Jeffrey Dach MD

  

The Eight Hundred Pound Gorilla in the Health Insurance Industry

 

Rocky Delgadillo, LA City Attorney, Modern Hero 

Files Suit Against Health Net for Cancelling Due to Pre-Existing Condition
Also this week, Los Angeles City Attorney, Rocky Delgadillo filed suit and criminal charges against the same company, Health Net, claiming it unfairly cancelled policies when patients needed expensive medical treatment. This is also known as cancelling for a Pre-Existing Condition.

Health Net Inc. saved about $35 million by illegally canceling the coverage of at least 1,600 patients over four years, the city attorney alleges in the lawsuit filed Wednesday. 

The Pre-Existing Condition Gimmick

A typical ploy the insurance company uses to cancell insurance coverage is the "pre-existing condition".  Los Angelos City Attorney Rocky Delgadillo said, "This is an industry with a history of putting profits before people.  Their practices are not only illegal, they are immoral and we are going to hold them accountable." In November, state regulators fined the company $1 million for lying about its incentive program for reaching cancellation targets. Delgadillo's office is pursuing a criminal investigation against individual employees who received bonuses based in part on canceling policies of people who have submitted substantial medical claims. (1)(2)  A California State legislature introduced a new law last week that would prevent this abusive cancellation for pre-existing  condition.

    

Nebraska is not happy with United HealthCare

 
New York Attorney General Andrew Cuomo, Modern Hero,  Goes After United HealthCare 

United HealthCare Corporate Profits Keep Going Up

Otherwise, we would have $5,000 electric bills every month.

 Stop Corporate Greed, and Take Action

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 MD
4700 Sheridan Suite T.
Hollywood Fl, 33021
954-983-1433
www.drdach.com
www.jeffreydach.com
www.naturalmedicine101.com
www.truemedmd.com

References

(1) www.knbc.com/health/15366673/detail.html
CityAttorney Files Lawsuit Against Health Net Inc.February 21, 2008 KNBC TV LA

(2) http://money.cnn.com/news/newsfeeds/articles/apwire/d4202f952209279a7d7a16cc586a24d8.htm
CNN 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.html
Jan 9, 2007 UnitedHealthCare Accused Of Breaking Insurance Law. WCCO Channel 4 TV

(4) http://www.jsonline.com/story/index.aspx?id=467942&format=print
State fines health insurer $600,000, UnitedHealthcare settles complaint, By GUY BOULTON
July 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,KBY
EDITORIAL, A Rip-Off by Health Insurers? February 18, 2008 New York Times

(7) http://earningspower.com/chart.html
Chart 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.htm
This 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_Care
TAKE 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.pdf
2002, 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.html
Tuesday, 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.xml
Disputes with United HealthCare over payments

(14) http://consumerist.com/356233/unitedhealth-group-accused-of-fraud
Uniterd 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_healthcare
Andrew 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?chan
Business 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.html
Huffington 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=slogin
New 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.html
Cuomo 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.html
UnitedHealth 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=142
Confessions 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=18974647
NPR Radio story on Andrew Cuomo And United Health

(26) http://www.mydd.com/story/2008/2/22/17219/1258
Health 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.story
L.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.html
File 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-story
California 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.DTL
Legislation 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.pdf
Clinton 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 administrative
thumb 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.html

UnitedHealth 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.pdf
A Consumer Guide to Handling Disputes with Your Health Plan or Insurance Carrier - Kaiser

(36) http://www.amazon.com/Making-Them-Pay-Insurance-Managed/dp/0312267606

The 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_1

The 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.php
Advocacy 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.pdf
Interview 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.asp
Law 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.htm

Florida 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.html

What 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#uslPageReturn
States 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

3:48 PM GMT  |  Read comments(0)

January 30

Cholesterol Lowering Statin Drugs for Women Just Say No by Jeffrey Dach MD

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 or relationship between low cholesterol and the progression of atherosclerosis – the number one cause of heart disease. Repeat that sentence. This became abundantly clear 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) Business Week Questions the Benefit of Lowering Cholesterol with Statin Drugs !! (17) In an historic turnaround, Business Week’s Jan 28, 2008 cover story asks the heretical question, "Do Cholesterol Drugs Do Any Good? Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated."    Astonishingly, Business Week makes the following statements: "Current evidence supports ignoring LDL cholesterol altogether " "Cholesterol lowering is not the reason for the benefit of statins". (17)                  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 results of the ENHANCE had to be released because now all trials must be pre-registered with the government because of new FDA rules Sept 2007. In the old days it would have been buried. (22B) The following quote about Vytorin-Enhance from Bill Sardi at LewRockwell.com is illuminating (18 ) "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. America Fooled Again More on the Merck Vytorin/Enhance Scandal: (19) (20) 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 Video Another Vytorin Ad Video Vytorin Ad video Parody by Mike Adams of NewsTarget The 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 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 (22) FDA Declares War on BioIdentical Hormones 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 33021 954-983-1443 _______________________________________________________________ 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

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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 articles Salivary estradiol 177 Salivary progesterone 317 Salivary testosterone 428   The FDA Claims Ignorance of Its Own FDA Approvals ! FDA says: Some pharmacies promote hormone therapy for men in the form of testosterone to treat a decline in the level of testosterone in older men, sometimes referred to as andropause. There are currently no FDA-approved products for the treatment of andropause. In addition, there are no FDA-approved testosterone drugs for women. My Reply: Testosterone insufficiency in older men is associated with increased risk of death over the next 20 years. (17) Testosterone has been FDA approved for both men and women for decades. FDA approved testosterone commercial products can be obtained at the corner drugstore. Androgel for example, is FDA approved and contains testosterone. Estra-test is an FDA approved hormone for women which contains testosterone. The following is a list of FDA-approved bio-identical hormone commercial products available at the drugstore commonly used to treat menopause and andropause: Alora (estradiol): FDA approved 1996 - Watson Labs Climara (estradiol): FDA approved 1994 - Bayer FemPatch : FDA approved 1997 - Parke Davis Vivelle-Dot (estradiol): FDA approved 1994 - Novartis Estraderm: FDA approved 1986 - Novartis Esclim: FDA approved 1998 - Women's First Healthcare Estrace (estradiol): FDA approved 1993 -Bristol Myers Squibb Estring: FDA approved 1996 - Pharmacia UpJohn Prometrium (natural progesterone): FDA approved 1998 - Solvay Androgel (natural testosterone): FDA approved 2000 - Unimed Pharmaceuticals Crinone: FDA approved 1997 - Columbia Labs FDA approved Estradiol containing products:Estrace, Progynova, estrofem, Alora, Climara, Vivelle, Vivelle-Dot, Menostar, Estraderm TTS Estrasorb Topical, Estrogel, Elestrin, Lunelle Estring, Femring FDA approved Progesterone products:Prometrium, Utrogestan, Minagest, Microgest, CRINONE, PROCHIEVE, Cyclogest FDA approved testosterone:Testoderm, Androderm, AndroGel  The FDA Tries to Ban Estriol ! Astonishingly, the FDA wants to ban estriol, a popular component of natural hormone therapy for women. FDA says: Some compounded “BHRT” drugs contain an estrogen component called estriol. No drug containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown. Pharmacies may not compound drugs containing estriol unless they have an FDA-sanctioned investigational new drug application. My Reply: Like many commonly prescribed drugs (e.g. quinine, Phenobarbital, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP). When Congress passed the FDA Modernization Act in 1997, it clearly indicated that drugs with a USP monograph could be compounded. 50,000 compounding pharmacists, 15,000 doctors and 2 million women have been prescribing, making and using estriol for decades. FDA approval is not required since this is regulated by the states, not the FDA.                            Finally, the Truth About Bio-Identical Hormones ! And now, The Truth about Bioidentical Hormones as quoted from the IACP from the Compounding Pharmacists web site. (48) Myth 1) Bioidentical hormone replacement therapy (BHRT) is unregulated. Fact: Bioidentical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bioidentical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia. Myth 2): Compounded bioidentical hormones are unsafe because they aren’t FDA-approved. Fact: Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability. Compounded medications are in a similar position as manufactured products prescribed for off-label use, which constitutes about a fifth of all prescriptions. They are not approved by the FDA for such use, and yet it is well accepted that physicians should be able to use their discretion to prescribe medications for off-label use. Myth 3): Bioidentical hormones are just as risky as manufactured products like Premarin and Prempro. Fact: There are no studies comparing the two types of therapies, so we cannot make any direct comparisons. The Women’s Health Initiative study examined only Premarin and Prempro, which do not use the same ingredients that are used to compound bioidentical hormones. To date there have been no studies that show a link between BHRT and cancer/strokes/heart attack, however the pharmacy community supports and funds studies to better determine the risk profile of BHRT. A physician is trained and licensed to diagnose disease and to determine appropriate therapy for patients. A physician uses clinical expertise to determine appropriate therapies for patients. Premarin and Prempro may be appropriate for some patients. Bioidentical hormones may be appropriate for others. It is up to doctors to make that determination. Myth 4): Pharmacists are recklessly promoting BHRT as safe and effective. Fact: Compounded medicines are a lot like off-label prescriptions: they are not subject to FDA approval and, as a result, cannot be marketed as safe or effective. In fact, the FTC Act, 15 U.S.C. § 41 et seq., prohibits unfair or deceptive acts and practices, including false and unsubstantiated advertising claims. It is already illegal for a pharmacy to make claims without substantiation or to overstate the health benefits of the products they promote. Myth 5): Bioidentical is a misleading term. Fact: The chemical structures of bioidentical hormones are identical to those produced by the human body. Because the chemical structure is identical, these hormones are often referred to as bioidentical. Don’t let the financial interests of the drug industry restrict your health freedom, call or email your senator today and voice your outrage at this blatant abuse of the FDA by special interest groups. Did you find this newsletter interesting? Feel free to Email it to a friend with the button on the bar below. Jeffrey Dach MD 4700 Sheridan Suite T Hollywood FL 33021 954 983-1443 Jeffrey Dach, M.D. BLOG TrueMedMD References and Links List of medical textbooks stating that bio-identical hormones have the same chemical structure as those in the human body and have the same effect. (all of them): Lehninger Principles of Biochemistry, Fourth Edition by David L. Nelson (Author), Michael M. Cox (Author) Textbook of Medical Physiology by Arthur C. Guyton Williams Textbook of Endocrinology Basic & Clinical Endocrinology by Francis S. Greenspan Review of Medical Physiology by Ganong, William F. MD Endocrinology (5th Edition) by Mac E. Hadley Endocrine Physiology by Susan Porterfield (1) January 9, 2008 FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (2) Compounded Menopausal Hormone Therapy Questions and Answers (3) Climacteric. 2002 Dec;5(4):332-40. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women.de Lignières B, de Vathaire F, Fournier S, Urbinelli R, Allaert F, Le MG, Kuttenn F. Service d'Endocrinologie et Médecine de la Reproduction, Hôpital Necker, Paris, France. The French Cohort Study showed that Bio-identical hormone therapy does not cause increased risk of breast cancer. (4)NEJM Volume 356:2591-2602 June 21, 2007 Number 25 Estrogen Therapy and Coronary-Artery Calcification JoAnn E. Manson, M.D., The NEJM CAT Scan Calcium Score study showed no increase in heart disease risk with estrogen. (5) Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women Principal Results From the Women's Health Initiative Randomized Controlled Trial Writing Group for the Women's Health Initiative Investigators JAMA. 2002;288:321-333. (6) Effects of Conjugated Equine Estrogen in Postmenopausal Women With Hysterectomy The Women's Health Initiative Randomized Controlled Trial,The Women's Health Initiative Steering Committee,* JAMA. 2004;291:1701-1712. (7) Assessment Of Sleep Dynamics In A Simulated Space Station Environment Lakshmi Putcha, Ph.D., Ram Nimmagudda, Ph.D., Chantal Rivera, Ph.D. (8) Entrez pubmed, A simple medline search shows a research studies validating the use of salivary hormone testing. salivary hormone 4075 articles, Salivary cortisol: 1478 articles, Salivary estradiol 177, Salivary progesterone 317, Salivary testosterone 428 (9) special committee on aging senate Hearings- Bioidentical Hormones: Sound Science or Bad Medicine? April 19, 2007 (10) Bioidentical hormone replacement therapy wikipedia (11) The Truth about Bioidentical Hormones-IACP (12) Irresponsible Journalism: BusinessWeek Regurgitates Wyeth’s Attacks on Pharmacy Compounding (13) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones (14) The Endocrine Society Position Statement Oct 2006 Bio-Identical Hormones (15) Bioidentical Hormones Lack Evidence for Safety and Effectiveness (16) Low levels of testosterone may increase risk of death in older men Men's Health News Published: Tuesday, 16-Oct-2007, Journal of Clinical Endocrinology & Metabolism (JCEM). (17) The Journal of Clinical Endocrinology & Metabolism Vol. 93, No. 1 68-75 Low Serum Testosterone and Mortality in Older Men, Gail A. Laughlin Testosterone insufficiency in older men is associated with increased risk of death over