FDA Warns of Selected Fraudulent Avian Flu Therapies

The FDA recently took action against several companies which it considered were making fraudulent claims related to treating or preventing avian flu. I have not examined any of the products involved so I can’t say whether or not the FDA’s actions are sound.

However what I can observe is that it is very convenient for the drug companies marketing billions of dollars worth of FDA approved products related to avian flu. How they must love their FDA staff, oh sorry, the FDA staff for eliminating competition.

Now if I seem a little sceptical here just bear with me for a few moments. First, let’s remember that avian flu is a disease that affects some birds and is not a human influenza at all. Use of the term "avian flu" in most cases is either an innocent expression of ignorance or a calculated attempt to manipulate.

The US government has already spent a fortune on drugs under the guise of dealing with avian flu knowing that the drugs purchased have associated risks yet actually offer zero benefit in dealing with avian flu. Yes, read that again and let it sink in. What you are witnessing is another example of profiteering by what I term hysteria-marketing. If you want to follow at least some of the money see my earlier articles here or here.

In the meantime, the FDA plays it’s ineffectual role, offering the all important appearance of being useful. At least it provides that much for the government of the day. So this is what they said recently.

The U.S. Food and Drug Administration (FDA) issued warning letters recently to nine companies marketing bogus flu products behind claims that their products could be effective against preventing the avian flu or other forms of influenza. FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu and the agency is concerned that the use of these products could harm consumers or interfere with conventional treatments.

"There are initiatives in place to deter counterfeiters and those who sell fraudulent or phony products to prevent or treat avian flu," said Andrew von Eschenbach, MD, Acting FDA Commissioner. "The use of unproven flu cures and treatments increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t. I consider it a public health hazard when people are lured into using bogus treatments based on deceptive or fraudulent medical claims."

FDA issued Warning Letters to nine firms marketing products making unproven claims that they treat or prevent avian flu or other forms of influenza. Eight of the products purported to be dietary supplements. Examples of the unproven claims cited in the Warning Letters include: "prevents avian flu," "a natural virus shield," "kills the virus," and "treats the avian flu." These alternative therapies are promoted as "natural" or "safer" treatments that can be used in place of an approved treatment or preventative medical product.

In the Warning Letters, FDA advises the firms that it considers their products to be drugs because they claim to treat or prevent disease. The Warning Letters further state that FDA considers these products to be "new drugs" that require FDA approval before marketing. The letters also note that the claims regarding avian flu are false and misleading because there is no scientific basis for concluding that the products are effective to treat or prevent avian flu. The companies have 15 days to respond to FDA.

FDA warning letters were sent to the following:

• Sacred Mountain Management Inc.
• BODeSTORE.com
• Melvin Williams
• Iceland Health Inc.
• PolyCil Health Inc.
• PRB Pharmaceuticals Inc.
• Chozyn, LLC
• Vitacost.com
• Healthworks 2000

Items such as the above are likely to continue as a way of supporting the ongoing marketing efforts of Big Pharma. Ongoing bird flu hype or even just an occasional follow-up reminder or scare will do wonders for the bottom line of many stock holders. You will find some of them behind the scenes or "hiding" openly in public office where no one suspects what they are really doing.

For information on helping prevent flu generally, see the Centers for Disease Control and Prevention http://www.cdc.gov/flu/protect/preventing.htm. However, note that I do not endorse the suggested vaccination practices.

What’s the current aspartame story? Well, it’s more saga than simple story but let’s put it in a nut shell. It goes like this.

Millions of people consume the chemical known as aspartame. This makes billions of dollars for the manufacturer and all the companies who add the chemical to products you consume. The very large sums of money involved are an essential part of this tale.

The chemical can be added to consumer products because it is approved by the FDA. How it achieved its approved status is a chapter in this story that’s filled with corruption, politics and intrigue, at the least. One of the villains is Donald Rumsfeld, which should come as little surprise. (For example, see the video at http://www.soundandfury.tv/pages.rumsfeld2.html)

The FDA was not initially so incompetent. As Pat Thomas stated in the September 2005 issue of The Ecologist:

Concerns over aspartame’s toxicity meant that for eight years, the US Food and Drug Administration (FDA) denied it approval, effectively keeping it off the world market. This caution was based on compelling evidence, brought to light by numerous eminent scientists, litigators and consumer groups, that aspartame contributed to serious central nervous system damage and had been shown to cause cancer in animals. Eventually, however, political muscle, won out over scientific rigour, and aspartame was approved for use in 1981 (see timeline for details).

The FDA’s about-turn opened the floodgates for aspartame’s swift approval by more than 70 regulatory authorities around the world. But, as the remarkable history of the sweetener shows, the clean bill of health given to it by government regulators – whose raison d’etre should be to protect the public from harm – is simply not worth the paper it is printed on.

For far too many years aspartame has poisoned countless millions of people. The chemical has been linked to several devestating central nervous system disorders. Like sheep, most doctors foolishly trust the FDA to look after us, and hence fail to practice scientifically, even intelligently. As the same article quoted above indicates, one doctor was different.

When aspartame was approved for use, Dr HJ Roberts, director of the Palm Beach Institute for Medical Research, had no reason to doubt the FDA’s decision. ‘But my attitude changed,’ he says, ‘after repeatedly encountering serious reactions in my patients that seemed justifiably linked to aspartame.’ Twenty years on, Roberts has coined the phrase ‘aspartame disease’ to describe the wide range of adverse effects he has seen among aspartame-guzzling patients.

He estimates: ‘Hundreds of thousands of consumers, more likely millions, currently suffer major reactions to products containing aspartame. Today, every physician probably encounters aspartame disease in everyday practice, especially among patients with illnesses that are undiagnosed or difficult to treat.’

As a guide for other doctors, Roberts, a recognised expert in difficult diagnoses, has published a lengthy series of case studies, Aspartame Disease: an ignored epidemic (Sunshine Sentinel Press), in which he meticulously details his treatment of 1,200 aspartame-sensitive individuals, or ‘reactors’, encountered in his own practice. Following accepted medical procedure for detecting sensitivities to foods, Roberts had his patients remove aspartame from their diets. With nearly two thirds of reactors, symptoms began to improve within days of removing aspartame, and improvements were maintained as long as aspartame was kept out of their diet.

Roberts’ case studies parallel much of what was revealed in the FDA’s report on adverse reactions to aspartame – that toxicity often reveals itself through central nervous system disorders and compromised immunity. His casework shows that aspartame toxicity can mimic the symptoms of and/or worsen several diseases that fall into these broad categories (see the box above).

In fact, you may be interested to learn that aspartame can produce symptoms that mimic all of the following:

• multiple sclerosis
• Parkinson’s disease
• Alzheimer’s disease
• fibromyalgia
• arthritis
• multiple chemical sensitivity
• chronic fatigue syndrome
• attention deficit disorder
• panic disorder
• depression and other psychological disorders
• lupus
• diabetes and diabetic complications
• birth defects
• lymphoma
• Lyme disease
• hypothyroidism

With growing mountains of clinical evidence one might imagine that the FDA would correct its error and act to protect consumers, which is supposed to be its job. However, Dr Betty Martini of Mission Possible International describes their performance like this.

Ten years ago FDA stopped listing victim complaints when they passed 10,000, and FDA no longer admits there ever was a list. It named 92 symptoms including seizures and death. FDA is now NutraSweet’s Washington Branch Office, faithfully promoting aspartame and publishing their propaganda, ignoring enormous injury to our people and rejecting a mountain of medical evidence. Who ever heard a Federal agency saying it was wrong? In the showcase of effete corrupt bureaucracies FDA proudly sits right there beside FEMA.

Actually you may like to see http://www.wnho.net/viva_new_mexico.htm to follow up on some of the links provided in Dr Martini’s article. That article introduced what is currently unfolding in New Mexico. Things didn’t go as smoothly as Dr Martini hoped back in October of 2005. The New Mexico chapter of this story is an interesting one and it is where we find some significant heroes locked in a David and Goliath like battle.

Dr Roberts was interviewed recently by Dr Carolyn Dean, MD, ND and Elissa Meininger for an article available at http://www.newswithviews.com/Dean/carolyn26.htm. He is reported to have said:

Aspartame should not have been approved in the first place. It was approved arbitrarily and unilaterally on the advice of in house FDA scientists. However, the General Accounting Office and a public board of inquiry both agreed that it should not be approved. After more than 20 years of clinical encounters and research and newer information, we now know that it constitutes an imminent public health hazard. New Mexico should be given credit for a lot of courage in looking into this matter because the Federal Government has not pursued it in any way it should have considering the large number of complaints.

So just what is happening in New Mexico? Dean and Meininger describe it like this.

The man most responsible for this hullabaloo, that has been going on since 1999, is an art gallery owner, Stephen Fox, who, along with his fellow citizens, just got fed up enough about aspartame in the food supply to take action. Fox, after doing his legal homework, sat down with a pencil and wrote legislation to create a state Nutrition Council with statutory powers to challenge the FDA if it mistakenly approves known carcinogens and neurotoxic food additives. The 2005 version of the bill passed the state Senate by an overwhelming 32-1 but after corporate lobbyists arm twisted their way through the cloakroom, it was killed in the House by a filibuster on the last day of the session.

Fox and his army of outraged citizens, doctors, lawyers, activists and victims, armed with the knowledge that New Mexico has the legal authority to ban aspartame, have just turned up the volume and expanded the campaign. PLEASE NOTE FOLKS, your state may also have the same legal power to ban aspartame, so you can learn from what Fox is doing and start your own campaign to make your state’s public servants do a proper job of protecting your food supply. In fact, when we interviewed Fox, he said he would be more than happy to help activists in other states and provinces in their battle to remove aspartame from the marketplace. We already know people who are going to take him up on his generous offer. You can reach Fox at stephen@santafefineart.com.

The 2006 campaign to get rid of aspartame is now expanding on two fronts. On the first front, another Nutrition Council bill has been introduced with the political support of Governor Bill Richardson, who has enthusiastically placed it on the agenda for the 2006 short session, which he controls, doubly endorsing it with an Executive Message.

The purpose of the bill is the same as the last one – to establish, by statute, a state agency called the Nutrition Council with the statutory power to challenge the FDA if it approves known carcinogens and neurotoxic food additives.

On the second front, there is a hearing, scheduled for July 2006, convened by the New Mexico Environmental Improvement Board (EIB) and the State’s Attorney General, a plan that was conceived after much public pressure from Fox and company. As you would expect, corporate lawyers from the makers of aspartame have threatened litigation to prevent the hearing from taking place, though, at the moment, Governor Richardson is standing firm that there needs to be a fair hearing.

One wonders on what grounds such a lawsuit would be based? Is it the need to prevent public servants from doing their job to protect the public? Or, more to the point, the need to protect Big Pharmaâ?Ts profits over the lives and health of innocent consumers?

So, as you can see, the well-funded, money making giants have so far managed their damage-control brilliantly and we are still being poisoned. Will this continue? Will you continue to suffer, see your friends and family suffer, see children who trust their parents and  ordinary citizens who trust the FDA be harmed while most doctors, a useless FDA and some company stock holders sit back and profit?

Yes, it comes down to what ordinary citizens acting together are willing to do. Right now there is a problem you can help with. As Dean and Meininger put it:

There will be two meetings in the first weeks of January in Santa Fe, New Mexico that could dramatically alter future events, or, for that matter, put an end to what the ordinary citizens of New Mexico have expressly stated as their will. One meeting is with the Attorney General’s Office and the Environmental Improvement Board and the other with the Pharmacy Board. At those meetings we hope that the Attorney General’s Office makes a recommendation that the July hearing goes forward as planned. So, if we are to act, it must be now to make sure this happens.

Once the July hearing is secured, it’s up to the people to keep the heat on to make sure it will be fair and impartial and no funny stuff goes on behind closed doors among the power brokers. Since what happens in Santa Fe in July has national and international ramifications, it is up to all of us to lend a hand to those in New Mexico who have done a spectacular job bringing the aspartame scandal to public view.

So you are asked to spend a few minutes this week to send this information to all your friends and urge them to join you in contacting the capital of New Mexico with e-mail messages from all over in support of the ordinary people of New Mexico.

Please have these e-mail messages sent to:

Governor Bill Richardson c/o Chief of Staff Dave Contarino at: dave.contarino@state.nm.us

Please thank the Governor for putting Senate Bill 525 to create the Nutrition Council on the Call and giving it his Executive Message.

Please tell him you support states’ rights to regulate harmful products especially now when it is obvious the FDA has failed in its regulatory responsibilities on a number of drugs and other products such as aspartame.

Attorney General,
The Honorable Patricia Madrid
ewood@ago.state.nm.us

Deputy General, Stuart Bluestone
sbluestone@ago.state.nm.us

Please tell both Ms. Madrid and Mr. Bluestone that you support their desire to defend New Mexico’s right to challenge the safety of an FDA-approved product such as aspartame, particularly when it is so obvious it should never been approved at all.

Please, do it now. This is important to all of us.

Welcome to 2006. There is high drama unfolding in New Mexico that will either resolve to ensure a substantial improvement in the health and wellbeing of the good people of that state, and support a flow-on effect of great importance to the health of many millions more people OR their will be a capitulation to the insideous powers of corporate giants and the influence they can buy, resulting in untold health damage now and for years to come.

The stakes are indeed high and you may be able to help tip the balance in a positive way. Will you help? Read the following article that I am reprinting here in the public interest, with assumed permission (I have not asked, but I believe the author would approve). Then, if at all possible, please take action as indicated at the end of the article. The article follows below.

Editorial from Gershon Siegel, Publisher, Monthly Sun, formerly Eldorado Sun permpress @ aol.com

Real consumer protection is not about the easiest path. Corporate interests need to be held in check and admonished and rebuked when it is necessary – not after the fact in huge lawsuits for damages like we just saw resolved in the Vioxx case in Texas.

Over the years the Sun has examined the medical and legal implications of the artificial sweetener aspartame. For New Mexico, a critical crossroads is approaching in the very near future, not concerning aspartame as a potential neurotoxin, but rather questioning whether or not the state of New Mexico, through its Board of Pharmacy, Environmental Improvement Board and Board of Education, has the right even to investigate such a potential.

This legal-authority question has been asked of the attorney general, Patricia Madrid, whose office is presently preparing a formal opinion as to whether our state’s boards can legitimately challenge a Food and Drug Administration-approved product like aspartame. The FDA’s approval was flawed, if not corrupt, to begin with, as was made clear in the September 2005 Sun article "Rumsfeld’s Disease." Therefore it seems incomprehensible that such a faulty FDA approval could not be questioned by a state board having heard a significant amount of evidence thus far.

But this is just what corporate lawyers representing the Japanese firm Ajinomoto, the world’s largest aspartame manufacturer, would like the boards and the attorney general to believe. Ajinomoto is joined in this legal effort by an industry front group, the Calorie Control Council. They have both hired high-powered lawyers to silence the boards on the grounds that aspartame is "safe" and that, besides, no one but the FDA, Congress and the federal courts can challenge any of the FDA’s approval processes, at least until someone dies from an FDA-approved product.

In spite of the industry front group’s innocent-sounding name, and given previous and most recent scientific studies indicating the harmful affects of aspartame, we take exception to Ajinomoto’s assertion of aspartame safety. Coincidently, Ajinomoto also happens to be the world’s largest manufacturer of another dubious food additive, monosodium glutamate. We encourage the attorney general to issue a strong opinion supporting the boards looking into aspartame in children’s medicines and in thousands of food products.

Neurodegenerative diseases are on the upsurge, especially in children and in the elderly, and no corporate interest can silence or thwart the ongoing quest for medical truth. Protecting our children lies at the very core of our existence, and most certainly the attorney general knows this.We’d like Madrid to recognize the obvious: that in 1981 the FDA’s approval was politically motivated and that these corporate interests have stymied the real truth about aspartame for the last 24 years through the evolution of "diet" beverages, "sugarless" gum, "low fat" yogurt and other pleasant delusions whose net effect has been shown to cause neurodegenerative mayhem in the human physiology. It is time to put an end to this destructive mythology and corporate deception.

Attorney General Madrid could roll over and capitulate to the corporate interests, as if it were the FDA itself that is making the preemption arguments, which is not the case. From a bureaucratic point of view, this might be the easiest thing to do. However, real consumer protection is not about the easiest path. Corporate interests need to be held in check and admonished and rebuked when it is necessary – not after the fact in huge lawsuits for damages like we just saw resolved in the Vioxx case in Texas.As part of the attorney general’s statutory duties and powers, it is her job to protect New Mexicans from further neurotoxic exposure. Therefore, we strongly encourage Madrid to say no to the corporate clamor insisting that the Board of Pharmacy and the Environmental Improvement Board remain silent on this issue, and instead affirm their right to move forward with aspartame hearings.

In the past, when local laws have threatened corporate bottom lines, big business has hauled out the Constitution’s supremacy and commerce clauses to support their profits-over-people argument. This tactic has usually proved successful. However, let us not forget the tobacco suits of the 1990s, which stunningly affirmed, in effect, that those corporations that knowingly sell products potentially harmful to the public risk paying billions in reparations to those states that take seriously the obligation of protecting the health and safety of their citizens.

The aspartame industry represents billions of dollars annually, and we understand the courage needed by the attorney general to stand tall at this critical juncture for the health and safety of the people of New Mexico. As with the aforementioned tobacco suits, her decision may potentially affect the actions of other attorneys general throughout the country and, therefore, affect millions of Americans and even more millions of consumers worldwide. However, for Madrid to now surrender to the industry’s legal saber rattling will be nothing less than a complete abnegation of the powers of her office and a further descent into the growing corporate control of all government processes.

To voice your input regarding this matter of consumer protection to the attorney general’s office, call (505) 827-6000 and 827-6004, and ask to leave a message for the Attorney General and for the Deputy Attorney General, Stuart Bluestone.

The quoted article ends above. If you can make the requested phone call, please do. This is not a minor or insignificant issue. There is no doubt that the aspartame producers know this and will apply immense pressure and nasty tactics to protect their financial interests over people’s wellbeing. You can expect many to support them to continue the cover-up of the corruption and incompetence that allowed aspartame to be approved in the first place.

Ultimately the famous saying is true: all it takes for evil to thrive is for good people to do nothing. Please, do something to help win this issue for the people of New Mexico and then the many others who will benefit when other states follow the lead of New Mexico.

Right now, New Mexico has a golden opportunity to provide health leadership in an area of vital importance. If you live in New Mexico please pay close attention. If you value your health and wellbeing and truely care about your family and friends it is time to take action.

If you don’t live in New Mexico then also pay close attention. Why? For two reasons, at least. First, the decision makers in New Mexico need to understand that their state is part of a nation and that since what they do affects people outside their state, many outsiders are watching their actions with interest. So watch them and maybe let them know in some way that you care about what they do. Second, pay attention to see if there is something you can either learn from what is happening or contribute to the cause.

Under current legislation people can be poisoned by chemicals known to be toxic and to cause cancer. The FDA, for example, approves known carcinogens and neurotoxic food additives and companies are then free to include them in the drugs you take and the foods you eat.

The FDA is a significant and powerful agency that does do some good but also makes many errors. It makes these errors with impunity and regardless of its reasons for believing its actions are right, overwhelming evidence proves beyond a shadow of doubt that the FDA gets things wrong. Eventually they do frequently issue corrections, but not before many people have suffered.

Not only does the FDA make errors of judgement, it is also resistant to changing its ways, which generally seem to be aligned with helping the pharmaceutical and manufactured food industries. For example, the FDA’s anti-nutrient bias is so clear, so strong and so resistant to change, a Bill has been introduced to Congress to force changes and compliance with other legislation.

On November 9, Rep. Ron Paul (R-Tex.) and seven other members of Congress introduced the Health Freedom Protection Act (H.R. 4282) to prevent the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) from censoring information about dietary supplements. That’s pretty amazing really, that it should come down to a need for legislation to force the FDA to do the right thing and to stop them doing the wrong thing.

Unfortunately, the best ideals of participatory democracy are just that, ideals. In the real world we see their corruption by money and power. The whole lobbyist based system is a thinly veilled form of corruption, it is a mechanism for the weilding of undue influence. The very large sums of money available to lobby for the best interests of various industries means that we will always have a need to be watchful.

Good legislation is one way to maintain that watchfulness. It isn’t perfect, but it can be effective. It is important to review and renew it from time to time.

So what’s happening in New Mexico? Well, that depends on the legislators. There is an opportunity now to pass legislation to create a powerful new New Mexico Nutrition Council, with express statutory powers to be able to challenge the errors of the FDA in approving known carcinogens and neurotoxic food additives.

Such a move would offer a massive improvement in the level of health protection for the people of New Mexico. It would also establish the state as a leader in health policy that the whole nation would be wise to follow.

The proposed Nutrition Council Bill was written after consulting with nutritionists, physicians, lawyers, toxicity victims, parents, teachers, about half of the United Nations Ambassadors, Ministers of Health in many nations, lots of elected officials at the state and federal level, and natural food enthusiasts. The Council it would establish could provide a safety shield to protect the people of New Mexico and other jursidictions would be wise to follow.

When State legislators are swayed by lobbyists representing corporate interests they sometimes hear about economic advantages that flow from supporting the industries’ interests. No, I’m not referring to direct bribes. I mean suggestions that range from manufacturing plant employment to taxation windfalls and other such alleged benefits to the State treasury.

However, legislators must recognize the importance of other considerations. What about the impact of long-term harm on people and possibly the environment? There is the suffering associated with illness, the grief that follows loss. For the hard nosed, there is also the massive cost associated with providing health care for the conditions caused by the very chemicals that should never have been allowed to be used.

The evidence shows that the FDA cannot be relied upon to provide protection for consumers. No amount of denial makes this untrue. States must take action to defend their own citizens from corporations that would happily poison them for gain and redress the false security afforded by impotent federal regulators who appear to collude with industry.

Make no mistake, as Stephen Fox, an architect of the Bill observes:

America is awash in a sea of pesticides, additives, neurotoxins, and even worse biochemicals which are coming soon. It is, in short, a Toxic Idiocracy of the worst kind. The entire European Union will be banning Aspartame, for example, soon, due to the reports on carcinogenicity from the Italian Ramazzini Study/European Institute for Oncology. The FDA might get it eventually, with a new President, perhaps.

Let these warnings sink in for a while. Consider the impact of these dangerous, but FDA approved, chemicals on your family’s health. The protection this important Bill can provide is of tremendous value. Don’t allow it to slip away or be stolen from you by paid lobbyists representing uncaring industries.

Now is the time to contact your representative and voice your support for this Bill. Ask your representative to vote for the Bill as a matter of conscience. There is more to come on this issue.