Our FDA opened the 2004 New Year by banning a beneficial and harmless herbal supplement. If I had to explain the Ephedra case in a paragraph, in a nutshell it has nothing to do with safety since its been around for about 4000 years with no problems, and everything to do with the FDA snatching another supplement for the pharmaceutical industry.
You can still walk into any store and buy cigarettes. According to the CDC approximately 442,398 deaths per year are attributed to cigarette smoking. And the FDA insisted tobacco should come under their jurisdiction because it's addictive and a drug. Dr. David Kessler was the one responsible for this. Was it to protect the tobacco industry since its still on the market, even after class action? A couple of years ago I saw a report on the Internet that actually said since the FDA didn't ban tobacco it has to now be considered safe! It took the lives of both of my parents.
According to Dave Fairbank in a January 6, 2004 article in the Daily Press, ephedra has been linked to more than 100 deaths. A comprehensive, FDA-commissioned review by the RAND Corporation that considered every adverse reaction recorded in the agency's files and the medical literature through 2002 identified only 20 cases of serious symptoms among ephedra uses where there was an attempt to rule out alternative explanations.
However, I would be willing to bet even in the 20 cases where there was an attempt to rule out other sources no one asked these users if they were also using aspartame. It has been said ephedra could be linked to strokes or seizures or cardiovascular problems. Aspartame is a seizure triggering drug and 4 different types of seizures are listed on the FDA's report of 92 documented symptoms triggered by this toxin including death. (http://www.dorway.com). It triggers strokes, and big time damages the cardiac conduction system and causes sudden death. It triggers an irregular heart rhythm and interacts with all cardiac medication. (Aspartame Disease: An Ignored Epidemic, http://www.sunsentpress.com or 1-800-827-7991 H. J. Roberts, M.D.)
Most people who are trying to lose weight and use Ephedra are the same people who are using aspartame (NutraSweet/Equal/Spoonful, E951, Canderel, etc.). And unless you asked the person using ephedra if he also uses aspartame, now being used by 2/3rds of the population, and 40% of our kids, there would be no way of knowing. And it can also be hidden in natural and artificial flavors.
Tim Sullivan said in the San Diego Union Tribune in Feb, 2003, that whether Steve Bechler's passing (23 year old Baltimore Oriole pitcher) should prompt baseball to ban ephedra-based products is a more complicated matter, one that raises questions of civil rights and individual responsibilities, and about the gap between medical opinion and governmental regulations. But Steve Bechler's death blamed on ephedra is a good example of exactly what I'm saying. At the time of his death, H. J. Roberts, M.D. immediately called the Broward County medical examiner, Dr. Joshua Perper and asked him how many diet drinks was Bechler drinking. Dr. Perper didn't even know why he asked. The Idaho Observer wrote the story, Aspartame Poisoning Cover for Ephedra. It was finally disclosed Steve Belcher had a weight problem, he would go without eating for a couple of days and then drink diet pop with aspartame all day. He had a family history of heart problems and aspartame destroys the heart. After researching the issue it's obvious that Steve Bechler did not die because he was using ephedra, it was just another aspartame death! Even Dr. Perper could only conclude that ephedrine "probably contributed" to his death but this doctor was not knowledgeable of aspartame's effect on the heart nor did he know that Steve Belcher was using it.
Consider silicone breast implants. These women who were concerned about beauty are the very same class of women concerned about weight. And even though aspartame is not even a diet product, but rather a neurotoxic drug that makes you crave carbohydrates, these women didn't know that. Studies were done on silicone and found not to cause systemic disease. Yet women were coming down with such things as multiple sclerosis and lupus. Aspartame has triggered a tremendous epidemic of MS and lupus. Basically it destroys the central nervous system and mimics MS. (See position paper by Dr. H. J. Roberts, MS or Aspartame Disease? on http://www.dorway.com) And we've gotten many off this toxin and had them walk out of wheelchairs, and some even reported their lesions disappeared. As to lupus, Dr. James Bowen pointed out that aspartame is an adjuvant, forms antigenic tissue, triggering immunologic attack. "The ability of methyl alcohol/formaldehyde to create antigenicity, especially as combined in aspartame molecules is so great as to cause severe autoimmune reactions to the tissues deformed by formaldehyde polemerization, adduct formation. The immune system turns against the victim's tissues: lupus." Did anyone ask the silicone breast implant victims if they were using aspartame? This is not to say that there aren't problems with silicone breast implants, especially if they rupture. An informant who called said he had worked with aspartame, formaldehyde, silicone and Kodak, and the problem is that when these silicone breast implants rupture and come in contact with the formaldehyde from aspartame, you will get all kinds of deformities. The President of DOW was concerned enough to contact Dr. Roberts but what happened after getting the facts we will probably never know. Did he contact Monsanto? Who knows. But they paid off in class action. Dr. Roberts wrote a small book on silicone breast implants and aspartame. http://www.sunsentpress.com
Dr. Bowen says because of aspartame's extreme toxicity even minute doses are destructive, damaging fetal nervous systems and related structures. Eyes and hearing come to mind. All tissues are similarly damaged as beyond its functional neurological intoxicating effects, methyl alcohol/formaldehyde is the strongest organic base in the living organism and is a polymerizing agent, turning tissue into plastic. From such poisoning there is no escape, it is obligatory metabolism by alcoholdehydrogenase of methyl alcohol into nascent formaldehyde, occurring 75% in the cytosol (cytoplasm) and 25% in the mitochondria. Ask the FDA why they allow aspartame on the market with free methyl alcohol. I guarantee they will not answer you. Dr. Roberts has asked them for years.
So again, we're back to the same point. It's like when Tryptophan was banned by the FDA after some deaths. No health food store would have sold it had they known it came from a manufacturer using genetic engineering. It was an isolated case. It had nothing to do with whether tryptophan was safe. It just wasn't safe to be sold in a health food store at $5.99. The last time I checked it was safe for a pharmaceutical company to sell a smaller amount of tryptophan for over $100.00 a bottle, and that was years ago.
The situation was stated correctly during congressional hearings. Cynthia Culmo, R.Ph., a former official with the Texas Department of Health said: "The situation isn't a scientific issue any longer. It's a political issue, won by a political agenda."
John W. Olney, M.D., was asked by the Ephedra Education Council to review some of the FDA cases. Go to (http://www.ephedrafacts.com) for the full report. Dr. Olney, one of the most renowned neuroscientists in the world founded the field of neuroscience called excitotoxicity. Read his CV on http://www.dorway.com. In l969 he published in Science, evidence that monosodium glutamate (MSG), destroys nerve cells in the brain when fed to infant animals. He also published evidence demonstrating that aspartame (NutraSweet) destroys nerve cells when fed to infant animals, and published evidence linking aspartame ingestion to an increased incidence of malignant brain tumors.
Dr. Olney along with Attorney James Turner, Washington, D.C. did everything possible to try and prevent the approval of aspartame. His excellent report to the Board of Inquiry of the FDA even explaining what would happen to the brains of our kids (prophecy fulfilled) is on CD and available from www.greatfallspro.com along with the Congressional Record on aspartame and the Board of Inquiry report of the FDA saying aspartame is not safe and should not be approved.
The adverse event reports Dr. Olney examined include those reviewed for FDA by Doctors Ricaute and Stoll. Dr. Olney says out of 28 cases, there is not a single case that the expert reviewers rated as having a highly probable causal association with ingestion of Ephedra.
In Case #12837, a self acknowledged cocaine addict inquires whether there are any class action lawsuits pending against ephedrine he can get in on.
In Case #13380 this 18-year-old college student worked out with weights. Brought unconscious to the hospital but expired in a "brain dead" condition the following day, it was the opinion of the neurologist who examined him and analyzed his CT scan this was a typical case of a ruptured berry aneurysm. Dr. Olney stated these aneurysms typically rupture at some point in early to mid-adulthood when an individual is physically straining, as in lifting weights. The blood screen for drugs revealed no detectable level of ephedrine but the urine analysis revealed trace amounts of ephedrine and norephedrine, suggesting he may have taken some preparation containing a small amount of ephedrine.
Dr. Olney points out the letter from Dr. Ricaute while concluding Ephedra represents a significant public risk, not to the general population but to specific individuals who have increased vulnerability to certain illness perhaps in combination with other stimulants. So that Olney says what Dr. Ricaurte has expressed is the type of concern that might be expressed for sodium chloride (common table salt) or caffeine.
In putting the situation in context, Dr. Olney says: "In that Dr. Ricaurte has not identified any EA related risk of central nervous system effects in the general population, his expert opinion does not strengthen, but rather weakens, the FDA position. In fact, Dr. Ricaurte's statement serves to highlight a basic insistency in the FDA position, which is that the regulatory agency is apparently attempting to apply a DOUBLE STANDARD, one standard for common constituents and/or additive to foods (e.g. sodium chloride, caffeine) which FDA does not attempt to police in the marketplace, and another standard for a dietary supplement Ephedra which FDA appears to be attempting to police. The FDA position is rendered even more untenable by the fact that the agency appears to be trying to police ephedrine in the dietary supplement marketplace but not in the over-the-counter marketplace. Thus, there appear to be glaring inconsistencies in the FDA position, regarding Ephedra, and Dr. Ricaurte's expert statement helps to make these inconsistencies apparent.
In Case 12464 a father believes his 22-year-old son is addicted to "Ripped Fuel". There is no evidence of addiction provided and Dr. Olney says this twitching about the mouth reported known in medicine as a "perioral dyskinesia" or "perioral tic" is a common affliction frequently seen in ones that have never ingested Ephedra.
Talking about addiction, consider aspartame. The chronic methanol poisoning affects the dopamine system of the brain and causes the addiction. Methanol is classified as a narcotic. Four support groups on line expose the suffering of those trying to break this addiction and get over the afflictions this chemical poison causes that fill a 1000 page medical text, Aspartame Disease: An Ignored Epidemic, by H. J. Roberts, M.D. http://www.sunsentpress.com or 1-800-827-7991
Charles Fleming was so addicted to aspartame he demanded his son keep the fridge filled with diet pop. It cost him his life. Fleming was a basketball player and death came soon after this and other exercise. Athletes everywhere appear to be dropping like flies because aspartame damages the cardiac conduction system and causes sudden death. According to neurosurgeon Russell Blaylock, M.D., in Excitotoxins: The Taste That Kills (http://www.russellblaylockmd.com) the heart's electrical system contains numerous glutamate receptors, making the heart very susceptible to injury by food based excitotoxins such as the aspartate in aspartame and MSG. He says this may explain the rising incidence of congestive heart failure and sudden cardiac death, following ingestion of meals containing high concentrations of excitotoxins.
In the case of Fleming the chronic methanol poisoning on autopsy from aspartame was thought to be murder, and his wife Diane, a sweet Sunday School teacher was sentenced to 50 years in a hardened Virginia prison. The FDA knows about this case but has no concern. Nor do they show any concern sudden cardiac death is the nation's #1 killer ending the lives of about a half a million people a year without warning, and that 2/3rds of the population is on this neurotoxic drug masquerading as an additive, as well as 40% of our children. The FDA is concerned about an herb, Chinese Mahaung that has been used for thousands of years.
Continuing with Dr. Olney report, case 12860. Here a mother believes her son's behavior has changed since he started taking an unidentified Ephedra product being distributed at a local gym. It seems her son has left his wife who is eight months pregnant, is drinking excessively and has stopped going to church. The son denies he has a problem.
Dr. Ricaurte suggested humans consuming Ephedra might place them at a high risk to develop parkinsonism. Dr. Olney pointed out this would seem highly speculative in that Parkinsonism involves a massive loss of dopamine nerve cells, causing the symptoms of tremor, disturbance in gait, etc. Yet animals exposed to Ephedra have not been shown to have a loss of dopamine nerve cells. Dr. Olney in discussing Dr. Ricaurte comments about Parkinsonism having to do with ephedra said: "... but if the animal data predict a type of risk (early onset of Parkinsonism) that has never materialized in two thousands years of human Ephedra consumption, these animal findings would appear to have no human relevance."
In the case of aspartame, it is so responsible for Parkinson's that it's already documented in three medical texts, Aspartame Disease: An Ignored Epidemic, and Defense Against Alzheimers Disease by H. J. Roberts, M.D., and Excitotoxins: The Taste That Kills by neurosurgeon Russell Blaylock, M.D. As Dr. James Bowen brought out in a paper relating to the Gulf War Syndrome, (http://www.wnho.net), aspartic acid, the excitotoxic component of aspartame does not cross the blood brain barrier but is secreted into the cerebral spinal fluid by the choroid plexus located in the ventricles of the brain. There, in the brain's lower area and upper terminus of the spinal cord is where Parkinson's Disease is most prominent, as well as Lou Gehrigs and Multiple Sclerosis. These critical locations are bathed in the toxin as it removes from the blood. From the third to fourth ventricle there is a narrow canal called sylvian aqueduct, which fills with this secretion and washes the roof of the hypothalamus. But the FDA with full knowledge pays no attention even though they know it even interacts with L-dopa and other Parkinson drugs. So Parkinson patients like Michael Fox, for instance, has no way of being warned. A former Diet Pepsi spokesman once made the comment that he didn't understand how he could get an old man's disease at the age of 30. Just get those supplements away from the public so the pharmaceutical companies can increase their greed every year. There is even a book about it by Mike Fillon, The Truth About Ephedra. He uncovers a scandalous connection between the pharmaceutical industry and government regulators to attack dietary supplements.
If the FDA were concerned about Parkinson's Disease and consumer safety there would be a lot of things banned. In Health & Nutrition Secrets To Save Your Life by neurosurgeon Russell Blaylock, M.D., there is discussion about aspartame and even mercury in triggering Parkinson's. And he says in l976 Dr. Wolfgang Klein and co-workers demonstrated that cells exposed to 1 ppm fluoride exhibit a 50 percent reduction in DNA repair enzyme activity. Not only does this increase cancer risk it also encourages aggravation of degenerative diseases of the nervous system such as Alzheimer's disease, Parkinson's disease and Lou Gehrigs disease (ALS), as well as other degenerative diseases of aging. When unrepaired DNA damage occurs in reproductive cells, the damage is passed on to children as well. It has been proven beyond any shadow of a doubt how deadly are vaccines with mercury, and amalgams. And fluoride is a deadly, deadly neurotoxin. If the FDA was concerned about Parkinson's disease, the first to go would be aspartame, MSG, and mercury long, long ago.
Dr. Blaylock brings out a profound point in this book, and that is in the case of diet drinks in aluminum cans, the very toxic brain aluminum fluoride compound co-exists with multiple toxins found in aspartame, thus creating the most powerful government approved toxic soup imaginable! And the FDA is concerned about ephedra, the healthful herbal plant, mahaung???? To ban ephedra with aspartame on the market is like choosing to ban brussel sprouts instead of cyanide!
Ephedra is a wonderful herb and it would be disastrous if herbalists lose the ability to use it. It's one of the best bronchodilators from the plant kingdom that is extremely valuable when used for asthma and allergies. Without it, one would have to turn to drugs, which is what the pharmaceutical industry wants. After all, the proof of drug company influence is that far higher doses of the concentrated synthetic analog of ephedra are still available, and in far higher doses per pill than the herbal form, as brought out by Allan Spreen, M.D. Sudafed stands for pseudo-ephedrine. He says there is no limit on the dose you might want to take. Dr. Spreen made the point hundreds of people die every year due to complications associated with aspirin and acetaminophen. But they are not going to take aspirin off the market.
Aspartame interacts with all cardiac medication, all anti-depressants, L-dopa, Coumadin, hormones and even insulin. The FDA knows it and shows no concern whatsoever. To make matters worse they lie to the public and tell them its safe when their own Board of Inquiry Report said its not and asked that aspartame not be approved. It was Dr. Arthur Hull Hayes who over-ruled that report. At the time Don Rumsfeld was CEO and said he would call in his markers and get it approved, which is in the Congressional Record and an eight month investigation of aspartame by United Press International (http://www.dorway.com).
Aspartame simulates and aggravates diabetic retinopathy and neuropathy, and even can precipitate diabetes. Aspartame is responsible for macular degeneration, diabetic blindness and glaucoma, known to result from excitotoxin accumulation in the retina. Aspartame not only can precipitate neurodegenerative disease but naturally they are worsened by aspartame and other excitotoxins. In addition, we now have good evidence that excitotoxins play a major role in exacerbation of MS and other demyelinating disorders including trigeminal neuralia. New studies have shown that excitotoxins trigger significant elevation of free radicals in the lining (endothelial cells) of arteries which means that products with aspartame can increase the incidence of heart attacks and strokes. And there is a tumor connection not only brain tumors, but mammary, testicular, thyroid, uterine, ovarian and pancreatic for starters. It is a Class A carcinogen and the FDA's own toxicologist, the late Dr. Adrian Gross, told Congress aspartame violated the Delaney Amendment which forbid putting something in food you know will cause cancer because without a shadow of a doubt it can trigger brain tumors and brain cancer. (Congressional Record SID835:131, August 1, l985).
Dr. Olney concluded in his report the FDA position is self-contradictory. "The reality is that ephedrine and its analogs have been in widespread use of OTC drugs for many years, during which neither their abuse potential nor their adverse side effect potential has been sufficiently impressive to cause FDA to even impose stringent labeling requirements on the OTC use of these agents. For many years, consumers have been ingesting large amounts of caffeine in coffee, tea, caffeinated soft drinks, etc. together with OTC ephedrine, and FDA has shown no concern that ingesting these sources of caffeine together with OTC ephedrine poses a problem from the standpoint of either abuse potential or side effect potential. To the best of my knowledge, FDA has not established that ephedra contained in dietary supplement preparations is less safe than ephedrine contained in OTC preparations. Given FDA's precedent of inaction and lack of concern regarding the use of OTC ephedrine, either alone or in combination with multiple sources of caffeine, it seems inconsistent and self contradictory for FDA to now claim that dietary supplement sources of ephedrine (but not OTC sources of ephedrine) pose a serious publish health problem."
PERSONAL NOTE TO FDA:
I would like to know how you would ever know if there is an ephedra reaction. It has been used for thousands of years without problems. Inasmuch, as aspartame is a seizure triggering drug that destroys the immune system, the central nervous system, the brain and the optic nerve, and ravages every organ in the system, unless you asked specifically if the consumer was using aspartame, there would be no way of knowing if these reactions were simply not the result of the Aspartame Disease Epidemic FDA approved in l981.
For years I've received comments from people who happened to run into one of the three scientists who worked on the aspartame project who left Searle in disgust. One lady said years ago "he said one day they will be dropping in the streets", and that is what is happening. I've already sent you the report on sudden death and aspartame. The autopsies of athletes that have been reported are classic of what you would find with aspartame even including cardiomyopathy. As Dr. James Bowen said in a paper cardiomyopathy from toxic and auto immune causes has long been appreciated. Since aspartame is indeed a toxic, mitochondrial and auto immune killer who could expect less! The heart is especially targeted in alcohol poisonings of all kinds. Since the intact aspartame molecule is an alcohol poison about twenty thousand times as toxic as most beverage alcohols, and since most of the damage from the beverage alcohol comes from its methanol content, aspartame, which has the methanol-formaldehyde-formic acid toxic axis as one of its highly aggravated toxic components, could very predictably cause extreme damage of all organs in the body.
H. J. Roberts, M.D., in his recent article, Aspartame Disease: An FDA-Approved Epidemic wrote that products containing the chemical sweetener aspartame can have multiple neurotoxic, metabolic, allergenic, fetal and carcinogen effects. Further he said "The existence of aspartame disease continues to be denied by the FDA and powerful corporate entities. Its magnitude, however, warrants removal of this chemical as an "imminent public health threat". The use of aspartame products by over two-thirds of the population, and inadequate evaluation by corporate-partial investigators underscore this opinion."
How do you allow a chemical poison on the market that interacts with just about very drug used to treat the problems it causes? John Hammell, President of the International Advocates for Health Freedom wrote: "The FDA ban on ephedra is illegal under the Administrative Procedures Act. Under the law, the FDA must act in a consistent way in their regulations. It is not legal for the FDA to ban the herb ma huang (ephedra) while leaving pseudoephedrine, which is far more dangerous, on the market in a slew of OTC cold formulas marketed by multinational drugs companies." He refers people to http://http://www.ephedrafacts.com to keep things in perspective and says: "If this ban is not challenged in court and overturned, it will set a horrible legal precent that would enable the FDA to ban literally ANY dietary supplement under equally false pretenses. All the FDA is actually doing with this ban is protecting the prescription market of pharmaceutical weight loss medication which is far more dangerous than ephedra. My concern is the ban on ephedra may not serve as the wake up call to the supplement industry that it should. This is an industry which has been set up for global destruction, but most vitamin companies, health food stores and consumers don't realize what's going on or what to do about it. That is because vitamin trade associations world wide are being denominated the top down by pharmaceutical interests which are actively keeping them in the dark regarding Codex, the EU Food Supplement Directive, and related globalization issues." A new article discusses this: http://www.thehealthcrusader.com/pgs/CrusadorNewsletterJan04.pdf
"Europe Declares War Against Supplements!! Directive to Ban Many Producers!" Had I known about the article and had the opportunity to speak to the writer, I would have told him the matter is far worse than thought. I have received several calls from the UK complaining of severe medical problems because they received pharmaceutical supplements that contained aspartame. One lady had almost lost her vision because of aspartame in her calcium. As you well know since the Community Nutrition Institute in Washington, D.C. petitioned the FDA in l986 to ban aspartame because of seizures and blindness, the methanol converts to formaldehyde and formic acid in the retina of the eye and destroys the optic nerve.
And this reminds me - my citizens petition for banning aspartame on the basis that FDA records show aspartame to be a chemical poison, and yet FDA lies to the public, has yet to be answered. The law allows 180 days and it's been over a year and a half. Your excuse of "competing priorities" is an example of how you refuse to answer when you know it will prove your guilt, and how the FDA is legend at serving above the law. Even Jerome Bressler said his FDA audit (http://www.dorway.com) was so damning of aspartame that FDA had the worst 20% removed when it was retyped. Dr. Roberts who he also spoke with had his congressman tell FDA to send the omitted part. The FDA letter mentioned that sometimes things are confidential. I would imagine they are always confidential when they indict the FDA of wrongdoing.
I write this report in the hope every member of Congress will receive the real facts, and a court action will finally provide justice for the consumer.
Dr. Betty Martini
Founder, Mission Possible International
9270 River Club Parkway
Duluth, Georgia 30097