CELEBRATING OUR ANNIVERSARIES AND PROUD ACHIEVEMENTS

20 years ago TRI-PAC Health and Wellness Advocacy  was established by Prof. Victor S. Dorodny, M.D., Ph.D., MPH (Founder & Chairman of the Board of Directors), and Mr. Robert Donin, MPA, President.

Over the past 20 years, TRI-PAC Health and Wellness Advocacy emerged as a nationally recognized and respected organization for its active participation in the areas of healthcare policy design and implementation.

In practical terms, we were fortunate to be able to assist thousands of patients coping with life changing illnesses with such issues as denial of care, appropriateness of care, access to care, limits of coverage, out-of-network services, to name a few.

It is a not for profit organization Governed by a respected Industry Advisory Board, TRI-PAC has been extremely effective working with local, state and national legislators and regulators to influence policy and politics of health care, as well as the practical aspects of delivery of health services.

We are proud to successfully defend the health consumers rights of our members/clients in their fights with the likes of Kaiser Permanente, Humana, Blue Shield, Health Net and others, whose bad faith actions and inaction's were jeopardizing patent's lives and well being.

***

We are also proudly celebrating the 10th Anniversary of the Naturopathic Evidence-Based Wellness (NEW™) Institute.

When family health and well-being are at stake, we all want the best information available. We all want the correct information. We want unbiased information.

The National Institute of Health (NIH), the Food and Drug Administration (FDA), and other agencies that we traditionally rely upon to serve as vanguards of medical authenticity are experiencing funding and manpower shortages. While these agencies are without doubt the most capable sources of evaluating legitimate health-benefit claims, they are buried by the sheer volume of their mandates, and have difficulty coping.

Dr. Dorodny, the founder of the non-profit NEW™ Institute, recognized the critical need for a repository of unbiased, timely medical research and information. The goal of NEW™ was and remains to provide such a repository of current, reliable, legitimate, hard information that empowers its members to make good, safe decisions for both consumers and providers.

The advocacy of NEW™ serves first and foremost as a member resource. When appropriate, it also assist regulatory agencies such as the FDA and the Federal Trade Commission (FTC) in determining the legitimacy of claims made by product suppliers and vendors.

Finally, it provides an authoritative resource for its members who manufacture food supplements to educate their markets about the true benefits of their products through compelling and compliant advertising and marketing.

All-in-all, please Be Well!
____________________________________________________________________________________

For more information on our organizations, membership, etc., please contact Mr. Robert A. Donin, M.P.A. by mail: 11693 San Vicente, Suite 346, Los Angeles, CA 90049, (310) 420-2169, or by e-mail: robertdonin@yahoo.com

Founder & Chairperson of Board, Victor S. Dorodny, M.D., PhD, MPH can be reached by e-mail: Dorodny@doctor.com
________________________________________________________________________________________________________
ПРАЗДНУЕМ НАШИ ЮБИЛЕИ И ГОРДЫЕ ДОСТИЖЕНИЯ

20 лет назад TRI-PAC –Организация Защиты Здоровья И Прав Медицинских Потребителей была создана Академиком Виктором С. Дородный, Доктор медицины, Доктор философии, Магистр Организации Здравоохранения. Основатель и Председатель Совета Директоров, и г-н Роберт Донин, MPA, Президент и Исполнительный Директор

За последние 20 лет, TRI-PA Организация Защиты Здо
ровья И Прав Медицинских Потребителей превратилась в национально признанную и уважаемую организацию которая активно участвует в области здравоохранения разработке и осуществлении медицинской политики государства и отдельных штатов..

В практическом плане нам повезло быть в состоянии помочь тысячам пациентов справляться с болезнями угрожавшими их жизни и бороться на их створоне к таких случаях, как отказ в помощи, адекватности медицинской помощи, доступа к медицинской помощи, пределы покрытия, вне сетевых услуг, и многих других.

Это некоммерческая организация, регулируемая Консультативным Советом была чрезвычайно эффективной в работы с местными, региональными и национальными законодателями и регуляторами влияющих на политику здравоохранения, а также практические аспекты доставки медицинские услуги.

Мы гордимся тем, что смогли успешно защитить здоровье тысяч и тысяч потребителей в их боях с подобными Kaiser Permanente, Humana, Blue Shield, Net и многими другими страховыми компаниями чья недобросовестность, действий и бездействия ушрожали жизни и здоровью пациентов.

***

Мы также с гордостью отмечаем 10-летие Института Натуропатической Доказательной Медицины-(NEW ™) институте.

Когда здоровье семьи и благополучие находятся под угрозой, мы все хотим наилучшую имеющейся информации. Мы все хотим правильную информацию. Мы хотим объективную и своевременную информацию.

Национальный институт здоровья (NIH), Национальная Администрация пищевых продуктов и медикаментов (FDA), и другими учреждениями, которые мы традиционно полагаемся проверять качесва и подлинность продуктов и пищевых добавок испытывают нехватки финансирование и рабочей силы. Хотя эти учреждения, без сомнения, наиболее надёжными источниками такой информации, они похоронены под объемами работы и мандатов.

Доктор Дородный, основатель некоммерческого NEW ™ института, вовремя оценил насущность и необходимость сщздания хранилища объективной, своевременной медицинской информациию

Цель NEW ™ была и остается предоставления такого виртуального хранилища, надежной, законной, краткой информации, которая дает возможность как потребителемб так и производителям, принимать правильныеб своевременные, и безопастные решения..

NEW ™ Институт, в первую очередь, служит ресурсом для потребителей. При необходимости, мы также помогаем регулирующих органов, таких как FDA и Федеральная торговая комиссия (FTC) в определении законности претензий, предъявленных поставщиками и продавцам продукции.

Наконец, он обеспечивает авторитетный ресурс для своих изготовителей пищевыч добавок и помогает им правильно и законно рекламировать и продавать свою продукцию..

Для получения дополнительной информации о нашых организациях., пожалуйста, свяжитесь с г-н Роберт А. Донин, MPA (Mr. Robert A. Donin. MPA) по почте: 11693 Сан-Висенте, Suite 346, Los Angeles, CA 90049, (310) 420-2169, или по электронной почте: robertdonin@yahoo.com

С основателем и председателем совета Академиком Виктор Семёновичем Дородным можно связаться по электронной почте: Dorodny@doctor.com

Physician Nexus Appoints Prof. V. Dorodny to its Esteemed Advisory Board

Professor Victor Dorodny Joins Physician Nexus Advisory Board

September 6, 2011, Malibu, CA---Physician Nexus, (www.PhysicianNexus.com ) based in Silicon Valley, is the fastest growing social network dedicated exclusively to physicians.

This global communications platform was developed with a vision to transform the field of medicine, allowing physicians to connect with each other in ways that were not possible before.

Physician networking, consultations, referrals, career planning, and other vital and powerful physician-specific features are now at your fingertips with Physician Nexus. It also serves as uniquely user-friendly platform for Tele-Medical and Medical Tourism application.

Physician Nexus appoints Prof. Victor S. Dorodny M.D., N.D., Ph.D., M.P.H. (www.DrDorodny.com), a specialist with over 30 years of clinical and executive experience, as well as a Doctorate in Health Information Technologies (HIT) and over 17 years of hands-on HIT/Telemedicine experience, to its esteemed Advisory Board.

Prof. Dorodny is the former Chief Medical Officer and Global Practice Leader for US-TeleMedicine Company and currently serves as the President & CEO of TeleMed Partners --global Health, Information, and Technology Integrators. (www.TeleMedPartners.com)

Professor V.S. Dorodny enjoys international recognition for advancing electronic health record technologies (EHR, EMR, PHR), and promoting confidentiality and security of health information.

He has served as Advisory Board Member of: The Association of Medical Directors of Information Systems (AMDIS); National Association of Managed Care Physicians (NAMCP) and The IPA Association of America (TIPAA).

He was one of the creators of the current Health Insurance Portability and Accountability Act of 1996 (HIPAA).

He conceived, designed, and led development of Knowledge–based Health Information Systems (KbHIS©) operational databases for healthcare organizations. He served as consultant to the Economic and Social Council of the United Nations; Technical Advisor to the United States Department of Justice and the FBI.

Prof. Dorodny originated the revolutionary concept of health and pharmaceutical care value (HCV©) that continues to shape emerging health systems. He consults for: the Institute for Alternative he , National Association of Consulting Pharmacists, the Joint Commission for Accreditation of Hospital Organizations (JCAHO), the National Pharmaceutical Council, and the FDA.

Prof. Dorodny is an accomplished Healthcare/HIT Physician-Executive and has successfully introduced his concepts into the marketplace as the Chief Medical Officer (CMO) of Clark Information Services, Inc., a software, applications and data warehousing company for pharmaceutical industry and other health care organizations; as the Executive VP & Chief Medical Information Officer of Superior Consultant Company, Inc., an integrated health care, pharmaceutical industry and information technology management company; as the Executive VP of Business Development for ICN, Pharmaceuticals, Inc., Eastern Europe.

Prof. Dorodny is Board Certified by the American Academy of Pain Management, Diplomate and Distinguished Fellow of the American College of Ethical Physicians, Associate in Medicine of the American College of Legal Medicine (ACLM), Diplomate and Distinguished Fellow of the American College of Hospital Physicians, graduate of USC Executive Management Institute in Health Care, and Registered Arbitrator.

Prof. Dorodny made significant contributions on diverse topics in major mass media publications, peer review journals and trade publications. He authored monographs and books. Among his editorial board appointments: Managed Healthcare, US Pharmacist, ADVANCE for Health Information Executives. As Reuters Healthcare Expert he often presents at national and international conferences, and guests on national TV and radio.

Diabetes, Heart Disease and Sea Vegetables.

Diabetes, Heart Disease, Obesity and Sea Vegatables originally published by Well Being Journal, Vol.13, #3, May-June 2004.

Fish Oil v Fish

From www.AskDrD.com, posted May 9, 2006


"A new tuna warning for pregnant women” article in the Health section of the June 12, 2006 issue of the Los Angeles Times stirred quite a controversy in the health and wellness community.

As a result, the NEW™ Institute in Malibu, California has received a number of inquiries. The original article (May 9, 2006) was published in response to legitimate concerns of the general public caused by mass media desire to cause a sensation, rather than provide useful information.

Fish oil supplementation has waxed and waned in popularity over the past decade.In the late 1990s when large clinical trials such as the GISSI study were published supporting the cardiovascular benefits of omega-3 fatty acids, fish oil became one of the most sought after supplements.

Hence, most health and wellness experts recommend consumption of fish and shellfish to meet some of the human bodies’ requirement for fish oil.However, due to fish oil's less than desirable taste characteristics, it was not well tolerated by even its most ardent supporters.

Improved molecular distillation processing has helped to enhance fish oil's purity and flavor and there are now even more studies to support the benefits of fish oil supplementation that reach beyond heart health.Some of the these studies were presented at the Omega-3 Fatty Acids: Recommendations for Therapeutics and Prevention Symposium, Institute of Human Nutrition, Columbia University College of Physicians and Surgeons, New York in October of 2005.

Recent studies by Craig L Jensen, M.D. (that included outcome measurements of gestational length and birth weight, preeclampsia, recurrent miscarriages, and maternal depression) have found positive associations between fish intake and gestational length and birth weight.

In a randomized multi-center trial, supplementation of 2.7g EPA and DHA from 20 weeks gestation or 6.1 g EPA and DHA from 33 weeks gestation reduced risk of preterm delivery.Preeclampsia is a common problem during pregnancy, especially as maternal age increases.

Observational data of potential effects of n-3 fatty acids on preeclampsia and related conditions show benefit.Additionally, the potential effects of n-3 fatty acids and recurrent miscarriages are promising.

Pilot study supplemented fish oil in patients with persistent anti-phospholipid syndrome associated recurrent miscarriages and found over a 3-year period, 86% of the patients had well babies.

Clinical depression has been associated with low levels of n-3 fatty acids, particularly DHA. A large, multi-country observational study of postpartum depression found a negative correlation between seafood consumption and/or breast milk DHA concentrations and postpartum depression.

Maternal DHA levels decline during pregnancy (as well as postpartum) as DHA is transferred to the fetus or newborn to aid in neural development.

Studies by Susan E. Carlson, M.D. clearly demonstrated that there is definitive evidence that DHA is essential in cognitive and visual development of a fetus/child because DHA is concentrated in the brain and retina.

Dr. Carlson discussed the positive long-term effects of early DHA supplementation related to higher Bayley Psychomotor Developmental Index (PDI) (gold standard for neurological development, measures body control, coordination and fine motor skills) in scores at 30 months, higher IQ at 4 years, higher MFFT (Matching Familiar Figures Test) score and speed at 6 years, and lower diastolic and mean blood pressure at 6 years of age.

However, the specific benefits of adequate DHA intake during periods of rapid brain development may not be measurable until older ages. Infant development studies often compare formula to human milk.

Human milk levels vary and the United States is considered an "at risk population" for low DHA levels, because US women consume lower levels of DHA compared to intake in other countries.
Human milk DHA content varies primarily as a result of mother's dietary intake differences.

The highest levels of DHA in human milk are found in the Japanese and marine China female populations.The United States has some of the lowest levels of DHA in human milk. In the United States, DHA was added to infant formula in 2002.

To reach worldwide median human milk DHA consumption levels, formula should contain 0.3% to 0.4 % DHA and women who are considering getting pregnant, who are pregnant and are breastfeeding should consider supplementation -- current recommendations are 300 mg/day.

Epidemiologic studies in the United States report 500 mg/day of n-3 fatty acids can decrease CHD (coronary heart disease) risk and mitigate many risks of pregnancy as well as to contribute to the fetal and neonatal cognitive development.The average American diet only provides 100 mg EPA and DHA per day.

This is 5 times less than the amount observed for cardiovascular benefit and also 5 times less than the WHO's current dietary recommendation for EPA and DHA. Not only are consistent recommendations needed, strategies to increase intakes are also necessary. Some recommendations are to increase fish intake, while others recommend specific amounts of EPA and DHA either as supplemental or marine sources.

Since March 2004, the Food and Drug Administration and the Environmental Protection Agency have recommended women who are pregnant, nursing or planning to become pregnant should eat no more than 6 ounces of albacore tune a week; and recommends up to 12 ounces (the amount of fish in two meals) per week of fish and shellfish low in mercury, such as shrimp, salmon, light tuna and catfish for general population.

Current prudent recommendations for consumption of fish (other than tuna) high in n-3 fatty acid contents are anchovies, mackerel, salmon, sardines, sea bass, swordfish, and trout.Some of these fish also need to be consumed in limited amounts because of mercury and other toxins. Swordfish, king mackerel, shark, and tilefish should be limited to 7 oz/week; red snapper should be limited to 14 oz/week; while salmon, catfish, and mahi-mahi have no restrictions.

Water sources have differing toxic levels of mercury, PCBs, digoxins, and others that may alter these general suggestions.However, Consumer Reports magazine published by Consumers Union recently said that 6% of canned tuna tested by the FDA “contained at least as much of the metal—in some cases more than twice as much—as the average albacore”.

It further recommends that women who are pregnant, nursing or planning to become pregnant eat neither “fresh”, nor canned tuna.

Again, this a “knee-jerk” overreacting by an ill qualified layman organization that creates panic, without informing the general population of the fact, that nutritional benefits of fish oil in seafood (especially in general population) easily outweigh the risk of trace amounts of contaminants.

Clearly, the general public often receives conflicting, and frequently contradicting, recommendations from mass media, Governmental and private sources--not only are consistent recommendations needed (please see above), but strategies to increase intakes are also necessary.

An effort by Kris-Etherton to substitute fish oil with walnut, flaxseed, soybean, and canola oil can contribute to meet LNA (pre-cursor of EPA and DHA) failed, despite the results from the landmark Lyon Diet Heart Study.

A Mediterranean style diet could provide approximately 0.6% to 1% energy or 2 g LNA, no more than 7 g per day LA, be rich in oleic acid, poor in saturated fat, and low in n-6 fatty acid sources.

The American diet, unfortunately, does not mimic these fatty acid intakes and is very high in n-6 fatty acid intake, which hinders the ability for LNA to be converted to EPA and DHA.

Having understood the critical importance of EPA and DHA for healthy childbearing and proper cognitive development of fetuses, infants, children and adults, and following the recent recommendation of the Consumer Reports, where should a pregnant and/or breastfeeding women to turn to?

Nutritional supplements of the health food grade fish oil, even in rather lower doses recommended by most of the over-the-counter manufacturers (700-1500 mg/day) generally provide a proper level of protection for pregnancy and child development.

Levels of in-organic (Dioxins, Mercury, etc), as well as microbial contamination of those supplements could be as high as in the fish it’s made from. However, in the recommended doses the possible side effects of contaminants are, probably, negligible.

The commercial grade fish oil is affordable and easily available.

Pharmaceutical grade (PG) oil is produced through 8-stage purification process followed by concentration with resulting no trans fats, and higher levels of EPA and DHA and low contaminants levels.

Some PG fish oil products contains 100 times less PCB's than health food grade fish oil, has twice the EPA and DHA as found in health-food grade fish oil.

Further, most people will not experience mild gastric problems often found with high doses of health-food grade fish oil.

The supply of this type of pharmaceutical grade fish oil is very limited since it takes 100 kg. of health-food grade fish oil to make just 1 kg. of pharmaceutical grade fish oil!

One teaspoon of the liquid OmegaRxTM contains 1.8 grams of EPA and 0.9 grams of DHA.

Such quality of fish oil is usually not available in health food stores because the supply of this type of pharmaceutical grade fish oil is very limited since it takes 100 kg. of health-food grade fish oil to make just 1 kg. of pharmaceutical grade fish oil!

And that is why one teaspoon of the liquid OmegaRxTM may contain 1.8 grams of EPA and 0.9 grams of DHA.

Although pharmaceutical-grade fish oil costs 10-20 times more than health-food grade, responsible manufacturers keep their price per gram of EPA and DHA as low as possible as shown below:

Product Grade: Price PerGram ofEPA & DHA

Lowest grade health food grade $0.30
Molecular distilled health food grade $0.54
OmegaRxTM Pharmaceutical grade capsules $0.56
OmegaRxTM Pharmaceutical grade liquid oil $0.49

All & all, pharmaceutical grade fish oil offers significant advantages and wellness benefits than the health food grade one, and, yes, higher concentration requires a lesser number of capsules to swallow!

Happy fishing and/or fish oiling.

Be Well!

***This article is to be used for education and general discussion purposes only. It does not constitute medical opinion and should not be used for or relied upon as medical advice. Publication of this newsletter does not create physician-patient relationship between the reader and the author. The article does not contain comprehensive description of the subject issues discussed. It is based on present medical knowledge which is subject to change and is unclear in numerous respects. Statements regarding the bio-efficacy of the nutritional supplements have not been evaluated by the FDA. They are not intended to diagnose, treat, cure or prevent any disease. The issues discussed can not be resolved without specific analysis of the specific circumstances of each person. The readers should consult with their individual health care/wellness professional to resolve their individual situation.

From Mangled Care to Direct Health CarING©

The process of health carING© is almost insurmountable in its multifaceted complexity, thus according to the rules of non-linear dynamics it simply can not be “managed”.

What can be managed, meaning rationed, are the ever-rising costs of such carING©.

“Managed care” is a primary oxymoron by default; in its present form is best described as mangled care.

When originally introduced to our naive country and promoted by then ,and still, misguided and ill qualified Mrs. Clinton and her Jackson Hole Task Force, mangled care was, defined as:

" A prepaid risk-based system of integrated health care delivery, having appropriate capabilities to improve quality of care and manage utilization and cost of a given population.” (Thomas Morrow, MD., at NMHCC/IT Fall 1998, Los Angeles, CA)

These for-profit extremely profitable mangled care companies have embraced, and function under divergent and practically mutually exclusive core values.

On one hand, these companies are obligated to provide rather than ration health care services.

On the other, their entire existence hinges on their obligation and ability to generate consistent profits for their executives and shareholders.

More often than not, provision of appropriate health carING© and profit margins of mangled care companies come into direct conflict.

This conflict fuels a “double explosion” of the system: while availability and quality of health services goes down; costs of services to purchasers and profits of mangled care companies go up.

This abominable situation creates significant financial “counter-incentives” to provision of appropriate, accessible, affordable health carING© which can be gauged by the divergence coefficient.

Such counter-incentives further negatively effect already financially squeezed powerless and frequently frustrated health providers.

In addition to divergent and conflicting core values, double explosion, financial counter-incentives and overall patient and provider frustration there is, what I coined, business disconnect.

Entire purpose for insurance, companies, HMOs and other "mangled" health care organizations existence is to grab as many pennies from consumer’s health care dollar as they are allowed to by the workers.

Business disconnects exist due to interlined logistical, financial, physical and ethical aspects of mangled health care:

•The recipient usually does not request, does not order, or pay for the service.

•The payor never requests, does not receive, nor order the service.

•The orderer does not pay, nor receive the service.

In order to achieve their business objectives, here are some of the strategies used:

•If someone is already paying a lot, let him or her continue.

•Even if a lot of people complain about managed care quality, it won’t contain cost.

•Never provide coverage unless the treatment is unpleasant.

•Quality is being in a waiting room with people who earn more money than you do.

Please visit www.workingamerica.org/healthcarehustle maintained by AFL-CIO for real life stories.

Despite such an unorthodox business model, they do grab a sizable chunk: 17 cents out of every healthcare dollar without actually working, being sick, or providing services.

Here are three of many “secrets” in health carING © that health insurance companies do not want health consumers to know:

• Health consumers can request and receive health carING© from doctors, nurses,

pharmacists, hospitals, labs, pharmaceutical companies, and others without mangled care.

• Doctors, nurses, pharmacists, hospitals, labs, pharmaceutical companies, and others can

provide health carING© without mangled care.

• Healthcare consumers can pay for health carING© without mangled care companies.

Only complete elimination of mangled care as the middle man, can generate enough money to provide appropriate, accessible and affordable health carING©.

Patient-driven health care model promoted by mangled care must give way to direct health consumer-administered health carING ©.

I, for one, am willing to make a difference and show the way.

We are making a difference (MAD), you decide!

Milestone achievement by the NEW™ Institute is a victory for health consumers.

Yesterday, September 23 2008 FDA finally launched a long awaited crackdown against companies marketing prescription medications without government approval.

The NEW™ Institute involvement with the skin cream containing papain, derived from the tropical papaya plant, provided evidence that manufacturers were selling it without federal validation of their safety and efficacy.

The cream is being touted by about a dozen of manufacturers for treatment of chronic (non-healing) skin ulcers from diabetes and other causes.

As of today, there is no single approved version of such cream in a "business" worth about $50 million a year.

The adverse reporting noted that frequently the cream was of no help to patients and caused life-threatening allergiс reactions.

Companies making this unapproved cream have till November 24 to file for FDA approval or cease production in lieu of FDA seizures and other legal actions.

Be Well!

Prof V.S. Dorodny to re-enter clinical practice

Having dedicated most of my professional activities since 2006 to pursuit of Academic and Research endeavors, I am happy to announce that I will be returning to Clinical Practice before the end of 2008.

A dully licensed California Physician & Surgeon with over 30 years of traditional medical experience, I am also a Naturopathic Doctor with over 10 years of experience of convergent, and, frequently, symbiotic approach to the management of all chronic and multi-systemic disease states.

My areas of expertise encompass traditional medical practice and naturopathy with a focus on nutrition, botanical medicine, homeopathy, hydrotherapy, physical manipulation, pharmacology and psychology.

Naturopathy is a philosophy which encompasses a view of life, a model for living a full life. The word naturopathy is a Latin-Greek hybrid which can be defined as 'being close to or benefiting from nature.'" - Stewart Mitchell, Naturopathy: Understanding the Healing Power of Nature.

Naturopathic Medicine is the practice of assisting in the health of patients through the application of natural remedies. Most naturopaths consider their care complementary, not supplementary, to the care a traditional medical professional.

However, the field and its practitioners remain mostly unregulated even in a progressive State of California with only few, at least for know, that can formally called themselves Doctors of Naturopathy. (N.D.)

There are tens of thousands of natural bio-active food supplements and preparations that are being marketed to the general public. Clearly, there is an expressed need for an orderly, studied and unbiased assessment of the benefits and risks of this burgeoning marketplace.

The recent (2007) shutdown by the FTC/FDA of the $250-million-a-year liquid vitamin manufacturer SeaSilver sent shock waves through the booming food supplement market.

While there are a number of lessons to be learned by long overdue and clearly warranted enforcement action, the most important message is probably this: A whole lot of people spent a great deal of money on a product which, as far as regulators were concerned, was marketed in wholly inappropriate and perhaps misleading fashion.

When family health and well-being are at stake, we all want the best information available. We all want the correct information.

We want unbiased information. The National Institute of Health (NIH), the Food and Drug Administration (FDA), and other agencies that we traditionally rely upon to serve as vanguards of medical authenticity are experiencing funding and manpower shortages, as well as conflicts of interest.

While these agencies are without doubt the most capable sources of evaluating legitimate health-benefit claims, they are buried by the sheer volume of their mandates, and have difficulty coping.

Having served as a Consumer Representative on the FDA’s general Scientific Advisory Board (1998-2002), the need was clear.

In July 2003, the FDA set forth the conditions under which it will exercise enforcement discretion for qualified health claims: "…when it determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence".

To provide a repository for scientific data about naturopathic supplements that empowers health consumers and providers to make good, safe decisions; and serves as an additional resource for the regulatory community, I founded the Naturopathic Evidence-based Wellness Institute (NEW™) in May of 2003 in Malibu, California.

Finally, the NEW™ Institute provides an authoritative resource for the manufacturers of food supplements to educate their markets about the true benefits of their products through compelling and compliant advertising and marketing.

Over the past 2 years we were inundated by requests for information, consultation and direct care. Responding to the needs of health care consumers I will be announcing the new physical location and contact information in mid-October 2008

Be Well!

Genome Unleashed

An expert on confidentiality and security of health information, co-author of HIPAA of 1996 and a former co-Editor of "Information Security" Journal I am compelled to sound off.

For "only" $1,000. web-based startup “23andMe” offers a person an “unguided” tour of geneology offering predictions of its genetic future as well as its ancestral past. Similarly, "Navigenics" will match your genes to current medical research calculating your risk for a number of diseases.

“23andMe” was funded personally by the co-founder of Google, Sergei Brin (later repaid by Google!?) who's also married to the co-founder of 23andMe Anne Wojcicki.

Google's investment in the company is driven by its desire to obtain, control, and sell valuable information without owners’ knowledge and/or consent.

Given that the vast majority of patients are unable to comprehend the results and will have to rely on the very same companies to “translate” them, most physicians are currently untrained for genomic medicine and are ill equiped to assist patients wielding printouts indicating “variations” in a particular gene possibly leading to successful claims of medical malpractice.

Issues of genomic information ownership and release create new fertile ground for litigation.
Who owns the genomic test results? Is it the patient, testing lab, Google, patient employer, insurance company, lending institution, state and/or federal government?

Fortunately for the genomic industry, Food & Drug Administration which strictly regulates diagnostic testing for diseases, has been “slow to respond” to business practices of these companies and its consequences!

An individual can finally make a quick life-changing decision (even deadly one) based on the results of a genetic test. Armed with individuals genomic information employers can deny employment and/or promotion'; insurance companies can and will deny coverage; banks will deny loans under the justification of unreasonable business risk?

We are Making a Difference (MAD), you decide.

Dr.D.

Great American Smokeout of just a Great Smoke Screen?

According to the results of a national survey conducted in 2006 roughly 1 in 5 adults in the US smoke cigarettes, a figure that has not changed much since 2004.

The new findings, which appeared in the November 9th issue of the Morbidity and Mortality Weekly Report, were released in advance of Great American Smokeout, to be held this year on November 15.

About 80% of current users reported smoking every day. Roughly 44% of current smokers had made an attempt to quit smoking in previous year and had stopped for more than 1 day.

This lack of decline in cigarette smoking is accompanied by simultaneous (and growing-400 so far) proliferation of hookah bars/clubs as a "safer" social (group activity) alternative.

Smoking cessation methodology probably failed due to the fact that most laboratory studies are conducted on non-humans. Dr. Edythe London, a leading researcher at UCLA, recently admitted in her Op-Ed article in LA Times that animal tobacco dependency model is completely different from that of humans.

Even Dr.London might concede that animals (primates) in the wild can rarely be found in hookah bars surrounded by the rest of the pack equipped with laptops.

In a recent (November 7, 2007) article in the LA Times by Animal Liberation Front (ALF) spokeswoman Lindy Greene claims that “data from one species cannot be extrapolated to another with more than 5% to 25% accuracy”

With 30% being within the acceptable margin of error for any study, Dr. London’s “esteemed” animal research is nothing more than a very expensive (for taxpayers and consumers) guesstimating.

Animal researchers, driven by quest for publishable data and financial well-being, solely dependent on grants from corrupt manufacturers, might do better by just flipping a coin--50% success rate.

Further, the study claims that smoking prevalence differed by gender and race: 23.9% of men vs. 18.0% of women smoked and 10.4% of Asians vs. 21.9% of whites were smokers. In addition, smoking prevalence fell as educational level rose and increased with poverty.

Studies at the National Institute of Environmental Health Sciences demonstrated that despite African-American children's having a lower exposure to tobacco compared to whites, they have higher levels of serum nicotine than white children.

Further studies are needed to determine whether there are racial differences in the metabolism of other tobacco-related toxins and to assess the efficacy of interventions to reduce ETS exposure among all children.

Race is not a definitive biologic construct, but rather an imprecise arbitrary categorization that is a proxy for multifaceted cross-connected environmental, cultural, socioeconomic, and biologic variables almost insurmountable in its complexity.

I dare Dr. London & Co. to account for all of the critical variables and to publicly admit that animal research can be only approximated, at best, to humans--a far cry from human-relevant data!?

The absurdity of continued animal research is propagated by unscrupulous pharmaceutical manufacturers, their “pet” scientists and the FDA despite the multiple thousands of consumer injuries and deaths every year from adverse reactions to drugs tested "safe" in animals (VIOXX any one?) and, conversely, causes potentially beneficial drugs tested "unsafe" to be discarded.

ALF’s methodology of protecting “creatures that society would arbitrarily place outside the circle of moral compassion and beyond the reach of effective defense” fails to properly use science to educate general public through mass media.

I firmly believe that only a strong outcry form educated public coupled with public refusal to buy products implicated in animal testing/abuse can make a tangible difference for the animals.

We are MAD, you decide!

Dr.D.

P.S. Making a Difference---MAD

Where do I stand on the issues of animal research.

I am a relatively new, at least publicly, opponent of animal research.

First, and foremost, I unconditionally condemn violence in any shape or form against individuals, organizations and/or their property. Further, I believe that attacks on researchers and their institution by some radical groups seriously undermines their own credibility as well as the legitimacy of mainstream organizations.

Hence, I am not and will never be associated with any individuals, groups and/or organizations that either commit, promote or condone violence as means to achieve their goals.

Second, my objections to animal research are purely scientific since animal-based research is foundationally flawed. Data obtained from animal research data can not be extrapolated to manufacture human-relevant information. There are numerous viable alternatives to produce human-specific data without the use and abuse of animals.

In additional to cell preparations, transgenic modeling, and live human volunteers (please see my early postings on the issue), yet another alternative to using ill-suited animal models could be the use of aborted fetuses and tissues and organs from recently deceased humans.

Fetuses aborted during the first trimester (legally one can do it only up to 10 weeks) provide a representative sample of tissues needed for the study of most biological processes.

I am referring only to fetuses that are already legally aborted. I will neither condone nor condemn legal abortion or legality of abortion.

Organs and tissues could be "kept alive" in recently deceased humans and then used for the studies of toxicity mechanisms.

For example: instead of sacrificing 40-50 rats and "blending" their livers to study the toxicity of alcohol, one can use the liver of a car-crash victim for the same purpose but with better results that are actually applicable to human physiology and relevant to studies of human disease model.

Despite my personal and professional objections to tactics and actions sometimes employed by the Animal Liberation Movement, and my disagreement with the published statements of its Press Officer Dr. Jerry Vlasak, I felt compelled to object to Los Angeles Times Editorial policies and actions and its childish mistreatment of Jerry Vlasak, MD, FACS.

Here is a copy of my "surprisingly" unpublished letter to the Editors of LA Times of November 2, 2007:

"Editors,

When the only paper in Los Angeles market decides to take a position on animal research (or any other issue) instead of reporting, and decides to suppress opposing views of similarly qualified professionals it should not be surprised with its shrinking circulation and profits.

LA Times made an editorial decision to condone animal testing and to deprive its readership from any formation about many scientifically valid ways to rapidly diminish and/or totally eliminate the need for laboratory animals.

Your publication of Dr. Vlasak's letter with the intentional omission of his professional titles and affiliations does not limit his credibility but does place the shame on you. Not extending this common courtesy to Dr. Vlasak while affording it to all other authors again proves your bias and, in fact diminishes your paper credibility and will hopefully result in further financial losses for the paper.

Intelligent compassionate people of LA enabled by the Internet will find the truth and spread the word."

We are MAD, you decide!

Dr.D.

P.S. Making a Difference! (MAD)

"Why do I use animals in research" or " Why do I abduct, detain, confine, mutilate, torture and kill animals" by Dr. E. London

Unfortunately for animals used in research Dr. London conducts those sadistic actions without animals expressed consent to participate in her research activities.

The damage inflicted to Dr. London's residence is stupid and reprehensible. Dr. London's fight against addiction to nicotine, methamphetamine and other drugs is admirable. Her use of primates and other animals is incomprehensible. Her justifications for use of animals in non-clinical research could not further away from truth.

Further, she deliberately avoids discussion of non-animal research options such as cell cultures, transgenic modeling and human volunteers to name a few.

Human volunteers recruited among prison inmates, well meaning researchers, executives of pharmaceutical and tobacco companies and their respective family members can provide a new dimension to research--subject's reporting, interactive feedback and ability to follow instructions.

Properly designed and conducted human volunteers study, with preference given to aforementioned groups, will reveal human-specific, hence human-relative data.

These (human) studies are much more likely to be conducted in an ethical and cruelty-free manner, with proper consent, compensation (except for inmates), pain relief, psychological counselling and treatment of any and all complications and adverse outcomes. ACLU can monitor compliance.

In her article Dr. London contradicts herself stating that “While monkeys receive drugs in the laboratory, they do not become “addicted” in the same sense that human…” So why torture monkeys and other animals when there are millions of potential human volunteers stupid enough to subject themselves to tobacco and other addictive substances.

Such (human) studies will invariably yield human-specific hence human-relevant information.

Being a child of Holocaust does not give one a license to inflict Holocaust on animals by using them in research. If nothing else it should have made Dr. London more sensitive to the plight of the weak and defenseless.

Without condoning violence in any shape or form I would like to point out that use and abuse of animals is UCLA researchers is funded and promoted by greedy pharmaceutical companies, such as Amgen that is in serious financial straits due to recent changes in reimbursement for its drugs.

In addition to promoting and conducting animal research (Amgen maintains an extensive vivarium where animals are routinely used for research) by UCLA through its clandestine invitation-only seminars promoting animal research (last conducted October 28, 2007) Amgen simultaneously taints the objectivity and validity of researcher conducted by UCLA.

Hiding behind frequently used and abused "unrestricted educational grant" can not fool any one, Hence, Dr. London's acceptance of tobacco company's money seriously jeopardises UCLA's standing as an "independent third party" seeker of truth!?

I challenge UCLA officials, leadership of Amgen, leadership of tobacco companies, and prominent researches to open a productive dialogue with mainstream activist to reduce and finally eliminate use of animals in research ( and related abuse and exploitation) in favor of genetic modeling and/or use of human volunteers.

We are MAD, you decide.

Dr.D.

Practical Alternative to Animal Research, or What Amgen Does Not Want You to Know?

Sporadic displays of animal cruelty by the likes of Michael Vick and Ellen DeGeneres usually get plenty of media coverage and generate necessary public outcry.

However, ongoing acts of animal abuse committed under the auspices of scientific necessity to “ensure and enhance human and animal health and protection of the environment” remain unnoticed by media and general public (1).

The justification used by researchers for use of animal-only model studies can be found in a handout distributed by Dr. Robert F. Phalen(2) during his clandestine lecture at Amgen, Inc. Corporate HQ October 28, 2007:

“…there is no more powerful tool for protecting human health than the combination of well conducted animal experiments and well conducted epidemiological experiments” Rall (1979).

“…a large number of values for man coincided with remarkable accuracy for the 70 kg animal”, Krasovski (1976).

“…these survey results support the value of in vivo toxicology studies to predict for many human toxicities associated with pharmaceuticals…”, Olson et all. (2000).

“…the human genome is remarkably similar to that of evolutionary ancient organism. Thus, the various life forms on earth share much more in common than anyone had previously envisioned”. Ballatori and Vilalobos (2002).

The Society of Toxicology (SOT) claims that research involving laboratory animals is “necessary” and that “research animals must be used in a responsible manner”. Therefore, according to Dr. Phalen, it is “…unethical to block or impede well-designed, humane animal studies”.

Unfortunately for animals, and despite the alleged strict adherence to the rules and regulations of the federal Animal Welfare Act (AWA) [P.L. 89-544] and the Health Research Extension Act [P.L.99-158] all animal studies in the world are missing a critical component— informed consent.

Interestingly, both the SOT and Dr. Phalen concede that there are major anatomical differences between humans, mammals, and other laboratory animals that might render results obtained from animal studies to be of limited value.

The SOT and most scientists further concede that animal studies proven less than reliable because in addition to anatomical and resulting physiological (functioning) differences, lifespan of laboratory animals is short; human disease models are generally poor; appropriate “metrics” are poorly understood; mass alone is seldom used; dosage comparisons across species are difficult (3); and individual differences are extremely large.

There are many exciting promising ways to conduct laboratory studies without use of laboratory animals.

With the entire sequence of human genome now deciphered, specific human genetic mutations might be induced and quantified in a cell culture; using organism into which human genes have been incorporated (transgenic systems) and many others. Such methods will enable the scientist to use solid experimental evidence to predict human diseases without use and abuse of animals.

Pending development and practical implementation of these technologies, the SOT’s
stated goal “…scientifically-valid research design to reduce, refine or replace the need for laboratory animals” falls short of offering the only logical solution—use of human volunteers with proper informed consent.

With the high and ever-rising costs of “housing” inmates in our jail system ($45,000.00 per inmate per year in California) and a burgeoning prison population, there is an untapped resource of human volunteers who might be willing and ready to redeem themselves by participating in laboratory studies.

Given prisons being a true society reflection, scientists should not have any problems recruiting age, race, size, gender-diverse volunteers willing to contribute.

Accurate human-derived (hence human-relevant) data can rapidly diminish or totally eliminate the need for laboratory animals now used and abused to ensure and enhance human health and protection of the environment.

We are MAD, you decide!

Dr.D.
___________________________________________________________________
1. The Society of Toxicology (SOT) 1821 Michael Faraday Dr., Suite 300, Reston, VA 21090;
phone (703) 438-31135; fax (703) 438-3113; sothq@toxicology.org;
http://www.toxicology.org/

2. Robert F. Phalen, PhD, Professor of Community & Environmental Medicine, College of
Medicine, Univ. of California Irvine CA.

3. Jarabek et al., 2005; Kuempel et al., 2006

Dr. Dorodny

Prof. Victor S. Dorodny is the Founder and Chief Scientist of the Naturopathic Evidence-based Wellness (NEW™) Institute in Malibu, California. Prof. Dorodny is dedicated to education of wellness consumers, and implementation his principles of complementary convergence of Naturopathy and traditional Medical Science to achieve and maintain Natural Health.

He is the Chief Medical Officer of the Malibu Medical Reserve Corpse (MMRC)—a volunteer organization under the guidance of the US Surgeon General dedicated to assisting authorities in a form of Medical Disaster Assistance Teams. (MDAT)

He is the past Vice-President, of ICN Eastern Europe, a Division of ICN Pharmaceuticals, Inc, Costa Mesa-based global pharmaceutical company and has many years of experience in pharmaceutical, vitamins and nutraceutical manufacturing.

As practicing/consulting physician, academician and technologist with 30 years of clinical and consulting experience he is an expert on Anesthesiology and Pain Management, Rehabilitation, and Multi-disciplinary approach to the management of chronic disease states.

Dorodny was founder and president of Health PRO Worldwide, Inc., a Health & Wellness consulting company in Pasadena, California since 1993. Since 1995 he is the Founder & Chairman of TRIPAC, National Health & Wellness Advocacy dedicated to ongoing transformation of health consumers and provider of health & wellness products and services, and team approach to utilization of traditional medicine and naturopathic strategies for optimal health.

He has served as consultant to the Economic and Social Council of the United Nations; Technical Advisor to the United States Department of Justice and FBI; past president of the National Association of Managed Care Physicians (NAMCP). He is a Board Member of Association of Medical Directors of Information Systems (AMDIS); Board member of the IPA Association of America (TIPAAA), National Managed Health Care Congress/Health Information Technologies (NMHCC/HIT); California State Pharmacy Partnership; Health Care Advisory Committee-Assembly; California Legislature and US Congress. Member (A) of the Scientific Advisory Board of the US Food and Drug Administration (US FDA).

A native of Odessa, USSR Prof. Dorodny received his M.D. and M.P.H. degrees from N.I. Pirogov Medical Institute in Odessa, USSR.He completed his residency in Anesthesiology at the USC-Los Angeles County Medical Center, ans is a Graduate USC Executive Management Institute in Health Care in 1993 and received Ph.D. in Health Informatics from International Informatization Academy in 1997. Prof. Dorodny is Board Certified by the American Academy of Pain Management, and is an Associate in Medicine of the American College of Legal Medicine (ACLM).

Prof. Dorodny has made significant contributions to major mass media publications, peer review journals and trade publications. He has authored numerous monographs and books, and his editorial board appointments include Managed Healthcare, and The Medical Reporter. He is the only physician in the USA on the editorial boards of US Pharmacist and Information Security Journal.

He is a frequently invited keynote presenter at national and international conferences, and featured guest on national TV and radio. Prof. Dorodny is an Active Academician with the International Informatization Academy (IIA) and a frequent participant in projects at the Institute for Alternative Futures, National Association of Consulting Pharmacist, and Joint Commission for Accreditation of Hospital Organizations (JCAHO), National Pharmaceutical Council, and US Food and Drug Administration.

_____________________________________
30765 Pacific Coast Hwy., Suite 285, Malibu, CA 90265,

(310) 663-2949, e-mail: healthpro@pol.net