Tired and Cranky — It May Not Be PMS It Could Be that You Just Need to Energize Your Diet Our eating habits play a powerful role in how well we function on every level. Fatigue-Fighting Nutrition Strategies Your Mother Was Right — Eat Your breakfast… even if you don’t feel hungry. British researchers at [...]
Inconvenient Women Are Willing To Take Responsibility For Their Own Wellness… In our last Blog we talked about the “likelihood of a woman being misdiagnosed” during the average “HMO-Office-Visit” Today we want to talk about how just a little more exercise during the week can yield BIG health benefits and help keep you out of [...]
Inconvenient Women Insist on Diagnostic Tests, Before Swallowing a “BIG-Pharma Cure” I have been researching the endocrine system and its integral role in a woman’s health. Our endocrine system is composed of a network of organs and glands responsible for producing, storing, and secreting hormones that help to maintain and control vital functions such as [...]
A woman is a cycling being, not a being at the mercy of a cycle. — Leslie C. Botha During a recent radio program, one of Leslie’s callers asked her a simple, yet extremely profound question. “OK, I get that I am being effected every month by my hormone cycle. NOW WHAT?” I thought Leslie’s [...]
Shouldn’t we ask the forbidden question at least once? Is it possible to develop a ‘simple metric’…like PROFIT PER FATALITY? In a time of diminishing public health resources and increased public health need, should we not look at allocation of health dollars using a needs / benefit ratio.
Merck & Co., Inc. announced today that the U.S. Food and Drug Administration has issued a second complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45. The agency has completed its review of the response that Merck provided in July 2008 and has recommended that Merck submit additional data when the 48 month study has been completed. The initial sBLA included data collected through an average of 24 months from enrollment into the study, which is when the number of pre-specified endpoints had been met. Following a review of the final results of the study, Merck anticipates providing a response to the agency in the fourth quarter of 2009. The letter does not affect current indications for GARDASIL in females ages 9 through 26 nor does the letter relate to the sBLA that was submitted in December 2008 for the use of GARDASIL in males.
The introduction of Gardasil (Merck & Co, Whitehouse
Station, NJ, USA) as a vaccine to the human papillomavirus
(HPV) has received much media attention worldwide since its
approval by the US Food and Drug Administration in 2006.
From the United States to the United Kingdom, New Zealand,
and Malaysia, news headlines have highlighted various issues
and controversies surrounding the HPV vaccine.
DA has stated clearly that the best way to show correlation is by developing drugs in parallel with biomarker diagnostics through prospective studies. However, genetic associations with response to a drug often emerge after the drug is already in use.
Due to the limited contact of the human papillomavirus (HPV) with the immune system, past infection does not guarantee lasting protection.
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