slimvictor
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Since Mother Jones broke the news on Monday that a European drugmaker, HRA Pharma, found that its popular morning-after pill may not work in heavier women, many readers have asked why the company chose to update its product labels with a hard weight limit—instead of a limit on BMI, an obesity measurement that relies on a height-to-weight ratio.
HRA Pharma was prompted to rethink its labels after University of Edinburgh Professor Anna Glasier linked emergency contraceptive failures and an obese body mass index (or BMI) in a 2011 analysis. The new label for the drug, Norlevo—a brand of emergency contraceptive pills which uses levonorgestrel to prevent pregnancy, and is identical to several US drugs, including Plan B—says it is not recommended for women who weigh 165 pounds or more, no matter their height.
Glasier, analyzing data from one study sponsored by the US National Institutes of Health and another sponsored by HRA Pharma, found that the risk of pregnancy in women using levonorgestrel pills increased significantly if a woman had a body mass index of 30 or higher—which the US Centers for Disease Control considers obese.
On Tuesday, HRA Pharma CEO Erin Gainer explained the company's decision further to Mother Jones. When HRA statisticians reviewed the data Glasier used for her analysis, Gainer says, they confirmed Glasier's findings about BMI—but they also found that their products' failure correlated even more strongly with weight, regardless of a woman's height.
"We were surprised," Gainer says. "But the findings were really quite striking from a statistical point of view." She adds that weight is easier for health care providers to discuss with their patients. "People don't walk down the street knowing what their body mass index is," she says.
cont at
http://www.motherjones.com/environm...pill-not-work-obese?google_editors_picks=true
HRA Pharma was prompted to rethink its labels after University of Edinburgh Professor Anna Glasier linked emergency contraceptive failures and an obese body mass index (or BMI) in a 2011 analysis. The new label for the drug, Norlevo—a brand of emergency contraceptive pills which uses levonorgestrel to prevent pregnancy, and is identical to several US drugs, including Plan B—says it is not recommended for women who weigh 165 pounds or more, no matter their height.
Glasier, analyzing data from one study sponsored by the US National Institutes of Health and another sponsored by HRA Pharma, found that the risk of pregnancy in women using levonorgestrel pills increased significantly if a woman had a body mass index of 30 or higher—which the US Centers for Disease Control considers obese.
On Tuesday, HRA Pharma CEO Erin Gainer explained the company's decision further to Mother Jones. When HRA statisticians reviewed the data Glasier used for her analysis, Gainer says, they confirmed Glasier's findings about BMI—but they also found that their products' failure correlated even more strongly with weight, regardless of a woman's height.
"We were surprised," Gainer says. "But the findings were really quite striking from a statistical point of view." She adds that weight is easier for health care providers to discuss with their patients. "People don't walk down the street knowing what their body mass index is," she says.
cont at
http://www.motherjones.com/environm...pill-not-work-obese?google_editors_picks=true
