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The FDA ’s Culture: Should Safety Dominate All Practices?
By STEVEN ZECOLA
An organization’s culture is an internal set of shared values, attitudes and practices. The cohesiveness of the organizational culture will affect whether the entity will meet its vision, purpose, and goals.
One type of organizational culture is hierarchical in nature. Unlike a risk-taking culture, this structure features policy, process and precision. It is best suited for mature and stable organizations.
The disadvantage of a hierarchal culture is that its stability and control can turn into rigidity. In many cases, the organization develops a negative attitude towards ideas s...
Source: The Health Care Blog - August 26, 2021 Category: Consumer Health News Authors: Christina Liu Tags: Health Policy FDA Parkinson's Disease Steven Zecola Source Type: blogs
George Halvorson HIMSS Changemaker Lifetime Achievement Award Acceptance Speech, Part 2
Former Kaiser Permanente CEO George Halvorson has written on THCB on and off over the years, most notably last year with his proposal for Medicare Advantage for All post-COVID. This month he was given a lifetime achievement award by HIMSS and we are running his acceptance speech in two parts. We ran part one last week, and here’s part two– Matthew Holt
We also initially have an important and continuously improving sense of the epigenetic processes that exist in all of us to develop our own responses to the world we are in at a biological level, and we should be able to use that information to improve ou...
Source: The Health Care Blog - August 23, 2021 Category: Consumer Health News Authors: matthew holt Tags: Health Tech Health Technology Early Childhood Education George Halvorson HIMSS Changemaker Lifetime Achievement Award payment models Source Type: blogs
If FDA Won ’t Rethink Rules on Off‐Label Drug Use, Courts Should
Walter OlsonAs Cato writershave longpointedout, the law takes a paradoxical stance toward so ‐called “off‐label” use of drugs approved for use by the Food and Drug Administration (FDA). On the one hand, it’s completely lawful for physicians to prescribe approved drugs for other than the FDA‐approved uses, and such uses are vital in everyday practice. Indeed, off‐la bel compounds oftenconstitute a “gold standard” of care in chemotherapy cancer treatments and other fields of medicine. On the other hand, the agency strictly prohibits makers of the compounds frompromoting such use, even when ...
Source: Cato-at-liberty - August 11, 2021 Category: American Health Authors: Walter Olson Source Type: blogs
Infrastructure Bill: Needless Expansion in Subsidies
Chris EdwardsCongress is considering a $550 billion increase in federal infrastructure subsidies. The subsidies and related new regulations will be damaging for many reasons, asRandal O ’Toole and I have noted.If Congress wanted to raise highway and transit spending, it could have done so with a one‐page bill, but the bill being considered is 2,702 pages. What is in all those pages? Likely, many new mandates and red tape that will reduce the freedom and autonomy of states, businesses, and individuals. Infrastructure bill supporter Senator Rob Portman (R-OH)claims that the bill will speed project permitting, but ...
Source: Cato-at-liberty - August 5, 2021 Category: American Health Authors: Chris Edwards Source Type: blogs
Anti ‐Vaxxers Turn to Big Government
Thomas A. FireyCOVID-19hospitalizations anddeaths are rising in the United States as the highly infectious Delta variant of the SARS-CoV-2 virus has becomethe dominant strain in the country. These serious cases arealmost entirely limited to people who are not vaccinated against the virus; for the vaccinated,infection rates are much lower and nearly all infections are no more troublesome than a cold or — at worst – a bout of the flu, and often go unnoticed altogether.COVID-19 causedat least11 percent of all U.S. deaths in 2020, making it thethird leading cause of death, behind only heart disease and cancer. So far in 20...
Source: Cato-at-liberty - August 2, 2021 Category: American Health Authors: Thomas A. Firey Source Type: blogs
Sunday Sermonette: Thuffering Thuccotash
Judges 12 describes what might be called the first civil war among the Israelites, though I ' m not sure that ' s really accurate since they don ' ' t have a central government and the religio-cultural unity created by the tabernacle and the pilgrimages seems to have vanished. Anyway, just to clarify the geography, the territory of Ephraim -- or I should say the putative territory, this is all fiction -- was in what is today central Israel on the west side of the Jordan. Jepthah and his army are based in Gilead, on the east side, in what is today Jordan. So what happens here is that the Ephraimites cross the river and end ...
Source: Stayin' Alive - July 18, 2021 Category: American Health Source Type: blogs
Life sciences vision
Department for Business, Energy& Industrial Strategy - This document outlines government and the life science sector ’s ambitions for the sector over the next decade. It sets out the government's plans to stimulate a thriving UK life sciences sector. It also focuses on how the sector can address the some of the UK ’s most significant healthcare challenges, including cancer, dementia, and obesity.DocumentPress release
Source: Health Management Specialist Library - July 12, 2021 Category: UK Health Authors: The King ' s Fund Library Tags: Digital health and data Source Type: blogs
On the bias of science: Part three
Okay, we have established that universities, as a class, do not have any agenda or preference for that the outcome of scientific investigations will be. The exceptions, obviously, are institutions like Liberty University, Bob Jones, and Oral Roberts, that deny evolution and cosmologya priori. But at colleges and universities that are not run by religious fanatics, faculty investigators are independent and they pursue their own lines of research, conduct investigations of their design, and interpret the results as they understand them. We have also established that the government does not have any agenda or preference for w...
Source: Stayin' Alive - July 11, 2021 Category: American Health Source Type: blogs
The explosion of mental health apps raises substantial opportunities –and tough questions
In the eyes of the tech industry, mental health treatment is an area ripe for disruption.
In any given year, 1 in 5 adults in the U.S. experience a form of mental illness, according to federal estimates. And research indicates only about half of them receive treatment in a system that is understaffed and ill distributed to meet demand.
For tech startups looking to cash in on unmet need, that translates into more than 50 million potential customers.
Venture capital firms invested more than $2.4 billion in digital behavioral health apps in 2020 — more than twice the amount invested in 2019 — touting support or treatment ...
Source: SharpBrains - June 28, 2021 Category: Neuroscience Authors: Kaiser Health News Tags: Brain/ Mental Health Technology & Innovation anxiety BetterHelp brain-illness Brightside cerebral depression digital behavioral health FDA Food and Drug Administration Ginger health apps mental illness mental-health-treatment Source Type: blogs
Does the DEA Have to Allow Psilocybin Access for Terminally Ill Patients?
Trevor BurrusA case at the Ninth Circuit is seeking to compel the DEA to allow psilocybin (magic mushrooms) use by terminally ill patients. The case,Advanced Integrative Medical Science Institute v. DEA, has been brought by a research institute, a doctor, and two terminal cancer patients who wish to use psilocybin.A lot has changed in psilocybin research in recent years. In 2018 and 2019, the FDAdesignated two psilocybin trials as “breakthrough therapies” for treating severe depression.Breakthrough ‐therapy status can be granted by the FDA when a new drug shows significant improvement over currently...
Source: Cato-at-liberty - May 28, 2021 Category: American Health Authors: Trevor Burrus Source Type: blogs
Let ' s Talk About Hospitals And Rural Healthcare (Particularly Mother-Baby Care): My Letter To The NC Government Commission/NC State Treasurer In Support Of Randolph County ' s Application For A Loan To Save Randolph Health
Author ' s Note: The lawyers have a saying, " Res Ipsa Loquitur " " . Translated from Latin, it means, " The thing speaks for itself " . This is the text of the letter I sent to theNC Local Government Commission (embellished with a few links and additional comments in red) . . .in support of the state of North Carolina granting a loan to Randolph County (via the NC Rural Healthcare Stabilization Act) . . . for purposes of assisting in the " rescue " of Asheboro ' s Randolph Health - in a bankruptcy Court-approved buy-out of Randolph ' s assets by American Healthcare Systems, LLC.On May 4th, afte...
Source: Dr.J's HouseCalls - May 7, 2021 Category: American Health Tags: Asheboro Atrium Health Bankruptcy Cone Health Duke Lifepoint LGC Medical Whistle-blower Mother-Baby Care NC Rural Heatlh NCDHHS Non-profit Randolph Health UNC Health Wake Forest Baptist Source Type: blogs
Health Data Privacy Gets the Attention It Deserves
The Partners in Privacy Conference gathered world-class experts to address some of health care ’s most vexing problems.John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform, wrote this article.The challenges involved in keeping patient and consumer health data private may seem daunting. Still, a recent virtual conference hosted by Mayo Clinic brought together over 80 world-class experts to address the issues. Their insights are worth a closer look.During his opening remarks atPartners in Privacy Conference: The Ethical and Respon...
Source: Life as a Healthcare CIO - May 5, 2021 Category: Information Technology Source Type: blogs
Healthcare AI, Limiting Biases, and Gold Standard Data Sets: Exclusive with Vatsal Ghiya, CEO of Shaip
Shaip is an online platform that focuses on healthcare AI data solutions and offers licensed healthcare data designed to help construct AI models. It provides text-based patient medical records and claims data, audio such as physician recordings...
Source: Medgadget - May 4, 2021 Category: Medical Devices Authors: Alice Ferng Tags: Exclusive Informatics Source Type: blogs
On Med Mal Reform, Democrats Are More Libertarian than Republicans
Michael F. CannonIn a recentpost, I announced the release of and provided excerpts from Cato’s latest health policy book,Medical Malpractice Litigation: How It Works, Why Tort Reform Hasn ’t Helped, by Bernard S. Black,David A. Hyman, Myungho S. Paik, William M. Sage, andCharles Silver (foreword by former Senate Majority Leader Tom Daschle).Medical Malpractice Litigationcompiles original research from states that capped damages in “med mal” cases to show that such reforms do not have the effects that physicians and other supporters claim. If anything, damage caps benefit physicians and insurance companies at th...
Source: Cato-at-liberty - May 3, 2021 Category: American Health Authors: Michael F. Cannon Source Type: blogs
Fight Aging! Newsletter, May 3rd 2021
Fight Aging! publishes news and commentary relevant to the goal of ending all age-related disease, to be achieved by bringing the mechanisms of aging under the control of modern medicine. This weekly newsletter is sent to thousands of interested subscribers. To subscribe or unsubscribe from the newsletter,
please visit:
https://www.fightaging.org/newsletter/
Longevity Industry Consulting Services
Reason, the founder of Fight Aging! and Repair Biotechnologies, offers strategic consulting services to investors, entrepreneurs, and others interested in the longevity industry and its complexities. To find out m...
Source: Fight Aging! - May 2, 2021 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
