FDA banned birth control pills
The FDA banned birth control pills containing more than 50 micrograms of estrogen in 1988.
Rather than reporting this data to the FDA, however, the study’s author instead applied a “correction factor,” reducing the estrogen figures by 40 percent. Although the author claimed this was meant to adjust for differing rates of estrogen absorption, such a “correction” was a deviation from the study procedure previously submitted to the FDA.
In the final report submitted to the FDA, Johnson & Johnson claimed that OrthoEvra exposed women to only 20 micrograms of estrogen per day. The “correction factor” was referenced only once in the 435-page study report, buried in a complex mathematical formula.
According to internal company emails, other clinical trials conducted before approval suggested that women were experiencing side effects such as breast soreness and nausea due to high estrogen doses, but the company did not warn the FDA that the patch might be delivering more estrogen than advertised. Nor did it tell the agency about other studies, in 1999 and 2003, showing that the patch exposed women to more estrogen than the pill.
When the FDA approved the product in 2001, Johnson & Johnson marketed it as releasing less estrogen than the pill, containing 20 micrograms per day.
The label was not revised until a 2005 investigation by the FDA, following reports of deaths resulting from use of the drug. At that point, the FDA made Johnson & Johnson add a warning that the product “exposes women to higher levels of estrogen than most birth control pills.”
But the company always knew this to be the case, several lawsuits now allege, and is thus responsible for the side effects that resulted: heart attacks, strokes, and even deaths in those who used the patch as directed. Studies have since confirmed that women on the patch may have twice the blood clot risk of women taking birth control pills, and prescriptions have fallen 80 percent, from a high of 900,000 in March 2004 to only 187,000 in February 2007.
http://www.naturalnews.com/024688.html
Tags: Facts, HRT, medicine, Women, Women's Health