Quality of life is an important consideration in the treatment of early prostate cancer. Laboratory and clinical data suggest that higher radiation doses delivered to the bulb of penis and proximal penile structures correlates with higher rates of post-radiation impotence. The goal of this investigation was to determine if intensity-modulated radiation therapy (IMRT) spares dose to the penile bulb while maintaining coverage of the prostate. 10 consecutive patients with clinically organ confined prostate cancer were planned with 3D conformal radiation therapy (3D-CRT) or IMRT to give a dose of 74 Gy without specifically constraining the plans to spare the penile bulb. All 10 patients were ultimately treated with IMRT. Dose-volume histograms were evaluated and the doses to prostate, rectum, bladder and penile bulb were compared. IMRT reduced the mean penile bulb doses compared with 3D-CRT (33.2 Gy vs 48.9 Gy, p<0.001), the percentage of penile bulb receiving over 40 Gy (37.7% vs 67.2%, p<0.001) and the dose received by >95% of penile bulb (5.3 Gy vs 11.7 Gy, p=0.003). Maximum penile bulb doses were higher with IMRT (81.2 Gy vs 73.1 Gy, p<0.001) although the volume of this high dose region was small. Both methods resulted in similar coverage of the prostate. The volume of rectum receiving 70 Gy was significantly reduced with IMRT (18.4% vs 21.9%, p=0.003) but the volumes of bladder receiving 70 Gy were similar (p=0.3). IMRT may potentially reduce long term sexual morbidity by reducing the dose to the majority of the penile bulb.
The American Orphan Drug Act has spurred international activities on orphan disease research and orphan drug research and development (R&D). Legislation has been enacted in Singapore and Japan, and is pending in Europe. Rare disease research facilities and information centers are operational in Scandinavia and Europe, facilitating the needs of patients, families, and medical personnel. Yet, the absence of a harmonized international orphan drug development program still hinders the wise use of economic and human resources in the most optimal and eflcient manner.
sources, and the Human Genome project had slightly higher success rates, but these represented a total of only 4% of the submitted R01 applications.For R29 awards, the success rates for unamended competing proposals for fiscal years 1993 and 1994 were 23.1% and 19.0%, respectively. In general, the distribution patterns for R29 and R01 applications were similar, but the success rate for R29 grants was a little higher. The total pool of these relatively low-cost R29 applications was much smaller, however.There has been a progressive deterioration over the past 10 years ( Fig. 1) in the funding of unsolicited, competing, unamended R01 applications for new (Type 1) and renewal (Type 2) applications. The data on renewal applications indicate that two out of three established investigators cannot continue their ongoing research programs. They are also deterred from propos-ing highly imaginative but speculative ideas that might lead to major scientific breakthroughs (2).Debates for the budget for fiscal year 1996 have begun, and further cuts in the NIH budget have been proposed. The NIH has shown itself to be an excellent financial investment, as measured by improved health care for our citizens as well as the progress of our biotechnology industry (3). Our political leaders must have the understanding and courage to protect government expenditures that have proved to be invaluable for this country and for mankind. p. 1261). They suggest that the RAC reduce its role in the supervision of human gene therapy and specifically suggest that the RAC end protocolby-protocol review and review of Phase I follow-up studies. We believe that separate issues are involved in these two suggestions that require further public discussion.With regard to protocol-by-protocol review, it should first be pointed out that an accelerated review process not requiring a wait for a quarterly meeting of RAC already speeds the approval of replicative protocols.For instance, at its recent June meeting, the RAC reviewed nine new protocols while it heard about the approval of three accelerated reviews and four minor modifications. The relative number of accelerated approvals compared to full RAC review could certainly be increased. Second, we believe that substantial safety issues, particularly regarding long-term potential effects of gene therapy experiments, remain sufficiently important to merit discussion in a public setting. It has not yet been 5 years since the approval of the first human
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