Copy of Statement Submitted to National Vaccine Advisory Committee
Natural Solutions Foundation
www.HealthFreedomUSA.org
“Health Freedom is Our First Freedom!”
March 14, 2009
National Vaccine Advisory Committee (NVAC)
Washington, D.C.
Via Internet: nvpo@hhs.gov
VACCINATION CLAIMS RESEARCH STATEMENT
Introduction
1.0. Overview:
The Natural Solutions Foundation, Inc. (hereinafter referred to as “the Foundation”) and all those who hereafter join in, bring to the attention of the Committee the need for scientific research regarding the often repeated, but unsubstantiated claims made in the Advertising and Promotion of Vaccinations to the professional community and lay public. Both health professionals and the Public are lead to believe that Vaccines are both “safe and effective” through many millions of dollars in annual advertising expenditures and publications, without adequate substantiating immunological, sociological or epidemiological research. Under current inadequate standards, pharmaceutical companies do not have to prove that any particular vaccination actually produces immunity to a particular disease organism, rather, all that is currently required is to demonstrate that there is some anti-body production after vaccination, justifying the use of the vaccine. The link between the production of these antibodies and their effectiveness in disease prevention, and the demonstration that the vaccine is safe on either a long or short term basis, alone or in combination with other vaccines or factors, is not required. This is clearly inadequate to demonstrate that any vaccine is “safe and effective” to protect against disease.
The Foundation is a nongovernmental organization (NGO) incorporated in the State of Nevada and recognized as exempt under Section 501(c)(3) of the Internal Revenue Code. The mission of the Foundation includes educating decision-makers with regard to natural solutions to health care needs and challenges. The Foundation has about 200,000 citizens on its opt-in Health Freedom eAlert System.
1.1. This Statement is submitted in response to the Committee “seeking public input into the scientific research agenda being developed by the Centers for Disease Control and Prevention’s (CDC) Immunization Safety Office (ISO)…” see: Draft Agenda Recommendations, April 11, 2008, http://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf
We make this Statement with regard to providing the Public truthful and not misleading information about both Mandated and Voluntary Vaccinations through Vaccination Advertising, Vaccination Information and Vaccination Labeling provided to physicians, patients, parents, and guardians.
1.2. We resolve and state that there is neither significant scientific agreement nor sufficient reliable and competent scientific evidence from reliable, independent and unbiased sources to allow the conclusion that individual and/or multiple vaccinations, particularly of young children, provide any measurable public health care benefit. This is true whether the vaccinations are mandated or voluntary.
Further, there is a large body of evidence which shows that repeated single and multiple vaccinations, especially in young children, can cause or precipitate, and has in fact caused and/or precipitated, devastating and irreparable harm to hundreds of thousands of the most vulnerable citizens: our children. Vaccination is an un-insurable medical risk which has never been demonstrated with convincing scientific rigor to be either safe or effective. For that reason, vaccination must never be mandated or offered on a voluntary basis without provisions for the broadest medical, philosophical, and religious exemptions. In addition, vaccination must only be offered under any circumstances upon fully informed voluntary consent.
1.3. Billions of dollars of special vaccine-dose assessment and tax funds have already been paid to families of vaccine-injured children under the auspices of the Federal Government’s National Vaccine Injury Compensation Program (VICP} which was created by the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) in part to “establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines.” In fact, vaccine injuries are so common that the VICP was established to deal with the devastating consequences of vaccination, of which parents and patients were not and are not informed. See: http://www.hrsa.gov/vaccinecompensation/ The VICP is a “no-fault” alternative to the traditional tort system for resolving vaccine injury claims that provides compensation to people found to be injured by certain vaccines. The U. S. Court of Federal Claims decides who will be paid.
1.4. The current vaccination injury compensation structure is at: http://www.hrsa.gov/vaccinecompensation/table.htm
1.5. Serious negative vaccine consequences are so common that the Vaccine Adverse Event Reporting System (VAERS) catalogs tens of thousands of vaccine- related injuries and deaths. See: http://www.whale.to/vaccines/vaers.html; New England Journal of Medicine, 2007; 357: 1275-9. It is of major significance to note that the CDC, FDA and other agencies estimate that only 1 to 10% of vaccine adverse events actually occurring are reported, so the actual magnitude of the problem is unknown and , according to the US Government’s own estimates, is highly likely to be substantially greater than current documentation of reported events suggests. (e.g., a National Vaccine Information Center survey of NY pediatricians found that only 2.5% report adverse events).
1.6. If the frightening facts reported in VAERS are considered, no reasonable regulator can permit the current system to continue. It must be halted immediately in order to stop the irreparable harm we demonstrate here and which full properly designed and implemented scientific research would amply confirm.
1.7. Further examples of both potential and actual harm to the Public abound and are very evident with many current Vaccination advertising practices.
1.8. For one example, a report cited on the Internet indicated, “Only after filing a lawsuit against the FDA was Judicial Watch able to uncover New FDA Records Detailing an additional 8 deaths among an additional1,824 Adverse Reaction Reports Related to Gardasil, Merck’s Human Papillomavirus (HPV) Vaccine between May 10, 2007 and Sept. 7, 2007. The death reports include 12 and 13 year old girls.” This brings the known total for this one vaccination to 3,461 adverse reactions, including 11 deaths, since the Food and Drug Administration (FDA) approval of the vaccine; see: http://ahrp.blogspot,com/2007/10/8-more-deaths-liked-to-gardasil-hpv.html
1.9. Current Vaccination Advertising and Labeling do not adequately warn the Public of the significant, but un-insurable, medical risks inherent in vaccinations, the complete lack of proven clinical efficacy in disease prevention inherent in the procedure which makes it, at best, experimental, nor do they disclose to the public their exemption rights. Full discussion of the risks and possible unproven benefits and informed consent waivers are not provided by physicians concerning the pros and cons of vaccination. Instead, like the students at the University of Maine campus, in December of 2007, who were vaccinated under duress, on pain of being locked out of their dormitories, eating halls, classrooms, libraries and all other University facilities unless vaccinated – or revaccinated – , patients, parents and guardians are not fully informed. No discussion of dangers, potential adverse events and other considerations pertaining to personal choice in the face of an un-insurable risk took place in Maine, nor was any discussion about personal exemptions, as established by law, permitted. The same is true in physicians offices, hospital emergency rooms and other vaccination sites across the United States.
1.10. The same was also true on November 17, 2007, when 2,300 children were vaccinated, literally at gunpoint, with the presence of police dogs, in the Prince George’s County Courthouse, Prince George’s County, Maryland, under the watchful eye of a Maryland Judge. The parents, mostly minority, poor and many unable to read, were threatened with jail and fines if they refused vaccination in a state which provides for exemptions were never discussed with the parents. It is important to note that the Maryland States’ Attorney, Mr. Genn Ivey, told our Foundation representative privately, and repeated during an international radio broadcast, that he had learned these vaccines were so dangerous that he availed himself of the exemption and did not allow his own children to receive the vaccines.
1.11. Thus the impact of misleading advertising, backed by coercion, was used to force 2,300 schoolchildren to be vaccinated; many against their parents’ will, in the absence of either due process or full disclosure. Many children were re-vaccinated with all vaccines because, as the Prince George’s County School District admitted, it had lost the children’s immunization records. These children were put at an increased risk by this process because the neurological and other related damage following vaccination is directly proportional to the total body burden of toxins introduced by vaccination. This fact is not disclosed to parents and was not disclosed to the parents of the Prince George’s County children. Instead, advertising, including unproven and scientifically flawed, weak professional documentation is used to portray vaccination as safe and effective in preventing diseases, creating an untruthful and misleading perception. All such advertising should stop until adequate warnings and disclosures can be approved and implemented and compelling scientific validation for these claims can be provided.
1.12. And by way of final example, the public media reported in late February and March, 2009 on the alleged “accidental” contamination of season flu vaccines delivered to 18 countries with live, infective human Avian Flu Virus. Had this contamination not been discovered in time, a world-wide Avian Flu Pandemic could have been triggered by mass vaccination. There is less than no proof that Avian Flu Vaccine is either safe or effective since the pandemic version of the disease does not yet exist. Although FDA approval to some versions of Avian Flu Vaccine has already been given in the absence of human testing, there is absolutely no evidence that any of these vaccines will protect against, either safely or otherwise, the development or severity of Avian Flu in human. Any claims for, or advertising of, these products must be halted until acceptable scientific proof can be provided. See: https://staging.drrimatruthreports.com/?p=2191
II. Actions Requested
2.0. We urge the Committee to take the following actions (hereinafter, the Statement Action Requests):
2.1. Issuance of an immediate Recommendation to suspend advertising of vaccinations by the manufacturer, public health agency or any other entity or person whether protected from liability under such Federal Laws as Title 42, Chapter 6A, Subchapter XIX, Part 2, Subpart A, Section 300aa-16, Limitations of Actions, or not until all reasonable scientific research shows that any particular vaccine is safe and effective.
2.2. Issuance of an immediate Recommendation to halt Interstate Commerce regarding vaccines and vaccine related goods, until all reasonable scientific research shows that each particular vaccine is safe and effective. At that time, Interstate Commerce of that vaccine may resume.
2.3. Issuance of a Recommendation that any practitioner or entity administering vaccines should be required to notify patients, parents or guardians in their own language that vaccines are currently the subject of scrutiny because of their lack of proven protection in communicable disease and their dangers to persons receiving them. Patients, parents or guardians wishing to proceed with vaccination should have a waiver form explaining the dangers, uncertainties, un-insurability, presented to them and State and or Federal exemption opportunities provided to them. Signing such an explicit waiver is the minimum required for truly informed consent under the terms of the Declaration of Helsinki, 1964, http://www.wma.net/e/policy/b3.htm – which constitutes part of the Law of Nations under the United States Constitution.
2.4. Issuance of a Recommendation that all appropriate Federal Agency rules ensure the public that the un-insurable medical risk of vaccination injury will not be mandated over the medical, philosophical and religious exemption rights of Citizens. States which threaten to withhold services such as schooling from unvaccinated children, forbid admission of unvaccinated students to universities and colleges or access to facilities and services after tuition or its equivalent has been paid, and similar coercive activities based on inaccurate and misleading advertising of vaccine efficacy and safety should be denied all Federal scientific research or other funds.
2.5. The Foundation expresses carefully considered doubt that the involved Federal Agencies have exercised prudent judgment in the face of abundant scientific, empirical and other information, supported by adverse event reporting, in permitting the production, shipment, sale and injection of vaccines. Scrutiny should focus on all ingredients in vaccines: active, inert, intended, adventitious, unintended, trace and adjunctive; since all ingredients, alone or in combination with each other or constitutional, environmental, pharmaceutical or other factors, may cause responses in the body leading to harm. Squalene, for example, is an adjuvant used to enhance immune response which may be safe when ingested or used as a topical agent, but is the cause of serious auto-immune disorders when injected. Many new generation vaccines contain Squalene as an adjuvant.
2.6. The Foundation urges that the Committee Recommend that all future Vaccination Advertising and Labeling contain, at a minimum, the following Warning and Disclosure –
“WARNING: The safety and efficacy of vaccination has not been demonstrated by reliable, independent, unbiased, and competent scientific or clinical evidence. DISCLOSURE: You or your children may have a right under law to a medical, philosophical or religious exemption from this vaccination.”
2.7. Vaccination remains an experimental modality. Under the Declaration of Helsinki, it is imperative to assure that all recipients or their parents or guardians are fully informed about the dangers they may face if they allow themselves or their charges to be vaccinated. A waiver must be required from patients, parents or guardians indicating that pros and cons of vaccination were fully discussed with, and understood by, them and that all exemption rights were also fully discussed and understood. The waiver must state clearly that the recipient, parent or guardian fully understands that manufacturers of vaccines have no liability for any damage which they may cause, including death and that the risks in vaccination are un-insurable.
2.8. At a minimum, to meet international standards regarding medical experimentation, such as the Declaration of Helsinki, a physician, upon appropriate consultation, must be permitted provide a valid medical excuse from current and future vaccinations recommended by any Federal Agency for any child who has suffered a reaction of any type to any previous vaccination. The child’s medical history, as reported by the parent, shall be taken to provide conclusive evidence of such reaction. No child shall be subjected to any vaccination unless the physician administering the vaccination shall have certified in writing that it is both safe and necessary that the particular child is vaccinated against that particular disease or diseases and why such vaccination is necessary. Physicians who find no justification for vaccination shall not be liable to censure, discipline and/or harassment by their state medical boards of jurisdiction or other professional organizations including, but not limited to, the American Medical Association (AMA), American Association of Pediatric Physicians (AAPP), and State Medical Associations.
2.9. As an executive agency advisory committee, the NVAC must “Take Care that the Laws be faithfully executed” (Article II, Section3, United States Constitution)
2.10. Further, the Committee should consider medical ethics as set forth in the AMA Code of Ethics, The Hippocratic Oath, the Oath of Maimonides, the UN Declaration of Human Rights and the Declaration of Helsinki. The Foundation urges the Commission to consider the overriding importance of the injunction to “…first do no harm…”
III. Statement in Support of Statement Requested Actions
3.0. When the Centers for Disease Control (CDC) recently recommended that infants and toddlers be subjected to the flu vaccine, the States began the process of mandating the vaccination before the child could be admitted to pre or public school. New Jersey became the first state to mandate the flu vaccination for children, publishing the final rule on January 7, 2008, effective January 2009. Such mandates condition the acceptance of a public benefit (“free public education”) or a private one (attendance at preschool) upon submission to a questionable, experimental and potentially dangerous medical procedure.
3.1. This is particularly troubling since those doses of flu vaccine supposedly manufactured without mercury continues to contain “trace” amounts of mercury since even the allegedly “mercury free” versions use mercury in the manufacturing process, adding a “trace” amount to the administered dose. There have been no safety studies done on Thimerasol (manufactured by Eli Lilly) since the 1929 study done by K.C. Smithburn on patients dying from meningitis. All patients to whom Thimerosal was administered died but Smithburn concluded that Thimerosal was safe since the patients would have died from other causes anyway. AllMSDS for Thimerosal states, “Exposure to mercury in utero and in children can cause mild to severe motor coordination impairment.” Eli Lilly MSDS June 13, 1991. None the less, this toxic component is being offered to patients, including pregnant women and children, increasingly as a mandated vaccination. Other components of vaccines are also highly troubling for similar reasons: the science establishing their safety is either non-existent, absurd or deeply flawed.
3.2. The Foundation, asking how much mercury is enough to cause harm, submits the following: “Most worryingly, exposure levels were not particularly high, Hair concentrations in the [Japanese] villagers averaged 4 micrograms of mercury per gram of hair. This is just a tenth of the level considered dangerous for adults by the World Health Organization, and not much higher than that found in many countries. In the US and Japan, for instance, the average mercury concentration in hair is around 1 and 2 micrograms per gram respectively.” This tends to show that the CDC’s claimed “trace” levels of mercury remaining in vaccines may very well be dangerous. See: http://www.eurekalert.org/pub_releases/2003-06/ns-esmo61103.php
3.3. According to the New York Times on April 5, 2003, “The Food and Drug Administration has begun using the Environmental Protection Agency’s much lower safe level for mercury in the human body, an official of the food and drug agency said this week, ‘Before the change, the F.D.A. guidelines set a safe level that was four times as high as that of ..environmental agency.. standard.’” See: http://query.nytimes.com/gst/fullpage.html?sec=health&res=9507EFDD1538F936A35757\C0A9659C8B63
3.4. Therefore, a question for scientific research becomes: “Is there a ‘trace’ amount of Mercury or other toxins in the recently recommended flu vaccination?” How much of a “trace” is needed in any vaccination to cause harm.
3.5. According to Centers for Disease Control (CDC), “Thimerosal still may be used in the early stages of making certain vaccines. However, it is removed through a purification process.” leaving a “trace” amount of “less than 0.3 mcg” in the final dose. See: http://www.ageofautism.com/2007/12/emails-from-cdc.html Additional research is necessary regarding the direct and cumulative effects of such trace dosages.
3.6. The existence of any trace amount of mercury is very troubling, especially as the “trace” amounts add up and accumulate over repeated vaccinations. Recent analysis shows that contrary to earlier reports, there is a measurable relationship between autism and mercury toxicity. See: http://mcs-america.org/January2008pg17.htm – citation: J Child Neurol. 2007 Nov; 22(11); 1308-1311. In this context we note the mushrooming autism rate appears to be in direct correlation with introduction of new vaccines (e.g., MMR), and we further note the conspicuous absence of autism in religious and other populations that do not vaccinate. This contradicts various authorities’ assertions that vaccines do not cause autism. On November 9, 2007 the Federal government’s lawyers conceded a Court of Federal Claims case involving autism caused by vaccines; there are 4900 other pending autism-vaccine injury cases before the Vaccine Injury Compensation Program. See: http://www.huffingtonpost.com/david-kirby/government-concedes-vacci_b_88323.html Other more recent cases seem to hold otherwise and the parents of injured children still believe they are not being treated fairly.
3.7. The Natural Solutions Foundation, however, does not limit its concern to mercury adulterated vaccinations. Even if vaccines become truly mercury free, they would still (a) lack proven effectiveness and (b) continue to contain other ingredients, such as Squalene, which assault healthy immune systems. The Foundation continues to object strongly to any mandated or voluntary vaccination which may cause harm to individuals either through its component or synergistic parts or through the impact of single or multiple vaccines on the immune system. These impacts are anything but trivial: although they can be immeasurable, extremely worrisome, troubling, debilitating and/or lethal. Despite deceptive advertising to the contrary, there are safe and effective alternatives to dangerous vaccinations that can, in a modern society with proper hygiene, prevent the spread of infectious disease. The Foundation reminds the NVAC that many diseases for which vaccinations are administered are self limiting and pose little or no human health threat. If not confronted successfully by the immune system, these diseases can be well treated using modern medical methods.
3.8. It is a serious affront to basic, inalienable human rights to force or mislead individuals, especially parents and guardians of minor children, to accept invasive medical treatments without fully informed, voluntary consent. See the discussion below regarding the World Medical Association’s Declaration of Helsinki in this regard; see: http://www.wma.net/e/policy/b3.htm
IV. Legal Authorities in Support of the Statement
4.0. This Statement is grounded in fundamental principles of inalienable right, law and equity.
4.1. The primary legal basis for submitting this Statement to the Commission is the First Amendment to the Constitution of the United States: “Congress shall make no law… abridging… the right of the people… to statement the Government for a redress of grievances.”
4.2. We also cite the World Medical Association 1964 Declaration of Helsinki; see: http://www.wma.net/e/policy/b3.htm This Declaration has the force of International Law and it clearly forbids experimental medication or medication without fully informed consent.
4.3. The Acts establishing the authority of the Federal Agency under which the Committee deliberates are also a legal basis for the Statement. The Department of Health and Human Services (HHS) exists solely to protect the Public, within the limits established by the Constitution of the United States of America. Among the principles established by the Laws and Regulations, long the explicit policy of the Federal Government, is that all commercial advertising must be “truthful and not misleading.”
4.4. The statute in the derogation of the common law and Constitutional limitations, establishing exemptions from liability of Vaccine Injuries, 42 USC 300aa-16 (and the Vaccine Injury Compensation Program, there under) is further cited as a law that must be strictly construed in favor of patients, guardians, parents and children, and strictly construed against the economic interests of the pharmaceutical industry and other exempt persons.
4.5. Basic common law principles prohibiting forced acquiescence under duress and limited or intentionally distorted information, as exemplified by the United States Supreme Court decision in the case of Thompson v Western States Medical Centers – 535 U.S. 357 (2002), as further described below.
4.6. Additionally, the Statutes authorizing the Federal Agency contain general provisions that support the actions requested in this statement. Federal Law includes provisions that grant the responsible persons in the Federal Agency broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”
4.7. The United States Supreme Court has spoken forcefully, enforcing the consumers’ right OR consumers’ rights to truthful information about healthcare issues. See: Thompson v Western States Medical Centers, 535 U.S. 357, where Justice O’Connor wrote, “If the First Amendment means anything, it means that regulating speech must be a last-not first-resort. . . We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. . . Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring . . . a warning that . . . its risks were unknown.”
4.8. The basic rule, announced by the case, to determine constitutionality permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction, such as the sale of Dietary Supplements or vaccinations) is a two prong test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If “no” to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is “substantial”, (2) the regulation must “directly advance “the governmental interest and (3) the regulation of Commercial Speech cannot be “more extensive than is necessary to serve that interest” (quoting Central Hudson v Public Service, 447 US 557, at 566).
4.9. The Federal Government, through the Federal Trade Commission, has stated its general rule for the advertising of products that are alleged to have health benefits, to ensure that such advertising is “truthful and not misleading.”
4.10. In this context, it is useful to recall the 1996 comments of then FTC Commissioner Starek, at the National Infomercial Marketing Association (comments the Federal Trade Commission (FTC) maintains on its web site). He explained the issue to which the Supreme Court alluded in Thompson – preventing misleading advertisements: “As many of you know, the FTC is charged with protecting consumers from unfair or deceptive acts or practices. In advertising and marketing, the law requires that objective claims be truthful and substantiated. The FTC does not pursue subjective claims or puffery—claims like ‘this is the best hairspray in the world.’ But if there is an objective component to the claim—such as ‘more consumers prefer our hairspray to any other’ or ‘our hairspray lasts longer than the most popular brands’—then you need to be sure that the claim is not deceptive and that you have adequate substantiation before you make the claim. These requirements apply both to explicit or express claims and to implied claims. Also, a statement that is literally true can have a deceptive implication when considered in the context of the whole advertisement, even if that implication is not the only possible interpretation.
“The substantiation requirement exists because every time an advertiser makes an objective claim, the advertiser also implies that there is a reasonable basis for the claim. This reasonable basis is substantiation. What constitutes a reasonable basis for a particular claim can vary, depending upon the nature of the claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation that experts in the field believe is reasonable. Health and safety claims generally require competent and reliable scientific evidence. And if a marketer makes a representation that a claim has a particular level of support—for example, ‘clinical studies prove…’– the law requires at least that level of substantiation.”
4.11. The required level of substantiation for alleged claims about medical products such as vaccines is “significant scientific agreement.” In the case of vaccines, there is no significant scientific agreement by unbiased sources regarding the vaccines and manufacturers’ claims for the safety and efficacy of the product which satisfies the rule against false advertising; especially where and when the public is misled by not being warned of either the dangers of the product or of any right of members of the public to refuse vaccination on religious, medical or philosophical grounds. We urge the Committee to consider that the advertising of vaccinations is clearly a case where “requiring… a warning that… its risks were unknown…” (Thompson v Western States, supra.) is the minimum required by Law to protect the public, and especially the most vulnerable among us, our children. No scientific research agenda which does not warn the Public of the unknown risks is a legally responsible agenda.
III. Conclusion
Due to the urgent and potentially cataclysmic results of unproven vaccinations on significant numbers of patients, extreme caution is necessary before these experimental treatments are advertised as either safe or effective. The scientific research agenda needs to address this critical issue. The emergent nature of the risk of unscientific pseudo-justifications for vaccination claims means that the lives of patients, including innocent children and adolescents is at stake and hangs in the balance, The Foundation urges the Committee to act immediately to Recommend appropriate Warning and Disclosure language, such as that suggested herein, be required, covering all vaccination-related communication to assure the Public that a proper scientific agenda has been adopted for vaccination research. Scientific research is needed regarding the cumulative effect of multiple vaccinations which continue to contain “trace” or larger amounts of mercury and other toxins. Populations which do not vaccinate, such as the Amish, need to be studied since it appears that such populations have not experienced horrific elevation of autism rates and other deleterious effects of vaccinations.
Vaccination remains an unproven, experimental medical procedure subject to the restrictions of the Declaration of Helsinki. Absent stringent, high quality research to document that vaccination is both safe and effective, any communication to the contrary is both false and misleading.
Natural Solutions Foundation
www.HealthFreedomUSA.org
Maj. Gen. Albert N. Stubblebine, III (U.S. Army, Ret.)
President & Trustee
Rima E. Laibow, MD
Medical Director & Trustee
Ralph Fucetola, JD.
Vice President, Trustee and Counsel
A Special Message to All HealthFreedomUSA.org Supporters:
To Join: www.NaturalSolutionsGreenPortal.net
Dr. Laibow’s video: http://www.youtube.com/v/A52DcIG4qYI

We look for solutions to social problems that support the natural environment. That’s why we’re pleased to introduce an exciting new way you can SAVE MONEY and get SIGNIFICANT CASH BACK on all your purchases at over 600 of the biggest online stores, including Wal-Mart, Target, Safeway, Best Buy, Home Depot, OfficeMax, eBay … the list goes on and on! We know you make environmentally friendly choices when you buy what you need. Now you can exercise those choices on-line, reducing your impact on the world while showing big retailers, through your choices (your "dollar votes") that you want them to serve consumer needs.
Additionally, you should also be able to save valuable time and gas (better for the environment) by shopping online at your very own personal savings "Green Portal" AND help support Natural Solutions Foundation in its continuing fight against "Big Agra," "Big Chema," and "Big Pharma" to protect the safety and quality of our food supply! Non-profit organizations like Natural Solutions that sponsor green portals receive donations from the retailers based on your savings!
Best of all, this Program is FREE to all our Members and Supporters, and by extension, to all their friends and families … and so on! That’s why we’re offering it to you as a simple "no-brainer" way to help yourself and others you know survive these tough economic times, while also helping NSF continue to raise the funds we so desperately need!
So we invite you to "Go Green" and "Go Viral" with this Program by clicking on the link below, viewing the 3-minute video, and signing up TODAY to start saving:
http://www.NaturalSolutionsGreenPortal.net
Then cut and paste the body of the suggested email below into a new "personalized" email and send it out ASAP to everyone you know and care about.
Please be creative and unique with your subject line to minimize the risk of your email getting blocked as "spam" by the internet service providers.
Happy Savings!
Natural Solutions Trustees
|
Dear Friends and Family — I just wanted to let you know that I’ve found a great new way to save money and get significant c*a*s*h-back on all my purchases at over 600 of the biggest online stores, including Wal-Mart, Target, Safeway, Home Depot, Office Max, Best Buy, eBay, etc… the list goes on and on! Additionally, I’m also saving valuable time and energy (better for the planet) by shopping online at my very own "savings portal" AND helping to protect the safety and quality of our food supply which is currently under assault (please see food safety alert at the bottom of this email)! Best of all, the program is F*R*E*E to join with no "strings" attached! That’s why I’m passing it on to you as a simple "no-brainer" way to help yourself and others you know survive these tough economic times, while also helping to protect and defend our endangered health freedom! So I invite you to "Go Green" and "Go Viral" with this program by clicking on the link below, viewing the video, and signing up TODAY to start saving! Then cut and paste the body of this email into a new personalized email and send it out to everyone you know and care about. Please be creative and unique with your subject line to minimize the risk of your email getting blocked as "spam" by the internet service providers. Together, we can all help each other AND make a real difference to protect our food safety and health freedom … so please pass this on! Happy Savings, {your name} * Your Food Safety and Health Freedom is currently under attack and may soon be taken away from you … UNLESS YOU ACT NOW to stop it. Please watch this video: Nutricide – Criminalizing Natural Health, Vitamins, and Herbs (http://video.google.com/videoplay?docid=-5266884912495233634&hl=en) to understand why. Then visit www.HealthFreedomUSA.org to learn how you can take quick and immediate action to protect your rights! |
Natural Solutions Foundation
www.HealthFreedomUSA.org
Action Item:
Here is the Action Item:http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
The new food safety agency bills pending before Congress contain language that may threaten organic and natural food and small farms and ranches, as well as dietary supplements. While large-scale industrialized agriculture may pose a threat to public safety, applying highly restrictive rules appropriate to large-scale agri business to these alternative producers will cause serious harm to them, while not increasing public safety.
Therefore, while we do support Divesting the FDA of food authority, we do not believe these bills are the way to do that. However, if Congress insists upon adopting this course of action, we seek an protective amendment to these bills similar to the amendment that was added to the 2007 FDA law, protecting dietary supplements.
This bill is being “fast-tracked” for passage during the “honeymoon” period of the new administration when its harmful potential will not be noticed unless we take action now!
Here is the text of the Petition to Congress:
PETITION
To Amend the Food Safety Modernization Act
H.R. 875 [and Substitutes]
By the Addition of the
Natural and Family Food and Farming Exclusion Amendment
To: The Members of the Congress of the United States of America:
Whereas the proposed Food Safety Administration within the Department of Health and Human Services should focus its activities on the significant public administration issues involving the capacity of large scale, industrialized agriculture to threaten public safety,
Whereas organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements are not a significant part of the food safety problem, and
Whereas Congress previously provided for an exemption for natural food dietary supplements from the increased agency authority granted by the FDA Modernization Act of 2007, through a rule of interpretation, added as section 1011 of that Act, and has on numerous occasions exempted small and family farms from the same level of regulation as has been deemed necessary in the case of industrialized agriculture,
The citizens ascribing to this Petition therefore hereby request that the Food Safety Modernization Act be defeated, or that it, or any substitute for it, such as H.R. 759, be amended to exclude organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements, through a rule of interpretation, as follows:
“Rule of Interpretation
“No provision of this act shall be deemed to apply (a) to any home, home-business, homestead, small farm organic or natural agricultural activity, (b) to any family farm or ranch, or (c) to any natural or organic food product, including dietary supplements regulated under the Dietary Supplement Health and Education Act of 1994.”
We also note the language of the Fair Labor Standards Act, 29 USC sec 203 (s) (2) which provides, “(2) Any establishment that has as its only regular employees the owner thereof or the parent, spouse, child, or other member of the immediate family of such owner shall not be considered to be an enterprise engaged in commerce or in the production of goods for commerce or a part of such an enterprise…” Language such as this would be helpful to allay our concerns.
If the FDA Center for Food Safety is to be moved into a new Food Safety Agency, then Dietary Supplements, regulated as foods under the Dietary Supplement Health and Education Act (DSHEA) should be included in such agency, with the proviso that such substances, as foods, are deemed safe when used as directed.
Furthermore, the ascribing citizens Petition the Congress of the United States to declare it the public policy of the United States that organic and natural agriculture, family farms and ranches, and natural or organic food products, including dietary supplements shall be at all times free from suit, vexation, trouble, penalty, or loss of their goods, for the inestimable values they confer upon the public.
————————-
Here is the Action Item:http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714
—————–
More information on this issue:
https://staging.drrimatruthreports.com/?p=2128
————————-
[March 7, 2009 – This Petition was prepared by Ralph Fucetola JD, a Trustee of the Natural Solutions Foundation, for educational purposes – www.HealthFreedomUSA.org]
Natural Solutions Foundation
www.Health Freedom USA.org
Action Item:
http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26830
This is the Open Letter to the President and Congress regarding the alleged “accidental” contamination of vaccines with live Avian Flu virus.
You can read more about the incident at:
https://staging.drrimatruthreports.com/?p=2220
—————
Dear President Obama and Members of Congress,
I am writing because of the horrible incident last month where Baxter Pharmaceutical “accidentally” contaminated vaccines with live Avian Flu virus. This contaminated vaccine could trigger a world-wide pandemic. I urge Congress and the Executive Branch to investigate this incident and assure the public that this was not an attempt to weaponize the Avian Flu.
Further, I PETITION the Congress of the United States to immediately adopt a civil rights act protecting each person’s right to refuse vaccination or any medical procedure.
The time has come for government to respect our right to Health Freedom as Our First Freedom (without it, no other freedom is effectively exercisable). That right was defined in President Obama’s Briefing Book on Change.gov as:
“Health Freedom means the right to control what happens to your body, choosing your own health path, making your own health choices as you see fit”
This is an urgent matter that needs immediate action to protect our rights.
—-end of letter–
More information:
March 2009 Update: https://staging.drrimatruthreports.com/?p=2220
Please support Natural Solutions Foundation with your tax deductible donations, so we can continue to educate the President, Congress and other decision makers about how Health Freedom is Our First Freedom.
https://staging.drrimatruthreports.com/?page_id=189
The careless, industry controlled FDA has been happy to approve drugs made from genetically modified molecules, including many from plants, since 1985 when it approved GMO insulin. These drugs are called “Biologicals”. A new analysis, published in the Journal of the American Medical Association, shows that biologicals are twice as dangerous as chemical (non GMO) drugs. We know how dangerous they are (over 100,000 deaths per year and 3 million hospitalizations per year for adverse events from properly used drugs in the US each year. Now multiply that danger by at least two and see what you get: a profit-driven disaster.
The excellent summary below makes it clear that while it is essential to divest the FDA and USDA of their food regulatory responsibilities, the dangerous and industry-supported FDA is not doing any better with their regulatory responsibilities on drugs than they are on food. At least with drugs, however, you have a chance, for the moment, of saying “yes” or “no” to their use. Food is compulsory. Drugs are [usually] voluntary. And that is why, of course, natural medicine options, in all their forms, are under such vigorous attack.
That is also why the Natural Solutions Foundation continually asks you to make sure that everyone in your contact list becomes aware of these issues and that you request that they take the actions that you take to prevent the loss of our health freedoms and to separate this dangerous agency (and the USDA) from your table and your health.
Here is the link to send to your contact list so they can sign up for the free, secure and vitally important Health Freedom Action eAlerts: https://staging.drrimatruthreports.com/?page_id=187. And here is the link for you – and your contacts – to make a tax exempt donation to the Natural Solutions Foundation: https://staging.drrimatruthreports.com/?page_id=189.
Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.GlobalHealthFreedom.org
www.NaturalSolutionsFoundation.org
www.ValleyoftheMoonCoffee.org
www.Organics4U.org
www.NaturalSolutionsMarketPlace.org
‘Biologicals’, Wonder Drugs with Problems
Protein drugs produced by genetic engineering cause adverse events including death more frequently than synthetic chemical drugs; yet they are being produced in transgenic crops grown in open fields Prof. Joe Cummins
‘Biologicals’ more dangerous than chemicals
‘Biologicals’ are drugs in which the active substance is produced by or extracted from a biological source (in contrast to synthetic chemicals). Biologicals are relatively recent, being for the most part, recombinant proteins produced by genetic engineering. The first biological was recombinant human insulin produced in recombinant bacteria and commercially approved in 1982. Currently, there are more than 250 biologicals on the market, including recombinant blood products, monoclonal antibodies and vaccines that have been approved by regulatory agencies in the United States and European Union (EU). Between 2003 and 2006 biologicals represented 24 percent of all new approvals in the US and 22 percent of new approvals in the EU [1]. Ten biologicals are listed among the top selling ‘blockbuster’ drugs valued at 1 to 3.2 billion dollars in sales. These drugs included treatments for red blood cell disorders, immune system disorders, cancer and insulin analogues [2].
Newly approved drugs are frequently found to cause unexpected problems; but biologicals are incurring problems even more frequently than synthetic chemical drugs. A recent study published in the Journal of the American Medical Association confirms that the biological drugs have provoked significantly more regulatory actions than newly introduced synthetic chemical drugs. The researchers, based in The Netherlands, followed up a group of biologicals approved in the US and EU between 1995 and 2008, and found that 24 percent of these have prompted safety regulatory actions. New chemical drugs have an 8.5 percent chance of safety warning within ten years of approval, compared to 17 percent for biologics [2]. The regulatory actions included warnings on general disorders and administration site conditions, infections and infestations, immune system disorders and cancers (benign, malignant and unspecified). Adverse events included many serious complications of the drug treatment such as increased mortality, anaphylaxis, cancer, heart failure, stroke, and infections [1]. However, industry representatives implied [2] that the diseases being treated were very serious, and the drugs were efficacious and the adverse events relatively rare. The study concluded [1]: “The nature of safety problems identified after approval for biologicals is often related to the immunomodulatory effect (infections). Because the biologicals first to be approved in a class were more likely to be subjected to regulatory action, close monitoring is recommended.”
FDA blaming the victims rather than the drugs?
A review of the Netherlands study published in Nature Biotechnology acknowledges the significance of the study and the problem of adverse events related to biologicals. The article mentions a caveat to the study’s conclusions added by Sandra Kweder, deputy director of FDA’s office of new drugs at the Center for Drug Evaluation and Research [2]: “Biological therapeutics are more likely to be developed to treat serious illnesses, she points out, and serious illnesses themselves are fertile ground for ‘toxicity’ whether related to the drug or disease, so interpreting data on the drug’s or biological’s risk must take that into account.” That seems to lay the blame for the adverse outcomes on those being treated rather than the drugs; and looks like an attempt to protect the billion-dollar industry.
The Nature Biotechnology review [2] further comments that industry insiders agree long-term safety monitoring will be crucial for biologics. While the antibody producing company InNexux’s chief scientific officer is reported to have said: “That long-term use may lead to problems I think is a given,” – a suspicion borne out by the latest study – the company’s chairman and ceo Jeff Morhet, finds at least one important consolation: “the study showed that no biological was pulled from the market for safety reasons.”
Lax FDA regulation and a profit-hungry industry
If anything, Morhet’s remark should offer no consolation to those being treated; as it exposes the lack of adequate regulation to protect the public in face of ‘miracle cures’ being offered by an industry whose primary concern is profit.
Significantly, no one has commented on the 2005 case of the drug Tysabri (natalizumab) a treatment for multiple sclerosis that was suspended following two deaths of patients from leukoencephalopathy (progressive damage or inflammation of the white matter of the brain) [3]. Nor indeed has anyone mentioned the catastrophic London drug trial of a biological monoclonal antibody drug that left six healthy young volunteers seriously ill [4] (London Drug Trial Catastrophe – Collapse of Science and Ethics, SiS 30).
The Institute of Science in Society (ISIS) has long been critical of the manner in which biological are tested and used in treatment. The adverse event, ‘cytokine storm’ unleashed in the immune system of the volunteers, was not exactly a surprise. The FDA had issued a long list of warnings on similar monoclonal antibody drugs [5] (Warnings on FDA Approved Monoclonal Antibody Drugs, SiS 30); but that seemed to have been ignored [6] (Post Mortem on the TGN1412 Disaster, SiS 30).
Pharm crops with dangerous biologicals in open field trials put the public at risk
Even more seriously, the secret trials of food crops (pharm crops) in open fields modified with mammalian genes expressing proteins used to treat human or animal disease continue unabated [7] (Drug Trial Catastrophe & Safety of Secretly Tested Pharm Crops, SiS 30). Pharm crops for vaccines and therapeutic antibodies have been trialed since 2004 and earlier [8] (Pharm Crops for Vaccines and Therapeutic Antibodies, SiS 24). Antibodies are produced in tobacco plants [9] (Antibodies from Hybrid GM Tobacco Plants, SiS 35) and in maize [10] (Transgenic Maize with Monoclonal Antibodies Grown in France, SiS 35). Biologicals are well known to have severe side effects on patients and on healthy people. There is no justification for exposing the unsuspecting public to these drugs produced in pharm crops grown in open fields.
References
1. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA. 2008, 300(16), 1887-96.
2. King J. JAMA casts cloud over biologic safety. Nature Biotechnology 2009, 27,11-12.
3. FDA Public Health Advisory Suspendec Marketing of Tysabri (natalizumab) 2005 updated 2007 http://www.fda.gov/cder/drug/advisory/natalizumab.htm
4. Ho M-W and Cummins J. London drug scandal catastrophe, collapse of science and ethics Science in Society 30, 41-43. 2006.
5. Cummins J. Warning on FDA approved monoclonal antibody drugs Science in Science in Society 30, 46-47. 2006.
6. Saunders PT. Post mortem on the TGN1412 disaster. Science in Society 30, 44-45+47,. 2006.
7. Cummins J and Ho M-W. Drug trial catastrophe & safety of secretlytested pharm crops Science in Society 30, 50, 2006.
8. Cummins J. Pharm crops for vaccines and therapeutic antibodies Science in Society 24, 22-23, 2004.
9. Cummins J and Ho M-W. Antibodies from hybrid GM tobacco plants. Science in Society 35, 51, 2007.
10. Cummins J, Ho M-W and Saunders PT. Transgenic maize with monoclonal antibodies grown in France Science in Society 31, 4, 2006.
ttp://www.i-sis.org.uk/biologicalsWonderDrugsWithProblems.php