Asthma Death Causes Research Suspension-NEWS
Question:
On May 4, > he gave the chemical to Ms. Roche. She began feeling ill the day > after she took the drug. A few days later she was admitted to the > hospital, the air sacs of her lungs collapsing. Her lungs failed > and she died on June 2, after spending weeks in an intensive care > unit, tethered to a respirator. A Hopkins committee investigating > the death reported last week that the hexamethonium was probably > what killed her. And it found reports in the medical literature > that Dr. Togias had apparently missed, indicating that the > chemical might injure the lungs > http://www.nytimes.com/2001/07/20/health/20RESE.html > [registration required-free]
A cursory search on hexamethonium using www.google.com came up with: Drug-Induced Lung Diseases http://www.pneumotox.com/pneumotox/hexamethonium.html 4. Doniach I, Morrison B, Steiner R E. Lung changes during hexamethonium therapy for hypertension. Br Heart J 1954; 16: 101-108 5. Robillard R, Riopelle J L, Adamkiewicz L, Tremblat G, Genest J. Pulmonary complications during treatment with hexamethonium. Can Med Assoc J 1955; 72: 448-451 6. Park W W, Cockersole F J. "Hexamethonium lung". Report of a case associated with pregnancy. J Obstet Gynaecol Brit Emp 1956; 63: 728-734 9. Petersen A G, Dodge M, Helwig F C. Pulmonary changes associated with hexamethonium therapy. Arch Intern Med 1959; 103: 285-288 11. Heard B E. Fibrous healing of old iatrogenic pulmonary edema ("Hexamethonium lung"). J Pathol Bacteriol 1962; 83: 159-164 Looks like neither the research doctor nor the ethics committee that approved the research, bothered to do much research on the dangers of this chemical. And the volunteer, who was paid about $350, was not warned of the potential danger of research that was of no possible benefit to her. Ellis
Response:
July 20, 2001 U.S. Suspends Human Research at Johns Hopkins After a Death After investigating the death last month of a young, healthy volunteer in a research study at Johns Hopkins University, a federal oversight agency yesterday suspended almost all the university’s federally financed medical research involving human subjects. One reason for its action, the agency, the Office for Human Research Protections, said in a letter to Hopkins, was that the ethics committee that approved the study in question had failed to take proper precautions to protect its subjects. Suspending research is an unusual step. The volunteer, Ellen Roche, died on June 2, a month after she inhaled an unapproved drug as part of a research study to examine the causes of asthma. Her lungs were destroyed, apparently by the chemical she inhaled, hexamethonium. She was 24 and a technician at Johns Hopkins. Dr. Togias went ahead with his study, without applying to the F.D.A. After assessing hexamethonium’s safety by searching the medical literature, he concluded that its main side effect was a possible transient lowering of blood pressure. The ethics committee approved his study, which was to involve 10 healthy volunteers. He then bought hexamethonium from a chemical supply house, sterilized it, and began giving it to his study subjects, in amounts as high as 1 gram each, which some doctors say is an extraordinarily large amount to inhale. The first person developed a cough and shortness of breath, but got better in a week. Dr. Togias did not report those symptoms, deciding that the volunteer had caught a cold or that her symptoms were caused by the acidity of the hexamethonium solution. He altered the chemical to make it less acidic and gave it to a second volunteer, who had no adverse effects. On May 4, he gave the chemical to Ms. Roche. She began feeling ill the day after she took the drug. A few days later she was admitted to the hospital, the air sacs of her lungs collapsing. Her lungs failed and she died on June 2, after spending weeks in an intensive care unit, tethered to a respirator. A Hopkins committee investigating the death reported last week that the hexamethonium was probably what killed her. And it found reports in the medical literature that Dr. Togias had apparently missed, indicating that the chemical might injure the lungs http://www.nytimes.com/2001/07/20/health/20RESE.html [registration required-free]
Response:
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