A MODEST PROPOSAL FOR RIGHTING THE SHIP

Part 1: The FDA

“15To the pure, all things are pure, but to those who are corrupted and do not believe, nothing is pure. In fact, both their minds and consciences are corrupted. 16They claim to know God, but by their actions they deny him. They are detestable, disobedient and unfit for doing anything good.” Titus 1:15-16

SARS-CoV-2 and it’s attendant COVID-19 has taught us an invaluable lesson or at least it should have. If you do not understand by now that the incestuous relationship between the pharmaceutical industry and our public health and medical research agencies is corrupt to its core and has wantonly killed millions of people around the globe in pursuit of wealth and power then you’ve lived the last two years with your head deep in the sands of lies they’ve told.

This relationship must be ended. Unfortunately the tentacles of the pharmaceutical industry are legion and have increased in numbers beyond our wildest imaginations so that there is now hardly a health related activity that they do not control and when the do see one creep up — they kill it. And so it is time that We, The People take our lives back from them.

The way to do this is to leave the pharmaceutical industry alone. Let them make any useless vaccine or chemotherapeutic agent or drug that they wish . Wish them well.

Now on to the Alphabet Health Agencies, the great AHAs.

The Food and Drug Administration (FDA)

Take them down and take them down now.

How?

Cut their money off.

A full 24% of FDA funding (see below) comes from “user fees” paid by the pharmaceutical companies. The FDA User Fee Program “…help(s) the Food and Drug Administration (FDA) to fulfill its mission of protecting the public health and accelerating innovation in the industry.” Here is a description of one Congressionally authorized user fee paid by the industry for prescription drugs.

In FY 2020, FDA had net collections of $1.020 billion in prescription drug user fees, spent $1.075 billion in user fees for the human drug review process, and carried a cumulative balance of $194 million forward for future fiscal years.

PDUFA user fees and non-user fee appropriations in FY 2020 supported 4,350 full-time equivalents, including salaries and operational expenses, to support the process for the review of human drug applications. Detailed program accomplishments can be found in the FY 2020 PDUFA Performance Report.

In case you’re wondering, a “full-time equivalent” (FTE) means the salary and other expenses needed to support ONE full time employee. This one user fee pays for the equivalent of 4,350 full time employees. The following is summary of the fee, the amount and the number of FTEs the pharmaceutical industry fee “supports”. In this instance it might be reasonable to say “employees”.

Program Fee FTEs

Animal Generic Drugs $24 M 116

Prescription Drugs $1,020 M 4,350

Animal Drugs $31 M 364

Bio-similar Drugs $38 M 135

Generic Drugs $483 M 2,106

Medical Devices $295 M 1,399
Total $1,891,000,000 8,470

The FDA’s FY 2020 Budget Request was $6.1 B dollars IN ADDITION to the User Fees. In other words user fees represent a bit more than 24% of the total FDA budget and the funding for roughly 47% of its 18,062 FTEs.


The CARES Act

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), signed into law March 27, 2020, provides over $2 trillion of economic relief to workers, families, small businesses, industry sectors, and other levels of government that have been hit hard by the public health crisis created by the Coronavirus Disease 2019 (COVID-19)

IF — your response to this is “HUH???” its the right response because it is a content free description that tells us nothing. But here’s one of things that we know for certain that the CARES Act pays for — payments to hospitals for COVID-19 related “expenses”.

Those hospital payments include:

• A “free” required PCR test in the Emergency Room or upon admission for every patient, with government-paid fee to hospital.

• Added bonus payment for each positive COVID-19 diagnosis.

• Another bonus for a COVID-19 admission to the hospital.

• A 20 percent “boost” bonus payment from Medicare on the entire hospital bill for use of Remdesivir instead of medicines such as Ivermectin.

• Another and larger bonus payment to the hospital if a COVID-19 patient is mechanically ventilated.

• More money to the hospital if cause of death is listed as COVID-19, even if patient did not die directly of COVID-19.

• A COVID-19 diagnosis also provides extra payments to coroners.

Why did I include the CARES Act here? Because the pharmaceutical industry makes the test kits and they make the vaccine and they make Remdesivir and the FDA approves regulates all of it including the ventilators. Hospitals are making money from COVID hand over fist.

One Last Piece

In 2020 the Director of the FDA was Scott Gottlieb, M.D. Doctor Gottlieb, upon leaving the FDA became a member of the Pfizer Board of Directors.

How Do We Fix It?

We fix this by having the political will to the following:

• Ban FDA employee’s who are GS-12 and above, Senior Executive Service or Officers of the US Public Health Service from employment in any entity regulated by the FDA for a period of ten years following their departure from government Service.

• Ban any person who worked for an entity regulated by the FDA from employment at the FDA for a period of ten years.

• Eliminate the User Fee Program and force the FDA to justify 8,470 FTEs that the User Fee Program supports. If they cannot then those positions will be eliminated.

• Reduce FDA discretionary spending by 50% and a 20% reduction in each subsequent budget year until discretionary spending reaches a ceiling of 1% of the total FDA budget.

• Eliminate the Emergency Use Authorization for vaccines.

• Demand that unless FDA produces compelling data to the contrary no off label use for any approved drug will be prohibited, discouraged or in any way disparaged.

This is a modest start.

The CDC is next.