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Natural Hormones on the Chopping Block Yet Again

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UPDATE: Good news—in a group of documents dated November 3, 2016, the FDA has responded to our concerns, indicating that compounded hormone creams WILL NOT BE on the agency’s chopping block at the next advisory committee meeting. We are glad to hear that the FDA is only considering the elimination of patches; creams, gels, foams, and ointments are not at risk, or at least not yet at risk. As welcome as this news is, we must still closely monitor the FDA’s ongoing review of compounding ingredients and delivery systems and fight for consumer access to important natural medicines including natural, bio-identical hormones delivered to the body in the appropriate way.

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It doesn’t look good. This time the FDA isn’t going after them directly—it’s going after the healthy way to deliver them. Unless there is massive consumer pushback, the FDA is likely to succeed because so few people understand what is involved. Extremely urgent Action Alert!

The FDA’s Pharmacy Compounding Advisory Committee (PCAC) has announced its next meeting, where it will make recommendations on whether creams can be used in compounding, and whether any of five specific substances will be allowed. The likelihood of their recommendation not being followed is remote.

Both transdermal and topical delivery systems have been nominated to the Demonstrably Difficult to Compound list, and are thus in extreme jeopardy. A decision against them will have dire consequences.

Unfortunately, very few people understand this. It is unlikely that even the members of the committee understand it. But Big Pharma and their allies at the FDA understand the situation fully—and are pulling the strings.

Natural hormone experts like Jonathan V. Wright, MD, have warned for years that many hormones should not be taken by mouth, either because the liver will “tag” them for elimination from the body before they can do their job or will abnormally alter them (in men, oral DHEA often is metabolized into unusually large levels of the hormone estrone); or because it is not healthy to take them this way—for example, in women, oral estrogens raise risk of blood clots and stroke.

The FDA listens only to big drug companies, which do not want the trouble of selling hormones in cream form—so the agency will refuse to offer them except as tablets. If compounded topical versions are no longer available, it means that many natural hormones will only be available in the ineffectual (or risky!) tablet form.

This would remove your ability to choose not only compounded bioidentical hormones, but also pain medications, and more. Many, many other medicines are delivered through topical creams or transdermal patches.

If the FDA decides to ban these delivery systems in pharmacies, many thousands of patients will be left in the lurch. Not only that, the FDA will severely cripple the entire compounding industry, as pain medicines and hormone replacement therapies are the largest component of many pharmacies’ business. The FDA knows this very well, which supports our contention that the elimination of the compounding industry has been the agency’s goal from day one.

As vitally important as the creams are, some of the other substances on the chopping block are important too. The five substances being reviewed are diindolylmethane (DIM), trichloroacetic acid, kojic acid, glycolic acid, and vasoactive intestinal peptide.

DIM is especially important. It is a naturally occurring compound found in Brassica vegetables like Brussels sprouts, cabbage, mustard greens, and kale, and has anti-cancer and immune-modulating properties. DIM can prevent hormone-related cancers, including breast and prostate cancer. It works, in part, by altering ratios of “good” and “bad” estrogen—reversing the effect, for example, of dihydrotestosterone, which is associated with prostate cancer.

It is critical that consumers maintain access to customized DIM medications. We can get DIM from cruciferous vegetables, but eating the amount of these vegetables required to get therapeutic levels of DIM day in and day out can be daunting. Moreover, an excessive consumption of cruciferous vegetables can negatively affect thyroid function.

Also on the chopping block is glycolic acid, derived from sugar cane, which is a natural exfoliator that helps with dry and wrinkled skin and acne.

If there isn’t a HUGE consumer backlash calling for the preservation of these substances, we can just say goodbye to them. In the past, the PCAC has voted to ban almost every substance that comes across their desk, no matter how safe it is. So far, PCAC has voted to remove curcumin, as well as boswellia, aloe vera, acetyl-L-carnitine, d-ribose, and more. Transcripts from previous meetings show that the committee almost always defers to whatever the FDA says, and then the FDA uses the committee for cover.

This makes sense when we consider that the committee has been a stacked deck from the beginning. Out of fourteen committee members, only one seems to be an expert on compounding specifically, rather than pharmacology in general, and that committee member can’t even vote! The other non-voting member is from a drug company with a clear conflict of interest, and one (voting) member is from an advocacy group with a clear bias against the compounding industry. The committee has clearly been chosen to destroy compounded medicines that millions of people rely on.

EXTREMELY URGENT Action Alert! Write to the FDA’s Pharmacy Compounding Advisory Committee. Tell them to maintain consumer access to transdermal and other safe natural medicines at traditional compounding pharmacies! Please send your message immediately.

Take-Action

 

Other articles in this week’s Pulse of Natural Health:

GMO: The Truth about the Science

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  • Mark T. Burger

    No, no, no, no, no … NOT Creams and Gels :: TDS (Transdermal Delivery SYSTEMS) aka patches.
    They aren’t considering banning creams and gels and ointments.
    Please! You’ve set off a false alarm.
    Please RETRACT.
    A compounding pharmacist who has read the List.

    • wren7

      Mark, you’ve stopped me from having a heart attack! I was going to call my compounding pharmacist tomorrow who compounds my BHRT cream. So you are positive that compounded creams/gels are NOT in the proposal to be eliminated? I.e., I will still be able to get my compounded E2/E3/testosterone cream and my compounded progesterone capsules? Many thanks!!!!

      • Mark T. Burger

        Yes, I am sure. I drilled into the FDA Document. It’s about DRUG PATCHES. Compounders have never (to my knowledge) tried to compound patches. They require a reservoir, special backing, semi-permeable plastic, Aluminum backing, and thorough testing over time to show that they deliver in a consistent, reproduceable manner.

        • wren7

          Thank you so much! Although I wonder why the FDA would go to the trouble to outlaw compounding something that was never compounded in that way (patches) to begin with?

    • zuriea

      Hi – I am confused.
      They are considering banning patches? They are considering banning creams?
      Did they ban aloe vera?
      What’s up? I remember having to fight in the Nineties when the FDA was even hauling some people away and destroying their offices.
      Thanks ~

  • Wendy Allen

    They have a drug version of DIM that a friend took to lower risk of breast cancer. They don’t want competition for their drug.

    • Mark T. Burger

      DIM and I-3-C can be purchased OTC. There is no need to compound it. And anyone who is going to come out with a DIM-like drug is stoopid as they will be competing with the OTC products.

      • Wendy Allen

        Many people just use what the doctor gave them and look no further. The doctor has folate and fish oil as a drug also with fillers/colors and cost more. People may think that is a better and let insurance pay for it instead of out of pocket cheap/healthy supplement.

  • Dogly

    I would gladly ban all animal derived hormones. You danced around the sources of those on your hot list. Estrogen from the unrine of pregnant mares – the ingredient in big pharm’s PREMARIN. (PREgnatMAresuRINe) should be outlawed for the savage deprivation and cruelty to pregnant horses and their foals.
    I also see “vasoactive intestinal peptide” and “carnitine” which are taken from the bodies of animals.
    Perhaps, for the sake of honest transparency, you could list both the names and whether the source of each is a plant derived hormone, or one stolen from the bodies of abused animals.
    I support the compounding of all plant derived medicines. But I would vote to ban the use of animals in alrernative or big pharm medicines.

    • Drew Mann

      Then you are an idiot.

      • Wendy Allen

        Coconut oil (if they can have it), no gluten/dairy/soy/sugar/GMO/vitamins/good oils/minerals..probiotic…LDN..detoxing. Mg/Zn/fish oil/HCl and enzymes/Vit B12 with intrinsic factor or shot etc. may help Alzheimer’s.

  • Rene

    For the love of God! Bioi-dentical patches as well as all the other options for bio-identicals are important!!!! So many women I know rely on the Bio-identical patches for steady release for the levels. Alarming is an understatement. The immune system is profoundly compromised without these supports, especially for those of us dealing with chronic illness.