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).
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).
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.
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 ECT. Ketamine 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.
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.
The penalty for lawyer nitpicking and for pretextual litigation, criminal and civil, should those of perjury. All three are meant to deceive, to manipulate, and are misleading. One is criticizing some mistake, when the real intent is to achieve something else. In the case of Trump convictions, the real aim is to stop his -re-election. One question to ask is, if Trump were not running, would the prosecution have proceeded? The answer is no. Therefore, the prosecutors, and their enabling judge and jury are lying in a tribunal. All should be prosecuted for perjury. The prosecutors and the judge are also guilty of Honest Services Fraud because they are paid by the taxpayer for protection from real criminals.
The claim is that the jury will review the facts, the defenses, and the law. The jury will weigh the burden of proof, and whether it has been met. Those prcesses should make all verdicts absolutely predictable. The unpredictability of the verdict means that none of those processes are taking place. What is taking place is the applicaton of the feelings of people from the street. They know nothing about the questions of the trial. If they like the defendant, the verdict will be not guilty.
Only half the murders are prosecuted, about 12000 a year. Verdicts decide very high stakes outcomes. There is an average of about 35.36 exonerations per year for murder cases. It's important to note that the exoneration rate for murder cases is influenced by various factors, including the type of evidence used, the quality of legal representation, and the prevalence of official misconduct. For instance, a significant proportion of exonerations (55%) involved Black individuals, which may reflect systemic issues within the criminal justice system.
Because of the stakes in criminal cases, each process requires validation. None of the validation steps have ever been carried out for the Rules of Criminal Procedure. Studies of exoneration showing an error rate of 1%, underestimate the rate of false guiilty verdicts. Many innocent people choose the plea deal to avoid the risks and expenses of going to trial. The rate of false guilty verdicts is far higher than 1%.
Reliability is required before validation. It means repeatability. Repeatability is the essence of scientific conclusions.
Reliability Statistics: (see this for more)
Once a high rate or reliability in each of the above types, like over 80%, is established, validations must be proven. Go HereHere.
Validity is the main extent to which a concept, conclusion, or measurement is well-founded and likely corresponds accurately to the real world.[1][2] The word "valid" is derived from the Latin validus, meaning strong. The validity of a measurement tool (for example, a test in education) is the degree to which the tool measures what it claims to measure.[3] Validity is based on the strength of a collection of different types of evidence (e.g. face validity, construct validity, etc.) described in greater detail below.
In psychometrics, validity has a particular application known as test validity: "the degree to which evidence and theory support the interpretations of test scores" ("as entailed by proposed uses of tests").[4]
It is generally accepted that the concept of scientific validity addresses the nature of reality in terms of statistical measures and as such is an epistemological and philosophical issue as well as a question of measurement. The use of the term in logic is narrower, relating to the relationship between the premises and conclusion of an argument. In logic, validity refers to the property of an argument whereby if the premises are true then the truth of the conclusion follows by necessity. The conclusion of an argument is true if the argument is sound, which is to say if the argument is valid and its premises are true. By contrast, "scientific or statistical validity" is not a deductive claim that is necessarily truth preserving, but is an inductive claim that remains true or false in an undecided manner. This is why "scientific or statistical validity" is a claim that is qualified as being either strong or weak in its nature, it is never necessary nor certainly true. This has the effect of making claims of "scientific or statistical validity" open to interpretation as to what, in fact, the facts of the matter mean.
Validity is important because it can help determine what types of tests to use, and help to ensure researchers are using methods that are not only ethical and cost-effective, but also those that truly measure the ideas or constructs in question.
Validity[5] of an assessment is the degree to which it measures what it is supposed to measure. This is not the same as reliability, which is the extent to which a measurement gives results that are very consistent. Within validity, the measurement does not always have to be similar, as it does in reliability. However, just because a measure is reliable, it is not necessarily valid. E.g. a scale that is 5 pounds off is reliable but not valid. A test cannot be valid unless it is reliable. Validity is also dependent on the measurement measuring what it was designed to measure, and not something else instead.[6] Validity (similar to reliability) is a relative concept; validity is not an all-or-nothing idea. There are many different types of validity.
Construct validity refers to the extent to which operationalizations of a construct (e.g., practical tests developed from a theory) measure a construct as defined by a theory. It subsumes all other types of validity. For example, the extent to which a test measures intelligence is a question of construct validity. A measure of intelligence presumes, among other things, that the measure is associated with things it should be associated with (convergent validity), not associated with things it should not be associated with (discriminant validity).[7]
Construct validity evidence involves the empirical and theoretical support for the interpretation of the construct. Such lines of evidence include statistical analyses of the internal structure of the test including the relationships between responses to different test items. They also include relationships between the test and measures of other constructs. As currently understood, construct validity is not distinct from the support for the substantive theory of the construct that the test is designed to measure. As such, experiments designed to reveal aspects of the causal role of the construct also contribute to constructing validity evidence.[7]
Content validity is a non-statistical type of validity that involves "the systematic examination of the test content to determine whether it covers a representative sample of the behavior domain to be measured" (Anastasi & Urbina, 1997 p. 114). For example, does an IQ questionnaire have items covering all areas of intelligence discussed in the scientific literature?
Content validity evidence involves the degree to which the content of the test matches a content domain associated with the construct. For example, a test of the ability to add two numbers should include a range of combinations of digits. A test with only one-digit numbers, or only even numbers, would not have good coverage of the content domain. Content related evidence typically involves a subject matter expert (SME) evaluating test items against the test specifications. Experts should pay attention to any cultural differences. For example, when a driving assessment questionnaire adopts from England (e. g. DBQ), the experts should consider right-hand driving in Britain. Some studies found how this will be critical to get a valid questionnaire.[8] Before going to the final administration of questionnaires, the researcher should consult the validity of items against each of the constructs or variables and accordingly modify measurement instruments on the basis of SME's opinion.
A test has content validity built into it by careful selection of which items to include (Anastasi & Urbina, 1997). Items are chosen so that they comply with the test specification which is drawn up through a thorough examination of the subject domain. Foxcroft, Paterson, le Roux & Herbst (2004, p. 49)[9] note that by using a panel of experts to review the test specifications and the selection of items the content validity of a test can be improved. The experts will be able to review the items and comment on whether the items cover a representative sample of the behavior domain.
Face validity is an estimate of whether a test appears to measure a certain criterion; it does not guarantee that the test actually measures phenomena in that domain. Measures may have high validity, but when the test does not appear to be measuring what it is, it has low face validity. Indeed, when a test is subject to faking (malingering), low face validity might make the test more valid. Considering one may get more honest answers with lower face validity, it is sometimes important to make it appear as though there is low face validity whilst administering the measures.
Face validity is very closely related to content validity. While content validity depends on a theoretical basis for assuming if a test is assessing all domains of a certain criterion (e.g. does assessing addition skills yield in a good measure for mathematical skills? To answer this you have to know, what different kinds of arithmetic skills mathematical skills include) face validity relates to whether a test appears to be a good measure or not. This judgment is made on the "face" of the test, thus it can also be judged by the amateur.
Face validity is a starting point, but should never be assumed to be probably valid for any given purpose, as the "experts" have been wrong before—the Malleus Malificarum (Hammer of Witches) had no support for its conclusions other than the self-imagined competence of two "experts" in "witchcraft detection", yet it was used as a "test" to condemn and burn at the stake tens of thousands men and women as "witches".[10]
Criterion validity evidence involves the correlation between the test and a criterion variable (or variables) taken as representative of the construct. In other words, it compares the test with other measures or outcomes (the criteria) already held to be valid. For example, employee selection tests are often validated against measures of job performance (the criterion), and IQ tests are often validated against measures of academic performance (the criterion).
If the test data and criterion data are collected at the same time, this is referred to as concurrent validity evidence. If the test data are collected first in order to predict criterion data collected at a later point in time, then this is referred to as predictive validity evidence.
Concurrent validity refers to the degree to which the operationalization correlates with other measures of the same construct that are measured at the same time. When the measure is compared to another measure of the same type, they will be related (or correlated). Returning to the selection test example, this would mean that the tests are administered to current employees and then correlated with their scores on performance reviews.
Predictive validity refers to the degree to which the operationalization can predict (or correlate with) other measures of the same construct that are measured at some time in the future. Again, with the selection test example, this would mean that the tests are administered to applicants, all applicants are hired, their performance is reviewed at a later time, and then their scores on the two measures are correlated.
This is also when measurement predicts a relationship between what is measured and something else; predicting whether or not the other thing will happen in the future. High correlation between ex-ante predicted and ex-post actual outcomes is the strongest proof of validity.
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If one wants to get a rating scale to be used in a class or in a personality test, one must go through these steps. If one wants to execute a guy, none of those steps are required, just the feelings of the jury. The lawyer profession is not just extremely stupid, uninformed, atavistic, and mired in 13th Century practices, it is quackery.
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Juries: The advantage of using a jury trial is the possibility of getting the Wisdom of the Crowd. The problems of the jury are less than those of the judge, an individual. The judge is a lawyer. He has the interests of the profession. His jobs depends on promoting litigation. The jury is rarely a real sampling of peers. If it were, there would be no excuses, no exclusions, no voire dire (delection by the lawyers). Only random sampling of the population would be permitted. The jury comes from a local culture. The jury is irritated by the interruption of their lives. They are irritated by the low pay. Jurors should be paid their usual day rate if they are going to lose their earnings during the trial. If there is a knowledgeable or passionate member, he may bully the rest. The rest just wants to go home, and will give in to a member with certainty and a dominant personality.
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Alternative: It is fair to say the current trial practices of judge and jury verdicts are 13th Century garbage practices. The adversarial system is copied from the disputation method of Scholasticism. That was cool in 1275 AD. Today, it is a ridiculous way for lawyers to double their income and add no value whatsoever. Scholasticism is a Catholic Church philosopy. The entire court trial violates the Establishment Clause. The court looks like a church. It has an altar on which the judge sits. It has a judge wearing clerical robes. It makes the congregants sit and stand several times, as in a Catholic church service. The modern trial is atavistic religious garbage with bad reliaiblity and validity statistics. It not only violates the Establishment Clause by its origins in Catholic Church practices. It also violates the Procedural Due Process Clauses of the Fifth and Fournteenth Amendments. One of its rights is a right to a fair hearing.
The remedy is to make judging a separate profession from lawyering. Start judge schools. They would admit mature middle aged people. Anyone who passed 1L would be disqualified because the intellect and the ethics of that person have been destroyed. The main message of the judge education would be to apply the law, and not to make the law. The judge would be allowed to investigate the question of the trial, being the smartest and most experienced person in the trial. Now, judges are totally muted, and will be removed if they investigate on their own. Judges should be liable for wrong decisions if they cause damages. They should carry insurance to cover their mistakes. If a judge makes many, his insurance will be cancelled, and he should not be on the bench.
It is unknown if these images hurt real children or lower the rate of sexual abuse of real children.
https://www.msn.com/en-us/news/us/in-novel-case-us-charges-man-with-making-child-sex-abuse-images-with-ai/ar-BB1mO208
This is the 2003 law. It exempts depictions with "serious literary, artistic, political, or scientific value". I guess the definition of these terms is up to the feelings and moods of a jury. They are not defined in the law. If a defendant claims a fascination with the beauty of children, is that literary value? One wonders if depictions of nude children playing in a tub or by a pool are unlawful.
This is another example of the law in failure. They failed to research the effects of a law. They failed to define essential terms in the law. They failed to consider the protection of real children from sexual abuse.
The US is one of the worst places for child sexual trafficking thanks to the failed lawyer profession.
https://www.savethechildren.org/us/charity-stories/child-trafficking-myths-vs-facts
Marijuana Use Catching Up to Alcohol Use - Implications for Violent Crime and Suicide
Here.
One expects violent crime and suicide to decrease. Half the murderers, the murder victims, and the suicide victims are legally drunk. Alcohol has the greatest behavioral toxicity of any substance. The policy of eyesight supervision of suicidal people should have a great impact in the case of the drunk people who cimmit suicide. It only has to be carried out for a few hours until the person sobers up.
April 28, 2024
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 CPAP Machines Over the Counter.
A. ACTION REQUESTED
For the reasons discussed in Section B, this petition requests the Commissioner to do the following:
Make CPAP machines available without prescription. A CPAP (Continuous Positive Airway Pressure) machine is a medical device used primarily to treat obstructive sleep apnea (OSA) and other sleep-related breathing disorders. It delivers a continuous flow of pressurized air to the airway, helping to keep it open during sleep and preventing episodes of breathing pauses or interruptions.
Require that sellers of CPAP machines provide instruction manuals written at the 6th grade level of reading ability and illustrations of the set up.
Here's how a typical CPAP machine works:
Air Pump: The CPAP machine contains a motorized air pump that generates a continuous stream of air at a prescribed pressure setting. The pressure is determined based on the severity of the individual's sleep apnea. Typically it is titrated during a sleep study or under the guidance of a sleep specialist. Some machines continually titrate the air pressure based on resistance.
Tubing: The air from the CPAP machine is delivered to the user's airway through a flexible tube. This tubing connects the machine to the mask worn by the user during sleep.
Mask: The mask is an essential component of the CPAP system, as it delivers the pressurized air to the user's airway. There are several types of masks available, including nasal masks, nasal pillows, and full-face masks. The choice of mask depends on factors such as comfort, breathing patterns, and individual preferences.
Humidifier (Optional): Some CPAP machines come with an integrated humidifier or have a humidifier attachment. The humidifier adds moisture to the pressurized air, which can help alleviate dryness and irritation in the airway and nasal passages.
Filters: CPAP machines typically contain filters that help purify the air being delivered to the user's airway. These filters help remove dust, allergens, and other particles from the air, ensuring clean and breathable air during sleep.
When a person with sleep apnea uses a CPAP machine during sleep, the continuous flow of pressurized air acts as a splint to keep the airway open. This prevents the collapse of soft tissues in the throat and tongue that can lead to obstructive sleep apnea episodes. By maintaining an open airway, CPAP therapy helps improve breathing patterns during sleep, reduce snoring, alleviate daytime sleepiness, and improve overall sleep quality. This makes sleep refreshing, and promotes alertness throughout the waking hours of the next day.
B. STATEMENT OF GROUNDS
Motivation for this Petition
The current requirement of a prescription for a CPAP machine to be purchased results in high costs of $500 to $1000. Insurance companies place many obstacles in obtaining them. The FDA’s obstruction of the availability results in 80% of apnea patients going undiagnosed. The cost in 2015 Dollars has been estimated to be $150 billion, in crashes, low productivity, extreme health consequences (https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf ) . Apnea results in daytime sleepiness. Daytime sleepiness causes the same impairment as legal alcohol intoxication ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1739867/pdf/v057p00649.pdf ) . The prevalence of untreated sleep apnea is 25 million people from the teens to the elder years. There is no way the nearly worthless,, and intentionally obstructionist system under current FDA oversight can accommodate that number. The FDA is just rent seeking professionals that knowingly kill thousands to protect their turf.
The result of CPAP machines availability without prescription will be an immediate increase in competition, and huge drops in prices. The same happened when hearing aids were made available over the counter, with up to 90% reductions in prices. Final Rule at ( https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf ). The cost went from $8000 to $963 at Costco today, in less than one year.
Self diagnosis is possible. Nothing is more reliable than reports of people who sleep with the person. If the spouse reports pauses in breathing but a polysomnography test is negative, the spouse must be believed. The sleep test measures the breathing of a single night. The report of the spouse reports on breathing over an extended period of time.
Accessibility: Some individuals may have difficulty obtaining a prescription for a CPAP machine due to various factors such as lack of access to healthcare, financial constraints, or delays in scheduling appointments with healthcare providers. Providing CPAP machines without a prescription could increase accessibility for these individuals, allowing them to address their sleep apnea symptoms more promptly.
Self-diagnosis: Some individuals may have already been diagnosed with sleep apnea in the past and are familiar with their condition. Allowing them to obtain cheap CPAP machines without a prescription may empower them to take control of their treatment without the need for additional medical consultations.
Unmet Healthcare Needs: In regions or communities where access to healthcare is limited, providing CPAP machines without a prescription could help address unmet needs for individuals with sleep apnea who may otherwise go untreated. This could potentially reduce the risk of complications associated with untreated sleep apnea, such as cardiovascular problems and daytime sleepiness. "Racial Disparities in Surgical Treatment of Obstructive Sleep Apnea: A National Study of 500,792 Individuals" by K. B. Smith et al., published in 2022. This study found significant racial disparities in the surgical treatment of obstructive sleep apnea, with Black race being independently associated with a decreased rate of surgery for the condition. The study analyzed data from Optum’s deidentified Clinformatics Data Mart database from 2004 to 2018, highlighting the health disparities in the management of sleep apnea among different racial groups in the United States. compared to white individuals, African-Americans are often diagnosed with more severe sleep apnea and use treatment with positive airway pressure devices less, based on their zip code. Additionally, black patients have been found to have more severe obstructive sleep apnea upon clinical presentation, but it's unclear if this reflects differences in symptoms or other standard measures of risk. Furthermore, racial disparities in health outcomes related to healthcare access and economic resources have an enormous impact on public health and social equity, with differences in rates of surgery for obstructive sleep apnea based on race. These disparities highlight the need for increased awareness and equitable treatment for sleep apnea across all racial and ethnic populations.
Education and Awareness: Providing CPAP machines without a prescription could also be an opportunity to educate individuals about sleep apnea and the importance of seeking proper diagnosis and treatment. This could lead to increased awareness and encourage individuals to seek professional medical advice if they suspect they have sleep apnea. An effect we call, This Old House Effect, may result. A show detailing all the steps to replacing a toilet is highly persuasive to hire a plumber. The availability of CPAP may increase the fraction of people with apnea seeking professional evaluation and advice.
Why the Current FDA Regulations Must be Changed
CPAP is a fan. It blows air. If the air is too much, and uncomfortable, the patient can turn it down, as if it were a window fan. It should not require long wait times and the costs of a polysomnography. The report of family members has far greater validity than those results. If supported by multiple days of sampling by sleep apps, the diagnosis is firm. The result of a sampling of a single night of polysomnography is not valid when it contradicts those multi-day reports. The result of the current professional rent seeking is Medicaid and Medicare fraud, since current procedures and their costs are not medically necessary.
The current fraudulent situation has hideous consequences. It results in foreseeable mass deaths of victims of accidents caused by sleepiness. These may include many historic catastrophes and their devastating effects.
Treated severe apnea patients have the same mortality as the population. Untreated apnea has a 3.8 rate of mortality between the ages of 30 to 49. These are the ages of greatest productivity and responsibility. Around 6000 people that age die needlessly from stroke or cardio-vascular disease, because of untreated severe apnea. The risk of sudden death is also doubled by untreated severe apnea ( https://newsnetwork.mayoclinic.org/discussion/obstructive-sleep-apnea-raises-risk-of-sudden-cardiac-death-mayo-clinic-finds/ )
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). Disparate treatment involves intentional discrimination and is per se
unconstitutional. Statistical disparity is sufficient for a legal showing of discrimination. 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 . . .”
Request for Action as Direct Final Rule
FDA slowness needlessly kills thousands of patients a year. Therefore you have 180 days to reply to this petition. If I do not get your reply 180 days from today, I will presume the petition has been denied. I will then seek to enjoin you in a federal lawsuit. I will also try to breach your self dealt and lawless immunity. I will seek damages from the FDA for the untreated sleep apnea and its consequences.
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 . . .” 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.” 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.
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. Accidental environmental disasters caused by sleepiness may drop in frequency if this change is enacted.
Exxon Valdez Oil Spill (1989): This disaster occurred when an oil tanker struck a reef off the coast of Alaska, spilling millions of gallons of crude oil into the sea. The captain, who had reportedly been drinking, left a third mate in charge who was possibly fatigued and not fully licensed to navigate the waters, contributing to the accident.
Chernobyl Nuclear Disaster (1986): Fatigue among the night shift workers who were conducting a poorly designed experiment led to the world's worst nuclear disaster. The tired staff made critical errors, including disabling emergency safety systems, which resulted in an explosion and large-scale release of radioactive material.
Three Mile Island Nuclear Accident (1979): Fatigue and inadequate training were contributing factors in this nuclear power plant accident in Pennsylvania, USA. Sleep-deprived operators failed to correctly diagnose and respond to a malfunction in the plant, leading to a partial meltdown.
Space Shuttle Challenger Disaster (1986): While not directly caused by sleepiness, the decision-making process might have been affected by fatigue. Engineers and NASA officials had been working extensive hours and under immense pressure, which led to poor decision-making and oversight in the face of critical safety concerns.
Texas City Refinery Explosion (2005): Overworked and sleep-deprived operators and supervisors were factors in one of the largest industrial accidents in the U.S. petroleum industry. The BP refinery explosion was due to neglected safety measures and tired staff failing to adhere to protocols.
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. Briefly, the greater availability of CPAP machines will result in precipitous drops in costs. The cost may drop to a point of working people no longer needing coverage by insurance companies. The prevention of accidents, crashes, low productivity, misery, strokes, heart attacks, sudden deaths at night, family disruptions. The value of suffering from these consequences has value way beyond the calculation of $150 billion in 2015 dollars.
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 make CPAP machines available without a prescription.
Disparate impact has been deemed evidence of discrimination by the Supreme Court ( Texas Dept. of Housing and Community Affairs v. Inclusive Communities Project, Inc., 576 U.S. 519 (2015) ). Racial minorities experience implicit bias in the health care system at the rate of 20% ( https://www.kff.org/report-section/kff-the-undefeated-survey-on-race-and-health-main-findings/#ExecutiveSummary ). Forcing them to seek care when not necessary results in disparate experiences and outcomes by race.
Respectfully submitted,
David Behar, M.D.
Any loss from hiring criminals should be compensated by the EEOC. Because it is a regulatory taking, Sheetz should be compensated under the Fifth Amendment. Say, an employee with a criminal record steals. Say, he assaults a customer, and the store is sued for the damages. The EEOC that forced the hiring should pay all the damages assessed to the store.
Here.
This is an analogous legal situation, laws protecting squatters' rights to the detriment of property owners interests.
Here.
Start with litigation using the civil rights laws. All DEI constitutes a hostile work environment. All DEI commits the Fischer Fallacy. A fallacy violates the Fifth Amendment procedural due process right to fairness. If litigation fails, proceed to more intrusive measures.
Fischer Fallacy.
https://frontline.news/post/made-in-china-how-mao-s-minions-weaponize-dei-to-subvert-america
Maybe there is a genetic explanation for the preference of educated people for liberal, leftist views. The more obvious one is rent seeking, money. Government collects taxes at the point of a gun, and pays the salaries of close to worthless people. No one else would pay for their services.
Here.
Left wing academic says, behavior is determined. Hug a thug. Punishment and reward are part of determinism. If behavior is determined, then only incapacitation is effective in the criminal law. The deceased have the lowest recidivism rate of all.
Stanford scientist, after decades of study, concludes: We don't have free will (msn.com)
Here.
Need more details of her care. How about the usual list for tratment resistant conditions, ketamine, electroconvulsive therapy, transcranial magnetic stimulation, exercise, clozapine, stimulants for energy, psylocybin? How about revisiting missed medical conditions, like infections, iron deficiency, endocrine disorders, brain conditions? It is possible everything has been done under Euro Commie Care. Commie Care is cheap care. Once you need expensive care, you may get on a waiting list and pass away there.
Do autistic people have boyfriends? Maybe her doctors made a mistake.
Should people lose their lives on the casual and inappropriate remark of a frustrated psychiatrist? I suggest replacing that remark with, "I have run out of ideas, time for a second opinion."
I suggest a trip to the Mayo Clinic before this drastic mistake. Get the works.
A person resisting a House of Representative subpoena sits in jail. The DOJ will not allow its lawyers to testify before a House Committee. Raw partisan power cancels the rule of law and professionalism.
Here.
Naturally CRT is a lawyer scheme to plunder the productive. It commits the Fischer Fallacy. Any application of it in a tribunal would violate the Fifth Amendment Procedural Due Process right of the defendant to a fair hearing. That would be true of any fallacy committed by the court.
A review of the Fischer Fallacy. Basically, some offense took place in the past. It is then applied to the present without justification, since the offense has stopped. It is used to scapegoat current defendants for past offenses they had nothing to do with.
In this story, black supremacist racist analysis is scapegoating white teachers, in the captive audience of mandatory training. It creates a hostile work environment. Teachers should remain silent, but file a complaint about each biased and hostile utterance by the black supremacists. Each should go to agencies overing the civil rights of the county, the state, and the federal jurisdiction. Once these are rejected, they may file a discrimination lawsuit.
To my knowledge, there are no data supporting this neo-Marxist indoctrination and Red Guard sytle re-education camps. The sole way for students to learn is repetition. If the student is stupid, just repeat more than others, and still master the subject. Chinese students study from 6 AM to 10 PM, and have a book open at lunch. They are not learning by rote. They are learning creative problem solving.
Elections may be a faster alternative. Most elections do not result in change, because entrenched interests resist change. Most of our beliefs will be held to be delusional in ever shorter periods of time. We may share 1% of the beliefs of 100 years ago. That period of rejection may be compressed to 20 years today. Data is influential, if trusted. Nothing is more persuasive than personal experience. Today, the media are outlets for billionaire interests, some of which are delusional, emotional, but always unjustly enriching to the owners. People imitate because they don't know how to act or what to believe. The media present models to imitate.
Giving the billionaires that own the media and the political parties a personal experience may be the quickest and most powerful method to change mass delusions. The concept of reciprocity should be kept in mind. Do unto others so they can feel your pain too.
Here. That article is panhandling for money for a magazine that stands for the facts and evidence. It does not offer a real solution.
This Good Friday, we should remember. Jesus became a nuisance. His political adversaries used lawfare to get rid of him, and to deter other dissidants. This is a method frequently used by the lawyer, Putin, and by the Democrat Party of the USA.
Living space with rooms on one floor
Telecommuting set up to continue working. Travel will be difficult for weeks.
Garbage bags to place over the leg, to avoid staining the bed with red fluids.
Knee Scooter for single floor living plus clip on cup holder.
4 X 4 dressing silicone pad for the knee to address pressure sores from the scooter
Cane with a single prong, not 4 prongs for stairs
Walker for a single step
Grabber Reacher, second one to pick up the first from the floor.
Ace bandages for when visiting nurses have none.
Leg cast sock cover for your toes.
Thermometer to catch a fever from a wound infection.
Bathtub transfer chair if have a big bathroom. Alternative: Bidet feature on toilet and sponge baths.
Aspirin 81 mg likely, twice a day to lessen clotting and a pulmonary embolus.
Hard boiled Eggs are nutritious but have zero bulk to avoid a bowel movement Day 1 or 2 post-op.
Imodium to avoid a bowel movement and its cleanup day one or two post op
Tylenol 500 mg, likely 2 twice or three times a day or Naprosyn 220 mg 2 tablets twice a day
Urinal to save trips to the toilet at night. Try this one, you may never urinate in a toilet again
Pulse Oximeter in case of a pulmonary embolism.
Vacu Vin Wine Cooler Sleeve for wine bottles, best because it cools the back of the foot and the bottom of the foot.
Hemp Cream to apply to painful area. It is cheap, over the counter. It is as affective and as rapid as $100 ketamine cream.
