Here you'll find the online coffee and chat salon of chick-lit/cozy mystery authors Diana Killian, Karen MacInerney, Michele Scott, Maggie Sefton, JB Stanley, Heather Webber, and Kate Collins. We'll be posting regularly about our writing, our lives, our latest releases... even where we'll be popping up next. So grab a cup of coffee, pull up a chair... and join the conversation! Also be sure to check out cozychicks.com for more information on us, our books, and contest opportunities.



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    Another Great FDA Decision (she said facetiously)

    Kate Collins Icon

    I’m furious. Did you see the story on Yahoo News entitled, “FDA cracks down on custom-made hormones”? If not, the gist of it is that the giant pharmaceutical company, Wyeth, whined to its buddies at the FDA that women weren’t buying as much of their synthetic hormones, but were instead purchasing bio-identical hormones from internet sites, thereby cutting into profits. Well, heaven forbid those of us who got wise to the dangers of synthetic hormones have a safe alternative at a lower price!

    So the FDA got busy looking for ways to “protect” us from the dangers of those natural products, stating that they were “no safer” than synthetic versions. EXCUSE ME? Are they joking? If they’d done their research, they would have found studies from the USA as well as all over the world (where bio-identicals have been used for years) on the benefits and safety of bio-identical hormones, and so far none have shown that they cause cancer, heart attacks or strokes. On the other hand, we know that synthetic hormones may cause them.

    In an apparent attempt to appease Wyeth, and other big pharma companies, the FDA zeroed in on seven internet sites that allegedly made “misleading” claims about the benefits of bio-identical hormones (maybe like natural progesterone’s ability to lift hormonal-related depression and get rid of hot flashes? Because they sure did for me and most of my friends).

    Dr. Janet Woodcock, FDA’s chief medical officer stated in the article, “We want to assure that Americans receive accurate information about the risks and benefits of drug therapies.” The agency, you see, professes to be concerned that claims for safety and effectiveness of those nasty natural hormones might mislead patients, as well as doctors and other health-care professionals. Yeah, right.

    It appears that the FDA would rather have us use something cooked up in a lab that has known risks, rather than something that our bodies recognizes as natural, in order to appease goliath Wyeth.

    I sent an email expressing my outrage at their decision and got a pat answer back. It was what I expected. You know the saying, “The squeaky wheel gets the grease?” Well, guess whose wheels got greased? Not ours.

    The lesson here is that all of us who resent being dictated to by companies that are solely interested in making a profit need to squeak louder and more often, demanding that the FDA stop pandering to big pharma. Natural hormones aren’t the danger here. You figure out who is.

    Kate, still fuming

    8 Responses to “Another Great FDA Decision (she said facetiously)”

    1. Dear Kate,

      I agree with you, it is obvious that the FDA has been waging a war
      against bioidentical hormones because of a citizen’s petition from Wyeth.

      Wyeth makes the synthetic hormone, prempro, a drug found to cause cancer and heart disease in the WHI study published in JAMA July 2002.

      Wyeth has lost 2 billion in sales since millions of women have switched away from the Wyeth product to compounded bioidentical hormones, a safer and more effective alternative.

      Wyeth wants to use the FDA to eliminate its competition.

      The problem is that the FDA does not regulate compounded bioidentical hormones, the states do the regulation.

      And the FDA’s actions have only demonstrated that the agency is completely inept and corrupted by special interest groups in the drug industry.

      To read more about this click here,

      http://jeffreydach.com/2008/01/11/fda-declares-war-on-bioidentical-hormones-by-jeffrey-dach-md.aspx

      Jeffrey Dach MD

      by jeffrey dach md on January 13th, 2008 at 7:47 am

    2. Thank you, Dr. Dach, for your great comment. Your newsletter on the subject was comprehensive and interesting, and I encourage all readers to check it out.

      Clearly, the FDA needs a complete overhaul — or elimination — if they have stopped serving the public’s needs in favor of the pharmaceutical companies.

      As I wrote in a blog last year, I became critically ill and was unable to get a diagnosis from eight specialists. Then I happened upon an internist in Chicago who knew exactly what was causing my ills, and part of her treatment was a prescription for bio-identical progesterone (and later, an elimination diet to get my adrenal gland functioning again, along with accupuncture.) The progesterone made all the difference. It pulled me from deep depression, took away my hot flashes and night sweats, and gave me back my energy.

      At the same time, my step-daughter was suffering from PCOS (polycystic ovarian syndrome) and had seen specialists who had put her on a birth control pill and another drug to control high insulin levels. The once healthy 27 year old then began to suffer from severe menopausal symptoms and low energy. I sent her to this same internist who helped me, and am excited to report that the PCOS is gone, she is off all meds, her insulin levels are normal, and she feels terrific.

      Take that Wyeth!

      by Kate Collins on January 13th, 2008 at 11:28 am

    3. Kate, you’ve nailed it. Sadly, the FDA is far more concerned with political and economic agenda than actually taking care of us!

      by Diana Killian on January 13th, 2008 at 5:27 pm

    4. Kate—you’re preaching to the choir, girl. I, too, use bioidentical hormones in a progesterone cream prescribed by my doctor. I agree, this action was a blatant attempt to appease Big Pharma.

      by Maggie on January 14th, 2008 at 1:59 am

    5. Excellent blog, Kate. For more information on this very disturbing trend, check out “”Industry Puts $44 Million into State Lobbying Campaigns” by M. Asif Ism. quoted by The Center for Public Integrity. > complete article can be found at: http://www.publicintegrity.org/rx/report.aspx?aid=794 . Keep up the good work, Kate!!!!

      by mary kennedy on January 14th, 2008 at 9:09 am

    6. Scary, typical big business. Thank You for informing us, Kate.

      by Michele on January 14th, 2008 at 12:31 pm

    7. Ddi you know that there is a wonderful program in Pennsylvania to deal with this issue–Roberta Collier is one of ten highly trained “unsales reps” whose job is to help doctors prescribe medications for their patients based on the best scientific evidence–not on the best commercial sales pitch. Please take a moment and read this informative artice (and then try to figure out a way to bring it your state! ) Keep plugging away at this, Kate! It’s an issue we can’t afford to ignore. The PA initiative is a step in the right direction. http://www.aarp.org/bulletin/yourhealth/drug_rep_ties_that_bind.sb1.html - 15k -

      by mary kennedy on January 14th, 2008 at 4:00 pm

    8. Thanks, Mary. For anyone concerned about doctors receiving only information the drup reps feed them, please read the info Mary provided.

      And to the FDA, who wrote that they are concerned about our safety (by allowing the sale of Vioxx, Celebrex, and others that have been pulled from the market) here is something shocking I just read at Mercola.com:

      “”While approximately 10,000 per year die from the effects of illegal drugs, an article in the Journal of the American Medical Association (JAMA) reported that an estimated 106,000 hospitalized patients die each year from drugs which, by medical standards, are properly prescribed and properly administered. More than two million suffer serious side effects. [3]”

      Where is the FDA when you need them? Maybe out to lunch with Wyeth and the like?

      by Kate on January 15th, 2008 at 10:34 am

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