Second Session

Wednesday, October 3, 2010

Henrietta Lacks: The Legal and Public Policy Implications

Possible Discussion Questions

  1. How did doctors justify using patients in public hospitals as medical research subjects without obtaining their informed consent or offering them financial compensation? How has this changed over the decades since Ms. Lacks was treated at Johns Hopkins? Why did the changes occur?
  2. Analyze the consent statement that Ms. Lacks signed on page 31. Based on this statement, do you believe that Drs. TeLinde and Gey had the right to obtain a sample from her cervix to use in their research?
  3. Why did Mrs. Lacks’ doctors need to ask for her family’s permission to remove tissue samples after her death? How did Day respond to the request?
  4. Who profited for the distribution and sale of HeLa cells?
  5. Do you agree with Dr. Pomerant’s suggestion that Dr. Gey should have “finished his own research” before releasing HeLa to colleagues?
  6. How did Dr. Southam justify his decision to inject HeLa cells into patients without their knowledge or consent?
  7. Why, specifically, did the doctors at the Jewish Chronic Disease Hospital object to Dr. Southam’s cancer study?
  8. What does the 1969 Johns Hopkins study reveal about the researchers’ attitudes and assumptions about race?
  9. Explain how Henrietta Lacks association with HeLa become widely known?
  10. Summarize John Moore’s story.

Questions used from the Random House Teacher’s Guide for use in studying The Immortal Life of Henrietta Lacks available at www.purdue.edu/sats/documents/HeLaTeachersGuide.PDF.

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5 Comments (+add yours?)

  1. Jessica Ramich
    Oct 01, 2012 @ 15:04:48

    1. Many scientists believed that since patients were treated for free in the public wards, it was fair to use them as research subjects as a form of payment. In today’s day of age, a patient has to sign a consent form just for walking in the door of a clinic or hospital. These changes occurred due to legal disputes much like Henrietta’s story.

    2. The consent form read: “I hearby give consent to the staff of Johns Hopkins Hospital to perform any operative procedures and under any anesthetic either local or general that they may deem necessary in the proper surgical care and treatment of.” The doctors had no right to obtain a sample from her cervix even after signing this consent form. The consent form only gave the doctors permission to treat Henrietta for any unforeseen complications that might have taken place during the surgery.

    3. Though no law or code of ethics required doctors to ask permission before taking tissue from a living patient, the law made it very clear that performing an autopsy or removing tissue from the dead without permission was illegal.
    Although Day originally refused to allow the John Hopkin’s doctors to do an autopsy, he consented after Dr. Gey said that the tissue samples might help his children someday.

    4. Samuel Reader, the owner of Microbiological Associates, and his business partner Monroe Vincent used HeLa cells as the springboard to launch the first industrial scale, for-profit cell distribution center. This was the beginning of the multibillion-dollar industry of selling human biological materials.

    5. Gey was trying to restrict the way other scientists used HeLa cells because they were conducting research and getting credit for ideas that Gey already came up with, but not yet published due to time constraints. Gey released HeLa to colleagues in hopes of medical and scientific break threws.

    6. Southam injected HeLa cells into cancer patients without telling them he was injecting someone else’s malignant cells – he told them he was testing their immune systems for cancer. This was partially true, because people with cancer would reject the cells more slowly than healthy people, therefore he would be able to find undiagnosed cases of cancer. Southam said he didn’t tell patients the cells were cancerous because he didn’t want to cause any unnecessary fear.

    7. The doctors at the Jewish Chronic Disease Hospital objected to Dr. Southam’s cancer study because of their familiarity with the Nuremberg trials where Nazi doctors were sentenced to death by hanging 16 years earlier. These doctors were conducting unthinkable research on Jews without consent.

    8. In 1969, a Hopkins researcher used blood samples from more than 7,000 neighborhood children—most of them from poor black families— to look for a genetic predisposition to criminal behavior. The researcher didn’t get consent. This reveals that the researcher thought black people were more prone to crime.

    9. It was not until Dr. Gey’s death in 1973 that Henrietta Lacks’ name was tied to the donor of the HeLa cells. Several Hopkins collegues decided to write an article about the history of the HeLa cell line as a tribute to Gey’s career.

    10. In 1976, John Moore was diagnosed with hairy-cell leukemia, a rare and deadly cancer that filled his spleen with malignant blood cells. Before going under for surgical removal of his spleen, Moore signed a consent form saying the hospital could “dispose of any severed tissue or member by cremation.” 7 years after several follow up visits consisting of bone marrow, blood, and semen draws, his surgery, he was asked to sign a consent form stating he “voluntarily grant to the Univeristy of California all rights I, or my heirs, may have in any cell line or any other potential product with might be developed from the blood and/or bone marrow obtained from me.” Moore’s doctor Golde had filed for a patent on Moore’s cells and several extremely valuable proteins the cells produced. Golde was about to sell the patent to a biotech company for more than $3.5 million.
    Moore sued Golde and UCLA for deceiving him and using his body in research without consent; he also claimed property rights over his tissues and sued Golde for stealing them. Researchers feared that if Moore won this case, patients in the future would block the progress of science by holding out for excessive profits. The judge threw Moore’s suit out of court, saying he had no case.
    Moore appealed, and in 1988 the California court of appeals ruled in his favor, pointing to the protection of human subjects in medical experimentation act which stated the “rights of individuals to determine what is done to their own bodies…a patient must have the ultimate power to control what becomes of his or her tissues. To hold otherwise would open the door to massive invasion of human privacy and dignity in the name of medical progress.”
    Golde then appealed and won. 7 years after Moore filed suit, the Supreme Court of California ruled against him in what became the definitive statement on the issue: When tissues are removed from your body, with or without your consent, any claim you might have had to owning them vanishes” The court did say that researchers should disclose financial interests in patient tissues.

    Reply

  2. Natale Dabulewicz
    Oct 03, 2012 @ 02:43:04

    Possible Discussion Questions
    1. How did doctors justify using patients in public hospitals as medical research subjects without obtaining their informed consent or offering them financial compensation? How has this changed over the decades since Ms. Lacks was treated at Johns Hopkins? Why did the changes occur?
    -The laws and ‘rules’ that protect patient privacy in this day and age did not exist when Henrietta got sick. The scientists and doctors claimed that these secretive experiments were for the progression of science. During the 1950’s there wasn’t such an organized research effort as there is now. This was the only way doctors/scientists did their testing. When Henrietta’s cells were taken no one knew they would be the tissues to change the history of science. Henrietta technically signed a paper that granted them rights to whatever they want. Nowadays there are many more clarifications that need to be given to the patient so they know exactly what is going to happen to their ‘donations.’
    2. Analyze the consent statement that Ms. Lacks signed on page 31. Based on this statement, do you believe that Drs. TeLinde and Gey had the right to obtain a sample from her cervix to use in their research?
    -I do not believe that Dr. TeLinde and Gey had the rights to take her tissues and use them after signing this consent. Reading this consent sounds like they will do anything necessary to help the patient. They mention the phrase “operative procedure” in the consent. This tells me that they could have taken a tissue sample, but using that sample for things other than helping Henrietta is out of the scope of what she signed the consent form for. Also Henrietta Lacks was a poor black woman, there is no way she understood most of the words in this consent form. Although at the time, the doctors did not realize what they were doing would in the future be considered wrong, it all seems very deceitful.
    3. Why did Mrs. Lacks’ doctors need to ask for her family’s permission to remove tissue samples after her death? How did Day respond to the request?
    -The doctors did not include an autopsy in consent form Henrietta signed, and since she was not alive to grant such a request they were obligated to ask the family. Although they did perform an autopsy, I think they dug much deeper into it once this consent was given than Day thought they would. Day was hesitant at first, but finally agreed to the autopsy when the doctors insisted they would not mangle her body.

    4. Who profited for the distribution and sale of HeLa cells?
    -The original discoverer of the HeLa cells- George Gey was in my opinion the person who should have profited from the distribution of these cells and did not. Instead biological companies that replicated these cells began selling them and making a profit that way. I think it is more unethical that they people who didn’t even discover the HeLa cells are the ones that made a profit out of it. It was bound to happen, but it’s unbelievable what a money maker the business of HeLa cells became.
    5. Do you agree with Dr. Pomerant’s suggestion that Dr. Gey should have “finished his own research” before releasing HeLa to colleagues?
    Dr. Gey will forever be known as the man who discovered the HeLa cells but that is all the credit he will be getting. I think giving HeLa cells to the public was a way of discovering many new things in a short period of time (such a vaccinations), but it means George Gey didn’t get credit for something he came up with first. Although it was not kind, I think Dr. Pomerant’s suggestion was realistic.
    6. How did Dr. Southam justify his decision to inject HeLa cells into patients without their knowledge or consent?
    Dr. Southam justified injecting healthy people with HeLa cells without their knowledge because he was sure that only healthy people were able to fight off the cancer. He informed the patients (only if they asked), that he was testing them for cancer. He thought if the patient had cancer the injection would not be attacked by the immune system. Dr. Southam also argued that he did not use the word ‘cancer’ because of there being such a negative connotation with the word and people may not agree to his experiments if they knew what he was actually doing. He was withholding the information because the patients would probably have not participated in the study if he had told them what he was actually doing.

    7. Why, specifically, did the doctors at the Jewish Chronic Disease Hospital object to Dr. Southam’s cancer study?
    Emanuel Mandel, director of medicine at the Jewish Chronic Disease Hospital in Brooklyn, asked several doctors to inject 22 patients with cancer cells for Southam. He told these doctors to do it without the patients’ consent and three young Jewish doctors refused, saying they wouldn’t conduct research on patients without their consent. All three knew about what research the Nazis had done to the Jewish prisoners, and they also knew about the Nuremberg traisl.

    8. What does the 1969 Johns Hopkins study reveal about the researchers’ attitudes and assumptions about race?
    In 1969, a Hopkins researcher used blood samples from more than 7,000 neighborhood children- most of them from poor black families- to look for a genetic predisposition to criminal behavior. The researcher didn’t get consent. The study was later halted. This reveals that the researchers were generalizing that only black children were prone to criminal behavior. This is a very predictable assumption for southern researchers in the 1960’s to have.
    9. Explain how Henrietta Lacks association with HeLa become widely known?
    In December 1971 two scientists wrote a tribute to George Gey after his death from pancreatic cancer. In this tribute which was published in a medical journal they said, “the biopsy… has secured for the patient, Henrietta Lacks as HeLa, an immortality which has now reached 20 years. Will she live forever if nurtured by the hands of future workers? Even now Henrietta Lacks, first as Henrietta then as HeLa has a combined age of 51 years.” This was the first time her name appeared in print, and also the first time a picture of her was published for the public to see.

    10. Summarize John Moore’s story.
    In 1976, John Moore started not feeling well and it turned out he had a rare form of hairy-cell leukemia. This cancer filled his spleen with malignant blood cells that bulged like an overfilled inner tube. He was referred to a doctor (David Golde) at UCLA who was going to remove his spleen. Moore signed a consent form saying that the hospital could, “dispose of any severed tissue or member by cremation.” For years every few months he flew between Seattle and Los Angeles for follow up exams. When he questioned what was going on the doctor offered to pay for his accommodations to get him to keep coming. One day in 1983, he was handed a paper that asked if he voluntarily granted the University of California any cell line or other potential product which might be developed from the blood and/or bone marrow obtained from me.” Moore circled do because he wasn’t sure if his doctor would reduce his level of care if he disagreed. When the nurse gave him one of the same forms to sign Moore circled do not. Golde had already called twice to have Moore “fix his mistake.” Golde kept harassing him about signing the letter, and finally Moore sent the sheet to an attorney. This is when Moore discovered Golde was developing a cell line called “Mo.” Golde was trying to patent Golde’s cells without his consent or knowledge. Moore ended up suing his doctor but lost the case.

    Reply

  3. Hiten Patadia
    Oct 03, 2012 @ 19:58:17

    1) Before the Nuremburg trails there were no law or protection for patients and their privacy. It is apparent that during the time, public hospitals justified taking specimens and information because they were offering care at a very discounted/free rate. They expected these specimens/information as financial compensation. Over the decades with new laws and cases that have put into place where patient’s privacy is protected with various laws and consent is needed for all procedures. The only problem is with low health care literacy, most times patients just sign things, but they don’t actually know what they are signing away.

    2) I do not believe the doctors had permission or the right to take the sample. The intention of the sample was not related to operative surgery and directly associated with research, which was not indicated in the intent of the consent form.

    3) The request was for doctors to conduct an autopsy on Henrietta, the problem was that Henrietta never consented to an autopsy so needed the families permission. Day wasn’t interested but then I think he realized he wanted to try to save his children in the future.

    4) I think the biological company that was named Microbiological associates was one of the great profiteers of the HeLa cells. According to the text, it was interesting that Johns Hopkins did not actually gain monetary value from the discovery of HeLa cells. If you also think about it, the general public and any one in contact with HeLa cells research in an indirect/direct way profited from the cells. I think it is just the way you define the word profit.

    5) I believe what Dr. Gey did was the right thing to do. I think the initial discovery was made and he had the recognition what more could he want? I think he realized the potential of HeLa cells and although not all the research was completed he wanted to get out and spread the discovery as soon as possible. I remember Dr. Gey being upset about his colleagues but who could argue with the advancements made because of the release of HeLa cells.

    6) He told his patients that he was treating their immune systems to see if they could respond to cancer (malignant cells). The patients didn’t actually realize that HeLa cells were being injected because if they did they probably would not have wanted to participate in the research. He eliminated the word cancer because he felt that it was unnecessary.

    7) They objected to the cancer study because Dr. Southam’s intended not to gain consent from their research subjects when they were going to inject 22 of them with cancer.

    8) The assumption was made that young black children are more prone to displaying criminal activities. They decided to look at blood samples from all these children and look for genetic pre-disposition to crime. Problem was, researchers didn’t get consent and showed that researchers believed that young black children were more prone to criminal activities.

    9) In the 1970’s, after Dr. Gey’s death, his colleagues at John’s Hopkins wrote a paper on Dr. Gey. In this article they explained the cell line research on the HeLa cells as a tribute to Dr. Gey.

    10) John Moore was diagnosed with a rare form of hairy-cell leukemia. The “Doctor” was going to remove the spleen and the hospital consent form was signed that allowed disposal of body by cremation. He was getting treated for approximately 10 years before he signed a voluntary consent the University of California rights to his cell line and any thing that might be developed from his bone/ bone marrow. Golde (the doctor) developed a patent protected cell line from John Moore’s cell and was going to sell it to a large biotechnology company. John More caught wind of this and sued Golde and University of California. The verdict in the case was that once the tissue samples leave the body that they are no longer associated with owner.

    Reply

  4. Peter Aiello
    Oct 03, 2012 @ 20:34:17

    1. Physicians justified using patients in public hospitals as research subjects, because in most cases, these patients were of low-income and were receiving free medical care. This was the case for Ms. Lacks, her physicians believed that because she was receiving medical care for free, using her cells for medical research was completely ethical. Over the decades, this mindset has drastically changed and has led to complete informed consent from each patient that may be part of a clinical research study. The changes were a result of a gradual uncovering of the work of these scientists – how they experimented on patients without their consent, many times going on to make millions of dollars.
    2. Nowhere in the statement does it state that Ms. Lacks’s discarded tissues would be used for medical research or studied in any way. The consent statement only states that the surgeons would be performing an operation to help treat a disease. While her discarded tissues could be considered medical waste, I think it is important for the patient to realize that the medical waste can be used for various purposes.
    3. The doctors needed permission to remove tissue samples after her death because there were laws in place that strictly prohibited autopsy without consent from the next of kin. Day initially responded to the request with a strong “no” but subsequently changed his mind when his family helped to convince him that an autopsy may help the family in the future. It could be said that the physicians mislead the Lacks family into thinking that they might gain something from allowing Henrietta Lacks.
    4. Surprisingly, Dr. Gey did not profit from the distribution of HeLa cells – the companies that started selling the cell cultures were the ones that profited tremendously from selling HeLa cells.
    5. I do agree with this statement because if Dr. Gey had the hindsight to think that he could have performed more research on the HeLa cells and that others were stealing his ideas – he should have not let anyone else work on the HeLa cell line until he had finished with his discoveries. I also find it interesting that Dr. Gey did not try to patent or pursue some type of intellectual property protection (realizing that patenting cell lines was not common practice at this point in history). For Dr. Gey to make the claim that others were stealing his work was something that he could have prevented by not releasing HeLa to others.
    6. Dr. Southam justified his decision to inject HeLa cells because patients had “phobia and ignorance” to the term cancer. He believed he was practicing “good medicine” by refraining from using the word cancer and that he was doing the patient’s a service by performing this procedure.
    7. These physicians specifically objected to conducting research on patients without informed consent. They had remembered what had happened to the German doctors during the Nuremberg Trials, many German doctors were sentenced to death for some of the procedures carried out on Jewish prisoners during the Nazi régime in Europe.
    8. Researchers’ attitudes and assumptions towards people of color were that they did not understand what medical research was and therefore did not have to have anything explained to them. If they were using the free health care services provided to them then the physicians were free to use these people for experimentation without their consent. This attitude was why physicians took the cells from Henrietta without her consent.
    9. Michael Rogers, who was a reporter for the Rolling Stone wrote an article on Henrietta Lacks and her connection to the HeLa cells.
    10. John Moore had his spleen removed because of a malignancy. His spleen was then used by his physician Dr. David Golde who was a cancer researcher at UCLA to develop a cell line called Mo. Mo was patented by Dr. Golde who made millions of dollars off of selling these cells. Moore sued Golde for not asking for his consent before doing research on his cells. The court ruled against Moore because his spleen was considered medical waste.

    Reply

  5. Jena Hallenbeck
    Oct 15, 2012 @ 23:31:20

    1. The doctors justified their actions in public hospitals based on the fact that the patients were given free healthcare. Since Henrietta’s time many ethics codes have established that disallow using patients or their information for experimental purposes without their consents. Henrietta Lacks, the Tuskegee syphilis study and the Nazi experiments were some of the cases that initiated the need for ethics codes.
    2. I do not believe the doctor had the right to take Henrietta’s tissue sample for Dr. Gey based on the informed consent she signed. The tissue sample taken was not necessary for treatment or care of her cancer.
    3. An autopsy without consent was prohibited; therefore a consent was needed from Henrietta’s husband. He at first said no but then was coaxed by the researchers when he was told that the autopsy would benefit his children.
    4. Although Dr. Gey and Johns Hopkins hospital gained notoriety from the HeLa cells they ironically did not profit financially from them. The companies that began selling and distributing HeLa cells in masses were the ones who profited financially from the cells.
    5. I think it would have been smart for Dr. Gey to finish his own research before releasing the HeLa cells. He had worked so diligently to find them and then he so easily let them go without realizing their true potential for financial and scientific gain.
    6. Southam was concerned that cancer could be contagious, and that the researchers that were in constant contact with HeLa cells may be at risk. To test this theory he began purposely injecting HeLa cells into cancer victims without their consent and only told the patients that he was “testing their immune systems.” He justified withholding the truth from the patients by telling himself and colleagues that he did not want to upset or confuse them with the word ‘cancer.’ However, in reality he did not tell the patients the truth because he did not want them to decline participating in the study.
    7. The doctors would not participate in the research because the patients were unaware of the study and they would not be signing consents. These doctors were aware of the Nuremberg trials and how the Jewish prisoners were used for research against their will; because of the ethics code established due to these trials the doctors would not participate in the research
    8. The research showed that Johns Hopkins believed that African Americans were more likely to commit crimes.
    9. Henrietta Lacks became officially associated with the HeLa cells in a tribute that was written about Dr. Gey after his death. It was not until after his death that her name was released because Dr. Gey did not want to release her name initially.
    10. John Moore had a type of cancer in his spleen which prompted the need for a splenectomy. After his spleen was removed the malignant cells were used to create a cell line called “Mo” that was worth nearly 3 billion dollars before Mr. Moore became aware of it. He took the doctor to trial but lost because his spleen was considered medical waste after it left the body.

    Reply

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