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Archive for NSF – Page 20

HR 2749 [HR875/S425]: Farm to Fork Food Fascism Comes to America

By Administrator on March 16, 2009 No Comments

Natural Solutions Foundation
www.GlobalhealthFreedom.org

We reproduce below, with permission, A Solemn Walk Through “Food Safety”.

Index
Introduction
A Solemn Walk
Natural Solutions White Paper

———————————————-

Introduction

Food is becoming a battle ground like no other: freedom, survival, fascistic take over of a once-free people (more or less, at least), corporate triumph over independent producers – it’s all happening around food. And the mechanism is simple: a set of bills ostensibly devoted to “food safety” and “food security”.

Urgent Action Item:

http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714

Tell Congress that the Farm Bills MUST be defeated. Time is short and the issue is of immense importance.

In essence, these bills are a sneak attack implementation of Codex Alimentarius. The Natural Solutions Foundation has been warning that organic farming and home growing, clean food and food freedom were under heavy attack. Here is the Mother of All Food Fascism Assaults and we still have some time to defeat it.

Congress often comes up with bad ideas. This is not just a bad idea: it is a catastrophically bad idea for health and freedom. In fact, it is nothing short of food tyranny and will kill not only organic farming, but lots of people as well, along with the entire private farming sector. Your own gardens are at risk as well.

I cannot urge you strongly enough to take action NOW (we have only a few days to create the urgent push-back needed to fend off this disastrous legislation. These are bad, deceptive and extraordinarily dangerous bills which make the eternal link between fascism and food crystal clear. But the bills are written in neutral, even calming tones. Please go to the articles below to read a brilliantly annotated version of the bills and a summary and learn just how dangerous they are. My thanks to Sue Diederich and Linn Cohen-Cole for their tireless work on this vital issue.

Just as –

~ “homeland security” is anything but assured by the Department of Homeland Security’s destruction of our rights,
~ “health” is not served by a healthcare system devoted to propagating illness for profit,
~ “democracy” is not served by corrupt voting machines and “man in the middle programs”

so food security and safety are not served by agencies and laws which –

~ drive independent farmers out of business,
~ forbid seed saving,
~ destroy safe food production and organic farming,
~ propagate dangerous and destructive industrial farming practices,
~ guarantee the total control of the food system by industrial forces known for unsafe food production while destroying the capacity of independent farmers to survive a regulatory onslaught created specifically to destroy them,
~ put home food production in jeopardy,
~ “HARMonize food production with pro-industry, pro-WTO controlled, lowest common denominator practices of Codex Alimentarius.

These are tragically solemn times calling for solemn re-dedication of each of us to the fight to retain and restore freedom. Food is just about the best place possible to start. Killing HR 875, S 425 and all related bills is the best place to start.

Click here (http://salsa.democracyinaction.org/o/568/t/1128/campaign.jsp?campaign_KEY=26714) to tell Congress in no uncertain terms how imperative killing these dastardly bills is to you. Then tell everyone you know how important this push-back is.

Now think for a moment how important this information is to your life, your liberty and your society. Would you have had it without the Natural Solutions Foundation? We work very hard at being your health freedom advocates and we need your help. Please make regular donations, small or large, to the Natural Solutions Foundation – an astounding 100% of your donations goes directly to our work. People write to us to tell us that you need us and we certainly need you. Click here (http://drrimatruthreports.com/?page_id=189) to make your tax deductible donation to the Natural Solutions Foundation.

This action, and this issue, cannot wait.

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

Index ——————————————-
Solemn Walk Through HR 875
By Sue Diederich and Linn Cohen-Cole

Walk Index
First Walk: Myths and Misinformation
Second Walk: End of Organics
Third Walk: Meaning of the Bills
Fourth Walk: Conclusion

Introduction to the Walk

The Pennsylvania Sustainable Agriculture Association, PASA, sent out information about HR 875 which lists ‘facts’ to counter ‘myths’ and ‘rumors’ on the internet. It gives no specifics to back up its ‘facts,’ so the following close up view of the bill and accompanying commentary offers readers a chance to decide for themselves what is myth and what is fact. Neither of us are lawyers, but we both can read. Sue Diederich heads the Illinois Independent Consumers and Farmers Association, an organization formed to protect the rights of farmers and consumers to deal directly with each other without government interference.

PASA’s assertions are in regular lower case font, as are the inserted portions of the bill which have all been provided by Sue Diederich who also provides her own comments in italics usually. My comments are in bold face. [Note: these type faces have been altered from the original to permit publication in the program used to publish this blog which lacks color font options – Dr. Rima]

Occasionally, we feel something is essential for people to see and those comments are in CAPITAL LETTERS. (It should all be in CAPITAL LETTERS [font changed to allow publication in this program – Dr. Rima], really, since so few organizations appear to have read the bill or seem to know how to read the bill or have thought through its massive cumulative impact or been concerned at its endlessly broad reach and over incredibly vague things.)

People seem to expect the bill to be titled “The Criminalization of Organic Farming and the Take over of the US Food Supply,” and when they don’t see any words to that effect anywhere in the bill, they declare “this bill is fine” and those seeing dangers are “alarmists.” Do they think the industrial side is composed of fools? These are the same people who make cheery cereals with cartoon characters on the box when, inside, high fructose corn syrup is all over the cereal which comes from Bt-corn associated with diabetes. HFCS is, too, and there is an epidemic of diabetes here even among children. They know how to package. Why do people understand that industrial food inside a box can be a problem and yet are so innocent about looking at the bills, not realizing there is packaging there, too, or how much is at stake that the public and even legislators not see since this is about taking control. The industrial side isn’t stupid.

Understanding parts of the bill at times depends on smelling smoke as you read it. Here in the US, we still have only smoke … an Ohio state ag department SWAT team raid on an organic coop, Pennsylvania ag department raids on horse and buggy Mennonites, California setting coliform levels so low fresh milk dairy farmers would need cows that produced pasteurized milk right out the udder, arrest and handcuffing of a single mother in front of her children for selling goat milk, the USDA paying its agents bonuses for foreclosing on farms, … But in the EU where 60% of the Polish farmers are now gone because of identical bills enacted into law there, and 60 UK farmers have committed suicide, there is fire. And in Iraq, where they have been rendered helpless serfs by the theft of their country’s seeds and criminalization of farmers’ collection of their own seed, it is roaring. And in India where 182,000 farmers have committed suicide since the WTO and IMF got hold of agriculture and our Big Ag firms went in there, and 8 million farmers have left the land, it is out of control.

The WTO, run by the multinational meat packers and genetic engineering corporations, want HR 875, here. The bills are “harmonized” rules for globalization of food and lower food safety standards to allow for it. Those corporations are members of NIAA, a corporate consortium that brought NAIS, created by Anne Veneman, to the USDA to be made into law.

Walk Index
First Walk… Myths and Misinformation

We begin with PASA offering FWW’s take on the bills to its members:

Myths and Facts? H.R. 875 – The Food Safety Modernization Act

PASA members: The following information about a bill now before Congress, HR 875, was developed by our friends at Food and Water Watch, and forwarded to us by the National Sustainable Ag Coalition (NSAC), of which PASA is a member.

This Myth/Fact sheet was developed to help answer some of the rumors that are fairly rampant on the Internet right now. We will keep a close eye on the situation, and share further updates from NSAC as they become available. ?

MYTH: H.R. 875 “makes it illegal to grow your own garden” and would result in the “criminalization of the backyard gardner.”

FACT: There is no language in the bill that would regulate, penalize, or shut down backyard gardens. This bill is focused on ensuring the safety of foods sold in supermarkets.

Though private residences are not specifically included, nor are they specifically excluded. While this does not immediately affect home owners growing tomatoes in the backyard, entered testimony leaves the door open for just that in the future. Referring back to the Bio-Terrorism Act, in a discussion on this very topic and entered in the official record of debate on the interim rule, (bold/underline = mine), the same argument exists here and no new definitions or exclusions have been provided in HR 875 – and “reasonable” is a subjective term in theory as well as practice…

(13) FOOD ESTABLISHMENT-

(A) IN GENERAL- The term ‘food establishment’ means a

Slaughterhouse (except those regulated under the Federal Meat

Inspection Act or the Poultry Products Inspection Act), factory,

Warehouse, or facility owned or operated by a person located in

Any State that processes food or a facility that holds, stores,

Or transports food or food ingredients.

Now, every home in the country holds food after buying it from the

Grocery store. Will they be included too?

Hell, no. They’re going to be magnanimous and say that, while they could,

They won’t right now.

Excerpted from the same Interim Rule:

“(Response) FDA has concluded that private individual residences are
Not ”facilities” for purposes of the registration provision of the
Bioterrorism Act. Under the Bioterrorism Act, the term ”facility”
Includes ”any factory, warehouse, or establishment.” Congress did not Specify any definition for these terms.

Under their common meanings,
The terms can include private residences. For example, according to Webster’s II New Riverside University Dictionary (1994), the most
Relevant definition of ”establishment” is ”a business firm, club,
Institution, or residence, including its possessions and employees.”
However, ”[I]n determining whether Congress has specifically addressed

The question at issue, the court should not confine itself to examining
A particular statutory provision in isolation * * *.

It is a fundamental canon of statutory construction that the words of a
Statute must be read in their context and with a view to their place in
The overall statutory scheme.”’ FDA v. Brown & Williamson Tobacco
Corp., 529 U.S. 120, 121 (2000).

Other parts of the registration Provisions in section 415 of the FD&C Act indicate that Congress only Intended businesses to register, and raise a question as to whether Congress intended that private individual residences, even though food Is manufactured/processed, packed, or held at such residences, be Considered facilities.

For instance, a registrant is required to submit”the name and address of each facility at which, and all trade names Under which, the registrant conducts business * * * ” (21 U.S.C.
350d(a)(2)).

Thus it is unclear whether Congress intended all Individual private residences at which food is manufactured/processed, Packed, or held to be included in the term ”facility.” Furthermore, The requirement that a facility submit its ”name” as well as its ”trade names” raises a question as to whether Congress intended ”facility” to include private individual residences since it is Unlikely that a home would have a name or a trade name.

Where the words Of the statute are ambiguous, an agency may make a reasonable Interpretation of the statute. Chevron, USA, Inc. V. NRDC, Inc., 467 U.S. 837, 842-843 (1984); Brown & Williamson, supra, at 132.

Consistent with the language of section 415(a)(2) discussed
Previously, the agency concludes that interpreting the term
”facility” to exclude private individual residences is a reasonable
Construction for purposes of registration.

This interpretation, However, does not necessarily preclude a reasonable construction of Other provisions of the FD&C Act to include such residences.”
[I do get that residences are easily included.]

MYTH: H.R. 875 would mean a “goodbye to farmers markets” because the bill would “require such a burdensome complexity of rules, inspections, licensing, fees, and penalties for each farmer who wishes to sell locally – a fruit stand, at a farmers market.” ?

FACT: There is no language in the bill that would result in farmers markets being regulated, penalized any fines, or shut down. Farmers markets would be able to continue to flourish under the bill. In fact, the bill would insist that imported foods meet strict safety standards to ensure that unsafe imported foods are not competing with locally-grown foods.

SECTION 406 CLEARLY STATES ALL FOOD OFFERED FOR SALE WILL BE VIEWED AS BEING IN INTERSTATE COMMERCE AND SUBJECT TOT HE PROVISIONS OF THIS BILL.

C. 406. PRESUMPTION.

In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist

8) CATEGORY 4 FOOD ESTABLISHMENT- The term ‘category 4 food establishment’ means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).

(9) CATEGORY 5 FOOD ESTABLISHMENT- The term ‘category 5 food establishment’ means a food establishment that stores, holds, or transports food products prior to delivery for retail sale.

14) FOOD PRODUCTION FACILITY- The term ‘food production facility’ means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.

[SUE, say it again and again, “this applies to farms and can apply to homes.” It certainly looks to me that families baking cookies for bake sales could easily be included.]

SEC. 206. FOOD PRODUCTION FACILITIES.

(a) Authorities- In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to–

(1) visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;

(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;

(3) set good practice standards to protect the public and animal health and promote food safety;

(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and

(5) collect and maintain information relevant to public health and farm practices.

(b) Inspection of Records- A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–

(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or

(2) to track the food in commerce.

(c) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall–

(1) consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;

(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;

(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water;

THEY NEVER MENTION SEEDS BUT THIS IS PRECISELY HOW THEY WILL CRIMINALIZE SEED BANKING AND ALL HOLDINGS OF SEEDS.

[Notice they mention harvesting, sorting and storage operations, then watch below.

To follow how this will be done, you must understand that:

1. there is a small list inside the FDA called “sources of seed contamination”
2. in which they have now defined “seed” as food,
3. so seeds can be controlled under “food safety.”
Those seeds (so far) include:

seeds eaten raw such as flax, poppy sesame, etc.;
sprouting seeds such as wheat, beans, alfalfa, most greens, etc.;
seeds pressed into oils such as corn, sunflower, canola, etc.;
seeds used as animal feed such as soy ….

That is most seeds. Seeds are essential to life and thus to freedom.

The “sources of seed contamination” include six little items:

agricultural water
manure (but NOT chemical pesticides or fertilizers)
harvesting, transporting and seed cleaning equipment
seed storage facilities

What you must realize is that seed cleaning equipment is THE single most critical piece of equipment for sustainable agriculture. It is how we save organic seed. It is the machinery used after plants “go to seed” to separate out (sort) the seeds from the plant material so the farmer can collect (harvest) and then save (put in storage) seed for the next year at little cost. With his own seed, the farmer stays free of patented, genetically engineered, corporately privatized seeds.

You must also understand that Monsanto is getting rid of the people who do the seed cleaning and many other means of our having access to seed .

This year, 2009, seed cleaning equipment is now illegal in some parts of the country which tips us off to both the intent to control seeds in this way and to how they could do things under this bill.

How can they make such vital equipment illegal? Quietly, and by saying it contaminates food.

“Contaminate” is their favorite word since the public fears the deadly contamination that industry itself – not farmers – has caused. Scare the public and thus push for “food safety standards” to be set.

And to eliminate seed cleaning equipment, they haven now set the standards so seed cleaning (the simple separation of seed from plant) will now require a million to a million and a half dollar building and/or equipment … per line of seed.

So, a farmer who has been seed cleaning flax for 40 years with a hand made seed cleaner can’t sell flax on the market anymore, though there are NO instances of anyone ever having gotten sick from seed cleaning equipment. A farmer who has been cleaning wheat, corn and soy each year with the same perfectly fine equipment would now need three to four and half million dollars for three pieces of equipment to continue.

(The FDA isn’t so bar-setting when it comes to other things like melamine in baby formula, though it is proven to sicken and kill infants), initially denying the melamine was in our baby formula and then quickly inventing a “foods safety” standard to okay it.)

Organic farmers are not aware of this happening, perhaps because the left is being treated with kid gloves until HR 875 and related bills are/were passed. Meanwhile, the FDA and USDA have been tromping on traditional (many of them farming organically, by the way) farmers for years. The organic community is disconnected from them so hasn’t been aware of what is happening to them. Indie farmers have a history of no one listening to them, which is too bad because it is they who are the ones bringing the warning that these bills are deadly. The organic community, measuring against its own seeming safety, hasn’t heard or understood.

NOTICE, THOUGH, THAT BECAUSE A SINGLE “FOODS SAFETY” BAR HAS BEEN RAISED, IN TIME ON ONE WILL BE ABLE TO GET ORGANIC SEEDS IN ANY NUMBER BECAUSE IT WILL BE ILLEGAL FOR ALL FARMERS TO SELL THEM TO ANYONE.

Now, look at the last item on the list – seed storage facilities.

They would be careful not to ban them all outright given the extreme reaction they would get. But now the method is more clear. “Food safety” is the weapon and public fear is the driver and they only need to set the bar at the level that is impossible to meet.

Farmers, gardeners, seed saving exchanges, seed companies, scientific seed projects, and seed banks, all require “seed storage facilities.” All are working overtime to protect biodiversity that is rapidly disappearing because of … genetic engineering.

Set the standard for “food safety” and certification high enough that no one can afford it and punish anyone who tries to save seed in a multitude of ways that have worked fine for thousands of years, and PRESTO, YOU HAVE JUST CRIMINALIZED SEED BANKING.

The penalties, I will assume, will be tremendous, the better to protect us from nothing dangerous whatever, but to make monopoly over seed more absolute. One is left with control over farmers, and end to seed exchanges, to organic seed companies, to university programs developing nice normal hybrids.

When you know that Monsanto with the help of the US government plundered ancient and rare seed banks in Iraq that held seeds with a genetic heritage (a biohistory belonging to all of us) going back 1000s of years and then made it a crime for farmers there to collect or use their own normal and non-patented seeds off their own land, you see how extreme the intent to control is.

Now, perhaps it is possible to see how the identical thing is being done here, only it comes in a heavily, heavily disguised way – through “food safety” that isn’t at all – and in only one tiny little paragraph within a very large bill.

The Iraqis are now abjectly dependent on Monsanto and the US for survival itself and will have to pay whatever prices are set for food. They cannot just grow their own and be free. So, no matter what form of government they may have, they are now slaves because the control over them is that extreme. Kissinger was right – control food and you control people.

    WE ARE INCHES FROM THIS OURSELVES. THE LEFT NEEDS TO WAKE UP.

This trick of setting bars above any ability to be in the game, is similar to how blacks had been treated. Click here. This trick of setting bars above any ability to be in the game while imposing fines that destroy people who fail to meet that standard, is sadistic. Then, taking the land as confiscatory payment, is theft by government become totalitarian and colonizing its own people.

There are other items of the list which surely will be controlled as well. In toto, that little list is the deconstruction of farming itself and given the inclusion of manure, especially of organic farming.]

(4) include, with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;

(5) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;

(6) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and

(7) include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.

(d) Variances- States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c). A request shall–

(1) be in writing;

(2) describe the reasons the variance is necessary;

(3) describe the procedures, processes, and practices that will be followed under the variance to ensure produce is not adulterated; and

(4) contain any other information required by the Administrator.

(e) Approval or Disapproval of Variances- If the Administrator determines after review of a request under subsection (d) that the requested variance provides equivalent protections to those promulgated under subsection (c), the Administrator may approve the request. The Administrator shall deny a request if it is–

(1) not sufficiently detailed to permit a determination;

(2) fails to cite sufficient grounds for allowing a variance; or

(3) does not provide reasonable assurances that the produce will not be adulterated.

(f) Enforcement- The Administrator may coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

(g) Imported Produce- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations to ensure that raw agricultural commodities and minimally processed produce imported into the United States can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to such commodities and produce produced in the United States.

Administrator shall have authority to grant exclusions to foreign producers.

[While it may be obvious to us that this is onerous beyond any capability of coping with it, it needs to be said and described in some detail what it would actually mean for farmers or for us. Here in story form is a taste of it, so anyone could feel the insanity of it:

SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.

(a) In General- The Administrator shall–

(1) develop, administer, and annually update a national food safety program (referred to in this section as the ‘program’) to protect public health; and

(2) ensure that persons who produce, process, or distribute food meet their responsibility to prevent or minimize food safety hazards related to their products.

[This is where I think it would be very helpful if you explained how astoundingly onerous that long list is and what its impact would be on any farmer who previously only needed to load up his goods and bringing them to a farmers market – though that in itself is a time consuming, physically effortful job that often begins pre-dawn on those mornings and ends late in the day, all of it separate from growing the food and boxing it up to bring.

A small farm is not an industry with staff to fill out paperwork, handle licensing, manage all the industrial bureaucracy that is being loaded on here, but is most often a couple who is also taking care of a family in addition to growing crops and raising animals. These are precisely the people who we need most as part of our food system and how will clearly be crushed by the grossly inappropriate application of such rules to small farms.]

· MYTH: H.R. 875 would result in the “death of organic farming.”

FACT: There is no language in the bill that would stop organic farming. The National Organic Program (NOP) is under the jurisdiction of the United States Department of Agriculture (USDA). The Food Safety Modernization Act only addresses food safety issues under the jurisdiction of the Food and Drug Administration (FDA).
[Of course, they are not going to come straight out and say it. But breaking this down to what is actually involved, you find that:]

The administrator is charged with developing minimum standards, not maximum limits on feed, fertilizers, nutrients etc- right here goes organics.

Secondly, this act creates a new agency, and the FDA becomes the Federal Drug and Device Agency. It combines offices currently under FDA and Commerce Department (National Marine Fisheries).

Third, FSA is to cooperate with the USDA in “promulgating rules and orders” which will have the bearing and impact of law.
To refer back to the previous “Myth”

[The one about foreign food having to meet our standard, right?]

– Alaska, Hawaii, US territories and foreign countries may apply for variances, so… NO… Imported foods do NOT necessarily have to meet the same standards. In fact, many countries have had to lower their standards due to WTO rules and trade agreements, and Australia had to further lower their regulatory standards when they instituted the NLIS program (their version of NAIS). There is no reason to think we would not have to do the same.

Walk Index
Second Walk… The End of Organic Farming

[NOW, COMES THE RESPONSE TO WHETHER THE BILLS WILL MEAN THE END OF ORGANIC FARMING.]

I’m going to format this differently to accentuate your points, Sue. This section should be a major education for people in how things have been working. This is in response to the myth that the bills will not affect organic farming, right?]

Animal health has traditionally meant medication and hormones, petroleum-based fly sprays and all sorts of other goodies.

Feed can be anything (GMO SOY OR CORN, ANYONE?),

environment can mean PESTICIDES, HERBICIDES USED ON PASTURES (IF pasturing is deemed “healthy” – internationally this is NOT so for poultry, in fact in many countries there is NO outdoor poultry anymore – by law).

Nutrients are not necessarily whole food based, many are produced SYNTHETICally, and again, PETROLEUM BASED …

Animal encroachment prevention can be anything from a scarecrow or plastic owl to POISON BATES AND BULLETS. Not one of these things is specified, yet there is no place for real public opinion in the decision making process provided. I will grant that there is usually a public comment period for federal register entries, for whatever that has been worth in the past.
[Meaning, it has been worth little to nothing. And obviously, the public is left having to respond ad infinitum to one issue after another. Someone compared the numbers of things being thrown at us to try to stop, to carpet bombing so you can’t comment on everything, even if it helped which is clearly often doesn’t.]

SEC. 206. FOOD PRODUCTION FACILITIES.

(a) AUTHORITIES.—In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to

(1) visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;

(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;

(3) SET GOOD PRACTICE STANDARDS to protect the public and animal health and promote food safety;
[This is where words that sound so friendly and innocuous and even good are code words for international rules set by the WTO that actually define industrial requirements which do not fit real farming in the least, much less organic farming, would be applied.

[This is where insane, anti-nature, anti-farming rules like “animals and crops can’t exist on the same farm” come into play. Where wild animals aren’t ever supposed to be near crops so the government has been poisoning deer and frogs. The list of such manufacturing rules for farming is long, and each very much “efficiency manager comes and wrecks the farm.”]

(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and
[Please, those of you who find the idea of NSA-spying intolerable, look carefully at those words. Now, imagine it were your farm, your home on that farm, and realize that the USDA and FDA have been run by and the new agency will be run by Monsanto, Cargill, Tysons, ADM. Their interest in helping consumers have safer food is nil The bills are meant to eliminate farmers as is now rapidly occurring in the EU with identical (“harmonized”) bills, now law there.

(5) collect and maintain information relevant to public health and farm practices.
[There needs to be a pause here to consider the implications of each of those on someone’s home – their family’s farm. This is quite different from applying them to industrial sites where no one lives, and beyond that, these powers are so broad and vague, they are dangerous if only in that.

Those things listed open the door to total control, warrantless entry and perpetual surveillance. Notice how innocuous they have made it appear, even beneficial – always about public health. Yet, the insincerity of this is boggling – the USDA and Big Ag have worked to prevent inspections to the point where farmers have had to actully sue to get them done , even after offering to pay for them.]

(b) INSPECTION OF RECORDS.—A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner
[Who defines “reasonable”? Does a farmer have to go to court each time there is an “unreasonable” manner and time? How wide open do we push the door to Big Ag-corrupted government control over farmers – the people creating the only safe food?

Look carefully and realize the USDA right now is countenancing state ag departments conducting terrorizing raids on non-corporate farms across the country. Imagine it were your home and USDA agents banging on your door to demand paper work and if you don’t have it, facing fines that would bankrupt you in a moment and lose you your land and home.]

, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator—
[Imagine again.]

(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or
[Be aware that in Pennsylvania where there has been an aggressive effort to destroy fresh milk dairy farmers, the tests by the states repeatedly do not match those of independent testers but the harm to farmers from such false tests and reporting of them is done and can’t be undone. Be aware that the USDA has a record of creating test results damaging to small farmers while it refuses to inspect even when farmers ask to pay.]

(2) to track the food in commerce.
[This could mean farmers bringing food to markets with USDA agents surveilling.]

(c) REGULATIONS.—Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall—
[Everything in this bill is being left to be filled in however the “Food Safety Tsar” – “the Administrator” decides? Right now, to give people pause and to wake them up a bit to how this is not a wise idea but in fact absurd, it appears that person could be Michael Taylor, a Monsanto lawyer infamous for approving rBGH – the first genetically engineered product ever approved – over the objections of doctors, scientists who said the numbers were being rigged, and the public.

How can anyone leave a bill so utterly vague in the hands of anyone to decide later what it all means? Do we not make laws here with specific meaning anymore? Or do we simply let totalitarian rules be applied by industry against non-industrial entities like farms and homes in any way they wish and with immense police power behind what they, for their own interests, decide?]

(1) consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;
[GOODBY RAW MILK.]

(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;

(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, NUTRIENTS, HYGIENE, PACKAGING, TEMPERATURE CONTROLS, ANIMAL ENCROACHMENT, AND WATER;

[GOODBYE ORGANIC FARMING.]

(4) include, with respect to animals raised for food, MINIMUM STANDARDS related to the animal’s HEALTH, FEED AND ENVIRONMENT which bear on the safety of food for human consumption;
[GOODBYE ORGANIC FARMING AND GRASS FED ANIMALS.]

(5) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;
[Oh, heavens, this looks like padding to throw in the word “reasonable” again but it has no explicit meaning whatever and so no safety for a soul.]

(6) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and

[This appears to be where Homeland Security works with the USDA for such things as “depopulation of animals” – for which 6 meetings are already scheduled in June and into which livestock owners are not allowed though foreigners are.

These “depopulation” plans look like what is happening in Asia where animal disease caused by industry (and worth a fortune to the pharmaceutical industry ) are then used by industry to wipe out its competition in heritage breeds of animals on small farms and to substitute genetically engineered animals that are patented by industry and thus owned by industry.

(7) include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.

(d) VARIANCES.—

    States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c)

.
[This is where the “fact” that foreign countries must meet our food safety requirements collapses by simply reading the bill.]

MYTH: The bill would implement a national animal ID system.?

FACT: There is no language in the bill that would implement a national animal ID system. Animal identification issues are under the jurisdiction of the USDA. The Food Safety Modernization Act addresses issues under the jurisdiction of the FDA.

This bill mandates NAIS BY claiming that it is already law,

then contradicts itself by citing COOL, which specifically prohibits mandatory tracking.

It justifies NAIS by claiming that the AHPA gives authority – but this is a bill (and supposedly a program) concerning interstate commerce (though any item of food for sale is “presumed” to be in interstate commerce, whether it is in reality or not.) and AHPA does not regulate interstate commerce.

How many contradictions in a single section do we need before red flags go up?
[YES, AND PUT UP RED FLAGS FOR WHOLE BILLS IF THIS CENTRAL PART IS SO CORRUPTLY BEING PUSHED.]

Below in CAPITALS [fonts altered – Dr. Rima] , Sue answers the absurd claim that NAIS is not mandatory. FWW has gotten this and many other items wrong. That would be fine if the whole organic movement and all our farms and freedom were not riding on our seeing these very real threats and stopping those bills completely – not compromising on them but demanding their complete withdrawal.]

(a) IN GENERAL – THE ADMINISTRATOR, IN ORDER TO PROTECT THE PUBLIC HEALTH, SHALL ESTABLISH A NATIONAL TRACEABILITY SYSTEM THAT ENABLES THE ADMINISTRATOR TO RETRIEVE THE HISTORY, USE AND LOCATION OF AN ARTICLE OF FOOD THROUGH ALL STAGES OF ITSPRODUCTION, PROCESSIN, AND DISTRIBUTION.

(b) APPLICABILITY – TRACEABILITY REQUIREMENTS UNDER THIS SECTION SHALL APPLY TO FOOD FROM FOOD PRODUCTION FACILITIES, FOOD ESTABLISHMENTS, AND FOREIGN FOOD ESTABLISHMENTS.

(c) REQUIREMENTS-

(1) STANDARDS- THE ADMINISTRATOR SHALL ESTABLISH STANDARDS FOR THE TYPE OF INFORMATION, FORMAT, AND TIMEFRAME FOR FOOD PRODUCTION FACILTITIES AND FOOD ESTABLISHMENTS TO SUBMIT RECORDS TO AID THE ADMINISTRATOR IN EFFECTIVELY RETRIEVING THE HISTORY, USE AND LOCATION OF AN ITEM OF FOOD.

(2) RULE OF CONSTRUCTION- Nothing in this section shall be construed as requiring the Administrator to prescribe a specific technology for the maintenance of records or labeling of food to carry out the requirements of this section.

(3) AVAILABILITY OF RECORDS FOR INSPECTION- Any records that are required by the Administrator under this section shall be available for inspection by the Administrator upon oral or written request.

(4) DEMONSTRATION OF ABILITY- The Administrator, during any inspection, may require a food establishment to demonstrate its ability to trace an item of food and submit the information in the format and time frame required under paragraph (1).

(d) Relationship to Other Requirements-

(1) CONSISTENCY WITH EXISTING STATUTES AND REGULATIONS- To the extent possible, the Administrator should establish the national traceability system under this section to be consistent with existing statutes and regulations that require recordkeeping or labeling for identifying the origin or history of food or food animals.

[Does this mean consistent with international laws under the WTO? Is this a means of locking everything together into Smart Grid or NAFTA or CAFTA or GATT and even, the worst of all,

    CODEX

?]

(2) EXISTING LAWS- For purposes of this subsection, the Administrator should review the following:

(A) Country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).

(B) The Perishable Agricultural Commodities Act of 1930 (7 U.S.C. 499a-t).

(C) Country of origin labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).

(D) The National Animal Identification System as authorized by the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.).

EC. 210. TRACEBACK REQUIREMENTS.

MYTH: The bill is supported by the large agribusiness industry.?

FACT: No large agribusiness companies have expressed support for this bill.

This bill is being supported by several Members of Congress who have strong progressive records on issues involving farmers markets, organic farming, and locally-grown foods.

[Who almost certainly have not read the bills or can’t interpret how it will work to destroy farmers, organic food, seed banking, and all of us.]

Also, H.R. 875 is the only food safety legislation that has been supported by all the major consumer and food safety groups, including:

[Perhaps others know details on each organization and why they might be supporting a bill that is so threatening to real food safety and to the survival of our farms and organic farming.]

?– Center for Foodborne Illness Research & Prevention

?– Center for Science in the Public Interest

?– Consumer Federation of America

The Consumer Federation of America (CFA) is a long-standing consumer organization based in Washington, DC. However, it has accepted funding from the ROCKEFELLER FOUNDATION to “develop an optimum regulatory regime” for genetically engineered food.

?– Consumers Union?– Food & Water Watch

[Food and Water Watch just put out a description of the bill in which it is apparent they do not understand what is in it and what it will do. With that as their starting point, they support it.]

?– The Pew Charitable Trusts

[They are also connected to the ROCKEFELLER FOUNDATION, and involved with them in mandatory vaccinations programs around the world and issues of reducing population.]

?– Safe Tables Our Priority ?– Trust for America’s Health

[There is no list here of groups opposing this bill, which include the people whose lives are most at risk from it and who know its dangers the best and who should have been the first people consulted. Instead, they have been shut out and when they have tried to report extreme dangers, they have ignored, dismissed, marginalized. Perhaps the other organizations listed here are as unfamiliar with the bill’s contents and ramifications as FWW.]

If you consider that not only is Rosa DeLauro married to Stanley Greenberg, who boasts Monsanto as one of his clients, but also that she receives the largest donations from agribusiness PAC’s of just about anyone in Congress, does industry NEED to come out and say they support this particular bill? If cash to the sponsor doesn’t count, and if formal positions supporting various specific aspects of the bill do not count, then what does? Would there not be massive public backlash against it if industry DID take a formal stand on every bill they want to see passed?

By the same token, I’ve not seen a single industrial ag company come out and oppose this bill, either. They have all been conspicuously silent. I seem to remember that they threw up quite a fuss over COOL, and caused enforcement to fall behind by more than 7 years… Not to mention the garbage with loopholes we’ve had to deal with since enforcement began. (What good does a “Canada, US, Mexico” label do for anybody? Especially with BSE in Canada and TB coming in daily from Mexico?) Where’s the hoot and holler over this?

MYTH: The bill will pass the Congress next week without amendments or debate.?

FACT: Food safety legislation has yet to be considered by any Congressional committee.?

I can’t speak to the time frame. [Note from NSF: our sources “on the Hill” told us they believed these bills had been “fast tracked” to be passed during President Obama’s “First 100 Days”]

[It came from those who first discovered the bills were there, inserted only one week after Vilsack had said the USDA wasn’t even considering centralizing the FDA and USDA at this time, so people saw how similar the bills were, knew who fast other things were being shoved through Congress without even reading those bills, and estimated how fast this could happen.

Perhaps with people alerted now, these bogus “food safety” bills can be stopped by the organic community once it realizes they will utterly destroy it.]

However, since I did have the luxury of listening to the farce taking place on the floor of the House of Representatives on March 11 concerning HR1105 (which FUNDS NAIS among its hundreds of other projects) while awaiting the Livestock, Dairy and Poultry subcommittee hearing on NAIS – I have no doubt that this bill will move quickly now that 1105 has passed and since it has so many co-sponsors.

Especially since the Representatives were honest enough to admit that though the Senators claimed everybill in the Omnibus Act had been heard and passed in the previous session, when in actuality, some 100 of the 170 bills in the package had NOT.

But this is my personal opinion.

The “ominous Omnibus Act” as several Representatives called it, went from introduction to the President in less than 13 working days.

I really have to question just who’s side those groups are really on that are in support of this bill…..

And finally,

Walk Index
Third Walk… Meaning of the Bills

WHAT THE NEW “FOOD SAFETY” BILLS MEAN TO YOU
by Gail Combs

Our food safety system was trashed in 1995 by Sec of Ag Ann Veneman (Board member of Monsanto). She appointed Dan Amstutz (VP of Cargill) who wrote the World Trade Organization Agreement on Agriculture (WTO AoA). Unlike GATT, WTO has major clout from trade sanctions and control of 90% of the international trade. http://www.publiceyeonscience.ch/images/the_wto_and_the_politics_of_gmo.doc

“Aims to ensure that governments do not use quarantine and food safety requirements as Unjustified trade barriers.. It provides Member countries with a right to implement traceability {NAIS} as an SPS measure.” WTO

In other words the WTO did away with “quarantine and food safety requirements” that gave us “the safest food in the world” and is graciously going to allow Farmers to track AND COUNT the world’s livestock for them instead. Now HR 875 and an FDA release indicate All food will be tracked and all food producers will have Food inspections and the threat of fines up to $1,000,000 a day will eliminate all the independent farms that have acted as a check on Corporate AG.

The FDA wants

to implement a more effective trace-back process, using technologies to rapidly and precisely track the origin and destination of contaminated foods, feed and ingredients

Nanotech in Food can make it happen “California’s Oxonica makes Nanobarcodes from nano-particles that contain silver and gold stripes varying in width, length and amount, such that billions of combinations can be created to tag individual products. The barcodes have been primarily used to assure brand and authenticity in pharmaceuticals, but applications could be forthcoming in tracing food batches”.

In regard to pets:

HR 875 uses “animals” and then “animals raised for food” and there are no exclusions. The Animal Welfare Act had exclusions for livestock, pets and people raising three or less litters of puppies a year. Therefore pets are not excluded.

“set good practice standards to protect the public and animal health and promote food safety”

“conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate”

“with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;

In regard to gardens:

The Feds Already have plans for controlling food “FROM FARM TO FORK” including home preparation since September of 1995 (WTO ratified in 1995)
HR 875

“require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;”

“include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water”

“include, with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;”

“set good practice standards to protect the public and animal health and promote food safety”

“..facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.”

Notice it does not say a person SELLING food, it says a person holds, stores, or transports food or food ingredients. The bill specifically states it covers commerce with in state but again there is no exclusion for food raised for home use. The fact you are growing veggies for your and friends and not selling them does not exclude you.

“in any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction SHALL BE PRESUMED TO EXIST.”

Under Ag Sec. Veneman …

in September, 1995, the USDA’s Food Safety & Inspection Service presented a 600-page document “Farm-To-Table” intended to control of every step in the food chain from production to home preparation.
This is a real life example of what has already occurred and what people may have in store:

Today a state Ag inspector and two county officials show up and scare the bee-jesus out of me. First they accuse me of selling products and milk, then explain that even “giving milk products away” is illegal in California. Now everything is pasteurized, but it is illegal to share milk products in any form! They explained it was even ILLEGAL to give it to my own children if they did not live under my roof! I can’t even take a lasagna dish to my grown sons home without risk of being fined, arrested and or jailed! This is OUTRAGEOUS!!!!…..” Donna Tue Aug 12, 2008 http://finance.groups.yahoo.com/group/Americans_Against_NAIS/message/26452

More stories on Feds raiding farms and co-ops

Walk Index
Last Walk… Conclusion

The related package of “food safety” bills are totalitarian. There are no two ways about it.

They allow government warrantless intrusion into and extreme, detailed, surveilled control over every aspect of farmers’ land and home, straight-jacketing them into a bureaucratic nightmare which precludes their even functioning as farmers. And yet for real food safety and for food security, it is exactly farmers we need.

We need the real food they produce and the farmland they spare and protect from industrialization and the heritage animals and seeds they raise and their knowledge about nature and animals, and we need the way of life they represent. Free. How interesting that to have real and clean and wholesome food, it requires that farmers have freedom.

These bills which claim to be about “food safety” but are proven in the EU already to be about the destruction of farmers, are so frighteningly broad, they allow the government to take over our lives, too. They allow the government to use rules written by multinational corporations within the WTO, to control whether we can garden or how, whether we chip our pets, even what happens inside our homes in our kitchens.

These controls all all for mandating things that make money for corporations just as we are all trying to get off the corporate grid of power, fuel, food, … Now it is easy to appreciate people’ resistance to mandated vaccines (and they keep adding more kinds).

There is point at which we must say stop. Our lives are our own, our property is our own, our decisions on what to eat and how to heal ourselves are our own. We must protect our own freedom and now it is apparent how intimately tied it is those who have been providing for us for ever – our farmers.

HR 875, SR 425, HR 814, HR 759 and all related bills must be withdrawn immediately and then trashed.
http://www.opednews.com/articles/A-solemn-walk-through-HR-8-by-Linn-Cohen-Cole-090314-67.html

Walk Index

Index ———————————-

Further information linking Codex Alimentarius (the World Food Code) and the (sic) Food (sic) Safety bills, see:

A Natural Solutions Foundation White Paper
Regarding U.S. Codex Office and Food Safety and Inspection Service (FSIS) for
Adoption of Codex Committee Policies by the U.S. Codex Delegation and FSIS
in Harmony with the Dietary Substances Health and Education Act (DSHEA),
19 USC 3512 (the Anti-Harmonization Statute) and other Statutory and Case Law

http://drrimatruthreports.com/?p=2394

Categories : About Codex Alimentarius, Blog / Vlog, CODEX Consequences, CODEX Industries, Disinformation, Divest Governement of Food Regulation, Food Crisis, GMOs, Legislation to Oppose, Organics, The Law & CODEX
Tags : Big Pharma, Codex, Codex Alimentarius, Dr. Rima, Farm to Fork, food, Food Fascism, Food Safety, Food Security, H 875, Health, health freedom, HR 875, HR 875 S 425, Natural Solutions Foundation, NSF, Rima E. Laibow MD, S 425

GMO Files: GMO Drugs Carry More Dangers than Chemical Ones

By Administrator on March 7, 2009 No Comments

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: http://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: http://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

Categories : Blog / Vlog, Disinformation, Divest Governement of Food Regulation, GMOs, Medical Hazards, Miscellaneous
Tags : Big Pharma, Biological Dangers, Biologicals, Divest the FDA, Divest USDA, Dr. Rima, Drug Recall, FDA, FDA Corruption, health freedom, JAMA, Journal of the American Medical Association, Natural Medicine, Natural Solutions Foundation, NSF, Pharmaceutical Dangers, Rima E. Laibow MD

Vaccine Files: Corrupt Journal Articles Help Determine Court Outcomes

By Administrator on March 6, 2009 No Comments

Barbara Loe Fisher is a tireless advocate of both vaccine truth and choice and the Natural Solutions Foundation nominates her for our Hall of Fame. Barbara continues to examine carefully the vaccine industry, its products and its corruption. Her site, www.NVIC.org, is a mine of information and assistance on vaccine and vaccination issues. She is an ally and a resource of great value.

Barbara’s latest commentary on the corrupt – and corrupting – vaccine industry is a very important read.
In it she points out that vaccine safety and effectiveness have not been demonstrated by the studies published about them even in prestige journals. Those studies are of poor quality and show little that can be relied upon scientifically, but are, none the less, used as the evidence relied upon by vaccine courts to determine whether vaccines have harmed or killed anyone.

The Natural Solutions Foundation has filed a Citizens Petition with the Federal Trade Commission demanding hearings on whether vaccines are safe and/or effective and asking for a ban on any advertising or materials which suggest that they are either safe, effective or both until that fact is established.

And click here (http://drrimatruthreports.com/?p=2220) to read the latest news on the “accidental” Baxter International contamination scandal in which live, virulent Avian Flu H5N1 virus was somehow mixed with seasonal flu vaccine shipped to 18 countries. This mixture would allow re-assortment or mutation of the Avian Flu virus which currently is very ineffective in causing human disease. Such alteration of the virus could potentially allow it to become as deadly as the Avian Flu has been predicted to be when it causes the next “inevitable” pandemic. Of course, if it is mixed in with other flu viruses and injected “by accident”, the next pandemic really IS inevitable.

Please share this information as widely as possible, and make a tax deductible donation (http://drrimatruthreports.com/?page_id=189) as generously as possible so that the Natural Solutions Foundation can continue to bring you vitally important information and fight for your health and freedom.

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


Vaccine Studies: Under the Influence of Pharma

Barbara Loe Fisher

If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout.
It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn’t get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection.
It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC’s policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.

How Big Pharma Influences Medical Journals
A recent study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.
This analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety.
The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D. who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade, by both Pharma-funded special interest groups, as well as public health officials maintaining close relationships with vaccine manufacturers.

Study Finds No Correlation Between Quality of Study and Publication
This recent review identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles.
The researchers also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.
The authors commented: “The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding”.

The HPV Vaccine — Just One Example of Inappropriate Influence Endangering Public Health
Last month the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates.
In 2006, Merck’s Gardasil vaccine was fast tracked by the FDA at Merck’s request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.
The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.

Massive Increase in Number of Vaccines Given
In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six.
Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.
In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.
Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective — evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children — then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.

Government Vaccine Recommendations Based on Tainted Evidence
The U.S. Court of Claims vaccine injury compensation awards, and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.
Kudos to the British Medical Journal for having the integrity to publish Dr. Jefferson’s comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S.
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Categories : Activism, Blog / Vlog, Citizen's Petition, Disinformation, Hall of Fame, Medical Hazards, Miscellaneous, Vaccination
Tags : Accidental Contamination, Barbara Loe Fisher, Baxter, Baxter International, Citizen's Petition, Corrupt Medical Journals, Dr. Rima, Federal Trade Commission, FTC, Hall of Fame, health freedom, Natural Solutions Foundation, NSF, Pandemic, Pharmaceutical Corruption, Rima E. Laibow MD, Seasonal Flu, Vaccination, Vaccine Injury Court

GMO Files: Monsanto’s Rural Cleansing: Hall of Shame

By Administrator on February 18, 2009 No Comments

Think GMOs don’t impact you because you grow 100% of your own food in a closed environment greenhouse to control all pollination? Think again. If you live in the US, your world is being reshaped in the image of Monsanto. If you don’t like that image, get your head out of the sand in your greenhouse and get busy defending both the American value system and your food, along with your society, from this malign influence.
And, if you tend to think that the Federal Government won’t let this happen, recall that Secretary of Agriculture Vilsek is a Monsanto man.
This kind of atrocity is just fine with the GMO-friendly Federal Government which clearly cannot be trusted to regulate our food. It is imperative to divest the FDA and USDA of their food regulatory responsibilities and get food regulation back into the hands of those of us who eat the food, at the State level. Click here, http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405, to tell Congress to get the Federal Government out of our pantries and off our dinner plates before these agencies do even more harm.
So get involved now.
Sign up for the Natural Solutions Foundation Health Freedom Action eAlerts, http://drrimatruthreports.com/?page_id=187, and ride the Freedom Mouse hard.

And remember these battles against Big Pharma and Big Biotech cost money. Make your tax deductible donation to the Natural Solutions Foundation by clicking here,http://drrimatruthreports.com/?page_id=189 . Do it now. Time is short and the enemy is large.

Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.NaturalSolutionsFoundation.org
www.ValleyoftheMoonCoffee.org
www.GlobalHealthFreedom.org
www.Organics4U.org www.NaturalSolutionsMarketPlace.org”>www.Organics4U.org
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Monsanto Investigator in Illinois Laughs They Are Doing ‘Rural Cleansing’
by Linn Cohen-Cole
www.opednews.com

As of last night, a US marshal, 2 state police and a county police are all over Mr. Hixon’s area, serving notices to farmers that they are being sued by Monsanto. They arrive in pairs, with two cars parked a quarter mile and half mile down the road. They’ve served 3 so far and said “a bunch more are coming.” No telling how many will be served since Hixon has between 200-400 farmers he cleans seeds for and these farmers have been repeatedly threatened by Monsanto thugs for the last two months, getting “visits,” letters, and calls daily.

Farmers report that a Monsanto investigator laughed that they were doing “rural cleansing.”

Steve Hixon is a seed cleaner in southern Illinois. He has equipment that takes the plant materials and “cleans” it so that the seeds are separated out and can be given back to farmers to save for the next season. It’s a mechanized step up from farmers hand picking seeds off their own plants, which, with hundreds of acres – or even 10 – would not be easy to do.

Mr. Hixon has the non-distinction of being attacked by Monsanto. He is far from alone. Monsanto has been picking off seed cleaners across the Midwest, having already done its thuggish thing in Pilot Grove, Missouri, and in Indiana, attacking Maurice Parr, destroying business for all of them.

Mr. Parr reports that when he was sued, the first think out of the judge said was how “honored to have a fine company like Monsanto in my courtroom.”

“Shortly after someone broke into Mr. Hixon’s office and he found his account book on his truck seat where he would never have left it, evey one of his remotely located and very scattered customers had three men (described as goons with “no necks”) arrived at each farm, going out onto it without permission … Mr. Hixon and state police who were called in, believe a GPS tracking device may have been put on Mr. Hixon’s equipment.” Click here.

In 2002, when Mr. Hixon was at the state legislature for a meeting, he said he told a Monsanto representative there, “If you guys wnt to tak over the seed industry so bad, you ought to buy guys like me out.” The Monsanto agent is supposed to have responded “We’d rather put you out of business, it’s more fun that way.”

Mr. Hixon says that when he is cleaning seeds, he is pouring $13,000 a hour into the local economy, which right now is being hit. A fence company has gone out of business and other businesses are in trouble. And in using seeds that have been cleaned, those seeds have carbon footprint, by Mr. Hixon’s figures, less than a fraction of 1% of that of GMO seeds delivered over 1000s of miles at 5 miles a gallon that semis require to run.

But Monsanto’s GM-soy and other seeds have a much heavier carbon footprint that the absurd transport of seed across the country by semis. Petroleum-based pesticides are the essence of genetic engineering, and Monsanto has a poorly known history of their relation to warfare.

“Huge excesses of nitrogenous compounds that accumulated during World War I provided the basis for the beginnings of the mass production of synthetic nitrate fertilizers. DuPont — now the sole owner of the world’s largest seed company, Pioneer HiBred — was the largest manufacturer of gunpowder in the United States during the early 19th century and the first World War. Monsanto increased its profits 100 fold during the World War, from $80,000 to well over $9 million per year, supplying the chemical precursors for high explosives such as TNT.

“In the 1930s, chemists working for the German company Bayer discovered the highly poisonous properties of organophosphate compounds. …. As all of German industry became absorbed into the growing Nazi war machine, Bayer’s organophosphate compounds were developed simultaneously as agricultural pesticides and as nerve gases for military use. These included such notorious chemical warfare agents as sarin, soman and tabun gases, all of which are still manufactured today. …

“In the 1930s, scientists at the Swiss J. R. Geigy Company were searching for new compounds to disinfect seeds and prevent moths from feeding on wool. … These researchers’ key discovery was that DDT … could accomplish both of their desired ends and more. … DDT was seen as the “atom bomb of insecticides,” capable of permanently eliminating various pest species.

“After World War II, DDT became the most widely applied chemical in human history …. The widespread use of DDT — for both agricultural and household uses — led to a dramatic shift in the chemical industry’s approach to pest control … was in many ways a direct outgrowth of its wartime origins. …

“During the 1960s, Monsanto was a leading manufacturer of the herbicide ‘Agent Orange,’ which was used by U.S. military forces to obliterate the dense jungles of Vietnam. Today Monsanto’s Roundup-family herbicides play a central role in the U.S. “drug war” via its widespread use to eradicate coca and poppy plants in Colombia and other countries….”

The shift to genetically engineered food seems a welcome change from such a history. But it appears there has been no change, only a more thorough and disguises means of ensuring its sales.

“Of all of Monsanto, DuPont and Dow’s agricultural products, genetically engineered food crops might appear to be the least tainted with immediate wartime origins. But this technology emerged from a period when the future of chemical agriculture appeared very much in doubt. With the rapid expansion of the agrochemical industry during the post-World War II era, these companies and their European counterparts had established a profound degree of control over agricultural practices. But as public pressure and the weight of scientific evidence curtailed the use of DDT and many other chlorinated pesticides in the 1970s, executives and corporate scientists saw the potential for limitless advances — and ever-expanding marketing potential — in the incorporation of technological advances into the genetics of seeds. During the 1990s, Monsanto alone spent nearly $8 billion acquiring leading commercial seed suppliers in the United States and internationally; DuPont and others quickly followed suit, leading to today’s widespread proliferation of genetically engineered food crops.” Click here.

Today, in Illinois, our federal agents and police, working on behalf of Monsanto, are terrorizing … whom? Drug dealers? Financiers who have stolen this country blind? The people who took us to war based on lies and have profited while thousands of American and 100s of thousands of Iraqi have died? No. Our tax dollars are being used to turn our marshals and police into Monsanto agents to terrorize our disappearing farmers.

Terror is palpable in rural America. It defines American farming communities now.

Monsanto, with its history of warfare and creating chemicals to “cleanse” both enemies and agricultural pests of any area desired, appears to bring this power and method of thinking to all it touches.

“Rural cleansing” is its stated goal, and our farmers the pests to be eliminated.

Where is the Illinois ACLU? Where is Amnesty?

Categories : Activism, Blog / Vlog, Divest Governement of Food Regulation, Food Crisis, Get Involved, GMOs, Medical Hazards
Tags : Dr. Rima, GMOs, Monsanto, Natural Solutions Foundation, NSF, Rima E. Laibow MD, Rural Cleansing

FDA Files: HHS Inspector General Finds FDA Scientists/Science Riddled with Conflict of Interest

By Administrator on February 18, 2009 No Comments

Click here (http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405) to tell Congress to divest the corrupt and inefficient FDA and USDA of their food regulatory responsibilities before they kill more of us!
In the last in a long, long string of documented failures, shortcomings and tragic errors by the FDA, a recent report documents that the FDA is not only prejudiced and biased, but so riddled with conflits of interest, now not even considered a problem at the failed agency, that there is no way to trust the honesty or accuracy of the decisions of the agency.
While this study looks at one aspect of the impact on drug regulation, food regulation is the same, only worse.
There, the same problems apply, along with the intentional down-regulation of food to support the pharmaceutical markets which profit from the poor drugs approved by the drug regulatory side of the FDA house since degraded food makes people sicker quicker, and makes the profit picture derived from the drugs to treat those illnesses stronger longer.

The picture is a dismal one but there is at least one solution: divest the FDA (and its equally corrupt partner in food crime, the USDA) of all food responsibilities. Rather than creating an new agency, as is currently being discussed by Congress, which will not deal with the fundamental issues and their deadly consequences, the answer, be believe, is to divest the Federal Government of all food regulatory responsibility and instead turn those responsibilities over to the unit of government which the people can impact: State governments.

This is an urgently important concept and must be enacted, even as numerous States are asserting their soverignty from the corrupt and dangerous United States.

Please support the Natural Solutions Foundation in its efforts to make food save once again, protecting food and freedom.

You can donate to the Natural Solutions Foundation at http://drrimatruthreports.com/?page_id=189. All US donations are tax deductible.
Spread the word and ask everyone you know to join the Health Freedom eAlerts, http://drrimatruthreports.com/?page_id=187, for up to the minute information and Action Items.

Please take a moment to help us Divest the US Government of its food regulatory responsibilities here http://salsa.democracyinaction.org/o/568/t/112/campaign.jsp?campaign_KEY=26405 and then spread the word!

Yours in health and freedom,
Dr. Rima
Rima E. Laibow, MD
Medical Director
Natural Solutions Foundation
www.HealthFreedomUSA.org
www.NaturalSolutionsFoundation.org
www.ValleyoftheMoonCoffee.org
www.GlobalHealthFreedom.org
www.Organics4U.org www.NaturalSolutionsMarketPlace.org”>www.Organics4U.org
www.NaturalSolutionsMarketPlace.org

FDA Not Effectively Monitoring Investigator Conflicts of Interest, HHS Watchdog Says

Neil Osterweil
Information from Industry
Assess clinically focused product information on Medscape.
Click Here for Product Infosites – Information from Industry.

January 16, 2009 — More than one third of new drug marketing applications approved by the US Food and Drug Administration (FDA) were missing information about potential conflicts of interest for clinical trial investigators, which could allow bias to creep into the approvals process, a government report released this week has found. The FDA has said that it agrees with most of the report’s findings.

Federal regulations require clinical trial sponsors to collect financial information from investigators at the outset of trials, and to report on their efforts to minimize the possibility that financial self-interest could color trial results, notes the report from the office of Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS).

Trial sponsors — usually the company developing or licensing the drug or device in question — only have to disclose this information when they apply for marketing approval, and even then there’s a loophole: they can claim that they “acted with due diligence” to collect financial information from each investigator to satisfy regulations.

Report Found Few Financial Disclosures

Yet 42% of new drug marketing applications filed in fiscal year 2007 were short on investigator financial disclosures, and in fully one fifth of cases where such information was disclosed, FDA reviewers took no action, the watchdogs reported.

“In FY 2007, only 1% of clinical investigators disclosed a financial interest,” the report’s authors write. “By way of comparison, the Journal of the American Medical Association reported that between 23% and 28% of academic researchers had financial interests in medical companies. Further, we found a number of limitations in FDA’s oversight, leaving FDA unable to determine whether sponsors submit financial information for all clinical investigators.”

In addition, the HHS inspector general’s staff found that FDA can’t verify whether relevant information has been collected on all investigators because of incomplete data and the lack of on-site verification procedures.

Collection and review of such information should be routine, as should appropriate action when required, and all of it should occur before a trial ever gets off the ground, contends a former FDA reviewer interviewed by Medscape Medical News.

“You want to intervene at a time when there’s an ability to do something about it,” said John H. Powers III, MD, now an assistant clinical professor of medicine at the George Washington University (GWU) and University of Maryland Schools of Medicine.

“To have a situation where the sponsor has already done the trial, submits the information, and then the FDA says ‘you have conflicts of interest with your investigators,’ puts the sponsor in a bad spot, the investigator in a bad spot, and it puts the FDA in a bad spot. It seems to me that if you’re going to regulate here that you should do it a proactive manner,” he said.

“Management Failure”

Federal regulations concerning drug marketing approvals require that “adequate measures are taken to minimize bias on the parts of the subject, observers, and analysts of the data,” Dr. Powers noted, yet one of the most common sources of potential bias — investigator relationships with industry — are overlooked or ignored.

“This is a management failure,” said David B. Ross, MD, PhD, a former FDA reviewer who is now a clinical assistant professor at GWU. “The managers who have set this policy have done nothing to enforce it and there are no consequences, and the reason is that nobody thinks it matters; they’re kind of doing this for show.”

When Dr. Ross was at the FDA, he and other reviewers warned agency management that a study used to support approval of the antibiotic telithromycin (Ketek, sanofi aventis) was marred by per-patient payments to investigators of up to $400, and, in at least one case, by fraud on the part of the investigator who enrolled the most patients (she was later sentenced to 57 months in federal prison), and by “serious violations in trial conduct” in 9 other trial sites, leading to 4 referrals for criminal investigation.

Despite the warning, and despite ongoing concerns about reported hepatotoxicity from the drug, FDA management failed to take substantive action in response to reviewer concerns, a failure that Dr. Ross said is emblematic of the agency’s apparent indifference to the possible influence of investigator financial relationships with industry.

“…CDER [the Center for Drug Evaluation and Research] is not doing that good of a job, and with what they do track, what are they doing with it? It’s like having laws against speeding and not writing any tickets,” Dr. Ross said.

Relationships Can Have Profound Effect

Eric G. Campbell, PhD, an associate professor at the Institute for Health Policy and the Department of Medicine at Massachusetts General Hospital and Harvard Medical School in Boston, said that financial considerations — whether honoraria, consulting fees, stock options, or direct payments — can have a profound effect on which trials get published or promoted.

“The important thing to remember is that relationships with industry — they may not always be conflicts — are ubiquitous in all aspects of medicine, medical research, and medical regulatory affairs,” Dr. Campbell said. “If a study is funded by a drug company to investigate its product and if the investigator also has relationships with that company, you can be darn sure that if the study makes it to publication, it’s going to favor that product,” he said.

Like Dr. Ross and Dr. Powers, Dr. Campbell pointed out that lax or absent regulatory oversight implies a lack of concern and a tacit acknowledgment of a lack of enforcement of existing rules.

“The bottom line is that if you don’t report stuff and nobody pays attention to whether it’s reported or not, you’re just signaling that it’s not important and that nobody cares, and clearly that’s the message that FDA is sending out,” he told Medscape Medical News.

Key Findings

The report, prepared by staff from the Chicago regional Office of Evaluations and Inspections in the HHS Inspector General’s Office, was based on reviews of financial forms, attachments, and accompanying FDA review notes for all 118 marketing applications approved by the agency in fiscal year 2007. The watchdogs also reviewed FDA regulations and guidance, conducted structured interviews with FDA officials, and surveyed FDA reviewers.

The key findings were:

* 1% of clinical investigators (206 of 29,691) disclosed a financial interest.
* FDA does not have a complete list of clinical investigators and does not use on-site inspections to confirm that submitted financial information is complete, meaning that reviewers cannot determine whether sponsors have submitted financial information for all clinical investigators
* 42% of FDA-approved marketing applications were missing financial information, 23% of approved marketing applications were missing a certification or disclosure form or required attachments, and in 28% of applications, sponsors used the due-diligence exemption to indicate that they were unable to provide complete financial information.
* FDA did not document a review of any financial information for 31% of marketing applications. Reviewers who followed a review template were more likely to include financial information than those who did not.
* In 20% of applications with disclosed financial conflicts, neither the FDA nor sponsors took action.

The Inspector General’s recommendations for the FDA were as follows:

* Ensure that sponsors submit complete financial information for all clinical investigators.
* Use a complete list of clinical investigators to check that sponsors have submitted financial information for all.
* Require that sponsors submit financial information for clinical investigators as part of the pretrial application process.
* Check that sponsors have submitted all required attachments to financial forms.
* Update guidance to sponsors regarding the due-diligence exemption.
* Add a review of financial information to the on-site inspection protocol.
* Ensure that reviewers consistently review financial information and take action in response to disclosed financial interests.
* Require that all centers consistently use a template that includes a prompt to document a review of financial information.
* Provide additional guidance and training to reviewers.

FDA Replies

In response to a request from Medscape Medical News for comment, FDA spokesperson Karen Riley sent a statement noting that the agency agreed with all of the HHS recommendations except the one stating that the FDA should request information from clinical investigators prior to trial initiation.

“The intent of clinical investigator financial disclosure is not to discourage investigators from being included in the study,” the FDA response says. “Rather, it allows sponsors to identify and manage potential conflicts throughout the development of a regulated product, from design through the conduct of the clinical trials.”

The statement goes on to say that this recommendation for financial disclosures before trial initiation could needlessly add to “the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of the data.”

This pretrial disclosure recommendation is not meant to be punitive or burdensome, Dr. Powers said, but it recognizes the fact that bias, whether intended or not, can slip into the process whenever money is involved.

“When people bristle at regulations, I always think of James Madison’s quote,” he remarked. “Madison said that ‘If all men were angels, no government would be necessary.’ The reasons why we do these things is not because everybody is inconsistent or immoral: it’s because some people are. It seems onerous to people who have no intention of doing the wrong thing, but unfortunately these rules are written for people who aren’t going to do the right thing.”
http://www.medscape.com/viewarticle/586980?sssdmh=dm1.423642&src=nldne

Categories : Activism, Blog / Vlog, Divest Governement of Food Regulation, Get Involved
Tags : Conflict of Interest, Corruption FDA, Divest FDA, Dr. Rima, FDA, food, Freedom, health freedom, HealthFreedomUSA.org, Natural Solutions Foundation, NSF, Rima E. Laibow MD
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