Treatment Policies, Regulatory Guidance, and Patient Care

Some readers and listeners may recall that I testified at the behest of the Texas Senate Health and Human Services Committee Hearing on June 27, 2022 regarding the COVIDcrisis, public health response and the vaccines.. My prepared remarks which were presented at that time can be found at this Substack link.

During this testimony. I was asked to specifically comment on Treatment Policies, Regulatory Guidance, and Patient Care, with a particular focus on the capacity for infectious disease control services provided in the state of Texas. The objective was to ensure that the state has transparent, data-driven recommendations on public health matters; and to consider establishing an independent, transparent state-based regulatory authority for developing and distributing disease treatment.

As of today, the report generated from this testimony has now been made available for public review.

For the section regarding Treatment Policies, Regulatory Guidance, and Patient Care, the Texas State Senate Health and Human Services Interim Report general recommendations are as follows:

• Assess the capacity by which infectious disease control services are provided in Texas. Ensure the state has transparent, data-driven recommendations on public health matters; and consider establishing an independent, transparent state-based regulatory authority for developing and distributing disease treatment.

• Examine statutory changes to ensure patients have access to prescriptions submitted by licensed physicians in Texas related to COVID-19;

• Prohibit future mask mandates;

• Prohibit COVID-19 vaccine mandates and maintain that vaccines remain voluntary;

• Form a special committee/working group on medical censorship; and

• Establish a grant program accessible to Texas-based independent entities to conduct research on the adverse events of the COVID-19 vaccines directly associated with vaccine use.

  
  

The specific report section entitled “Treatment Policies, Regulatory Guidance, and Patient Care” reads as follows:

Treatment Policies, Regulatory Guidance, and Patient Care

(References are in the original document)

Throughout the early variant surges during the pandemic, various early treatment options emerged including hydroxychloroquine, ivermectin, Paxlovid, plasma infusions, and the use of steroids. Yet, there was little effort by agencies to catalog patients according to treatments received (15).

In most cases, the National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID) have been the primary decision-makers in terms of treatment policy and guidelines during the COVID-19 pandemic with little input from independent and or practicing physicians (16). Multiple studies submitted by physicians across the country have shown through the use of early treatment options there is a 95% reduction rate in hospitalization and death among those infected (17). Data reflecting the success rate of early treatment of the virus provide a potential blueprint for future outbreaks and infectious disease responses (18).

Instead, federal guidance, and subsequent guidance from DSHS, touted the need for mass vaccination against COVID-19. Little to no data on early treatment efficacy were collected from hospitalized patients, making effective treatments difficult to track(19). The use of early treatment measures varied according to federal guidelines and hospital policy (20). With the extension of Emergency Use Authorizations (EUAs) for the COVID-19 vaccines, the development of repurposed drugs and other strategies to combat the virus have been blocked by NIH and the Food and Drug Administration (FDA) due to requirements within the statutory language of EUAs (21).

Current numbers place the antibody rate for the state of Texas at 98%. (22). The rate is considered a combination of prior COVID-19 infections and vaccinated individuals. Despite the high antibody rate, and other factors associated with natural immunity, some hospitals continued to require vaccinations for employees.

When COVID-19 vaccine requirements for employees were first implemented, the initial understanding was immunity from vaccinations was much stronger than natural immunity, yet new information currently calls that understanding into question. Current data demonstrate that the vaccine has only reduced 20-30% of hospitalizations and deaths (23). With Omicron and its subvariants becoming the dominant strain, the evolution of the spike protein within the virus raises concern for the future efficacy of the vaccine along with the onset of immune imprinting (24). According to Dr. Robert Malone, immune imprinting occurs following a prior infection with the original COVID-19 strain, followed by vaccinations, and reinfection with Omicron which reveals a paradox in a reduction in neutralizing antibodies among an estimated 30% of the immunocompromised (25). This leads to a relatively selective immune deficiency leaving the specific population with a higher chance of chronic reinfection (26). Data from Lessons from COVID-19 suggests continual boosting exacerbates the reinfection rate, particularly due to the focus on the spike protein which has a high rate of mutation (27).

Additionally, the push for the expediency of the vaccine resulted in agencies bypassing long- standing clinical and nonclinical trial protocols (28). Vaccine trials failed to follow the normal process for clinical observations of at least 24 months with COVID-19 observational trials lasting two months (29). The vaccines remain listed as Emergency Use Authorization Investigative, which means they are unsure as to what adverse events may occur after a person receives the shot (30). As of June 2022, the CDC's VAERS data system, which catalogs adverse events from vaccines, reported 13,388 deaths in the United States associated with the COVID-19 vaccine (31). Worldwide, the largest vaccine databases have reported 40,000 deaths associated with the vaccine (32). According to Dr. McCullough, in less than one year the polio vaccine was recalled after 10 reported deaths, and the swine flu vaccine was recalled after 53 deaths (33). Yet no legislative body within the U.S. federal or state government has acted upon a global call to recall vaccines from the market following 28,000 reported associated deaths (34).

For patients, some hospital officials have reported they were treated regardless of vaccination status (35).3 During the Omicron surge, patients were tested before entry/treatment but were not denied treatment based on test results (36). Some reports indicated during the pandemic individuals were denied treatment due to their vaccination status (37). However, there are no data to determine if it was widespread or simply an isolated event. In the case of many hospitals in Texas, treatment protocols and infection mitigation were based on CDC and NIH guidance.*

(* Treatment protocols authorized under an EUA allowed the FDA to approve previously unapproved drugs to treat, diagnose, or prevent serious illness. COVID-19 vaccines were approved under EUAs along with certain drugs for use against COVID-19. The nature of the EUAs limited authority for use of certain treatments for COVID-19, restricting medical professionals from using unapproved treatments without an EUA).

The vacillating guidance on COVID treatments throughout the pandemic left unanswered questions as to why off-label treatments were deemed unsafe despite signs of efficacy during early treatment. Multiple medical associations, including the American Medical Association, have issued statements cautioning medical professionals from prescribing off-label treatments for COVID-19 patients (38). In certain cases, similar statements included language threatening the suspension or revocation of their medical license (39). Complaints associated with COVID-19 and patient care received by the Texas Medical Board (TMB) accounted for 1,863 from March 2020- June 2022 (40). Of the 1,863 complaints, 16 received remedial plans and three agreed to disciplinary orders (41).

Under the current administrative code, TMB allows physicians to prescribe off-label use, so long as full disclosure is provided to the patient and paperwork is included (42). The lack of clarity around board rules as well as media stories led physicians to fear disciplinary action for prescribing off- label drugs. In response, the Texas Medical Board (TMB) issued a statement clarifying the board does not prohibit any drug or treatment and that licensed physicians should not fear reprisal for their support of one or more COVID-19 treatments (43). Despite the TMB statement, medical professionals experienced reprisals for their actions related to COVID-19. Physicians across Texas have experienced complaints associated with their prescription of COVID-19 treatments and offering alternative narratives in opposition to the CDC and the FDA. TMB reports that, as of June 6, 2022, 361 complaints were filed pertaining to hydroxychloroquine and ivermectin, this includes complaints for both the prescribing and refusal to prescribe these medications (44).

Physicians and other health professionals have experienced a negative reaction to public comments related to vaccine efficacy and COVID-19 treatments. In a May 2021 Senate Health and Human Services Committee hearing, public statements by Dr. Peter McCullough have been deemed as misinformation and subject to reprisal by the American Board of Internal Medicine (ABIM) despite citing reputable medical sources (45). U.S. officials have attempted to create an open dialogue with ABIM, the American Medical Association (AMA), and other medical organizations to mediate between the medical entities and physicians facing reprisal (46). According to Dr. McCullough, the effort appears to have failed and the medical entities have strengthened their resolve (47).

In conjunction with TMB, the Texas State Board of Pharmacy (TSBP) offered the same statement regarding the filling of prescriptions by pharmacists (48). TSBP had previously issued a ruling limiting the distribution of early treatment drugs like hydroxychloroquine but the ruling later expired and was not renewed (49). As for complaints, TSBP saw an increase of 43.08% submitted during the pandemic as opposed to the same time frame before the start of the public health emergency (50). According to the agency, only 234 out of 13,776 complaints were related to COVID-19 (51). However, the keyword search used was limited, and the 43.08% increase from the previous two years raises the question of what the additional complaints were for if not COVID-19 related. Some of the complaints were likely a result of reports of pharmacists denying prescription requests from physicians related to COVID-19 treatments (52).

Questions were raised on this issue based on previous legislation authorizing pharmacists to overrule prescription requests based on their conscientious objection (53). Current statute provides pharmacists across the state with the authority to overrule any prescription request but encourages them to contact the physician, provider, and/or patient for further clarification (54). COVID-19 allowed for greater flexibility within pharmacies and their operational abilities, but it also revealed areas for review, including the possibility for on-call pharmacy staff (55).

Federalism in Pandemic Response

Federal and quasi-federal agencies have remained the dominant voices within the pandemic conversation. Yet the CDC has been found to have withheld information on vaccine adverse events out of fear of creating vaccine hesitancy (56). To avoid further vaccine hesitancy, there is evidence that the CDC and NIH retaliate against independent physicians through social media censorship targeting information related to adverse events and other COVID-19 treatments (i.e. Ivermectin, vitamin cocktails, etc.), according to Dr. Robert Malone (57). Florida state officials reported that the federal government withheld disbursement of additional monoclonal treatments to the state for failing to follow federal protocols related to the pandemic (58).

The expansion of federal oversight and the encroachment into the practice of medicine has left states scrambling as to how they can manage their health care systems. A likely remedy to some of the confusion is to seek an independent state-based public health monitoring analysis of infectious disease risks and outcomes due to the unreliability of the CDC to provide transparent, timely, and accurate data for Texas physicians to treat patients (59). Texas must have the capability to collect the data, analyze it promptly, and provide guidance to the state on how to handle current and future public health crises. Recently, Florida's surgeon general issued a warning against further vaccination for young men due to adverse events related to cases of myocarditis (60). This warning contradicts accepted CDC guidance on vaccines and is an acknowledgement of the additional information that is surfacing about the problems of COVID-19 vaccines. Twitter determined the study referenced by Florida's surgeon general to be misinformation and subsequently censored him from their platform (61).

Consequences of COVID-19 Response

As was the case of early lockdown efforts, the decision to shut down the nation and the economy led to more harm than good (62). The economic and physical toll of non-pharmaceutical interventions (NPIs) are difficult to overlook, and the full reasoning behind some NPIs raises additional questions as to their real intention (63). The shifting of NPIs, such as the governor's executive orders restricting elective medical procedures, will likely lead to future strain on the state's health care system (64). Currently, there is no data being collected on the effects of delayed treatments due to the COVID-19 pandemic (65).

Additionally, there has been a rise in mental health concerns—as well as other issues including higher rates of crime, human trafficking, learning losses, and drug abuse—associated with COVID-19 since the initial outbreak. For example, according to the Texas Children's Hospital Association, there has been an increase in children seeking mental health care, with at least 350 mental health crisis patients per month since August of 2021 and more than 400 per month since February 2022 (66). As variants of SARS-CoV-2 emerged school closures fluctuated prompting uncertainty for parents and particularly students. Dr. Thomas Kim on behalf of the Texas Medical Association referred to the rise in mental health crises as having more than one cause (67). Furthermore, the rise in referrals and cases is not novel. The upward trend is associated with multiple crises and has been an area of concern for the mental health profession for many years.68 When asked whether NPI measures like the masking of school children, despite low efficacy among adolescents, have a substantial mental impact Dr. Kim showed support for masking if the situation warranted their use (69). In recommending areas of improvement to handle "non-medical drivers of health," further codification of regulations supportive of telehealth care would help facilitate ease of access to proper care in a timely fashion (70). Additional investment in health and wellness measures for Texans before a crisis would support the effort in avoiding the "after the fact" approach to mental health care (71).

Conclusion

The COVID-19 pandemic appears to be entering the endemic phase where it could follow a similar trajectory to seasonal influenza as reports indicate COVID-19 booster shots will be offered annually (72). Nothing is for certain when illness and humanity intersect, but it is paramount that efforts are made to limit the worst of human nature and its influence on policy. Many of the consequences of decisions made during the pandemic cannot be undone, but they can be used as a learning opportunity. It is inevitable there will be another viral outbreak in the future, along with other public health emergencies. Reviewing previous decisions through an unbiased lens will aid in crafting plans to weather future emergencies and avoid the mistakes made over the course of the pandemic that ultimately caused more public health damage than it prevented.

NPIs have their need, but the pandemic revealed sweeping mandates create unintended consequences like economic hardship, delayed preventative treatments, and at times death. Preference for one treatment over another led to confusion and corporate steerage in the medical profession and led the populace to lose trust in the medical industry. To slow the spread and prevent severe illness, government and medical officials hastily distributed vaccines without proper clinical trials, possibly leading to additional unforeseen consequences. The consequences of the pandemic, both natural and man-made, have led many to lose trust in the health care system. However, leadership and experience through COVID-19 have laid a path to take the first few steps toward protecting Texans from future emergencies.

Recommendations (as read above):

Assess the capacity by which infectious disease control services are provided in Texas. Ensure the state has transparent, data-driven recommendations on public health matters; and consider establishing an independent, transparent state-based regulatory authority for developing and distributing disease treatment.

Examine statutory changes to ensure patients have access to prescriptions submitted by licensed physicians in Texas related to COVID-19;

Prohibit future mask mandates;

Prohibit COVID-19 vaccine mandates and maintain that vaccines remain voluntary;

Form a special committee/working group on medical censorship; and

Establish a grant program accessible to Texas-based independent entities to conduct research on the adverse events of the COVID-19 vaccines directly associated with vaccine use.

I applaud the State of Texas Senate Health and Human Services for coming out with these recommendations and for making such a strong statement. These dark times require courage, and the Texas State Senate has risen to the occasion.

Now for those of us who have painstakingly researched the COVID-19 “pandemic response”, none of the information presented in the report is new or earth shattering. However, that the Texas Senate Health Committee is now acknowledging the corruption, malfeasance and harms done by these policies to the people of the State of Texas.

I encourage everyone to read the full interim report, which has significantly more granularity and covers many other topics relating to this pandemic.

The report can be downloaded at the The Malone Institute Documents archive page (December 20, 2022)