FDA Action Threatens to Cut Off Access to Needed Medications

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August 28, 2008 | 42,387 views

Physicians who prescribe hormones containing estriol have grown concerned about the FDA’s so-called “abbreviated” Investigational New Drug (IND) application for estriol. The process will effectively ban most physicians from prescribing a medication they consider best for their patients.

The IND places a significant financial burden on physicians, most notably by requiring them to submit applications to an Institutional Review Boards (IRB). Submitting necessary documentation and contracting for a private IRB can easily cost between $10,000 and $25,000 and can take months.

The FDA’s new policy threatens the access of this important medication for patients who rely on hormones containing estriol to relieve the symptoms of menopause. It could force them off treatment their doctors have deemed necessary, and would either deny them treatment or subject them to the unnecessary expense and inconvenience of a new treatment regime.

Millions of women have been prescribed estriol and have used it safely for decades.

Estriol is a bioidentical hormone that is sometimes used in hormone replacement therapy drugs, available through compounding pharmacies. However, estriol is not an FDA approved drug, and according to the FDA estriol “has not been shown to be safe and effective for the uses for which it is being prescribed.”

Therefore, the FDA has proposed to allow estriol-containing prescriptions to be filled only if accompanied by Investigational New Drug (IND) application, stating that the use of INDs is “routine,” and therefore shouldn’t cause any major inconvenience or limitation on estriol’s use, if and when a physician believes it’s in his patient’s best interest.

Physicians who routinely prescribe bioidentical hormones disagree, and some worry that this will limit their ability to prescribe a much safer, natural alternative to synthetic hormones. (If you are BHRT-prescribing physician, please see my call to action at the end of this article.)

Bioidentical Hormones – Do You Need Them?

Estriol is bioidentical to the primary human female hormone, as opposed to Premarin (the most popular estrogen replacement), which contains conjugated estrogens isolated from pregnant mare’s urine. As such, estriol can be very useful in certain situations, particularly after a premenopausal hysterectomy.  

Unfortunately, there is still much unnecessary concern about bioidentical estriol supplementation. What the FDA, most doctors, and patients do not realize is that bioidentical hormone supplements can actually optimize your health – something that cannot be said for animal and/or synthetic estrogens and progestins.

It’s actually the synthetic progestins (like Provera) that are responsible for many of your side effects of hormone replacement therapy (HRT), which include:

However, many uninformed physicians still thrust synthetic HRT on women as the “cure” for menopause, as if menopause was a disease.  Menopause is in fact a completely normal phase of life that happens to most women. Its symptoms are not signs of illness, and they can be effectively relieved without toxic chemicals such as synthetic hormones.

In fact, the unpleasant symptoms we have come to associate with menopause are common only in a small group of women in history: American and Northern European women in the past 75 years. Outside that group, menopause is not so problematic and is taken more in stride as a natural phase in a woman's life, with little fanfare.

It seems that the simpler your lifestyle, and the simpler your diet - the more effortless your transition.

However, there are conditions where hormone replacement IS appropriate, such as when you’ve had your ovaries surgically removed, or your blood supply has been permanently damaged due to a hysterectomy.

I also believe that menopausal hot flashes that do not resolve with phytoestrogens such as black cohosh, are another valid indication for short-term estrogen use, along with natural progesterone.

The Importance of Natural Progesterone

Progesterone is the sister hormone to estrogen, whose functions are equally important. One of them is to maintain your hormonal balance, but if your estrogen levels get too high, progesterone can no longer keep the dynamic balance. This is exactly what happens in American women who live their entire adult lives with pathologically high levels of estrogen.

The three main reasons for these high levels of estrogen are:

Refined carbohydrates, hard fats, empty foods, and too much of them all serve to raise estrogen to abnormal levels, as much as twice the normal, which are maintained for the better part of the adult lives of most American women.

In cases like these, natural progesterone can be beneficial to restore your hormonal balance.

I am not a great fan of the cream version of natural progesterone, but some women may be able to do well with it, as long as they monitor their levels of progesterone. The main concern is that the cream has a tendency to deposit into the fat tissue, and can build up to very high levels in some women if not carefully monitored.

Conquering Menopause with Simple Lifestyle Changes

It’s important to remember that the unpleasant symptoms of menopause are directly related to the amount of estrogen you have maintained during your adult life, prior to menopause.

A lifetime of stress and nutritional deficiencies deplete your adrenals, which deplete progesterone, which promotes estrogen imbalance, which causes symptoms of menopause.

Natural phytoestrogens (plant-estrogens) are found in plants like licorice, black cohosh, alfalfa, and many others, in very small amounts. Phytoestrogens are weak estrogens and block the stronger forms such as environmental xenoestrogens. 

A diet abundant in phytoestrogens before menopause will go a long way to moderate your day-to-day estrogen level so that when menopause arrives, your estrogen levels will not drop as markedly.

Unless you fall into a category where natural hormone supplementation is truly appropriate, these simple lifestyle changes can offer you your natural means to optimize your hormone levels and ease menopausal symptoms:

Physicians and Health Care Professionals – Call to Action

Are you a physician who prescribes bioidentical hormones, and would like to continue to prescribe them freely to patients whom you believe would benefit from them? 

If so, please see the Health Freedom Foundation’s website. They have created an alert that will be faxed directly to the FDA Commissioner, and also be emailed to your Congressional representatives. You can personalize your letter if you wish. 

In this particular case, your voice will carry much more weight in this matter than those of your patients. For more information on how to contact the FDA regarding this issue, please see this link.

[+]Sources and References [-]Sources and References