No OTC Chelation, FDA Warns … All over-the-counter sales of "chelation" treatments are illegal, the FDA says. The federal agency sent warning letters to eight companies that sell chelation treatments online. The companies were told to immediately stop selling the products. "These are in fact unapproved drugs," Michael Levy, director of the FDA's division of new drugs and labeling compliance, said at a news conference. "These companies falsely claimed that these drugs treat a variety of ailments, including autism and heart disease." Chelation is a technique for treating people who have been poisoned with heavy metals such as lead, mercury, iron, and arsenic. Approved chelation drugs are available only by prescription and should be administered only by trained health professionals. Several of the companies cited today by the FDA promoted their chelation products as treatments for autism and other chronic diseases. "Unapproved chelation products are dangerously misleading because they target patients and the caregivers of patients with untreatable conditions," Levy said. – Web MD
Dominant Social Theme: Government steps in to save lives once again.
Free-Market Analysis: Well, the FDA is at it again. Now it is chelation that has received the brunt of the FDA's nannyism. Chelation was developed during the World War I to help veterans exposed to poison gas attacks. After World War II, the treatment found favor helping those in the military who had received lead poisoning as a result of painting ships. Sub dominant social theme: "Chelation is a scientifically approved treatment, but it sure can't be administered properly by anyone who is not part of the medical establishment."
How does chelation work? Here's Wikipedia: "Chelation therapy is the administration of chelating agents to remove heavy metals from the body. For the most common forms of heavy metal intoxication—those involving lead, arsenic or mercury—the standard of care in the United States dictates the use of dimercaptosuccinic acid (DMSA). Other chelating agents, such as 2,3-dimercapto-1-propanesulfonic acid (DMPS) and alpha lipoic acid (ALA), are used in conventional and alternative medicine. No approved medical research has found any benefits to chelation therapy for other diseases or ailments."
Sounds reasonable. The problem that the FDA has with current applications of chelation is that it is being used outside of the traditional mainstream medical community to treat heart conditions and more recently to treat autism. Of course it sad that various Internet forums are jammed with heart-rending comments from parents who want to find a chelation provider for their autistic children but cannot. The FDA apparently must save these parents from themselves.
On the other hand we have austism-treatment pioneers such as Professor James Adams who spent a good deal of time conducting a fairly rigorous testing procedure to see if chelation helped children with autism. Here's an excerpt from a late 2009 article (November) over at the Autism Research Institute (based on a press release) commenting on the results:
Two studies published by the Southwest College of Naturopathic Medicine in the October issue of BMC Clinical Pharmacology investigated the use of oral dimercaptosuccinic acid (DMSA), a prescription medicine approved by the FDA for treating lead poisoning, and used off-label in these studies for treating heavy metal toxicity in children with autism. In the investigations, DMSA was given to 65 children with autism (ages 3 -8years) to determine its effects. The researchers found that DMSA dramatically increased excretion of several toxic metals, including a 10-fold increase in excretion of lead. In terms of safety, the study found that there was no adverse effect on standard safety tests, including no effect on kidney or liver function.
Of greatest interest was a surprising finding that DMSA therapy had a dramatic effect on glutathione levels. Glutathione is the body's primary defense against toxic metals, and it was very abnormal in children with autism. Treatment with DMSA for only 3 days normalized glutathione levels for at least 1-2 months in almost all children. DMSA therapy also had promising effects on possibly reducing some of the symptoms of autism, including improvements in language, cognition, and sociability. However, a formal randomized double-blind placebo-controlled study is needed to confirm those results.
The study was led by Matthew Baral, N.D., Chair of the Department of Pediatric Medicine and Associate Professor of Pediatrics at Southwest College of Naturopathic Medicine (SCNM) and James B. Adams, Ph.D., Adjunct Professor in the Division of Clinical Sciences at SCNM and Science Director for the Autism Research Institute.
DSMA is a main ingredient in modern chelation treatment. In making its announcement, the FDA seems to have ignored the Baral/Adams results. Perhaps that is because the testing was still not rigorous enough. Or perhaps it has to do with a general FDA crackdown on non-mainstream administered medicine. Last year, the FDA went after numerous firms selling walnuts based on the claim that they were a heart-healthy food.
Diamond Foods was one of the companies that received an FDA warning letter. Diamond Foods reported on the controversy as follows: "The FDA has determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts 'are not generally recognized as safe and effective' for the medical conditions referenced on Diamond Foods' website. According to the FDA, these walnuts are now classified as 'drugs' and the 'unauthorized health claims' cause them to become "misbranded," thus subjecting them to government 'seizure or injunction.'"
Diamond Foods goes on to point out that ironically the FDA allows Frito Lay to sell "heart healthy" potato chips and does not seem inclined to do pursue US fast-food vendors that aggressively market artery-clogging meals that are heavily fried and laden with animal fats. Diamond Foods analyzes the Frito Lay "heart-healthy" claims at length, as follows:
You might not associate these mostly-fried snack foods as being good for you, but the FDA has no problem allowing the Frito-Lay® website to state the following:
"Frito-Lay snacks start with real farm-grown ingredients. You might be surprised at how much good stuff goes into your favorite snack. Good stuff like potatoes, which naturally contain vitamin C and essential minerals. Or corn, one of the world's most popular grains, packed with Thiamin, vitamin B6, and Phosphorous – all necessary for healthy bones, teeth, nerves and muscles. And it's not just the obvious ingredients. Our all-natural sunflower, corn and soybean oils contain good polyunsaturated and monounsaturated fats, which help lower total and LDL "bad" cholesterol and maintain HDL 'good' cholesterol levels, which can support a healthy heart. Even salt, when eaten in moderation as part of a balanced diet, is essential for the body."
Wow! Based on what Frito-Lay® is allowed to state, it sounds like we should be living on these snacks. Who would want to ingest walnuts, pomegranate, or green tea (which FDA now says are illegal drugs) when these fat-calorie laden, mostly-fried carbohydrates are so widely available? According to the Frito Lay® website, Lays® potato chips are now "heart healthy" because the level of saturated fat was reduced and replaced with sunflower oil.45 Scientific studies do show that when a polyunsaturated fat (like sunflower oil) is substituted for saturated fat, favorable changes in blood cholesterol occur.46
Fatally omitted from the Frito-Lay® website is the fact that sunflower oil supplies lots of omega-6 fats, but no omega-3s.47 The American diet already contains too many omega-6 fats and woefully inadequate omega-3. Excess omega-6 fats in the diet in the absence of adequate omega-3s produces devastating effects including the production of pro-inflammatory compounds that contribute to virtually every age-related disease including atherosclerosis. For the FDA to allow Frito-Lay® to pretend there are heart benefits to ingesting their high-calorie snack products, while censoring the ability of walnut companies to make scientifically-substantiated claims, is tantamount of treason against the health of the American public.
Here is perhaps the crux paragraph in the letter the FDA sent to Diamond Foods: "Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]."
This is the "hot button" for the FDA which is evidently and obviously beholden to the American medical establishment. The idea that individuals can "self-diagnose" is absolutely anathema to the FDA, which institutionally seems to take the position that American citizens are generally idiots who will hurt themselves without FDA protections. (How could it be otherwise?)
We could go on and on about the FDA's predictable "regulatory capture" by the mainstream medical community, America's largest food-vendors and, of course, Big Pharma itself. The FDA justifies its authoritarianism using the fig leaf of "double blind" tests. Theoretically double blind (or triple-blind) tests are a foolproof scientific construct. But reality is not so clear. If the testing pool is too small, if there are other agents that are not considered but that might somehow have interfered with the testing, or if the testing procedure itself is corrupted purposefully, then the double blind tests are worthless.
Of course, we would have more faith in a real life application of double-blind testing if the FDA hadn't been immersed in so many scandals and recalls. It seems every time one turns around, the FDA is dealing with another failed drug that promised so much on its initial introduction but then ended up causing kidney and liver problems, or cancer or other unanticipated side effects. These recalls occur with depressing regularity despite the "double blind" protocols that are supposed to prevent such occurrences.
With remarkable fortitude, the FDA stumbles on nonetheless. Knowledgeable health care consumers will note that Europe's Codex Alimentarius treaty, which seeks to ban such things as vitamins (without a prescription) is probably what is really being "harmonized" here. On the FDA website itself we find the following: "Under the WHO umbrella, the Codex Alimentarius Commission develops food standards, guidelines and codes of practice under the Joint FAO/WHO Food Standards Programs. FDA participates and exercises leadership in relevant Codex committees. Harmonization and Multilateral Relations representatives coordinate Codex activities within FDA and other U.S. agencies to encourage the development of science-based, international food safety and labeling standards."
The real problem we have with the FDA is something that is never discussed by the mainstream media. It is the same problem we have in fact with libertarian solutions to government initiatives, on occasion (intellectual property comes to mind). Of course, it is actually good to discuss private market solutions and to challenges one's own preconceptions. (Ayn Rand's dictum comes to mind in this regard: "Check your premises.")
In any event, the REAL way that one can winnow out what is efficacious and what is not is to use the market itself and market failure. This is very simple logic, and it is why the regulatory state (regulatory democracy) is ultimately such an abomination. By substituting regulations enforced by massive government programs and subject to the pressures of the regulatory state itself (and its mercantilist tendencies) one inevitably ends up with something that is usually the reverse of what is intended. The most powerful and corrupt entities are able to use the system to legalize what the market might otherwise likely reject while ensuring that competitive products that might provide a rational alternative are kept off the market.
There is no reason not to allow people to seek out chelation if they wish for their autistic children. There is no reason why groups that are not affiliated with mainstream medicine and its licensing ought not to be allowed to provide chelation treatment – much of which is administered by cream rather than intravenous means. There is no reason, either, why vendors selling walnuts ought to be barred from claiming health benefits.
It is in fact (in America) an unconstitutional abridgement of free speech. But that does not seem to trouble the FDA. What will tell in the long run is the truth-telling of the Internet itself, which is giving both the FDA and the mainstream medical establishment a great deal of difficulty. Codex Alimentarius was supposed to "harmonized" with little fanfare and fuss. Instead homeopathy, vitamin therapies, acupuncture and, generally, alternative treatments have exploded in the past decade. The invasive approach to medicine, which stems from the Anglo-American barber shop with its primitive surgeries was supposed dominate in the 21st century. Instead, we would suggest, resistance is growing.
Regulatory democracy is inherently based on the misconception that the West's feudal law system can replace marketplace competition. With increasing vigor, elite promotions focus on presenting the state itself as the fount of wisdom and the appropriate replacement for the greed and venality of the private marketplace. In fact, this stands civil society on its head. Authoritarian constructs are NOT preferable to the laissez-faire "spontaneous order" of a market-based society.
The concept of regulatory democracy has been pushed relentlessly by the elite in the 21st century. Fear-based promotional campaigns have ratcheted up even as their efficacy has been undermined by the truth-telling of the Internet. Still the misery and corruption gets worse and worse with every regulatory "fix." To continue down this road is madness. "Insanity is doing the same thing over and over and expecting a different result." Are Western regulatory democracies, in aggregate, increasingly insane?