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The FDA’s Scheme to Reclassify Nutrients as Drugs
August 2, 2011
The FDA and Senator Durbin’s latest attack against the dietary supplement industry should leave consumers for natural health options at affordable prices up in arms. This attack will target some of the most popular and effective dietary supplements, removing them from the free market and placing them under control of large pharmaceutical companies. This move will drastically drive up the price of dietary supplements while severely limiting access to extremely safe and effective nutrients. For example, the GlaxoSmithKline prescription drug version of DHA fish oil (at a therapeutic dose) sells for $189 a month, whereas the equivalent, therapeutic amount of molecularly-distilled DHA sells for $35 a month in the dietary supplement marketplace. It is not surprising that DHA is one of the first nutrients the FDA plans to go after. Other powerful nutrients, such as curcumin and resveratrol, are soon to follow.
This is the second article in what will be a series of articles on this critical topic. In my first article, “Senator Durbin & the FDA Viciously Attack Dietary Supplements,” I outlined the scope and nature of the attack and called readers to take action. And it is still critically important that you do take action, so please visit our new TAKE ACTION page immediately following reading this article.
The newly-proposed FDA regulations are complicated. We are just beginning to understand the full scope of their ploy. The FDA is hoping that the complexity of their regulations will confuse consumers so they do not understand the coming changes and resulting repercussions. It is my job to give you some concrete examples of how this will affect you.
It is not just DHA, curcumin and resveratrol that are slated for pharmaceutical industry takeover, hundreds of other nutrients and herbs are at risk. The unfortunate reality is if the FDA is allowed to carry out their illegal strategy then thousands of products currently on the market are likely to be deemed “misbranded drugs” and forced off the market under the FDA’s criminal campaign to wipe out an industry, and ultimately gain even greater power and profit.
Mapping the human genome was supposed to usher in the next generation of pharmaceutical “wonder” drugs. Scientists would identify a gene or set of genes causing each and every disease. New biotech drugs operating at the genetic level would fix the problems or compensate for them, ushering in “The Golden Age of Cures” and reaping huge 21st century profits for the pharmaceutical conglomerate.
This wishful thinking is not the case. Their first biotech drugs have caused more death and injury than benefit. At the same time, rapid advancements in tools to analyze gene function made it obvious that Mother Nature already provided a treasure trove of potential golden cures—natural, safe and effective substances already widely utilized in the dietary supplement industry.
Multiple circumstances threaten hundreds of billions in drug company profits. Their pipeline of new drugs with widespread consumer application is scant, as they gamble their future on dangerous biotech drugs with limited use. Hundreds of their top-selling drugs are losing patent protection in the next few years, exposing them to generic competitors and massively driving down inflated profits. Widely-publicized adverse side effects and unnecessary deaths caused by many commonly-used pharmaceutical drugs have cast suspicion over their entire industry.
On the political front, Congress is looking for ways to control health care costs, even suggesting incentives for making people well—a far different tune than paying for lifetime drug prescriptions that seldom improve health. In fact, the gene science is actually proving that Western Medicine’s drugs are damaging the human genome and are a significant cause in the onset of many of the diseases of aging—the very diseases they are pretending to treat.
Pharmaceutical companies define their primary assets as patent-protected drugs, giving the drug 15 to 20 years of product sales with no competition. It is vital for them to figure out a strategy to turn dietary supplement ingredients, especially those that could be used for type 2 diabetes, cardiovascular disease, obesity, depression, Alzheimer’s, and cancer treatment into drug company “assets,” eliminating from the free market many of the most helpful dietary supplement ingredients while drastically driving up prices for consumers.
Until the advent of the new gene-regulating drugs, virtually all medications worked on the principle of poisoning the function of a cell or enzyme system to hopefully produce a change that the doctor thinks “beneficial.” If taking a drug results in a better-looking blood sugar, blood pressure, or cholesterol number, then doctors automatically assume the person is healthier. Rather, health has nothing to do with it. It is in the financial interests of drug companies to dispense more and more drugs, on an ongoing basis.
There is a night-and-day difference in quality of health between a person who has good numbers because they are healthy and a person who has reasonably-looking numbers because they are poisoned with drugs. Studies using high doses of metabolic and cardiovascular drugs to attempt to drive numbers down to the levels of healthy people invariably injure and even kill the participants—clearly failing to improve health quality and extend lifespan.
To make matters worse, the pharmaceutical industry fraudulently hides the actual risks of the drugs from both patients and doctors. This includes slanting, to blatantly falsifying, studies routinely published in medical journals and used for marketing, illegally promoting off-label use of drugs, using funding to bribe research universities to publish only favorable results and blacklisting researchers who refuse to accept, and paying influential doctors to present their data as independent research at medical meetings.
The scope and magnitude of the drug safety issue is a nightmare. In 2006 the Institute of Medicine (IOM) conducted interviews with FDA management and hundreds of FDA employees to ascertain issues leading to drug safety problems. Widespread conflict of interest and many other issues led IOM investigators to label FDA management as dysfunctional. Little has changed.
The human body is no slouch when it comes to elaborate complexity. It is often the case that the same exact gene signal is “good” or “bad” depending on the context in which it is activated. In fact, the same genes often behave differently in different areas of the body. Unlike earlier toxic drugs that force cell and enzyme behavior at a rather crude level, biotech drugs turn gene signals “on” or “off” at a powerfully fundamental level of cell function. Unfortunately for consumers, our understanding of genes is in its infancy. There is daunting complexity in gene regulation, making use of any gene-regulating drug highly questionable.
One example of this problem involves diabetes drugs Avandia and Actos, which turn on the gene PPAR gamma. This gene signal helps to break down triglycerides. These drugs also stimulate the formation of new fat cells, which are more metabolically fit and therefore produce more adiponectin that stops insulin resistance. Thus, in theory, they are potentially great drugs for lowering triglycerides and benefiting people with type 2 diabetes. As these drugs became blockbusters it was soon observed that the patients taking them were experiencing devastating side effects. These drugs have no way to know the context in which they should be operating. They activate PPAR gamma in the wrong places, such as the heart, leading to a 40 percent increased risk for heart failure or heart attack. Additionally, inappropriate PPAR gamma activation in bones causes them to break more easily.
The FDA rushed these drugs to market despite the objections of its own safety supervisor who wanted to employ a black box warning for heart failure. In other words, the FDA knew about the risks but prevented the public from understanding them, and still allowed the drugs to go to market. This was a major scandal at the FDA. The FDA has finally restricted Avandia, but Actos remains available in full swing. Actos has recently been highly restricted in Europe, but in America, the FDA continues to drag its feet. This is likely because the FDA has mud on its face for approving these biotech nightmares in the first place and would rather consumers suffer injury and even die than look bad. The mainstream media fails to aggressively report on or investigate this tragic issue as they are large recipients of drug company advertising dollars. Even when one of their own, Tim Russert, was likely killed by Avandia or Actos, they turned a blind eye.
The new frontier of science is the field of epigenetics. A true genetic change means there is a change in the DNA sequence. Epigenetics explains factors that are not such DNA changes. Rather, epigenetic changes relate to how genes are expressed. Some are set in response to early environmental influences such as prenatal malnutrition or nutrient deficiency. As cells split and divide, however, epigenetic factors play a large role in determining life-long human health1 and are strongly linked to poor health and the onset of disease. Epigenetic weaknesses magnify during aging and are major factors in the cause of cancer, heart disease, neurological and cognitive disorders, obesity, diabetes, infertility and sexual dysfunction.
This new science is finding that when toxins interfere with the human genome, they can cause lasting damage in the form of adverse epigenetic changes which can occur at any point in one’s life. This is not simply an issue of pollution. Researchers are now demonstrating that regular use of many drugs2 can cause adverse toxic epigenetic changes, a finding that has alarming implications for today’s medical practices. Up to this point in time, drug safety has not involved studying the impact of any drug on epigenetics. Science now has the ability to see what is going on in this realm. The pharmaceutical industry and the FDA, unsurprisingly, have no interest in understanding and considering this new, ground-breaking information as the public would significantly reduce their intake of drugs.
There should be no question in anyone’s mind as to why the pharmaceutical industry wants to claim these powerful nutrients as patent-protected drug assets. The question is more about how they plan to pull off this major scheme, this heist, from the dietary supplement industry.
Curcumin (turmeric) has been around for thousands of years and is consumed in very large amounts in Eastern and Middle Eastern cultures. This means the basic spice is protected by DSHEA. Unfortunately, curcumin has relatively poor bioavailability and raw material companies have sought to produce purified extracts with advanced production technology and combine curcumin with other nutrients such as piperine, which can elevate the biological activity up to 2,000 percent.
Under the proposed FDA guidelines for NDIs, such curcumin extracts would retroactively become NDIs as they were not available prior to 1994. The immediate impact would be the removal of curcumin from the dietary supplement market while submitting an NDI application. Sabinsa, however, has already been granted several investigational new drug applications for their curcumin complex. Under the new FDA guidelines the net result would be eliminating all high grade curcumin extracts from the dietary supplement market, as no NDI will be granted for any ingredient that is under investigation as a new drug. Sabinsa, a dietary supplement raw material supplier, will be able to sell its rights to its curcumin compound to the highest pharmaceutical bidder while all other competing curcumin extracts, including Sabinsa’s product, will be forced off the dietary supplement market.
It is a similar story for resveratrol, which is also under investigation as a new drug. In fact, numerous highly-effective and therapeutic extracts will be targeted in this way by the pharmaceutical industry. The FDA has a glaring conflict of interest and can easily approve investigational new drug applications for any nutrient of interest to the pharmaceutical cartel, automatically blocking them from entry or existence in a competitive dietary supplement marketplace. Dietary supplement companies could spend millions trying to get the FDA to pass a NDI application. The FDA just sits on the NDI application, to ultimately approve the nutrient as an investigational new drug and deny the dietary supplement company’s NDI application.
Consumer options for therapeutic nutrition will rapidly dwindle. What is left on the market will be far more expensive and many nutrients will no longer be available without prescription. Once the pharmaceutical industry gains control of the nutrient, the new price will be ten to fifty times what consumers pay now.
The most important force capable of preventing skyrocketing prices and the elimination of therapeutic nutrition from the dietary supplement marketplace is you, the consumer. If you wait to act until the products actually begin to disappear, it could be too late. Act now and help preserve your right to a wide range of these powerful and valuable dietary supplement ingredients and products at affordable prices. Say NO to the FDA's illegal strategy to help drug companies take over the dietary supplement industry. Go to our TAKE ACTION page and, please, let your voice be heard.
This is the second article in what will be a series of articles on this critical topic. In my first article, “Senator Durbin & the FDA Viciously Attack Dietary Supplements,” I outlined the scope and nature of the attack and called readers to take action. And it is still critically important that you do take action, so please visit our new TAKE ACTION page immediately following reading this article.
The newly-proposed FDA regulations are complicated. We are just beginning to understand the full scope of their ploy. The FDA is hoping that the complexity of their regulations will confuse consumers so they do not understand the coming changes and resulting repercussions. It is my job to give you some concrete examples of how this will affect you.
It is not just DHA, curcumin and resveratrol that are slated for pharmaceutical industry takeover, hundreds of other nutrients and herbs are at risk. The unfortunate reality is if the FDA is allowed to carry out their illegal strategy then thousands of products currently on the market are likely to be deemed “misbranded drugs” and forced off the market under the FDA’s criminal campaign to wipe out an industry, and ultimately gain even greater power and profit.
The Pharmaceutical Industry’s Perfect Storm of Economic Collapse
Mapping the human genome was supposed to usher in the next generation of pharmaceutical “wonder” drugs. Scientists would identify a gene or set of genes causing each and every disease. New biotech drugs operating at the genetic level would fix the problems or compensate for them, ushering in “The Golden Age of Cures” and reaping huge 21st century profits for the pharmaceutical conglomerate.
This wishful thinking is not the case. Their first biotech drugs have caused more death and injury than benefit. At the same time, rapid advancements in tools to analyze gene function made it obvious that Mother Nature already provided a treasure trove of potential golden cures—natural, safe and effective substances already widely utilized in the dietary supplement industry.
Multiple circumstances threaten hundreds of billions in drug company profits. Their pipeline of new drugs with widespread consumer application is scant, as they gamble their future on dangerous biotech drugs with limited use. Hundreds of their top-selling drugs are losing patent protection in the next few years, exposing them to generic competitors and massively driving down inflated profits. Widely-publicized adverse side effects and unnecessary deaths caused by many commonly-used pharmaceutical drugs have cast suspicion over their entire industry.
On the political front, Congress is looking for ways to control health care costs, even suggesting incentives for making people well—a far different tune than paying for lifetime drug prescriptions that seldom improve health. In fact, the gene science is actually proving that Western Medicine’s drugs are damaging the human genome and are a significant cause in the onset of many of the diseases of aging—the very diseases they are pretending to treat.
Pharmaceutical companies define their primary assets as patent-protected drugs, giving the drug 15 to 20 years of product sales with no competition. It is vital for them to figure out a strategy to turn dietary supplement ingredients, especially those that could be used for type 2 diabetes, cardiovascular disease, obesity, depression, Alzheimer’s, and cancer treatment into drug company “assets,” eliminating from the free market many of the most helpful dietary supplement ingredients while drastically driving up prices for consumers.
The Poison-Dispensing Era of Western Medicine
Until the advent of the new gene-regulating drugs, virtually all medications worked on the principle of poisoning the function of a cell or enzyme system to hopefully produce a change that the doctor thinks “beneficial.” If taking a drug results in a better-looking blood sugar, blood pressure, or cholesterol number, then doctors automatically assume the person is healthier. Rather, health has nothing to do with it. It is in the financial interests of drug companies to dispense more and more drugs, on an ongoing basis.
There is a night-and-day difference in quality of health between a person who has good numbers because they are healthy and a person who has reasonably-looking numbers because they are poisoned with drugs. Studies using high doses of metabolic and cardiovascular drugs to attempt to drive numbers down to the levels of healthy people invariably injure and even kill the participants—clearly failing to improve health quality and extend lifespan.
To make matters worse, the pharmaceutical industry fraudulently hides the actual risks of the drugs from both patients and doctors. This includes slanting, to blatantly falsifying, studies routinely published in medical journals and used for marketing, illegally promoting off-label use of drugs, using funding to bribe research universities to publish only favorable results and blacklisting researchers who refuse to accept, and paying influential doctors to present their data as independent research at medical meetings.
The scope and magnitude of the drug safety issue is a nightmare. In 2006 the Institute of Medicine (IOM) conducted interviews with FDA management and hundreds of FDA employees to ascertain issues leading to drug safety problems. Widespread conflict of interest and many other issues led IOM investigators to label FDA management as dysfunctional. Little has changed.
The Gene-Experimentation Era of Western Medicine
The human body is no slouch when it comes to elaborate complexity. It is often the case that the same exact gene signal is “good” or “bad” depending on the context in which it is activated. In fact, the same genes often behave differently in different areas of the body. Unlike earlier toxic drugs that force cell and enzyme behavior at a rather crude level, biotech drugs turn gene signals “on” or “off” at a powerfully fundamental level of cell function. Unfortunately for consumers, our understanding of genes is in its infancy. There is daunting complexity in gene regulation, making use of any gene-regulating drug highly questionable.
One example of this problem involves diabetes drugs Avandia and Actos, which turn on the gene PPAR gamma. This gene signal helps to break down triglycerides. These drugs also stimulate the formation of new fat cells, which are more metabolically fit and therefore produce more adiponectin that stops insulin resistance. Thus, in theory, they are potentially great drugs for lowering triglycerides and benefiting people with type 2 diabetes. As these drugs became blockbusters it was soon observed that the patients taking them were experiencing devastating side effects. These drugs have no way to know the context in which they should be operating. They activate PPAR gamma in the wrong places, such as the heart, leading to a 40 percent increased risk for heart failure or heart attack. Additionally, inappropriate PPAR gamma activation in bones causes them to break more easily.
The FDA rushed these drugs to market despite the objections of its own safety supervisor who wanted to employ a black box warning for heart failure. In other words, the FDA knew about the risks but prevented the public from understanding them, and still allowed the drugs to go to market. This was a major scandal at the FDA. The FDA has finally restricted Avandia, but Actos remains available in full swing. Actos has recently been highly restricted in Europe, but in America, the FDA continues to drag its feet. This is likely because the FDA has mud on its face for approving these biotech nightmares in the first place and would rather consumers suffer injury and even die than look bad. The mainstream media fails to aggressively report on or investigate this tragic issue as they are large recipients of drug company advertising dollars. Even when one of their own, Tim Russert, was likely killed by Avandia or Actos, they turned a blind eye.
The Rise of Epigenetics
The new frontier of science is the field of epigenetics. A true genetic change means there is a change in the DNA sequence. Epigenetics explains factors that are not such DNA changes. Rather, epigenetic changes relate to how genes are expressed. Some are set in response to early environmental influences such as prenatal malnutrition or nutrient deficiency. As cells split and divide, however, epigenetic factors play a large role in determining life-long human health1 and are strongly linked to poor health and the onset of disease. Epigenetic weaknesses magnify during aging and are major factors in the cause of cancer, heart disease, neurological and cognitive disorders, obesity, diabetes, infertility and sexual dysfunction.
This new science is finding that when toxins interfere with the human genome, they can cause lasting damage in the form of adverse epigenetic changes which can occur at any point in one’s life. This is not simply an issue of pollution. Researchers are now demonstrating that regular use of many drugs2 can cause adverse toxic epigenetic changes, a finding that has alarming implications for today’s medical practices. Up to this point in time, drug safety has not involved studying the impact of any drug on epigenetics. Science now has the ability to see what is going on in this realm. The pharmaceutical industry and the FDA, unsurprisingly, have no interest in understanding and considering this new, ground-breaking information as the public would significantly reduce their intake of drugs.
There should be no question in anyone’s mind as to why the pharmaceutical industry wants to claim these powerful nutrients as patent-protected drug assets. The question is more about how they plan to pull off this major scheme, this heist, from the dietary supplement industry.
Curcumin (turmeric) has been around for thousands of years and is consumed in very large amounts in Eastern and Middle Eastern cultures. This means the basic spice is protected by DSHEA. Unfortunately, curcumin has relatively poor bioavailability and raw material companies have sought to produce purified extracts with advanced production technology and combine curcumin with other nutrients such as piperine, which can elevate the biological activity up to 2,000 percent.
Under the proposed FDA guidelines for NDIs, such curcumin extracts would retroactively become NDIs as they were not available prior to 1994. The immediate impact would be the removal of curcumin from the dietary supplement market while submitting an NDI application. Sabinsa, however, has already been granted several investigational new drug applications for their curcumin complex. Under the new FDA guidelines the net result would be eliminating all high grade curcumin extracts from the dietary supplement market, as no NDI will be granted for any ingredient that is under investigation as a new drug. Sabinsa, a dietary supplement raw material supplier, will be able to sell its rights to its curcumin compound to the highest pharmaceutical bidder while all other competing curcumin extracts, including Sabinsa’s product, will be forced off the dietary supplement market.
It is a similar story for resveratrol, which is also under investigation as a new drug. In fact, numerous highly-effective and therapeutic extracts will be targeted in this way by the pharmaceutical industry. The FDA has a glaring conflict of interest and can easily approve investigational new drug applications for any nutrient of interest to the pharmaceutical cartel, automatically blocking them from entry or existence in a competitive dietary supplement marketplace. Dietary supplement companies could spend millions trying to get the FDA to pass a NDI application. The FDA just sits on the NDI application, to ultimately approve the nutrient as an investigational new drug and deny the dietary supplement company’s NDI application.
Consumer options for therapeutic nutrition will rapidly dwindle. What is left on the market will be far more expensive and many nutrients will no longer be available without prescription. Once the pharmaceutical industry gains control of the nutrient, the new price will be ten to fifty times what consumers pay now.
A Call for Consumer Action
The most important force capable of preventing skyrocketing prices and the elimination of therapeutic nutrition from the dietary supplement marketplace is you, the consumer. If you wait to act until the products actually begin to disappear, it could be too late. Act now and help preserve your right to a wide range of these powerful and valuable dietary supplement ingredients and products at affordable prices. Say NO to the FDA's illegal strategy to help drug companies take over the dietary supplement industry. Go to our TAKE ACTION page and, please, let your voice be heard.
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