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Business Law and the Regulation of Business 11th Edition by Richard Mann, Barry Roberts
Edition 11ISBN: 978-1133587576Business Law and the Regulation of Business 11th Edition by Richard Mann, Barry Roberts
Edition 11ISBN: 978-1133587576 Exercise 6
Should the Terminally Ill Be Asked to Await FDA Approval of Last-Chance Treatments?
FACTS Mrs. Barnett is a seventy-three-year-old widow who has just been diagnosed with ovarian cancer. Because of the lack of adequate screening procedures for this type of cancer, Mrs. Barnett's cancer has long gone undetected and has progressed considerably.
Dr. Jason, Mrs. Barnett's doctor, will perform immediate surgery, but the surgery will not effectively cure the cancer. He has recommended that she undergo rigorous chemotherapy on a monthly basis for eighteen months following surgery. Thereafter, an exploratory operation can be conducted to assess the success of the treatment. The proposed chemotherapy will cause severe side effects, including nausea, oral lesions, and complete hair loss.
Dr. Jason has informed Mrs. Barnett and her two daughters, June and Sarina, that although chemotherapy will defer their mother's immediate death, her chances of a recovery are slim. Dr. Jason stated that while, on average, one in three patients undergoing such treatment could expect to recover, he believed Mrs. Barnett's recovery was highly unlikely. A second opinion from a reputable cancer treatment center confirmed Dr. Jason's diagnosis and recommendations for treatment.
Sarina has heard of an experimental cancer drug being tested in Europe. Thus far the results seem promising. Though the drug may be obtained in Europe, it is not yet legal in the United States. The Food and Drug Administration (FDA) has just begun to review the drug, but it will be years before the drug could receive FDA approval.
Sarina is strongly opposed to the painful regimen of chemotherapy that has been proposed, particularly because the treatment seems futile. She wants to fly to Europe, obtain the experimental drug, and return with it to the United States. Mrs. Barnett is much too ill to travel. June, on the other hand, is opposed to any course of treatment that does not have the approval of the FDA. Mrs. Barnett, who is weak and confused, is looking to her daughters for guidance.
Social, Policy, and Ethical Considerations
Should the FDA apply different drug approval standards with regard to children who suffer from life-threatening diseases?
FACTS Mrs. Barnett is a seventy-three-year-old widow who has just been diagnosed with ovarian cancer. Because of the lack of adequate screening procedures for this type of cancer, Mrs. Barnett's cancer has long gone undetected and has progressed considerably.
Dr. Jason, Mrs. Barnett's doctor, will perform immediate surgery, but the surgery will not effectively cure the cancer. He has recommended that she undergo rigorous chemotherapy on a monthly basis for eighteen months following surgery. Thereafter, an exploratory operation can be conducted to assess the success of the treatment. The proposed chemotherapy will cause severe side effects, including nausea, oral lesions, and complete hair loss.
Dr. Jason has informed Mrs. Barnett and her two daughters, June and Sarina, that although chemotherapy will defer their mother's immediate death, her chances of a recovery are slim. Dr. Jason stated that while, on average, one in three patients undergoing such treatment could expect to recover, he believed Mrs. Barnett's recovery was highly unlikely. A second opinion from a reputable cancer treatment center confirmed Dr. Jason's diagnosis and recommendations for treatment.
Sarina has heard of an experimental cancer drug being tested in Europe. Thus far the results seem promising. Though the drug may be obtained in Europe, it is not yet legal in the United States. The Food and Drug Administration (FDA) has just begun to review the drug, but it will be years before the drug could receive FDA approval.
Sarina is strongly opposed to the painful regimen of chemotherapy that has been proposed, particularly because the treatment seems futile. She wants to fly to Europe, obtain the experimental drug, and return with it to the United States. Mrs. Barnett is much too ill to travel. June, on the other hand, is opposed to any course of treatment that does not have the approval of the FDA. Mrs. Barnett, who is weak and confused, is looking to her daughters for guidance.
Social, Policy, and Ethical Considerations
Should the FDA apply different drug approval standards with regard to children who suffer from life-threatening diseases?
Explanation
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The case deals with a mot...
Business Law and the Regulation of Business 11th Edition by Richard Mann, Barry Roberts
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