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Life Arts    H4'ed 6/12/10

Bioidentical Hormones According to Chris Woolston of the LA Times

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Jeffrey Dach
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FDA approval is sometimes waved about like a majestic frond, as if it grants magical qualities to a drug. In reality, FDA approval does not automatically mean the drug is effective or desirable. Ten percent of all FDA approved drugs are later recalled or banned and designated as "bad drugs ". Another ten per cent of FDA approved drugs later receive black box warnings. FDA approval means a major drug company has paid a lot of money for studies showing efficacy over placebo. Sometimes these studies are fudged.

Catch 22 for Natural Substances

Another important fact omitted by Woolston is that the FDA approval process is so expensive that it makes financial sense only for patented drugs with prospects for large returns. It is unlikely that any drug company will invest the millions for FDA approval studies when the drug in question is a natural substance such as a bioidentical hormone that cannot be protected by a patent. Even the publicly financed Women's Health Initiative study sponsored by the NIH was done with patented hormones, Premarin and Provera, not the natural non-patentable bioidentical hormones. This no doubt reflects drug company control over NIH research dollars. The NIH should be studying natural substances like bioidentical hormones, and they are not doing it.

In One Corner, We Have: Dr Kent Holtorf

"Dr. Kent Holtorf, a physician and proponent of bioidentical hormones ...The website for Holtorf's clinic says that women using bioidentical hormones "feel great" without suffering any of the side effects of "synthetic hormones," said to include fatigue, depression and weight gain, along with the increased risk of breast cancer and heart disease. In a phone interview, Holtorf said that bioidentical hormones are more effective and safer than traditional treatments. "Over and over, women have told me that they feel much better" after taking the bioidentical hormones, he says."

In the Other Corner, We have Dr. Nanette Santoro Representing Mainstream Medicine and Synthetic Hormones

"Bioidentical hormones have an obvious appeal to women seeking relief for menopausal symptoms, says Dr. Nanette Santoro, chair of the department of obstetrics and gynecology at the University of Colorado Health Sciences Center in Denver and vice president of clinical science for the Endocrine Society. After all, it just seems to make sense that anything that exactly mimics a woman's own hormones must be better than mare's urine or a man-made compound that doesn't exist in nature."

"But Santoro says there is no proof that bioidentical hormones are any safer or more effective than traditional treatments. "All of the evidence that we have suggests that all of these hormones should be painted with the same brush," she says."

Dr Santoro represents mainstream medicine and synthetic hormones sold by the major drug companies, and as such uses coded language which requires translation. "Traditional Treatments" means synthetic chemically altered hormones sold by the drug companies. Painted with the same brush is the usual attempt to confuse the difference between chemically altered hormones and bioidentical hormones, claiming they are all the same thing. They are not the same thing. Chemically altered hormones are "Monster Hormones" that cause cancer and heart disease. Bioidentical hormones have the same chemical structure as the hormones in the human body and are safe and effective.

Dr Kent Holtorf Article

Dr Kent Holtorf's article in Postgraduate medicine quotes 196 articles showing bioidentical hormones are safer and more effective than synthetic altered hormones. Chemically altered hormones are MONSTERS that should never have been approved for human use. Lehninger's textbook of biochemistry uses the word hormone which means a "bioidentical" hormone. Synthetic chemically altered hormones do not exist in the human body. The sole purpose of chemically altering a hormone chemical structure is to obtain a patent to protect profits of the drug industry. These chemically altered monster hormones are a recent invention in the history of medicine and are MONSTERS that should never have been approved for human use. Alternatively, bioidentical hormones and other natural substances by definition, cannot be patented and therefore not profitable for the drug industry.

Dr. Nanette Santoro Has Concerns

"She has many concerns about bioidentical hormones that don't have FDA approval. For one thing, she says, it's impossible to know if unapproved creams have the promised amounts of hormones. "I've seen patients on these compounds actually losing bone mass because they were getting an insufficient dosage," she says. "Why take that chance?"

We already discussed the FDA approval issue above. Compounding pharmacies are regulated by the states, not the federal government, so FDA approval is neither required nor desired for compounded preparations. The issue of quality control and proper dosage is a real consideration that applies to ALL TYPES of medications whether FDA approved or not. To get the best quality, I recommend working with a knowledgable physician familiar with the best compounding pharmacies with the highest reputation for quality and service.

"Why take a chance ?" says Santoro. This is typical drug company propaganda and fear mongering that is usually seen with drug company television advertising. This is a snide attempt to plant doubts in the mind of the reader. The reality is that synthetic hormones are the monsters, and the bioidentical hormones are the safe and effective choice.

Dr. Cynthia Stuenkel, clinical professor of medicine at UC San Diego

"Dr. Cynthia Stuenkel, clinical professor of medicine at UC San Diego and president of the North American Menopause Society, shares this concern. "Some progesterone creams may contain little or no progesterone, while others contain so much that they definitely should be available only with a prescription," she says. Taking hormones without the careful guidance of a doctor is risky business, Stuenkel says. Among other things, too many hormones can potentially cause blood clots and endometrial hyperplasia, a precursor to uterine cancer."

Dr Steunkel is correct in that progesterone creams are safe, and available without a prescription. She is also correct in that the OTC progesterone creams may vary in potency, and that the highest quality progesterone creams are made by compounding pharmacies, freshly prepared according to the prescribed dosage written by the physician. This is all OK.

Blood Clots and Endometrial Hyperplasia and Uterine Cancer - Omitting History

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Jeffrey Dach MD is a physician and author of three books, Natural Medicine 101, and Bioidentical Hormones 101, and Heart Book all available on Amazon, or as a free e-book on his web sites. Dr. Dach is founder and chief medical officer of (more...)
 

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