01 March 2011

Experiments on people: data from unclassified archives

Cost-effective inhumanity
Oleg Lischuk, Mednovosti

At a gathering in Washington, organized by the Presidential Commission on Bioethics, the American authorities admitted that in the last century they conducted dozens of cruel experiments on people without their consent. The Associated Press news agency conducted a large-scale analysis of old publications in medical and mass periodicals (Ugly past of U.S. human experiments uncovered) and found details of more than 40 inhumane studies conducted by American scientists in the XX century.

The reason for the rally was the story that surfaced in the fall of 2010 about the deliberate infection with sexually transmitted infections (STIs) of Guatemalans, which was carried out on the instructions of the American government. Records of these experiments, made by a former researcher of the US Public Health Service John Cutler, were found in the archives of the University of Pittsburgh by a historian from Wellesley College in Massachusetts, Susan Reverby.

As it followed from these records, from 1946 to 1948, researchers from the United States, as part of tests of newly discovered penicillin, deliberately and secretly infected Guatemalan prisoners, soldiers and the mentally ill with STIs. At the same time, not all of the 696 subjects managed to achieve recovery.

Following the release of this story, US President Barack Obama, Secretary of State Hillary Clinton and Health Secretary Kathleen Sibelius apologized for the government's actions in the past. In addition, the Institute of Medicine was instructed to investigate the details of the incident.

At a meeting dedicated to this issue, officials mentioned that dozens of similar experiments were conducted. In the course of a journalistic investigation conducted by AP, details of more than 40 of them were revealed.

Some of these works have never been covered in the media, notes about the rest were focused on the prospects of experimental treatment without mentioning the technique of conducting experiments.

Experimental mentally illFirst of all, the attention of AP employees was attracted by research on the insane.

For example, in 1942, the inhabitants of the corresponding shelter in the Michigan city of Ypsilanti were injected with an experimental influenza vaccine, after which they were infected with the virus. At the same time, many test subjects could not not only understand what was being done to them, but also describe their symptoms. In this work, by the way, the future developer of the polio vaccine, Jonas Salk, "lit up".

In the same 1940s, World Health Organization expert Paul Havens Jr. conducted a series of experiments on infecting mentally ill people with viral hepatitis. Thanks to this, he became one of the first scientists to study the causes and varieties of these infections, but this did not make it easier for those infected.

Laboratory prisonersAs it turned out, one of the "favorite" contingents for ethically unthinkable research of modern times were, unsurprisingly, prisoners.

In 1915, the recognized epidemiologist Joseph Goldberger placed prisoners from Mississippi on a lean diet to prove that the severe disease of pellagra develops due to a lack of vitamin B3 in food. The prisoners were subsequently apologized without any material compensation, and Goldberger was nominated for the Nobel Prize five times for his work on pellagra.

In the next few decades, the number of such experiments decreased dramatically, but the essence of some of them, to put it mildly, is impressive. So, in the 1920s, the doctor of the California prison San Quentin L.L. Stanley (L.L. Stanley) conducted a series of experiments to restore the "vitality" of elderly prisoners by transplanting them the sex glands of cattle and executed criminals.

During the Second World War, interest in research on convicts resumed, because the army needed them. For example, in three Illinois prisons, they were infected with malaria in order to test potential medicines for this infection needed by soldiers fighting in Oceania.

Studying the ways of transmission of intestinal infections in the 1940s, experimenters went even further, forcing prisoners from the correctional camp in Coxackie (Coxackie, New York) to drink unfiltered suspension of feces of patients, as well as inhale it in a sprayed form.

With the development of the pharmaceutical industry in the 1950s and 60s, government and corporate research on prisoners was, in fact, put on stream, despite a number of fresh trials of Nazi experimenters in memory. By the 1960s, at least half of the American states allowed such research.

Some of these experiments became public and generated a wave of criticism from the media and the masses. During one of them, employees of the Jewish Hospital for Chronic Diseases in Brooklyn, New York injected cancer cells into 19 elderly disabled people, of course, without their consent. The head of the institution stated that consent is not required in this case, since the cells are considered safe. However, by the efforts of lawyer William Hyman, this practice was discontinued.

The testing ground for another resonant study was the Willowbrook State School for Mentally Retarded Children. From 1963 to 1966, students of this school were infected with viral hepatitis to test the developed antibodies.

The last straw was in 1972, the leak of information about the study of syphilis in the Alabama city of Tuskegee. As it became known, in 1932, the US Public Health Service decided to investigate the development of this infection in blacks. For this purpose, 399 people with initial manifestations of the disease were identified, after which medical supervision was established for them. Since the goal of scientists was to study all stages of syphilis, attempts to cure the participants of the experiment were not made even after the inclusion of penicillin in the treatment regimen for this infection in 1947. Moreover, the subjects were specifically restricted access to information about treatment.

The Tuskegee study is considered by many to be the most shameful medical study in the history of the United States. It marked the beginning of a lengthy congressional hearing, during which representatives of the pharmaceutical industry admitted that prisoners for experiments were "cheaper than chimpanzees." The proceedings led to the fact that in the mid-1970s pharmaceutical companies stopped being allowed into prisons.

Not your own – it 's not a pityHaving lost the opportunity to conduct experiments on convicts, the researchers moved their experiments abroad, where they could be carried out with less cost and restrictions.

One of these studies was the infection of Guatemalans with syphilis. However, it was not the last.

At least two drug trials over the past 15 years have been found to be inconsistent with ethical principles. One of them was passive monitoring of pregnant HIV-infected women from Uganda in order to assess the risk of transmission of the virus to the child. At the same time, the researchers were well aware that the appointment of a common antiviral drug azidothymidine reduces this risk.

In another, a Pfizer antibiotic was prescribed to Nigerian children with meningitis, although its effectiveness in this disease has not been confirmed. According to prosecutors, this led to 11 deaths and many disabilities. The company paid $75 million in compensation in court, but did not recognize its actions as erroneous.

From the editorial office of "VM":
Perhaps both the danger and the unconfirmed efficacy of the Trovan antibiotic in this murky story are actually exaggerated:
“At the time of the Kano study, Trovan was in late stage development and had been tested clinically in more than 5,000 patients in the United States, Europe and elsewhere both in oral and intravenous forms. Results of those studies demonstrated Trovan to be effective against several types of bacteria known to cause meningitis, to have excellent activity against all meningitis pathogens...”
However, the results (issued in compliance with all the rules and with the consent of the Nigerian authorities!) clinical trials are by no means fateful:
With a survival rate of 94.4%, Trovan was at least as effective as the best treatment available at Kano’s IDH. The overall survival rate in Nigeria was less than 90%.
It is unlikely that all the sick Nigerians received the best treatment, and Pfizer himself writes all this (a selection of his excuses is at the end of this page), but this whole story really smacks of the desire of the servants of the Nigerian people to cut down a bag of bucks from the white colonizers in their favor...
As follows from last year's report by the senior inspector of the US Department of Health and Social Security, in 2008 from 40 to 65 percent of clinical trials of medicines subject to federal regulation were conducted outside the country. American supervisors were able to verify only less than one percent of these foreign studies.

Work on bugsAfter receiving information about the Guatemalan case, Obama instructed the bioethics commission that organized the meeting to investigate this incident in detail with the involvement of both full-time and freelance experts.

In addition, due to the current state of affairs with foreign research, the American president set the commission the task of further evaluating the conduct of these works.

The commission's response on both issues should be provided by September 2011. According to a number of experts, such as Arthur Kaplan, director of the Center for Bioethics at the University of Pennsylvania, such a tight deadline is unlikely to allow ethics experts to collect a significant amount of data and draw serious conclusions from them.

However, even based on the available historical and current data, it is safe to say that the desire to save on expensive research will force their not particularly picky customers and performers to look for ethical circumventions for a long time.

As Kaplan correctly noted, regardless of the era, goals, methods and results, such experiments are united by one thing: violation of the fundamental principle of medicine "do no harm".

Portal "Eternal youth" http://vechnayamolodost.ru01.03.2011

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