Issues, Poverty, Technology, Uncategorized, Wealth

Watch “Jordan Peterson | Using Money Productively” on YouTube

Welcome to another edition of Friday’s Philosophical Foray Beyond Healthcare brought to you by the Sovereign Patient blog.

Professor Peterson discusses the implications of the genetic lottery, hard work, success, competence hierarchies, merit and fairness as determinants of social stability in a post-industrial age.