Chapter 7: Human Experimentation
|Section 5. Decision Scenarios
Summary of Methodology for Analyzing and resolving Cases involving moral dilemmas in Health Care:
Paradigm for the Method: http://depts.washington.edu/bioethx/tools/4boxes.html
Sample Case Analysis: http://depts.washington.edu/bioethx/tools/cecase.html
Introduction to Clinical Ethics, 4th edition using the case of Dax Cowart.:
For each of the scenarios you should consider how a person would reach a decision if that person were using the basic principles from EACH of the following traditions:
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page no. 544 Decision Scenario #1
On April 6, 1998, researchers at the National Cancer Institute announced that the clinical trials of the drug tamoxifen had produced enough statistical data to show that there was a clear difference in the incidence of breast cancer among women taking the drug, compared with women who were not. Because half of the 13,388 women in the study were receiving a placebo instead of an active drug, the study was stopped before its originally planned date so that all of them could receive the drug’s benefits. The trial had lasted six years and was intended to determine whether tamoxifen had a protective effect against breast cancer. “We all felt that question had been answered,” said Leslie Ford of the National Cancer Institute.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page no. 545 Decision Scenario #2
You are an agent of the ethics committee of the National Association of Physicians. You have been sent to Laurel, Mississippi, to look into the experimental work of Dr. Joseph Camwell at the Laurel State Hospital.
“Our basic concern,” Dr. Camwell tells you, “was to test the effectiveness of a hormone-based substance in controlling conception by the regulation of ovulation.”
“A birth control pill.”
“Exactly,” says Dr. Camwell. “We ran a double-blind test with HB-4, the test substance, and a sucrose-based compound flavored and shaped to be phenomenologically indistinguishable from the tablets of HB-4.”
“So that neither the experimenter nor the subjects knew who was getting HB-4 and who was getting the sugar pills. But who were your test subjects/”
“Patients who presented at our state-sponsored outpatient clinic and requested contraceptive medication formed our candidate population. We drew from them subjects with a good medical history and no present major illnesses, who seemed reliable enough to take their medications on schedule.”
“What were the racial percentages?”
“We didn’t consider that a relevant factor in the experiment. It happened that about 90 percent of our subjects were black, although race was not a criterion for selection.”
“Did you secure from these women their informed consent to be subjects in this experiment?”
“Of course,” Dr. Camwell says. “I explained to each of them that they were going to participate in an experiment but that it wouldn’t hurt them. I told them they’d be given birth control pills that we were testing for effectiveness. ‘You might get pregnant while you’re taking these pills,’ I said.”
“But you didn’t tell them that at least half of them would be receiving sugar pills that would do absolutely nothing to prevent pregnancy?”
“I think that I warned them sufficiently,” says Dr. Camwell. “I told them they might get pregnant. None of these women is able to understand medical sophistications. If I tried to tell them about the experiment they wouldn’t understand me. They knew they might get pregnant, and I figured that was enough.”
“Did they all agree to participate?”
“Every last person we approached agreed to participate,” Dr. Camwell says. “People always wan tot help out doctors, and they’ll do it if you just put it to them in the right way. I never have any trouble getting subjects for my work.”
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page 545 Decision Scenario #3
In 1988 the Environmental Protection Agency decided to exclude from a study it had commissioned the use of all Nazi data on the effects of phosgene gas. Those favoring the exclusion held that data obtained by unethical mean should never be used. Opponents of this view held that making use of such data is a way of honoring and remembering those who were sacrificed to obtain it.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page 546 Decision Scenario #4
“ In effect,” said Dr. Sanchez, “the drug is a powerful tranquilizer. We’re not sure howit works, but we know that it has a great calming effect on people diagnosed as schizophrenics. It’s much like thorazine, which you have heard of.”
“Does it have any side effects?” Monica Jones asked.
“If taken over a period of a couple of weeks. It produces a palsied condition—muscular tremors, difficulty in walking and in controlling the face muscles, and so on. These don’t seem to be permanent.”
“We don’t know the likely effects in other people.
Perhaps you will notice no change at all or maybe you’ll never develop the muscular tremors. But it’s possible you’ll develop the muscular tremors. But it’s possible you’ll develop the sooner or more severely. That’s part of what we need to find out.”
“I’m not in danger of death, then?”
“All medication has associated with it some risk. But we don’t believe the risk here to be great. There is some possibility of long-term nerve or brain damage. We simply don’t know the risks here.”
“And you need so-called normal people like me to act as subjects so that you can compare the effects of the drug on us with its effects on schizophrenics?”
“Exactly right,” said Dr. Sanchez. “But I should tell you that you may not get the drug. None of involved in the experiment as patients or experimenters will know who is getting tranquilizer and who is getting a placebo.”
“So maybe I’m not runny any risk at all,” said Monica.
“Maybe not. But you participation is still important. This drug may do much to relieve the symptoms of a great number of schizophrenics.”
“Now, if I understand correctly,” said Monica Jones, “ I will be paid for my participation.”
“That’s right. You will be paid a flat fee for participation—half at the beginning of the study and the rest at the end. I want you to be clear on one thing, however. You must waive your right to claim compensation due to any injury or ill effects you may suffer s a result of the medication.”
“I understand that. I’ve got to take a risk. I’m not too happy about that, but I don’t get a job and I need the money so I can go back to school next semester.”
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page 546 Decision Scenario #5
The drug DES, diethylstilbestrol, was once believed to be effective in preventing miscarriages. But in 1971 sufficient evidence was available to establish a link between DES and vaginal cancer and cervical cell abnormalities in the daughters of women given the drug. About 1 million women were give DES in the first trimester of pregnancy, and over 120 daughters of these women have been shown to have cancer. Sons apparently do not develop cancer, but the group shows a higher-than-average proportion of genital abnormalities and sterility.
In late 1951 and early 1952, women receiving prenatal care at the University of Chicago’s Lying-In Hospital were given unmarked tablets of DES as part of a study conducted by Dr. William Dieckmann. One of those receiving the tablets was Ms. Patsy Mink, who later became an assistant secretary of state.
“I remember quite clearly the doctor giving me those pills and telling me they were vitamins,” Ms. Mink told a reporter.
Ms. Mink’s daughter, Gwendolyn, was born in the hospital in 1952. Ms. Mink was not notified that she had been given DES until twenty-four years later. She rushed her daughter to a medical examination, and it was discovered that Gwendolyn had abnormal cell changes in the cervix—a condition know as adenosis and thought to be a precursor to cancer.
Ms. Mink later felt outranged by the experiment in which she was an unwitting subject. She felt she had not been given the drug for a legitimate medical reason and was deceived by her doctor. “There’s no way we could know,” she said. “If they had given me a choice, if they had said, ‘We think you are a risk case and this drug may help you,’ that’s different. That’s the choice we should have been presented with. But I wasn’t a risk case, and I wasn’t told anything.”
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page 547 Decision Scenario #6
“You realize,” Dr. Thorne said, “that you may not be in the group that receives medication. You may be in the placebo group for at least part of the time.”
“Right,” Ms. Ross said. “You’re just going to give me some medicine.”
“And do you understand the aims of the research?”
“You wan tot help me get better,” Ms. Ross suggested hesitantly.
“We hope you get better, of course. But that’s not what we’re trying to accomplish here. We’re trying to find out if this medication will help other people in your condition if we can treat them earlier than we were able to treat you.”
“You want to help people,” Ms. Ross said.
“That’s right. But you do understand that we may not be helping you in this experiment?”
“Not exactly. I mean, we aren’t going to try to harm you. But we aren’t necessarily going to be giving you the preferred treatment for your complaint either. Do you know the difference between research and therapy?”
“Research is when you’re trying to find something out. You’re searching around.”
“That’s right. And we’re asking you to be part of a research effort. As I told you, there are some risks. Besides the possibility of not getting treatment that you need, the drug may produce limited hepatic portal damage. We’re not sure how much.”
“I think I understand,” Ms. Ross said.
“I’m sure you do,: said Dr. Thorne. “I understand that you are freely volunteering to participate in this research.”
“Yes, sir. Mrs. Woolend, she told me if I volunteered I’d get a letter put in my file and I could get early release.”
“Mrs. Woolend told you that the review board would take your volunteering into account when they consider whether you should be put on work-release.”
“Yes, sir. And I’m awfully anxious to get out of here. I’ve got two children stay with my aunt, and I need to get out of this place as quick as I can.”
“I understand. We can’t promise you release, of course. But your participation will look good on your record. Now I have some papers here I want you to sign.”
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 . Page no. 548, Decision Scenario #7
The ad in the newspapers was simple and uninformative: “Subjects (male and female) wanted to participate in scientific study. Must be 21 or over. $2 per hour.” Karen Barty wrote down the address. She could use the money, and in 1962, $2 an hour wasn’t bad pay for what was sure to be very little work. Besides, the hours were probably flexible, and she could fit the time into her class schedule.
The next Tuesday morning at ten o’clock, Karen and nine other people reported to Room711 of the Basic Sciences Building in the Western Medical Center. A man, who introduced himself as Dr. Carlo Raphael, explained what would be required of them as research subjects.
“First of all, you must sign consent forms,” he said. “These state that you are voluntary participants in this study and that for your assistance you will receive a financial reward. If you are not willing to sign the forms, then we cannot accept you as a subject.” He interrupted himself to pass out badly mimeographyed sheets of paper that had “Voluntary Consent of Research Subjects” printed at the top. Karen signed hers at once, without bothering to read it. The others in her group, she noticed, did the same thing.
“Very good,” Dr. Raphael said, after collecting the forms. “We are going to ask that you provide us with the answers to a series of questions. Some of you may think of these as ‘tests,’ but I want to assure you that they are not tests in the ordinary sense. You can neither pass nor fail. Just five us you immediate and truthful responses.”
With the help of two assistants, Dr. Raphael distributed test booklets with coded answer sheets tucked inside. Everyone was then supplied with a black IBM pencil with soft, black lead. Karen listened, half bored, as Dr. Rahael explained how the answer sheets were to be filled in. Then they got down to work.
At noon, they handed in their booklets and broke for lunch. When they reported back, it was to another room in the same building. It was not a classroom this time but a lounge. A long table at the front was draped with white crepe paper, and pitchers of water surrounded by glasses were set at one end. At the opposite end, a red cafeteria try with small paper cups was watched over by a woman Karen hadn’t seen before.
“Let the cube dissolve in your mouth,” Dr. Raphael had told them. “Then have some water, if you like, but don’t eat or drink anything else.”
It was disgusting, eating plain sugar. But within twenty minutes, Karen knew that it wasn’t just plain sugar. She was sitting on one of the sofas talking to another woman about an English group called the Beatles. The woman had never heard of them, and Karen spelled the name for her.
But as she started to spell it, she suddenly found it was hard to concentrate. She knew where she was and what she was doing, but the woman in front of her began to look strange. The woman’s face seemed to be surrounded by a halo of brightly colored light, then her features became twisted and distorted.
Karen gave up trying to talk. Somewhere at the back of her mind, she felt fear and confusion. But what was happening to her wasn’t unpleasant. It was interesting, really, and she surrendered herself to the fantastic images that seemed to take over her mind without her being able to control them.
Somewhere in that time, she fell asleep or at least she thought she did. She vaguely remembered one of Dr. Raphael’s assistants holding her by the arm and leading her back to the classroom. She tried to talk to him, but she wasn’t sure what she said. When she was handed another test booklet, she was surprised to find how easy it was to fill out the answer sheet.
By five o’clock that afternoon, Karen was herself again. It was not until seventeen years later that she realized she had been an unwitting participant in a research project sponsored by the army to determine the psychological effects of LSD.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 ., Page 549, Decision Scenario #8
In April 1979, a suit was filed in Illinois by the Cook County Public Guardian against the Illinois Department of Mental Health. The suit alleged that during the 1950s and the 1960s between 25 and 100 patients underwent “unauthorized and secret” surgery at a state mental health center.
The suit charged that the patients, without their consent, were subjected to experimental surgery to remove their adrenal glands. A memo from a psychiatrist was cited that described the health center as “virtually a human dog lab.”
A spokesman for the mental health department publicly denied the charges in the suit. He claimed that an internal investigation showed that consent from the patients had been obtained and each had been informed of the possible risks and of the short and long-term effects.
Moreover, the surgery was said to have a therapeutic aim, as well as an experimental one. A theory at the time suggested that the removal of the adrenal gland might correct a hormonal imbalance that some research psychiatrists believed to be a cause of schizophrenia. Furthermore, it was claimed that only four schizophrenic patients were involved.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 ., Page 550, Decision Scenario #9
At 6 A.M. on Wednesday, March 6, 1985, Dr. Kevin Cheng of Phoenix got a call from cardiac surgeon Dr. Cecil Vaughn. “Is your heart ready to be implanted?” Dr. Vaughn asked.
Dr. Cheng thought the question was about implanting the artificial heart he had invented into a calf, and experiment he and Dr. Vaughn had done once before and were planning to do again. When he learned that the intended recipient was a human, he hesitated. “Wait a minute,” Dr. Cheng said. “It’s designed for a calf and not ready for a human yet.”
“Think about it, decide, and I’ll call back in ten minutes,” Dr. Vaughn told him.
The heart was needed because Thomas Creighton, a thirty-three-year-old automobile mechanic and divorced father of two children, had rejected the heart he had received from an accident victim. Dr. Jack Copeland and the transplant team at University Medical Center in Tuscon immediately began a search for another donor heart, and Mr. Creighton was placed on the heart-lung machine. Dr. Copeland had also called Utah and requested that the Jarvik-7 heart be flown in.
“I knelt and prayed,” Dr. Chen recalled later.
When Dr. Vaughn called him back, he said “The pump is sterile and ready to go.”
Around noon of the same day, Dr. Vaughn implanted the device in Thomas Creighton. Mr. Creighton’s physicians had decided that it would be dangerous to leave him on the heart-lung machine any longer, and the Jarvik-7 heart had not yet arrived. The Phoenix heart maintained Mr. Creighton’s circulation until a donor heart was located.
At 11 P.M., the device was turned off, and Creighton was put back on the heart-lung machine. At 3 A.M. on Thursday, Dr. Copeland transplanted the second donor heart. However, despite all efforts, Mr. Creighton died the following day. The Phoenix heart had nothing to do with causing his death. However, in deciding to use the Phoenix heart, Dr. Vaughn and Dr. Copeland had apparently violated FDA regulations by employing a device that had not been approved for experimental use in humans.
They and their defenders justified their actions by claiming that their use of the device was an emergency measure. They were not performing an experiment with Mr. Creighton but attempting to save his life. The only other option was just to let him die. “We had nothing to lose by using the heart,” Dr. Copeland said.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 ., Page 550, Decision Scenario #10
The first human heart was transplanted in 1967 in South Africa by Dr. Christiaan Barnard. However, this was not the first heart transplant on a human being. In January 1964, Dr. James Hardy of the University of Mississippi transplanted a chimpanzee heart into Boyd Rush.
Boyd Rush was a deaf-mute who was brought to the University of Mississippi Medical Center unconscious and on the verge of dying. A stepsister, the only relative who could be located, signed a consent form permitting, if necessary, “the insertion of a suitable heart transplant.” The form made no reference to the sort of heart that might be employed. Mr. Rush lived for two hours after the transplant.
Dr. Hardy justified the use of the chimpanzee heart on the ground that it was impossible to obtain a human heart. Also, he was encouraged to think the transplant might be successful because of the limited success obtained by Dr. Keith Reentsma in transplanting chimpanzee kidneys into a man dying of glomerulonephritis. The kidney recipient lived for two months.
Dr. Leonard Bailey, the surgeon who transplanted the baboon heart into the child known as Baby Fae, expressed his view of Dr. Hardy in an interview. “He’s an idol of mine because he followed through and did what he should have done…he took a gamble to try to save a human life.”
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 ., Page 551, Decision Scenario #11
Cardiologist William O’Neill decided he would have to go to Germany to do a clinical test on a device to clean out clogged arteries. Several years previously, researchers at the Centers for Disease Control planned to test the effectiveness of giving vitamin supplements to pregnant women to prevent spina bifida in their children. The National Institution for Child Health and Development objected to the plan to withhold vitamins from the control group. The researchers found Chinese collaborators who arranged for the clinical studies to be done.
Some clinical researchers believe cases like these are widespread and increasing. More and more often, researchers and drug companies are choosing to test medical devices, therapies, and drugs in foreign countries.
Two reasons are mentioned as responsible for the increase. First, the FDA and other federal agencies require so many levels of approval and so much paperwork that efforts to mount clinical trials are discouraged. Second, overzealous advocates of patients’ rights have both complicated the approval process and made it difficult to recruit test subjects. Speaking of informed-consent forms to test a new clot—dissolving drug used during a heart attack, one British researcher said: “The American documents were three pages of legalistic junk. That’s not the sort of thing you want to push under someone’s nose as he’s having a heart attack, terrified with chest pain, on morphine. You want to tell him about the trial, but you want to be humane.”
Furthermore, critics of testing have made people so suspicious of medical research that they refuse to participate when asked. By contrast, patients in other countries are more trusting and give their consent more readily.
The situation has been encouraged by an FDA decision to accept data from some foreign trials. The aim of the policy change was to make effective drugs more quickly available in the United States, but a consequence has been to encourage researchers to avoid problems at home by going abroad.
From: Munson, Ronald. INTERVENTION AND REFLECTION.6th ED.,Belmont, California: Wadsworth Publishing Company,2000 ., Page 55, Decision Scenario #12
During the two years he had worked for the Bioplus Foundation, Dennis Quade had been in many labs. Before he could renew the funding of a grant, he was required to make an on-site inspection of the facilities and review the work of the investigators. Now he was sitting in a small, chilly conference room about to watch a videotape of a phase of the work done at Carolyn Sing’s lab.
Sing herself was sitting at the table with him, and she leaned forward and pushed the play button. “The experimental subjects we used are baboons,” she told him. “We think they possess facial and cranial structures sufficiently similar to humans to make them the best animal models.” Dennis nodded, then watched the monitor in complete silence. He was appalled by what he saw. An adult animal, apparently limp from anesthesia, was strapped to stainless-steel table. Its head was fitted into a viselike device, and several clamps tightened to hold it immobile. The upper-left side of the baboon’s head had been shaved and the area painted with a faintly purple antiseptic solution. A dark circle had been drawn in the center of the painted area.
The while-coated arms of an assistant appeared in the tight focus of the picture. The assistant was holding a device that looked like an oversized electric drill. A long, transparent plastic sleeve stuck out from the chuck-end of the device, and through it Dennis could see a round, stainless-steel plate. A calibrated dial was visible on the side of the device, but Dennis couldn’t read the marks.
“That’s an impact hammer,” Dr. Sing said. “We thought at first we were going to be able to use on off the shelf, but he had to modify one. That’s an item we didn’t anticipate in our initial budget.”
The assistant centered the plastic tube over the spot marked on the baboon’s head and pulled the trigger of the impact hammer. The motion of the steel plate was too swift for Dennis to see, but he saw the results. The animal’s body jerked in spasm, and a froth of blood, brain tissue, and bone fragments welled up from the purple spot.
Dennis Quade turned away from the monitor, unable to stand the images any longer.
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