A controlled trial of HA-1A in a canine model of gram-negative septic shock

Article Abstract:

The use of human immunoglobulin M monoclonal antibody (HA-1A) against bacterial endotoxin appears to have no effect on septic shock in dogs and may actually increase the risk of death. Endotoxin occurs in the outer cell membrane of certain bacteria and is thought to play a major role in inducing septic shock. Twenty-seven dogs were infected with the bacterium Escherichia (E.) coli 111:B4 to induce septic shock. Thirteen dogs were then treated with HA-1A, and the other 14 served as controls. For the first 24 hours after infection, survival was the same for both groups. After 24 hours however, the survival rates significantly diverged. Compared with the controls, dogs treated with HA-1A had significantly lower blood pressure and body temperature, and their heart function was significantly worse. By seven weeks after infection, only two of the dogs treated with HA-1A had survived compared with eight of the controls.

Health aspects, Models, Monoclonal antibodies

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Nitric oxide and septic shock

Article Abstract:

Researchers believe that inhibitors of nitric oxide synthase (NOS) may be effective in treating septic shock, however this belief is based on some unproven assumptions and these inhibitors may harm certain patients. NOS produces nitric oxide which is believed to cause low blood pressure during septic shock, when vital organs are threatened by circulation disorders. However, low blood pressure during septic shock may be caused by agents other than nitric oxide and NOS inhibitors may not specifically raise blood pressure during septic shock. NOS inhibitors may also cause side effects such as high blood pressure in the lungs, reduced circulation of oxygen, and weakening of the immune system. Thus patients who could be seriously harmed by such effects should not be included in trials. The physiological effects of nitric oxide should be studied further to lead to other therapies for septic shock.

Causes of, Physiological aspects, Nitric oxide

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Surviving sepsis - practice, guidelines, marketing campaigns and Eli Lilly

Article Abstract:

The challenges involved in developing medical guidelines and performance standards for the treatment of sepsis, which are aggravated by the intrusion of marketing strategies in the disguise of as evidence-based medicine, are discussed. The Food and Drug Administration's (FDA) approval of Eli Lilly's Xigris for the treatment of sepsis, on the basis of a single controversial phase 3 trial, is one such case, which highlights the strategy of pharmaceutical firms, taking over guideline development for commercial purposes.

Product development, Government regulation, Pharmaceutical preparations, Care and treatment, United States, Pharmaceutical industry, Eli Lilly and Co., Licensing, certification and accreditation, LLY, United States. Food and Drug Administration, Sepsis, Xigris (Medication)

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