The simple solution is for the states to regulate the health insurance industry same way they regulate the public utilities. Some states are actually starting this process of regulation. Lawmakers in several states are passing new laws which limit health insurers' ability to cancel health policies for pre-existing conditions. (45)Contact Your State Insurance Commissioner and File a Complaint, the State Regulators will start a review.Do you have a complaint about your insurance company? Call or write to your state insurance commissioner:Use this handy map to find your insurance commissioner contact information for any state.(8)Florida Insurance Commissioner:Kevin M. McCarty Commissioner of the Office of Insurance Regulation Office of the Commissioner 200 East Gaines Street Tallahassee, Florida 32399-0305 850-413-3140 Florida State Dept of Insurance Toll-free helpline, 1-877-693-5236, is available 8 a.m. to 5 p.m. M-F Stop the Shakedowns. Make Your Insurance Company Pay Your Medical Bills Whether your health plan is a traditional insurer, a PPO or an HMO, and whether it dismisses your claim or agrees to pay only part of the bill—here are the steps to take: These instructions are found here. (9)
1. Know Your Rights When coverage is denied for a treatment or drug, it is up to you to collect information and make the case for coverage. This is true whether you are seeking pre-authorization before you receive a service or are disputing an Explanation Of Benefits form sent to you in response to an unreimbursed claim. First, check your rights under your health-care plan and under state law. If your employer provides your insurance, call your human-resources department to get a copy of the policy. Read it carefully. The policy will tell you what is covered and what mechanism you can use to challenge your health plan’s decisions. If you don’t understand the provisions, ask someone in human resources for help or call your insurer’s customer-relations number for an explanation. Health plans are required to follow state and federal law for handling complaints and appeals. Find out your own health plan’s internal review process, then follow it. 2. Contact the Insurer Get your paperwork together before you call the health-plan insurer. (You’ll find the phone number on the form that was sent to you with denial of your request for reimbursement. It also will be on your policy.) Be prepared to lay out all the evidence to convince your insurer that your position is correct. Your dispute may be resolved with your first informal call, but that call also may be the start of a lengthy process. Make a file and start keeping accurate records of every contact you make: whom you spoke with, the date of the conversation, what was said and when they said the next step would occur. 3. File a Written Appeal If you don’t get results from a phone call, file a written appeal with the health plan. To prepare the appeal, request a copy of your entire claim file from the health plan, advises Jennifer C. Jaff, an attorney who is the executive director of Advocacy for Patients With Chronic Illness. The file will include the plan’s specific rationale for rejecting your claim. Tailor your letter to the plan’s criteria for denial or acceptance and attach supporting documents. If the claim file says the treatment was “unnecessary,” attach your medical records. These should include test results and an explanation of why other treatments have failed as well as a letter from your doctor about why you needed that treatment. If payment for your treatment is declined as “experimental,” you’ll have to show that the procedure you had is now medically accepted. You can do this by searching on the Internet or at your public library for articles in medical journals that demonstrate the effectiveness of the novel treatment you are trying to get covered. Make sure you file the appeal within the designated time limit. Some plans, for example, require that you challenge a reimbursement denial within 60 days. The two biggest mistakes patients make in their appeals are not providing enough background material to justify coverage and not meeting deadlines. 4. Get Outside Help If you have a chronic condition such as diabetes or cancer, or even a rare condition such as Crohn’s disease, the advocacy organization devoted to that disease can help you frame your appeal. For example, the website for the American Diabetes Association, www.diabetes.org, provides information for people who are having trouble getting health-care coverage. Although the website is targeted to people with diabetes, the advice is helpful for all patients. 5. Demand An Independent Review Starting in 1990, managed-care enrollment in the U.S. increased by 85%. As more patients signed up, more of them also began to complain to their legislatures about denials of coverage by their health plans. State lawmakers listened: 43 states plus the District of Columbia have enacted some version of a Patient’s Bill of Rights. As a rule, these laws give consumers the right to an independent medical review when a health plan denies coverage for care or access to out-of-network providers. But few people make use of these mechanisms. In Illinois, where about 1.5 million people are enrolled in HMOs, only one in 225 members a year files a complaint with the HMO. Far fewer—one in 2250—take the appeal to the next level by asking for an independent review of their claim. That’s a mistake. Although success rates differ from state to state, consumers tend to prevail in these challenges about 50% of the time. Health-care insurers made profits in the billions last year. Know your rights, so profits will not be taken unfairly from your own benefits.
Jeffrey Dach MD
Jeffrey Dach MD4700 Sheridan Suite T.Hollywood Fl, 33021954-983-1433www.drdach.comwww.jeffreydach.comwww.naturalmedicine101.comwww.truemedmd.com
References(1) www.knbc.com/health/15366673/detail.htmlCityAttorney Files Lawsuit Against Health Net Inc.February 21, 2008 KNBC TV LA(2) http://money.cnn.com/news/newsfeeds/articles/apwire/d4202f952209279a7d7a16cc586a24d8.htmCNN Money: LA Sues Health Net Over Cancellations, Los Angeles City Attorney Sues Insurer Health Net, Alleging Scheme to Cancel Policies. February 21, 2008:(3) http://wcco.com/business/UnitedHealthCare.Group.broke.2.364251.htmlJan 9, 2007 UnitedHealthCare Accused Of Breaking Insurance Law. WCCO Channel 4 TV(4) http://www.jsonline.com/story/index.aspx?id=467942&format=printState fines health insurer $600,000, UnitedHealthcare settles complaint, By GUY BOULTONJuly 14, 2006, Milwaukee Journal Sentinel(5) http://www.unitedhealthcare.topinsurance.org/A typical complaint found here: <quote>They are the worst company I've ever had. They refuse to pay any of the claims, even though they recognize they absolutly have to and should cover those charges. I'v spent hours on the phone with them for almost 3 months. At this point my company is dealing with them through their representative to resolve payments. It would be 10 times cheaper for me to just go to the doctor and pay whatever then pay them and now I have to pay the hospital too for whatever the reason is they can't explain.. <endquote>(6) http://www.nytimes.com/glogin?URI=http://www.nytimes.com/2008/02/18/opinion/18mon1.html&OQ=_rQ3D1&OP=c1ade63Q2F.nwS.Q5EJ(ueJJKT.TWWQ3E.WT.@Q3E.JV808J0.@Q3EBJ0@X,KBYEDITORIAL, A Rip-Off by Health Insurers? February 18, 2008 New York Times(7) http://earningspower.com/chart.htmlChart showing obscene profits of United Healthcare increasing every year. Shares of UnitedHealth are up 563% for the five years ending 2004, versus a 17% loss for the benchmark S&P 500.
(8) www.naic.org/state_web_map.htmThis is a Link to Your State Insurance Web Site - witn a Handy Map of US, All States.(9) http://www.parade.com/articles/editions/2008/edition_01-20-2008/Fight_for_Your_Health_CareTAKE CONTROL OF YOUR HEALTH, Fight for Your Health Care, By Lori Andrews Published: January 20, 2008 Parade(10) http://www.auanet.org/advocacy/news/cpt/unitedHC.pdf2002, Michael D. Maves, MD, MBA, Executive Vice President and Chief Executive Officer, AMA, Letter to United HealthCare CEO Dr. William McGuire complaining about miscoding CPT codes, etc.(11) http://www.usatoday.com/money/industries/health/2006-10-15-unitedhealth-ceo_x.htm USA Today, UnitedHealth CEO McGuire, retires amid options scandal Updated 10/16/2006 9:13 AM ET (12) http://hcrenewal.blogspot.com/2007/03/unitedhealth-declares-health-care.htmlTuesday, March 20, 2007 UnitedHealth Declares "The Health Care System Isn't Healthy" - But Is the Company Part of the Problem? (13) http://www.theindustryradar.com/Home/?currentHome=/Accounts/IndustryRadar/layouts/Hospital%20Disputes.xmlDisputes with United HealthCare over payments(14) http://consumerist.com/356233/unitedhealth-group-accused-of-fraudUniterd HealthGroup Accused of Fraud(15) Listing of News Stories on United Health Group(16) http://www.oag.state.ny.us/press/2008/feb/feb13a_08.html Press Release by Office of the Attorney General, Andrew Cuono ANNOUNCES INDUSTRY-WIDE INVESTIGATION INTO HEALTH INSURERS’ FRAUDULENT REIMBURSEMENT SCHEME (17) http://news.yahoo.com/s/ap/20080213/ap_on_bi_ge/cuomo_healthcareAndrew Cuomo to sue major health insurers By MICHAEL GORMLEY, Associated Press Writer Wed Feb 13.(18) http://www.businessweek.com/magazine/content/08_09/b4073028422999.htm?chanBusiness Week, February 21, 2008, Wrangling Over 'Reasonable' Fees, It's a no-holds-barred battle between health insurers and hospitals, with customers caught in the middle. By Chad Terhune, with Brian Grow (19) http://www.huffingtonpost.com/eve-gittelson/falling-in-love-with-a_b_86758.htmlHuffington Post, Falling in Love with Andrew Cuomo by Eve Gittelson Feb 14 2008.(20) http://www.nytimes.com/2008/02/14/business/14health.html?_r=3&hp=&adxnnlx=1202963413-6MEt1k7Cow4EtTala2dF0Q&pagewanted=all&oref=slogin&oref=sloginNew York Times, Andrew M. Cuomo, New York State attorney general, announced an inquiry into health insurance Wednesday. By REED ABELSON, February 14, 2008(21) http://www.marketwatch.com/news/story/new-york-state-charges-unitedhealths/story.aspx?guid={A6E79417-6D6C-48EE-9DC0-BB52F816DB09}UnitedHealth unit charged with fraud New York state says alleged practices left consumers shortchanged By Russ Britt, MarketWatch Feb. 13, 2008(22) http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021303128.htmlCuomo to Sue Biggest Health Insurer, Others to Receive Subpoenas Over Reimbursements, N.Y. Attorney General Andrew Cuomo says he will sue UnitedHealth over setting artificially low limits on how much patients are reimbursed for medical-care claims. (By Robert Caplin -- Bloomberg News) Washington Post
(23) http://labsoftnews.typepad.com/lab_soft_news/2008/02/unitedhealth-dr.htmlUnitedHealth Draws Criticism for Its Out-of-Network Reimbursement Policies. I have posted a number of previous notes about UnitedHealth, particularly with regard to its punitive policies toward physicians for out-of-network lab testing. (24) http://chipsblog.pcc.com/?p=142Confessions of a Pediatric Practice Consultant, True stories from the land of pediatric practice management.Andrew Cuomo, UnitedHealthCare: Duh. February 14, 2008 . Cuomo’s investigation also found a clear example of the scheme: United insurers knew most simple doctor visits cost $200, but claimed to their members the typical rate was only $77. The insurers then applied the contractual reimbursement rate of 80%, covering only $62 for a $200 bill, and leaving the patient to cover the $138 balance. (25) http://www.npr.org/templates/player/mediaPlayer.html?action=1&t=1&islist=false&id=18974670&m=18974647NPR Radio story on Andrew Cuomo And United Health(26) http://www.mydd.com/story/2008/2/22/17219/1258Health Insurer to Face CRIMINAL CHARGES by California Nurses Shum, Fri Feb 22, 2008 This could be the start of something huge. The sociopaths who run our nation's health insurance corporations might--just might--begin to face justice for the countless Americans that have suffered at their hands. Health Net, one of the largest insurers in the nation, is facing multiple civil and criminal charges for retroactive recissions, their habit of kicking people off the insurance rolls as soon as they get sick.This practice is not a coincidence--it's at the heart of their business plan, in fact of the whole model of for-profit health insurance. Los Angeles City Attorney Rocky Delgadillo was brave in standing up to the practice,and justified. We need other activist prosecutors to follow his lead, and help turn the public disgust with insurance corporations into national momentum for replacing them with universal, non-profit guaranteed coverage...also known as single-payer healthcare.(27) http://www.latimes.com/business/la-fi-insure21feb21,0,5347492.storyL.A. sues insurer over cancellations, The city attorney says Health Net defrauded policyholders by dropping patients who needed costly care. By Lisa Girion, Los Angeles Times Staff Writer,February 21, 2008. (28) www.protectingtheinsured.org/default.htmlFile your health insurer complaint with LA City Attorney Delgadillo: "If you believe your health insurer has wrongfully denied or delayed your claim and/or canceled your coverage, we urge you to provide us with a description of your complaint. If you are a health care provider who has had payment withheld, payment delayed or has been retroactively denied payment for services rendered under a health plan or insurance policy."(29) http://www.guaranteedhealthcare.org/node/add/user-storyCalifornia Nurses Association. Submit Your Story Web Site. Are you getting the healthcare you need, when you need it, at a price you can afford? Nearly 48 million Americans have no health insurance at all and nearly 50 million more are under insured with high deductibles and co-pays discouraging them from seeking the care they need in the preventative stages. We've created this form to collect your stories, which may be used on our websites, in the news, to educate the public, and/or at legislative hearings. (30) http://google-sina.com/2008/02/21/ny-attorney-general-investigation-highlights-problems-in-navigating-out-of-network-charges/N.Y. Attorney General Investigation Highlights Problems In Navigating Out-of-Network Charges(31) http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/02/14/BUGGV1ML2.DTLLegislation would crack down on insurers. Victoria Colliver, San Fransisco Chronicle Staff Writer, Thursday, February 14, 2008. A California lawmaker introduced legislation Wednesday that would require health insurers to get permission from state regulators before retroactively canceling a member's coverage. The bill, introduced by Assemblyman Hector De La Torre, D-South Gate (Los Angeles County), comes on the heels of news this week that Blue Cross of California had been sending letters to doctors asking them to report pre-existing conditions and discrepancies that could be used to cancel a new member's policy.(32) http://www.nyas.org/publications/sciences/pdf/ts_01_94.pdfClinton Health Care Proposal called Managed Competition (Jan 1994) starts on page 6 of document.Under managed competition, all doctors and other caregivers will be under the administrativethumb of six or eight immense, for-profit insurance companies,which will have gobbled up hundreds of smaller insurers.(33) http://www.themoneytimes.com/articles/20061016/unitedhealth_shakes_up_over_options-id-101879.htmlUnitedHealth shakes up over Options by Shubha Krishnappa - October 16, 2006 The Money Times. McGuire, the longtime chief executive of UnitedHealth Group Inc., who worked hard to turn the Group into a behemoth in its field, was forced yesterday to resign from the company and to give up a portion of the $1.1 billion he holds in severely criticized stock options. The options that McGuire had been granted over the years have led to criminal and civil investigations and public disapproval.(34) http://www.floir.com/Florida State Office of Insurance Regulation. The Office serves Floridians through its responsibilities for regulation, compliance and enforcement of statutes related to the business of insurance. (35) http://www.kff.org/consumerguide/upload/7350ConsumerGuidev4_080805.pdfA Consumer Guide to Handling Disputes with Your Health Plan or Insurance Carrier - Kaiser(36) http://www.amazon.com/Making-Them-Pay-Insurance-Managed/dp/0312267606The Book, Making Them Pay: How to Get the Most from Health Insurance and Managed Care by Rhonda Orin "It's time to get down to business-and that means learning the nuts and bolts of health plans..." (37) http://www.amazon.com/Fight-Back-Win-Health-Insurance/dp/0887231721/ref=pd_sim_b_img_1The Book, Fight Back and Win: How to Get HMOs and Health Insurance to Pay Up by William Shernoff , Lawyer who won 9 million dollar settlement from Helath Net last week.(38) http://www.advocacyforpatients.org/health.phpAdvocacy for Patients with Chronic Illnesses, Jennifer C. Jaff attorney and founder of Advocacy for Patients with Chronic Illness, Inc., a tax-exempt organization that provides free information, advice and advocacy services to patients with chronic illnesses(39) http://www.advocacyforpatients.org/healthtalk%20transcript.pdfInterview with Jennifer Jaff talking about finding and getting health insurance, and then making them pay for your medical bills.(40) http://www.sbd-law.com/Bio/WilliamShernoff.aspLaw Firm of William Shernoff(41) http://www.msnbc.msn.com/id/23307983/Insurer fined $9M for dropping cancer patient. Cancellation had left woman with more than $129,000 in unpaid bills. Insurance company pays up. Feb. 23: A woman battling breast cancer had her policy cancelled during her treatment. NBC's Chris Jansing reports that action is costing the insurance company dearly.Associated Press.LOS ANGELES - A woman who had her medical coverage canceled as she was undergoing treatment for breast cancer has been awarded more than $9 million in a case against one of California's largest health insurers. Patsy Bates, 52, a hairdresser from Lakewood, had been left with more than $129,000 in unpaid medical bills when Health Net Inc. canceled her policy in 2004. On Friday, arbitration judge Sam Cianchetti ordered Health Net to repay that amount while providing $8.4 million in punitive damages and $750,000 for emotional distress.(42) http://www.myfloridacfo.com/Consumers/medical_provider_request/index.htmFlorida State Division of Consumer Services, Medical Provider Informational Memorandum Attention:Florida Medical Providers Assistance, Complaints, Inquiries, online inquiry form. The state regulatory agency with file inquiry with the insurance company. (43) http://blogs.wsj.com/law/2008/02/14/ny-ag-on-unitedhealth-database-garbage-in-garbage-out/February 14, 2008, NY AG on UnitedHealth Database: Garbage In, Garbage Out Posted by Dan Slater , New York Times(44) http://blog.hittransition.com/2008/02/denial-engine-v.htmlWhat is a Denial Engine? That's the computer software that denies your claim. Read more here:Denial Engine Vendor Ingenix Keeps more than Usual and Customary Dollars. In my warnings to providers about denial engines -- those sophisticated analytics tools that payers are increasingly using to reduce, deny, or re-collect claims payments -- I try to emphasize that they can be used ethically. (45) http://www.usatoday.com/money/industries/health/2008-02-20-cancel_N.htm#uslPageReturnStates act to protect individual health insurance coverage, By Julie Appleby, USA TODAY 2/21/08(c) 2008 jeffrey dach md disclaimer Original article available here
Cholesterol Lowering Statin Drugs for Women
Just Say No to Statin Drugs by Jeffrey Dach MD Click Here for the Original Version of this Article
__________________________________________ A Woman on Lipitor With Leg Muscle Pain Sally, a 56 year old retired real estate agent, came to see me in the office with the chief complaint of hot flashes, night sweats, mood disturbance and weight gain which are all fairly typical post-menopausal symptoms. In addition, she also had leg pain for the past 3 months, which prevented exercising. Lumbar Spine MRI Scan to evaluate the leg pain showed only a bulging disk and was otherwise negative. About 6 months ago, Sally’s cholesterol was 245, and her cardiologist prescribed a cholesterol lowering statin drug, Lipitor. Sally has no history of heart disease, does not smoke, eats a healthy diet, and takes a few vitamins, and doesn’t supplement with CoEnzyme Q-10. MRI Scan of Leg Muscles
I explained to Sally that her leg pain was a well known adverse side effect of Lipitor, a valid reason for stopping the drug. The leg muscle pain is caused by Lipitor depletion of Co-Enzyme Q 10, which is important for energy production in the muscle cells. I suggested to Sally that she supplement with CO-enzyme Q-10, and strongly recommended stopping the statin drug. What is the definition of elevated cholesterol? When I was a medical student in 1976, normal cholesterol was 240. However, this was changed in 1993 to the new guidelines. New Cholesterol Guidelines in 1993 above 240: high above 200: borderline high below 200: desirable The cholesterol guidelines were revised downward to 200 by a committee of 9 doctors, 8 of whom were receiving money from statin drug companies. There was no science behind this revision. (1 ) (2) (3) A 2006 paper in the Annals of Internal Medicine (October 3, 2006; 145(7): 520-530) argues that there is NO EVIDENCE to support the target numbers outlined by the Cholesterol Guidelines panel, challenging the mainstream medical belief that lower cholesterol levels are always better. “This paper is not arguing that there is strong evidence against the LDL targets, but rather that there’s no evidence for them,” said Dr. Rodney A. Hayward, a study author, The laboratory will flag any cholesterol test results above 200 as abnormal. Please ignore this. In reality a cholesterol reading above 200 and below 240 is normal. If above 240, then nutritional supplements containing niacin, omega 3 oils, and plant sterols are used to bring it down to 240. (4) Mary Enig says: "Blood cholesterol levels between 200 and 240 mg/dl are normal. These levels have always been normal. In older women, serum cholesterol levels greatly above these numbers are also quite normal, and in fact they have been shown to be associated with longevity. Since 1984, however, in the United States and other parts of the western world, these normal numbers have been treated as if they were an indication of a disease in progress or a potential for disease in the future. (4) A cholesterol of 240 is NOT ELEVATED. This is normal and compatible with good health. Medical Terrorism through Drug Company Advertising: The reality is that there is no mortality benefit from lowering cholersterol with statin drugs: Both lines on the chart below are superimposed meaning the number of deaths in the statin drug group was identical to the number of deaths in the placebo group. Chart Courtesy of (Eddie Vos). Just say NO When Your Doctor Prescribes a Statin Drug. The truth is that NO woman should ever be given Lipitor or any other statin drug for elevated cholesterol. Dr. Rose says, "There are no statin trials with even the slightest hint of a mortality benefit in women and women should be told so". (5). In other words, statin drugs don’t work for women. No Female Should Ever Take A Statin Drug Let me repeat that so this is very clear: No female should ever take a statin drug to lower cholesterol for primary prevention of heart disease. They don’t work for women. Women who take Lipitor or any other statin drug to lower cholesterol do not live any longer than women who don’t take the drug. There is no benefit in terms of prolonging your life for women. On the other hand, there are plenty of adverse side effects which include muscle pain, cognitive impairment, neuropathy, congestive heart failure, transient global amnesia and dementia.
Why do Cardiologists Give Statin Drugs to Women? Why do cardiologists and mainstream docs continue to prescribe statins to women? It is very simple, they succumb to the drug company “spin” from the drug reps and the medical journals which are slanted in favor of statins. In addition, the mainstream doctors succumb to patient's demands and expectations for the drugs after seeing the celebrity TV ads. Are You Still Not Convinced?Mary Enig writes, "No study has shown a significant reduction in mortality in women treated with statins. The University of British Columbia Therapeutics Initiative came to the same conclusion, with the finding that statins offer no benefit to women for prevention of heart disease." (6) (7) Are you still not convinced that women should NOT take Statin Drugs? Don’t take my word for it. Take the word of Judith Walsh MD who wrote this in JAMA, 4 years ago in an article entitled, Treatment of Hyperlipidemia in Women: "For women without cardiovascular disease, lipid lowering does not affect total or CHD (Cardiovascular Heart Disease) mortality. Lipid lowering may reduce CHD events, but current evidence is insufficient to determine this conclusively. For women with known cardiovascular disease, treatment of hyperlipidemia is effective in reducing CHD events, CHD mortality, nonfatal myocardial infarction, and revascularization, but it does not affect total mortality."(8) Translation: Cholesterol lowering with statin drugs does not reduce total mortality in women, PERIOD. It doesn’t reduce mortality in women without heart disease, called primary prevention. It doesn’t reduce mortality in women with heart disease, called secondary prevention. Still not convinced?, then read this article by Malcolm McKendrick, a doctor in England, in the British Medical Journal, May 2007, entitled: "Should Women be Offered Cholesterol Lowering Drugs? NO"."(8A) "To date, none of the large trials of secondary prevention with statins has shown a reduction in overall mortality in women. Perhaps more critically, the primary prevention trials have shown neither an overall mortality benefit, nor even a reduction in cardiovascular end points in women. This raises the important question whether women should be prescribed statins at all. I believe that the answer is clearly no."(8A) Note: Secondary prevention means women with known heart disease. Primary prevention means women without known heart disease. Still not convinced ? Then read this June 2007 article by Electra Kaczorowski, of the National Women’s Health Network (9) "There is currently no indication that women of any age or any risk level will benefit from taking statins to prevent CHD and other heart conditions – yet this is precisely how statins are being marketed to women. "(9) Still not convinced ? Are statin drugs good for anybody? Read this review article by Joel Kauffman PhD, Dec 2003, in which the best statin trial results (the HPS simvastatin study) had an absolute reduction of all cause death rate of 0.38% per year. Yet this performance was inferior to the less expensive alternatives of buffered aspirin or Omega-3 oils.(10) Quote: "The most favorable (statin) trial with seemingly impeccable reporting and minimal financial conflict of interest was the Heart Protection Study (HPS), on simvastatin for 5 years, in which secondary prevention in men (86% of patients) of any unwanted vascular event gave a RR = 0.76 (5.5% absolute, 1.1% per year), and an all-cause death rate drop of 0.38% per year.16 Since this performance is inferior to that of either Bufferin in men or omega-3 fatty acid supplements, both of which have lesser side-effects, and are far less expensive, the logic of prescribing simvastatin seems faulty.".(10) Still not convinced ? Then read this article by Harriett Rosenberg from Women and Health Protection from June 2007, Do Cholesteriol Lowering Drugs Benefit Women ? (11) Evidence for Caution: Women and statin use By Harriet Rosenberg Danielle Allard Women and Health Protection June 2007 Quote: "Our review of these fields identifies a troubling disjuncture between the widespread use of statin medication for women and the evidence base for that usage. What we found instead was evidence for caution."Still not convinced ? Not only are statin drugs a failure for women, they also should never be prescribed to the elderly. Mortality in the elderly goes up as cholesterol goes down. Read this Letter to the Editor by Eddie Vos. (12) Quote:"Regarding women, two 2004 analysis found no reduction in deaths from statin over placebo. In actual patient outcomes, the J-LIT study in 41,801 hypercholesterolemic Japanese (2/3rds women) found mortality in the 2 lowest on-statin cholesterol categories 2-3 times higher; its authors cautioned about ‘hyperresponders’ to statin. The 4S study ended with 3 more dead women on statin vs.placebo, and another ‘successful’ study, HPS, found no significant mortality benefit in women." See article for references.Still not convinced ? Then read this article by Bill Sardi, Who Will Tell the People? It Isn't Cholesterol ! (13) " If physicians were truly honest with their patients, there probably would be very few people being treated for primary prevention with a statin drug."
Still not convinced? Then read this Jan 2007 Lancet article by Harvard trained MD, John Abramson, "Are lipid-lowering guidelines Evidence-Based ? ". (14)
Quote:" No studies have shown statin cholesterol-lowering drugs to be effective for women at any age, nor for men 69 years of age or older, who do not already have heart disease or diabetes. Better than 50 adults have to take a cholesterol-lowering drug for 1 patient to avoid a mortal heart attack, and that figure only applies to high-risk patients. There is a vanishing benefit to lowering cholesterol for healthy adults." Dr. Abramson calls for cholesterol treatment guidelines to be revised. [Lancet 2007; 369:168-169]
Still not convinced? Then read this e-book by Shane Ellsion, "The Hidden Truth About Cholesterol-Lowering Drugs! ", by Shane Ellison, MS, Organic Chemistry. (15) "Among healthy people, statin drugs do not prevent early death from heart disease, despite their cholesterol lowering effects. This is because there is no correlation orrelationship between low cholesterol and the progression of atherosclerosis – the number one cause of heart disease. Repeat that sentence. This became abundantlyclear with the statin drug trials." The New York Times Questions the Value of Lowering Cholesterol with Statin Drugs !! In a surprise turnaround, The New York Times questions the value of treating cholesterol with statin drugs in this article, "New Questions on Treating Cholesterol", By ALEX BERENSON, New York Times January 17, 2008 . (16)
"In the last 13 months, however, the failures of two important clinical trials have thrown that hypothesis into question. (that cholesterol lowering is beneficial). First, Pfizer stopped development of its experimental cholesterol drug torcetrapib in December 2006, when a trial involving 15,000 patients showed that the medicine caused heart attacks and strokes. That trial — somewhat unusual in that it was conducted before Pfizer sought F.D.A. approval — also showed that torcetrapib lowered LDL cholesterol while raising HDL, or good cholesterol. Torcetrapib’s failure, Dr. Taylor said, shows that lowering cholesterol alone does not prove a drug will benefit patients. Then, on Monday, Merck and Schering-Plough announced that Vytorin, which combines Zetia with Zocor, had failed to reduce the growth of fatty arterial plaque in a trial of 720 patients. In fact, patients taking Vytorin actually had more plaque growth than those who took Zocor alone. Despite those drawbacks, that trial, called Enhance, also showed that patients on Vytorin had lower LDL levels than those on Zocor alone. For the second time in just over a year, a clinical trial found that LDL reduction did not translate into measurable medical benefits." endquote from Alex Berenson New York Times (16)
Both Merck and Pfizer are now under Investigation by the John Dingell's House Committee and by New York Attorney General Andrew Cuomo !! 1) Senator John Dingell’s House Committee of Energy and Commerce has recently subpoenaed both Merck and Pfizer. Merck's subpoena was for the Vytorin - Enhance scandal asking for records. Pfizer's subpoena was for the Jarvik Lipitor Celebrity Ads, investigating why Jarvik was selected as spokeman for Lipitor even though Jarvik was never licensed to practiced medicine. John D. Dingell, Democratic Representative from Michigan and Chairman of the House Committee on Energy and Commerce Click Here for Dingell's Letter to Merck on Vytorin Scandal Click Here for Dingell's Letter to Pfizer Investigating Jarvk-Lipitor Ads 2) The Enhance Vytorin scandal has prompted New York Attorney General Andrew Cuomo to issue a subpeana to Merck & Co and Schering-Plough Corp to investigate the allegations of deceitful marketing and insider trading. The Vytorin Enhance Data showed no benefit for the Zetia/Zocor combination compared to Zocor alone. This created a scandal because of the late registration of the Enhance study, and accusations of insider trading at Pfizer, dumping stock in advance of the unfavorable results. Merck and Schering sat on the results of an unfavorable study for almost two years. They claim they haven’t peeked at the data, but Schering President Carrie Cox dumped 28 Million worth of stock back in the spring of 2007. 3) 2 drug trials in the past 13 months show no health benefit of lowering LDL cholesterol. (ENHANCE and Torcetrapib) Dr Steven Nissen, cardiologist at Cleveland Clinic, said this of the Merck Enhance-Vytorin data:
”ENHANCE results were a big surprise and a big disappointment. The data show no benefit for ezetimibe (Zetia) on top of simvastatin (Zocor). In fact, the data on both the rate of progression of atherosclerosis and cardiovascular events are trending in the wrong direction. This is a pretty clear failure. Physicians should now stop using ezetimibe or Vytorin except as a last resort. The drug doesn’t work”.
"The revelation that statin cholesterol drugs may be of little or no benefit, as revealed in a lengthy cover story in January 28 issue of Business Week (BW) magazine, begs the question: how did this misdirection go on for so long? As the BW article pointed out, statin drugs "are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006." How can anyone question the benefits of such a drug, asks BW, when they are "thought to be so essential that, according to the official government guidelines from the National Cholesterol Education Program (NCEP), 40 million Americans should be taking them. Some researchers have even suggested – half-jokingly – that the medications should be put in the water supply, like fluoride for teeth. And it's almost impossible to avoid reminders from the industry that the drugs are vital. A current TV and newspaper campaign for one statin drug, as endorsed by Dr. Robert Jarvik, artificial heart inventor, proclaims that this drug ‘reduces the risk of heart attack by 36%...in patients with multiple risk factors for heart disease’." Statin drug ruse revealed: But the cholesterol/statin drug ruse finally unraveled when, after two years of foot dragging delays to release data from a large study involving Zetia, a cholesterol-lowering drug that inhibits cholesterol absorption from foods, and Vytorin, which is a combination of Zetia plus Zocor, the latter a statin drug that inhibits formation of cholesterol in the liver, revealed no health benefits. Even though this drug combo lowered circulating cholesterol numbers better than either drug alone, it did not reduce plaque formation in arteries and did not confer a projected reduction in mortality. In fact, an earlier review published last year in the British journal Lancet by Drs. John Abramson of Harvard Medical School and James M. Wright MD of the University of British Columbia, could find no evidence for a reduction in cardiac mortality in a combined review of all published statin drug studies. [The Lancet 2007; 369:168–169] Falsifying the numbers: The Business Week report says statin drugs benefit only 1 in 100 users, but they claim to reduce the risk of a non-mortal heart attack by 36%. But that figure is a relative number, not a hard one. About 3% of patients taking an inactive placebo pill will experience a heart attack compared to 2% taking a statin drug, which produces the so-called 30-plus percent risk reduction. But in hard numbers, this is only a 1% reduced risk. This type of misleading advertising wouldn’t pass Federal Trade Commission guidelines. But public health agencies, serving as free publicity agents for the statin drug manufacturers, repeat the claim to give it a ring of credibility." end quote from Bill Sardi on Lew Rockwell.com.
Merck ran these these Cholesterol Lowering-Vytorin Televison Ads over the course of about a year spending 160 million dollars, allowing a windfall of 1-2 billion dollars on the sale of Vytorin. All the time they knew that the ENHANCE study showed that Vytorin didn't work. Take at look at the TV ads that fooled a nation into spending a fortune for drugs that don't work. Vytorin Ad VideoAnother Vytorin Ad VideoVytorin Ad video Parody by Mike Adams of NewsTargetThe Vytorin Ads have been pulled, so you won't be seeing them on national TV anymore.Here is the Wall Street Journal story, "Congress Investigates Vytorin Ads", by Anna Wilde Mathews: (22A) Here is a story by blogger Rich Thomaselli, "Vytorin Ad Shame Taints Entire Marketing Industry Cholesterol Drug's Ad Campaign Turns Into PR Nightmare, Fanning Flames of Public Mistrust of DTC" by Rich Thomaselli Published: January 21, 2008 (22C). Lipitor and the Dracula of Medical Technology In a previous newsletter Lipitor and the Dracula of Medical Technology, I discussed the Robert Jarvik celebrity ads for Lipitor. One year later after this first newsletter, John Dingell’s House Committee on Energy and Commerce is now investigating the matter. They have issued Subpoenas to Pfizer CEO, Jeffrey B Kindler, asking for information about the Jarvik-Lipitor Ad Materials. Here is the Dingell letter (22). Among other things, Chairman John Dingell wants to know why Jarvik takes Lipitor, and why Jarvik appears to be representing a doctor in the Ads, yet has never actually been licensed to practice medicine. Jarvik never actually prescribed Lipitor or any other drug for that matter. Robert Jarvik, MD, Inventor of the Jarvik Heart and Spokesman for Lipitor The New York Times dubbed the Jarvik Heart, "the Dracula of Medical Technology". Until the Jarvik Heart was finally banned, all Jarvik Heart recipients died a slow agonizing death from multi-organ failure and sepsis, and had the Kevorkian option of assisted suicide with a small button to turn off the machine, ending their lives.Here is a Wall Street Journal story about the letter from Dingell asking why Jarvik was chosen to sell Lipitor (23). Here is a Lipitor Television Ad Video with Robert Jarvik selling Lipitor to the masses (60 seconds).(24) Can you imagine what Jarvik would think about Lipitor if Jarvik actually looked at the J-Lit data shown in the chart below which shows that mortlity is the highest at the lowest cholesterol and LDL levels, a result just the opposite to what one would expect if cholesterol lowering was beneficial to one's health. Notice the lowest mortal (lowest red bar) is located at 240-250 total cholesterol, and as cholesterol is lowered below 230, mortality goes up. The LDL chart below shows the same findings. J-Lit Mortality Data Chart courtesty Eddie Vos, from Circ J 2002;66:1087–1095, Mortality is highest at lowest cholesterol vales.If Jarvik knew what this chart showed, would he then recant his position, and write an editorial opposing the use of statin drugs, and return the Pfizer Lipitor television ad money? If Doctor Jarvik has an ounce of moral fibre that is exactly what he should and must do. We are waiting.Could this be the END of the Liptor Era? Maybe. Maybe Not. Did you find this newsletter interesting? Feel free to Email it to a friend, or sign up for the newsletter with the link on the left sidebar. Can't convince your doctor NOT TO prescribe statin drugs for you? Print this newsletter and give it to your doctor.Jeffrey Dach MD 4700 Sheridan Suite T Hollywood FL 33021 954 983-1443 Jeffrey Dach, M.D. BLOG TrueMedMD disclaimer References (1) The new cholesterol guidelines, Applying them in clinical practice Brian L. Pearlman, MD, FACP VOL 112 / NO 2 / AUGUST 2002 / POSTGRADUATE MEDICINE (2) The new cholesterol guidelines (3) USA Today, 2004, Cholesterol guidelines become a morality play the Associated Press (4) Mary Enig, Cholesterol and Heart Disease-- A Phony Issue (5) Questioning the benefits of statins Eddie Vos and Colin P. Rose , CMAJ • November 8, 2005; 173 (10). doi:10.1503/cmaj.1050120. (6) Dangers of Statin Drugs: What You Haven’t Been Told About Popular Cholesterol-Lowering Medicines By Sally Fallon and Mary G. Enig, PhD (7) Therapeutics Initiative, Do Statins have a Role in Primary Prevention? There were 10,990 women in the primary prevention trials (28% of the total). Only coronary events were reported for women, but when these were pooled they were not reduced by statin therapy, RR 0.98 [0.85-1.12]. Thus the coronary benefit in primary prevention trials appears to be limited to men, RR 0.74 [0.68-0.81], ARR 2.0%, NNT 50 for 3 to 5 years. (8) Drug Treatment of Hyperlipidemia in Women Judith M. E. Walsh, MD, MPH; Michael Pignone, MD, MPH JAMA. 2004;291:2243-2252. (8A) BMJ 2007;334:983 (12 May), doi:10.1136/bmj.39202.397488.AD Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No Malcolm Kendrick, general practitioner (9) Women's Health Activist May/ June 2007: Exploring Statins: What Does the Evidence Say? By Electra Kaczorowski, National Women’s Health Network (10) Statin Drugs: A Critical Review of the Risk/Benefit Clinical Research, Joel M. Kauffman, Ph.D. Professor of Chemistry Emeritus USP Philadelphia, PA, USA 9 Dec 2003 (11) Evidence for Caution: Women and statin use By Harriet Rosenberg Danielle Allard Women and Health Protection June 2007 (12) LETTER TO THE EDITOR: Statins for women, elderly: Malpractice? Nutrition, Metabolism & Cardiovascular Diseases (2007) 17, e19ee20 Eddie Vos 127 Courser Rd, Sutton (Qc), (13) Who Will Tell the People? It Isn't Cholesterol! by Bill Sardi (14) Lancet: Vol 369 January 20, 2007 Are lipid-lowering guidelines evidence-based? J Abramson and JM Wright (15)"The Hidden Truth About Cholesterol-Lowering Drugs! ", by Shane Ellison, MS, Organic Chemistry (16)"New Questions on Treating Cholesterol", By ALEX BERENSON, New York Times January 17, 2008 (18) Government Health Agencies Complicit in Cholesterol Ruse by Bill Sardi on Lew Rockwell.com(19) Zetia Enhance trial (20)January 14, 2008, 9:11 am Zetia Doesn’t Enhance Zocor Posted by Shirley S. Wang Wall Street Journal (21) Vytorin video AD 30 sec, Humorous clothes which look like the food. (22) Letter from John Dingel Mich to CEO of Pfizer asking for records on Jarvik and Lipitor, celebrity endorsement of Lipitor Ads. (22A) Wall Street Journal January 16, 2008, 3:44 pm Congress Investigates Vytorin Ads Posted by Anna Wilde Mathews (23) January 7, 2008, Wall Street Journal, Congress to Pfizer: Why is Robert Jarvik the Lipitor Man? Posted by Shirley S. Wang (24) Lipitor Ad with Robert Jarvik 60 seconds (25) New Questions on Treating Cholesterol By ALEX BERENSONPublished: January 17, 2008 For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol. Study Reveals Doubt on Drug for Cholesterol (January 15, 2008) Times Health Guide: Cholesterol But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say. “The idea that you’re just going to lower LDL and people are going to get better, that’s too simplistic, much too simplistic,” said Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute in La Jolla, Calif. LDL, or low-density lipoprotein, is the so-called bad cholesterol, in contrast to high-density lipoprotein, or HDL. 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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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 articlesSalivary estradiol 177Salivary progesterone 317Salivary 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 LabsClimara (estradiol): FDA approved 1994 - BayerFemPatch : FDA approved 1997 - Parke DavisVivelle-Dot (estradiol): FDA approved 1994 - NovartisEstraderm: FDA approved 1986 - NovartisEsclim: FDA approved 1998 - Women's First HealthcareEstrace (estradiol): FDA approved 1993 -Bristol Myers SquibbEstring: FDA approved 1996 - Pharmacia UpJohnPrometrium (natural progesterone): FDA approved 1998 - SolvayAndrogel (natural testosterone): FDA approved 2000 - Unimed PharmaceuticalsCrinone: 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. GuytonWilliams Textbook of EndocrinologyBasic & Clinical Endocrinology by Francis S. Greenspan Review of Medical Physiology by Ganong, William F. MDEndocrinology (5th Edition) by Mac E. HadleyEndocrine 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 Visit our new NewsGroups on Google Groups: Just for Fun: The Day the Earth Stood Still by Jeffrey Dach TrueMedMD NewsGroup .... Breast Cancer Prevention NewsGroup .... Vitamin C NewsGroup Vitamin B12 NewsGroup * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Jeffrey Dach, M.D. TrueMedMD Catalog of NewsLetters _______________________________________________________________ Enter your email address to subscribe to newsletter. Your email is safe and will never be shared. Please enter your email address:_______________________________________________________________ (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 _______________________________________________________________ Catalog of Articles Published on Hank Barnes World, You Bet Your Life, by Jeffrey Dach MD _______________________________________________________________ (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 _______________________________________________________________ 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 33021954-983-1443 _______________________________________________________________ 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. If this email is sent to you in error, please accept our apology, and simply remove your email from the list with the unsubscribe button on the bar below this text. Sorry for the inconvenience. (c) 2007 all right reserved Jeffrey Dach MD disclaimer
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 articlesSalivary estradiol 177Salivary progesterone 317Salivary 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 LabsClimara (estradiol): FDA approved 1994 - BayerFemPatch : FDA approved 1997 - Parke DavisVivelle-Dot (estradiol): FDA approved 1994 - NovartisEstraderm: FDA approved 1986 - NovartisEsclim: FDA approved 1998 - Women's First HealthcareEstrace (estradiol): FDA approved 1993 -Bristol Myers SquibbEstring: FDA approved 1996 - Pharmacia UpJohnPrometrium (natural progesterone): FDA approved 1998 - SolvayAndrogel (natural testosterone): FDA approved 2000 - Unimed PharmaceuticalsCrinone: 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. GuytonWilliams Textbook of EndocrinologyBasic & Clinical Endocrinology by Francis S. Greenspan Review of Medical Physiology by Ganong, William F. MDEndocrinology (5th Edition) by Mac E. HadleyEndocrine 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
__________________________________________ Special Television Announcement : Watch Dr. Dach on Channel 7 News talking about Bio-Identical Hormones. Click Here for Video Special Radio Announcement : Listen to Dr. Dach on Radio Show, Alternative Mainstream Click Here to Listen (Dr. Dach comes on air 15 minutes after start, so be patient) ______________________________________________________
The Untold Message of Breast Cancer Awareness Month
by Jeffrey Dach MD
for original article go here: http://www.jeffreydach.com
http://jeffreydach.com/2007/11/04/the-untold-message-of-breast-cancer-awareness-month.aspx
Breast Cancer Awareness Month Fails to Disclose Limitations of Mammography
October was Breast Cancer Awareness Month, which is an advertising campaign for national mammography screening. An eminent radiologist, Leonard Berlin MD says this message fails to disclose the limitations of screening mammography, namely that mammography will miss 30-70% of breast cancers, and leads to over diagnosis and over treatment. He also says mammography disclosures should be mandated, just like the cigarette and drug warnings that appear on their ads. Otherwise, we create unrealistic expectations for mammography which cannot be met. The public expects every breast cancer to be detected. They are not. This translates into increased medical malpractice payouts for the missed cancer, which is now the most prevalent medical malpractice case against all physicians. (1) (1A) (1B) (2) (3) (4) The fact is that mammograms are difficult to interpret, cancers can be hidden, and many are missed. This cancer miss is not from lack of training or competency on the part of the radiologist. It is inherent in the mammogram technique itself. The American College of Radiology says that 30-70% of breast cancer are missed on the initial mammogram, and are seen in retrospect a year later by going back to the previous mammogram interpreted as normal.With this legal environment, it is a miracle that mammography has survived at all.(5) (6) Screening Mammography is Not Prevention. Leonard Berlin points out that 57% of the American women believe that mammograms prevent breast cancer, a misleading message from Breast Awareness Month. (1B) Mammograms are designed to detect cancer, not prevent it. Thinking that a mammogram can prevent breast cancer is like thinking that checking your house annually for broken windows, prevents robberies. Secondly. the most likely outcome of a positive mammogram is an unnecessary biopsy, causing emotional distress, breast deformity and scarring. 80% of all breast biopsies done for a positive finding on a mammogram are negative for cancer. (5) My Own Experience with Mammography When I began residency training in radiology at Rush Presbyterian Hospital in Chicago in 1971, the state of the art was Xeromammography. This was a machine made by the Xerox Company which was prone to mechanical failure, and always breaking down. It produced a blue photo on paper with blue toner powder. (27) (29) Example of Xeromammogram Example of X-ray Film Mammogram In those days, Franklin S Alcorn MD, was the only brave soul willing to read the Xerox images, and the book was Xeroradiography by John N. Wolfe. In 1972, the consensus in the department was that mammography was an orphan procedure and might never become acceptable. Some docs thought xeromammography was bordering on quackery, and screening mammogram had not been invented yet. (30) Useful to the Surgeon In those early days, the surgeon's criteria for doing a breast biopsy was a palpable mass. Many women have palpable lumps and bumps called fibrocystic breast disease which is quite common, and now known to be caused by iodine deficiency. (7) Cyst or Solid Breast Mass? In those days, the surgeon approached a breast mass with needle aspiration to differentiate between a fluid containing cyst or a solid mass. Nowadays, ultrasound determines this easily. Back to the needle aspiration procedure; if the lesion is a cyst, the fluid is removed and the mass disappears. If no fluid can be obtained, then the mass is solid, and surgical removal is the next step. This is where the surgeons found the xeromammogram useful, occasionally showing a second occult mass or calcification which alerts the surgeon to remove additional tissue. Invention of Needle Localization Sometimes the surgeon had trouble actually finding the tiny calcifications at surgery since they couldnt feel them, so needle localization was invented. The radiologist placed a needle in the breast tissue near the calcifications which guided the surgeon to the spot to be removed. The surgically excised breast tissue was returned to the X-ray department for another mammogram of the specimen to determine if the lesion had been removed (see below). Example of excised specimen with needle localization (done for calcifications) Example of Needle Localization for spiculated mass typical for malignancy in specimen. The Switch from Blue Paper to Gray Xray Film Grey X-Ray film mammograms replaced the blue Xerox paper images around 1982. By that time, I had joined a radiology group in Hollywood, Florida, but they were still using the xerox machine even though the whole country had already made the switch to regular x-ray film. This inevitable switch-over to X-ray film made possible the large scale national breast screening programs, since the mammogram could be done at any hospital x-ray department. (27) Finally, We All Learn Mammography My radiology group made the plunge into film mammography. None of us had prior training or experience reading mammograms, so we traveled to expensive meetings and teaching courses on mammography from leaders in the field, such as Marc Homer MD and Laszlo Tabar MD (Sweden), and then we started reading on our own. (8) From Breast Needle Biopsy to the Creation of a New Department Soon we were doing the needle localizations (using the Marc Homer needle) and needle biopsies in the radiology department. Initially, biopsies were done with simple supplies, a standard 20 gauge needle and 10 cc disposable syringes. A few years later, the radiology industry came out with spring loaded and vacuum assisted biopsy guns, and later invented dedicated biopsy tables using stereo-tactic guidance. This machine allows the operator to take two x-rays at different angles, and uses a computer to calculate the exact position for the biopsy needle. By 2005, the cranky unreliable blue toner xeromammogram had been replaced with a shiny new department on the third floor with all the new modalities: hi-resolution digital mammography, stereotactic biopsy, breast ultrasound, and breast MRI. There is no question that the combination of these modalities makes a powerful and useful tool for diagnosis, treatment and follow up of breast cancer cases. However, this is quite different from screening mammography which is discussed below. Victimization of Women?, No, Merely Good Medical Care. When we started the screening mammogram program, many of the suspicious findings were false positive meaning they looked like something, but were in fact nothing. The radiologist would send a report of "suspicious requires biopsy" to the doctor who would tell the patient it might be cancer, and the terrorized woman would then not only submit to surgical biopsy under anesthesia, she would become hysterical and insist on the biopsy immediately. The negative biopsy would be a relief to the patient making the surgeon a hero. Feminists call this victimization of women, and healthcare professionals would call this good medical care. Occasionally, about 10-20% of the time, a real cancer would be found at surgery. These were typically spiculated masses or branching tell-tale calcification patterns. In the early days, the punctate calcifications and the milk-of calcium (teacup) were called benign and did not require biopsy, and the branching calcifications indicated malignancy requiring biopsy and further treatment, However, nowadays, even the benign calcifications are routinely sent for biopsy, sometimes showing a controversial non-aggressive cancer called DCIS. (9) (10) What's Your Track Record ? At first, we had no idea how many of our mammogram readings of suspicious for cancer were actually found to be cancer by surgical biopsy and pathology evaluation. So, we started compiling the pathology data and attended monthly conferences to review the data and our track record. The average is one cancer every 5 biopsies, but each radiologist and hospital may have more or less. Optimally, this information should be posted on the wall of the waiting room. Unfortunately, this type of data is rarely available to the patient. Questioning Screening Mammography In the 1980s I believed, along with every one else in the health care industry, that mammography was capable of early detection of breast cancer, and that mass screening programs were capable of reducing breast cancer mortality. I even wrote a short editorial that appeared in the Miami Herald to this point which won the praise of my associates at the hospital. Starting around 1995, however, I began to question the idea of screening mammography. Even from the beginning, there was a debate between proponents and critics of mammogram screening. They argued that the studies either did, or did not show reduction in breast cancer mortality. The critic, Samuel Epstein says mammograms cause harm from overtreatment with unnecessary breast biopsies, and the radiation increases breast cancer risk. Luck of the Draw - Mammography Malpractice One of radiologists in my group had the misfortune of being sued for malpractice. He missed a cancer on a mammogram that was visible in retrospect a year later. Remember, this happens 30-70% of the time, routinely. This event happened early in his career, just out of training, before I joined the group. His insurance company quickly settled the case by paying the woman a settlement of a million dollars, with no attempt at defending the case. As you can imagine, this was a major event which changed how he interpreted mammograms. After that, he was gun shy, almost always did a callback for additional views, and always recommended biopsy for any vague density. The problem is that almost every mammogram has vague densities. Almost all of these biopsies were unnecessary for the patient, but they were quite necessary for the radiologist, considering the medico-legal climate. The x-ray techs quickly learned to bring the mammograms over to my reading area for a quick negative, rather than to the other reading room, where they usually end up doing more views and send the patient for biopsy of a questionable area. This went on for years, and I was never sued for malpractice on a mammogram reading during my entire career. I consider this "the luck of the draw". Realizing the high rate of false positive biopsies and the emotional impact on women, I did my best to call the negative mammograms negative realizing there could be a cancer hiding somewhere, and the visible cancers were sent to biopsy. Biopsy Everything and Anything The reality of a hostile medico-legal malpractice climate and financial pressure dictates the practice of mammography in most community hospitals. Current practice is to basically biopsy anything and everything that shows up on the mammogram, as long as the patient is compliant. Its not difficult getting compliance by telling patient that it might be cancer, we cant be sure. That usually is enough to make the woman hysterical and submit to biopsy. The radiologist is happy because he thinks he is reducing his chances of being sued for malpractice. His partners and the hospital administrators are happy because the procedures bring in more income. If cancer is found, the surgeons are happy because they have more lumpectomies and cancer operations to keep them busy. DCIS, the Controversial Non-Aggressive Cancer Over half of the cancers detected with mammography are DCIS (ductal carcinoma in situ). This is a non-aggressive form of cancer which has a 98% survival after 5 years even with no treatment, although when found, they are treated with surgery as any other cancer. Some consider this detection and treatment of DCIS a form of overtreatment, others consider it good medical care. Example small calcifications representing DCIS on an old Xerox-mammogram.. Some critics have said that increased mammographic detection of DCIS has skewed the statistics, falsely reducing breast cancer mortality. This makes it look like we are reducing breast cancer mortality, and we are not. Without mammography, most of these DCIS cases would go undetected, and probably never cause a problem. Autopsy studies of women dying from car accidents have shown occult DCIS in up to 15% of the population. The actual incidence of cancer mortality is 0.4 per cent, not 15 per cent, suggesting that 96% of DCIS cases never go on to clinical disease. Yet, when DCIS is detected on the mammogram, these cases are treated with the same mastectomy or lumpectomy. A third of the time, pathologists will disagree on the diagnosis of DCIS while looking at the same case. (11) (12) Lung Cancer Screening Screening tests in radiology have been tried before. For example chest x-ray screening for lung cancer was tried, studied and abandoned. It was found that when you do a chest X-ray on smokers every 6 months, find the cancers and send the patient to surgery for treatment, there is no change in mortality figures. No lives are saved. In addition to make matters worse, when you go back to the earlier films 6 months before, on the film that was read as negative or normal in retrospect the lesion is visible 90% of the time. (13) (14) We thought these problems would be solved by moving up to CAT scans, a more advanced imaging technique. However, now we have a problem with seeing too many "suspicious" lesions and the false positive diagnosis. The net result is that lung cancer screening even with CAT scanning has not caught on. (15) Mammogram screening in the under 50 age group NOT recommended by all other countries. Current guidelines recommend a screening mammogram every 2 years for the 40-50 year age group. No other western country does this, as these women have dense breast tissue difficult to image and are most prone to a false positive reading, or a diagnosis of DCIS, the controversial less aggressive form of cancer. Most European countries restrict screening to post-menopausal women, after 50, when breast tissue involutes to fat and the cancers become more conspicuous. Efficacy of Breast Cancer Screening - Does It Reduce Mortality? The public perception is that breast cancer screening reduces breast cancer mortality. The reality is that this is a fiercely debated question in the medical literature with no clear winner. Leonard Berlin's articles summarize this debate in the medical literature. (3) The debate is best shown by one example mentioned Dr. Berlin in the Sept 2002 issue of the Annals of Internal Medicine in which two conflicting articles appeared in the same issue, one stating that mammography has no mortality benefit, and the other saying it does. Here are the two articles: (1) Canadian researchers concluded that mammography screening did not reduce breast cancer mortality (16) (17) (2) United States Preventive Services Task Force concluded mammography reduces breast cancer mortality among women 40-74 years old. (18) (19) Another excellent review of major Mammography Screening Studies can be found at the National Breast Cancer Coalition (web site). (44) Bottom line, the debate rages on with no clear winner. One observation which might clarify the debate is this: in two countries with socialized medicine, Canada and Sweden, careful studies of mammography screening were found to have NO Mortality Benefit compared to breast clinical exam. Here in the US, however, with a 4 billion dollar fee-for-service screening mammogram industry, the mammography studies are interpreted to show that Yes, there is a Mortality Benefit of about 15-20% . The influence of money and politics over medical science is pervasive, and mammography is certainly not immune. A few MD PHD's from Canada or Sweden are not about to derail a 4 billion dollar industry in the US. Conflict of Interest in Sponsoring Breast Cancer Awareness Month? Screening mammography critic, Samuel Epstein MD, irritates the establishment every time he points out that in 1984, the American Cancer Society created the October National Breast Cancer Awareness Month sponsored by money from the Astra-Zeneca Company, the maker of Tamoxiphen, the best selling breast cancer drug. In addition, Astra-Zeneca also manufactures industrial chemicals that cause breast cancer. Some consider this a conflict of interest. Epstein also points out that past ACS advertisement promised early detection results in a cure nearly 100% of the time. Even more seriously, the Awareness Month advertisements avoid any reference to information on avoidable causes and prevention of breast cancer. (20) (21) What is breast cancer prevention? A previous newsletter discusses Iodine supplementation as the most effective way to prevent breast cancer. Iodine tablets are safe, inexpensive and readily available. This is true prevention.(7) Samuel Epsteins landmark book, "The Politics of Cancer" discusses carcinogenic chemicals in our food supply, home and workplace. Removing them can reduce breast cancer. This is true prevention. (22) (23) The Untold Message of Breast Cancer Awareness Month: To summarize, here is the untold message of Breast Cancer Awareness Month: 1) mammography screening is detection, not prevention and has several limitations, namely 30-70% missed cancers, and a tendency towards over diagnosis and over treatment. (5) 2) Many different carcinogenic chemicals cause breast cancer, and removing these chemicals from the workplace or home can reduce breast cancer rates. (22) (23) 3) Iodine deficiency causes fibrocystic disease, and Iodine supplementation prevents breast cancer.(7) 4) Synthetic hormones like Provera increase breast cancer risk. (WHI Study)(24) 5) Bio-Identical Hormone programs are safe, and do not increase risk of breast cancer. (French Cohort Study) (25) Will mainstream medicine ever endorse Dr. Leonard Berlin's Truth-in-Mammography disclaimers ? No, this will never happen. The public's unrealistic expectation that a breast cancer nodule will be detected 100% of the time will continue, and the high cost of medical malpractice will simply be absorbed into "the cost of doing business". The screening mammogram is here to stay. As for my own opinion, I am not opposed to the status quo of mammogram screening in the over 50 age group. However, I am opposed to creating unrealistic expectations with false and misleading advertising.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 MD 4700 Sheridan Suite T Hollywood Fl 33021 954 983 1443 Jeffrey Dach, M.D. BLOG TrueMedMD disclaimer References (1) American Cancer Society Breast Cancer Prevention Page: Yearly mammograms are recommended starting at age 40 and continuing for as long as a woman is in good health. (1A) 3-29-2005 Leonard Berlin, M.D, FACR, Chairman of Radiology at Rush North Shore Medical Center, Skokie, will be awarded the Distinguished Service Gold Medal Award of the Chicago Radiological Society, its highest honor at a ceremony on April 21, in Chicago, IL. The Gold Medal is awarded annually to an individual who has rendered unusual service to the science of radiology and will be presented to Dr. Berlin by his son, radiologist Jonathan W. Berlin, M.D. Berlin is Charman of Skokie Valley Hospital Department of Radiology. (1B) Leonard Berlin, MD Mammography Screening Can Survive Malpractice . . . If Radiologists Take Center Stage and Assume the Role of Educator (2) Berlin L. The missed breast cancer redux: time for educating the public about the limitations of mammography? AJR Am J Roentgenol 2001; 176:1131–1134. (3) Malpractice Issues in Radiology, Breast Cancer, Mammography, and Malpractice Litigation: The Controversies Continue Leonard Berlin,Excellent discussion of controversy of screening mammography and impact on mortality figures. (4) Perspective Dot Size, Lead Time, Fallibility, and Impact on Survival Continuing Controversies in Mammography Leonard Berlin MD (5) STATEMENT of Leonard Berlin, M.D. To the U.S. Senate Committee on Health, Education Labor and Pensions Re: Mammography Quality Standards Act Reauthorization April 8, 2003. Leonard Berlin: Suffice it to say that research studies performed at some of the most prestigious medical institutions in the United States reveal that as many as 90% of lung cancers, and 70% of breast cancers, can at least partially be observed on previous studies read as normal. (6) A Manifesto for Truth-in-Mammography Advertising by Leonard Berlin MD Imaging Economics, November 2004 From cigarettes to pharmaceuticals to financial services, all advertisements feature a disclaimer: Why not those for mammography? Of all medical malpractice lawsuits filed in the United States that allege a delay in the diagnosis of breast cancer, radiologists are the most frequently sued specialists. Of all medical malpractice lawsuits lodged against radiologists, the most frequent cause is the allegation of a missed breast cancer on mammography. Why has "missed breast cancer" risen to first place in the medical malpractice standings? I suggest that it is because we have oversold mammography. We have marketed mammography without informing the American public all that we know about not only the benefits, but more important the limitations and potential harms of mammography. (7) Iodine Prevents Breast Cancer by Jeffrey Dach MD (8) Screening mammogram studies Swedish Study by Dr. Laszlo Tabar (1977- 1984) Population-based randomized controlled study 31% reduction in breast cancer mortality in women 50 plus (9) INTERACTIVE MAMMOGRAPHY ANALYSIS WEB TUTORIAL Images of benign calcifications, secretory disease, milk of calcium, etc. (10) Tutorial 2 : CALCIFICATIONS ASSOCIATED WITH A HIGH PROBABILITY OF MALIGNANCY (11) Ductal Carcinoma In Situ of the Breast Elisabeth L. Dupont, MD; Ni Ni K. Ku, MD; Christa McCann, BA; and Charles E. Cox, MD, FACS DCIS, 60% of DCIS cases are discovered solely by mammography Seven major autopsy studies of women not known to have had breast cancer have provided insight. Six studies found an incidence of 4% to 18%.7 The seventh and largest study showed a 0.2% incidence (1 in 519 cases).8 However, this study included a significant proportion of groups known to have a smaller than usual risk of breast cancer. Of the more than 1,000 cases comprising these seven studies, only one case of invasive cancer was detected. Further analysis with fixed criteria is needed. (DCIS) this type of cancer now accounts for nearly half of mammographically detected cases of cancer. (12) Using Autopsy Series To Estimate the Disease "Reservoir" for Ductal Carcinoma in Situ of the Breast: How Much More Breast Cancer Can We Find? H. Gilbert Welch, MD, MPH, and William C. Black, MD Annals of Internal Medicine December 1997 Volume 127 Issue 11 Pages 1023 (13) DOES LUNG CANCER SCREENING SAVE LIVES? (14) Lung cancer screening (15) Corporate Medical Policy Lung Cancer Screening, CT Scanning or Chest Radiographs BC BS doesn’t cover Lung cancer screening with chest CAT or Xrays. (16) Miller AB, To T, Baines CJ, Wall C. The Canadian national breast screening study. 1. Breast cancer mortality after 11 to 16 years of follow-up. Ann Intern Med 2002;137:305 312 After 11 to 16 years of follow-up, four or five annual screenings with mammography, breast physical examination, and breast self-examination had not reduced breast cancer mortality compared with usual community care after a single breast physical examination and instruction on breast self-examination. The study data show that true effects of 20% or greater are unlikely. Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality.The Editors (17) Journal of the National Cancer Institute, Vol. 92, No. 18, 1490-1499, September 20, 2000 Canadian National Breast Screening Study-2: 13-Year Results of a Randomized Trial in Women Aged 50–59 Years Anthony B. Miller, Teresa To, Cornelia J. Baines, Claus Wall, For the Canadian National Breast Screening Study-2 Results: Randomization achieved virtually equal distribution of demographic and breast cancer risk variables. At the first annual screen, 21% of the cancers found by mammography alone (in the mammography plus physical examination group) were 20 mm or more in size compared with 46% of those found by physical examination in the mammography plus physical examination group and 56% in the physical examination-only group. The corresponding percentages for screens were 10%, 42%, and 50%, respectively. Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group. By December 31, 1993, 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group, and 610 and 16 were ascertained in the physical examination-only group. At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups, the cumulative rate ratio was 1.02 (95% confidence interval = 0.78 ). Conclusion: In women aged 50 - 59 years, the addition of annual mammography screening to physical examination has no impact on breast cancer mortality. (18) Humphrey LL, Helfand M, Chan BKS, Woolf SH. Breast cancer screening: a summary of the evidence for the U. S. Preventive Services Task Force. Ann Intern Med 2002;137:347 -360 The U.S. Preventive Services Task Force recommends screening mammography, with or without clinical breast examination, every 1 to 2 years for women aged 40 and older. (19) United States Preventive Services Task Force concluded mammography reduces breast cancer mortality among women 40-74 years old. (20) Dangers and Unreliability of Mammography: Breast Examination is a Safe, Effective, and Practical Alternative Samuel S. Epstein, Rosalie Bertell, and Barbara Seaman International Journal of Health Services, 31(3):605-615, 2001. (21) Cancer, Inc - National Breast Cancer - Awareness Month Sierra, Sept, 1999 by Sharon Batt, Liza Gross THEY MAKE THE CHEMICALS, THEY RUN THE TREATMENT CENTERS, AND THEY'RE STILL LOOKING FOR "THE CURE"--NO WONDER THEY WON'T TELL YOU ABOUT BREAST CANCER PREVENTION Astra Zeneca Sam Epstein (22) Cancer Prevention Coalition (23) The Politics of Cancer, Revisited 1998 By Samuel S. Epstein, M.D. Foreword by Congressman David Obey,Introduction by Congressman John Conyers In this book, world-cancer expert Dr. Samuel Epstein indicts the National Cancer Institute and the American Cancer Society for responsibility in losing the cancer war- (24) Postmenopausal Hormone Replacement Therapy Scientific Review Heidi D. Nelson, MD, MPH; Linda L. Humphrey, MD, MPH; Peggy Nygren, MA; Steven M. Teutsch, MD, MPH; Janet D. Allan, PhD, RN JAMA. 2002;288:872-881. (25) French Cohort Study (26) Leonard Berlin MD biography (27) Breast Imaging: From 1965 to the Present Edward A. Sickles, MD, Radiology. 2000;215:1-16.) Examples of xeromammograms and film mammograms, speculated lesion, needle localization. (28) Case 41: Ductal Carcinoma in Situ, Alanna T. Harris, MD The detection of ductal carcinoma in situ has increased markedly in recent years secondary to the widespread use of screening mammography, and it now accounts for 25 to 40% of mammographically detected breast cancers (29) History of Breast Cancer WILLIAM L. DONEGAN (30) History: Narratives Radiology in Illinois By Franklin Alcorn, M.D. Dr. Alcorn's history appeared in the program of the Chicago Radiological Society at the Centennial of Radiology in 1995. (31) Miller AB, To T, Baines CJ, Wall C. The Canadian national breast screening study. 1. Breast cancer mortality after 11 to 16 years of follow-up. Ann Intern Med 2002;137:305-312 After 11 to 16 years of follow-up, four or five annual screenings with mammography, breast physical examination, and breast self-examination had not reduced breast cancer mortality compared with usual community care after a single breast physical examination and instruction on breast self-examination. The study data show that true effects of 20% or greater are unlikely. Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality.The Editors (32) Journal of the National Cancer Institute, Vol. 94, No. 20, 1546-1554, October 16, 2002 Detection of Ductal Carcinoma In Situ in Women Undergoing Screening Mammography Virginia L. Ernster Results: A total of 3266 cases of breast cancer were identified, 591 DCIS and 2675 invasive breast cancer. The percentage of screen-detected breast cancers that were DCIS decreased with age (from 28.2% [95% confidence interval (CI) = 23.9% to 32.5%] for women aged 40 to 49 years to 16.0% [95% CI = 13.3% to 18.7%] for women aged 70 to 84 years). However, the rate of screen-detected DCIS cases per 1000 mammograms increased with age (from 0.56 [95% CI = 0.41 to 0.70] for women aged 40 to 49 years to 1.07 [95% CI = 0.87 to 1.27] for women aged 70 to 84 years). Sensitivity of screening mammography in all age groups combined was higher for detecting DCIS (86.0% [95% CI = 83.2% to 88.8%]) than it was for detecting invasive breast cancer (75.1% [95% CI = 73.5% to 76.8%]). Conclusions: Overall, approximately 1 in every 1300 screening mammography examinations leads to a diagnosis of DCIS. Given uncertainty about the natural history of DCIS, the clinical significance of screen-detected DCIS needs further investigation. (33) Ductal Carcinoma In Situ of the Breast Elisabeth L. Dupont, MD; Ni Ni K. Ku, MD; Christa McCann, BA; and Charles E. Cox, MD, FACS DCIS, 60% of DCIS cases are discovered solely by mammography Seven major autopsy studies of women not known to have had breast cancer have provided insight. Six studies found an incidence of 4% to 18%.7 The seventh and largest study showed a 0.2% incidence (1 in 519 cases). However, this study included a significant proportion of groups known to have a smaller than usual risk of breast cancer. Of the more than 1,000 cases comprising these seven studies, only one case of invasive cancer was detected. Further analysis with fixed criteria is needed. (DCIS) this type of cancer now accounts for nearly half of mammographically detected cases of cancer. (34) STATEMENT of Leonard Berlin, M.D. To the U.S. Senate Committee on Health, Education Labor and Pensions Re: Mammography Quality Standards Act Reauthorization April 8, 2003. Leonard Berlin: Suffice it to say that research studies performed at some of the most prestigious medical institutions in the United States reveal that as many as 90% of lung cancers, and 70% of breast cancers, can at least partially be observed on previous studies read as normal. (35) A Manifesto for Truth-in-Mammography Advertising by Leonard Berlin MD Imaging Economics, November 2004 From cigarettes to pharmaceuticals to financial services, all advertisements feature a disclaimer: Why not those for mammography? Of all medical malpractice lawsuits filed in the United States that allege a delay in the diagnosis of breast cancer, radiologists are the most frequently sued specialists. Of all medical malpractice lawsuits lodged against radiologists, the most frequent cause is the allegation of a missed breast cancer on mammography. Why has "missed breast cancer" risen to first place in the medical malpractice standings? I suggest that it is because we have oversold mammography. We have marketed mammography without informing the American public all that we know about not only the benefits, but more important the limitations and potential harms of mammography. (36) Mammography Books (37) AJR 2001; 176:1123-1130 Perspective Dot Size, Lead Time, Fallibility, and Impact on Survival Continuing Controversies in Mammography Leonard Berlin mammography had become the most prevalent procedure involved in malpractice lawsuits filed against radiologists, and that the allegation of an error in the diagnosis of breast cancer had become the most prevalent condition precipitating medical malpractice lawsuits against all physicians. An article published in the ACR (American College of Radiology) Bulletin pointed out that 30-70% of breast cancers detected at followup mammography are visible in retrospect on initial mammograms that had been interpreted as showing normal findings The debate as to whether screening mammography saves lives and lengthens survival rages on and will certainly not be resolved in the foreseeable future . This article is not intended to be a comprehensive review of all available data on the subject of mammographic efficacy. Even if it were, no definitive answer to the question of whether mammography does indeed reduce mortality from breast cancer would be found. (38) Journal of the National Cancer Institute, Vol. 92, No. 18, 1490-1499, September 20, 2000 Canadian National Breast Screening Study-2: 13-Year Results of a Randomized Trial in Women Aged 50 to 59 Years Anthony B. Miller, Teresa To, Cornelia J. Baines, Claus Wall, For the Canadian National Breast Screening Study-2 Results: Randomization achieved virtually equal distribution of demographic and breast cancer risk variables. At the first annual screen, 21% of the cancers found by mammography alone (in the mammography plus physical examination group) were 20 mm or more in size compared with 46% of those found by physical examination in the mammography plus physical examination group and 56% in the physical examination-only group. The corresponding percentages for screens were 10%, 42%, and 50%, respectively. Screening detected 267 invasive breast cancers in the mammography plus physical examination group compared with 148 in the physical examination-only group. By December 31, 1993, 622 invasive and 71 in situ breast carcinomas were ascertained in the mammography plus physical examination group, and 610 and 16 were ascertained in the physical examination-only group. At 13-year follow-up, with 107 and 105 deaths from breast cancer in the respective groups Conclusion: In women aged 50 to 59 years, the addition of annual mammography screening to physical examination has no impact on breast cancer mortality. (39) Pink Ribbon Madness: Say No to Breast Cancer Exploitation for Corporate Profit (40) article critical of mammographhy (41) Dangers and Unreliability of Mammography: Breast Examination is a Safe, Effective, and Practical Alternative Samuel S. Epstein, Rosalie Bertell, and Barbara Seaman International Journal of Health Services, 31(3):605-615, 2001. (42) AJR 2001; 176:1131-1134 Malpractice Issues in Radiology The Missed Breast Cancer Redux Time for Educating the Public About the Limitations of Mammography? Leonard Berlin (43) Cancer, Inc - National Breast Cancer - Awareness Month Sierra, Sept, 1999 by Sharon Batt, Liza Gross THEY MAKE THE CHEMICALS, THEY RUN THE TREATMENT CENTERS, AND THEY'RE STILL LOOKING FOR "THE CURE"--NO WONDER THEY WON'T TELL YOU ABOUT BREAST CANCER PREVENTION Astra Zeneca Sam Epstein (44) National Breast cancer Coalition, Position Statement on Screening Mammography Updated May 2007 Excellent review of all studies up to May 2007. Overall, mammography screening has a modest effect on breast cancer mortality. When analyzed in absolute terms, the death rate is reduced by just 0.05%. (45) Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. Does Screening Mammography Save Lives? Numbers May Not Justify Practice for Routine Mammograms OPINION By NORTIN HADLER. M.D. In the United States, radiologists are so hesitant to read a mammogram as "normal" that false positive rates can reach 80 percent. This hedging on the readings is driven by the fact that "missing a breast cancer" on mammography is the most frequent reason for malpractice litigation in the United States. But screening mammography is so terribly blunt that it approaches useless: It finds very few cancers that are truly treatable, it misses many of these and it is awash in false positives. Norway, Sweden, Australia and the United Kingdom are re-examining their national experience with screening mammography because of appraisals similar to mine. If a woman's life was saved because of early detection of an evil breast cancer, she should thank her lucky stars rather than her mammographer. I would relegate mammograms to the archives of false starts, next to radical mastectomy (46) After 40 Years, Mammography Remains as Much Emotion as Science Judith Randal Journal of the National Cancer Institute, Vol. 92, No. 20, 1630-1632, October 18, 2000 For the better part of a century, it would have been unthinkable to treat primary breast cancer with anything but the operation pioneered in the 1890s by William Halsted, M.D., one of the most prominent surgeons of his day. Beginning in the 1970s, the Halsted era drew gradually to a close when randomized controlled trials found that the operation generally known as radical mastectomy was no more effective than less drastic surgery (sometimes in combination with radiation). Could a similar fate await the current gold-standard status of screening mammography? Will a time come when its popularity dwindles, too? mammography now a $4 billion a year industry in the United States alone Absent unforeseen developments, it is probably safe to predict that mammography for screening will continue to be as much about strongly held opinions and political pressures as about science. (47) Good News and Bad News About Breast Cancer by David Plotkin M.D. The Atlantic Monthly Breast cancer is a major public-health concern; it kills 0.04 percent of all American women yearly. Most of the time the news is reassuring; two thirds to four fifths of all biopsies reveal that the abnormality is not malignant. (Women in their forties are more likely than older women to have negative biopsies, because mammograms of their naturally lumpier breasts are harder to interpret.) An official nationwide mammography program would be a huge commitment: 51.5 million American women are aged forty or above. And one must bear in mind the cost of needless medical procedures generated by the huge number of false-positive mammograms—two to four false positives for every true positive, according to some measures. On balance, then, I reluctantly support the status quo. When my patients come in for their mammograms, I do not try to dissuade them. But I tell them that the most optimistic interpretation of the available evidence suggests that routine mammography has only a marginal effect on a woman's chances of surviving breast cancer—and that it may have no effect at all. (48) Journal of Clinical Oncology, Vol 21, Issue 1 (January), 2003: 41-45 High Prevalence of Premalignant Lesions in Prophylactically Removed Breasts From Women at Hereditary Risk for Breast Cancer N. Hoogerbrugge, P. Bult, L.M. de Widt-Levert, L.V. Beex, L.A. Kiemeney, M.J.L. Ligtenberg, L.F. Massuger, C. Boetes, P. Manders, H.G. Brunner Full text The fact that an occult carcinoma was present in only one of 67 patients in our study might indicate that surveillance is as effective as prophylactic mastectomy. However, in our study, all 10 DCIS cases were missed by surveillance, and it was recently shown by Meijers-Heijboer that surveillance is less effective than prophylactic mastectomy in preventing breast cancer deaths. (49) Mammographic Screening for Breast Cancer Suzanne W. Fletcher, M.D., and Joann G. Elmore, M.D., M.P.H. NEJM Volume 348:1672-1680 April 24, 2003 Number 17 (50) POINT COUNTERPOINT On the efficacy of screening for breast cancer David A Freedman,1 Diana B Petitti,2 and James M Robins International Journal of Epidemiology 2004;33:4355 (51) International Journal of Epidemiology 2004;33:6973 Rejoinder David A Freedman, Diana B Petitti and James M Robins REJOINDER (52) Screening for Breast Cancer. Joann G. Elmore, MD, MPH; Katrina Armstrong, MD; Constance D. Lehman, MD, PhD; Suzanne W. Fletcher, MD, MSc JAMA. 2005;293:1245-1256. All major US medical organizations recommend screening mammography for women aged 40 years and older. Screening mammography reduces breast cancer mortality by about 20% to 35% in women aged 50 to 69 years and slightly less in women aged 40 to 49 years at 14 years of follow-up. Approximately 95% of women with abnormalities on screening mammograms do not have breast cancer with variability based on such factors as age of the woman and assessment category assigned by the radiologist. Studies comparing full-field digital mammography to screen film have not shown statistically significant differences in cancer detection while the impact on recall rates (percentage of screening mammograms considered to have positive results) was unclear. (53) Cancer Epidemiology Biomarkers & Prevention Vol. 13, 501-510, April 2004 Fear, Anxiety, Worry, and Breast Cancer Screening Behavior: A Critical Review Nathan S. Consedine, Carol Magai, Yulia S. Krivoshekova, Lynn Ryzewicz and Alfred . Neugut3 Women's fears surrounding breast cancer seem to encompass nearly "everything" but certainly include fear of a breast cancer diagnosis, fear of pain/discomfort, and more complicating, fear of embarrassment. To this list, we can add fear of the medical establishment, radiation, nonspecific "cancer worry" general anxiety, or phobia . (54) Cancer: When it isn’t a killer DCIS: Precancer, benign cancer or what? What Doctors Don't Tell You (Volume 13, Issue 10) The cancer establishment was recently rocked to its core when Professor Michael Baum, an eminent and well-respected breast surgeon and researcher, claimed that screening for breast cancer should be scrapped because it caused hundreds of healthy women to undergo risky, mutilating and unnecessary treatments even when they may never develop the disease. His comments, made at a meeting of the Royal Society of Medicine, cut even more deeply because Baum was one of the physicians who helped set up the 50-million-a-year breast-screening service (Frith M, Scrap Breast Cancer Screening, Evening Standard, 10 December 2002, p 1). Baum has stated publicly that the most dramatic consequence of the rise in the numbers of routine mammographies has been a huge increase in the incidence of small, well-contained, relatively benign breast cancers known as ductal carcinoma in situ (DCIS) (BMJ Rapid Responses at bmj.com/cgi/eletters/325/ 7361/418#24945, 24 August 2002). (55) Michael Baum, Emeritus Prof. of Surgery University College London The Portland Hospital, 212-214 Great Portland Street, London W1W 5QN Re: Screening and Mastectomy rates (56) 'Scrap breast cancer screening' By Maxine Frith, Health Correspondent, Evening Standard 10.12.02 The man who helped to set up the NHS breast screening programme claims today that it does more harm than good. Professor Michael Baum, a leading expert in the field, said that screening for the disease causes hundreds of healthy women to have risky, mutilating and unnecessary treatments even when they may never develop the disease. Fifteen years after he established one of the first screening centres in the UK, Professor Baum has now called for the £50million a year service to be shut. He believes the techniques used for screening are not accurate enough and lead to too many false alarms. Professor Baum, who is to address the Royal Society of Medicine in London today, has been a long-standing critic of screening but has never before gone so far as to say it should be scrapped entirely, He is one of the most eminent breast surgeons in the country and a respected researcher into the disease. His comments have sparked a furious row among experts over the benefits of the NHS breast screening programme (57) Breast screen 'wrong care' fears, Breast screening may produce false positives. Concerns have been raised that breast cancer screening might lead to some women undergoing unnecessary treatment. Researchers looked at international studies on half a million women. They found that for every 2,000 women screened over a decade, one will have her life prolonged, but 10 will have to undergo unnecessary treatment. UK experts said women over 50 should go for their breast checks, but a screening pioneer raised doubts about the NHS programme's future. The report, published in the Cochrane Library, involved a review of breast cancer research papers from around the world. (58) Doubts raised by the pioneer of screening By Nic Fleming, Medical Correspondent 18/10/2006 (59) Screening for breast cancer with mammography. Gotzsche PC, Nielsen M Cochrane Reviews Main results: Seven completed and eligible trials involving half a million women were identified. We excluded a biased trial from analysis. Two (Canada and Malmo)trials with adequate randomisation did not show a significant reduction in breast cancer mortality, relative risk (RR) 0.93 (95% confidence interval 0.80 to 1.09) at 13 years; four trials with suboptimal randomisation showed a significant reduction in breast cancer mortality, RR 0.75 (0.67 to 0.83) (P = 0.02 for difference between the two estimates). RR for all six trials combined was 0.80 (0.73 to 0.88). The two trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, RR 1.02 (0.95 to 1.10) after 10 years, or on all-cause mortality, RR 1.00 (0.96 to 1.04) after 13 years. We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. Numbers of lumpectomies and mastectomies were significantly larger in the screened groups, RR 1.31 (1.22 to 1.42) for the two adequately randomised trials; the use of radiotherapy was similarly increased. Authors' conclusions: Screening likely reduces breast cancer mortality. Based on all trials, the reduction is 20%, but as the effect is lower in the highest quality trials, a more reasonable estimate is a 15% relative risk reduction. Based on the risk level of women in these trials, the absolute risk reduction was 0.05%. Screening also leads to overdiagnosis and overtreatment, with an estimated 30% increase, or an absolute risk increase of 0.5%. This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily. It is thus not clear whether screening does more good than harm. Women invited to screening should be fully informed of both benefits and harms. (60) Should We Offer Routine Breast Cancer Screening with Mammography? SEAN P. DAVID, M.D., S.M., Brown Medical School, Pawtucket, Rhode Island July 15 2003 (61) Screening for breast cancer with mammography Gotzsche PC, Nielsen M cochrane collaboration 2006 full text pdf (62) BMJ 2001;323:956 (27 October) Row over breast cancer screening shows that scientists bring "some subjectivity into their work Susan Mayor, London The review claimed that there was no reliable evidence to support the value of mammo-graphy screening in reducing deaths from breast cancer and alleged an association with increased rates of breast surgery. Ole Olson and Peter Gotsche from the Nordic Cochrane Centre, Righospitalet, Copenhagen, Denmark, reassessed as part of a Cochrane review a meta-analysis of seven randomised trials of screening mammography which they had previously carried out. This confirmed their original conclusion, they said, that there was no evidence of a reduction in either total or breast cancer mortality in two of the trials that they considered to be of sufficient quality to analyse. They added: "We have also confirmed that screening leads to more aggressive treatment, increasing the number of mastectomies by about 20% and the number of mastectomies and tumourectomies by about 30%" (Lancet 2001;358:1340-2 ). (63) BMJ 2002;324:677 ( 16 March ) Hazel Thornton, independent advocate for quality in research and healthcare. Letters Breast screening seems driven by belief rather than evidence. (64) BMJ 2001;323:1131 ( 10 November ) Letters. Office of NHS cancer screening programme misrepresents Nordic work in breast screening row Peter C Gotzsche, director. Nordic Cochrane Centre, Rigshospitalet, DK-2100 Copenhagen ø, (65) List of articles in Lancet on Screening Mammography (66) Professor of Radiology Course Director LÃzlo³ TabÃr, M.D. Professor of Radiology Course Director 2007 BREAST SEMINAR SERIES Covering the world of breast diagnosis (67) Screening mammogram studies Swedish Study by Dr. Laszlo Tabar (1977- 1984) Population-based randomized controlled study 31% reduction in breast cancer mortality in women 50 plus (68) National Breast Cancer Coalition (NBCC) The Mammography Screening Controversy:Questions and Answers February 8, 2002 (69) www.stopbreastcancer.org National Breast Cancer Coalition 1707 L Street, NW, Suite 1060 Washington, D.C. 20036 (202) 296-7477 voice (202) 265-6854 fax Position Statement on Screening Mammography Updated May 2007 (70) BreastCancerChoices.org cancer advocacy Iodine Supplement Informationcontact lynne. Breast Cancer Choices, Inc., a nonprofit organizationhelping patients make informed choices about breast screening, diagnostic procedures and treatment. Womens perception of the benefits of mammography screening: population based survey in four countries. Domenighetti G, DAvanzo B, Egger M, et al.Int J Epidemiol 2003; 32:816 821. Xeromammography is not quackery done by quacks says John Wolfe MD, author of Xeromamogram interpretation. Film screen mammography replaced it shortly there-after.Enthusiasm for cancer screening in the United States. JAMA 2004; 291: 7178. Schwartz LM, Woloshin S, Fowler FJ Jr, Welch HG Bartow SA, Pathak DR, Black WC, et al. Prevalence of benign atypical, and malignant breast lesions in populations at different risk for breast cancer: a forensic autopsy study. Cancer. 1987;60:2751-2760. Ringberg A, Palmer B, Linell F, et al: Bilateral and multifocal breast carcinoma: A clinical and autopsy study with special emphasis on carcinoma-in-situ. Eur J Surg Cancer 17:2029, 1991 9:38 AM GMT | Read comments(0)October 25Talking about Vitamin B12 Deficiency by Jeffrey Dach MD4:07 PM GMT | Read comments(1)Vitamin D Deficiency by Jeffrey Dach MD 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 8:32 AM GMT | Read comments(12)Vaccination, Autism Link, Real or Imagined? by Jeffrey Dach MD
Special Television Announcement : Watch Dr. Dach on Channel 7 News talking about Bio-Identical Hormones. Click Here for Video
Special Radio Announcement : Listen to Dr. Dach on Radio Show, Alternative Mainstream Click Here to Listen (Dr. Dach comes on air 15 minutes after start, so be patient) ______________________________________________________ Do Vaccinations Cause Autism ?If you ask this question to anyone in the medical establishment, government or drug industry, the answer would be a firm NO, with supportive peer review medical publications. However, if you asked this question to mothers of autistic children, or the (DAN) physicians treating them, the answer would be a an equally emphastic YES, of course , pointing to their own supportive medical studies. (1) (2) (3) (3A) (4) (5) Canary in the Coal Mine Autistic kids are the canaries in the coal mine, having genetic variations making it difficult for them to eliminate environmental toxins from their bodies. The most toxic is the ethyl mercury preservative in vaccines, unwittingly injected into young children before the are old enough to eliminate the mercury. Mercury impairs the immune system, causes auto-immune diseases, and is directly toxic to the brain, causing neurological disorders. (6) (7) (8) (9) It's a Crime in California In California, Governor Arnold Schwarzenegger signed the Thimerosal (Mercury) Law which took effect on July 1, 2006 prohibiting injection of mercury-containing vaccines to pregnant women or to children under age three. At the federal level, however, Pres. George Bush plans to veto similar legislation (FY 2008 HHS-Labor-Education Appropriations Bill). (10) (11) The Most Bitter Debate There is no greater rancor in medicine than the autism-vaccine debate, and this debate has reached the federal vaccine court where 5000 autistic kids and their families are requesting compensation for vaccine injury. Vaccination Deemed Necessary to Protect Society Society has deemed vaccination necessary to protect the nation from diseases such as smallpox, polio, diphtheria, and tetanus. In return for these benefits, society accepts the inevitable injury or death of the unlucky few from adverse effects. After all, vaccines contain foreign substances which provoke an immune response. Examples of vaccine injury include the 1 death per million from viral encephalitis and disseminated viral infection after smallpox vaccination. Another example of vaccine injury is paralytic polio after receiving the live Sabin oral polo vaccine. With the eradication of polio, there are now more polio cases caused by the vaccine then are prevented by it in the US. (12) (13) (14) The swine flu vaccine caused more deaths than did the Swine Flu itself, and there were 500 cases of vaccine associated Guillan Barre paralysis. Both the live polio vaccine and the swine flue vaccines have been discontinued in the US for these reasons. (15) (16) The National Childhood Vaccine Injury Act Large jury awards arising from DPT vaccine injury litigation in the 1980’s induced some vaccine makers to cease production, representing a threat to national military readiness in the case of biological warfare. (17) (18) So, Congress passed the 1986 National Childhood Vaccine Injury Act to provide for uninterrupted vaccine production. This law made the vaccine manufacturers immune from civil litgation, and instead established a Federal Court system to provide speedy compensation for vaccine-related injuries or death. (19) The court uses a table which lists the types of injuries which automatically qualify for compensation. However, Autism is not included in this table. (20) 5000 Autism Cases Before the Vaccine Court There are currently 5000 cases before the Federal Vaccine Court requesting compensation for vaccine related autism, and a ruling is expected within the next 6-12 months. (21) (22) The 5000 autistic families are represented by Kevin P. Conway, Ronald C Homer & Syvia Chin-Caplan, 16 Shawmut Street, Boston, MA 02116, Phone: 617-695-1990 (23) (24) Acceptance by the Medical Establishment Not Necessary A previous case was a victory. In Capizzano 05-5049 (3/9/2006), the Court decided that peer-reviewed scientific literature was not needed to win compensation. All that was needed was a medical theory linking an injury to the vaccine, a logical sequence of cause and effect, and a temporal relationship between them. This can be accomplished by medical records, or by an expert opinion. Peer-reviewed literature, pathological markers, rechallenge and general medical acceptance, are not required to win compensation. In other words, it is not necessary for the acceptance by the medical establishment that vaccines cause autism. It is not necessary for the peer review literature to show that vaccines cause autism. All that is needed is to show via medical records that Johnny was OK before the vaccination and after the vaccination, Johnny developed autism. 280 Billion Dollars for Autistic Children - Do the Math The current rate of autism as 1 in 150 children. Since there are 4 million live births annually in the US, this calculates out to 28,000 autistic kids annually, or 280,000 autistic kids per decade. Assuming the 5000 autistic families prevail in court with an average payout of one million dollars per autistic child, with the potential for 280,000 claims, the potential payout could amount to 280 billion dollars, an incredibly large amount of money, about the same amount of spending for 2 years of war in Iraq. (25) For this reason alone, it seems inconceivable that the federal vaccine court would grant compensation for autism. However, only time will tell. Vaccine-Strain Measles Detected in Autistic Kids The Vaccine Court’s compensation table includes Vaccine-strain measles infection, so these autistic kids would automatically be entitled to compensation. There are a number of reports of measles infection in the small bowel in autistic kids shown with endoscopic biopsy and PCR testing. Of course, mainstream medicine claims these findings are debatable. (26) (27) (28) Lack of Evidence of Harm As expected, the medical establishment claims there is a lack of evidence that thimerosol vaccines cause autism, and lack of evidence that the MMR vaccine causes persistent measles infection. (29) (30) (31) (32) (33) (34) (35) (36) A Sept 2007 NEJM article speaks against the notion that thimerisol containing vaccines cause neurological problems. (37) Autism is Increasing to Epidemic Proportions A decade ago, the rate of autism was 1 per 10,000. The CDC now says that the current autism rate is 1 per 150. This dramatic rise in autism rates correlates with the increase in mercury exposure with Thimerosal. See diagram below. (38) Mothers Report the Children Are Fine until the Vaccinations, and then Develop Autism Thousands of families reported their normal children changed after receiving mercury-containing vaccines, and began displaying Autism symptoms which mimic mercury poisoning. Children with autism have more measurable mercury in their bodies than normal children. Here is one of many video stories posted on U-Tube, in which the child develops normally, is then vaccinated and becomes autistic. After biologic treatment by a DAN physician the child dramatically improves. (Click Here for Video) (39) A typical mercury dose received by a two-month old after three mercury vaccines is 125 times EPA's daily allowable exposure levels. In 2001, the Institute of Medicine (IOM) stated it is "biologically plausible" that Thimerosal in vaccines caused autism, ADD/ ADHD and neurodevelopment disorders in general. (40) (41) (42) (43) (44) (45) (46) (47) (48) What are the Features of autism? The autistic child becomes non-verbal, with no self expression, and assumes postures to put pressure on lower abdomen (indicating pain). There may be hand flapping, and stacking objects. The autistic child shows no interest in other people, or he may be interested in people, but does not know how to talk with, play with, or relate to them. Initiating and maintaining a conversation is difficult. Speech and language skills may begin and then be lost, or they may develop very slowly, or they may never develop. The autistic child may have repeated ritualistic actions such as spinning, rocking, staring, finger flapping, and hitting self. Autistic kids have neurological disorders including epilepsy, gastro-intestinal problems, fine and gross motor deficits, and anxiety and depression. Boys are nearly 4 times more likely to have a parent-reported autism diagnosis than girls. There are about (80 Videos) on You Tube which show the typical signs of Autism: (49) See Dr. Arthur Krigsman’s (video presentation) on Autism (DAN 2004 meeting)(50) (52) (53) Biologic Treatment of Autism proposed by Dr. Arthur Krigsman 50-70 % of autistic kids get a gasterointestinal disorder called autism associated entero-colitis, with inflammation of small bowel, stomach, and esophagus. They will have abdominal pain, diarrhea (loose stool, unformed stool, chronic oatmeal consistency, undigested food, malabsorption, constipation, malodorous stools. There may be no obvious cause on routine labs. Endoscopy finds pathology in 70% who may have constipation/diarrhea with difficulty passing stool, or 3-4 days without a bowel movement. They may have abdominal distention, due to bowel inflammation and excessive gas. Growth curve may show regression at the onset of GI symptoms and onset of cognitive regression at the 15 month time frame. Endoscopy of small bowel shows lymphoid nodular hyperplasia, and severe LNH resembles Crohns disease. Leaky Gut Syndrome in Autistic Kids Autistic kids have an inflamed gut membrane which has increased intestinal permeability, also called “leaky gut” syndrome. In leaky gut, the undigested food macromolecules are absorbed by the leaky gut into the blood stream, an abnormal event. Metabolic pathways to break down these macromolecules are not normally in use. Gluten from bread, and Casein from milk derivatives produce opioids, which are found in urine of autistic children. By removing the offending foods, the opioids disappear. There are 28 other proteins present in urine. Urine testing can be done at the Great Plains Lab, William Shaw. (54) (55) (56) Gut inflammation can be controlled on long term basis with anti-inflammatory drugs for biopsy proven inflammation on endoscopy. These are the 5ASA drugs, Sulfadiazines, and Salicylates. Very few patients cannot tolerate these drugs. Some kids need steroids (2-4 weeks) same as Crohn’s disease cases. Anti-Fungals (nystatin, diflucan) are widely used by DAN practitioners. Parents will say the kids do better. Even though it is difficult to demonstrate fungus found on culture, urine tests typically show presence of fungal metabolites which disappear with anti-fungal drugs. Autistic kids are also given digestive enzymes and probiotics, and the GI symptoms and cognitive symptoms improve. Mothers Claim their Autistic Children Improve with Chelation Therapy which removes Mercury Katie Wright revealed that her autistic son Christian (grandson of NBC Chair Bob Wright), recovered significant function after chelation treatments to remove mercury. As customary, she was viciously attacked by the medical establishment for her public statement. Katie was vigorously defended by John F Kennedy Jr. in this Huffington Post article. (57) (58) (59) How To Make Vaccinations Safer To make vaccination safer, Stephanie Cave MD and Sherry Tenpenny have suggested waiting until child is older to give the vaccinations, use single dose mercury-free vaccines, and use vitamin supplements such as Vitamin A and C prior to vaccination. They suggest avoiding vaccination when the child is sick. (60) (61) Dr. Cave recommends waiting to vaccinate until ther child is at least 6 months of age, preferably older. Do only one vaccine at a time, at least a month apart Vaccination is NOT mandatory. Use an Exemption Information on exemptions was mentioned in a previous newsletter. (62) New Medical Discoveries Are Usually Rejected Ignatz Semmelweis, for example, was ridiculed for his suggestion that surgeons should wash their hands before an operation. (63) The British Navy finally gave limes to sailors 50 years after James Lind’s showed citrus fruit cured scurvy. (64) As a reward for his discovery that elevated homocysteine causes heart disease, Kilmer McKully MD, was fired from his job and research grant terminated. (65 ) The thimerisol-autism connection is just another example of the above. Thimerisol Vaccines Belong in the Antique Medical Musem In California it is a illegal to inject a newborn with mercury (thimerisol Hep-B shot), and it should be a crime in your state as well. Hopefully, the barbaric practice of injecting mercury into newborns will soon become a relic of the ancient past, taking its rightful place in the museum along with bloodletting and leeches. Until then, there is much work to be done to remove mercury from our vaccinations and the environment in general. As a nation, we can’t afford not to. (66) 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 References References for Autism (1) Do Vaccines Cause Autism (2) DEFEAT AUTISM NOW! (DAN!) Physician Referral List: Implementing the Defeat Autism Now! (3) Biological Evidence of Significant Vaccine Related Side-effects Resulting in Neurodevelopmental Disorders. Presentation to the Vaccine Safety Committee of the Institute of Medicine, The National Academies of Science, February 9, 2004.Jeff Bradstreet MD, ICDRC, 321-953-0278 (3A)Molecular Aspects of Thimerosal-induced Autism Richard C. Deth, Ph.D. Professor of Pharmacology Northeastern University Boston, Massachusetts (4) Deth's research has uncovered evidence thimerosal creates deficits in the D4 receptor-mediated phospholipids methylation essential for detoxification and sustaining attention to tasks. The research provides the first scientific link between attention deficits and autism. Deth has identified the metabolic process, called methylation, whereby thimerosal can cause the brain damage associated with autism. (5) An enzyme critical to methylation, methionine synthase, uses an active form of vitamin B12 to complete its chemical function, according to Deth. Thimerosal interferes with the conversion of dietary forms of B12 into the active form and so impedes DNA methylation and disrupts some normal gene actions. (6) Mercury Poisoning (7) EPA mercury Site (8) HHS agency for Toxic Substances (9) Mass Dept of Environmental Protection (10) California Mercury Law (11) Bush will VETO similar Mercury Law (12) WHO Cessation of Oral (live) polio vaccine,Policy paper. (13) Oral Polio Vaccine Cessation (14) vaccinia smallpox CDC info (15) Swine Flu Vaccination (16) The Sky is Falling: An Analysis of the Swine Flu Affair of 1976, by Joel Warner (17) The Tainted History of the DPT Vaccine by Harold Stearley (18) At Risk: Truth About Vaccines, Lawsuits & Shortages Barbara Loe Fisher (19) Office of Special Masters of the U.S. Court of Federal Claims, (20) Vaccine Injury Table outlining which vaccine related injuries are to be compensated. (21) Current status of 4900—claims for vaccine injuries resulting in autism spectrum disorder before US Court of Federal Claims, Special masters Patricia Campbell Smith, Denise Vowel and George L Hastings Jr. Ruling is expected after Jan 15, 2008. (22) Audio and written transcripts of this first test case. the Cedillo Case No. 98-916V are available at this page: (23) Homer legal web site. news and links relating to vaccine litigation. (24) Federal Vaccine Court decisions with summary and full pdf file of transcripts. (25) The Possible Costs to the United States of Maintaining a Long-Term Military Presence in Iraq September 2007 (26) references pertaining to measles MMR vaccine and autism. The vaccine strain of measles virus has been found in 85% of samples taken from the guts of children with regressive autism, according to Dr. Stephen Walker of the Wake Forest University School of Medicine.The study replicates findings made by Dr. Andrew Wakefield, a gastroenterologist, in 1998, and by Prof. John O’Leary, a pathologist, in 2002. (27) Potential viral pathogenic mechanism for new variant inflammatory bowel disease V Uhlmann,1* C M Martin,2* O Sheils,2 L Pilkington,1 I Silva,1 A Killalea,1 S B Murch,3 J Walker-Smith,4 M Thomson,4 A J Wakefield,4 and J J O'Leary1 Mol Pathol. 2002 April; 55(2): 84–90. Results: Seventy five of 91 patients with a histologically confirmed diagnosis of ileal lymphonodular hyperplasia and enterocolitis were positive for measles virus in their intestinal tissue compared with five of 70 control patients. Measles virus was identified within the follicular dendritic cells and some lymphocytes in foci of reactive follicular hyperplasia. The copy number of measles virus ranged from one to 300 000 copies/ng total RNA. onclusions: The data confirm an association between the presence of measles virus and gut pathology in children with developmental disorder. (28) VACCINES AND AUTISM Detection of measles virus in children with ileo-colonic lymphoid nodular hyperplasia, enterocolitis and developmental disorder Molecular Psychiatry (2002) 7, S47–S48. Martin CM, Uhlmann V, Killalea A, Sheils O, O'Leary JJ. (29) wikipedia MMR vaccine (30) VACCINES AND AUTISM MMR vaccine and autism: a review of the evidence for a causal association Molecular Psychiatry (2002) 7, S51–S52 CDC finds NO causal association F DeStefano National Center on Birth Defects and Developmental Disabilities, CDC (31)New Data refutes Measles Virus from Vaccine in Children with Autism (32) PEDIATRICS Vol. 118 No. 1 July 2006, pp. e139-e150 Pervasive Developmental Disorders in Montreal, Quebec, Canada: Prevalence and Links With Immunizations Eric Fombonne, MDa, Rita Zakarian, MEda, Andrew Bennett, PhD, CPsychb, Linyan Meng, MSca and Diane McLean-Heywood, MAb The findings ruled out an association between pervasive developmental disorder and either high levels of ethylmercury exposure comparable with those experienced in the United States in the 1990s or 1- or 2-dose measles-mumps-rubella vaccinations. (33) The "Wakefield" Studies: Studies Hypothesizing That MMR Causes Autism Dr. Paul Offit, M.D., FAAP, Chief of Infectious Diseases and Director of the Vaccine Education Center at Children's Hospital of Philadelphia. Those who claim that MMR causes autism often cite two papers by Andrew Wakefield and colleagues. This section summarizes those studies and lists their critical flaws.Conclusion; autism is not caused by thimerosol vaccines (34) Web site which states that Autism not caused by vaccines, funded by CDC (35) The relationship between the MMR vaccine and autism, From The Vaccine Education Center Newsletter AMA page denying link between thimerosol vaccines and autism (36) VACCINE STUDY IN NEW ENGLAND JOURNAL OF MEDICINE WRONG IN CONCLUDING MERCURY EXPOSURES ARE HARMLESS, STATES SAFEMIN"Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years," appearing in the New England Journal of Medicine (NEJM, 9/27/07 issue), DS (37) A Sept 2007 NEJM article speaks against the notion that thimerisol containing vaccines cause neurological problems. Volume 357:1281-1292 September 27, 2007 Number 13 Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years (38) VOLUME 114 | NUMBER 7 | July 2006 • Environmental Health Perspectives diagram of autism epidemic rise (39) Video BioMedMom,on YouTube showing Autistic Child Development (40) Critical Issues, Mercury from Safe Minds.org (41) Stephanie Cave Book, What Your Doctor May Not Tell You About Children's Vaccinations, by Stephanie Cave, M.D., F.A.A.F.P and Deborah Mitchell. (42) Video: Dr. Mark Geier Speaks at Mercury-Free Vaccines Rally in front of CDC 2007 (43) Video You Tube: Dr. Mary Megson Speaks on Autism Epidemic and Vaccines in front of CDC 2007 (44) Video: Boyd Haley, PhD Speaks at Mercury-Free Vaccines Rally at CDC 2007 (45) Video: Shows How Mercury Kills the Brain ~ Autism Connection (46) Sherri J. Tenpenny, D.O. Vaccinations, Alternative Medicine, Mothering MAgazine. (47) A prospective study of mercury toxicity biomarkers in autistic spectrum disorders. Geier DA, Geier MR. J Toxicol Environ Health A. 2007 Oct;70(20):1723-30. (48) Urinary porphyrin profile analysis (UPPA) to assess body-burden and physiological effects of mercury in children diagnosed with ASDs. (49) Video on You Tube: Signs of Autism (50) Video:Current Concepts in the Treatment of Autistic Spectrum Associated Enterocolitis, Arthur Krigsman, M.D.Presented at DAN conference 2004. next meeting appearance National Autism Association November 9-11, 2007, Atlanta (52) Arthur Krigsman MD Web Site, pediatric gasteroenterologist, Bio (53) Arthur Krigsman MD Gasteroenterologist Wikipedia (54) Great Plains Lab web site (55) Biological Treatment of Autism by William Shaw PhD (56) The Official Autism 101 Manual is the most comprehensive book on Autism" (57) Robert F. Kennedy Jr defends attack on Mothers, The poisonous public attacks on Katie Wright this week--for revealing that her autistic son Christian (grandson of NBC Chair Bob Wright), has recovered significant function after chelation treatments to remove mercury -- surprised many observers unfamiliar with the acrimonious debate over the mercury-based vaccine preservative Thimerosal. But the patronizing attacks on the mothers of autistic children who have organized to oppose this brain-killing poison is one of the most persistent tactics employed by those defending Thimerosal against the barrage of scientific evidence linking it to the epidemic of pediatric neurological disorders, including autism. Mothers of autistics are routinely dismissed as irrational, hysterical, or as a newspaper editor told me last week, "desperate to find the reason for their children's illnesses," and therefore, overwrought and disconnected. (59) Video: Christian and Makena, Non verbal aggressive little guy has turned into a wonderful healthy little boy with the help of the specific carbohydrate diet, vitamins, supplements, chelation therapy, ABA, Occupational and Speech therapy. (60) Interview with Stephanie Cave MD, Mothering MAgazine (61) Dr. Sherry Tenpenny. In 1987, the World Health Organization advocated the combined administration of Vitamin A with the measles vaccine. When a dose of 100,000 IU of Vitamin A is given with the vaccine, lower rates of side effects occur, and antibodies still develop. Therefore, be sure to give your child is given Vitamin A on the day s/he receives the vaccine. I would also suggest giving powdered Vitamin C (10mg per pound), for 3 days before, the day of, and for 5 days after any vaccine. If you chose to vaccinate, I recommend that you wait until your child is at least 6 months of age, preferably older. Do only one vaccine at a time, at least a month apart (62) Guard Your Daughters from Gardasil (63) Ignaz Semmelweiss (64) James Lind and the Story of Scurvy (65 ) Kilmer McCully MD and the discovery of the Homocytseine cause for heart disease (66) Blood Letting Antique Medical Museum (67) Wakefield AJ and Montgomery SM. Autism, viral infection and measles mumps rubella vaccination. Israeli Medical Association Journal 1999;1:183-187 (68) A prospective study of mercury toxicity biomarkers in autistic spectrum disorders. Geier DA, Geier MR. J Toxicol Environ Health A. 2007 Oct;70(20):1723-30. (69) Press Release September 30, 2007 WASHINGTON, DC – A new peer-reviewed scientific/medical case study confirms that many children with autistic spectrum disorders (ASDs) suffer from mercury poisoning. The new study, “A Prospective Study of Mercury Toxicity Biomarkers in Autistic Spectrum Disorders” by Mr. David A. Geier and Dr. Mark R. Geier has been published in the most recent issue of the Journal of Toxicology and Environmental Health, Part A (volume 70, issue 20, pgs 1723-1730). (70) Uhlmann V., Martin C, Shiels, Wakefield AJ, O’Leary JJ. Possible viral pathogenesis of a novel paediatric inflammatory bowel disease. Molecular Pathology 2002;55:84-90 (71) Singh VK, Lin SX, Yang VC. Serological association of measles virus and human herpesvirus-6 with brain autoantibodies in autism. Clin Immunol Immunopathol. 1998;89:105-8. (72) Singh VK, Jensen RL, Elevated levels of measles antibodies in children with autism, Pediatric Neurology, 2003;28:292-294. (73) Abnormal measles-mumps-rubella antibodies and CNS autoimmunity in children with autism. Singh VK, Lin SX, Newell E, Nelson C.Department of Biology and Biotechnology Center, Utah State University, Logan, Utah 84322, USA. singhvk@cc.usu.edu, J Biomed Sci. 2002 Jul-Aug;9(4):359-64. (74) Wakefield, A.J., et al.Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children Lancet 351: 637-641, 1998. (75) Uhlmann, V., et al. Potential viral pathogenic mechanism for new variant inflammatory bowel disease. Journal of Clinical Pathology: Molecular Pathology 55:1-6, 2002. (76) Taylor, B., et al. Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association. Lancet 353:2026-2029,1999. (77) VACCINES AND AUTISM IMMUNIZE, Paul A. Offit, MD, Director, Vaccine Education Center, Children’s Hospital of Philadelphia (78) Dales, L., et al. Time trends in autism and in MMR immunization coverage in California. JAMA 285:1183-1185, 2001 (79) Lancet. 2000 Oct 7;356(9237):1273.Response to the MMR question.Taylor B, Miller E, Farrington CP. (80) Kaye, J.A., et al. Mumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis. Brit Med J 322:460-463, 2001. (81) Taylor, B., et al. Measles, mumps, and rubella vaccination and bowel problems or developmental regression in children with autism: population study. Brit Med J 324:393-396, 2002. (82) Adrien, J., et al. Blind ratings of early symptoms of autism based upon family home movies. J Am Acad Child Adolesc Psychiatry 32:617-626, 1993. (83) Adrien, J., et al. Early symptoms in autism from family home movies: evaluation and comparison between 1st and 2nd year of life using I.B.S.E. scale. Acta Paedopsychiatrica 55:71-75, 1992. (84) Adrien, J., et al. Autism and family home movies: preliminary findings. J Autism Devel Disorders 21:43-49, 1991. (85) Osterling, J., et al. Early recognition of children with autism: a study of first birthday home videotapes. J Autism Devel Disorders 24:247-257, 1994. (86) Mars, A.E., et al. Symptoms of pervasive developmental disordeers as observed in prediagnostic home videos of infants and toddlers. J Pediatr 132:500-504, 1998. (87) Proc Natl Acad Sci U S A. 1998 Nov 10;95(23):13982-7. Links Movement analysis in infancy may be useful for early diagnosis of autism.Teitelbaum P, Teitelbaum O, Nye J, Fryman J, Maurer RG. (88) Jefferson T, Price D, Demicheli V, Bianco E. Unintended events following immunization with MMR: a systematic review. Vaccine 2003; 21: 3954-3960 (89) Demicheli V, Jefferson T, Rivetti A, Price D. Vaccines for measles, mumps and rubella in children (Review). The Cochrane Collaboration 2005 (90) Balzola F, Daniela C, Repici A, Barbon V, Sapino A, Barbera C, Calvo PL, Gandione M, Rigardetto R, Rizzetto M. Autistic enterocolitis: confirmation of a new inflammatory bowel disease in an Italian cohort of patients. Gastroenterology. 2005;128:Suppl.2;A-303 (91) Balzola F., Barbon V.,Repici A., Rizzetto M., Clauser D., Gandione M., Sapino A., Panenteric IBD-Like Disease in a Patient with Regressive Autism Shown for the First Time by the Wireless Capsule Enteroscopy: Another Piece in the Jigsaw of this Gut-Brain Syndrome? American Journal of Gastroenterology. 2005;100:979 (92) González L., López K., Martínez M., Navarro D., Negrón L., Rodríguez R., Villalobos D., Flores L., Sabrá A. Endoscopic and Histological Characteristics of the Digestive Mucosa in Autistic Children with Gastrointestinal Symptoms. Preliminary Report. G.E.N. Suplemento Especial de Pediatría-Nº 1, 2005; pp41-47. (93) Autism articles and References (94) Measles-Mumps-Rubella Vaccine and Autistic Spectrum Disorder: Report From the New Challenges in Childhood Immunizations Conference Convened in Oak Brook, Illinois, June 12-13, 2000 Neal A. Halsey, MD, Susan L. Hyman, MD, and the Conference Writing Panel Conclusions. Although the possible association with MMR vaccine has received much public and political attention and there are many who have derived their own conclusions based on personal experiences, the available evidence does not support the hypothesis that MMR vaccine causes autism or associated disorders or IBD. Separate administration of measles, mumps, and rubella vaccines to children provides no benefit over administration of the combination MMR vaccine and would result in delayed or missed immunizations. PEDIATRICS Vol. 107 No. 5 May 2001, p.e84 (95) Vaccine truth (96) Regressive Autism, Ileal-Lymphoid Nodular Hyperplasia, Measles Virus and MMR Vaccine Summary of Published Studies Offering Evidence for Linkages By David Thrower (97) Vaccine Autoimmune Project for Research and Education (VAP) VAP's co-founder Ray Gallup and Dr. Yazbak examine the most recent United States Department of Education statistics and reveal that the 1 in 150 estimate is outdated by five years. They report that the present prevalence of ASD may be as high as 1 in 67. (98) Biological Evidence of Significant Vaccine Related Side-effects Resulting in Neurodevelopmental Disorders. Presentation to the Vaccine Safety Committee of the Institute of Medicine, The National Academies of Science, February 9, 2004. Jeff Bradstreet MD, ICDRC, 321-953-0278 (99) Gastrointestinal comorbidity, autistic regression and Measles-containing vaccines: positive re-challenge and biological gradient Andrew J. Wakefield, FRCS FRCPath; Carol Stott, PhD; and Kirsten Limb, BSc A.J. Wakefield, C. Stott, K. Limb / Medical Veritas 3 (2006) 796–802 Books: Vaccines, Autism and Childhood Disorders: Crucial Data That Could Save Your Child's Life (Paperback) by Neil Z. Miller (Author), Bernard Rimland (Foreword) What Your Doctor May Not Tell You About Children's Vaccinations (Paperback) by Stephanie Cave MD(Author), Deborah Mitchell A Shot in the Dark (Paperback) by H. Coulter (Author) How to Raise a Healthy Child in Spite of Your Doctor (Mass Market Paperback) by Robert S. Mendelsohn MD Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy (Paperback) by David Kirby Vaccines: Are They Really Safe and Effective (Paperback) by Neil Z. Miller Vaccinations: A Thoughtful Parent's Guide: How to Make Safe, Sensible Decisions about the Risks, Benefits, and Alternatives (Paperback) by Aviva Jill Romm Vaccine Guide: Risks and Benefits for Children and Adults (Paperback) by Randall Neustaedt Autism Web sites: (AUTISM RESEARCH INSTITUTE & DEFEAT AUTISM NOW!) (AUTISM SOCIETY OF AMERICA) (AUTISM ONE) (MEDIGENESIS) (GENERATION RESCUE) (SCHAFER AUTISM REPORT) (NATIONAL AUTISM ASSOCIATION Bernard Rimland) (SAFE MINDS) (TACAnow) (TREATING AUTISM) (UNLOCKING AUTISM ) (Clinical Studies, MMR-Autism Association )