Posts tagged Heart

Bioidentical Hormones, Waking Up From the Synthetic Hormone Nightmare

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Shirley is 52, and suffering from menopausal symptoms of hot flashes, night sweats, insomnia and mood disturbance. The next chance she had, Shirley asked her doctor for bioidentical hormones. Instead,  her doctor offered her a prescription for Lexapro, an SSRI antidepressant.  Shirley declined the prescription and ran out the door crying all the way home. A few days later, Shirley was sitting in my office asking, “Why won’t my doctor give me what I want, bioidentical hormones?”

Ghost Writing – A Shocking Medical Scandal

I explained to Shirley that her doctor’s opinion is shaped by misleading information in medical journals corrupted by a technique called medical ghostwriting, a shocking scandal uncovered by  Senator Grassley’s Committee.(1)  In this sinister practice, the prestigious name of an academic MD “opinion leader” appears as author.  However, unknown to the reader, the article is actually written by the drug company’s paid-for-hire writers.  Grassley discovered that sixty articles on women’s hormones were ghostwritten, downplaying the adverse effects of synthetic hormones, and casting doubts about bioidentical hormones.  Medical ghostwriting is scientific misconduct and fraud which harms society and corrupts the medical literature.

A Brief History of Synthetic Hormones – Re-Living the Nightmare

Let’s review a short history of synthetic hormone replacement as brought to you by the Drug Industry. (2)  Many people have forgotten about the disaster of DES, Diethylstilbestrol, the first synthetic hormone invented in 1938.  This carcinogenic, monster hormone was approved by the FDA and given to millions of women from 1940 until it was banned in 1975 when it was shown carcinogenic.  The first report of cervical cancer in the daughters of DES treated women was published in April 1971 in the New England Journal of Medicine.(3-4)

Next, the Drug Industry invented Premarin, a horse estrogen isolated from the urine of pregnant horses.   Available since FDA approval in 1942, Premarin has caused an estimated 15,000 cases of endometrial cancer, representing the largest epidemic of serious iatrogenic disease ever reported.(5-8)    One might think this would be the end of any drug.   However Premarin was promptly rehabilitated with the addition of another synthetic hormone, a progestin, to prevent endometrial cancer.  Thus, in 1995, Prempro was born, a synthetic hormone pill containing both Premarin (the horse estrogen) and Provera (the progestin).  Again, this was FDA approved,  thought safe and handed out freely to millions of women.

However, storm clouds soon appeared on the horizon when four large scale studies showed increased breast cancer and heart disease from this estrogen-progestin combination pill.  The  Breast Cancer Detection Demonstration Project, published in 2000, showed an eight fold increase in breast cancer for estrogen-progestin users.(9)  The Swedish Record Review, published in 1996, had a fourfold increase in breast cancer with progestin use.(10)  The Million Woman study, published in Lancet in 2003, had a fourfold increase in breast cancer for estrogen-progestin combination users compared to estrogen alone users.(11)  The brakes came on to this synthetic hormone experiment in 2002 with the JAMA publication of the Women’s Health Initiative (WHI), an NIH funded study terminated early because of increased breast cancer and heart disease in the estrogen-progestin users.(12)

Abandoning the Synthetic Hormone Ship

Two important things happened after this 2002 WHI study was published.  Smart women abandoned synthetic hormones and switched in large number to bioidentical hormones, producing an immediate decline in breast cancer rates of about nine per cent.(13,14)  A second important thing happened.  Apparently, women have decided to turn to lawyers to protect them, since the FDA has been unable to do so.  Thirteen thousand women have filed cases in court claiming synthetic hormones caused their breast cancer.  These cases are slowly working their way through the court system, and the jury is still out, so stay tuned.(15)

Dispelling the Myths and Misconceptions

Over the years, I have compiled a list of myths and misinformation commonly encountered about bioidentical hormones in newspapers and magazines.  Here are a few of them, followed by the corrections.  The misinformation is in italics, with the correct information to follow.

Myth Number One: “The term bioidentical hormone is undefined and has no meaning.”

This is incorrect.  Bioidentical is a term which is defined as having the exact same chemical structure as hormones found naturally in the human body.   Bioidentical Hormones are the ones circulating in your blood stream right now.

Myth Number Two: “There is no proof that Bioidentical Hormones are safer and more effective than synthetic hormones…All of the evidence that we have suggests that all of these hormones should be painted with the same brush,”

This is incorrect and misleading.  As we have seen in the above short history of synthetic hormones, there exists a large body of science showing that synthetic chemically altered hormones cause cancer and heart disease.(9-14)  On the other hand, medical studies have found bioidentical hormones are safe with no increase in breast cancer or heart disease compared to non-hormone users. (33-41)  An excellent review of this medical science can be found in a 2009 article by Kent Holtorf MD in Postgraduate Medicine. (16)

Myth Number Three: “Bioidentical Hormones are not FDA approved.”

This is blatantly incorrect.  There are twenty or so FDA approved bioidentical hormone preparations widely available at corner drug stores. Here are a few examples: Vivelle-Dot, Estrace,  Climara, Prometrium, Androgel , etc.

Myth Number Four: “Bioidentical Hormones made by compounding pharmacies are Non-FDA approved.”

This is not only incorrect, it is misleading and deceptive.  Compounding pharmacies are regulated at the state level, and do not fall under FDA jurisdiction.   So, of course compounding is not FDA approved.  No FDA approval is required or even desired.  Your local hospital pharmacy is a compounding pharmacy that makes up life saving medication such as IV antibiotics with no FDA oversight or “approval”.  The FDA approval process is designed for manufactured capsules and tablets, and is impractical and unnecessary for compounded medications prepared to order by hand.   Are we going to reject IV antibiotics from the hospital pharmacy because these are non-FDA approved compounded medication?  Of course not.  Compounding is here to stay.

Myth Number Five: “Unless a woman has symptoms of hot flashes and night sweats, she doesn’t need hormones.”

This is incorrect.  In addition to night sweats and hot flashes, there are many other valid symptoms of hormone deficiency such as insomnia, cognitive dysfunction, menopausal arthritis, evaporative dry eye, anxiety, panic, mood disorder, vaginal dryness, and decreased libido and post hysterectomy.  These are all good indications for prescribing bioidentical hormones. (17-25)

Myth Number Six:  “The idea that Menopause is a Hormone Deficiency Disease was disproven, and the idea that hormone replacement rejuvenates youth, or prevents degenerative diseases is also disproven….Hormones decline with age, and is normal and does not require treatment.”

This is incorrect. There is no question that hormonal decline is a health risk. Three separate studies have shown low testosterone in males carries a 40% increase in mortality.(26-28)  Studies in females show the same findings, with low hormone levels in women after hysterectomy associated with increased mortality. (29)(30)  Hormonal decline is a direct cause of degenerative diseases of aging, all of which may be prevented or partially reversed by replenishing hormone levels, a vastly more effective treatment which competes directly with the Drug Industry.(42-46)

Myth Number Seven: “Hot flashes and sweats in menopausal women can be treated with SSRI antidepressants.  They don’t need to use hormones.”

This is not only wrong, it is criminal. The use of SSRI antidepressants for menopausal symptoms is NOT FDA approved, and is a cruel mistreatment and medical victimization of women.  This practice should be halted immediately.  Studies of SSRI drugs show they are no better than placebo for most cases of depression(31), and they are not much better than placebo for menopausal hot flashes. (32)  Synthetic hormones are bad enough, they cause cancer and heart disease.  SSRI drugs like Lexepro,  Effexor and Pristiq are even worse; they are chemically addictive with horrendous withdrawal effects.  Avoid becoming a medical victim.  Stay away.

In Conclusion:

It is time to awaken from the nightmare of synthetic hormones, known for decades to cause cancer and heart disease.  You can put lipstick on a pig, and it is still a pig.  The drug industry can spin, deceive, and misleading the medical journals and media.  Yet, after all the lies and propaganda, synthetic hormones remain monsters that should be avoided.   Smart women have made the switch to safer and more effective bioidentical hormones.  The future of medicine is your choice to make.  Hopefully, this article has awakened you to the natural choice.

For More Information, here are some leaders in the field of bioidentical hormones providing trustworthy information in books, articles and web sites:  David Brownstein MD, Kenton Bruice MD,  John Crisler DO, Kent Holtorf MD, Steve Hotze MD, Sangeeta Pati MD, CW Randolph MD, Ron Rothenberg MD, Erika Schwartz MD,  Jonathan Wright MD, and Joseph Mc Wherter MD.

Disclaimer: This article is for educational purposes and not intended as medical advice, and it is recommended you work closely with a knowledgeable physician before making any decisions regarding hormone treatment.  Please feel free to share this article with your doctor.

Jeffrey Dach MD
7450 Griffin Road, Suite 190
Davie, Florida 33314
(954) 792-4663 begin_of_the_skype_highlighting (954) 792-4663 end_of_the_skype_highlighting

http://www.drdach.com

Author Biography: Jeffrey Dach MD is founder of  the TrueMedMD clinic in Davie, Florida specializing in bioidentical hormones and natural thyroid.  He is the author of the book, Natural Medicine 101 available on Amazon, and offers a free email newsletter.

References

(1) http://grassley.senate.gov/about/upload/Senator-Grassley-Report.pdf  Ghostwriting in Medical Literature Minority Staff Report 111th Congress United States Senate Committee on Finance Sen. Charles E. Grassley, Ranking Member June 24, 2010

(2) http://www.nytimes.com/2009/12/13/business/13drug.html  Menopause, as Brought to You by Big Pharma By NATASHA SINGER and DUFF WILSON Published: December 12, 2009

(3) http://www.nejm.org/doi/pdf/10.1056/NEJM197104222841604  Adenocarcinoma of the Vagina — Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women.  Arthur L. Herbst, M.D., Howard Ulfelder, M.D., and David C. Poskanzer, M.D. N Engl J Med 1971; 284:878-881April 22, 1971

(4) http://www.jstor.org/pss/2683841  Epidemiologic Evidence for Adverse Effects of DES Exposure during Pregnancy Theodore Colton and E. Robert Greenberg The American Statistician Vol. 36, No. 3, Part 2: Proceedings of the Sixth Symposium on Statistics and the Environment (Aug., 1982), pp. 268-272

(5) http://ajph.aphapublications.org/cgi/reprint/70/3/264.pdf  The Epidemic of Endometrial Cancer:A Commentary Hershel Jick et al.Am J Public Health 70:264-267, 1980.

(6) http://www.nejm.org/doi/full/10.1056/NEJM197512042932303 Increased Risk of Endometrial Carcinoma among Users of Conjugated Estrogens.  Harry K. Ziel, M.D., and William D. Finkle, Ph.D. N Engl J Med 1975; 293:1167-1170 December 4, 1975

(7) http://www.ncbi.nlm.nih.gov/pubmed/213722  N Engl J Med. 1979 Jan 4;300(1):9-13. Endometrial cancer and estrogen use. Report of a large case-control study. Antunes CM, Strolley PD, Rosenshein NB, Davies JL, Tonascia JA, Brown C, Burnett L, Rutledge A, Pokempner M, Garcia R.

(8)  http://www.ncbi.nlm.nih.gov/pubmed/3358913
The dose-effect relationship between ‘unopposed’ oestrogens and endometrial mitotic rate: its central role in explaining and predicting endometrial cancer risk.Key TJ, Pike MC.
Br J Cancer. 1988 Feb;57(2):205-12.

(9) http://jama.ama-assn.org/content/283/4/485.abstract   Menopausal Estrogen and Estrogen-Progestin Replacement Therapy and Breast Cancer Risk. Catherine Schairer, PhD et al.  JAMA. 2000;283(4):485-491.

(10) http://onlinelibrary.wiley.com/doi/10.1002/(SICI)1097-0215(19960729)67:3%3C327::AID-IJC4%3E3.0.CO;2-T/pdf
see also http://www.ncbi.nlm.nih.gov/pubmed/8707404
Cancer incidence and mortality in women receiving estrogen and estrogen-progestin replacement therapy—long-term follow-up of a Swedish cohort.  Ingemar Persson et al. International Journal of Cancer Volume 67, Issue 3, pages 327–332, 29 July 1996

(11) http://www.ncbi.nlm.nih.gov/pubmed/12927427    Lancet. 2003 Aug 9;362(9382):419-27. Breast cancer and hormone-replacement therapy in the Million Women Study. Beral V; Million Women Study Collaborators.

(12) http://jama.ama-assn.org/cgi/content/abstract/288/3/321
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.

(13) http://www.nejm.org/doi/full/10.1056/NEJMsr070105 The Decrease in Breast-Cancer Incidence in 2003 in the United States. Peter M. Ravdin, Ph.D., M.D et al. N Engl J Med 2007; 356:1670-1674 April 19, 2007.  A comparison of incidence rates in 2001 with those in 2004 (omitting the years in which the incidence was changing) showed that the decrease in annual age-adjusted incidence was 8.6% .

(14) http://jnci.oxfordjournals.org/content/early/2010/09/23/jnci.djq345.abstract Breast Cancer Incidence and Hormone Replacement Therapy in Canada by Prithwish De, C. Ineke Neutel, Ivo Olivotto and Howard Morrison. JNCI J Natl Cancer Inst (2010) . This drop occurred concurrently with a 9.6% decline in the incidence rate of breast cancer

(15) http://www.bloomberg.com/news/2010-08-27/pfizer-settles-arkansas-prempro-case-before-retrial-over-punitive-damages.html Pfizer Said to Pay $330 Million to Settle Prempro Lawsuits Claiming Cancer By Jef Feeley – Feb 9, 2011 4:42 PM ET

(16)http://jeffreydach.com/files/80618-70584/The_Bioidentical_Hormone_Debate_Ken_Holtorf_MD.pdf
Postgraduate Medicine: Volume 121: No.1 January 2009. The Bioidentical Hormone Debate:Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy? Kent Holtorf, MD

(17) http://www.ncbi.nlm.nih.gov/pubmed/11386980 Arch Gen Psychiatry. 2001 Jun;58(6):529-34.  Efficacy of estradiol for the treatment of depressive disorders in perimenopausal women: a double-blind, randomized, placebo-controlled trial. by Soares CN et al.

(18)  http://www.neurology.org/cgi/content/abstract/57/4/605 Neurology 2001;57:605-612, 2001 American Academy of Neurology  High-dose estradiol improves cognition for women with AD Results of a randomized study by S. Asthana, MD et al.

(19)  http://www.ncbi.nlm.nih.gov/pubmed/19804793 Estradiol reduces anxiety- and depression-like behavior of aged female mice by Alicia A. Walf and Cheryl A. Frye  Neuroscience

(20)  http://www.ncbi.nlm.nih.gov/pubmed/16142740   Arthritis Rheum. 2005 Sep;52(9):2594-8. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Felson DT, Cummings SR.

(21) http://www.ncbi.nlm.nih.gov/pubmed/9609575  Am J Obstet Gynecol. 1998 May;178(5):1002-9.When does estrogen replacement therapy improve sleep quality? Polo-Kantola P et al.

(22)  http://cme.medscape.com/viewarticle/512093 “Menopausal Arthritis” May Develop in Women Receiving Estrogen-Depleting Treatments News Author: Laurie Barclay, MD CME Author: Désirée Lie, MD, MSEd

(23)  http://www.emaxhealth.com/70/3606.html Women treated with aromatase inhibitors often experience joint pain and musculoskeletal aching: severe enough, in some cases, to make them stop the treatment.

(24) http://www.ncbi.nlm.nih.gov/pubmed/11173183 Maturitas. 2001 Jan 31;37(3):209-12. Treatment of keratoconjunctivitis sicca with topical androgen. by Worda C et al.

(25) http://abstracts.iovs.org/cgi/content/abstract/44/5/2450 Invest Ophthalmol Vis Sci 2003;44: E-Abstract 2450. Treatment of Dry Eye with a Transdermal 3% Testosterone Cream by C.G. Connor.

(26) http://eurheartj.oxfordjournals.org/content/31/12/1494.abstract  Eur Heart J (2010) 31 (12): 1494-1501. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20–79, Robin Haring et al.

(27) http://circ.ahajournals.org/cgi/content/abstract/116/23/2694  Endogenous Testosterone and Mortality Due to All Causes, Cardiovascular Disease, and Cancer in Men European Prospective Investigation Into Cancer in Norfolk (EPIC-Norfolk) Prospective Population Study (Circulation. 2007;116:2694-2701.)

(28) http://archinte.ama-assn.org/cgi/content/abstract/166/15/1660  Vol. 166 No. 15, Aug 14/28, 2006 Low Serum Testosterone and Mortality in Male Veterans Molly M. Shores, MD et al.  Arch Intern Med. 2006;166:1660-1665.

(29) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2755630  Menopause. 2009 Jan–Feb; 16(1): 15–23. Increased cardiovascular mortality following early bilateral oophorectomy.  Cathleen M. Rivera, MD et al.

(30) http://www.ncbi.nlm.nih.gov/pubmed/19384117 Obstet Gynecol. 2009 May;113(5):1027-37.Ovarian conservation at the time of hysterectomy and long-term health outcomes in the nurses’ health study. Parker WH et al.

(31) http://jama.ama-assn.org/content/303/1/47  Antidepressant Drug Effects and Depression Severity A Patient-Level Meta-analysis. Jay C. Fournier et al. JAMA. 2010;303(1):47-53.

(32) http://jama.ama-assn.org/content/305/3/267  Efficacy of Escitalopram for Hot Flashes in Healthy Menopausal Women A Randomized Controlled Trial Ellen W. Freeman, PhD; JAMA. 2011;305(3):267-274

(33) http://www.ncbi.nlm.nih.gov/pubmed/15551359  Int J Cancer. 2005 Apr 10;114(3):448-54. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Fournier A et al.

(34) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2211383/  Breast Cancer Res Treat. 2008 January; 107(1): 103–111. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Agnès Fournier et al.

(35) http://www.ncbi.nlm.nih.gov/pubmed/19752341  J Clin Oncol. 2009 Nov 1;27(31):5138-43.  Estrogen-progestagen menopausal hormone therapy and breast cancer: does delay from menopause onset to treatment initiation influence risks? Fournier A et al.

(36) http://www.ncbi.nlm.nih.gov/pubmed/17651686  Ann Endocrinol (Paris). 2007 Sep;68(4):241-50. Epub 2007 Jul 24. Hormonal replacement therapy (HRT) in postmenopause: a reappraisal. Caufriez A.

(37) http://jeffreydach.com/files/80618-70584/Hormones__in_wellness_and_disease_prevention_common_practices_current_state_evidence_Erika_Schwartz_Kent_Holtorf.pdf
Prim Care. 2008 Dec;35(4):669-705. Hormones in wellness and disease prevention: common practices, current state of the evidence, and questions for the future. Schwartz ET, Holtorf K.

(38) http://www.jpands.org/vol13no2/hotze.pdf   Point/Counterpoint:The Case for Bioidentical Hormones by Steven F. Hotze, M.D. Donald P. Ellsworth, M.D. Journal of American Physicians and Surgeons Volume 13 Number 2 Summer 2008 p43.

(39) http://www.ncbi.nlm.nih.gov/pubmed/18775609  Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review.  L’hermite M, Simoncini T, Fuller S, Genazzani AR. Maturitas. 2008 Jul-Aug;60(3-4):185-201.

(40) http://www.thorne.com/altmedrev/.fulltext/11/3/208.pdf  A Comprehensive Review of the Safety and Efficacy of Bioidentical Hormones for the Management of Menopause and Related Health Risks Deborah Moskowitz, ND Altern Med Rev 2006;11(3):208-223

(41) http://online.wsj.com/article/SB123717056802137143.html  March 16, 2009 The Truth About Hormone Therapy Wall Street Journal By Erika Schwartz , Kent Holtorf , and David Brownstein

(42)  http://www.tasciences.com/pdf/Harley_CMM_final.pdf   Current Molecular Medicine 2005, 5, 29-38 205 Telomerase Therapeutics for Degenerative Diseases. By Calvin B. Harley.

(43) http://mcb.asm.org/cgi/content/full/20/11/3764  Molecular and Cellular Biology, June 2000, p. 3764-3771, Vol. 20, No. 11 Induction of hTERT Expression and Telomerase Activity by Estrogens in Human Ovary Epithelium Cells. Silvia Misiti, et al.,

(44) http://cancerres.aacrjournals.org/content/59/23/5917.full  Estrogen Activates Telomerase. Satoru Kyo et al.  Cancer Res December 1, 1999 59; 5917

(45) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC120798/  Microbiol Mol Biol Rev. 2002 September; 66(3): 407–425. Human Telomerase and Its Regulation. Yu-Sheng Cong et al.

(46) http://www.nature.com/nature/journal/vaop/ncurrent/full/nature09603.html  Telomerase reactivation reverses tissue degeneration in aged telomerase-deficient mice by Ronald A. DePinho et al.  Nature November 2010.

Jeffrey Dach MD
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Today, the Food and Nutrition Board has Failed Millions

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After 13 years of silence, the quasi governmental agency, the Institute of Medicine’s (IOM) Food and Nutrition Board (FNB), yesterday recommended that a three – pound premature infant can take virtually the same amount of vitamin D as a 300 pound pregnant woman. While that 400 IU/day dose is close to adequate for infants, 600 IU/day in pregnant women will do nothing to help the three childhood epidemics most closely associated with gestational and early childhood vitamin D deficiencies: asthma, auto-immune disorders, and, as recently reported in the largest pediatric journal in the world, autism (1).  Professor Bruce Hollis of the Medical University of South Carolina has shown pregnant and lactating women need at least 5,000 IU/day, not 600.

The FNB also reported that vitamin D toxicity might occur at an intake of 10,000 IU/day (250 micrograms), although they could produce no reproducible evidence that 10,000 IU/day has ever caused toxicity in humans and only one poorly conducted study indicating 20,000 IU/day may cause mild elevations in serum calcium but not clinical toxicity.

Viewed with different measure, this FNB report recommends that an infant should take 10 micrograms/day (400 IU) and the pregnant women 15 micrograms/day (600 IU).  As a single 30 minutes dose of summer sunshine gives adults more than 10,000 IU (250 micrograms), the FNB is apparently also warning that natural vitamin D input “as occurred from the sun before the widespread use of sunscreen” is dangerous. That is, the FNB is implying that God does not know what she is doing.

Disturbingly, this FNB committee focused on bone health, just like they did 14 years ago.  They ignored the thousands of studies from the last ten years that showed higher doses of vitamin D helps: heart health, brain health, breast health, prostate health, pancreatic health, muscle health, nerve health, eye health, immune health, colon health, liver health, mood health, skin health, and especially fetal health.  Tens of millions of pregnant women and their breast-feeding infants are severely vitamin D deficient, resulting in a great increase in the medieval disease, rickets.  The FNB report seems to reason that if so many pregnant women have low vitamin D blood levels then it must be OK because such low levels are so common.  However, such circular logic simply represents the cave man existence of most modern day pregnant women.

Hence, if you want to optimize your vitamin D levels ‘not just optimize the bone effect’ supplementing is crucial.  But it is almost impossible to significantly raise your vitamin D levels when supplementing at only 600 IU/day (15 micrograms).  Pregnant women taking 400 IU/day have the same blood levels as pregnant women not taking vitamin D; that is, 400 IU is a meaninglessly small dose for pregnant women.  Even taking 2,000 IU/day of vitamin D will only increase the vitamin D levels of most pregnant women by about 10 points, depending mainly on their weight.  Professor Bruce Hollis has shown that 2,000 IU/day does not raise vitamin D to healthy or natural levels in either pregnant or lactating women.  Therefore supplementing with higher amounts — like 5000 IU/day — is crucial for those women who want their fetus to enjoy optimal vitamin D levels, and the future health benefits that go along with it.

For example, taking only two of the hundreds of recently published studies, Professor Urashima and colleagues in Japan gave 1,200 IU/day of vitamin D3 for six months to Japanese 10 year-olds in a randomized controlled trial.  They found vitamin D dramatically reduced the incidence of influenza A as well as the episodes of asthma attacks in the treated kids while the placebo group was not so fortunate.  If Dr. Urashima had followed the newest FNB recommendations, it is unlikely that 400 IU/day treatment arm would have done much of anything and some of the treated young teenagers may have come to serious harm without the vitamin D.  Likewise, a randomized controlled prevention trial of adults by Professor Joan Lappe and colleagues at Creighton University, which showed dramatic improvements in the health of internal organs, used more than twice the FNB’s new adult recommendations.

Finally, the FNB committee consulted with 14 vitamin D experts and ‘after reading these 14 different reports’ the FNB decided to suppress their reports.  Many of these 14 consultants are either famous vitamin D researchers, like Professor Robert Heaney at Creighton, or in the case of Professor Walter Willett at Harvard, the single best-known nutritionist in the world.  So, the FNB will not tell us what Professors Heaney and Willett thought of their new report?  Why not?  Yesterday, the Vitamin D Council directed our attorney to file a federal Freedom of Information (FOI) request to the IOM’s FNB for the release of these 14 reports.

I, my family, most of my friends, hundreds of patients, and thousands of readers of the Vitamin D Council newsletter, have been taking 5,000 IU/day for up to eight years. Not only have they reported no significant side-effects, indeed, they have reported greatly improved health in multiple organ systems.  My advice: especially for pregnant women, continue taking 5,000 IU/day until your (OH)D] is between 50 ng/ml and 80 ng/ml (the vitamin D blood levels obtained by humans who live and work in the sun and the mid-point of the current reference ranges at all American laboratories).  Gestational vitamin D deficiency is not only associated with rickets, but a significantly increased risk of neonatal pneumonia (2), a doubled risk for preeclampsia (3), a tripled risk for gestational diabetes (4), and a quadrupled risk for primary cesarean section (5).

Yesterday, the FNB failed millions of pregnant women whose as yet unborn babies will pay the price.  Let us hope the FNB will comply with the spirit of “transparency” by quickly responding to our freedom of Information requests.

John Cannell, MD

The Vitamin D Council

1241 Johnson Avenue, #134

San Luis Obispo, CA 93401

(1) Cannell JJ.. On the aetiology of autism. Acta Paediatr. 2010 Aug;99(8):1128-30. Epub 2010 May 19.

(2)Karatekin G, Kaya A, Salihoglu O, Balci H, Nuhoglu A. Association of subclinical vitamin D deficiency in newborns with acute lower respiratory infection and their mothers. Eur J Clin Nutr. 2009;63(4):473-7.

(3) Bodnar LM, Catov JM, Simhan HN, Holick MF, Powers RW, Roberts JM. Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab. 2007;92(9):3517-22.

(4) Zhang C, Qiu C, Hu FB, David RM, van Dam RM, Bralley A, Williams MA. Maternal plasma 25-hydroxyvitamin D concentrations and the risk for gestational diabetes mellitus. PLoS One. 2008;3(11):e3753.

(5) Merewood A, Mehta SD, Chen TC, Bauchner H, Holick MF. Association between vitamin D deficiency and primary cesarean section. J Clin Endocrinol Metab. 2009;94(3):940-5.

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Why Fish Oils Work Swimmingly Against Inflammation and Diabetes

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Researchers at the University of California, San Diego School of Medicine have identified the molecular mechanism that makes omega-3 fatty acids so effective in reducing chronic inflammation and insulin resistance.

The discovery could lead to development of a simple dietary remedy for many of the more than 23 million Americans suffering from diabetes and other conditions.

Writing in the advance online edition of the September 3 issue of the journal Cell, Jerrold Olefsky, MD, and colleagues identified a key receptor on macrophages abundantly found in obese body fat. Obesity and diabetes are closely correlated. The scientists say omega-3 fatty acids activate this macrophage receptor, resulting in broad anti-inflammatory effects and improved systemic insulin sensitivity.

Macrophages are specialized white blood cells that engulf and digest cellular debris and pathogens. Part of this immune system response involves the macrophages secreting cytokines and other proteins that cause inflammation, a method for destroying cells and objects perceived to be harmful. Obese fat tissue contains lots of these macrophages producing lots of cytokines. The result can be chronic inflammation and rising insulin resistance in neighboring cells over-exposed to cytokines. Insulin resistance is the physical condition in which the natural hormone insulin becomes less effective at regulating blood sugar levels in the body, leading to myriad and often severe health problems, most notably type 2 diabetes mellitus.

Olefsky and colleagues looked at cellular receptors known to respond to fatty acids. They eventually narrowed their focus to a G-protein receptor called GPR120, one of a family of signaling molecules involved in numerous cellular functions. The GPR120 receptor is found only on pro-inflammatory macrophages in mature fat cells. When the receptor is turned off, the macrophage produces inflammatory effects. But exposed to omega-3 fatty acids, specifically docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the GPR120 receptor is activated and generates a strong anti-inflammatory effect.

“It’s just an incredibly potent effect,” said Olefsky, a professor of medicine and associate dean of scientific affairs for the UC San Diego School of Medicine. “The omega-3 fatty acids switch on the receptor, killing the inflammatory response.”

The scientists conducted their research using cell cultures and mice, some of the latter genetically modified to lack the GPR120 receptor. All of the mice were fed a high-fat diet with or without omega-3 fatty acid supplementation. The supplementation treatment inhibited inflammation and enhanced insulin sensitivity in ordinary obese mice, but had no effect in GPR120 knockout mice. A chemical agonist of omega-3 fatty acids produced similar results.

“This is nature at work,” said Olefsky. “The receptor evolved to respond to a natural product — omega-3 fatty acids — so that the inflammatory process can be controlled. Our work shows how fish oils safely do this, and suggests a possible way to treating the serious problems of inflammation in obesity and in conditions like diabetes, cancer and cardiovascular disease through simple dietary supplementation.”

However, Olefsky said more research is required. For example, it remains unclear how much fish oil constitutes a safe, effective dose. High consumption of fish oil has been linked to increased risk of bleeding and stroke in some people.

Should fish oils prove impractical as a therapeutic agent, Olefsky said the identification of the GPR120 receptor means researchers can work toward developing an alternative drug that mimics the actions of DHA and EPA and provides the same anti-inflammatory effects.

Co-authors of the paper are Da Young Oh, Saswata Talukdar, Eun Ju Bae, Hidetaka Morinaga, WuQuiang Fan, Pingping Li and Wendell J. Lu, all in the Department of Medicine, Division of Endocrinology and Metabolism at the University of California, San Diego; Takeshi Imamura, Division of Pharmacology, Shiga University of Medical Science; and Steven M. Watkins, Lipomics Technologies, Inc.

ScienceDaily (Sep. 2, 2010)

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‘Fountain of youth’ steroids could protect against heart disease.

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A natural defense mechanism against heart disease could be switched on by steroids sold as health supplements, according to researchers at the University of Leeds.

The University of Leeds biologists have identified a previously-unknown ion channel in human blood vessels that can limit the production of inflammatory cytokines – proteins that drive the early stages of heart disease.

They found that this protective effect can be triggered by pregnenolone sulphate – a molecule that is part of a family of ”fountain-of-youth’ steroids. These steroids are so-called because of their apparent ability to improve energy, vision and memory.

Importantly, collaborative studies with surgeons at Leeds General infirmary have shown that this defence mechanism can be switched on in diseased blood vessels as well as in healthy vessels.

So-called ‘fountain of youth’ steroids are made naturally in the body, but levels decline rapidly with age. This has led to a market in synthetically made steroids that are promoted for their health benefits, such as pregnenolone and DHEA. Pregnenolone sulphate is in the same family of steroids but it is not sold as a health supplement.

“The effect that we have seen is really quite exciting and also unexpected,” said Professor David Beech, who led the study. “However, we are absolutely not endorsing any claims made by manufacturers of any health supplements. Evidence from human trials is needed first.”

A chemical profiling study indicated that the protective effect was not as strong when cholesterol was present too. This suggests that the expected benefits of ‘fountain of youth’ steroids will be much greater if they are used in combination with cholesterol-lowering drugs and/or other healthy lifestyle strategies such as diet and exercise.

“These ‘fountain of youth’ steroids are relatively cheap to make and some of them are already available as commercial products. So if we can show that this effect works in people as well as in lab-based studies, then it could be a cost-effective approach to addressing cardiovascular health problems that are becoming epidemic in our society and world-wide,” Professor Beech added.

The paper is published in Circulation Research.

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For further information and interviews contact Paula Gould, University of Leeds Press Office – 0113 343 8059/4031 or p.a.gould@leeds.ac.uk

Notes to editors

1. “Pregnenolone sulphate- and cholesterol-regulated TRPM3 channels coupled to vascular smooth muscle secretion and contraction” by Jacqueline Naylor, Jing Li, Carol J. Milligan, et al is published in Circulation Research (doi:10.1161/circresaha.110.219329).

2. One of the UK’s largest medical and bioscience research bases, the University of Leeds is an acknowledged world leader in bioengineering, cancer, cardiovascular, epidemiology, molecular genetics, musculoskeletal, dentistry, psychology and applied health economics research. Treatments developed in Leeds are transforming the lives of people worldwide with conditions such as diabetes, HIV, tuberculosis and malaria.

The University is one of the UK’s leading research institutions with a vision of securing a place among the top 50 by 2015. www.leeds.ac.uk

3. The research was funded by the Wellcome Trust and the British Heart Foundation.

4. The Wellcome Trust is a global charity dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests. www.wellcome.ac.uk

5. The British Heart Foundation (BHF) is the nation’s heart charity, dedicated to saving lives through pioneering research, patient care, campaigning for change and by providing vital information. But we urgently need help. We rely on donations of time and money to continue our life-saving work. Because together we can beat heart disease. For more information visit bhf.org.uk/pressoffice

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Does Cholesterol Really Matter?

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I’d like to shine the spotlight on one of medicine’s sacred cows- the belief that lowering cholesterol with drugs protects against heart attacks and premature death. Our obsession with cholesterol began in the 1950s when studies linked high consumption of animal fat with high rates of heart disease. This opened the door for clinical trials that laid the foundation of a new paradigm: the cholesterol theory of cardiovascular disease.

This theory has had profound ramifications. It changed the way we eat (fats bad, carbohydrates good) and contributed to our problems with obesity and diabetes. It wormed its way into “clinical practice guidelines”- cholesterol management has become a “standard of care” that doctors are expected to follow. It spawned the invasive heart surgery industry, based on the presumption that cholesterol-laden blockages must be bypassed or propped open. And it led to the creation of the best-selling class of medications in history: cholesterol-lowering statin drugs, which generate more than $15 billion in worldwide sales every year.

But it’s all a house of cards. No matter what you’ve been led to believe, a high cholesterol level is not a reliable sign of an impending heart attack. In fact, growing numbers of experts question whether cholesterol matters at all. As for statin drugs, for most of the 40-plus million Americans recommended to take them for the rest of their lives, they’re an ineffective, expensive, side effect-riddled fraud.

Statin-Free Zone

When a patient taking Lipitor, Zocor, or another statin drug comes to Whitaker Wellness, we discontinue it at once. “But my cholesterol level is 240.” “My doctor told me I’ll have a heart attack if I don’t take this drug.”My father died of heart disease, so I have to take it.” I’ve heard all these justifications and more, and I still recommend that my patients get off statins. Here’s why.

First, they’re not very effective. These drugs do lower cholesterol, but so what? We’re not treating lab numbers. We’re treating patients, and the ultimate goal in cholesterol management is to reduce risk of cardiovascular disease. Except for a very limited number of people, there is absolutely no evidence that statins protect against heart attack or premature death.

Are you over age 65? Not a single study suggests you’ll receive any benefits, even if your cholesterol goes down substantially. A woman of any age? Same story. A man younger than 65 who has never had a heart attack? Ditto, no help at all. For middle-aged men who have had a heart attack, statins may lower risk of a repeat heart attack, but that’s the extent of it.

I know this is hard to buy in light of the multiple drug advertisements and glowing endorsements from doctors. But keep in mind that pharmaceutical companies do a superb job of pulling the wool over the eyes of consumers and physicians alike by withholding unfavorable study results and making false, misleading, and often deceptive claims.

A Statistic We Can Understand

That’s why I want to step around confusing statistics and tell you about an easy-to-understand measure that you’ll never hear about in drug ads. It’s called “number needed to treat,” or NNT, and it describes the number of patients who would need to be treated with a medical therapy in order to prevent one bad outcome. Experts consider an NNT over 50 to be “worse than a lottery ticket.”

Lipitor ads claim that it reduces risk of heart attack by 36 percent. Sounds pretty good until you look at the fine print, do the math (which John Carey did in a great article in Business Week), and figure out that the drug’s NNT is 100. This means that 100 people must be treated with Lipitor in order for just one heart attack to be prevented. The other 99 people taking the drug receive no benefit.

To put this into perspective, the NNT of antibiotics for treating H. pylori, the underlying cause of stomach ulcers, is 1.1. These drugs knock out the bacteria in 10 out of 11 people who take it, making them a reliable, cost-effective therapy. At the other end of the spectrum are statins, which as a class have an NNT of 250, 500, or higher depending on the study you look at. What a deal for drugs that can cost more than a thousand bucks a year and are almost guaranteed to cause problems.

Goodbye Drugs, So Long Symptoms

Statins lower cholesterol by suppressing the activity of an enzyme in the liver involved in the production of cholesterol. But this enzyme has multiple functions, including the synthesis of coenzyme Q10. CoQ10 is a key player in the metabolic processes that energize our cells. No wonder statin users often suffer from fatigue, muscle pain and weakness, and even heart failure- the cells are simply running out of juice.

The second most frequent adverse effects of statins are problems with memory, mood, suicidal behavior, and neurological issues. Other common complaints include sexual dysfunction, and liver and digestive problems. Symptoms range from minor (achiness, forgetfulness) to serious (complete but temporary amnesia, permanent memory loss) to lethal (congestive heart failure, rhabdomyolysis or complete muscle breakdown). One statin drug, Baycol, was taken off the market a few years ago after it caused dozens of deaths from rhabdomyolysis. Several studies have also linked statin drugs with an increased risk of cancer.

Because physicians rarely warn of these side effects, few patients suspect their drugs may be the reason they begin feeling bad- and it’s often a revelation when they put two and two together. Simply discontinuing these medications can result in tremendous improvements in health and well-being. Texas cardiologist Peter Langsjoen, MD, published a study showing that when symptomatic patients got off their statins and started taking 240 mg of CoQ10 per day, they had significant decreases in fatigue, myalgias (muscle aches), dyspnea (shortness of breath), memory loss, and/or peripheral neuropathy.

Not a Drug But a Program

As you can see, we need to shift away from this myopic focus on statin drugs and lowering cholesterol, and take a more holistic view. Folks, you don’t need statins- you need a program that addresses all the known risk factors for heart attack, stroke, and other cardiovascular disorders.

Inflammation, not high cholesterol, is the primary cause of heart disease. Harvard researchers have discovered that a high blood level of C-reactive protein, a marker of inflammation, is more predictive of heart disease than cholesterol. To get a handle on inflammation, lose weight- especially if you carry excess fat in the abdominal area. Exercise. Stop smoking. Eat plenty of vegetables and several weekly servings of salmon, sardines, and other omega-3 fatty acids, and avoid sugars and starches.

The beauty of this program is that it targets not only inflammation but other conditions that contribute to cardiovascular disease, including high blood pressure, diabetes, even cholesterol. Best of all, it’s a foundation for overall good health.

Necessary Nutrients

Your program should include a well-rounded nutritional supplement regimen, as well. My number-one suggestion for inflammation in all its guises is fish oil. This supplement also improves blood flow, discourages excess clotting, helps normalize heart rhythm, and saves lives by reducing risk of sudden cardiac death.

Folic acid and other B-complex vitamins are important because they lower levels of homocysteine, a toxic substance that damages the arteries. The mineral magnesium relaxes the arterial walls, which improves blood flow, lowers blood pressure, and helps prevent arrhythmias. And antioxidants, such as vitamins C and E, provide protection against damaging free radicals- another contributor to cardiovascular disease.

Supplements that boost the heart’s energy are recommended as well. One is coenzyme Q10. In addition to serving as a potent antioxidant, CoQ10 also increases the heart muscle’s efficiency and protects against the adverse effects of statin drugs. Another is D-ribose, a natural sugar that is the structural backbone of adenosine triphosphate (ATP), the energy that fuels cellular function.

Don’t Fret About Cholesterol

As far as cholesterol lowering is concerned, there are a number of natural therapies that work well, including flaxseed and other sources of fiber, niacin, plant sterols, and policosanol.

In short, do what you can to manage your cholesterol, but don’t worry about it if your level is particularly stubborn. The average cholesterol of people who have heart disease isn’t much higher than the level of those who don’t. If high cholesterol runs in your family, concentrate on what you can control, and remember, numbers aren’t everything.

Julian Whitaker,  NaturalNews,  Mon, 15 Mar 2010

http://www.ilifelink.com/red_rice_yeast_600_mg_x_120_capsules.html


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