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This Week in NEJM: Apr 7, 2011


The US Food and Drug Administration approved sipuleucel-T, marketed as Provenge, last April for the treatment of a form of prostate cancer, and, with a $31,000 price tag per treatment, the Centers for Medicare and Medicaid Services decided to conduct its own review of the drug, write James Chambers and Peter Neumann from Tufts Medical Center in an online first New England Journal of Medicine perspective. Much of the new review was a duplication of effort, they write, though the agencies have different goals; FDA looks at the safety and effectiveness of a drug while CMS evaluates whether it is a reasonable and necessary treatment. The decision to re-review the drug was unusual, Chambers and Neumann say, and it seems to be due to the impact the drug will have on the budget. "In all likelihood, sipuleucel-T is a harbinger of many more cases of expensive emerging technologies, particularly therapies for cancer. With the CMS unable to absorb the costs of all high-priced technologies, future coverage decisions promise to be complex and perhaps contentious affairs," Chambers and Neumann say.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.