FDA’s Culture: When Perfect Becomes the Enemy of the Good

An organization’s culture is an internal set of shared values, goals, 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, typically with a top-down, established chain-of-command. Unlike a risk-taking culture, this structure features policy,…

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Cognitive Testing for DBS Surgery Is Unproven and Can Be Counterproductive

Earlier this year, my neurologist referred me to a neuropsychologist for a four-hour assessment to ascertain whether I qualify to undergo Deep Brain Stimulation (DBS) for Parkinson’s disease (PD).  This practice is the industry standard.  For example, the Parkinson’s Foundation says that neuropsychological testing is strongly recommended before proceeding with DBS. The Michael J. Fox…

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THE FDA IS NOT ORGANIZED TO MEET TODAY’S CHALLENGES

The Food and Drug Administration (FDA) is responsible for the oversight of more than $3 trillion per year in spending for food, medical products, and tobacco. It does an excellent job in fulfilling its mandate of consumer safety for these items.  However, the FDA was formed long before spiraling healthcare costs became the industry’s not-so-hidden…

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The Case to Realign Parkinson’s Disease Research

Crocodile and a tortoise laying the grass together

If asked, the leaders of the research organizations working on Parkinson’s disease would say that they have made tremendous progress and are optimistic on finding a cure for the disease. In truth, this viewpoint understates the magnitude of the challenge and results in insufficient resources being devoted to PD. Given the size of the challenge…

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FDA’s Culture: When Perfect Becomes the Enemy of the Good

An organization’s culture is an internal set of shared values, goals, 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, typically with a top-down, established chain-of-command. Unlike a risk-taking culture, this structure features policy,…

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HEALTHCARE TODAY – A PERSONAL ACCOUNT

A man walking in the snow wearing a cap

The following letter was sent via Priority Mail to the CEO of Reston Hospital Center on March 19, 2021. It catalogs my experience at the Hospital over a 30-day period.  I received a response from the VP of Quality at the hospital dated May 9th containing various platitudes. For example, the VP says: “We are sorry…

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“Medicare for All” Would Be an Operational Disaster and Would Not Fix the Real Problem with Healthcare

I. Introduction In his call for “Medicare for All”, Bernie Sanders is silent on the implementation and the operational details of his proposal. That is a big oversight because what he is proposing would be extraordinarily difficult to implement and operate, subjecting over 150 million people to the risk of deteriorating healthcare brought on by an…

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A New Approach for Drug Approvals in the Age of “Big Data”

I. Introduction and Summary The amount of health-related information available to researchers is expanding exponentially as a result of the technical advancements in the world of “Big Data”. To most people, this signifies a quicker path to cures of debilitating diseases and/or to better care of people on a personalized basis. But that is not…

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A PROPOSAL TO IMPROVE HEALTHCARE IN THE UNITED STATES

Introduction Americans spend about $3 trillion per year on healthcare, or about $10,000 per person per year. Despite these expenditures, Americans are worse off than their international counterparts with respect to infant mortality, life expectancy and the prevalence of chronic conditions. In policy debates, Republicans mostly prefer to let the marketplace devise the appropriate outcomes,…

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