The poet must be flying: We thought that former Poet Laureate Louise Gluck, 65,  had already gotten every literary prize out there. But that was before we learned she’d scored the Academy of American Poets’ $100,000 Wallace Stevens Prize, for a lifetime of “outstanding and proven mastery in the art of poetry.”  Academy chancellor Robert Pinsky said as the award was announced: “Louise
sometimes uses language so plain it can almost seem like someone is
speaking to you spontaneously — but it’s always intensely

Knew it was too good to be true: Yesterday, the FDA came down hard on  Pfizer, saying that its new anti-osteoporosis drug Fablyn may strengthen bones but increase our chances of dying:

Pfizer Inc.’s experimental treatment for women with weak bones may increase the chances of death from cancer or stroke, according to new data submitted to U.S. regulators. The risks of the once-a-day tablet, Fablyn, must be weighed against its ability to prevent fractures in postmenopausal women with osteoporosis, the Food and Drug Administration’s staff said in a report today on the agency’s Web site……

Fablyn, or lasofoxifene tartrate, was rejected by the FDA in September 2005 as a medicine to prevent osteoporosis. Pfizer and partner Ligand Pharmaceuticals Inc. decided last year to resubmit the drug after re-examining safety data. Osteoporosis affects about 10 million Americans, mostly older women, and the aging of the population has sparked demand for new treatments.

“The committee is asked to consider if the overall safety profile for lasofoxifene is acceptable for the demonstrated benefit in the treatment of postmenopausal women with osteoporosis,” the FDA staff wrote.

New York-based Pfizer said an increase in deaths cited by the FDA staff for a low dose of Fablyn doesn’t appear to be related to the drug and may be due to chance. A statistically significant increased risk wasn’t seen at the higher dose for which the company is seeking approval.

“No dose-response relationship, pattern of death causality, or plausible mechanistic explanation accounts for the observed difference in numbers of deaths,” Pfizer said in a document also posted today on the FDA’s Web site. “Rather, the observed difference appears to be due to an unusually low mortality rate for the placebo group” in one of the regions where the study was conducted.

Sarah who? Michelle’s got MORE. As the new Republican candidate for vice president continues to dazzle and/or bewilder the public, MORE Magazine prepares to launch its long-sought cover of Michelle Obama. Women’s Wear Daily notes that the cover has been in the works for nearly a year:

Few women are as in demand for women’s and fashion
magazines as Michelle Obama — though if Sarah Palin lasts, she may give
Obama a run for her money. Lucky for More, then, that it started
negotiating a women’s magazine cover exclusive for the wife of the
Democratic nominee posing alone (rather than in the ubiquitous family
portraits) before Barack Obama had even clinched the nomination. Editor
in chief Lesley Jane Seymour said getting Michelle Obama was the first
thing she wanted to do “the day I walked in the door,” back in January,
and that if her husband hadn’t won the nomination, Michelle Obama would
have been an inside “second act” story. The cover and accompanying
story by Pulitzer Prize-winning writer Geraldine Brooks were moved up a
month in part to allow other magazines to run Obama in November, per the campaign’s request.




— Chris L.

Start the conversation

This site uses Akismet to reduce spam. Learn how your comment data is processed.