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.
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 . 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 .
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 . 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 . However, industry representatives implied  that the diseases being treated were very serious, and the drugs were efficacious and the adverse events relatively rare. The study concluded : “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 : “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  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) . Nor indeed has anyone mentioned the catastrophic London drug trial of a biological monoclonal antibody drug that left six healthy young volunteers seriously ill  (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  (Warnings on FDA Approved Monoclonal Antibody Drugs, SiS 30); but that seemed to have been ignored  (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  (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  (Pharm Crops for Vaccines and Therapeutic Antibodies, SiS 24). Antibodies are produced in tobacco plants  (Antibodies from Hybrid GM Tobacco Plants, SiS 35) and in maize  (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.
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.
Health Freedom is the most basic freedom of all. It is the necessary condition upon which our ability to pursue Life, Liberty and the Pursuit of Happiness rests and is the precondition upon which all other rights rest. Yet Industry has forged a cozy relationship with US Policy and Regulatory Makers so that their rights, not ours, are being cared for while natural options are attacked.
Effective, inexpensive and safe natural cures exist in other countries for diseases that we suffer and die from needlessly because our Health Freedom is compromised. Emphasizing and supporting those natural strategies will reduce our health care costs significantly while increasing our health and wellness. Clean, unadulterated, clearly labeled food is attacked while dangerous, degraded food is permitted by food standards which make us the least healthy country in the developed world. Dangerous drugs and vaccines, sometimes on a mandatory basis, are supported while natural supplements, herbs and treatments are attacked.
Free men and women have control over what happens to their bodies and those of their children. Without that autonomy and control, our very bodies do not belong to us. Our Medical Records are no longer ours and if they are invaded, our doctors may not tell us that they have been searched or the information in them mined and sold unless they commit a felony offense.
Federal and State agencies knowingly allow our food, injections and drugs to be contaminated with dangerous or deadly substances/processed by techniques known to create disease, yet they permit that contamination at the request of the industries to which they are beholden. Personal and professional conflicts of interest are condoned and acknowledged inside government and academia. The consequences are unsafe food and drugs. Agency thugs, regulatory assault and cover-ups routinely attack safe and natural sources including health food stores, clinics and advanced practitioners.
Dangerous drugs and vaccines are routinely approved while manufacturers are protected from any type of liability no matter how many people they harm or kill, protected by both the Courts and Congress.
Because of commercial interests, FDA and other agencies intervene to curtail true and accurate information about natural health choices, increasingly forbid access to natural health options and brutally attack those who make such information, products and care available.
Clean, unadulterated food is the single most effective economic competitor to pharmaceutical medicine. US Policy permits adulteration and unhealthy food in every sector while it consistently degrades Organic standards to suit industry tastes.
Although more than 80% of us in the US distrust and want to avoid genetically modified foods (“GM”, “GMO” or “Franken Food”), US policy literally forbids labeling food for its GMO content. Silently, these unwholesome, bioengineered foods have entered more than 85% of the US food supply and are being permitted to genetically contaminate all other crops, including organic ones regardless of the dangers which are increasingly well documented.
International science shows that GMOs cause sterility and immune dysfunction: the US unscientifically prohibits any government review of testing, literally forcing Franken Foods down our throats while it declares that GMO foods are “substantially equivalent” to unmodified foods. Environmental degradation is permanent and cataclysmic.
US Policy permits up to 10% GMO contamination in so-called Organic food; international regulation permits no more than 1% GMO contamination.
Health Freedom means that all GMO food is labeled clearly and we can choose GMO-free food if we wish. It also means that scientific analysis of all GMO foods is rapidly undertaken during a 10-year period of total moratorium on all GMO crops or animals.
Health Freedom means that unhealthy and untested food processing procedures like spraying meats with viruses is forbidden or food so treated is clearly labeled.
Health Freedom means that consumers, scientists, nutritionists and environmental medicine specialists who have no conflicts of interest direct, oversee and assess food and health policy in the US.
Health Freedom means that all international health regulatory participation by the US is also under the control of consumers, scientists and physicians free of any conflicts of interest.
Health Freedom means that the corrupt and often deadly FDA is fully divested of its Food Regulatory Authority since its ability to regulate food is compromised by its financial conflicts of interest with the pharmaceutical, biotech and commercial agriculture industries.
Health Freedom means that neither you nor your children can be subjected to “Treatments”, drugs, chipping or injections to which you do not agree. Current US Federal and State laws permit forcible drugging, including injections, of both children and adults and must be changed to allow personal choice in keeping with well-established international principles such as the UN Declaration of Human Rights and the Helsinki Declaration.
Health Freedom means that your Constitutional First Amendment Rights to Free Speech are fully protected and that you are able to access science-based, true and accurate information about the health benefits of food, supplements, herbs, frequency/energy medicine and a host of other health strategies which compete with industry interests, but which might serve you very well.
Health Freedom means that you are free to seek out and receive services from health care practitioners of your own choice in the US who use treatments or strategies which you, and they, agree on in an open climate. It means that neither you nor they are subjected to government attack because the treatment they offer you is not pouring money into Big Pharmaâ€™s coffers.
Health Freedom means that you can purchase food, supplements, herbs, and health devices which are accurately labeled, free of dangers without government interference.
Health Freedom means that if drugs or devices harm you, you are free to seek appropriate redress since drug and vaccine companies are forced out from behind the protective screen which Congress, FDA/USDA/FTC/EPA, etc. and the Courts have set up to free them from all liability responsibility to you and your loved ones no matter what their products have done to you.
Health Freedom means that treatments and cures for diseases like cancer, arthritis, heart disease, and similar serious problems are easily and openly available so you do not need to travel to other countries for the treatments you want.
Health Freedom means that insurers recognize and pay for natural treatments and therapies of your choice, saving them, and you, enormous amounts of money if that is your choice.
Health Freedom means that the use of dangerous, ineffective, but profitable drugs and vaccines may be your choice, but cannot be forced upon you or your children under any circumstances.
Health Freedom means that you and your children cannot be denied access to education or other public resources if you do not agree to be medicated or vaccinated.
Health Freedom means that informed consent cannot be waived and that children in foster care and prisoners may not be used for drug and pesticide experimentation.
Health Freedom means that if you want to drink raw milk, or eat bitter almonds, use Black Salve, or other non-drug, leading edge, ancient or innovative health strategies you may do so openly and without fear of reprisal.
Health Freedom means that REAL organic farming, not fake organic farming with standards so degraded that the designation means nothing, is supported and family farms are encouraged to produce the highest quality food by states and the federal agencies which impact food production.
Health Freedom means that State and Federal Law is changed so that the makers of GMO crops which invade non-GMO farms are liable for criminal trespass and other serious crimes.
Health Freedom means that if food is irradiated or subjected to other â€œtreatmentsâ€ and contamination (including pesticides, antibiotics given to animals, herbicides, fungicides, fluoridation or other potentially or conclusively harmful treatment) that fact must be clearly indicated on the label.
Health Freedom means that we can expect that food animals to be raised and slaughtered humanely, fed wholesome diets in sanitary, suitable environments without the use of antibiotics and other dangerous drugs so that food in America is once again clean, wholesome and health-giving or clearly labeled to indicate that it does not meet these standards.
Health Freedom means that your medical records are totally private and the only people who can access them are those to whom you give specific, written permission.
Health Freedom means that the protection offered to supplements and herbs under the 1994 Dietary Supplements Health and Education Act (DSHEA) which treats these products as foods must be enforced and extended to other health products.
Health Freedom means that the regulatory agencies of the US, and their participation in international regulatory bodies like Codex Alimentarius, must be consumer and scientist led, with industry barred from US participation in their deliberations or decisions.
In short, health freedom means that US food and healthcare policy gives Americans the right, information and opportunity to learn, select, practice and offer natural health and healing strategies supported by their government, not opposed by it.
Health Freedom IS Our First Freedom: We must have the right to determine what happens to our own bodies and those of our children.
For more information on Health Freedom issues, visit