NOVEMBER 2, 2010. What's wrong with this picture? Millions of Americans are sitting out there in their homes tonight, watching election returns, and these millions are advocates of health freedom, and yet their opinion isn't reflected by a single candidate in any federal or state race.
Zero representation. Zilch. Nada.
I've been thinking about this fact for a long time, ever since I ran a primary campaign for a seat in the US Congress, in 1994-on a platform of health freedom.
For those readers who don't know what health freedom means, let boil it down: unimpeded access to the widest possible range of nutritional supplements; the ability to choose any treatment from any health practitioner, on one's own responsibility; the solid assurance and knowledge that big government will never meddle in these areas.
I recently interviewed constitutional attorney, Jonathan Emord, about these questions. His answers were more than interesting.
NOVEMBER 2, 2010. What's wrong with this picture? Millions of Americans are sitting out there in their homes tonight, watching election returns, and these millions are advocates of health freedom, and yet their opinion isn't reflected by a single candidate in any federal or state race.
Interesting, Innovative and Investigative Reporting
OCTOBER 21, 2010. As this year’s election draws close, it’s business as usual, as far as Health Freedom is concerned. This issue isn’t just in the shadows. It’s in the closet behind the shadows, locked in tight.
The avalanche of pharmaceutical ads on TV drones on. The attacks on natural health set off firecrackers here and there: “Patients shouldn’t be allowed to choose alternative remedies, because that will take them away from medicines that really help.”
“We, the medical elites, know what’s best for you, and we’ll shove it down your throats.”
But wait. This is supposed to be the Year of the Conservative. Conservatives want less government intrusion, more individual freedom. Why isn’t Health Freedom front and center?
by Sharry Edwards, MEd
Director of the Institute of BioAcoustic Biology
The August 14th, 2010 issue of Science News, "Separating wheat from chaff in celiac disease", reported that a research team led by gastroenterologist Robert Anderson of the Walter and Eliza Hall Institute of Medical Research in Parkville, Australia, had identified specific triggers (gluten sensitivities) associated with celiac disease.
Since our research efforts often evaluate clients who exhibit gluten sensitivity and a myriad of associated diseases, it was imperative that this important information be added to our software databases. I translated the three proteins into BioAcoustic bio-frequency (biomarkers)* and was immediately inundated with an avalanche of novel data showing that the metabolic pathways distorted by these proteins were linked to nearly all systems of the human body; causing immune distortion, acute cellular inflammation and disruptions in cell communication.
The article listed three proteins, w-5 gliadin (wheat), g-3 hordein (barley) and g secalins (rye) that were implicated in the production of the specific anti-gliadin antibody reactions. These proteins, which have been proven to be responsible for the allergic reactions, are associated with grain glutens from which they are derived.
Patent records indicated the grains involved are clones developed in a laboratory by Monsanto, a multinational agricultural biotech conglomerate. This would confirm that the present day epidemic of gluten sensitivities/allergies stem from laboratory created grains. These gluten-distorted, allergic causing, grain clones are being used to create foods that we eat everyday; bread, cereals, crackers, pastry, seasonings, even some packaged chip products contain wheat. As I developed the BioAcoustic correlations I was aghast with the realization of how thoroughly our health is being negatively influenced by these genetically modified foods (GMO's).
Further investigation revealed that the cloned genes contained two substitutions that distorted the way the body processes two sulfur rich amino acids: proline and glutamine. Disturbances in these amino acid substitutions impede the methylation of these two essential nutrients.
BioAcoustically speaking, Glutamine distortions seem to be the most destructive. The enzyme required to utilize glutamine is glutamate decarboxylase (GAD). Glutamate is a key molecule in cellular metabolism and the most abundant excitatory neurotransmitter in a vertebrate nervous system.
In mammals, GAD exists in two isoforms encoded by two different genes - Gad1 and Gad2. GAD1 and GAD2 are expressed in the brain where GABA is used as a neurotransmitter; GAD2 is also expressed in the pancreas.
This led to an evaluation of the GAD genomes and what happens when these genes are activated:
Glutamate decarboxylase aka glutamic acid decarboxylase (GAD) is an enzyme that catalyzes the decarboxylation (part of the process of breaking down for use by the body) of glutamate to GABA (gamma aminobutyric acid) and CO2.
GABA is a natural tranquilizer and an important inhibitory neurotransmitter that helps regulate neuron activity and the body's nanosensors. Starting with the GAD enzyme response and moving toward GABA in conjunction with the active form of B6 (PLP), the nanotransmitters of the body are created and regulated. The movement of electrical energy and hence magnetic potential within the body are controlled by these nanotransmitters.
GAD uses PLP (pyridoxal 5 0-phosphate) as a cofactor. PLP was granted a patent by the US government patent office to the Canadian company, Medicure. PLP is now under the control of the pharmaceutical industry. Its lack is often associated with blood clotting distortions, migraines, neural disorders and seizures.
Nanotransmitters produced in conjunction with GAD metabolism show direct associations with a multitude of diseases: diabetes, autism, arthritis, Parkinson's, ALS, Multiple Sclerosis, joint pain and deterioration, auditory disorders, Celiac Disease, Crohns, Irritable Bowel syndrome, diverticulitis, schizophrenia, bipolar and anxiety disorders, aspartame sensitivity, MSG reactions, Lupus, Fibromyalgia, depression, seizures, brain signaling, the use of calcitonin (cancer related), histidine function (seasonal allergies), cellular inflammation and vaccination reactions.
Of particular importance is GAD's involvement with cancer via Calcitonin, a 32-amino-acid peptide/hormone that participates in calcium and phosphorus metabolism. BioAcoustically Speaking, calcitonin is a major player in the role of how the body handles any cancer threat.
Parkinson's is an incurable, debilitating disease that also shows GAD involvement. The activity of glutamic acid decarboxylase (GAD), the enzyme involved in formation of the inhibitory neurotransmitter γ-aminobutyric acid (GABA), was studied in autopsy brain samples from six Parkinson's patients and 13 controls. The activity of GAD was significantly reduced in brain samples of patients with Parkinson's disease, being about 50 percent; of that in controls. Moreover, levodopa treatment showed a tendency to increase the activity of GAD. The results suggest the involvement of GABA neurons in Parkinson's disease.
A search of the GAD literature stated that acetylcholine, γ-aminobutyric acid, dopamine, calcitonin gene-related peptides, choline acetyltransferase and enkephalins are involved with the metabolism of GAD. It would be important to include these biochemicals when testing subjects for GAD presence and methylation.
Glutamate is the same Frequency Equivalent* as aspartame and is part of MSG (mono-sodium glutamate). James Oschman in his publication, Energy Medicine, states that cells emit frequency-based signals as a request for needed biochemicals to gather at the site where they are needed. Since Glutamate and Aspartame are the same frequency, this may explain why Aspartame has been implicated in so many muscle and joint disorders.
These observations are based on the mathematical matrix of BioAcoustic Biology developed over the last twenty years by the Sound Health Research Center located in Albany, Ohio, USA. The system allows for the evaluation of any item associated with the body in terms of numeric mathways. Sharry Edwards, the recognized pioneer of this emerging technology states, "I expect this information will be the impetus that opens the world to the potential of BioAcoustic Biology and the hope of allowing access to Self Health care; even after the appearance of a disease process".
Quoting from the original Science News article:
"Three protein fragments are looking like the guilty parties in celiac disease, an intestinal ailment that affects as many as one in 133 people in the United States. These partial proteins, or peptides, are the part of gluten in wheat, rye and barley that triggers the immune systems of celiac patients, damaging the small intestine. An Australian research team reports the new findings in the July 21 Science Translational Medicine."
"This is an impressive and very comprehensive study," says immunologist Ludvig Sollid of the University of Oslo. "The authors find that most celiac patients make a response to these three gluten peptides."
Are GMO producers aware of the damage to health that is being caused? Why are GMO producers and the US government boldly attempting to prevent package warnings that would notify people that they were eating GMO products? Is it greed, ignorance or a misguided attempt to improve our food supply that is in fact poisoning our food, our population, and our genetic pool? Is this assault on our food supply intentionally creating a future that will keep us ill and medication dependent?
* all issues expressed in terms of Frequency Equivalent™ (a "term of use" for BioAcoustic Biology) a numeric representation of a person, place, thing or emotion.
|By Rick Jervis, USA TODAY|
Scientists on the research ship Cape Hatteras found oil in samples dug up from the seafloor in a 140-mile radius around the site of the Macondo well, said Kevin Yeager, a University of Southern Mississippi assistant professor of marine sciences. He was the chief scientist on the research trip, which ended last week.
Oil found in samples ranged from light degraded oil to thick raw crude, Yeager said.
A research team on a ship called the Arctic Sunrise, sponsored by the environmental activist group Greenpeace, also turned up traces of oil in sediment samples as well as evidence of chemical dispersants in blue crab larvae and long plumes of oxygen-depleted water emanating from the well site 50 miles off Louisiana's coast.
Greenpeace was scheduled to announce its findings at a news conference today. Its trip also ended last week.
"Clearly, there appears to be vast volumes of oil present on the seafloor," Yeager said. "We saw considerable evidence of it."
Yeager said his team still needs to "fingerprint" the samples in labs to determine definitively that the oil came from the runaway well. The sheer abundance of oil and its proximity to the well site, though, makes it "highly likely" that the oil is from the Macondo well, he said.
The findings add to an ongoing debate between academic researchers and federal scientists, who have differed on the oil spill's impact on the Gulf. The Deepwater Horizon rig exploded and sank in April, killing 11 crewmembers and releasing more than 100 million gallons of oil before it was sealed Sept. 18. BP leased the rig and is responsible for the spill's cleanup, while the U.S. Coast Guard is overseeing response and cleanup work.
Federal officials have said that most of the oil has evaporated or been devoured by oil-eating microbes. Last week, Steve Lehmann, a scientist with the National Oceanic and Atmospheric Administration (NOAA) and a top science adviser to the Coast Guard, told the New Orleans Times-Picayune that his agency has not found any oil on the seafloor.
"The concept of a big slick of oil sinking to the bottom is kind of an anathema," he said. "We have not found anything that we would consider actionable at 5,000 feet or 5 feet."
Debbie Payton, a NOAA oceanographer leading the agency's subsurface oil monitoring, said NOAA scientists have detected an oily sheen in some of the sediments samples they've taken near the well site, but early results from lab analysis so far have not shown any oil particles.
Part of the discrepancy between federal and academic scientists may come from how NOAA scientists lower the multi-ton machinery used to collect the samples, known as a "multiple corer," into the sea, said Samantha Joye, a University of Georgia marine sciences professor who was one of the first to discover oily sediment in the seafloor.
Lowering the multiple corer too fast could disrupt the fine sediment on the seafloor and disperse oil particles, she said.
"These are really fine layers," Joye said. "If you don't know what you're doing, you're not going to find oil."
The three-month Greenpeace research trip aboard the Arctic Sunrise included scientists from Tulane University and Texas A&M University at Galveston, said John Hocevar, Greenpeace's oceans campaign director who participated in the expedition.
The Tulane scientists found traces of what appeared to be the dispersant Clorexit, used to break up the gush of oil during the spill, in blue crab larvae, Hocevar said. A third team of scientists took whale recordings in the deep Gulf and will study them to see if the mammal's numbers have dwindled and, if so, what role the oil might have played, he said.
Clif Nunnally, a doctoral student and manager of the deep sea biology lab at Texas A&M who was on the Arctic Sunrise, said he gathered sediment samples 6 miles north of the well site that clearly had oil in them.
"There's definitely oil there," Nunnally said. "Now it's a matter of getting all the samples up and determining what the impact is on the animals there."
Yeager said the next step is to try to determine what lasting effects the oil in the sediment may have on the worms, plankton and other invertebrates burrowed in the seafloor muck and what ripple effects that could trigger up the food chain to humans.
"From this point forward, this becomes largely a bottom-up story," he said. "What's troubling to me is we know almost nothing about what's happening on the seafloor in relation to this oil."
THE THREAT TO HEALTH FREEDOM NOW
AN EXCLUSIVE INTERVIEW WITH ATTORNEY JONATHAN EMORD
By Jon Rappoport
October 25, 2010.
As a medical investigative reporter for 28 years, I've seen public interest in health freedom come and go. Right now, in 2010, it is at a low point.
In the early 1990s, there was a tremendous fervor in America. Millions of people, perceiving a threat from the federal government, realized they could be cut off from the right to improve their health according to their own wishes, judgments, and decisions.
In practical terms, health freedom has come to mean: the right to have access to the widest possible range of nutritional supplements, health practitioners, and treatments--with no government obstruction.
Back in 1993, millions of Americans believed in that principle, and sent letters to Congress. Rallies were held. Celebrities appeared and supported traditional American liberty.
The final blow was struck with the passage of the Dietary Supplement Health Act of 1994 (DSHEA). It appeared to promise the results citizens were looking for. The FDA would not be permitted to limit access to the full range of nutritional supplements.
Then the furor died down and people went back to their lives. The internet grew into a giant. Millions of pages discussing health issues appeared. More freedom. More access.
But there has been an overall dampening of that spirit of the early 90s. Many people believe the major battle has been won.
To examine whether this is the case, and whether the DSHEA Law is actually keeping Americans safe, I interviewed a widely revered lawyer, Jonathan Emord.
Emord is one of the nation's leading free speech attorneys. He has defeated the Food and Drug Administration a remarkable seven times in federal court, more times than any other attorney in American history, earning him the title, "FDA Dragon Slayer."
He is the 2007 recipient of the Cancer Control Society's Humanitarian Award for "winning and preserving our great civil rights to life, to liberty, and to health freedoms."
Mr. Emord has practiced constitutional and administrative law in Washington, D.C. for the past twenty-five years. He is routinely consulted by industry, Congress, and the media on regulatory issues that affect health freedom. He is the author of four critically acclaimed books: Freedom, Technology and the First Amendment (1991); The Ultimate Price (2007); The Rise of Tyranny (2008); and Global Censorship of Health Information (2010).
I hoped Mr. Emord would give us real and detailed information on substantive issues facing Americans today. He responded in kind, and went the extra mile. He cleared up a number of popular confusions, and offered several predictions based on his long experience as an attorney in the field of health freedom.
One of the most critical points Mr. Emord makes: The laws Congress passes can be twisted by the federal agencies responsible for overseeing those laws. For example, the FDA has reinterpreted health law to suit its own slanted purposes. This is an extreme violation of the Constitution, and it endangers the American Republic. Federal agencies can, in effect, illegally become legislators and enforcers.
This is not a brush-off interview. Mr. Emord provides a compelling and extensive case that should be read, studied, and acted on by other attorneys, health-freedom advocates, nutritional-company executives, and all citizens who value their freedom.
JON RAPPOPORT: DSHEA is a federal law that was passed in 1994 to protect the public's right to buy and take a wide range of nutritional supplements. It's considered our best bulwark against invasive actions by the FDA. Did DSHEA really give us reliable protection? Where do things stand today?
Has the FDA eroded that law over the last 16 years?
Are we in trouble?
JONATHAN EMORD: DSHEA has not given reliable protection against FDA censorship or FDA restrictions on access to products. In certain respects the law itself is to blame because of flaws in its design; in other respects FDA has purposefully misconstrued the law to defeat its plain and intended meaning. Congress has been derelict in counteracting the agency's abuses--in no small measure because the drug industry benefits from those abuses and has such influence over the House Energy and Commerce Committee and the Senate Health Committee that no meaningful reforms ever occur.
I was invited to comment on the bill when it was in draft form. I said then that certain provisions in the bill would enable the FDA to censor health information and restrict access to supplements. I opposed inclusion of those provisions to no avail.
In particular, DSHEA requires supplement companies to file, with the government, notice of use of structure/function claims [statements about the positive effects of a nutrient on the structure or function of the body]. At the time the bill was being debated, I explained that since structure/function claims were protected speech under the First Amendment, there was no sound justification for requiring any company to submit them to the FDA for review, and that forcing companies to do so would invite FDA mischief. I explained that inevitably FDA would use structure/function claim review to redefine claims from the category of structure/function to the category of prohibited drug claims, thus reducing the quantity of free speech available for expression. That has happened.
The DSHEA permits the HHS Secretary to adopt good manufacturing practice guidelines [GMP] for supplements [how supplements should be made in the lab-factory]. I warned at the time the bill was being debated that this provision would invite considerable agency mischief, that FDA would use GMP regulation to put the industry under its thumb and stop the marketing of supplements on technicalities, thereby ridding the market of any product it did not like. That is now happening.
We hired Steve Hanke, the Senior Economist on President Reagan's Council of Economic Advisors, to evaluate the impact of the GMP rule. He determined that the cost of compliance per year [to supplement companies] would exceed the finances of roughly one-third of all dietary supplement manufacturers, resulting in their elimination from the market. In the GMP rule, FDA put the estimate more conservatively, but admitted that it would eliminate about one-quarter of the market. The evaluation we were provided also concluded that there would be less variety of product available to consumers and that the cost of product would increase. The FDA also admitted these effects in its GMP Final Rule. FDA is vigorously pursuing its inspection agenda. Within the next several years we should see the fall-out. FDA has increased its reliance on direct court action instead of negotiated settlements of disputes with the industry. That too will result in a loss of companies and a reduction in consumer offerings.
The DSHEA adulteration provision included language limiting FDA action to ban supplements to instances where the agency could prove that they presented a significant or unreasonable risk of illness or injury. Congress intended for this to be a meaningful barrier to FDA, compelling the agency to prove supplements capable of causing harm before removing them from the market. FDA has construed this language to give it virtually unbridled discretion. In its ephedra ban, for example, FDA in effect rejected the Paracelsian model for assessing dietary supplement adulteration (i.e., dose determines toxicity) in favor of the precautionary principle. Under that [precautionary] principle, if a nutrient causes harm at some dose level (a universal fact because everything, including, water, causes injury at some dose level), it would be presumed adulterated until the industry proved it safe beyond doubt at another dose level. That shifted the burden of proof from FDA (where Congress placed it) to the industry (where FDA prefers that it be), enabling FDA to ban any nutrient it wishes on evidence readily available that at some dose level [at preposterously high doses] it causes harm.
The DSHEA included a provision to permit dietary supplement companies to distribute scientific literature on nutrient-disease associations [a nutrient can help alleviate a disease] to the public, including to their customers. At the time, I warned that the provision included ambiguous requirements that FDA could construe to emasculate the speech-protective intent of Congress. FDA has in fact gone farther than I had anticipated. FDA completely eviscerated this provision by taking the position that any scientific publication that associates a nutrient with a [positive effect on a] disease...can still be forbidden by FDA because company provision of the literature to customers would constitute "evidence of an intent to sell the product as an unapproved new drug."
I also opposed the provision that required submission of a new dietary-ingredient notice to FDA for every nutrient first sold after the date of passage of the DSHEA. Under that provision, if FDA does not object to the notice, the product is legally marketable. I thought that if a product met the definition of a dietary supplement, FDA should have no power to prevent its marketing. I warned that FDA could use its discretion to require a degree of proof for safety that was so high as to make it impossible for any new dietary ingredient to enter the American market. While FDA has not construed it to be absolutely prohibited, it has made it very difficult to market lawfully any nutrient first introduced to the American market after the date of passage of DSHEA.
The dietary supplement industry is in trouble because the FDA harbors an unscientific bias against supplements, principally arising from its desire to protect the agency's foremost regulatee, the drug industry. I remember when folks were arguing that the GMPs were a good idea because industry leaders had connections with FDA and could assure that the agency would not abuse its power. The dietary supplement industry has never had a very effective lobby and is a Lilliputian compared to the Leviathan drug industry. I have often used the following metaphor to describe the power triangle at work. The drug industry is like an enormous elephant, and the FDA is like a blind jockey atop the elephant incapable of altering the elephant's course. The dietary supplement industry is like a flea on the elephant. So long as the flea does not irritate the elephant, everything proceeds smoothly, but as soon as the flea causes irritation, the elephant signals its displeasure and the blind jockey whacks about the surface of the elephant with his riding crop until he nails the flea. Some in the trades and in the dietary supplement industry have an inflated view of their influence over FDA. The drug industry they are not, and to the drug industry they are entirely beholden for any regulatory crumb that falls off that industry's table.
RAPPOPORT: Many commentaries about Codex have circulated on the Web over the past decade.
What is Codex and what is its goal, vis-à-vis nutritional supplements?
Are the American people going to be forced to accept the provisions of Codex? Is this a looming reality?
EMORD: The Codex Alimentarius Commission is an organization of the United Nations Food and Agriculture Organization and the World Health Organization. It is a standard setting body. The standards it adopts each member state is expected to implement or, if not, to explain why it has chosen not to do so. If the failure to adopt a standard caused a member state to discriminate against imports, that state could be challenged for its failure before the World Trade Organization. More commonly, however, the Codex Commission serves as a forum for member states to exercise influence over one another in the adoption of domestic standards governing the availability of dietary supplements and the dose levels in the market. By adopting a standard, as Codex has done, recommending that member states determine whether vitamins and minerals are safe at particular dose levels and ban them at dose levels not determined safe, the Commission places the onus on members to implement regulatory regimes based on dose and, implicitly, on the government-preferred precautionary principle. That has encouraged the development of extensive EU prior restraints on the availability of dietary supplements in the market and has advanced the European attachment to and advocacy for the precautionary principle as the best means to assess toxicity. In short, Codex has become a coercive force in favor of restrictions on dietary supplements and what can be said [what health claims can be made] about them.
The U.S. Food and Drug Administration admires the European system of controls and can alter its interpretative construction of existing regulations to "harmonize" the American model more closely with the European model of regulation. U.S. delegates to Codex should be opposing the movement toward greater restrictions on supplements and claims. Instead, they quietly acquiesce in those restrictions and work toward effecting similar restrictions within the United States through reinterpretation of existing agency rules.
RAPPOPORT: What can you tell us about the legal status of nutritional supplements in Europe? Is the EU really destroying the public's right to buy a wide range of nutrients? What's the situation? Are there serious implications for America?
EMORD: Under the European Union Directive governing dietary supplements, no dietary supplement is legal to market without first being found safe and bioavailable by the European Food Safety Authority [EFSA]. Moreover, no claim--not even structure/function claims--concerning health effects of a dietary supplement may appear on labels, in labeling, or in advertising of a dietary supplement in Europe without first being approved by EFSA. This massive system of prior restraint has imposed a nutrition Dark Age on Europe. As the EFSA determinations continue to be enforced by the EU member states, hundreds of products that had been safely consumed for decades will be removed from the market. Also, claims will disappear, leaving Europeans in the dark as to the potential of nutrients to affect health and disease.
This system is a form of Lysenkoism or state created orthodoxy over science. It is dumbing down the European market and removing from it health enhancing substances. In the end, there will be a rise in age-related diseases for which risk is diminished by supplementation, such as cancer and cardiovascular disease. EFSA will be responsible for creating a very unhealthy environment all in the guise of protected European consumers from anything less than certain science.
In truth almost nothing in science is certain; nearly everything is inconclusive, yet we make decisions every day based on the inconclusive science--based on personal bets on the extent to which we think evidence of association [is] correctly indicative of ultimate outcome. Remove from us that evidence of association by force of law and we become incapable of making informed bets.
EU censorship of all information in the market not proven conclusively true necessarily censors information on nutrient-disease relationships that will in time be proven true. That present censorship will cause those who would bet on the ultimate truths to be denied the opportunity of guessing right and, thus, they will lose out in potentially fatal ways.
That is precisely what happened to the FDA. We sued the FDA when it refused to authorize a claim associating folic acid with a reduction in the risk of neural tube defects [NTD]. FDA took the position that the association had not been proven that folic acid containing supplements could reduce NTD risk. FDA censored the information for some six years, contributing to over 2,500 preventable NTDs each year and to countless NTD related abortions. We ultimately defeated FDA's censorship in Pearson v. Shalala. That then led in time to FDA allowance of the claims when we beat the agency a second time for refusing to permit the claims. The result has been a steady reduction in the incidence of NTDs in the United States as more and more women of child bearing age learn of the need to take folic acid supplements containing 400 (and preferably 800) mcgs each day before they become pregnant.
What will the scientists within EFSA think of themselves if five, ten, twenty, or more years from now proof positive arises that certain nutrients they have condemned are associated with significant reductions in the risk of cancer and cardiovascular disease such that tens of thousands of Europeans could have lived had they been given market access to information concerning the association years prior?
The EU ban on supplements and supplement claims (unless pre-approved by EFSA) is now in place. EU depends on its member states for enforcement. Each state is variously engaged in enforcement with some using more aggressive methods than others. Over the next several years, however, we can expect to see crack downs in each of the member states with products being removed from the market following each crack down.
The present FDA admires the European example of broad censorship and restrictions on supplement access and is aggressively ridding from the American market claims and products. We need to replace that administration and put into law new constraints on the exercise of government power. I have written for Congressman Ron Paul a bill that would strip FDA of its prior restraint on claims, leaving the federal government limited to acting against claims it can prove with clear and convincing evidence to be false. That bill, the Health Freedom Act, needs public support and would, if passed, usher in a new era of speech freedom for claims in the United States.
RAPPOPORT: During the debate and run-up to the passage of ObamaCare, the national health insurance plan, I heard very little concern expressed in the health freedom community about the future implications of this bill. It's obvious to me that, with control being vested in the Department of Health and Human Services, we could eventually see the day when alternative health care and nutrition are edged out further and further from permitted treatments. And citizens would be required to accept conventional medical treatments, whether they want them or not.
Along a similar line, I see very little evidence, these days, of action being taken by health freedom groups and nutritional companies to keep health freedom alive. Certainly, we see nothing like the enormous campaign launched in the early 1990s, when Congress received millions of letters protesting the actions of the FDA to limit our access to supplements, and celebrities came out of the woodwork to support health freedom.
What am I missing? Is some back-door deal in place now? Have nutritional companies been given assurances that, if they keep their heads down and their mouths shut, they'll be allowed to do business as usual?
I'm at a loss to explain the eerie silence from groups that should be continuing to fight VERY VISIBLY for our freedom in this area. I sense a soft attitude.
I was very active in the health freedom movement of the early 90s. My approach was to go after the FDA for their ongoing crimes, to attack. At the time, some people told me to dial it back, we were going to get a good bill passed in Congress, and aggressive actions could injure our cause. Is that the prevailing mood now? Is something on the table we don't know about? A new bill?
EMORD: There has been a recurrent pattern by supplement trade groups and certain leading companies in the industry (epitomized by the industry move to draft and advocate FDA adoption of GMP rules giving FDA broad discretion) to engage in self-flagellation. In its nascent, more competitive years, the industry more stridently opposed FDA regulation. The movement of consumers away from specialty supplement brands towards less costly generic varieties combined with bad economic times contributed to consolidation of the supplement market, and certain industry leaders have for the last several years moved away from robust contest with FDA to compromise with the agency. There is an economic motive for this, to be sure. Large [supplement] industry players believe they benefit from greater FDA regulation because it creates costly barriers to entry that keep out smaller competitors.
There is also a mistaken view promoted by certain industry trade associations that if the industry confesses fault to FDA and Congress, even when no fault exists, and professes a keen interest in ridding itself of bad practices, even when those practices are unrepresentative of the industry, it will curry favor with the powers that be. Instead, it has provided those powers with more ammunition to use against the industry, compounding the industry's problems and creating a major public relations problem.
The fact is dietary supplements with few exceptions are the safest ingestible products, far safer than foods and far safer than drugs. That is a remarkable fact that one would think the industry would recite at every turn. Instead, certain trade associations and industry leaders voice grave concerns about supplement safety and agree to greater federal regulation on the notion that greater regulation is either inevitable or will favor the market position of the leading companies. To listen to what Congressmen Waxman or Dingell have to say, you would swear that supplements were fissile materials. It is the rare exception rather than the rule that a dietary supplement causes harm.
By buying into the self-flagellation argument (the argument of supplement opponents that there is something inherently wrong with the market that necessitates extraordinary new regulation lest we all succumb), the industry is inviting its own demise.
Industry leaders who buy into this on the notion that it will reduce competition and shore up their market shares are in fact deluded, however, because, in the end, the FDA is the drug industry's, not the supplement industry's, to control. In other words, FDA will be pleased to expand its regulatory power over the supplement industry but not for the benefit of the supplement industry's leaders. Rather, FDA will invariably use greater regulatory power over the supplement industry to aid its favored regulatee, the drug industry, not to shore up the market share of large supplement companies. The drug industry, not the supplement industry, holds almost all the cards at FDA and in Congress. The supplement industry has relatively little clout by comparison.
Instead of engaging in self-flagellation, the industry ought to refute false representations against supplement safety and efficacy and promote public awareness of the many benefits supplements bring to consumers. Supplements are rarely the cause of human injury. The science concerning their health enhancing effects abounds and grows weekly. The potential for nutrients to reduce the risk of, prevent, and even treat disease is profound. Science is unraveling truths about human biochemistry that support the conclusion that our lifestyle choices very much affect our disease risks and that healthful living in reliance on organic foods, above levels of certain key nutrients, reduction in stress, and faith and hope have a profound impact on our health, our quality of life, and our longevity.
Rather than engage in self-flagellation, the industry should celebrate its strengths, advertise them continually to the public and the government, and act to defend on grounds of principle the freedom to market and sell safe and potentially life-saving and health enhancing supplements.
RAPPOPORT: I have searched the most popular conservative radio and television shows and websites and blogs--in other words, the places where one would expect to find a defense of our freedom to choose whatever means we want to, to maintain and improve our health--and I come up with a big fat zero. Why do you think the silence there on this issue is deafening?
EMORD: There may be some truth to the notion that because the media are financed in no small measure from drug ads, there is a natural economic interest in avoiding communication that attacks drug safety and efficacy. The FDA and the FTC have not been shy about informing media of regulatory risks associated with supplement advertising, thus creating a general chilling effect on the interest of media to present supplement advertising and discuss supplement health effects. Finally, as with many areas of emerging science, there is still widespread ignorance in the media on the association between nutrients and disease. That ignorance is forged into prejudice when negative press on supplement-disease associations is widely disseminated, but positive press on those associations is more often than not ignored or given short shrift.
RAPPOPORT: This past summer, Congress took up a food safety bill (S.510). What's its present status? Does its wording really suggest we may be subject to Codex regulations vis-à-vis the sale of nutritional supplements? What are the shortcomings of the bill?
EMORD: This bill is a significant threat to the supplement industry. It contains a provision that permits FDA to charge the hourly cost of its inspections of [nutritional-supplement] establishments if the agency finds a violation warranting a re-inspection. That creates an incentive for FDA to find fault on first inspections and to do re-inspections as a revenue raiser. The bill also includes a provision that encourages FDA to evaluate harmonization between domestic and foreign regulation. That invites the agency to construe its regulations to effect a change in them favoring the EU model. At a time when the FDA is in great disrepute for abusing its powers (approving unsafe drugs, failing to force the withdrawal of unsafe drugs form the market, and censoring health information concerning supplements), the Congress is about to entrust the agency with yet more vast new regulatory powers. That is a big mistake. Congress should be moving rapidly in the other direction, taking away power from this corrupt agency. The problem is that Congress, too, is quite corrupt. Senator Harry Reid said that he would not move the bill forward in the Senate until after the election. The election is likely to result in Republican control of the House and either Republican control of the Senate or a loss of Democratic dominance in the Senate. If that happens, S. 510 could become a casualty of an angry electorate desirous of stopping the regulatory train before it leaves the station.
RAPPOPORT: In a radio interview we did some months ago, you made a number of points that need much wider dissemination. I'd like you to expand on two of those points. First, you said we have a federal government that, actually and disastrously, is run by and through its regulatory agencies, whose employees stay on during one administration after another. And two, despite your string of unprecedented victories in court against the FDA, you have the sense that the Agency is quite prepared to ignore the court rulings limiting its illegal intrusions into our affairs--in fact, the Agency fully intends to carry on without paying one iota of attention to those court rulings...making it, in my eyes, a rogue Agency.
EMORD: In my book, The Rise of Tyranny, I explain how our federal government has been transformed from a limited federal republic into a bureaucratic oligarchy since the 1930s. Under our Constitution, Congress is vested with the power to make laws. We have a separation of powers that prevents any one branch from exercising combined legislative, executive, and judicial powers, and we have a non-delegation doctrine, that forbids those branches vested with those powers from delegating them to other entities. In the 1930's, the Supreme Court at first held efforts by President Roosevelt to delegate governing power to bureaucratic agencies unconstitutional. In response, President Roosevelt advocated the passage of legislation that would have packed the court, adding a justice for every one sitting who had reached 70 and one-half years, thus altering the composition of the Court to receive jurists who would favor the New Deal agencies. The bill was not passed but caused what the media of the day referred to as "the switch in time that saved nine." In 5 to 4 majority decisions, the Court switched from defending the separation of powers and the non-delegation doctrines to abandoning them. Since that time, despite the creation of over 183 federal agencies, many with these combined powers, there has not been a single instance in which the Supreme Court has held the delegation of governing power outside the [three basic] constitutional branches to be a violation of the non-delegation doctrine. As a result, today over ninety percent of all federal law is not the product of our elected representatives but regulation promulgated by unelected heads of the bureaucratic agencies. We founded this country on the notion that no American should be taxed without being represented, and yet today we are taxed and those who create almost all laws governing us are unelected. James Madison, Thomas Jefferson, John Adams, Alexander Hamilton, and George Washington each stated that if ever our country were to reach a point where legislative, executive, and judicial powers were combined in single hands that would be the end of liberty and the birth of tyranny. Sadly, I believe we are there. A bill I wrote for Ron Paul would restore constitutional governance by preventing any regulation from having the force of law until it was passed into law by Congress in the way the Constitution requires. That bill, the Congressional Responsibility and Accountability Act, is pending in Congress.
RAPPOPORT: A more general question: From your experience and training as a constitutional lawyer, what is your view on what the Constitution put in place, through word and intent, regarding individual freedom? Constitutionally, what is the meaning and range of freedom?
EMORD: Ours is designedly a Constitution of liberty. It is remarkably unique. The Declaration of Independence perhaps best sums up the legal creed that underlies the Constitution. Just governments are instituted among men to protect the rights of the governed. Just governments are derived from the consent of the governed. When governments become destructive of those rights, it is the duty of the people to alter or abolish them so as to restore governance in protection of, rather than derogation of, those rights.
The Constitution is an extraordinary document precisely because it is a written limit on the power of the state. Before it, no government on earth had such written limits. Under it, no power rightfully exists in the state except that which is expressly given to it by the instrument. It enumerates the powers of Congress; it separates legislative, executive, and judicial powers; it makes law-making the province of an elected branch but only for enumerated purposes; it makes war declaration the province of that same branch, albeit war prosecution the province of the executive. It makes treaty negotiation the province of the executive, but reserves consent to the Senate for treaties negotiated. It makes the individual sovereign by limiting federal powers, preserving state powers as a check on the federal ones, and forbids in the Bill of Rights government from acting beyond the powers enumerated in the Constitution against the reserved rights of the states and the people. Those reserved rights create for us a universe of freedom that is meant to be extremely broad. Its scope is perhaps best conveyed in Thomas Jefferson's definition of liberty:
"Of liberty I would say that in the whole plenitude of its extent, it is unobstructed action according to our will. But rightful liberty is unobstructed action according to our will within limits drawn around us by the equal rights of others. I do not add 'within the limits of the law,' because law is often but the tyrant's will, and always so when it violates the right of an individual."
That ideal, that scope of freedom, we do not presently have because the plain and intended meaning of the Constitution is now largely dishonored.
RAPPOPORT: What is your view of the so-called "living, evolving Constitution" promoted by many, many judges?
I have given much thought to this. My thinking is reflected in my books Freedom, Technology, and the First Amendment and Global Censorship of Health Information.
In brief, the Constitution's words spring from underlying principles. Those principles are static. Yet, as we progress in science, technology, and knowledge, we are confronted with new facts. That environment, the life of the Republic, is dynamic. The Constitution permits amendment through a precise process prescribed in Article V. Its meaning, i.e., the principles designedly protected by its words, may not be reasoned out of the document or altered, except by amendment in the way the document designates. Consequently, those principles must be preserved in the face of the evolution of our Republic, but that is not to say facts arising from that evolution, because not previously known, justify departure from first principles. To the contrary, the aim must be to ensure that first principles are upheld despite the evolution. So, for example, while the electronic media was not known to the Founders, it is nevertheless media and therefore should be entitled to the same full First Amendment protections afforded the print media. We thus preserve freedom for the message (the aim of the First Amendment) regardless of the medium.
RAPPOPORT: When a pharmaceutical company is found guilty of pushing a drug on the public it knew was dangerous; and when the drug has been shown to have caused considerable injury and death; when law suits for grievous harm result in huge money judgments; why aren't persons in that company prosecuted criminally and thrown in prison for long sentences? What keeps that from happening?
EMORD: You raise an excellent question. I believe those who knowingly introduce into the market substances that are likely to cause mortal injury, not just those in industry but also those in government, should be prosecuted criminally for homicide or, at a minimum, criminal negligence.
RAPPOPORT: On what Constitutional basis does the federal government pour billons of dollars into the National Institutes of Health, a federal agency, for ongoing medical research?
EMORD: None. Ideally, the federal government should be limited to Justice, State, Treasury and Defense. The health and safety power was meant to be a state power, and I think we in this and many other respects have exceeded the intended bounds of the federal government.
RAPPOPORT: Could you comment on the legality/illegality of ways in which the government partners with conventional medicine, making it the preferred method of health treatment in all areas.
EMORD: On the state level, medical boards engage in anti-competitive regulation, largely designed to deem it a failure of the standard of care for a physician to innovate in medicine and create a market for the innovation that would harm the economic interests of those who practice conventionally. On the federal level, Medicare establishes treatment orthodoxies through its coverage determinations that bleed into all areas of care and invite charges of abuse for those physicians who would provide a different degree, nature, or quality of treatment than is accepted by Medicare. That condition is destined to worsen as the Health Reform law causes care for all Americans to be federally scrutinized and subject to a Medicare-type system of second-guessing of physician services. The FDA contributes to this regime because nothing can be used for treatment of disease in the United States unless it has been approved by the FDA as a drug. Because it costs on average about $600 million to get a drug approved in the United States, tens of thousands of potential therapeutic agents are never legally available to treat patients and, thus, secure a monopoly for drug companies in the treatment of Americans. FDA is an example of industry capture. The drug industry controls the agency. The drug industry also largely dictates the content of medical education and the prescription practices of physicians. Its influence is pervasive and reinforces allopathic medicine at every turn.
RAPPOPORT: What do you think our best strategy is, here in America, to head off what the FDA is going to do?
EMORD: In my book The Rise of Tyranny I provide a detailed explanation of the changes needed to restore the Framer's Republic. In short, I urge people to vote out of office those who have not supported deregulation and to press members of Congress to support two of the bills I have written for Congressman Ron Paul--the Congressional Responsibility and Accountability Act and the Health Freedom Act. The former would prevent any regulatory agency from enforcing any regulation it promulgated until that regulation is passed into law by Congress in the way in which the Constitution designates. This would prevent the agencies from exercising unchecked power and would restore the law-making function to Congress, preventing a lot of abusive regulation from ever being enforced. The latter bill would disarm FDA of any power to require advance review of claims for supplements. That system of prior restraint violates the First Amendment and should be dismantled. Those who would defraud the public by falsely advertising their products should be prosecuted after the fact but those who wish to tell the truth should not be required to convince the FDA before they are allowed to speak. There are many other reforms we need to institute, including removing from FDA the drug approval power and vesting in universities, through a blinded system, drug reviews so that science, rather than politics and favoritism, determines the outcome of drug evaluations.
EMORD AND ASSOCIATES
By Ed Silverman
October 19th, 2010
An in-depth analysis of the money paid by drugmakers to doctors has been undertaken by ProPublica, which has just published a detailed look that is sorted by company, doctor, state and activities for which docs were compensated.
The database includes payments made by seven drugmakers in 2009 and early 2010 - $257 million went to about 17,700 docs. Although as ProPublica notes, more than 70 companies have yet to publicly disclose their payments but will be required to by 2013 under the federal health care reform law. And existing disclosure are not done so on a uniform basis - travel fees and research payments rarely show up.
By Matt Wasserman
October 19, 2010
Hemp is the far bigger economic issue hiding behind legal marijuana.
If the upcoming pot legalization ballot in California were decided by hemp farmers like George Washington and Thomas Jefferson, it would be no contest. For purely economic reasons, if you told the Constitutional Convention in 1787 that the nation they were founding would someday make hemp illegal, they would have laughed you out of the room.
If California legalizes pot, it will save the state millions in avoided legal and imprisonment costs, while raising it millions in taxes.
But with legal marijuana will come legal hemp. That will open up the Golden State to a multi-billion-dollar crop that has been a staple of human agriculture for thousands of years, and that could save the farms of thousands of American families.
Oct 16, 2010
Journals mislead public over drugs
While drugs should undergo various tests before receiving approval in Europe, pharmaceuticals often mislead consumers and authorities by not publishing the results.
According to an article published in the British Medical Journal, pharmaceuticals only publish the positive points of the trial. The publication bias overestimates the benefits of many medications.
October 16, 2010
(Los Angeles) In his latest film, international award-winning filmmaker Kevin P. Miller (The Promised Land, Generation RX) examines the possibilities of a future where international government bureaucracies like the WTO and Codex Alimentarius -- working in league with multinational corporations, control the food and medicine supply worldwide.
"SHADOWS OF THE FUTURE was produced to help consumers understand the threat Codex standards and 'guidelines' present to them," Mr. Miller explained. "People need to know how 'Free Trade' deals with the WTO have tied us into a strange bureaucratic alliance, and how it imposes restrictions on our lives and freedoms."
The New York Times
By ALLEN FRANCES
Published: August 14, 2010
A startling suggestion is buried in the fine print describing proposed changes for the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders — perhaps better known as the D.S.M. 5, the book that will set the new boundary between mental disorder and normality. If this suggestion is adopted, many people who experience completely normal grief could be mislabeled as having a psychiatric problem.
Suppose your spouse or child died two weeks ago and now you feel sad, take less interest and pleasure in things, have little appetite or energy, can’t sleep well and don’t feel like going to work. In the proposal for the D.S.M. 5, your condition would be diagnosed as a major depressive disorder.