Plants with genetically modified events combined by conventional breeding: an assessment of the need for additional regulatory data.

Crop varieties with multiple GM events combined by conventional breeding have become important in global agriculture. The regulatory requirements in different countries for such products vary considerably, placing an additional burden on regulatory agencies in countries where the submission of additional data is required and delaying the introduction of innovative products to meet agricultural needs. The process of conventional plant breeding has predictably provided safe food and feed products both historically and in the modern era of plant breeding. Thus, previously approved GM events that have been combined by conventional plant breeding and contain GM traits that are not likely to interact in a manner affecting safety should be considered to be as safe as their conventional counterparts. Such combined GM event crop varieties should require little, if any, additional regulatory data to meet regulatory requirements.

Kidney transplants in African Americans and non-African Americans: equivalent outcomes with living but not deceased donors.

BACKGROUND: The outcome differences between ethnic groups after kidney transplantation have led to the characterization of African Americans (AA) as having high immune risk. Several multicenter clinical trials have reported better outcomes when AA receive higher doses of immunosuppression (I/S), suggesting pharmacokinetic (PK) and pharmacodynamic (PD) differences. However, the donor source has not been cited as an risk factor for outcome. METHODS: Patient and graft survival rates of 469 AA were compared with 308 non-African Americans (nAA) who received kidney transplants between January 1, 1995 and December 31, 2002, and were followed-up through December 31, 2003. Gender, age, and I/S protocol were not different between the groups. Based on outcomes, open and laparoscopic donor groups were combined for analysis. Deceased donor kidneys comprised 49% of the AA kidneys but only 32% of the nAA kidneys (P < .000). Kaplan-Meier survival statistics were used for both patient and graft survival. RESULTS: Patient survival rates for AA compared with nAA at 1, 3, 5, and 7 years were not statistically different for living (log rank statistic, 1 df, P = .56) versus deceased donor kidneys (log rank statistic, 1 df, P = .15). Kidney graft survival rates for AA compared with nAA at 1, 3, 5, and 7 years for living donor were similar (log rank statistic, 1 df, P = .493), but significantly different for deceased donor kidneys (log rank statistic, 1 df, P = .026). CONCLUSIONS: The majority of living donation occurred between ethnically similar donor-recipient pairs, whereas deceased donors tended to be nAA. The difference demonstrated by donor source suggests that antigens may be more dissimilar or uniquely different between ethnic groups.

Augmentation of activity of cis-diamminedichloroplatinum(II) and mitomycin C by interferon in human malignant mesothelioma xenografts in nude mice.

Two human mesothelioma xenograft lines, BG and ES, serially passaged in athymic mice, were studied to determine the efficacy of alpha-interferon in this type of tumor. Treatment began after progressive tumor growth was established. Recombinant human alpha-interferon-2a (Roferon- A) was given by s.c. injection, at a site distant from the tumor, at a dose of 2 x 10(5) IU 5 days per wk for 5 wk. Mild inhibitory activity was noted in both lines with interferon alone. cis-Diamminedichloroplatinum(II) (CDDP) (4 mg/kg) weekly x 5 was effective in line BG, while mitomycin C (1.5 mg/kg) weekly x 3 was effective in line ES. CDDP was not as effective in line ES. The moderate activity of CDDP in line BG and of mitomycin C in line ES was markedly increased by the addition of alpha-interferon. The combination of mitomycin C and alpha-interferon was as effective as mitomycin C and CDDP. No additional toxicity was noted by the addition of alpha-interferon. The combination of recombinant human alpha-interferon-2a and active chemotherapeutic agents is effective in mesothelioma xenografts.

Cardiac rehabilitation exercise program: outcome assessment.

Medically supervised exercise programs have increasingly gained acceptance in management of the coronary patient. Beneficial postexercise results published include: Improved exercise and work tolerance, a decrease in frequency and severity of angina, and earlier return to work. The present retrospective study evaluates the outcome of a three-month cardiac rehabilitation exercise program with changes in exercise performance, compliance with postdischarge exercise routine, and return to work pattern. The study group included 38 patients with documented coronary artery disease and two participants free of ischemic heart disease. Thirty patients were treated with beta blocker medications, ten were not. Time of follow-up ranged from six months to two years. Pre- and postexercise performance expressed in VO2 ml/kg/min was assessed at target heart rate using a modified exercise protocol. Training resulted in statistically significant increases in median exercise performance in both patient groups: 2.38 ml O2/kg/min (range 1.33, 7.18; p 0.0068, one-tail) in the untreated group, and 3.45 ml O2/kg/min (range 2.63, 11.48; p 0.001, one-tail) in the beta blocker treated group. Fifty-seven percent of the participants complied with a postdischarge exercise routine while 7/12 (58%) patients unemployed at time of referral resumed work during or following completion of the exercise program. Such programs appear to be a valuable component in the management of the coronary patient. Further studies involving larger numbers of patients are indicated to document cost effectiveness of such programs.