The Use and Abuse of Humans in Biomedical Research Torah Academy of Bergen County Book Day 2015 Dr. Jim Whitfield

The Use and Abuse of Humans in Biomedical Research

Torah Academy of Bergen CountyBook Day

2015Dr. Jim Whitfield

Two Types of Human Research


• Research with the consent of the subject


• Research with the consent of the subject• Research without the consent of the subject

Research Without Consent

• Far to often research has been conducted on individuals (or groups) without their consent or knowledge



• Rarely have these research projects actually benefitted the research subjects.



• Rarely have these research projects actually benefitted the research subjects.

• All to often the results of these research studies have inflicted great harm on the research subjects

Informed Consent• Prior to the 1940’s the idea of informed

consent was not a part of the medical lexicon in the United States. Some individual researchers were more concerned with it than others. However, it was not widely practiced and more often then not the people who were being researched on were not truly in a position of object

Informed Consent

• It was not until after the Nuremberg Trials did the idea of informed consent become codified in law.

Informed Consent

• It was not until after the Nuremberg Trials did the idea of informed consent become codified in law.

• The Establishment of the Nuremberg Code stated that, “The voluntary consent of human subjects is absolutely essential before any subsequent research can be performed..”

Herta Oberhauser, physician at the Ravenbrueck concentration camp, sentenced at the Doctors’ Trial in Nuremberg, August 20, 1947.

A sentence of death by hanging is pronounced by a US War Crimes Tribunal upon Adolf Hitler's personal physician, 43-year old Karl Brandt. Brandt was also Reich Commissar for Health and Sanitation

United States of America v. Karl Brandt, et al. The Doctor’s Trial - 1946 - 1947

However, we will see that simply establishing a code or a law does not guarantee that the requirements set down in that code will be followed

Informed Consent

• Perhaps the most intensely debated philosophical and ethical question with regard to the use of biomedical research involving human subjects is “do the ends justify the means?”

Informed Consent and Research


• Perhaps this is better phrased as



• Perhaps this is better phrased as• Can research obtained through unethical

means be used for ethical and beneficial results?


• Or is data collected in an unethical manner always



• Fruit of the Poisonous Tree?



• Fruit of the Poisonous Tree?• Remember certain groups such a prisoners,

children, the mentally disabled, wards of the state and soldiers need special protection

Should Data Collected in an Unethical Fashion Ever be Used?

• Dr. Sigmund Rascher studied the effects of hypothermia on Polish prisoners at Dachau Concentration Camp

• He immersed more than 300 prisoners into icy water and then made them stand outside in the Winter for times ranging from hours to days

• Most were monitored until they died


• Some were saved just before death and different methods of warming and resuscitation were studied

• In a second studied Prisoners were placed in decompression chambers until their brains exploded

• Their brains were dissected and he learned how cerebral clots formed in pilots subject to rapid decompression


• While there is no doubt the studies were terrible and unethical, Rascher was an excellent researcher and took meticulous notes

• In 1990 Dr. Robert Pozo’s of the University of Minnesota was denied publication in the NEJM after he used Racher’s data to fill in gaps in his research


• Pozo’s showed that contrary to the widely used practice of slow passive warming Racher’s more painful method of rapid active rewarming was actually more effective

• Pozo’s argued that using this data could save the lives of hypothermia victims and that there was no other way to collect human data therefore using the data was justified


• He further argued that using this data would help to acknowledge the suffering of those that died to obtain it, and would honor the sacrifices they made and serve as a reminder of Nazi atrocities

Experiments on Chinese Prisoners by The Japanese During WWII

• Most Americans are familiar with Nazi atrocities, however the Japanese were equally as brutal if not more so to the Chinese and POW’s of all nationalities

• The most infamous of the Japanese “research” centers was called Unit 731 located in Harbin China


• During a three year period from 1941-1944 more than 30,000 people were killed in studies ranging from the effects of close impact shrapnel wounds, to exposure to typhoid and bubonic plague, to hypothermia, induced gangrene and gas warfare

• Vivisection was very widely practiced. This is the dissection of living individuals who are awake without anesthetic


• Unlike the Germans who’s experiments, while vicious generally had some scientific merit the Researchers at Unit 731 seemed to make it up as they went. One famous series of experiments involved removing a patients stomach and then attaching his esophagus to his intestines to see how long he would survive

• The Japanese referred to their victims as Maruta (logs) as in, “How many logs did we burn today.”

Shiro Ishii the commander of Unit 731 was never tried for war, nor were any of his subordinates. Instead theywere granted immunity for all their crimes by theUnited States Government in exchange for all their chemical and germ warfare data. General Douglas Macarthur and The United States Government believed that this data would put us decades ahead of the soviets.

After the War Ishii lived in Maryland for many years. He Returned to Japan in the 1950’s were he continued to practice Medicine. In died in 1959 from throat cancerAnd was hailed as a hero by many of the people ofJapan

Unfortunately Not All Unethical Research Has Been Confined to Other

Countries• Questionable and Unethical Research in the

United States– Yellow Fever vaccination studies– Tuskegee Syphilis studies– Holmesburg Prison experiments– Hepatitis Research at Willowbrook Psychiatric

Center

Yellow Fever Vaccinations

• Following the end of the Spanish – American War, the United States occupied Cuba

• Thousands of service men were contracting and dying from yellow fever and other tropical diseases such as typhoid

• Major General Walter Reed was sent to Cuba to set up a yellow fever vaccination study


• At this point is was not completely understood that yellow fever was transmitted by mosquito’s or that a vaccine would be effective

• Under the direction of Reed his two chief researchers (Lazear and Carroll) vaccinated several hundred US soldiers and local Cubans. They also vaccinated themselves


• They suffered approximately 30% mortality among those intentionally infected (including Lazear)

• Those soldiers were paid to participate. Some participated of “Duty to Country” but many felt they had no option but to participate as there commanding officer was in charge of the program.


• “Volunteering to Dr. Carroll for experimental yellow fever was I can assure you a cold-blooded proposition. Their were no heroics in at as far as I was concerned….I suspected that I would probably get the fever anyway, so I decided I rather get it under more favorable conditions”

John Bullard Yellow fever survivor

Tuskegee Syphilis Experiment


• Between 1932 and 1972 the United States Public Health Service experimented on more than 600 African-American males that either had syphilis or were given it.

• These were very poor and overwhelmingly illiterate individuals who received a small amount of money and burial services from the government

• They were never told what they were being experiment on with

• The purpose was to study the natural course of the disease when left untreated


• However, for a significant portion of the time Penicillin was an available effective treatment

• Thousands of people were treated with Penicillin, but not this research group.

• In the end only 74 of the original patients survived. 80 of their wives contracted syphilis and 19 children were born with it.


• “The men’s status did not warrant ethical debate, they were subjects not patients, clinical material not sick people…for the most parts researchers simply did their jobs, some simply followed orders, others did it for the joy of science.”

– Dr. John Heller, Director of Venereal Diseases USPH 1945-48


• Who does that sound like?


• Who does that sound like?• Simply following orders was the defense of

the Nazi’s during the Nuremburg trials• It didn’t work then or now!

“What was done cannot be undone. But we can End the silence. We can stop turning away. WeCan look you in the eyes and finally say on behalf Of the American people that what the US Government did was shameful and I am sorry.”

President Bill Clinton 05/16/97

Holmesburg Prison Studies

• Holmesburg is a prison outside of Philadelphia that conducted a series of controversial research experiments on prisoners for over two decades

• Dr. Albert Klingman, a dermatologist at the University of Pennsylvania was the lead investigator on all the projects


• Albert Klingman referred to Holmesburg as the perfect anthropomorphic colony, it was packed with mostly healthy men under perfectly controlled conditions.

• “When I look the men I see acres of skin”


• Klingman tested everything from the innocuous such as toothpaste and deodorant to the truly dangerous.

• He experimented with LSD fed to the prisoners for up to 3 months at a time

• He exposed them to Dioxin (agent orange) at 435x’s the legal limit

• He injected them with herpes virus

Holmesburg Prison Studies• Eventually the federal government shut down

both Klingman and the hospital• Klingman, the University of PA, Johnson &

Johnson and Dow Chemical were sued by 300 prisoners.

• However, the statute of limitations had expired and their case was dismissed

• Klingman rejected any claims he did anything wrong. He stated he followed the ethical norms of the day which stated that prisoners had few if any rights


• After the closing of Holmesburg Prison the government enacted new reforms on the use of prisoners in experiments.

• These reforms are referred to as the Belmont Accord which established the use of Institutional Review Boards (IRB) to oversee and approve or reject any proposed research using human subjects.


• The requirements laid out in the Belmont Accord are generally referred to as “the common rule”


Speaking at a Senate inquiry, Senator Ted Kennedy, remarked how, in spite of the sets of ethical principles laid out in the 1947 Nuremberg Code and the later Declaration of Helsinki, the poorer members of society typically bore the brunt of unethical biomedical research; Kligman's research at Holmesburg prison has become a textbook example of such unethical experimenting, and has been denounced as equivalent to "the barbarity and sadism of Auschwitz and Dachau.”

Andrew (Ender) Wiggans

• How did they “experiment” on Ender?• Did they care about how it made Ender feel?• What were they most concerned about?• Ender is manipulated in a psychological

experiment to commit xenocide


• Will we ever learn?


• Even in the future humans are performing atrocities

• “They didn’t move, they didn’t respond to anything, even when our scientists vivisected some of them to see if we could learn a few more things about the buggers.”

Documents

The Use and Abuse of Humans in Biomedical Research Torah Academy of Bergen County Book Day 2015 Dr. Jim Whitfield