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FDA Fails Women on Birth Control Safety
November 7, 2007
A preliminary study shows that for every 10 years of birth control pills there is a 20 – 30 percent increase in peripheral artery small plaques. The study was presented at the yearly meeting of the American Heart Association, placing it in the national news spotlight. News stations have been carrying the story and the typical medical spokespeople are trying to allay the fears of millions of birth control pill users. There are two main issues here: the FDA “ineptitude issue” and the “what to do about it issue.”
This is one more case in a long list of examples wherein the FDA has failed millions of Americans. It is unthinkable that a drug that has been used for so long and has so many users has never had proper follow up testing as to its safety. This is the rule with drugs, not the exception. The truth is that the true meaning of the results of the current study are unknown and will not be known for several more years – assuming there is an effort to actually find out if there is a problem or not. This void of credible information as to the postmarket safety of birth control pills, as well as almost all drugs on the market, is the fault of the FDA and nobody else. The new FDA legislation is intended to address this issue; however, unless FDA management changes its priorities and stops being a revolving door with the industry it is supposed to be regulating, it is unlikely that Americans will know the true safety profile of any drug on the market.
The use of estrogen and progesterone to manipulate the menstrual cycle and pregnancy will be problematic for a percentage of women for a variety of reasons. Any time a natural process is disrupted there will be side affects to some degree. As far as the risk of plaque goes, this will be a factor for women who have other risk factors and are already heading in that direction. Some of the more common ones include: family history, poor diet, too much stress, smoking, excess alcohol, etc. The circulatory system is the weak link in the health chain, so using birth control pills with other cardiovascular risk factors will undoubtedly turn out to be a problem. This is easy to predict based on existing science, but it is up to the FDA to clearly define the risks and paint a very clear picture.
One factor in this study is a correlation to elevated levels of C-Reactive Protein, a low grade inflammation maker that can irritate arteries and initiate the process of plaque formation. The woman on birth control has one more reason to balance her life in terms of stress-related demands. She should strive to manage daily wear-and-tear, a key factor in maintaining the normal, healthy structure of arteries.
This is one more case in a long list of examples wherein the FDA has failed millions of Americans. It is unthinkable that a drug that has been used for so long and has so many users has never had proper follow up testing as to its safety. This is the rule with drugs, not the exception. The truth is that the true meaning of the results of the current study are unknown and will not be known for several more years – assuming there is an effort to actually find out if there is a problem or not. This void of credible information as to the postmarket safety of birth control pills, as well as almost all drugs on the market, is the fault of the FDA and nobody else. The new FDA legislation is intended to address this issue; however, unless FDA management changes its priorities and stops being a revolving door with the industry it is supposed to be regulating, it is unlikely that Americans will know the true safety profile of any drug on the market.
The use of estrogen and progesterone to manipulate the menstrual cycle and pregnancy will be problematic for a percentage of women for a variety of reasons. Any time a natural process is disrupted there will be side affects to some degree. As far as the risk of plaque goes, this will be a factor for women who have other risk factors and are already heading in that direction. Some of the more common ones include: family history, poor diet, too much stress, smoking, excess alcohol, etc. The circulatory system is the weak link in the health chain, so using birth control pills with other cardiovascular risk factors will undoubtedly turn out to be a problem. This is easy to predict based on existing science, but it is up to the FDA to clearly define the risks and paint a very clear picture.
One factor in this study is a correlation to elevated levels of C-Reactive Protein, a low grade inflammation maker that can irritate arteries and initiate the process of plaque formation. The woman on birth control has one more reason to balance her life in terms of stress-related demands. She should strive to manage daily wear-and-tear, a key factor in maintaining the normal, healthy structure of arteries.
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