Useful links from Jeffrey Dach MD
Useful links to message boards:

http://www.medkb.com/Uwe/Forum.aspx/arthritis-forum/19105/Cordyceps-the-Energy-Superfood-by-Jeffrey-Dach-M-D
Cordyceps, the Energy Superfood by Jeffrey Dach M.D.

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http://www.health-forums.com/arthritis/jeffrey-dach-book-announcement-natural-medicine-101-a-162168.html
A New Book Natural Medicine 101 by Jeffrey Dach

http://newsgroups.derkeiler.com/Archive/Alt/alt.support.arthritis/2011-06/msg00003.html
A New Book Natural Medicine 101 by Jeffrey Dach

———————————————————-

http://sci.tech-archive.net/Archive/sci.med.nutrition/2011-01/msg00003.html
Jeffrey Dach Book Announcment, Natural Medicine 101
——————————————————————————–
http://sci.tech-archive.net/Archive/sci.chem/2011-01/msg00022.html
Announcing a New Book, Natural Medicine 101 by Jeffrey Dach
——————————————————————————–
http://sci.tech-archive.net/Archive/sci.med/2007-01/msg00104.html
Hypertension by Jeffrey Dach, M.D.
——————————————————————————–
Nutritional Supplementation: Back to the Basics
http://sci.tech-archive.net/Archive/sci.med/2006-12/msg00147.html
——————————————————————————–

http://newsgroups.derkeiler.com/Archive/Alt/alt.support.arthritis/2010-12/msg00085.html
Jeffrey Dach Book Announcment, Natural Medicine 101
——————————————————————————–

Jeffrey Dach MD
7450 Griffin Road
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http://www.jeffreydach.com
http://www.drdach.com
http://www.naturalmedicine101.com

http://disc.yourwebapps.com/Indices/244124.html
http://disc.yourwebapps.com/Indices/244066.html
http://disc.yourwebapps.com/Indices/244067.html
http://disc.yourwebapps.com/Indices/244161.html
http://disc.yourwebapps.com/Indices/244163.html
http://www.bioidenticalhormones101.com

 

Quote

FDA Declares Misguided War on Bio-Identical Hormones by Jeffrey Dach MD


Jeffrey Dach, M.D. NewsLetter

Inept FDA Declares Misguided War

on Bio-Identical Hormones,

and Promptly Shoots Own Foot

                                   Click Here for Original Article at My Blog
                             ________________________________________

FDA Tries to Protect Wyeth From Financial Losses

Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study. Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.

Wyeth Files a Citizen’s Complaint with the FDA

October 2005, in a move to prevent further financial losses, Wyeth filed a Citizen’s Complaint with the FDA, requesting the FDA take action against Wyeth’s competition, prohibiting compounding pharmacies from providing bio-identical hormones to their patients. More than 66,000 doctors, patients, and pharmacists filed comments in favor of bioidentical hormones and against Wyeth. In spite of this public outcry, Wyeth continues to abuse the FDA to the harm and detriment of millions of women who use bio-identical hormones.

Analysis of the FDA Statements:

Here is an analysis of the recent FDA statements: a comedy of errors, omissions, contradictions, and Orwellian DoubleSpeak. The statements can be found at the
FDA website. January 9, 2008, FDA Takes Action Against  Compounded Menopause Hormone Therapy Drugs (1)(2)

                           

Astonishingly, the FDA does not recognize the term, “bio-identical” !

FDA says:

The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

My Reply:

The term bio-identical has a definite meaning and is widely used. The term, bioidentical, means a hormone chemical structure which is identical to that found in human biology. Both the Endocrine Society and ACOG recognize the term, and even though their definitions use slightly different terminology, they are essentially identical in meaning.

 Astonishingly, the FDA is UNAWARE of a basic fact of biochemistry !

Astonishingly, the FDA is UNAWARE that identical chemical structures have the same biological effects. This is the basis for all biochemistry. A water molecule, for example, will have the same biologic effect in the body regardless of how it is synthesized, and this is also true for any other chemical, including hormones.

FDA says:

Many compounding pharmacies use Bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims.

My Reply:

Bio-identical hormones are (1) natural and (2) have effects identical to hormones made in the body. These are basic axioms of biochemistry, and accepted as basic truth by all of biochemistry, including the following medical textbooks Lehninger Principles of Biochemistry, Guyton Textbook of Medical Physiology, and Williams Textbook of Endocrinology.

It is astonishing that the FDA can be UNAWARE of the scientific evidence that is present in every medical textbook, and thousands of Medline references that state that bio-identical hormones ARE natural and DO produce the same effects as human hormones !!

 
The FDA Does Recognize this basic fact of biochemistry when looking at Synthetic Hormone Structures !

Astonishingly, for the FDA, when it comes to synthetic hormones, all of a sudden, chemical structures that are identical DO have the same biologic effects !!

FDA says:

Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

My Reply:

This is Orwellian DoubleSpeak again. Compounded natural bio-identical hormones DO NOT have the same chemical structure as synthetic hormones. Compounded hormones are natural and bio-identical, and DO NOT increase risk of increased cancer and heart disease, as was demonstrated for the synthetic hormones in the WHI study. The Women’s Health Initiative study published in JAMA July 2002 showed that Provera, a chemically altered form of progesterone causes increased risk of cancer and heart disease, while the natural, human bioidentical progesterone does not. (5) (6)

The following two studies show that bio-identical hormones are safe: One is the French Cohort Study which showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.(3) The second is the June 2007 NEJM Calcium Score study which showed no increase in heart disease risk with estrogen. (4)

 
The FDA Attacks Saliva Hormone Testing !

FDA says :

Some compounding pharmacies and other promoters of “BHRT” claim that estrogen levels in a person’s saliva can be tested by practitioners to help practitioners estimate the amount of hormone a person needs and purportedly to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on a patient’s symptoms.

My Reply:

Salivary hormone testing has been done by two large companies for many years, Diagnos-Techs and ZRT. Both Web Sites list plenty of scientific evidence validating saliva hormone testing. ZRT lists references supporting salivary hormone testing here and here.

In addition, salivary hormone testing for other hormones such as cortisol and melatonin is accepted and used in scientific publications. NASA uses salivary testing for cortisol and melatonin. (7) A PubMed Medline search shows many research studies validating the use of salivary hormone testing.(8) Key Word Search:

Salivary hormone 4075 articles
Salivary cortisol: 1478 articles
Salivary estradiol 177
Salivary progesterone 317
Salivary testosterone 428

 
The FDA Claims Ignorance of Its Own FDA Approvals !

FDA says:

Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.
My Reply:

Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone.

The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause:

Alora (estradiol): FDA approved 1996 – Watson Labs
Climara (estradiol): FDA approved 1994 – Bayer
FemPatch : FDA approved 1997 – Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 – Novartis
Estraderm: FDA approved 1986 – Novartis
Esclim: FDA approved 1998 – Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb
Estring: FDA approved 1996 – Pharmacia UpJohn
Prometrium (natural progesterone): FDA approved 1998 – Solvay
Androgel (natural testosterone): FDA approved 2000 – Unimed Pharmaceuticals
Crinone: FDA approved 1997 – Columbia Labs

FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring

FDA approved Progesterone products:Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest

FDA approved testosterone:Testoderm, Androderm, AndroGel

 The FDA Tries to Ban Estriol !

Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women.

FDA says:

Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.

My Reply:

Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.

                          

Finally, the Truth About Bio-Identical Hormones !

And now, The Truth about Bioidentical Hormones

as quoted from the IACP from the Compounding Pharmacists web site. (48)

Myth 1) Bioidentical hormone replacement therapy (BHRT) is unregulated.

Fact:

Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia.

Myth 2): Compounded bioidentical hormones are unsafe because they aren’t FDA-approved.

Fact:

Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use.

Myth 3): Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro.

Fact:

There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT.

A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination.

Myth 4): Pharmacists are recklessly promoting BHRT as safe and effective.

Fact:

Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote.

Myth 5): Bioidentical is a misleading term.

Fact:

The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical.

Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups.

Did you find this newsletter interesting? Feel free to Email it to a friend with the button on the bar below.

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

References and Links

List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them):

Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author)
Textbook of Medical Physiology by Arthur C. Guyton
Williams Textbook of Endocrinology
Basic & Clinical Endocrinology by Francis S. Greenspan
Review of Medical Physiology by Ganong, William F. MD
Endocrinology (5th Edition) by Mac E. Hadley
Endocrine Physiology by Susan Porterfield

(1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

(2) Compounded Menopausal Hormone Therapy Questions and Answers

(3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d’Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France.

The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.

(4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen.

(5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women’s Health Initiative Randomized Controlled Trial Writing Group for the Women’s Health Initiative Investigators JAMA. 2002;288:321-333.

(6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women’s Health Initiative Randomized Controlled Trial,The Women’s Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712.

(7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D.

(8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing.

salivary hormone 4075 articles, Salivary cortisol: 1478 articles, Salivary estradiol 177, Salivary progesterone 317, Salivary testosterone 428

(9) special committee on aging senate Hearings- Bioidentical Hormones: Sound Science or Bad Medicine? April 19, 2007

(10) Bioidentical hormone replacement therapy wikipedia

(11) The Truth about Bioidentical Hormones-IACP

(12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding

(13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness

(16) Low levels of testosterone may increase risk of death in older men Men’s Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM).

(17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.

(18) DrErika Blasts Wyeth’s War on Bioidentical Hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(19) Wyeth’s War on Women and Bioidenticals, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones.

(20) Bioidentical Hormones are not snake oil: They are available commercially at your local drugstore with a prescription from your regular MD . Erika Schwartz blog, web site. Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(21) FDA says alternative hormone claims unsupported Wed Jan 9, Reuters news service

(22) Listing of references in the Scientific Literature on validating use of bio-identical hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(23) Wednesday, Jan. 09, 2008 FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones International Academy of Compounding Pharmacists

(24) FDA Asserts New Policy To Restrict Women’s Access To Bioidentical Hormones,medicalnewstoday, 10 Jan 2008

(25) FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” , IACPRX

(26) Tell Congress: Don’t Take Away My Compounded Medications! Send a letter to your congressman.

(27) Hot Flash: FDA Warns About BHRT Drugs,January 9th, 2008 2:51 pm By Ed Silverman Pharmalot

(28) E- Book on natural progesterone

(29) Understanding the Controversy:Hormone Testing and Bioidentical Hormones

(30) Vivelle dot, estradiol fda approved

(31) About USP—An Overview Who We Are, The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements

(32) Estriol listing in USP

(33) Pharmacies Warned About Compounding Estriol, Touting Mixture’s Benefits Does the FDA have jurisdiction over these compounding pharmacies?There’s a court battle going on right now to determine the answer to that question. Oral arguments are expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The fda is appealing a lower court ruling, which found that they do not have jurisdiction over drug preparations produced by compounding pharmacies.

(34) FDA Goes After ‘Natural’ HRT Claims Compounding Pharmacies Told to Stop Marketing ‘Bio-identical Hormone Replacement Therapy’

(35) C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(36) Judge Issues Landmark Decision in Compounding Pharmacy Case Friday, May 26, 2006Midland, Texas, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(37) Wyeth Pharmaceuticals tries to STOP your access to Bio-Identical Hormone Replacement Therapies (BHRT). BHRT-A BATTLE FOR THE TRUTH, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(38) Bio-Identical Hormone Drug Information

(39) Wyeth web site

(40) Sepp Hasslberger web site, Wyeth Asks FDA: Prohibit Bio-Identical Hormones, Excellent Summary of Wyeth Activities and War Against BioIdentical Hormones

(41) wyeth earnings report 2006

(42) Wikipedia bio-identical hormone therapy definition

(43) Double speak

references for salivary hormone testing

(44) Salivary testosterone levels in preadolescent children, Daniela Ostatníková1

(45) Pathol Biol (Paris). 2001 Oct;49(8):660-7., Saliva assays in clinical and research biology.Lac G., Département génie biologique,

(46) Patterns of Salivary Estradiol and Progesterone across the Menstrual Cycle, BEATRICE K. GANDARA,a LINDA LERESCHE,a and LLOYD MANCLb

(47) FDA Approves Biex Test to Aid in Identifying Risk of Preterm Labor and Delivery. 5/5/1998 Biex, Inc. announced today the FDA granted marketing approval for the Company’s salivary estriol test to help physicians identify risk for spontaneous preterm labor and delivery.

(48) The Truth about Bioidentical Hormones-IACP

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Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

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(1) My Vitamins Are Killing Me by Jeffrey Dach MD !!!

(2) Stroke Prevention and Vitamin C by Jeffrey Dach MD

(3) Testosterone Risks and Benefits by Jeffrey Dach MD

(4) Medical School Days and SSRI Research by Jeffrey Dach MD

(5) Iodine and Breast Cancer Prevention by Jeffrey Dach MD

(6) Hypothyroidism Part One by Jeffrey Dach MD

(7) Hypothyroidism Part Two Thryroflex by Jeffrey Dach MD

(8) Guard Your Daughter from Gardisil, Virginia Tech Rampage Seung-Hui Cho by Jeffrey Dach MD

(9) Orthomolecular Medicine Meeting in Toronto 2007 by Jeffrey Dach MD

(10) B12 Deficiency by Jeffrey Dach MD

(11) Rachel Carson and Silent Spring by Jeffrey Dach MD

(12) Vitamin D Deficiency by Jeffrey Dach MD

(13) Andrew Weil AARP, and Human Growth Hormone HGH by Jeffrey Dach MD

(14) Michael Moore’s SICKO by Jeffrey Dach MD

(15) Blood Pressure Pills for Hypertension, When to Treat? by Jeffrey Dach MD

(16) Low Dose Naltrexone (LDN) by Jeffrey Dach MD

(17) Protect Your Family From Bad Drugs by Jeffrey Dach MD

(18) Roger Federer, Race Horses and Pulsed ElectroMagnetic Devices by Jeffrey Dach MD

(19) Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD

(21) The Importance of the Pelvic Sonogram by Jeffrey Dach MD

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(1) Lipitor and "The Dracula of Modern Technology" by Jeffrey Dach MD

(2) Osteoporosis, Bisphosphonate Drugs and Toulouse Lautrec by Jeffrey Dach MD

(3) Prozac, Paxil and SSRI Drugs – Part One by Jeffrey Dach MD

(4) Prozac, Paxil and SSRI Drugs – Part Two by Jeffrey Dach MD

(5) Max Essex and Virological Failure in the NEJM by Jeffrey Dach MD

(6) The Origins of HIV by Jeffrey Dach MD

A Medical Article that I Published in 1980:

(7) Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614

Jeffrey Dach, M.D.
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office phone 954-983-1443

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Dr. Dach is Board Certified by the American Board of Radiology and a member of the Board of the American Academy of Anti-Aging Medicine. He has 25 years experience in the Memorial Hospital System as an interventional radiologist. His current practice focuses on Bio-identical hormone supplementation for men and women, menopause, andropause, HGH, testosterone, natural thyroid and the use of natural substances rather than drugs in the appropriate setting.

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Quote

FDA Declares Misguided War on Bio-Identical Hormones by Jeffrey Dach MD


Jeffrey Dach, M.D. NewsLetter

Inept FDA Declares Misguided War

on Bio-Identical Hormones,

and Promptly Shoots Own Foot

                                   Click Here for Original Article at My Blog
                             ________________________________________

FDA Tries to Protect Wyeth From Financial Losses

Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study. Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.

Wyeth Files a Citizen’s Complaint with the FDA

October 2005, in a move to prevent further financial losses, Wyeth filed a Citizen’s Complaint with the FDA, requesting the FDA take action against Wyeth’s competition, prohibiting compounding pharmacies from providing bio-identical hormones to their patients. More than 66,000 doctors, patients, and pharmacists filed comments in favor of bioidentical hormones and against Wyeth. In spite of this public outcry, Wyeth continues to abuse the FDA to the harm and detriment of millions of women who use bio-identical hormones.

Analysis of the FDA Statements:

Here is an analysis of the recent FDA statements: a comedy of errors, omissions, contradictions, and Orwellian DoubleSpeak. The statements can be found at the
FDA website. January 9, 2008, FDA Takes Action Against  Compounded Menopause Hormone Therapy Drugs (1)(2)

                           

Astonishingly, the FDA does not recognize the term, “bio-identical” !

FDA says:

The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

My Reply:

The term bio-identical has a definite meaning and is widely used. The term, bioidentical, means a hormone chemical structure which is identical to that found in human biology. Both the Endocrine Society and ACOG recognize the term, and even though their definitions use slightly different terminology, they are essentially identical in meaning.

 Astonishingly, the FDA is UNAWARE of a basic fact of biochemistry !

Astonishingly, the FDA is UNAWARE that identical chemical structures have the same biological effects. This is the basis for all biochemistry. A water molecule, for example, will have the same biologic effect in the body regardless of how it is synthesized, and this is also true for any other chemical, including hormones.

FDA says:

Many compounding pharmacies use Bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims.

My Reply:

Bio-identical hormones are (1) natural and (2) have effects identical to hormones made in the body. These are basic axioms of biochemistry, and accepted as basic truth by all of biochemistry, including the following medical textbooks Lehninger Principles of Biochemistry, Guyton Textbook of Medical Physiology, and Williams Textbook of Endocrinology.

It is astonishing that the FDA can be UNAWARE of the scientific evidence that is present in every medical textbook, and thousands of Medline references that state that bio-identical hormones ARE natural and DO produce the same effects as human hormones !!

 
The FDA Does Recognize this basic fact of biochemistry when looking at Synthetic Hormone Structures !

Astonishingly, for the FDA, when it comes to synthetic hormones, all of a sudden, chemical structures that are identical DO have the same biologic effects !!

FDA says:

Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

My Reply:

This is Orwellian DoubleSpeak again. Compounded natural bio-identical hormones DO NOT have the same chemical structure as synthetic hormones. Compounded hormones are natural and bio-identical, and DO NOT increase risk of increased cancer and heart disease, as was demonstrated for the synthetic hormones in the WHI study. The Women’s Health Initiative study published in JAMA July 2002 showed that Provera, a chemically altered form of progesterone causes increased risk of cancer and heart disease, while the natural, human bioidentical progesterone does not. (5) (6)

The following two studies show that bio-identical hormones are safe: One is the French Cohort Study which showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.(3) The second is the June 2007 NEJM Calcium Score study which showed no increase in heart disease risk with estrogen. (4)

 
The FDA Attacks Saliva Hormone Testing !

FDA says :

Some compounding pharmacies and other promoters of “BHRT” claim that estrogen levels in a person’s saliva can be tested by practitioners to help practitioners estimate the amount of hormone a person needs and purportedly to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on a patient’s symptoms.

My Reply:

Salivary hormone testing has been done by two large companies for many years, Diagnos-Techs and ZRT. Both Web Sites list plenty of scientific evidence validating saliva hormone testing. ZRT lists references supporting salivary hormone testing here and here.

In addition, salivary hormone testing for other hormones such as cortisol and melatonin is accepted and used in scientific publications. NASA uses salivary testing for cortisol and melatonin. (7) A PubMed Medline search shows many research studies validating the use of salivary hormone testing.(8) Key Word Search:

Salivary hormone 4075 articles
Salivary cortisol: 1478 articles
Salivary estradiol 177
Salivary progesterone 317
Salivary testosterone 428

 
The FDA Claims Ignorance of Its Own FDA Approvals !

FDA says:

Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.
My Reply:

Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone.

The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause:

Alora (estradiol): FDA approved 1996 – Watson Labs
Climara (estradiol): FDA approved 1994 – Bayer
FemPatch : FDA approved 1997 – Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 – Novartis
Estraderm: FDA approved 1986 – Novartis
Esclim: FDA approved 1998 – Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb
Estring: FDA approved 1996 – Pharmacia UpJohn
Prometrium (natural progesterone): FDA approved 1998 – Solvay
Androgel (natural testosterone): FDA approved 2000 – Unimed Pharmaceuticals
Crinone: FDA approved 1997 – Columbia Labs

FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring

FDA approved Progesterone products:Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest

FDA approved testosterone:Testoderm, Androderm, AndroGel

 The FDA Tries to Ban Estriol !

Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women.

FDA says:

Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.

My Reply:

Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.

                          

Finally, the Truth About Bio-Identical Hormones !

And now, The Truth about Bioidentical Hormones

as quoted from the IACP from the Compounding Pharmacists web site. (48)

Myth 1) Bioidentical hormone replacement therapy (BHRT) is unregulated.

Fact:

Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia.

Myth 2): Compounded bioidentical hormones are unsafe because they aren’t FDA-approved.

Fact:

Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use.

Myth 3): Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro.

Fact:

There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT.

A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination.

Myth 4): Pharmacists are recklessly promoting BHRT as safe and effective.

Fact:

Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote.

Myth 5): Bioidentical is a misleading term.

Fact:

The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical.

Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups.

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Jeffrey Dach MD
4700 Sheridan Suite T
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954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

References and Links

List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them):

Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author)
Textbook of Medical Physiology by Arthur C. Guyton
Williams Textbook of Endocrinology
Basic & Clinical Endocrinology by Francis S. Greenspan
Review of Medical Physiology by Ganong, William F. MD
Endocrinology (5th Edition) by Mac E. Hadley
Endocrine Physiology by Susan Porterfield

(1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

(2) Compounded Menopausal Hormone Therapy Questions and Answers

(3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d’Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France.

The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.

(4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen.

(5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women’s Health Initiative Randomized Controlled Trial Writing Group for the Women’s Health Initiative Investigators JAMA. 2002;288:321-333.

(6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women’s Health Initiative Randomized Controlled Trial,The Women’s Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712.

(7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D.

(8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing.

salivary hormone 4075 articles, Salivary cortisol: 1478 articles, Salivary estradiol 177, Salivary progesterone 317, Salivary testosterone 428

(9) special committee on aging senate Hearings- Bioidentical Hormones: Sound Science or Bad Medicine? April 19, 2007

(10) Bioidentical hormone replacement therapy wikipedia

(11) The Truth about Bioidentical Hormones-IACP

(12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding

(13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness

(16) Low levels of testosterone may increase risk of death in older men Men’s Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM).

(17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.

(18) DrErika Blasts Wyeth’s War on Bioidentical Hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(19) Wyeth’s War on Women and Bioidenticals, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones.

(20) Bioidentical Hormones are not snake oil: They are available commercially at your local drugstore with a prescription from your regular MD . Erika Schwartz blog, web site. Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(21) FDA says alternative hormone claims unsupported Wed Jan 9, Reuters news service

(22) Listing of references in the Scientific Literature on validating use of bio-identical hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(23) Wednesday, Jan. 09, 2008 FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones International Academy of Compounding Pharmacists

(24) FDA Asserts New Policy To Restrict Women’s Access To Bioidentical Hormones,medicalnewstoday, 10 Jan 2008

(25) FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” , IACPRX

(26) Tell Congress: Don’t Take Away My Compounded Medications! Send a letter to your congressman.

(27) Hot Flash: FDA Warns About BHRT Drugs,January 9th, 2008 2:51 pm By Ed Silverman Pharmalot

(28) E- Book on natural progesterone

(29) Understanding the Controversy:Hormone Testing and Bioidentical Hormones

(30) Vivelle dot, estradiol fda approved

(31) About USP—An Overview Who We Are, The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements

(32) Estriol listing in USP

(33) Pharmacies Warned About Compounding Estriol, Touting Mixture’s Benefits Does the FDA have jurisdiction over these compounding pharmacies?There’s a court battle going on right now to determine the answer to that question. Oral arguments are expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The fda is appealing a lower court ruling, which found that they do not have jurisdiction over drug preparations produced by compounding pharmacies.

(34) FDA Goes After ‘Natural’ HRT Claims Compounding Pharmacies Told to Stop Marketing ‘Bio-identical Hormone Replacement Therapy’

(35) C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(36) Judge Issues Landmark Decision in Compounding Pharmacy Case Friday, May 26, 2006Midland, Texas, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(37) Wyeth Pharmaceuticals tries to STOP your access to Bio-Identical Hormone Replacement Therapies (BHRT). BHRT-A BATTLE FOR THE TRUTH, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(38) Bio-Identical Hormone Drug Information

(39) Wyeth web site

(40) Sepp Hasslberger web site, Wyeth Asks FDA: Prohibit Bio-Identical Hormones, Excellent Summary of Wyeth Activities and War Against BioIdentical Hormones

(41) wyeth earnings report 2006

(42) Wikipedia bio-identical hormone therapy definition

(43) Double speak

references for salivary hormone testing

(44) Salivary testosterone levels in preadolescent children, Daniela Ostatníková1

(45) Pathol Biol (Paris). 2001 Oct;49(8):660-7., Saliva assays in clinical and research biology.Lac G., Département génie biologique,

(46) Patterns of Salivary Estradiol and Progesterone across the Menstrual Cycle, BEATRICE K. GANDARA,a LINDA LERESCHE,a and LLOYD MANCLb

(47) FDA Approves Biex Test to Aid in Identifying Risk of Preterm Labor and Delivery. 5/5/1998 Biex, Inc. announced today the FDA granted marketing approval for the Company’s salivary estriol test to help physicians identify risk for spontaneous preterm labor and delivery.

(48) The Truth about Bioidentical Hormones-IACP

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Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

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(1) My Vitamins Are Killing Me by Jeffrey Dach MD !!!

(2) Stroke Prevention and Vitamin C by Jeffrey Dach MD

(3) Testosterone Risks and Benefits by Jeffrey Dach MD

(4) Medical School Days and SSRI Research by Jeffrey Dach MD

(5) Iodine and Breast Cancer Prevention by Jeffrey Dach MD

(6) Hypothyroidism Part One by Jeffrey Dach MD

(7) Hypothyroidism Part Two Thryroflex by Jeffrey Dach MD

(8) Guard Your Daughter from Gardisil, Virginia Tech Rampage Seung-Hui Cho by Jeffrey Dach MD

(9) Orthomolecular Medicine Meeting in Toronto 2007 by Jeffrey Dach MD

(10) B12 Deficiency by Jeffrey Dach MD

(11) Rachel Carson and Silent Spring by Jeffrey Dach MD

(12) Vitamin D Deficiency by Jeffrey Dach MD

(13) Andrew Weil AARP, and Human Growth Hormone HGH by Jeffrey Dach MD

(14) Michael Moore’s SICKO by Jeffrey Dach MD

(15) Blood Pressure Pills for Hypertension, When to Treat? by Jeffrey Dach MD

(16) Low Dose Naltrexone (LDN) by Jeffrey Dach MD

(17) Protect Your Family From Bad Drugs by Jeffrey Dach MD

(18) Roger Federer, Race Horses and Pulsed ElectroMagnetic Devices by Jeffrey Dach MD

(19) Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD

(21) The Importance of the Pelvic Sonogram by Jeffrey Dach MD

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(1) Lipitor and "The Dracula of Modern Technology" by Jeffrey Dach MD

(2) Osteoporosis, Bisphosphonate Drugs and Toulouse Lautrec by Jeffrey Dach MD

(3) Prozac, Paxil and SSRI Drugs – Part One by Jeffrey Dach MD

(4) Prozac, Paxil and SSRI Drugs – Part Two by Jeffrey Dach MD

(5) Max Essex and Virological Failure in the NEJM by Jeffrey Dach MD

(6) The Origins of HIV by Jeffrey Dach MD

A Medical Article that I Published in 1980:

(7) Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614

Jeffrey Dach, M.D.
Member of the Board of the American Academy of Anti-Aging Medicine
Board Certified by the American Board of Radiology

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office phone 954-983-1443

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Dr. Dach is Board Certified by the American Board of Radiology and a member of the Board of the American Academy of Anti-Aging Medicine. He has 25 years experience in the Memorial Hospital System as an interventional radiologist. His current practice focuses on Bio-identical hormone supplementation for men and women, menopause, andropause, HGH, testosterone, natural thyroid and the use of natural substances rather than drugs in the appropriate setting.

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Jeffrey Dach, M.D. NewsLetter

Inept FDA Declares Misguided War on Bio-Identical Hormones,
and Promptly Shoots Own Foot


 

Click Here for Original Article at My Blog
__________________________________________

FDA Tries to Protect Wyeth From Financial Losses

Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study. Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.

Wyeth Files a Citizen’s Complaint with the FDA

October 2005, in a move to prevent further financial losses, Wyeth filed a Citizen’s Complaint with the FDA, requesting the FDA take action against Wyeth’s competition, prohibiting compounding pharmacies from providing bio-identical hormones to their patients. More than 66,000 doctors, patients, and pharmacists filed comments in favor of bioidentical hormones and against Wyeth. In spite of this public outcry, Wyeth continues to abuse the FDA to the harm and detriment of millions of women who use bio-identical hormones.

Analysis of the FDA Statements:

Here is an analysis of the recent FDA statements: a comedy of errors, omissions, contradictions, and Orwellian DoubleSpeak. The statements can be found at the FDA website.

January 9, 2008

FDA Takes Action Against

Compounded Menopause Hormone Therapy Drugs (1)(2)

Astonishingly, the FDA does not recognize the term, “bio-identical” !

FDA says:

The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

My Reply:

The term bio-identical has a definite meaning and is widely used. The term, bioidentical, means a hormone chemical structure which is identical to that found in human biology. Both the Endocrine Society and ACOG recognize the term, and even though their definitions use slightly different terminology, they are essentially identical in meaning.

Astonishingly, the FDA is UNAWARE of a basic fact of biochemistry !

Astonishingly, the FDA is UNAWARE that identical chemical structures have the same biological effects. This is the basis for all biochemistry. A water molecule, for example, will have the same biologic effect in the body regardless of how it is synthesized, and this is also true for any other chemical, including hormones.

FDA says:

Many compounding pharmacies use Bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims.

My Reply:

Bio-identical hormones are (1) natural and (2) have effects identical to hormones made in the body. These are basic axioms of biochemistry, and accepted as basic truth by all of biochemistry, including the following medical textbooks Lehninger Principles of Biochemistry, Guyton Textbook of Medical Physiology, and Williams Textbook of Endocrinology.

It is astonishing that the FDA can be UNAWARE of the scientific evidence that is present in every medical textbook, and thousands of Medline references that state that bio-identical hormones ARE natural and DO produce the same effects as human hormones !!

The FDA Does Recognize this basic fact of biochemistry when looking at Synthetic Hormone Structures !

Astonishingly, for the FDA, when it comes to synthetic hormones, all of a sudden, chemical structures that are identical DO have the same biologic effects !!

FDA says:

Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

My Reply:

This is Orwellian DoubleSpeak again. Compounded natural bio-identical hormones DO NOT have the same chemical structure as synthetic hormones. Compounded hormones are natural and bio-identical, and DO NOT increase risk of increased cancer and heart disease, as was demonstrated for the synthetic hormones in the WHI study. The Women’s Health Initiative study published in JAMA July 2002 showed that Provera, a chemically altered form of progesterone causes increased risk of cancer and heart disease, while the natural, human bioidentical progesterone does not. (5) (6)

The following two studies show that bio-identical hormones are safe: One is the French Cohort Study which showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.(3) The second is the June 2007 NEJM Calcium Score study which showed no increase in heart disease risk with estrogen. (4)

The FDA Attacks Saliva Hormone Testing !

FDA says :

Some compounding pharmacies and other promoters of “BHRT” claim that estrogen levels in a person’s saliva can be tested by practitioners to help practitioners estimate the amount of hormone a person needs and purportedly to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on a patient’s symptoms.

My Reply:

Salivary hormone testing has been done by two large companies for many years, Diagnos-Techs and ZRT. Both Web Sites list plenty of scientific evidence validating saliva hormone testing. ZRT lists references supporting salivary hormone testing here and here.

In addition, salivary hormone testing for other hormones such as cortisol and melatonin is accepted and used in scientific publications. NASA uses salivary testing for cortisol and melatonin. (7) A PubMed Medline search shows many research studies validating the use of salivary hormone testing.(8) Key Word Search:

Salivary hormone 4075 articles
Salivary cortisol: 1478 articles
Salivary estradiol 177
Salivary progesterone 317
Salivary testosterone 428

The FDA Claims Ignorance of Its Own FDA Approvals !

FDA says:

Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.

My Reply:

Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone.

The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause:

Alora (estradiol): FDA approved 1996 – Watson Labs
Climara (estradiol): FDA approved 1994 – Bayer
FemPatch : FDA approved 1997 – Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 – Novartis
Estraderm: FDA approved 1986 – Novartis
Esclim: FDA approved 1998 – Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb
Estring: FDA approved 1996 – Pharmacia UpJohn
Prometrium (natural progesterone): FDA approved 1998 – Solvay
Androgel (natural testosterone): FDA approved 2000 – Unimed Pharmaceuticals
Crinone: FDA approved 1997 – Columbia Labs

FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring

FDA approved Progesterone products:Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest

FDA approved testosterone:Testoderm, Androderm, AndroGel

The FDA Tries to Ban Estriol !

Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women.

FDA says:

Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.

My Reply:

Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.

Finally, the Truth About Bio-Identical Hormones !

And now, The Truth about Bioidentical Hormones-quoted from the IACP from the Compounding Pharmacists web site. (48)

Myth 1): Bioidentical hormone replacement therapy (BHRT) is unregulated.

Fact: Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia.

Myth 2): Compounded bioidentical hormones are unsafe because they aren’t FDA-approved.

Fact: Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use.

Myth 3): Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro.

Fact: There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT.

A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination.

Myth 4): Pharmacists are recklessly promoting BHRT as safe and effective.

Fact: Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote.

Myth 5): Bioidentical is a misleading term.

Fact: The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical.

Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups.

Did you find this newsletter interesting? Feel free to Email it to a friend with the button on the bar below.

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

References and Links

List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them):

Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author)
Textbook of Medical Physiology by Arthur C. Guyton
Williams Textbook of Endocrinology
Basic & Clinical Endocrinology by Francis S. Greenspan
Review of Medical Physiology by Ganong, William F. MD
Endocrinology (5th Edition) by Mac E. Hadley
Endocrine Physiology by Susan Porterfield

(1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

(2) Compounded Menopausal Hormone Therapy Questions and Answers

(3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d’Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France.

The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.

(4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen.

(5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women’s Health Initiative Randomized Controlled Trial Writing Group for the Women’s Health Initiative Investigators JAMA. 2002;288:321-333.

(6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women’s Health Initiative Randomized Controlled Trial,The Women’s Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712.

(7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D.

(8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing.

salivary hormone 4075 articles, Salivary cortisol: 1478 articles, Salivary estradiol 177, Salivary progesterone 317, Salivary testosterone 428

(9) special committee on aging senate Hearings- Bioidentical Hormones: Sound Science or Bad Medicine? April 19, 2007

(10) Bioidentical hormone replacement therapy wikipedia

(11) The Truth about Bioidentical Hormones-IACP

(12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding

(13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness

(16) Low levels of testosterone may increase risk of death in older men Men’s Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM).

(17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.

(18) DrErika Blasts Wyeth’s War on Bioidentical Hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(19) Wyeth’s War on Women and Bioidenticals, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones.

(20) Bioidentical Hormones are not snake oil: They are available commercially at your local drugstore with a prescription from your regular MD . Erika Schwartz blog, web site. Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(21) FDA says alternative hormone claims unsupported Wed Jan 9, Reuters news service

(22) Listing of references in the Scientific Literature on validating use of bio-identical hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(23) Wednesday, Jan. 09, 2008 FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones International Academy of Compounding Pharmacists

(24) FDA Asserts New Policy To Restrict Women’s Access To Bioidentical Hormones,medicalnewstoday, 10 Jan 2008

(25) FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” , IACPRX

(26) Tell Congress: Don’t Take Away My Compounded Medications! Send a letter to your congressman.

(27) Hot Flash: FDA Warns About BHRT Drugs,January 9th, 2008 2:51 pm By Ed Silverman Pharmalot

(28) E- Book on natural progesterone

(29) Understanding the Controversy:Hormone Testing and Bioidentical Hormones

(30) Vivelle dot, estradiol fda approved

(31) About USP—An Overview Who We Are, The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements

(32) Estriol listing in USP

(33) Pharmacies Warned About Compounding Estriol, Touting Mixture’s Benefits Does the FDA have jurisdiction over these compounding pharmacies?There’s a court battle going on right now to determine the answer to that question. Oral arguments are expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The fda is appealing a lower court ruling, which found that they do not have jurisdiction over drug preparations produced by compounding pharmacies.

(34) FDA Goes After ‘Natural’ HRT Claims Compounding Pharmacies Told to Stop Marketing ‘Bio-identical Hormone Replacement Therapy’

(35) C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(36) Judge Issues Landmark Decision in Compounding Pharmacy Case Friday, May 26, 2006Midland, Texas, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(37) Wyeth Pharmaceuticals tries to STOP your access to Bio-Identical Hormone Replacement Therapies (BHRT). BHRT-A BATTLE FOR THE TRUTH, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(38) Bio-Identical Hormone Drug Information

(39) Wyeth web site

(40) Sepp Hasslberger web site, Wyeth Asks FDA: Prohibit Bio-Identical Hormones, Excellent Summary of Wyeth Activities and War Against BioIdentical Hormones

(41) wyeth earnings report 2006

(42) Wikipedia bio-identical hormone therapy definition

(43) Double speak

references for salivary hormone testing

(44) Salivary testosterone levels in preadolescent children, Daniela Ostatníková1

(45) Pathol Biol (Paris). 2001 Oct;49(8):660-7., Saliva assays in clinical and research biology.Lac G., Département génie biologique,

(46) Patterns of Salivary Estradiol and Progesterone across the Menstrual Cycle, BEATRICE K. GANDARA,a LINDA LERESCHE,a and LLOYD MANCLb

(47) FDA Approves Biex Test to Aid in Identifying Risk of Preterm Labor and Delivery. 5/5/1998 Biex, Inc. announced today the FDA granted marketing approval for the Company’s salivary estriol test to help physicians identify risk for spontaneous preterm labor and delivery.

(48) The Truth about Bioidentical Hormones-IACP

Did you find this newsletter interesting? Feel free to Email it to a friend with the button on the bar below.

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

disclaimer

All after tax profits from TrueMedMD clinic operations are donated to charity.

(c) 2007-2008 all rights reserved jeffrey dach md


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Catalog of NewsLetters

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(1) My Vitamins Are Killing Me by Jeffrey Dach MD !!!

(2) Stroke Prevention and Vitamin C by Jeffrey Dach MD

(3) Testosterone Risks and Benefits by Jeffrey Dach MD

(4) Medical School Days and SSRI Research by Jeffrey Dach MD

(5) Iodine and Breast Cancer Prevention by Jeffrey Dach MD

(6) Hypothyroidism Part One by Jeffrey Dach MD

(7) Hypothyroidism Part Two Thryroflex by Jeffrey Dach MD

(8) Guard Your Daughter from Gardisil, Virginia Tech Rampage Seung-Hui Cho by Jeffrey Dach MD

(9) Orthomolecular Medicine Meeting in Toronto 2007 by Jeffrey Dach MD

(10) B12 Deficiency by Jeffrey Dach MD

(11) Rachel Carson and Silent Spring by Jeffrey Dach MD

(12) Vitamin D Deficiency by Jeffrey Dach MD

(13) Andrew Weil AARP, and Human Growth Hormone HGH by Jeffrey Dach MD

(14) Michael Moore’s SICKO by Jeffrey Dach MD

(15) Blood Pressure Pills for Hypertension, When to Treat? by Jeffrey Dach MD

(16) Low Dose Naltrexone (LDN) by Jeffrey Dach MD

(17) Protect Your Family From Bad Drugs by Jeffrey Dach MD

(18) Roger Federer, Race Horses and Pulsed ElectroMagnetic Devices by Jeffrey Dach MD

(19) Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD

(21) The Importance of the Pelvic Sonogram by Jeffrey Dach MD

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Catalog of Articles Published on Hank Barnes World,
You Bet Your Life, by Jeffrey Dach MD

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(1) Lipitor and "The Dracula of Modern Technology" by Jeffrey Dach MD

(2) Osteoporosis, Bisphosphonate Drugs and Toulouse Lautrec by Jeffrey Dach MD

(3) Prozac, Paxil and SSRI Drugs – Part One by Jeffrey Dach MD

(4) Prozac, Paxil and SSRI Drugs – Part Two by Jeffrey Dach MD

(5) Max Essex and Virological Failure in the NEJM by Jeffrey Dach MD

(6) The Origins of HIV by Jeffrey Dach MD

A Medical Article that I Published in 1980:

(7) Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614

Jeffrey Dach, M.D.
Member of the Board of the American Academy of Anti-Aging Medicine
Board Certified by the American Board of Radiology

4700 Sheridan, Suite T
Hollywood Fl 33021
office phone 954-983-1443

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Jeffrey Dach, M.D.
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Dr. Dach is Board Certified by the American Board of Radiology and a member of the Board of the American Academy of Anti-Aging Medicine. He has 25 years experience in the Memorial Hospital System as an interventional radiologist. His current practice focuses on Bio-identical hormone supplementation for men and women, menopause, andropause, HGH, testosterone, natural thyroid and the use of natural substances rather than drugs in the appropriate setting.

All after-tax profits from TrueMedMD office operations (including nutritional supplement sales) are donated to charity.

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Jeffrey Dach, M.D. NewsLetter

Inept FDA Declares Misguided War on Bio-Identical Hormones,
and Promptly Shoots Own Foot


 

Click Here for Original Article at My Blog
__________________________________________

FDA Tries to Protect Wyeth From Financial Losses

Acting as agent for drug maker Wyeth this week, a dysfunctional and inept FDA fired the opening salvo in a misguided war on bio-identical hormones. Using typical Orwellian DoubleSpeak, the FDA issued a series of nonsensical and contradictory statements intended to serve the financial interests Wyeth, maker of synthetic hormones Premarin and Prempro, found to cause cancer and heart disease in the 2002 NIH sponsored Women’s Health Initiative Study. Since the study’s release, millions of women have switched to the safe and more effective bio-identical hormones, currently prescribed by thousands of physicians, available as FDA approved products at local drug stores and compounding pharmacies. Wyeth has lost market share and suffered financial loss as synthetic hormone profits have declined from 4.4 to 1.2 billion annually from 2001 to 2006.

Wyeth Files a Citizen’s Complaint with the FDA

October 2005, in a move to prevent further financial losses, Wyeth filed a Citizen’s Complaint with the FDA, requesting the FDA take action against Wyeth’s competition, prohibiting compounding pharmacies from providing bio-identical hormones to their patients. More than 66,000 doctors, patients, and pharmacists filed comments in favor of bioidentical hormones and against Wyeth. In spite of this public outcry, Wyeth continues to abuse the FDA to the harm and detriment of millions of women who use bio-identical hormones.

Analysis of the FDA Statements:

Here is an analysis of the recent FDA statements: a comedy of errors, omissions, contradictions, and Orwellian DoubleSpeak. The statements can be found at the FDA website.

January 9, 2008

FDA Takes Action Against

Compounded Menopause Hormone Therapy Drugs (1)(2)

Astonishingly, the FDA does not recognize the term, “bio-identical” !

FDA says:

The term “bio-identical” has no defined meaning in any medical or conventional dictionary, and FDA does not recognize the term. Even different medical groups define the term differently. The Endocrine Society, for example, defines “bio-identical” hormones as “compounds that have the exact same chemical and molecular structure as hormones that are produced in the human body,” while the American College of Obstetricians and Gynecologists (ACOG) defines “bio-identical” hormones as “plant-derived hormones that are biochemically similar or identical to those produced by the ovary or body.”

My Reply:

The term bio-identical has a definite meaning and is widely used. The term, bioidentical, means a hormone chemical structure which is identical to that found in human biology. Both the Endocrine Society and ACOG recognize the term, and even though their definitions use slightly different terminology, they are essentially identical in meaning.

Astonishingly, the FDA is UNAWARE of a basic fact of biochemistry !

Astonishingly, the FDA is UNAWARE that identical chemical structures have the same biological effects. This is the basis for all biochemistry. A water molecule, for example, will have the same biologic effect in the body regardless of how it is synthesized, and this is also true for any other chemical, including hormones.

FDA says:

Many compounding pharmacies use Bio-identical as a marketing term to imply that drugs are natural, or have effects identical to those from hormones made by the body. FDA is not aware of credible scientific evidence to support these claims.

My Reply:

Bio-identical hormones are (1) natural and (2) have effects identical to hormones made in the body. These are basic axioms of biochemistry, and accepted as basic truth by all of biochemistry, including the following medical textbooks Lehninger Principles of Biochemistry, Guyton Textbook of Medical Physiology, and Williams Textbook of Endocrinology.

It is astonishing that the FDA can be UNAWARE of the scientific evidence that is present in every medical textbook, and thousands of Medline references that state that bio-identical hormones ARE natural and DO produce the same effects as human hormones !!

The FDA Does Recognize this basic fact of biochemistry when looking at Synthetic Hormone Structures !

Astonishingly, for the FDA, when it comes to synthetic hormones, all of a sudden, chemical structures that are identical DO have the same biologic effects !!

FDA says:

Compounded products that have identical chemical structures to synthetic hormones can be expected to have the same benefits—and risks— associated with FDA-approved hormone therapy.

My Reply:

This is Orwellian DoubleSpeak again. Compounded natural bio-identical hormones DO NOT have the same chemical structure as synthetic hormones. Compounded hormones are natural and bio-identical, and DO NOT increase risk of increased cancer and heart disease, as was demonstrated for the synthetic hormones in the WHI study. The Women’s Health Initiative study published in JAMA July 2002 showed that Provera, a chemically altered form of progesterone causes increased risk of cancer and heart disease, while the natural, human bioidentical progesterone does not. (5) (6)

The following two studies show that bio-identical hormones are safe: One is the French Cohort Study which showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.(3) The second is the June 2007 NEJM Calcium Score study which showed no increase in heart disease risk with estrogen. (4)

The FDA Attacks Saliva Hormone Testing !

FDA says :

Some compounding pharmacies and other promoters of “BHRT” claim that estrogen levels in a person’s saliva can be tested by practitioners to help practitioners estimate the amount of hormone a person needs and purportedly to “customize” the hormone therapy for individual patients. There is no scientific basis for using saliva testing to adjust hormone levels. Instead, practitioners should adjust hormone therapy dosages based on a patient’s symptoms.

My Reply:

Salivary hormone testing has been done by two large companies for many years, Diagnos-Techs and ZRT. Both Web Sites list plenty of scientific evidence validating saliva hormone testing. ZRT lists references supporting salivary hormone testing here and here.

In addition, salivary hormone testing for other hormones such as cortisol and melatonin is accepted and used in scientific publications. NASA uses salivary testing for cortisol and melatonin. (7) A PubMed Medline search shows many research studies validating the use of salivary hormone testing.(8) Key Word Search:

Salivary hormone 4075 articles
Salivary cortisol: 1478 articles
Salivary estradiol 177
Salivary progesterone 317
Salivary testosterone 428

The FDA Claims Ignorance of Its Own FDA Approvals !

FDA says:

Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women.

My Reply:

Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone.

The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause:

Alora (estradiol): FDA approved 1996 – Watson Labs
Climara (estradiol): FDA approved 1994 – Bayer
FemPatch : FDA approved 1997 – Parke Davis
Vivelle-Dot (estradiol): FDA approved 1994 – Novartis
Estraderm: FDA approved 1986 – Novartis
Esclim: FDA approved 1998 – Women’s First Healthcare
Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb
Estring: FDA approved 1996 – Pharmacia UpJohn
Prometrium (natural progesterone): FDA approved 1998 – Solvay
Androgel (natural testosterone): FDA approved 2000 – Unimed Pharmaceuticals
Crinone: FDA approved 1997 – Columbia Labs

FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring

FDA approved Progesterone products:Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest

FDA approved testosterone:Testoderm, Androderm, AndroGel

The FDA Tries to Ban Estriol !

Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women.

FDA says:

Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application.

My Reply:

Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.

Finally, the Truth About Bio-Identical Hormones !

And now, The Truth about Bioidentical Hormones-quoted from the IACP from the Compounding Pharmacists web site. (48)

Myth 1): Bioidentical hormone replacement therapy (BHRT) is unregulated.

Fact: Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia.

Myth 2): Compounded bioidentical hormones are unsafe because they aren’t FDA-approved.

Fact: Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use.

Myth 3): Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro.

Fact: There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT.

A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination.

Myth 4): Pharmacists are recklessly promoting BHRT as safe and effective.

Fact: Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote.

Myth 5): Bioidentical is a misleading term.

Fact: The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical.

Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups.

Did you find this newsletter interesting? Feel free to Email it to a friend with the button on the bar below.

Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

References and Links

List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them):

Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author)
Textbook of Medical Physiology by Arthur C. Guyton
Williams Textbook of Endocrinology
Basic & Clinical Endocrinology by Francis S. Greenspan
Review of Medical Physiology by Ganong, William F. MD
Endocrinology (5th Edition) by Mac E. Hadley
Endocrine Physiology by Susan Porterfield

(1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

(2) Compounded Menopausal Hormone Therapy Questions and Answers

(3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d’Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France.

The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer.

(4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen.

(5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women’s Health Initiative Randomized Controlled Trial Writing Group for the Women’s Health Initiative Investigators JAMA. 2002;288:321-333.

(6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women’s Health Initiative Randomized Controlled Trial,The Women’s Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712.

(7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D.

(8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing.

salivary hormone 4075 articles, Salivary cortisol: 1478 articles, Salivary estradiol 177, Salivary progesterone 317, Salivary testosterone 428

(9) special committee on aging senate Hearings- Bioidentical Hormones: Sound Science or Bad Medicine? April 19, 2007

(10) Bioidentical hormone replacement therapy wikipedia

(11) The Truth about Bioidentical Hormones-IACP

(12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding

(13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones

(15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness

(16) Low levels of testosterone may increase risk of death in older men Men’s Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM).

(17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over the following 20 yr, independent of multiple risk factors and several preexisting health conditions.

(18) DrErika Blasts Wyeth’s War on Bioidentical Hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(19) Wyeth’s War on Women and Bioidenticals, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones.

(20) Bioidentical Hormones are not snake oil: They are available commercially at your local drugstore with a prescription from your regular MD . Erika Schwartz blog, web site. Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(21) FDA says alternative hormone claims unsupported Wed Jan 9, Reuters news service

(22) Listing of references in the Scientific Literature on validating use of bio-identical hormones, Erika Schwartz, MD, Patients’ Health Advocate and Leading Expert on Bioidentical Hormones

(23) Wednesday, Jan. 09, 2008 FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones International Academy of Compounding Pharmacists

(24) FDA Asserts New Policy To Restrict Women’s Access To Bioidentical Hormones,medicalnewstoday, 10 Jan 2008

(25) FDA Asserts New Policy to Restrict Women’s Access to Bioidentical Hormones Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term “Bio-identical” , IACPRX

(26) Tell Congress: Don’t Take Away My Compounded Medications! Send a letter to your congressman.

(27) Hot Flash: FDA Warns About BHRT Drugs,January 9th, 2008 2:51 pm By Ed Silverman Pharmalot

(28) E- Book on natural progesterone

(29) Understanding the Controversy:Hormone Testing and Bioidentical Hormones

(30) Vivelle dot, estradiol fda approved

(31) About USP—An Overview Who We Are, The United States Pharmacopeia (USP) is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements

(32) Estriol listing in USP

(33) Pharmacies Warned About Compounding Estriol, Touting Mixture’s Benefits Does the FDA have jurisdiction over these compounding pharmacies?There’s a court battle going on right now to determine the answer to that question. Oral arguments are expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The fda is appealing a lower court ruling, which found that they do not have jurisdiction over drug preparations produced by compounding pharmacies.

(34) FDA Goes After ‘Natural’ HRT Claims Compounding Pharmacies Told to Stop Marketing ‘Bio-identical Hormone Replacement Therapy’

(35) C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(36) Judge Issues Landmark Decision in Compounding Pharmacy Case Friday, May 26, 2006Midland, Texas, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(37) Wyeth Pharmaceuticals tries to STOP your access to Bio-Identical Hormone Replacement Therapies (BHRT). BHRT-A BATTLE FOR THE TRUTH, C.W. (Randy) Randolph, Jr., M.D. As a trained pharmacist and Board Certified practicing gynecologist, web site.

(38) Bio-Identical Hormone Drug Information

(39) Wyeth web site

(40) Sepp Hasslberger web site, Wyeth Asks FDA: Prohibit Bio-Identical Hormones, Excellent Summary of Wyeth Activities and War Against BioIdentical Hormones

(41) wyeth earnings report 2006

(42) Wikipedia bio-identical hormone therapy definition

(43) Double speak

references for salivary hormone testing

(44) Salivary testosterone levels in preadolescent children, Daniela Ostatníková1

(45) Pathol Biol (Paris). 2001 Oct;49(8):660-7., Saliva assays in clinical and research biology.Lac G., Département génie biologique,

(46) Patterns of Salivary Estradiol and Progesterone across the Menstrual Cycle, BEATRICE K. GANDARA,a LINDA LERESCHE,a and LLOYD MANCLb

(47) FDA Approves Biex Test to Aid in Identifying Risk of Preterm Labor and Delivery. 5/5/1998 Biex, Inc. announced today the FDA granted marketing approval for the Company’s salivary estriol test to help physicians identify risk for spontaneous preterm labor and delivery.

(48) The Truth about Bioidentical Hormones-IACP

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Jeffrey Dach MD
4700 Sheridan Suite T
Hollywood FL 33021
954 983-1443

Jeffrey Dach, M.D. BLOG TrueMedMD

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All after tax profits from TrueMedMD clinic operations are donated to charity.

(c) 2007-2008 all rights reserved jeffrey dach md


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Catalog of NewsLetters

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(1) My Vitamins Are Killing Me by Jeffrey Dach MD !!!

(2) Stroke Prevention and Vitamin C by Jeffrey Dach MD

(3) Testosterone Risks and Benefits by Jeffrey Dach MD

(4) Medical School Days and SSRI Research by Jeffrey Dach MD

(5) Iodine and Breast Cancer Prevention by Jeffrey Dach MD

(6) Hypothyroidism Part One by Jeffrey Dach MD

(7) Hypothyroidism Part Two Thryroflex by Jeffrey Dach MD

(8) Guard Your Daughter from Gardisil, Virginia Tech Rampage Seung-Hui Cho by Jeffrey Dach MD

(9) Orthomolecular Medicine Meeting in Toronto 2007 by Jeffrey Dach MD

(10) B12 Deficiency by Jeffrey Dach MD

(11) Rachel Carson and Silent Spring by Jeffrey Dach MD

(12) Vitamin D Deficiency by Jeffrey Dach MD

(13) Andrew Weil AARP, and Human Growth Hormone HGH by Jeffrey Dach MD

(14) Michael Moore’s SICKO by Jeffrey Dach MD

(15) Blood Pressure Pills for Hypertension, When to Treat? by Jeffrey Dach MD

(16) Low Dose Naltrexone (LDN) by Jeffrey Dach MD

(17) Protect Your Family From Bad Drugs by Jeffrey Dach MD

(18) Roger Federer, Race Horses and Pulsed ElectroMagnetic Devices by Jeffrey Dach MD

(19) Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD

(21) The Importance of the Pelvic Sonogram by Jeffrey Dach MD

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Catalog of Articles Published on Hank Barnes World,
You Bet Your Life, by Jeffrey Dach MD

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(1) Lipitor and "The Dracula of Modern Technology" by Jeffrey Dach MD

(2) Osteoporosis, Bisphosphonate Drugs and Toulouse Lautrec by Jeffrey Dach MD

(3) Prozac, Paxil and SSRI Drugs – Part One by Jeffrey Dach MD

(4) Prozac, Paxil and SSRI Drugs – Part Two by Jeffrey Dach MD

(5) Max Essex and Virological Failure in the NEJM by Jeffrey Dach MD

(6) The Origins of HIV by Jeffrey Dach MD

A Medical Article that I Published in 1980:

(7) Dach J, Patel N, Patel S, Petasnick J. Peritoneal mesothelioma: CT, sonography, and gallium-67 scan. AJR Am J Roentgenol. 1980 Sep;135(3):614

Jeffrey Dach, M.D.
Member of the Board of the American Academy of Anti-Aging Medicine
Board Certified by the American Board of Radiology

4700 Sheridan, Suite T
Hollywood Fl 33021
office phone 954-983-1443

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Don’t forget to visit my web site for more information, and we you might like to attend one of our free seminars on Wednesday Nights. Please call for reservations for the seminar, though.

Do you have a testimonial, or a question for the newsletter? Send it in via email reply.

Sincerely Yours
Jeffrey Dach, M.D.
4700 Sheridan Suite T.
Hollywood, Fl 33021
954-983-1443

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Dr. Dach is Board Certified by the American Board of Radiology and a member of the Board of the American Academy of Anti-Aging Medicine. He has 25 years experience in the Memorial Hospital System as an interventional radiologist. His current practice focuses on Bio-identical hormone supplementation for men and women, menopause, andropause, HGH, testosterone, natural thyroid and the use of natural substances rather than drugs in the appropriate setting.

All after-tax profits from TrueMedMD office operations (including nutritional supplement sales) are donated to charity.

Conflict of Interest Disclaimer: We receive no money from the pharmaceutical industry or from the NIH. We do not sell any products to the public at large. We do however, make available selected nutritional supplements to our office clients at a small markup to cover our costs.

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Jeffrey Dach, M.D. NewsLetter

Vitamin D Deficiency

the Ignored Epidemic of the Developed World

__________________________________________

Is it a New Bio-Tech Drug, or is it Vitamin D?

What if I told you I discovered a Bio-Tech company with a new drug that could reduce the number of cancer deaths in the US by 43,000 annually, reduce colon cancer by 50%, and breast and ovarian cancer by 30%. Would you be impressed?

What if I then told you this same drug could safely prevent or alleviate the following medical conditions: Osteoporosis, Hypertension, Cardiovascular disease, Cancer, Depression, Epilepsy, Type One Diabetes, Insulin resistance, Autoimmune Diseases, Migraine Headache, Polycystic Ovary Disease (PCOS), Musculoskeletal and bone pain, Psoriasis, and Rheumatoid Arthritis, Inflammatory Bowel Disease (Cohn’s), chronic lymphocytic leukemia (CLL)(15), as well as improve calcium absorption and reduce hip fractures.(5A)

Would you then be even more impressed and rush out to buy the company stock and get rich quick?

Of course you would, but we don’t need a new Bio-Tech drug to do this, because, all of the above benefits can be obtained with Vitamin D, an inexpensive vitamin which is free with sun exposure.

Vitamin D Deficiency in Florida, Surely You must Be Joking:

We all know it’s a fact: Everyone in Florida gets plenty of Vitamin D from the Florida Sun. This would have been true except for the fact that as Floridians, we are all told to avoid the sun to prevent solar skin damage (brown wrinkling) and to avoid skin cancer.

So the question remains, do we get enough Vitamin D from sun exposure? To answer this question, we actually measured blood Vitamin D levels, and we were surprised to discover that the majority showed Vitamin D deficiency (less than 20 ng/ml), or insufficiency (less than 40 ng/ml).

What if you are not fortunate to live in sunny Florida and you live up north above the Mason Dixon Line, in Boston, New York, Chicago, Canada or Scandinavia? Northern latitudes have an even more serious vitamin D deficiency because of the lack of UV sunlight during the winter months. The angle of the sun through the atmosphere closes off the UltraViolet Light from reaching the earth.

An Epidemic of Vitamin D Deficiency

Vitamin D deficiency has been reported in 57% of 290 medical inpatients in Massachusetts, 93% of 150 patients with overt musculoskeletal pain in Minnesota, 48% of patients with Multiple Sclerosis, 50% of patients with lupus and fibromyalgia, 42% of healthy adolescents, 40% of African American Women, and 62 % of the morbidly obese, 83% of 360 patients with low back pain in Saudi Arabia, 73% of Austrian patients with Ankylosisng Spondylitis, 58% of Japanese girls with Graves’s Disease, 40% of Chinese adolescent girls, 40-70% of all Finnish medical patients. (5A)

Vitamin D Toxicity

Vitamin D excess and toxicity requires daily dosage in excess of 40,000 units over a period of months, so 5,000 units a day is safe and far below the level needed to develop vitamin D toxicity. Remember Vitamin D is a fat soluble vitamin, so toxicity is possible with massive doses over long periods of time. Vitamin D toxicity causes elevated calcium levels. That’s why Vitamin D supplementation should done only under your physician’s supervision with monitoring of serum 25-Hydroxy Vitamin D levels.

Space Satellite Maps

Maps of UV Sunlight exposure correlate with incidence of Cancer and Multiple Sclerosis.

If you take NASA space satellite photos of North America and color code the UV sunlight exposure as Dr. Grant has done on his web site, Sunarc.com (3), you will see a pattern remarkably similar to the incidence of cancer and multiple sclerosis. This is thought to be due to differences in Vitamin D levels. The farther north with less sun exposure and lower Vitamin D levels, there is an increased incidence of cancer and multiple sclerosis.

Diseases Caused By, or Associated With Vitamin D Deficiency:

Again here is the list: Osteoporosis, Hypertension, Cardiovascular disease, Cancer, Depression, Epilepsy, Type One Diabetes, Insulin resistance, Autoimmune Diseases, Migraine Headache, PolyCystic Ovary Disease (PCOS), Musculoskeletal and bone pain, Psoriasis, and chronic lymphocytic leukemia (CLL)(15).

The current recommendation for Vitamin D deficiency in those people who must avoid the sun is 5,000 IU of Vitamon D per day which costs 5 cents a day..

Vitamin D is not really a Vitamin, it is a Hormone.

Like all other steroidal hormones, vitamin D is made from a cholesterol precursor, converted in the skin by sunlight. Like all other hormones, Vitamin D enters the nucleus of the cell and binds to the DNA where it gives a message to the DNA to manufacture proteins.

Vitamin D And Multiple Sclerosis.

A review by Dr. Brown reported that Vitamin D supplementation prevented the development and progression of experimental autoimmune encephalitis, an animal model of MS, in mice. A large, prospective, cohort study found that vitamin D supplementation was associated with a 40% reduction in the risk of developing MS. Four small, noncontrolled studies suggested that vitamin D supplementation may decrease exacerbation of MS symptoms. (20)

MRI studies of multiple sclerosis lesions show improve during summer months and worsen during winter months suggesting a Vitamin D link. (36)

Vitamin D and Cancer

A four-year clinical (trial), involving 1,200 women found those taking the vitamin had about a 60-per-cent reduction in cancer incidence, compared with those who didn’t take it, a drop so large — twice the impact on cancer attributed to smoking — it almost looks like a typographical error. The study was done by professor of medicine Robert Heaney of Creighton University in Nebraska and will be published in June 2007. (36A)

Vitamin D Supplementation for Adults

The RDA in America is only 400 IU per day, yet current research suggests that our daily Vitamin D requirement is closer to 4,000 to 5,000 IU. Twenty minutes of Sun exposure will give us ten to twenty thousand IU of Vitamin D.

Adult Supplementation with Carlson’s Cod Liver Oil can provide Vitamin D along with Vitamin A . However, for an intake of 5,000 IU vitamin D per day, inexpensive Vitamin D3 capsules are widely available for about 5 cents a day. We provide these as a convenience to our office patients.

Vitamin D Testing at the Lab

Optimal serum 25-hydroxyvitamin D values are 45-50 ng/ml. Below 40 ng/ml is called Vitamin D insufficiency, and below 20 ng/ml is deficiency.

Conclusion

Our health care system is in crisis. We are spending billions on expensive procedures like coronary artery bypass and organ transplantation, yet measurements of health are lower than other countries that spend less. In terms of getting more bang for your health care buck, Vitamin D testing and supplementation for the population is one solution which is guaranteed to improve overall health of the population at a ridiculously low cost.

The cost saving in reduced cancer rates, and lower osteoporotic fracture rates would be enormous, and we would all enjoy improved health. My goal as a physician in our community is to improve the health of of our community, and Vitamin D testing and supplementation is one way to achieve that goal with no adverse side effects and enormous cost savings.

Did you find this newsletter interesting?
Feel free to email this to a friend with the button on the bar at the bottom of the page.

Regards,

Jeffrey Dach, M.D. BLOG TrueMedMD
4700 Sheridan, Suite T.
Hollywood Florida, 33021
954 983 1443

ICD-9 code is 2689

References

(1) Highly recommended Web Cast video presentation on Vitamin D by Dr. Vieth

(2) Interview with William B. Grant, Ph.D.

(3) Satellite Maps, Cancer mortality rates and multiple sclerosis prevalence rates for U.S. states compared to UVB doses for July, William B. Grant, Ph.D.

(4) Vitamin D Supplementation in the Fight Against Multiple Sclerosis, Ashton F. Embry, Ph.D. 2004, Journal of Orthomolecular Medicine, v.19, p. 27-38.

(5) Vitamin D Council, John Cannell MD Web Site:

(5A) Excellent review article on Vitamin D by John Cannell MD full PDF File Clinical Importance of Vitamin D: A Paradigm Shift.

(6) Best Vitamin D articles on the web

(7) Cancer Defeated: Vitamin D Pill For All Economical Pill Would Cut Cancer Rates In Half.

(8) Just One Pill Away by Bill Sardi review of Vitamin D on Lew Rockwell

(9) Healthcare Professionals Ignore Vitamin D Deficiency Epidemic by John Cannell MD

(10) Beware of prescription Vitamin D supplements, info from Mercola

(11) Vitamin D info from Mercola.com

(12) Linus Paulng Institute on Vitamin D

(13) Linus Pauling Institute Vit D References with Links:

(14) 10 Myths Myths about Vit D

(15) Chronic Lymphocytic Leukemia Web Site: CLL topics: vitamin D is quite cytotoxic to CLL cells?

(16) Vieth , Reinhold. Vitamin D supplementation, 25-hydroxyvitamin D concentrations, and safety. American Journal of Clinical Nutrition, Vol. 69, No. 5, 842-856, May 1999

(17) Vieth, Reinhold, Vitamin D and Reduced Risk of Breast Cancer: A Population-Based Case-Control Study. Cancer Epidemiology Biomarkers & Prevention 16, 422-429, March 1, 2007.

(18) Veith R, Chan P-C R, MacFarlane G D. “Efficacy and safety of vitamin D3 intake exceeding the lowest adverse effect level.” Am J Clin Nutr 2001; 71: 288-294

(19) Munger, Levin,. Hollis, PhD Howard, Ascherio, Serum 25-Hydroxyvitamin D Levels and Risk of Multiple Sclerosis JAMA. 2006;296:2832-2838 Epidemiological and experimental evidence suggests that high levels of vitamin D, a potent immunomodulator, may decrease the risk of multiple sclerosis.

(20) Brown, Sherrill J, The Role of Vitamin D in Multiple Sclerosis , DRUG INFORMATION ROUNDS, The Annals of Pharmacotherapy: Vol. 40, No. 6, pp. 1158-1161. DOI 10.1345/aph.1G513

(21) Michael F Holick, Editorial: Too little vitamin D in premenopausal women: why should we care?

(22) Michael F Holick, Vitamin D: importance in the prevention of cancers, type 1 diabetes, heart disease, and osteoporosis American Journal of Clinical Nutrition, Vol. 79, No. 3, 362-371, March 2004

(23) Holick , Michael F VITAMIN D AND HEALTH IN THE 21ST CENTURY: BONE AND BEYOND, Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease American Journal of Clinical Nutrition, Vol. 80, No. 6, 1678S-1688S, December 2004. Excellent full text article review.

(24) Michael Holick Vitamin D Book Online:

(25) Margherita T. Cantorna, Carey Munsick, Candace Bemiss and Brett D. Mahon 1,25-Dihydroxycholecalciferol Prevents and Ameliorates Symptoms of Experimental Murine Inflammatory Bowel Disease . Journal of Nutrition. 2000;130:2648-2652

(26) Holick, Michael F, The Influence of Vitamin D on Bone Health Across the Life Cycle, The Vitamin D Epidemic and its Health Consequences J. Nutr. 135:2739S-2748S, November 2005

(27) The Miracle of Vitamin D by By Krispin Sullivan, CN

(28) Webcasts : Contemporary Diagnosis and Treatment of Vitamin D-Related Disorders , American Society for Bone and Mineral Disorders.

(29) Garland CF, Comstock GW, et al. “Serum 25-hydroxyvitamin D and colon cancer: eight-year prospective study,” Lancet 1989; 2(8,673: 1,176-1,178

(30) Li YC. “Vitamin D regulation of the renin-angiotensin system.” J Cell Biochem 2003; 88(2): 327-331

(31) Hypponen E, Laara E, Reunanen A, Jarvelin MR, Virtanen SM. “Intake of vitamin D and risk of type 1 diabetes: a birth-cohort study.” Lancet 2001; 358(9,292): 1,500-1,5003

(32) Borissova AM, Tankova T, Kirilov G, Dakovska L, Kovacheva R. “The effect of vitamin D3 on insulin secretion and peripheral insulin sensitivity in type 2 diabetic patients.” Int J Clin Pract 2003; 57(4): 258-61.

(33) Pfeifer M et al. “Effects of a short-term vitamin D3 and calcium supplementation on blood pressure and parathyroid hormone levels in elderly women.” J Clin Endocrinol Metab 2001; 86: 1,633-1,637

(34) Lind L et al. “Reduction of blood pressure during long-term treatment with active vitamin D (alphacalcidol) is dependent on plasma renin activity and calcium status. A double-blind, placebo-controlled study.” Am J Hypertens 1989; 2: 20-25

(35) Lind L et al. “Vitamin D is related to blood pressure and other cardiovascular risk factors in middle-aged men.” Am J Hypertens 1995; 2: 20-25

(36) Embry AF, Snowdon LR, Vieth R.Ann Neurol. 2000 Aug;48(2):271-2. Vitamin D and seasonal fluctuations of gadolinium-enhancing magnetic resonance imaging lesions in multiple sclerosis.

(36A) Vitamin D casts cancer prevention in new light by MARTIN MITTELSTAEDT, From Saturday’s Globe and Mail, April 28, 2007

(37) Problems with our health care system.

(38) Wikipedia Vitamin D PAge with Links