Directives for Human Experimentation
http://ohsr.od.nih.gov/guidelines/nuremberg.html
1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonable to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.
The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
______________________
Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S. Government Printing Office, 1949.
6 comments:
By DARLENE PRINCE
Health Editor
(a crucial excerpt)
The Baumans learned of a doctor in Germany, who has invented a new method of keyhole surgery known as gasless laparoscopy. Dr. Kruschinski believes the most important things for success in adhesiolysis are: the patient who is motivated enough to get adhesion free, the surgeon, gasless laparoscopy and SprayGel.
--------------------------------------------
The Hawkins told the Baumans they would pay for Danny's surgery by the doctor in Germany. That would be their Christmas gift to them.
Mic discovered that in order to contact the German doctor (Dr. Daniel Kruschinski), they had to work through Lisa Graven, a patient advocate living in Maumee.
Events finally started to fall into place for the Baumans. Graven put them in touch with Dr. Kruschinski in Germany.
Bauman said Dr. Kruschinski was "90 percent sure he could help me."
"Our health insurance would not pay for the surgery because it was considered experimental," Mic said. The cost of Danny's surgery was about $9,000.
Dr. Kruschinski operates a medical facility, the Emma Klinik, in Seligenstadt, Germany.
Karen, didn't you state your insurance company paid?????
Hey, how come his surgery was only 9 grand?????
Hmmmmmmmm......
experimental.
When we went we were led to believe all experimentaion had been done! I did not sing on to be a test rat for a fat bald rat
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
So Danny Boy....are you going to have a gasless lap like the rest of us?
Wow, a $9000 Christmas gift from the Hawkins to the Baumanns. These people are in the big league!
Dear Hawkins,
Would you be willing to contribute to a very desperate woman? She made three trips for surgery from Kru, with no relief, and is in fact much much worse! Kru has dimissed her and told her not to come back to him, because he does not believe she has pain. What he wrote on her operative reports was that "all adhesions were removed", then when the pain persisted he said, "Well, come back because I left some adhesions that were hard to reach, and I will get them out now."
She has spent all of her and her family's money, and is deeply in debt but unable to work because of constant excruciating pain.
Do you have a philanthropic organization set up? If so, it would be tax-deductible for you.
Thanks.
This is not a joke.
Here is the complete newspaper article.
It is found on Bombobeach press gallery.
By DARLENE PRINCE
Health Editor
------------------------------------------------------------------------
When a person is standing at death's door, and then is suddenly yanked back and given another chance, it tends to make that individual more appreciative of a second opportunity at life.
That is exactly how Defiance resident Danny Bauman, 49, feels now after two years spent battling a mysterious and insidious illness that nearly killed him - and had the medical profession baffled as to its identity.
Danny and his wife, Mary (Mic), are the owners of B&H Alignment in Defiance. He likes working on cars, fishing, golf and walking his dog...none of which he has been able to do for some time.
"It began in October 2000," the tall, lanky auto mechanic said. "I felt a lump under my left rib cage. It was very painful, a very severe pain when I moved. It went on for about a year."
During that time Bauman saw physicians in Defiance, Fort Wayne, Toledo and Cleveland.
"I had about $80,000 to $90,000 worth of tests," he said. "They gave me three or four MRIs and four or five Cat Scans. I even had a heart catherization."
"They checked him from head to toe," Mic added.
"Two doctors told me it was in my head," he said. At one point Bauman said a Toledo physician told him whatever was causing the pain was because he is a smoker. The physician refused to treat him unless he gave up smoking.
Finally, one of Bauman's local physicians decided to give him a nerve block to his rib cage in hopes of stopping the pain.
Unfortunately, Bauman's lung was punctured during the nerve block attempt.
"They gave me six units of morphine to kill the pain, but it didn't work," he said. "They were going to give me more morphine; but I couldn't take any more and still stay coherent."
Bauman's physicians decided it was time for exploratory surgery; and when his surgeon went in, he found an adhesion that had attached Bauman's colon to his chest wall - and was drawing them together and causing the pain he felt.
Unfortunately, the surgery to remove the adhesions did not work. "After a month, the adhesions came back with a vengeance," Bauman said. Bauman was having severe pain again from the adhesions.
An adhesion is an abnormal union of separate tissue surfaces by new fibrous tissues. Puzzled by how adhesions had begun forming in his body, Bauman began asking questions about his problem. He said that no one ever answered his questions completely - not until much later, when he decided to go to Germany to have surgery.
After doing some research on the Internet concerning adhesions, Mic said she discovered that adhesions often come back after surgery; and when they come back, they often become much worse than they were before surgery.
The Baumans learned of a doctor in Germany, who has invented a new method of keyhole surgery known as gasless laparoscopy. Dr. Kruschinski believes the most important things for success in adhesiolysis are: the patient who is motivated enough to get adhesion free, the surgeon, gasless laparoscopy and SprayGel.
"SprayGel keeps adhesions from forming and from attaching to other abdominal organs," Mic explained.
It was January of 2002, and Danny needed to have surgery.
"My doctor, Dr. (Alan) Gardner told me to 'hang in there'; because he thought the FDA would approve SprayGel very soon and then I could have my surgery done here," Bauman said.
But, while the Bauman's were considering surgery again, they ran into another roadblock. He had waited for months and still the SprayGel was not approved.
"SprayGel is not approved by the FDA in the United States," Danny said. "Even though SprayGel is made here - and has been used in Europe since December 2001 - it has not been approved for use here."
One evening, in November 2002, while they were playing bingo with Mic's father and mother, Harold and Thelma Hawkins, Bauman was asked what he wanted for Christmas.
"I told them I just wanted to get fixed," he said.
The Hawkins told the Baumans they would pay for Danny's surgery by the doctor in Germany. That would be their Christmas gift to them.
Mic discovered that in order to contact the German doctor (Dr. Daniel Kruschinski), they had to work through Lisa Graven, a patient advocate living in Maumee.
Events finally started to fall into place for the Baumans. Graven put them in touch with Dr. Kruschinski in Germany.
Bauman said Dr. Kruschinski was "90 percent sure he could help me."
"Our health insurance would not pay for the surgery because it was considered experimental," Mic said. The cost of Danny's surgery was about $9,000.
Dr. Kruschinski operates a medical facility, the Emma Klinik, in Seligenstadt, Germany.
"People come from all over the world to the clinic," Mic said. "Seligenstadt is about 23 miles outside of Frankfurt. Many of the
town's residents live there and work in Frankfurt.
"Usually, it is women who have problems with adhesions," Mic explained. "It turned out that Danny was Dr. Kruschinski's first male patient." She said that adhesions can begin forming in the body a few hours after surgery.
The Baumans arrived in Seligenstadt, Germany on January 7th - and stayed at an apartment complex next to the Emma Klinik.
"Seligenstadt is located on the Main River," Mic said. "Even though it's an old city, it looks a lot like Defiance in many places along the river."
"Danny had two laparoscopic surgeries," Mic said. "His first surgery to remove adhesions was on January 10th. It was discovered that new adhesions had formed in his body. The adhesions had completely covered his spleen and liver - attaching his small and large intestine to his diaphragm. Slowly, the adhesions were drawing these organs together.
Bauman was told by Dr. Kruschinski that - at some time earlier in his life - his spleen had been injured and had healed itself. When this happened, he had bled internally. It is known that any blood, left within the abdominal cavity, will cause adhesions to form. The excess blood from the spleen had resulted in adhesions that were causing Bauman's health problems.
"Eventually, the adhesions would have killed me," he said. "They probably would have stopped my heart."
One week later he had a second look laparoscopy to check and see if everything was okay.
"After the second look, they found some bleeders, but no more adhesions," Danny said. "They used five kits of the SprayGel during my first surgery. As many as six kits can be used."
Both of the Baumans said the German people were very kind and helpful toward them. Dr. Kruschinski and Dr. Harry Reich -a
surgeon from the United States, who also performs operations at the Emma Klinik - even took the Baumans out to supper one evening.
"We were there for two weeks," Mic said. The Baumans returned to Defiance on January 22nd.
Now some 60 pound lighter after his surgeries, Bauman said he is "feeling super."
"I am sore from the surgeries and I don't have much strength yet; but I feel great," he said.
He says he is still dependent on morphine after using it for a year and a half; however, he is being weaned from the drug over a three-month period.
Mic is amazed by the difference after the surgeries. "For a man, who was literally dying a few months ago, and now he is well," she said. "How can we repay these people that saved Danny's life?" Mic asked. "We are so grateful."
"I got my life back," Danny said. "Dr. Kruschinski gave my life back to me. I'm going to do some fishing and a little golfing. And I'm going to enjoy my life."
IHRT ASKS:
Why is it that some people knew Kru's surgery was "experimental", yet he said MANY times on his message board "There was NO STUDY, it was not RESEARCH".
He said that as recently as Spring 2006, in response to someone who was asking (on his message board)for research reports to substantiate his claims of surgical success.
His grandiose lifestyle of mistresses and sports cars is his business, but IHRT FINDS THAT HIS EXCESSIVE CONSUMPTION OF ALCOHOL IS NOT ACCEPTABLE. Quite possibly, his alcohol abuse/alcoholism is the reason that some people were helped and some were harmed. Maybe some pts. just got him on a bad hangover day.
AND WHO CAN RATIONALIZE OR OVERLOOK THE FACT THAT HE DID NOT TELL PATIENTS THAT THEY WERE IN A RESEARCH STUDY, AND THAT HIS METHODS WERE EXPERIMENTAL?
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