Question

Medical Research and Duty to Warn

About 5,000 patients at Michael Reese Hospital and Medical Center, located in Chicago, Illinois, were treated with X-ray therapy for some benign conditions of the head and neck from 1930 to 1960. Among them was Joel Blaz, now a resident of Florida, who received this treatment for infected tonsils and adenoids while a child in Illinois from 1947 through 1948. He has suffered various tumors, which he now attributes to this treatment. Blaz was diagnosed with a neural tumor in 1987.

In 1974, Michael Reese set up the Thyroid Follow-Up Project to gather data and conduct research among the people who had been subjected to the X-ray therapy. In 1975, the program notified Blaz by mail that he was at increased risk of developing thyroid tumors because of the treatment. In 1976, someone associated with the program gave him similar information by phone and invited him to return to Michael Reese for evaluation and treatment at his own expense, which he declined to do.

Dr. Arthur Schneider was placed in charge of the program in 1977. In 1979, Schneider and Michael Reese submitted a research proposal to the National Institutes of Health stating that a study based on the program showed “strong evidence” of a connection between X-ray treatments of the sort administered to Blaz and various sorts of tumors: thyroid, neural, and others. In 1981, Blaz received but did not complete or return a questionnaire attached to a letter from Schneider in connection with the program. The letter stated that the purpose of the questionnaire was to “investigate the long-term health implications” of childhood radiation treatments and to “determine the possible associated risks.” It did not say anything about “strong evidence” of a connection between the treatments and any tumors.

In 1996, after developing neural tumors, Blaz sued Michael Reese’s successor, Galen Hospital in Illinois, and Dr. Schneider, alleging, among other things, that they failed to notify and warn him of their findings that he might be at greater risk of neural tumors in a way that might have permitted their earlier detection and removal or other treatment. There is a clear duty to warn the subject of previously administered radiation treatments when there is a strong connection between those treatments and certain kinds of tumors. The harm alleged, neural and other tumors would here be reasonably foreseeable as a likely consequence of a failure to warn and was in fact foreseen by Schneider. A reasonable physician, indeed any reasonable person, could foresee that if someone were warned of “strong evidence” of a connection between treatments to which he had been subjected and tumors, he would probably seek diagnosis or treatment and perhaps avoid these tumors, and if he were not warned he probably would not seek diagnosis or treatment, increasing the likelihood that he would suffer from such tumors. Other things being equal, therefore, a reasonable physician would warn the subject of the treatments.

Ethical and Legal Issues

1. Discuss the ethical and legal principles violated in this case.

2. What preventative measures should be taken to prevent recurrence of cases such as this?

Answer 1

1. The ethical and legal principles violated in this case is accountability , fidelity , veracity and non - beneficence . The researchers or the physicians who were conducting the research haven't provided explained details regarding the side effects of the treatment and what will there sign and symptoms because which he haven't paid more attention to the sign and symptoms of the disease and have not went for the treatment which resulted in complication of the disease and detection in late stage .

2. The preventive measures that should be taken to prevent such recurrences are :-

- strict following of ethical and legal principles

- taking consent from the patient after explaining the detailed treatment including the side effects to the patient in a language which is understood by the patient and his relatives.

- surveillance of the research project

- stringent actions towards those who don't follow the legal principles to be followed during conducting a research like holding the research , not giving clearance , imposing fine etc.