In the Name of Good . . .

#TheTuskegeeExperiment #HealthandHumanServices #RogueMedicine #AnnaPerdue

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[1] https://www.cdc.gov/tuskegee/timeline.htm

In 1932, the United States Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis. It was originally called the “Tuskegee Study of Untreated Syphilis in the Negro Male” (now referred to as the “USPHS Syphilis Study at Tuskegee”). The study initially involved 600 Black men – 399 with syphilis, 201 who did not have the disease. Participants’ informed consent was not collected.


Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. By 1943, penicillin was the treatment of choice for syphilis and becoming widely available, but the participants in the study were not offered treatment. In 1972, an Associated Press story about the study was published. As a result, the Assistant Secretary for Health and Scientific Affairs appointed an Ad Hoc Advisory Panel to review the study.


The advisory panel concluded that the study was “ethically unjustified”; that is, the “results [were] disproportionately meager compared with known risks to human subjects involved.” In October 1972, the panel advised stopping the study. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the study. In March 1973, the panel also advised the Secretary of the Department of Health, Education, and Welfare (HEW) (now known as the Department of Health and Human Services) to instruct the United States Public Health Service to provide all necessary medical care for the survivors of the study.


The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, participants’ wives, widows and children were added to the program. In 1995, the program was expanded to include health, as well as medical, benefits. The last study participant died in January 2004. The last widow receiving The Tuskegee Health Benefit Program benefits died in January 2009. Participants’ children continue to receive medical and health benefits. Later in 1973, a class-action lawsuit was filed on behalf of the study participants and their families, resulting in a $10 million, out-of-court settlement in 1974. [1] The Tuskegee education center tells us...

[2] https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

...the study took place in Macon County, Alabama, the county seat of Tuskegee referred to as the "Black Belt" because of its rich soil and vast number of black sharecroppers who were the economic backbone of the region. The research itself took place on the campus of Tuskegee Institute.


The intent of the study was to record the natural history of syphilis in Blacks. The study was called the "Tuskegee Study of Untreated Syphilis in the Negro Male." When the study was initiated, there were no proven treatments for the disease. A total of 600 men were enrolled in the study. Of this group 399, who had syphilis were a part of the experimental group and 201 were control subjects. Most of the men were poor and illiterate sharecroppers from the county. The men were offered what most Negroes could only dream of in terms of medical care and survivors' insurance.


They were enticed and enrolled in the study with incentives including: medical exams, rides to and from the clinics, meals on examination days, free treatment for minor ailments and guarantees that provisions would be made after their deaths in terms of burial stipends paid to their survivors. There were no proven treatments for syphilis when the study began. When penicillin became the standard treatment for the disease in 1947 the medicine was withheld as a part of the treatment for both the experimental group and control group.


On July 25, 1972 Jean Heller of the Associated Press broke the story that appeared simultaneously both in New York and Washington, that there had been a 40-year nontherapeutic experiment called "a study" on the effects of untreated syphilis on Black men in the rural south. That was back in the day when the press was still honest. Between the start of the study in 1932 and 1947, the date when penicillin was determined as a cure for the disease, dozens of men had died and their wives, children and untold number of others had been infected. This set into motion international public outcry and a series of actions initiated by U.S. federal agencies.


The Assistant Secretary for Health and Scientific Affairs appointed an Ad Hoc Advisory Panel, comprised of nine members from the fields of health administration, medicine, law, religion, education, etc. to review the study. While the panel concluded that the men participated in the study freely, agreeing to the examinations and treatments, there was evidence that scientific research protocol routinely applied to human subjects was either ignored or deeply flawed to ensure the safety and well-being of the men involved.


These scientists were as wicked then as they are today. Specifically, the men were never told about or offered the research procedure called informed consent. Researchers had not informed the men of the actual name of the study, i.e., "Tuskegee Study of Untreated Syphilis in the Negro Male," its purpose, and potential consequences of the treatment or non-treatment that they would receive during the study. The men never knew of the debilitating and life-threatening consequences of the treatments they were to receive, the impact on their wives, girlfriends, and children they may have conceived once involved in the research.


The panel also concluded that there were no choices given to the participants to quit the study when penicillin became available as a treatment and cure for syphilis. This experiment seems eerily familiar with the live exercise experiment we are seeing today in real-time. Where is the Ad Hoc Advisory Panel today? Reviewing the results of the research, the panel concluded that the study was "ethically unjustified." Yet, they are conducting a deadly ethically unjustified study on all peoples this very day world-wide. The panel articulated all of the above findings in October of 1972 and then one month later the Assistant Secretary for Health and Scientific Affairs officially declared the end of the Tuskegee Study.


Class-Action Suit, In the summer of 1973, Attorney Fred Gray filed a class-action suit on behalf of the men in the study, their wives, children and families. It ended a settlement giving more than $9 million to the study participants. In the beginning of the 20th Century, the U.S. Public Health Service (PHS) was entrusted with the responsibility to monitor, identify trends in the health of the citizenry, and develop interventions to treat disease, ailments and negative trends adversely impacting the health and wellness of Americans.


It was organized into sections and divisions including one devoted to venereal diseases. All sections of the Public Health Service conducted scientific research involving human beings. The research standards were for their times adequate, by comparison to today's standards dramatically different and influenced by the professional and personal biases of the people leading the U.S.


Public Health Service. Scientists believed that few people outside of the scientific community could comprehend the complexities of research from the nature of the scientific experiments to the consent involved in becoming a research subject. These sentiments were particularly true about the poor and uneducated Black community. The U.S. Public Health Service began working with Tuskegee Institute all the way back to 1932 to study hundreds of black men with syphilis from Macon County, Alabama.


As part of the class-action suit settlement, the U.S. government promised to provide a range of free services to the survivors of the study, their wives, widows, and children. All living participants became immediately entitled to free medical and burial services. These services were provided by the Tuskegee Health Benefit Program, which was and continues to be administered by the Centers for Disease Control and Prevention in their National Center for HIV, STD and TB Prevention. In February of 1994 at the Claude Moore Health Sciences Library in Charlottesville, VA, a symposium was held entitled "Doing Bad in the Name of Good:


The Tuskegee Syphilis Study and Its Legacy." Resulting from this gathering was the creation of the Tuskegee Syphilis Study Legacy Committee which met for the first time in January 18th & 19th of 1996. The committee had two goals; (1) to persuade President Clinton to apologize on behalf of the government for the atrocities of the study and (2) to develop a strategy to address the damages of the study to the psyche of African-Americans and others about the ethical behavior of government-led research; rebuilding the reputation of Tuskegee through public education about the study, developing a clearinghouse on the ethics of scientific research and scholarship and assembling training programs for health care providers.


After intensive discussions, the Committee's final report in May of 1996 urged President Clinton to apologize for the emotional, medical, research and psychological damage of the study. On May 16th at a White House ceremony attended by the men, members of the Legacy Committee and others representing the medical and research communities, the apology was delivered to the surviving participants of the study and families of the deceased. [2]


[3] https://www.mcgill.ca/oss/article/history/40-years-human-experimentation-america-tuskegee-study

To really understand the heinous nature of the Tuskegee Experiment requires some societal context, a lot of history, and a realization of just how many times government agencies were given a chance to stop this human experimentation but didn’t.


This article from McGill Office for Science and Society tells that in 1865, the ratification of the Thirteenth Amendment of the U.S. Constitution formally ended the enslavement of black Americans. But by the early 20th century, the cultural and medical landscape of the U.S. was still built upon and inundated with racist concepts. Social Darwinism was rising, predicated on the survival of the fittest, and “scientific racism” (a pseudoscientific practice of using science to reinforce racial biases) was common.


Rather than simply observing and documenting the natural progression of syphilis in the community as had been planned, the researchers intervened: first by telling the participants that they were being treated (a lie), and then again by preventing their participants from seeking treatment that could save their lives. The Henderson Act was passed in 1943, requiring tests and treatments for venereal diseases to be publicly funded, and by 1947, penicillin had become the standard treatment for syphilis, prompting the U.S. Public Health Service to open several Rapid Treatment Centers specifically to treat syphilis with penicillin.


All the while they were actively preventing 399 men from receiving the same treatments. In 1947 the Nuremberg code was written, and in 1964 the World Health Organization published their Declaration of Helsinki. Both aimed to protect humans from experimentation, but despite this, the Centers for Disease Control (which had taken over from the U.S. Public Health Service in controlling the study) actively decided to continue the study as late as 1969.


It wasn’t until a whistleblower, Peter Buxtun, leaked information about the study to the New York Times and the paper published it on the front page on November 16th, 1972, that the Tuskegee study finally ended. By this time only 74 of the test subjects were still alive. 128 patients had died of syphilis or its complications, 40 of their wives had been infected, and 19 of their children had acquired congenital syphilis. [3] Oh, there is more to this story. UNIVERSITY OF MISSOURI-KANSAS CITY Research Services writes that...


[4] https://ors.umkc.edu/services/compliance/irb/history-of-research-ethics.html

...in the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA. The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.


Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide. In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and "non-therapeutic research."


The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today. Issues addressed in the Declaration of Helsinki include: Research with humans should be based on the results from laboratory and animal experimentation. Research protocols should be reviewed by an independent committee prior to initiation. Informed consent from research participants is necessa