Sunday, June 23, 2024

Law in Failure: Pretextual Criminal Prosecutions Are Torts and Apply to the Trump Prosecutions

 These are illegal, says the Supreme Court  in Gonzalez v. Trevino602 U.S. ___ (2024). This decision is highly relevant to the prosecution of President Trump. His lawyers should be suing the jurisdictions. The question is, would there be a prosecution if he were not running for office. Were others in similar circumstances prosecuted as well? If not, the prosecutors should be sued. 

Law in Failure: The Biggest Fraud Score in History, the COVID Caper, Allowed by the Lawyer Profession

 Covid. It was a flu like virus that affected people in proportion to their age. The young were little affected by it at all. If they were, they had mild flu like symptoms. 

It gave the elites around the world to attack their societies in hideous but highly profitable ways. They shut dow all transportation, including walking outside. They used men with guns, the police,  to impose this tyranny. The example was set by the smartest of them all, the Chinese hierarchy. This brilliance was imitated by left wing elites and politicians around the world with the same results. The Chinese tech billionaires scored an additional $2 trillion in income, the American ones, $1.7 trillion. They closed and bankrupted their local shopping competition. The scary John Hopkins COVID dashboard was a computer simulation, not a real count. There was no way they were based on instantaneous reports. 

In the US, a bounty was placed on case finding. Hard pressed hospitals were offere $35000 to subsidize the care of COVID per case. Thus everyone who died with COVID, and not just from COVID. the case number shot up, fueling the false panic in the left wing billionaire owned media. The governor of New York lowered the criteria to clinical assessment, rather than testing for COVID. So an accident victim who was heard to cough, could have OVID added to the death certificated for a $35000 payment. Any doctor questioning the veracity of the death certificated probably did not last long at his job. The usual 60000 deaths from the flu among vulnerable patients disappeared completely.

The federal government spent over $40 billion on the COVID vaccines. Naturally, none of the advertised benefits were true. Vaccinated people got multiple episodes of COVID. They also spread COVID to others.  ("In plain English, the shots were a colossal failure at preventing Covid [15]. Moreover, the Covid shots have caused an unprecedented number of severe adverse events, including at least one million deaths [16]. If the “swift action” that was taken in the past failed to arrest Covid, what then is proposed to stop future outbreaks?" 


Intelligent Israel and Palestine Unity Against Shia Iran, the Unity in Genetics

 See the article about the semitic genes of European Ashkenazi Jews. See the advanced technology of the 7th Century Arabs of Baghdad. Some was reached in Europe in the 19th Century. 


I do not understand why both nations are missing the obvious. Hamas and Hezbollah are funded and controlled by Iran, a Shia nation. The death toll has been a million, including the slaughter of mothers and children. Of course, killing a female prevents the birth of seven future enemies. 


One wonders why Hamas would use human shields. Simple. They are Sunnis. if they are killed by Israel, Iran wins. They kill Sunnis, and make Israel look like criminals against humanity. 

One wonders the intelligent Israelis have not bought out Sunni Palestinian leaders to unify against a mutual enemy, the Shia of Iran. If they are not persuaded, try bribery. It is far cheaper and more intelligent than the current plan. 

Saturday, June 22, 2024

Oregon Licensing Board Mandates Reporting of Micro-Aggressions in the Health Setting

Here is the rule

Here is a legal analysis by Prof. Jonathan Turley. It focuses on the violation of the Free Speech Clause. 

This rule will have a disparate impact on whites and on those from cultures that are loud. It imposes a supremacist culture of British upper class stoicism. Disparate impact is evidence of discrimination according to Texas Department of Housing and Community Affairs v. The Inclusive Communities Project, Inc.576 U.S. 519 (2015).

Friday, June 14, 2024

Law in Failure: Legal Immunity Justifies Violence in Formal Logic

This is from formal logic. It has more certainty than the laws of physics. The contrapositive of a true assertion is always true. All bats are mammals ( A then B is true). This animal is not a mammal, it cannot be a bat (not B then not A must be true). 

Legal liaibility for damages replaced endless cycles of violent revenge. The rule of law made civilization possible. People did not have to spend full time on personal safety anymore. They could engage in more productive activity. Productive activity enriched the human group. 

That means legal immunity justifies violent revenge for damages (the contrapositive, not B then not A is true). 

Law in Failure: Competing Theories of Death, Jury Bias, Fear of Civil Unrest -Problems with the Jury System

 The jury was a great advance in the 11th Century. It is less so now as described in this article. Here.


The remedy is to professionalize judges with their own judge schools. Allow them to investigatge the case. Then make them liabile for their mistakes. End the adversarial approach of the trial. It  imitates the Disputation Method of Scholasticism. Because the latter is a methodology of the Catholic Church, the adversarial system of trial violates the Establishment Clause. It is designed to generate fees for lawyers. It has no scientific reliability or validation statistics. It is wasteful and inaccurate. Most of the cases are settle by a plea deal. Trial procedures and othe incentives force innocent people into accpeting guilty pleas to avoid the risk and costs of a trial. The exoneration rate is far higher higher than 1 or 2%, as claimed. That rate does not count the iinocent defendants accepting a plea deal. 

Sunday, June 9, 2024

Wow, Psychiatrist Serial Euthanizer, Still in Business, and At It

Dutch euthanasia for depression, in healthy people, one as young as 16. Wow. Depression at that young age has a good chance of just going away with age even if nothing works. There is a good chance of misdiagnosis. Mood disorder at such a young age (average onset age is 39) is likely the onset of bipolar disorder. The latter tends to not respond to the treatments for unipolar depression. 

There is no mention that these patients in the article have had the list of treatments for treatment resistant depression. The best is ECTKetamine infusion is FDA approved. It works in 45 minutes, not in 45 days like anti-depressants. It stops suicidal urges even in people whose depression does not improve. There are multiple mood stabilizers that stop suicidal ideas, aripiprazole, clozapine, brexpiprazole, and several others. These should be enhanced by regular exercise, a proven treatment for depression. 

The average psychiatrist who has run out of treatments for resistant depression, will then start over. One will ask, is a physical condition presenting as depression being missed. One organizes the 500 cuases by systems, endocrine, infectious, cardio-vascular, such as anemia, nutritional. All depressed patients should have normal or high levels of Vitamin D, and of folic acit (Vitamin B9). People with good folic acid levels had suicide rates 40% lower than those with a deficiency. Infections include Lyme disease, bartonella, and many others. That includes changes in gut microbiome

Sunday, June 2, 2024

FDA Petition to Place Sertraline 25 mg Over the Counter

 Dockets Management Branch

Food and Drug Administration

Department of Health and Human Services, Room 1-23

12420 Parklawn Drive

Rockville, MD 20857


Dear Commissioner:

CITIZEN PETITION

This petition is submitted pursuant to 21 C.F.R. § 10.30. This petition requests that the 

Commissioner of Food and Drugs place sertraline 25 mg over the counter, available without a prescription for the treatment of post traumatic stress disorder (PTSD), an FDA approved indication. 

A. ACTION REQUESTED

For the reasons discussed in Section B, this petition requests the Commissioner to do the following:

1. Place sertraline 25 mg over the counter, for post-traumatic stress disorder, an FDA approved indication. It is approved in patients down to age 6. 

2. Require that makers of it include a consumer package insert written at the 6th grade reading level. It should add that a small fraction of people may get anxious or agitated day 1 or 2. Such agitation may lead to dangerous acts, and that such people should stop taking it. This warning is not in the current package insert, but should be. 

B. STATEMENT OF GROUNDS

1. Motivation for this Petition

Petitioner is a board-certified psychiatrist with patients. Petitioner may legally stand in for his patients’ medical interest in federal court. He intends to seek declaratory relief and to  enjoin the FDA if it fails to put this petition in action. FDA obstructionism kills thousands of Americans a year. 

Petitioner respectfully requests that the Commissioner

1. End the prescription requirement to obtain sertraline 25 mg tablets. 

2. Makers should require that makers of it include a consumer package insert written at the 6th grade reading level. It should add that a small fraction of people may get anxious or agitated day 1 or 2. Such agitation may lead to dangerous acts, and that such people should stop taking it. This warning is not in the current package insert, but should be. 

According to the CDC ( https://www.cdc.gov/nchs/data/databriefs/db478.pdf ), PTSD is prevalent in 6% of the population. That rate makes it one of the most common psychiatric condition. 

According to the National Center for PTSD, about 6% of the general population will experience PTSD at some point in their lives. However, the likelihood of developing PTSD varies widely depending on the specific traumatic event and individual circumstances.

Here are some estimates of PTSD prevalence among trauma victims:

- Sexual assault: 50-90%

- Combat veterans: 11-20%

- Natural disasters: 4-20%

- Car accidents: 2-10%

- Physical or emotional abuse: 20-50%

(See: - Sexual assault survivors: Foa, E. B., & Rothbaum, B. O. (1998). Treatment of posttraumatic stress disorder. Journal of Clinical Psychology, 54(2), 171-182.

- Combat veterans: Kang, H. K., & Hyams, K. C. (2005). Mental health care needs among recent theater veterans. Journal of Psychiatric Research, 39(5), 459-466.

- Natural disaster survivors: Galea, S., Nandi, A., & Vlahov, D. (2005). The epidemiology of posttraumatic stress disorder after disasters. Epidemiologic Reviews, 27, 78-91.

- Car accident survivors: Blanchard, E. B., & Hickling, E. J. (2004). After the crash: Assessment and treatment of motor vehicle accident survivors. American Psychological Association.

- Physical or emotional abuse survivors: Heim, C., & Nemeroff, C. B. (2001). The role of early life experiences in the development of depression. Molecular Psychiatry, 6(1), 14-27. )

There is a racial disparity in the prevalence of PTSD. 

Here are some racial disparities in PTSD rates ¹:

- Blacks: 8.7%

- Hispanics: 7.0%

- Whites: 7.4%

- Asians: 4.0%

(See: https://pubmed.ncbi.nlm.nih.gov/20346193/ )

The likelihood of 12 million people going to their health providers for the treatment of PTSD is not realistic. What is more realistic is the likelihood of self diagnosis using multiple available rating scales ( from:  https://www.ptsd.va.gov/ ). 

1. PTSD Checklist for DSM-5 (PCL-5)

The PCL-5 is a self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It asks you to rate how much you've been bothered by each symptom in the past month on a scale from 0 (not at all) to 4 (extremely).


2. Davidson Trauma Scale (DTS)

The DTS is a 17-item self-rating scale that measures the frequency and severity of PTSD symptoms. You rate each symptom based on how often you experienced it and how severe it was over the past week.

3. PTSD Symptom Scale - Self-Report Version (PSS-SR)

The PSS-SR is another self-report questionnaire that evaluates the presence and severity of PTSD symptoms based on the DSM criteria. It includes questions about re-experiencing, avoidance, and hyperarousal symptoms.

This lack of access is especially troublesome for racial minorities. They face race based traumatic stress and racially motivated less access to healthcare, in additional to all the ordinary traumatic events.

 "Racism and Health" by Minority Health, CDC ( https://nihcm.org/publications/systemic-racism-health-care-covid-treatment )


- "Systemic Racism in Health Care" by theSkimm ( https://www.theskimm.com/wellness/systemic-racism-in-health-care )


- "Systemic Racism and Minority Disparities in Health Care" by The Bridge: Interdisciplinary Perspectives on Legal & Social Policy ( https://www.cdc.gov/minorityhealth/racism-disparities/index.html )


- "Systemic Racism & Health Care, COVID & Treatment" by NIHCM ( https://digitalscholarship.tsu.edu/thebridge/vol6/iss3/1/ )

They could then begin effective, FDA approved  treatment with sertraline 25 mg over the counter. Black patients are more impacted by the systemic racism of access to treatment. Only 19% get any form of treatment at all. The consequences of untreated PTSD include the following:

- Increased symptom severity

- Longer recovery time

- Physical health problems, such as:

- Chronic pain

- Headaches

- Gastrointestinal issues

- Heart disease

- Diabetes

- Autoimmune diseases

- Substance abuse

- Relationship problems

- Work and financial problems

- Depression

- Anxiety

- Suicidal thoughts

- Anger and aggression issues

- Cardiovascular and autoimmune diseases

- Obesity

- Metabolic syndrome

- Cognitive impairment

https://www.sabinorecovery.com/what-happens-if-ptsd-is-left-untreated/ 

https://healthmatch.io/ptsd/what-happens-if-ptsd-is-left-untreated 

Far from reducing interest in the psycho social and effective cognitive behavioral treatment of PTSD, such availability will increase it. Availability may also replace the currently harmful remedies of drinking alcohol, and of smoking marijuana. 

Sertraline is far safer in use and in overdose than any other over the counter drug now available, once patients are warned about the low rate of agitation of 1 in 100. It has very few drug-drug interactions with other prescribed and OTC medications. 

4. Why the Current FDA Regulations Must be Changed

Discrimination in medicine is a medical practice that includes both differential treatment on the basis of a protected class (disparate-treatment discrimination) and treatment on the basis of inadequately justified factors that disadvantages a particular group (disparate-impact discrimination).(National Research Council (2004). Measuring Racial Discrimination. The National Academies Press, Washington, DC. p. 40. Available at http://www.nap.edu/catalog.php?record_id=10887 (last accessed Feb. 20, 

2012))

Disparate treatment involves intentional discrimination and is per se unconstitutional. Statistical disparity is sufficient for a legal showing of discrimination. ( Texas Dept. of Housing and Community Affairs v. Inclusive Communities Project, Inc., 576 US ____ (2015).) In contrast, a determination as to the legality of disparate-impact discrimination depends upon whether the practice is supported by a sufficiently compelling reason and whether alternative processes exist that would not give rise to disparities. Disparate-impact liability mandates the “removal of artificial, arbitrary, and unnecessary barriers . . .” ( Griggs v. Duke Power Co., 401 US 424, 431 (1971)).

Petitioner contends that the current FDA regulations governing the use of sertraline are 

unconstitutional because they discriminate against individuals with mental illness, prohibiting such groups of individuals from obtaining what often is the only effective medication available to treat or control their symptoms.

In terms of disparate impact, the current FDA regulations have the effect of discriminating against  individuals with mental illness and of black patients, by prohibiting them from the use of an effective treatment. There is no compelling reason why such a prohibition should exist, especially given the fact that sertraline is safer than all over the counter medications in use and in overdose. 


Petitioner also contends that the current FDA regulations governing the use of  are 

unconstitutional because they constitute an undue burden by placing a substantial obstacle in the  path of millions patients seeking unavailable treatment for PTSD. In Planned Parenthood of Southeastern Pennsylvania v. Casey, the Supreme Court defined undue burden as an invalid provision of law whose purpose or effect is to place a substantial obstacle in the path of a patient seeking treatment. ( Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 US 833 (1972).) The Supreme Court further refined the definition in Whole Woman’s Health v. Hellerstedt, 136 S. Ct. 2292, 2309 (2016), in which the Court held that it was “wrong to equate the judicial review applicable to the regulation of a constitutionally protected personal liberty with the less strict review applicable [in other contexts.” In other words, the undue burden test is a form of heightened scrutiny that rejects the judicial deference to legislative claims afforded under the rational basis test even if the benefits are minimal or the laws is unnecessary to achieve them. The test articulated in Whole Woman’s Health has three requirements: 

1) the law must actually further a valid state interest; 

2) the benefits of the law must outweigh the burdens imposed by the law; 

and, 

3) there must be an evidence-based inquiry based on reliable methodology. 

Whole Woman’s Health v. Hellerstedt, 136 S. Ct. 2292, 2309 (2016) issued in the context of a woman’s right to seek an abortion, they are broadly applicable to cases in which laws limit individual rights when their constitutionality depends on whether the law is actually advancing valid interests in a way that justifies the harm placed on the individual. Here,  it may be argued that the regulations at issue further a valid state interest in that they seek to minimize the risk of sertraline. 

With respect to the third requirement, the Court held that “The statement [] that legislatures, and not courts, must resolve questions of medical uncertainty is also inconsistent with this Court’s case law.” Thus, Petitioner believes the prescription requirement for sertraline 25 mg constitutes an undue burden and consequently an unconstitutional regulation. Petitioner is confident that should the FDA refuse to place sertraline 25 mg over the counter, the current regulations would not withstand a disparate-impact discrimination challenge brought by Petitioner on behalf of his patients under Title II of the Americans with Disabilities Act Amendments Act of 2008. Should Petitioner’s petition be denied, Petitioner also intends to pursue an undue burden challenge, which, given recent jurisprudence, Petitioner believes the will not survive. Petitioner prays that wisdom will prevail, making initiation of such a challenge unnecessary.

5. Public Benefit of Action

The actions in this petition have great public benefit. Petitioner finds it difficult to put into words how significant the increase in quality of life for those patients will be. The savings in terms of societal and social costs are difficult to quantify but would be significant. In addition, adopting these requests will decrease the disparity that currently exists with respect to the use of second-generation antipsychotics in the treatment of schizophrenia, which, as noted above, is an acute problem in the United States; as the Department of Health and Human Services noted, “‘the combined costs of health inequalities and premature death in the United States were $1.24 trillion’ between 2003 and 2006.”26 Finally, the requests herein are fully aligned with the HHS’s goals 

7. Request for Action as Direct Final Rule

FDA regulations at 21 C.F.R. § 10.40(e)(1) provide that “[t]he requirements of notice and public procedure . . . do not apply . . . [w]hen the Commissioner determines for good cause that they are . . . unnecessary . . .”28 This FDA exemption mirrors a similar exemption in the Administrative Procedure Act (“APA”).29 When enacting the APA exemption, Congress stated that the “lack of public interest in rule-making warrants an agency to dispense with public procedure.”30 Here, as there appears to be no question of law or fact in dispute, the Commissioner may dispense with advance notice and opportunity for comment. Therefore, Petitioner requests that the FDA effect creation of a national registry for clozapine patients having benign ethnic neutropenia and the proposed changes to package inserts and regulations by direct final rule.



C. ENVIRONMENTAL IMPACT

FDA regulations at 21 C.F.R. § 10.30 require Petitioner to prepare an environmental assessment under 21 C.F.R. § 25.40. However, an environmental assessment is not necessary here. 21 C.F.R. § 25.40 defines environmental assessment as “a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an [environmental impact statement] or a [finding of no significant impact].” (21 C.F.R. § 25.40; see also 40 C.F.R. § 1508.9.)  The environmental assessment fulfills the FDA’s obligations under the National Environmental Policy Act of 1969 (“NEPA”).32 NEPA requires all federal agencies to assess the environmental impact of their actions “significantly affecting the quality of the human environment.” ( 42 U.S.C.A. § 4332.) The requests embodied in the instant petition have no environmental implications. Consequently, no environmental assessment is warranted. 

D. ECONOMIC IMPACT

Pursuant to 21 C.F.R. § 10.30, information under this section is to be submitted only when 

requested by the Commissioner following review of the petition.

(Id. at p. 8.; 28 21 C.F.R. § 10.40(e)(1); Administrative Procedure Act, 5 U.S.C.A. § 553(b)(B). S. Doc. No. 248, 79th Cong., 2d Sess. at 200 (1946); SW Environmental Impact Statements, 38 Fed. Reg. 7001 (Mar. 15, 1973), amended by 42 Fed. Reg. 19986 (Apr. 15, 1977) and 50 Fed. Reg. 16636 (Apr. 26, 1985).)

E. CERTIFICATION

The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to Petitioner that are unfavorable to the petition.

F. CONCLUSION

For the foregoing reasons, Petitioner requests that this petition be granted and that the 

Commissioner contemporaneously require modifications to package inserts and FDA guidance and regulations to place sertraline 25 mg over the counter.

Respectfully submitted,

David Behar, M.D.