Doctors giveth and the FDA taketh away
Someone's been reading my diary. Or...well...perhaps they simply read last week's Guide to Good Health. Because, no sooner did I recommend bioidentical hormone replacement than the FDA went and pulled it off the shelf.
Why? Quite simply because Big Pharma giant, and producer of synthetic estrogen replacement drugs, Wyeth Pharmaceuticals, asked them to. Perhaps you recall, back in 2002, a major hormone replacement therapy (HRT) study was halted because of the horrible health risks and side effects incurred by an inordinate number of women in the test group. Well, as luck would have it, Wyeth is the producer of two drugs, Premarin and Prempro, that were being evaluated in the study. And as a result of its outcome, millions of women have stopped using them both.
Causing a bit of a dent in Wyeth's fat wallet I'm sure, they've since filed a "citizen petition" with the FDA to pull estriol off of pharmacy shelves. Estriol is a bioidentical form of estrogen used by compounding pharmacies to make customized treatments for women. In fact it's used in about 90 percent of such preparations. It occurs naturally in the human body and has been used for decades. And while the FDA admits that estriol has never been associated with adverse events or health risks...it just has to go.
Co-founder of the Bioidentical Hormone Initiative (BHI), Erika Schwartz, M.D., firmly believes that, "The FDA has succumbed to pressure from Wyeth in its attempt to clear the market of safer alternatives for its unsafe products."
Another BHI founder, David Brownstein, M.D., added that the, "FDA's actions are clearly misguided. They have no legitimate reason or even the legal authority to limit a licensed physician's use of a safe and effective bioidentical hormone. There are numerous positive studies and countless successful outcomes with estrogen treatments containing estriol."
A record number of complaints, more than 77,000, have been filed with the FDA in response to the petition. Yet, despite its decades-long history of effective use. And despite the fact that estriol has a long-standing United States Pharmacopeia monograph, the FDA's less-than-rational response to the record-breaking outcry, and reason for the yanking, is that estriol simply isn't the component of any FDA approved drug.
That would be a slightly more palatable explanation if it weren't for the fact that aspirin falls under this same classification. And despite a small laundry list of adverse events and health risks, no one's canvassing to have it yanked out of reach.
In the meantime, the FDA has already sent out warning letters to seven compounding pharmacies who're still providing these all-important medications to women across the country.So, if this affects you, someone you love or you're simply as outraged as I am, the International Academy of Compounding Pharmacists have set up a website with a link to an editable form letter that they will automatically forward to your local congressman. You can learn more and send a copy of this letter by clicking here.
I'll be sure to keep you posted as this story develops further.
Yours in good health,
Allan Spreen, M.D.
Chief Research Advisor
NorthStar Nutritionals
Doctors giveth and the FDA taketh awaySomeone's been reading my diary. Or...well...perhaps they simply read last week's Guide to Good Health. Because, no sooner did I recommend bioidentical hormone replacement than the FDA went and pulled it off the shelf.Why? Quite simply because Big Pharma giant, and producer of synthetic estrogen replacement drugs, Wyeth Pharmaceuticals, asked them to. Perhaps you recall, back in 2002, a major hormone replacement therapy (HRT) study was halted because of the horrible health risks and side effects incurred by an inordinate number of women in the test group.Well, as luck would have it, Wyeth is the producer of two drugs, Premarin and Prempro, that were being evaluated in the study. And as a result of its outcome, millions of women have stopped using them both. Causing a bit of a dent in Wyeth's fat wallet I'm sure, they've since filed a "citizen petition" with the FDA to pull estriol off of pharmacy shelves.Estriol is a bioidentical form of estrogen used by compounding pharmacies to make customized treatments for women. In fact it's used in about 90 percent of such preparations.It occurs naturally in the human body and has been used for decades. And while the FDA admits that estriol has never been associated with adverse events or health risks...it just has to go.Another BHI founder, David Brownstein, M.D., added that the, "FDA's actions are clearly misguided. They have no legitimate reason or even the legal authority to limit a licensed physician's use of a safe and effective bioidentical hormone. There are numerous positive studies and countless successful outcomes with estrogen treatments containing estriol."A record number of complaints, more than 77,000, have been filed with the FDA in response to the petition. Yet, despite its decades-long history of effective use. And despite the fact that estriol has a long-standing United States Pharmacopeia monograph, the FDA's less-than-rational response to the record-breaking outcry, and reason for the yanking, is that estriol simply isn't the component of any FDA approved drug.That would be a slightly more palatable explanation if it weren't for the fact that aspirin falls under this same classification. And despite a small laundry list of adverse events and health risks, no one's canvassing to have it yanked out of reach. In the mean time, the FDA has already sent out warning letters to seven compounding pharmacies who're still providing these all-important medications to women across the country.So, if this affects you, someone you love or you're simply as outraged as I am, the International Academy of Compounding Pharmacists have set up a website with a link to an editable form letter that they will automatically forward to your local congressman. You can learn more and send a copy of this letter by clicking here.
I'll be sure to keep you posted as this story develops further.Yours in good health,Allan Spreen, M.D.
Chief Research Advisor
NorthStar Nutritionals