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Category: FDA

By Byron J. Richards, CCN (originally from NewsWithViews.com)
December 11, 2006

Part I

Benjamin Franklin and Thomas Jefferson not only rolled over in their graves, they had a stake driven through their coffins by the departing 109th Congress. Big Pharma is now fully in charge of the FDA. Therapeutic nutrition is now marked for elimination from the free market. How did this happen? What does it all mean? Why did the House Democrats, at 3:06 A.M., while Americans slept, stab our people in the back? It is an ominous sign of things to come.

As the lame duck session drew to a close, it became clear that the Republican’s scorched-earth policy was intended to make it difficult for the Democrats to get anything done next year. They are hoping to regain voter confidence by making Democrats look even worse than the Republican’s near-total ineptitude, which is not a very tall order.

However, the Republicans and Democrats were able to agree on several key points regarding your health: health options for Americans should be curtailed and the American public should be subjected to massive drug experimentation. Thus, with little fanfare or reporting by the general media, the Destroy Effective Supplements and Poison Americans with Biotech Drugs Innovation Act of 2006 (S.666 and HR.1832), was passed in the middle of the night, just as the lame duck session came to a close.

Americans seem almost numb to the fact that Big Pharma kills several thousand of us every week. Kudos to the 109th Congress, those numbers will now dramatically rise.

Big Pharma Now Runs the FDA

Yes, the fox is now officially in charge of the henhouse. Over the objection of a small handful of Senators Big Pharma couldn’t buy, Andrew von Eschenbach, M.D, was confirmed to head the FDA. His clearly stated agenda is, and always has been, speeding new and dangerous drugs onto the market with little testing for safety or effectiveness. Von Eschenbach would like to turn every doctor’s office in America into a large clinical trial run by an FDA supercomputer, he would like a computer chip in your arm, and your DNA in his supercomputer – and if you don’t comply you soon won’t get medical services (read Fight for Your Health: Exposing the FDA’s Betrayal of America). The experiment, known as the Critical Path Initiative, is now full steam ahead! Of course, when Americans are injured and killed, von Eschenbach is pushing heavily to make sure no one can sue for damages.

Andrew von Eschenbach is up to his eyeballs in Big Pharma connections. As director of the National Cancer Institute he perverted billions of taxpayer dollars away from solid science on desperately needed cancer research and into the coffers of his biotech and pharmaceutical pals, collectively known as C-Change. Now, he actually wants to turn part of the FDA into a drug company and even has a name for it, the Reagan-Udahl Center for Biomedical Research. Big Pharma co-sponsors, Senator Edward Kennedy (D-MA) and Mike Enzi (R-MT), are attempting to fund his new FDA drug company with taxpayer money, which could easily be funneled through the National Cancer Institute, into the hands of his C-Change friends, and then used to pay for FDA drug approvals (S.3807). In other words, the American taxpayer will soon be slated to pay for the development of all these new biotech drugs, and then pay exorbitant drug prices for the “privilege” of being part of a human experiment.

As temporary head of the FDA, von Eschenbach proved he could adeptly cover for drug companies, even when they blatantly lied to the FDA! Such was the case with Trasylol, the Bayer heart bypass drug that needlessly kills and causes permanent kidney damage, which, thanks to von Eschenbach, is still on the market injuring Americans this holiday season.

Senator Charles Grassley (R-IA) was hot and heavy on the von Eschenbach protection agenda for Big Pharma and had placed a hold on his nomination over von Eschenbach’s flagrant violations of law and the FDA’s cover-up of fraud relating to the Ketek antibiotic. Von Eschenbach’s utter disdain of Congressional oversight should be a major concern to all Americans. On December 7, 2006, this is what Grassley had to say:

People ought to be ashamed of saying Dr. Andrew von Eschenbach has done a superb job in the position he is currently occupying [acting head of the FDA].…That is an insult….In my interactions with the Department of Health and Human Services and the FDA these last 8 months, I have seen a complete and utter disrespect for congressional authority and hence the law.…In Cedar Rapids, IA, I have a family that lost an 18-year-old because of a drug [Ketek] that was on the market then and which is not on the market now….It seems to me that if you are concerned about the safety of drugs, this information is important, and if you are going to have it covered up in the FDA, you aren't protecting the public.…This body [the Senate] should not walk hand in hand with the executive branch and sit idly by as instances of abuse and fraud continue to endanger the health and safety of American people.

Following these frank and chilling statements of fact, the opinions of Orrin Hatch (R-UT) were put forth to quell the concerns just raised:

To me it is simply unconscionable that the Food and Drug Administration, one of the best little agencies in Government, has gone leaderless for such a period of time…I know Dr. von Eschenbach well. He is a man of integrity….I urge my colleagues--no, I implore my colleagues--to do what is right and vote [for] this nomination….it is what the American people deserve.

Such a character endorsement, coming from a man at the top of Big Pharma’s payout list, is hardly an encouragement to anyone. What is it that constitutes integrity in Hatch’s mind? And just what is it that the American people deserve? These questions were answered for us by Grassley, in his follow-up testimony:

A vote for this nominee would be an endorsement of the stonewalling, but, more importantly, the disrespect for Congress he has shown by not cooperating with congressional oversight.…Under Dr. Von Eschenbach, the FDA has not only avoided transparency, it also has threatened those who are trying to desperately expose the truth….

This started back in January with Ketek and our getting involved in the oversight. There was fraud in this Ketek study….In June, Dr. Von Eschenbach held a meeting of FDA staff involving this drug I have been investigating, questioning how it was handled--Ketek. FDA employees who were present say that he used a lot of sports metaphors regarding being a “team player” and keeping opinions “inside the locker room.” Basically, he said to not criticize the FDA outside the locker room, “outside the locker room” being his words. Apparently he stated that anyone who spoke outside the locker room might find themselves “off the team”…

This nominee held this meeting in the midst of this ongoing congressional investigation of this drug Ketek. He called the meeting after a number of critical reports in the media about the FDA's handling of Ketek. A number of FDA employees interviewed by the committee were offended by his comments, found them highly questionable, inappropriate, and potentially threatening. I don't think there was any “potential”' about it, they were meant to be threatening, and I agree with the employees.

Leaders of an agency should not hold a meeting to suggest that dissenters will be kicked off the team, particularly when the lives of American people are at stake, when drugs are going to be put on the line and they might not be safe. I can refer to the death of an 18-year-old in Cedar Rapids, IA. His is the type of action that shows the true stripes of the nominee….The way the Food and Drug Administration under this nominee has handled the investigation of Ketek shows the agency would like to keep its business secret.

This gives us a very clear understanding of how Hatch defines a “man of integrity.”

The Rise of the Hatch-et-man

In the gospel according to Orrin Hatch (R-UT), the R now stands for regulation. It has been somewhat difficult for him taking large sums of money from the supplement industry and Big Pharma at the same time; however, after 30 years of Senate politicking Hatch-et-man has talking out of both sides of his mouth down to a science. And unfortunately for the supplement industry, he takes the most money from Big Pharma. He has even been able to completely forget that Republican core values center around less government regulation, not more - especially when such regulation is totally unnecessary.

Under the false guise of consumer safety, Hatch-et-man was clearly the driving force that ramrodded AER (Adverse Event Reporting) legislation for dietary supplements, without any testimony or hearings, through the Senate and the House. The net effect of the legislation will be to remove therapeutic nutritional supplements from the market, health options millions of Americans count on to remain well. This is a favor to Big Pharma, not the supplement industry.

Of course, Democrats love the smell of any legislation smacking of increased regulation of health care, thus they pounced on the bill, driving it through the House with Democrats voting 134-4 to pass it. This is the first of many bills the Democrats will endorse in the coming months to undermine the supplement industry. Leading the charge against health freedom will be the Big Pharma Democrat cartel. This group is composed of the vitamin-hating Senator Dick Durbin (D-IL), along with Rep. John Dingell (D-MI), Rep. Henry Waxman (D-CA), Rep. Susan Davis (D-CA), Senator Diane Feinstein (D-CA), Senator Charles Schumer (D-NY), Senator Edward Kennedy (D-MA), and Senator Hilary Clinton (D-NY). These Big Pharma sponsors are sure to pile on in the coming months.

Now there are those out there who think Hatch-et-man is a friend of the supplement industry, based on his long ago support of DSHEA. Well times have change. Hatch-et-man wears a supplement industry suit and has a heart of Big Pharma gold. His veins are icy cold, filled with a synthetic FDA-approved blood.

Emboldened by his rise to power as a profit broker between Big Pharma, the FDA, and the supplement industry, Hatch-et-man actually started to publicly spill the beans. Maybe all the idiots in the supplement industry that either supported the AER legislation or did little or nothing to stop it will start to wake up. 

In his December 6, 2006 Senate testimony he tells us that he has spoken to Andrew von Eschenbach to ensure that the FDA will more vigorously pursue supplement companies. His AER legislation was crafted with the help of over twenty meetings with the supplement-despising FDA. He pays special thanks to David Dorsey, a Senator Kennedy staffer, once a top FDA lawyer, who was instrumental in drafting the bill, and his own Bruce Artim who has now, but not surprisingly, moved on to a top position at Eli Lilly.

Yes, our wonderful Big Pharma-sponsored legislative system has now produced draconian supplement-regulating legislation that could easily obliterate natural therapeutic health options from planet earth, the true competition to Big Pharma profits.

In Part 2 of this report I will explain how Hatch-et-man accomplished the sell out of health options and health freedom for Americans, with special help from traitors within the supplement industry itself.


by Byron J. Richards, CCN
(originally from NewsWithViews.com)
December 18, 2006

Part II

In the middle of the night the House passed a bill at the conclusion of the lame duck session known as Adverse Event Reporting legislation for dietary supplements (S.3546). The bill was pushed through the Senate and the House by Senator Orrin Hatch (R-UT), also known as the Hatch-et-man. Many Congressional leaders were hoodwinked by Hatch to back the bill, as he passed around letters of various trade organizations to imply the bill had wide support amongst stakeholders (it does not). Others were most likely bribed with threats to hold other legislation hostage in the Senate unless Hatch-et-man’s bill was passed in the House.

AER legislation will enable doctors to viciously attack vitamin supplements based on Big Pharma propaganda, and with the help of the FDA have effective dietary supplements removed from the market. Despite considerable grass roots pressure the House buckled under to Hatch pressure and AER legislation was ramrodded through in despicable fashion while Americans slept. Americans will pay a heavy toll; the von Eschenbach-run FDA, the AMA, and Big Pharma are quite pleased with this huge legislative victory. So are various traitorous trade organizations within the dietary supplement industry itself that sold you out.

What is AER Legislation and What Does it Mean to You?

The idea put forth by Hatch was that there have been and will be criminal dietary supplement companies and this necessitates the entire supplement industry be subjected to mandatory Adverse Event Reporting so as to weed out the “bad actors.” In his recent Senate testimony Hatch pointed to the problems of ephedra and one bad-apple company, Metabolife, that hid serious ephedra-related adverse event reports from health authorities.

During the last six months it was made very plain, behind the scenes, that anyone in the supplement industry opposing AER legislation would draw the wrath of Hatch-et-man and co-conspirator Tom Harkin (D-IA). The public relations spin from the likes of controlled opposition group Citizens for Health (Jim Turner and Elwood Richard, founder of Now Foods) used to support the bill was to make “safe supplements even safer.”

The growing supplement industry would be demonstrating “maturity” and acting responsibly by accepting these draconian FDA-concocted guidelines for regulation. Anyone opposing the legislation was branded as anti-regulation libertarians, dishonest companies, and fly-by-night operations seeking to scam the unsuspecting public. And if that didn’t work we were all told to accept this legislation now or whatever vitamin-hating Senator Dick Durbin (D-IL) will do in the new Congress will be far worse.

Mandatory AER legislation, especially as written, is unnecessary and unwise. It is nothing but an example of expanded government regulation that will reduce the quality of health for Americans. There is already an FDA-voluntary serious adverse event reporting system in place for dietary supplements known as MedWatch. It is easy for a consumer or health care professional to report a serious adverse health event to the FDA via MedWatch. In fact, this voluntary system had over eight hundred serious adverse event reports on ephedra by the mid 1990s and over nineteen thousand by the time the FDA took ephedra off the market, meaning the existing reporting system worked just fine. Who stood in the way of the FDA taking action on Metabolife? You guessed it: Hatch-et-man and Harkin.

Hatch took in $30,500 in campaign donations from Metabolife during the FDA investigation. This is a drop in the bucket compared to the several million of lobbying money taken in by his son, Scott Hatch, as fully exposed in the LA Times back in 2003. The LA Times article explains how Hatch and Harkin (who controlled FDA budget appropriations) chided the FDA for trying to remove ephedra from the market and got in the way of FDA efforts to do anything. It seems the “bad actors” here are Hatch and Harkin. Why do we need mandatory AER legislation for all supplement companies when the source of the problem, politicians for hire, is easy to identify?

Supplement companies have paid Hatch for favors and mob-like protection on a regular basis. Herbalife did it in the early 90’s ($33,750 to Hatch, $129,752 to Harkin) and now XanGo is doing it ($46,200). Paying off a powerful Senator comes in handy when the FDA looks into blatantly false health claims. When asked to comment on the FDA warning letter, Hatch said, "XanGo is well-known in Utah and throughout the supplement industry for its quality products. I know they will take this seriously and work with the FDA to address these concerns."

The Big Pharma and FDA Campaign to Undermine Your Health Options

AER legislation for dietary supplements is best understood in the context of Big Pharma and FDA efforts to brand dietary supplements as dangerous and categorize them as drugs. This effort is taking place internationally, regionally, and within the United States. Many FDA actions in this campaign are blatantly illegal and undermine American sovereignty.

Ever since DSHEA was passed in 1994, Big Pharma, with the help of the FDA, has been seeking to undermine supplements on a regular basis, viewing the industry as major competition to its pharmaceutical drug cartel. These facts are fully explained in my book, Fight for Your Health: Exposing the FDA Betrayal of America. Big Pharma is not trying to eliminate the market; they are seeking to own the market for profit.

In 1996 German drug companies Bayer and BASF were instrumental in setting up a new committee for Codex called the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), hosted by the Germans. Its goal is to classify therapeutic supplements as drugs, using drug-based risk evaluation to falsely brand dietary food supplements as toxic and dangerous above very low doses, thus having them removed internationally from the free market via trade rules and trade sanctions. FDA has stated in congressional testimony they are 100% behind this initiative, even though their website scams Americans by currently telling them it will not affect their access to dietary supplements (a blatant lie). The “risk assessment” technology is owned by the German government, and FDA is colluding towards the goal of implementing international Codex guidelines behind the backs of Americans.

In 1998 Big Pharma created IADSA, the International Alliance of Dietary Food Supplement Associations, whose stated goal is to implement Codex internationally. NNFA (now NPA – Natural Products Association) joined IADSA and thereafter spews their globalist garbage to American consumers, thus controlling the opinion of health food store owners and their customers.

Another industry trade group, CRN (Council for Responsible Nutrition), opened its doors to Big Pharma companies and is now run by Bayer, BASF, Wyeth, and the like. CRN now works closely with NNFA and IADSA, adopting complementary approaches to facilitate international Codex implementation and causing large numbers of Americans to not take any action through their Big Pharma sponsored propaganda. CRN has many network marketing company members, thus considerable potential grass roots support for health freedom is neutralized by the owners of network marketing companies like Mannatech and Herbalife.

The FDA has embarked upon an illegal collusion with Canada and Mexico called the Trilateral Cooperation Charter, a subset of the North American Union, which is a subset of Codex. The goal is to harmonize U.S. health law with Canada and Mexico, whom already have horrid dietary supplement laws.

The FDA is seeking to undermine U.S. law from within, and create the false appearance that vitamins are dangerous and require excessive regulation. The recent ephedra case in Utah is truly alarming, as FDA used a drug-based risk principle to keep ephedra off the market even in low doses, a legal precedent that can now be applied to any dietary supplement. This, in fact, is the goal of the FDA-concocted AER legislation, to brand dietary supplements as dangerous above a certain level using risk analysis.

Thus, internationally, regionally, and within the United States there is a Big Pharma/FDA-sponsored movement to remove therapeutic dietary supplements from the free market by classifying them as drugs that require drug-like risk evaluation. Dietary supplements must not be classified as drugs or have drug industry risk analysis used to fraudulently evaluate their safety. Dietary supplements are foods, and far safer than the general food supply.

The billion dollar questions are:

1) Why are various supplement trade organizations behind the effort to sell out your rights to natural health options?
2) Why are various supplement companies like Now Foods and Jarrow lending their support?
3) Why are you buying supplements from companies and health food stores who are either directly undermining health freedom or are doing nothing to help stop this slide into loss of effective natural health options for American citizens?

The Natural Products Association (NPA, formerly NNFA)

NPA played a major role in helping to pass the AER legislation. Not surprisingly, one of Hatch’s sons, Parry, works at NPA. NPA sent out a call to action for all health food store owners to support AER legislation. With the exception of Nutraceutical Corp who adamantly opposed AER, and Herbalife, who adamantly supported AER, the majority of board members of NPA who were contacted directly, didn’t know what AER legislation involved or how it would affect their companies.

On December 11, 2006 NPA warned its members not to be scared by people like me, saying those opposed to AER are spreading false propaganda. David Taylor, president of NPA then goes on to blatantly deceive about what the AER bill means, “The bill includes several provisions that were key to earning the Natural Products Association’s support. These include requiring that the bill: Be limited to serious adverse events and not require reporting of just any complaint.”

This statement is very deceptive, as any adverse event must be recorded, even non serious ones. The bill circularly defines such “adverse events” as “any event that is adverse.” While these complaints don’t need to be submitted, they must be kept track of for six years! The FDA will now publish rules as to what this means, but could include almost any symptom a person experiences. Supplement distributors will need to make a file of such complaints available to the FDA for routine inspection. No drug could meet these standards of reporting and no food would be left to eat following these stupid guidelines. The brain-dead NPA thinks this is just fine.

Big Pharma will pay for fraudulent science, as was done to attack vitamin E, and doctors across the country will tell their patients to report any symptom as an adverse event relating to vitamin E (or anything else), simply because the person is taking vitamin E. Then, the FDA will apply drug-like risk analysis to the information they collect from vitamin companies, and slant statistics with a goon-like twisted “public health” perspective. They will then rule numerous vitamins to be unsafe at various levels of intake. This is completely compatible with their already stated international and regional agenda. The net effect is clearly to remove therapeutic nutrition, the only competition for Big Pharma, from the free market.

The Problem Will Be the Worst for Health Professional Supplement Companies

Companies that sell to health professionals make up a significant part of the supplement industry. Oddly, these companies were noticeably lacking in their efforts to stop AER legislation, buying into the propaganda that only “bad actors” would be affected. These companies sell products through chiropractors, nutritionists, and other health professionals. It is these companies that will be the first to be destroyed by the recently passed AER legislation.

Patients who seek out professional nutritional assistance already have long lists of daily symptoms that classify as “adverse events,” simply by the nature of their pre-existing health situations. Nutrients often produce new symptoms in such people as they seek to improve, and many are “sensitive” to multiple things they ingest including a majority of foods.

These people will go to their doctors with their collection of puzzling symptoms and the doctors will ask them what supplements they are taking. The doctors will then blame all of their symptoms on their supplements, and either file reports themselves or browbeat naive patients into filing such reports. This has nothing to do with serious adverse events and everything to do with destroying competition. And just like that, the supplement companies that stand as the last hope for millions of drug-injured Americans will be wasting millions of dollars in court defending themselves or the FDA will simply take numerous products of theirs off the market.

What Should You Do?

This bill will be signed into law by Bush and go into effect within one year. Over a several year period there are likely to be major problems, setting the stage for full Codex implementation within the U.S. and near complete eradication of your health freedom and many dietary supplements you today take for granted.

You should demand of any supplement company whose products you use or any place of business you purchase supplements (health food store, health professional, Whole Foods, Wild Oats, Co-op, GNC, etc), a clear statement of that company’s position on the AER legislation, the FDA Trilateral Cooperation Charter, and Codex. Any company that pretends these are not major issues and does nothing to defend health freedom should be avoided like the plague.

How you spend your money matters, and it is the last thing that does.

A Truly Heavy Chain

Hatch-et-man toiled long and hard this year adding to the burdensome chain he has forged in life. In addition to reprehensible AER legislation he was exposed perverting lawmaking for huge profits of one Utah company, he raised millions of dollars of unnecessary campaign funding which he then distributed to his friends, and he adamantly supports the Plan D Medicare rip off of Americans. He is also fully behind Kennedy and Enzi’s bill (S.3807) to turn the FDA into a drug company. Hatch, like the FDA, perceives himself above the rule of law and has been caught red-handed violating ethics rules. He lets Big Pharma pay travel expenses for his staff, he has created monopoly rights for Big Pharma worth billions, and he has defended specific drug companies so as to cost taxpayers a fortune. Over the last decade Hatch has become one of Big Phrama’s greatest friends, to the detriment of the supplement industry. 

Yes, this holiday season there will be visions of sugar plums dancing in the minds of millions of innocent children, not knowing they are target of a Big Pharma mind-control agenda. And as Hatch settles in for a long winters nap, a visit from the ghost of Jacob Marley is about the only thing that may offer reclamation. The sun is setting on health freedom in America.

© 2006 Truth in Wellness, LLC - All Rights Reserved

Byron J. Richards, Founder/Director of Wellness Resources, is a Board-Certified Clinical Nutritionist and nationally-renowned health expert, radio personality, educator, and author.

Richards encourages individuals to take charge of their health, stand up for their health rights, and not blindly succumb to propaganda from the vested-interests who profit from keeping Americans sick. Author of Mastering Leptin and Fight for Your Health, Richards is now joining forces with health freedom leaders in the U.S. and throughout the world. Visit his health blog for up to date happenings. www.truthinwellness.com

As founder of Wellness Resources, Inc. of Minneapolis, MN (since 1985), he has personally developed 75 unique nutraceutical-grade nutritional formulas. www.wellnessresources.com

Charter Member of the International and American Associations of Clinical Nutritionists (IAACN) (since 1991) Richards has presented hundreds of educational classes to health professionals and individuals who want to take charge of their health!

E-mail: byron@truthinwellness.com