An uncontrollable system

And how it impacts your health

In concluding my questions to Congressmen Jim McGovern, I note how the biologics division at the FDA and the CDC are out of control. In particular, I considered how a positive feedback loop appears to have been created such that the manufacturer’s trial data showing evidence of harm and ineffectiveness is now interpreted as safe and effective.

Questions for Jim McGovern

This article explores this topic by using basic control theory, my specialty, to show how to create a stable and robust system to reject disturbances such as dangerous vaccines in order to ensure that they will not be administered to the general public. In presenting this model of control I can then show how to compromise this system to render it unstable such that its output, the total number of dangerous vaccines, will grow unbounded and supplied to the general public. Now, the system of ensuring a safe and effective vaccine supply is complex and has many mechanisms which can help protect the public from harm. I plan to add details to this model; however, I would like to first summarize some of the key mechanisms for sensing and control which have been compromised:

• liability protection (control), first in 1986 the Vaccine Injury Court was created by Congress to remove liability from the manufacturer for all childhood vaccine injury claims more recently the Prep Act was created to remove liability from the manufacturer and the government for any countermeasure such as vaccines and therapies such as Remdesivir

• limit safe and effective therapies (control), effective early treatment for SARS-CoV-2 infections continue to be ruthlessly suppressed; however, I did not fully appreciate the depth of the treachery until watching the Eulogy for a selfless Truth Warrior (Dr. Zelenko who died this past 06/30/2022) when at the nine-minute mark we watch how BARDAs Dr. Rick Bright prevented Donald Trump from making HCQ, a zinc ionophore, readily available to the American public which could have stopped the pandemic in its tracks.

• limit a parent’s ability to protect their children from further vaccine injury (control), after being freed of liability from harm BigPharma focused its sites on state legislatures by creating vaccine mandates which remove children from school and their services (even online) if they do not receive every vaccine on the CDC schedule.

• use kangaroo committees that approve dangerous vaccines from being added to the CDC schedule (control), the FDA and CDC rely on “advisory committees” such as ACIP to review manufacturer safety data and vote to offer a “recommendation” for approval. Many of the members have deep ties to Big Pharma and “serve” mostly to provide cover for the regulators for if they tred too far from the consensus they could soon see themselves replaced with “temporary” voting members.

The remaining parts of this article are as follows:

• A proposed mathematical model to describe the regulation of vaccines

• A case study on how this model relates to the 1976 Swine Flu vaccine.

• The creation of a baseline for a functioning regulatory agency’s authority

• A proposed definition for regulatory capture followed by a discussion on GBS injuries incurred following the administration of COVID-19 vaccines

• With a conclusion on what we learned and some key questions on what can be done to bring our system in control and halt the COVID-19 vaccination program.

A Control Model for the Regulation of Vaccines

Definitions:

1. Vaccine supply desired (S_d >= 0): The manufacturer desires to produce S_d millions of doses per week for the American public. It is somewhat guided by what the CDC demands from the manufacturers yet is ultimately driven by profit, as they have no liability for injuries caused by their product when supplied under an Emergency Use Authorization (EUA).

2. Regulating authority (k_authority >= 0): the regulating authority an agency exerts to insure a safe and effective vaccine will be non-negative. If the regulating authority is zero then the manufacturer will be able to introduce all of their desired vaccine supply to the American public even if every vaccine injures every vaccine recipient.

3. The free press (0 <= f_p <= 1): If a free press is completely free and not controlled by government regulation and funding then f_p will have a value of one, if the press is completely captured then the value is zero.

4. Effective authority (k_effective): Is the product of the regulating authority and the free press.

5. Vaccines per week (vaccines_per_week >= 0): Is the number of vaccine doses administered to the American public each week.

6. Total vaccines (vaccines_total >= 0): Is the total number of vaccines administered to the American public since the initiation of a vaccination program. It is the integral of vaccines per week with respect to time, t, in which time is denoted in weeks.

7. Probability of injury (0 <= p_d <= 1): Is the probability a vaccine recipient will be injured from the vaccine. In the limits p_d = 0 if the vaccine is entirely safe and results in no injuries, conversely if p_d = 1 then every vaccine administered will result in an injury.

8. Reported injuries (reportedInjuries >= 0): Is the total reported injuries to a publicly accessible vaccine monitoring system such as VAERS following vaccination of a given group or type (ie. one could consider the total reported deaths following vaccination as another injury type such as Guillain-Barre Syndrome (GBS) or all death and injuries).

9. Total injuries (totalInjuries >= 0): Is the total number of injuries caused by the total vaccines administered to the American public. The CDC claims that the Vaccine Safety Datalink (VSD) is an accurate measure of total injuries; however, it can not be audited by the American public. Independent second parties can try to estimate the total injuries by surveying the American public.

10. Under-reporting factor (1 <= URF < infinity): The under-reporting factor is the ratio of total injuries to reported injuries.

Relationships:

1. vaccines_per_week = (S_d - TotalInjuries x k_authority x f_p )

2. TotalInjuries = URF x reportedInjuries = p_d x vaccines_total.

Observations:

1. The distribution of vaccines halts when the (total injuries/(k_authority x f_p)) is greater than the supply demanded by the manufacturer, therefore the effective authority is the ratio of the doses per week to the total allowable injuries required to halt the program.

2. The program will halt after (3/(p_d x k_effective)) weeks.

Case Study the 1976 Swine Flu Vaccination Program

Many will refer to the Swine Flu vaccination program as a “fiasco” or a “debacle”, however, I would argue that it was a success and provides an excellent opportunity to estimate a functioning regulatory system that successfully identified a dangerous vaccine, removed it from the general population and may have even compensated some of the victims. In order to complete our analysis, we rely on the following:

1. Neustadt RE, Fineberg HV. The Swine Flu Affair: Decision-Making on a Slippery Disease. Washington (DC): National Academies Press (US); 1978. C, Swine Flu Chronology January 1976-March 1977.

   • 1976-07-22 – American Insurance Association sends memo to Cooper; explains that the industry refuses to provide coverage because: (1) the legal climate is too unsettled to permit actuarial calculation, (2) the casualty insurance industry lost more than $7 billion worldwide underwriting product liability in 1974 and 1975, and (3) the insurers feel that the Federal Government ought to defend all claims

   • 1976-08-12 President signs the Tort Claims bill into law, PL 94-380

   • 1976-10-1 first swine flu shots given

   • 1976-10-11 three elderly Pittsburgh people die shortly after receiving inoculation at same clinic

   • 1976-10-12 preliminary autopsy results are released on two of the three elderly persons whose deaths touched off the scare; results indicate that cause of death in each case was heart attack; however, Allegheny County Coroner Dr. Cyril Wecht sounds skeptical on the TV Evening News; suggests deaths may not have been coincidental

   • 1976-10-22 CDC announces 41 deceased vaccinees to date; still no known connection to vaccine

   • 1976-12-14 CDC issues press release on Guillain-Barré; says that 54 cases in 10 states have thus far been reported, and of the 54, 30 received shot anywhere from one to thirty days before onset of symptoms

   • 1976-12-17 (11 weeks since the program began) Kennedy subcommittee holds a hearing; chairman says program is dead, and Cooper agrees that it would be difficult to get the program started again, if and when such is recommended; Foege estimates the incidence of Guillain-Barré in vaccinated group is about four times greater than normal

   • 1976-12-30 – President tells TV news reporters that he concurred in the December decision to suspend

   • 1977-01-06 Assistant HEW Secretary for Health, Dr. Theodore Cooper announces resignation, effective Inauguration Day

   • 1977-01-14 ACIP meets in Atlanta and concludes that the moratorium on all influenza vaccine ought to be lifted; observes that flu shots do appear to entail some slight additional risk of contracting Guillain-Barré (estimated at one case for every 100,000 to 200,000 vaccinations)

   • 1977-01-20 Califano sworn in as Secretary of HEW

   • 1977-02-04 Califano sends a memo to President Carter, summarizing the history of the moratorium

   • 1977-02-04 Justice Department reveals that 104 damage claims have been filed against the Federal Government under PL 94-380; total value is almost $11 million

   • 1977-02-07 During meeting it becomes known that Califano wants Sencer's resignation as director of CDC

   • 1977-03-11 Califano convenes an ad hoc, advisory panel to make suggestions and recommendations on flu vaccine policy for the next year … swine flu vaccine is not recommended

2. Wade N. 1976 Swine Flu Campaign Faulted Yet Principals Would Do It Again New Series, Vol. 202, No. 4370 (Nov. 24, 1978), pp. 849+851-852.

   • 48 million citizens were inoculated

3. Wallace M. 60 Minutes: Swine Flu (1976) November 4, 1979.

   • 300 claims [are] now pending from the families of GBS victims who died

     Well 46 million of us obediently took the shot, and now 4,000 Americans are claiming damages from Uncle Sam amounting to three and a half billion dollars because of what happened when they took that shot. By far the greatest number of the claims – two thirds of them are for neurological damage, or even death, allegedly triggered by the flu shot.

4. Netto, A.B., Taly, A.B., Kulkarni, G.B., Rao, U.G. and Rao, S., 2011. Mortality in mechanically ventilated patients of Guillain Barré Syndrome. Annals of Indian Academy of Neurology, 14(4), p.262.

   The objective of our study was to analyze the circumstances and factors related to mortality in mechanically ventilated patients of GBS. The mortality was 12.1%.

5. Schonberger, L. B., Bregman, D. J., Sullivan-Bolyai, J. Z., Keenlyside, R. A., Ziegler, D. W., Retailliau, H. F., ... & Bryan, J. A. (1979). Guillain-Barré syndrome following vaccination in the national influenza immunization program, United States, 1976–1977. American journal of epidemiology, 110(2), 105-123.

   The estimated attributable risk of vaccine-related GBS in the adult

   population was just under one case per 100,000 vaccinations.

   The relative risks in the adult population overall for the six weeks

   following vaccination was 7.6 [as compared to the background rate of GBS].

6. Hughes, R.A. and Cornblath, D.R., 2005. Guillain-barre syndrome. The Lancet, 366(9497), pp.1653-1666.

   In 25% of cases, weakness of the respiratory muscles requires artificial ventilation.

The baseline for a functioning regulatory agency

Before Senator Kennedy and his committee shut down the Swine Flu vaccination program we had 41 reported deaths and 54 reported cases of GBS. Yet within that timeframe, we also had an estimate by the CDC that the rate of attack was four times greater than normal and after the suspension of the program, the risk of developing GBS from the swine flu vaccine was somewhere between one in 100,000 to one in 200,000 vaccinations. The implicit admission by the CDC is that the URF was (48,000,000/100,000)/54 which equals 480/54 roughly nine times. This estimate is apparently confirmed three years later by Schonberger et all who confirm the risk of developing GBS to be one in 100,000 vaccinations amounting to 7.6 times greater than the background rate during that six-week vaccination campaign. However, even with active surveillance, the analysis appears to have fallen far short. This estimate would mean that 480 Americans developed GBS which we would expect (480/4) 120 would have been ventilated and of those 12% would have died resulting in 14 dead Americans from the Swine Flu vaccine. However, this is clearly a nearly impossible result as Mike Wallace reported that 300 claims were filed on behalf of the dead victims’ families who succumbed to GBS. This means the URF is not nine but probably at least (300/(.12*.25))/54 which equals ten thousand actual cases divided by the fifty-four reported cases on 1976-12-14, URF=185! In which the risk of developing GBS was not one in one hundred thousand but possibly as high as one in (48,000,000/10,000) one in 4,800 swine flu vaccinations.

With at least 2,500 GBS injured Americans requiring ventilators, it seems unsurprising that Mike Wallace reported that two-thirds of the 4,000 injury claims involved neurological injury (2,667). Accounting for inflation, roughly every claimant was asking for $3,000,000. Yet questions remain. How many Americans failed to file a claim? Were they ever compensated? The second-largest number of flu vaccines administered in a single season before 76 was half this amount. Roughly, half a million doses were given per week as compared to the five million per week in 1976. Is it a small wonder that attack rates were roughly 10 times the background rates (5 cases per week) reported in Schonberger et all? To date, GBS is one of the table injuries listed for compensation in the vaccine injury court.

For simplicity of discussion, we shall use the following numbers for the 76 Swine flu.

1. The Vaccine supply desired, supply_desired, was 5 million doses per week.

2. Only 54 reports of GBS occurred before the Swine flu vaccine was halted, the CDC eventually admits the URF was at least nine; however, the 300 dead victims of GBS imply a more accurate estimate of 185.

3. The total number of GBS injuries, TotalInjuries, was at least 10,000 Americans.

4. The effective authority, k_effective, was 5,000,000/10,000 which equals 500 doses per injury per week.

5. The probability of GBS injury, p_d, was one in five thousand doses.

6. At least 300 Americans died from the swine flu vaccine due to GBS probably many more died due to the unexplained 41 reported deaths which appeared unrelated to GBS injuries, i.e. heart attacks.

The model predicts that the campaign would completely halt in 3/(500/5000) 30 weeks. However, it was discontinued after eleven weeks which is approximately the time constant of our proposed model of 10 weeks. Our model would have throttled the delivery rate by at least 67% after 10 weeks. Other, factors such as the 41 reported deaths, probably came into play for the committee’s decision to halt the program. It is notable that none of the reported deaths were connected to GBS in the briefing. Clearly, not all those killed from the swine flu vaccine were due to GBS-related effects and would have played a significant role in guiding their decision. Finally, the committee felt compelled to act because the press was reporting on the injuries being incurred. This motivates our following proposed definition.

The regulatory capture ratio is the ratio of the effective authority for the agency that discontinued the swine flu vaccine, 500 doses per injury week, to the effective authority for an agency that should remove a dangerous vaccine.

The COVID-19 Vaccination Campaign 2021-present

The CDC has provided little evidence to date that their passive vaccine safety monitoring system, VAERS, is any better or worse than the monitoring systems used in 1976. Therefore, we shall assume the URF of 185 for reporting GBS following vaccination. As of July 10, 2022, nearly 600 million COVID-19 vaccines have been administered to Americans. An average weekly rate of 600/82 7.3 million doses per week. The campaign has not halted and appears as if it will never be halted because they can’t prevent infection and may have been able to prevent a single case of death of the original strain for every 20,000 vaccinations given yet continue to fail in every meaningful way. For simplicity of discussion, we shall assume that if the campaign was halted on July 10, 2022, what would be the resulting regulatory capture ratio as it related to GBS injuries following COVID-19 vaccination in the USA.

According to VAERS reports, there have been:

1. 895 reported cases of GBS of which 18 died (2%) which is slightly less than our estimated mortality rate for GBS of 12/4 (3%). Notably, the known reported cases of GBS were 50% male and 50% female; however, the men accounted for two-thirds of the reported deaths thus making them twice as likely to die from GBS following vaccination than the females. The increased death-rate risk appears to be more consistent with Hughes's observation in the Lancet that “All reports agree that men are about 1·5 times more likely to be affected than are women” whereas the reported case rate is no difference between the two populations.

2. For comparison, during this time frame, 31 cases were also reported following all administration of influenza shots. This shows that the attack rate is roughly (895/(2x31)) fourteenfold.

Therefore, these reports allow us to draw the following conclusions for the current program as it relates to GBS following COVID-19 vaccinations:

1. The Vaccine supply desired, supply_desired, was 7.3 million doses per week.

2. 894 reports of GBS occurred which included 18 deaths.

3. The total number of GBS injuries, TotalInjuries, could be at least 894 x 185 = 165,390 Americans if the URF is 185.

4. The effective authority, k_effective, will be 7,500,000/165,390 which equals 45 doses per injury per week.

5. The probability of GBS injury, p_d, is one in 3,630 doses for COVID-19 vaccines.

6. At least 4,962 Americans died from the COVID-19 vaccine due to GBS.

7. The regulatory capture ratio would be (500/45) 11.1 if the COVID-19 vaccine program was halted today.

8. Assuming GBS victims would require $3.5 million per claim we can estimate the government’s liability could be as much as $580 billion dollars just for these victims if the URF is as high as 185. This accounts for just the tip of the iceberg for injuries which will probably go down in history as the most dangerous medical intervention ever to be mandated on the American people.

Conclusion

The motivation behind this paper was to attempt to measure how captured the CDC and FDA biologics division as it relates to the COVID-19 vaccination campaign. If we simply compare the injuries related to GBS following vaccination then if the program was halted on July 10, 2022, the loss in regulatory authority would be over tenfold. Yet the consequences are immense. Senator Ted Kennedy’s committee canceled the Swine Flu vaccination campaign and 4,000 injured Americans filed claims totaling $3.5 billion. We don’t know if the 4,000 injured Americans who filed for help ever received any aid from the government.

What we did learn, however, was astounding, in spite, of the continued narrative that the swine flu vaccine campaign only injured 480 Americans with GBS at a rate of one per one hundred thousand doses. The injury rate appears to possibly be at least one case of GBS for every five thousand doses administered because at least 300 alleged Americans died from GBS following a swine flu vaccination, and possibly 3% of people died from GBS. This could result in an underreporting factor of at least 185 (which suggests the CDC’s “active reporting” URF was at least 9). If the URF is as high as 185 then at least 165,000 Americans could be injured with GBS following the COVID-19 vaccine of which 41,250 would probably need to be intubated. GBS injuries following the COVID-19 vaccine could be nearly half a trillion dollars, a tip of the iceberg estimate. The consequences of this loss of regulatory capture are immense and are a direct result of removing a free-press corp. The CDC received over $3 billion dollars into effectively “marketing” these untested vaccines in which

funds could be used to identify and train trusted members of the community to conduct door-to-door outreach to raise awareness about COVID-19 vaccines and help individuals sign up for appointments.

Furthermore, the administration banned any reporting of information related to the safety of these mandated vaccines as it may cause vaccine hesitancy. Can the mainstream media free itself from the control of the federal government in order to stop this disaster? Have we reached the point of no return? What else can be done to stop this apparent medical catastrophe?

Addendum/ Updates

After further review of The Swine Flu Affair on p. 61 and 62, we get a confirmation that their initial estimates of the rate of death were one in (2,000,000/105,000) nineteen cases of GBS (our estimate from the Lancet and Annals of Indian Neurology suggest it should be one in thirty-three). If we use the smaller number 19 then our URF would be reduced to 110. From the Swine Flu Affair (pp. 61-62):

The risk of developing Guillain-Barré syndrome seemed to be eleven times greater with vaccination than without. But the risk was still remote, about 1 in 105,000, and the risk of death but 1 in 2 million. [a tacit admission that at least 23 Americans died from the Swine flu vaccines due to GBS]