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Biomedical subjects

Michael D Green

Publications and source records attributed to Michael D Green.

23 records · Page 2Linked to original sources

A phase I study of recombinant human leukemia inhibitory factor in patients with advanced cancer.

PURPOSE: Leukemia inhibitory factor (LIF) is a pleiotropic molecule of the interleukin 6 family of cytokines. We aimed to examine the safety, pharmacokinetics, and biological effects of recombinant human LIF (rhLIF, emfilermin) in patients with advanced cancer. EXPERIMENTAL DESIGN: In stage 1 of the study, 34 patients received rhLIF or placebo (3:1 ratio) at doses of 0.25-16.0 micro g/kg/day or 4.0 micro g/kg three times daily for 7 days. In stage 2, 40 patients received rhLIF or placebo, either once daily for 14 days commencing the day after chemotherapy (0.25-8.0 micro g/kg/day) or for 7 days commencing the day before chemotherapy (4.0 micro g/kg three times daily). The chemotherapy was cisplatin 75 mg/m(2) and paclitaxel 135 mg/m(2). RESULTS: In stage 1, platelet counts increased in most patients, including those who received placebo. Blood progenitor cells increased in response to rhLIF. In stage 2, platelet recovery to baseline levels was earlier for patients receiving higher doses of rhLIF (>/=4.0 micro g/kg/day; P = 0.02). The neutrophil nadir after chemotherapy was less severe in patients receiving >/=4.0 micro g/kg/day of rhLIF. In stages 1 and 2, increases in C reactive protein were seen at higher doses. Several patients developed evidence of autonomic dysfunction, in particular impotence and episodic hypotension. The dose-limiting toxicities were hypotension and rigors. Pharmacokinetic studies demonstrated a short half-life (1-5 h) independent of dose. CONCLUSIONS: We demonstrated a biological effect of rhLIF on blood progenitor cells, C reactive protein levels, and hemopoietic recovery after chemotherapy.

Adult↗

High-performance liquid chromatographic assay for the simultaneous determination of sulfadoxine and pyrimethamine from whole blood dried onto filter paper.

A method using solid-phase extraction and high-performance liquid chromatography is evaluated for the simultaneous determination of sulfadoxine and pyrimethamine from 0.1 ml of whole blood dried onto filter paper. Extraction recoveries are about 60% for both drugs. The coefficient of variation for intra-assay precision, inter-assay precision and accuracy is less than 10% for sulfadoxine (10-100 microg/ml) and pyrimethamine (1-10 microg/ml).

Antimalarials↗

An alternative method of determining standard of care in alleged cases of malpractice.

BACKGROUND: Physician experts hired and prepared by litigants provide most information on standard of care for medical malpractice cases. Because this information may not be objective or accurate, we examined the feasibility and potential value of surveying peer physicians to assess standard of care. METHODS: The survey method was evaluated for a medical malpractice case involving a patient hospitalized with abdominal pain. An abstract of the medical record was created that included the patient characteristics and physician decisions most likely to influence patient outcome. The abstract and questionnaire were sent to 16 academic family physicians and to 20 randomly chosen primary care physicians in Iowa who practiced in communities of similar size to the defendant's community. RESULTS: All 16 academic and 18 (90%) community physicians completed the survey. All respondents judged the patient as presenting with an acute abdomen, and 89% of the community physicians and 100% of the academic physicians judged the care as below standard. More than half the physicians surveyed listed the autopsy diagnosis (perforated ulcer) in their differential. CONCLUSION: Surveys of randomly selected physicians are feasible to perform for medical malpractice cases. A pro-physician bias has little if any influence on the results.

Adult↗

Malpractice litigation reform: empirical approaches to establishing the legal standard of care.

This article proposes that the legal standard of care in malpractice cases should be established through empirical methods rather than only with experts'subjective opinions. The authors outline and critique two approaches for doing so and explain the legal advantages and barriers to implementing these legal reforms. Basing the legal standard of care on evidence of actual physician behaviors and views would help to improve medical practice by reducing the need to engage in defensive medicine and by making it safer to institute quality improvement measures.

Data Collection↗