Chelation: Compounding Pharmacy’s Problems

Chelation is the provision of a substance to increase the body’s excretion of heavy metals. In poisoning situations (lead, aluminum, iron, etc.), chelation is medically necessary, objectively effective, and approved for use. But the same term has a completely different meaning in the alternative medicine universe, where proponents often believe heavy metal toxicity is the “one true cause” of disease, and chelation can undo microvascular inflammation, atherosclerosis, and even aging itself. From early days as an unproven treatment of coronary artery disease, its use has expanded to include autism, Alzheimer’s disease, cancer, and dozens of other diseases. Today, chelation is widely available. Regrettably, my own profession, pharmacy,  facilitates this pseudoscience by manufacturing and selling chelation products.

Provoked urine tests are a common entry point to chelation therapy. Patients are given a product to provoke heavy metal excretion. The urine is tested and the patient is informed that they’re “toxic” and require chelation. Unfortunately, these results are meaningless and provide no evidence that chelation is medically necessary. But that’s the justification used for advocating a treatment regimen that will be useless at best and fatal at worst. A recent Medical Letter review concluded:

Medical Letter consultants believe that the use of chelation therapy in non-standard protocols for unsubstantiated indications should be discouraged. The results of provoked urine testing are not an acceptable basis for such treatment.

Providing chelation to patients isn’t a straightforward matter. It’s typically an intravenous infusion (though there are some oral products). Unless you’re part of the dubious TACT trial, which has administration centres across the United States and Canada, there are few products commercially available. For example, edetate calcium disodium (EDTA) is approved for sale in the United States but not Canada. Edetate disodium (also called EDTA) is not approved for sale in either country. But these products are widely available: they’re manufactured by pharmacists in pharmacies.

Not that many decades ago, almost all prescriptions were custom manufactured, or compounded. The pharmacist combined raw chemicals into dosage forms like capsules, tablets, liquids and creams. Compounding allows complete customization of a prescription — from a new strength of a capsule, to a liquid form of a tablet, to creams with combinations of ingredients that can be completely individualized. With the proper equipment, even sterile injectables can be made.

These days, commercial manufacturers supply most drug products, and the need for in-pharmacy compounding has dwindled. At the same time, regulatory oversight, by agencies like Health Canada and the FDA, ensure product uniformity, purity, potency, efficacy, and safety standards for consumers. However, any pharmacy is still capable of providing compounded prescriptions, and some specialize, calling themselves “compounding pharmacies” and aggressively promoting the service. In compounding pharmacies, the same level of regulatory oversight and scrutiny does not exist. Professional Compounding Centers of America, provides training, formulations (recipes), and raw ingredients to compounding pharmacies. To pharmacies and pharmacists, compounding is a business opportunity, and an ideal way for independent pharmacies to compete against large chain stores, which typically do not offer these services.

The relationship between compounding pharmacies that prepare chelation treatments, and the practitioners that prescribe these products, is a symbiotic one — each group needs the other to offer these treatments. Consider this article in a pharmacy publication, entitled, Chelation for Antiaging: The Pharmacist’s Role, which touts the benefits of chelation:

Removing toxic metals from the body is one of the most important antiaging therapies available. The results from many scientific studies indicate that an increased accumulation (body burden) of toxic metals—such as mercury, lead, cadmium, and arsenic—increases the risk for common diseases, including cancer, cardiovascular disease, diabetes, Alzheimer’s disease, and attention-deficit/ hyperactivity disorder.


Serious toxic-metal problems must be managed by an experienced physician. It is becoming increasingly recognized, however, that virtually everyone has a chronic accumulation of toxic metals in the body, which contributes to health problems and accelerates the aging process. Pharmacists who take the time to become knowledgeable about the correct use of OTC detoxification products can provide a much-needed service. At the same time, guiding customers on detoxification protocols also can become a new source of income for pharmacists who charge for their consultation time.

It’s a huge, burgeoning, evidence-free marketplace that pharmacies have stepped in to fill. College Pharmacy in Colorado has a “Hot List” of chelation protocols including the DAN! protocol — all of which can be ordered. Dallas-based ApothéCure offers a huge list of intravenous chelation options. Quantum Pharmacy in San Francisco touts a long list of benefits from EDTA infusions. Smith’s Pharmacy in Toronto offers chelation among a number of biomedical treatments for autism.

If there’s no evidence to support its use, why the persistent interest in chelation? Despite anecdotal evidence of success, my sense is chelation is simply another manifestation of sympathetic magic: specifically, contagious magic. Patients remove these non-existent “toxins” and become “cleansed” through a sciencey-looking purification ritual that is repeated dozens of times. With no objective measurement of efficacy, protocols and treatment measurements vary widely, but typically lack a defined endpoint. According to the Medical Letter, regimens of 20-50 infusions are common, at costs of $100-$300 per treatment.

Regulators have had difficulty finding a balance between allowing the legitimate practice of individualized compounding of products to meet unique patient needs, and the desire to limit pharmacy compounding as a workaround to prepare products that are pointedly not approved for use, or are used as a means of commercially selling products that require FDA evaluation and approval for sale. The FDA has taken action against a number of pharmacies who have been alleged to contravene federal food and drug regulations. There’s been little action from pharmacy regulators themselves against these practices.

Unfortunately for patients, a network of pharmacies continues to facilitate the provision of compounded chelation therapies, in the absence of any persuasive evidence to support their use. That state and provincial pharmacy regulators ignore these activities is an embarrassment to the profession of pharmacy, and consumers quite literally are paying the price.

Posted in: Health Fraud, Medical Ethics, Pharmaceuticals

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33 thoughts on “Chelation: Compounding Pharmacy’s Problems

  1. qetzal says:

    Regulators have had difficulty finding a balance between allowing the legitimate practice of individualized compounding of products to meet unique patient needs, and the desire to limit pharmacy compounding as a workaround to prepare products that are pointedly not approved for use, or are used as a means of commercially selling products that require FDA evaluation and approval for sale.

    Can you give some examples where there’s a clear and legitimate need for individualized compounding?

  2. pedsnurse says:

    @qetzal re: legitimate need for individualized compounding, I work in a large pediatric center where many of our patients need compounded medications either because they need them in liquid form or such small doses that the manufacturers do not provide, an example is rovadio aka viagra which is used to treat pulmonary hypertension in infants and children.

  3. Angora Rabbit says:

    Great post and I am in complete agreement with one caveat, that I hope you are not suggesting that all compounding be banned.

    >Can you give some examples where there’s a clear and legitimate need for individualized compounding?>

    My example come from veterinary medicine, where my vet prescribes medications in off-label format because almost zero drugs have been approved for use in the species that I do rescue work in. Pina colada-flavored fluroquinolones are a big hit with our foster rabbits in treating upper respiratory infections, as an example. It can be challenging to “pill” a rabbit and the injections create nasty subcutaneous abscesses. We rely on compounders to supply certain medications in oral format. Liquids allow me also to precisely control dose based on weight, rather than trying to quarter or eighth-cut pills and tablets.

    I would love to see the chelators put out of business; the practice is horrific and a great risk to human health. I cannot imagine someone doing this in an i.v. setting. But there needs to be a balance between legitimate and illegitimate uses, and I am not sufficiently informed to see how such legislation could be constructed.

  4. WilliamLawrenceUtridge says:

    Other examples are turning a pill into a capsule, lozenge, liquid, skin patch, topical cream or suppository because of swallowing difficulties; allergy to the filler compounds used in pills; patient preference for one modality over another; adjusting dosing (two small pills into one big one, one big one into two small ones) for convenience; possibly if you’re a really large or really small patient. There’s a fair number of possible reasons, but they’re generally pretty rare as they’re depend on unusual patient characteristics that make conventionally-manufactured products inappropriate for some reason. There’s a reason most companies produce the variations and doses they do, it’s ’cause they work well for most people.

    Compounding is big in the bioidentical hormone replacement therapy crowd as well ( It’s the only way you can get certain compounds that are otherwise illegal or unavailable – estriol is an example, you can only get it from a compounded preparation because it lacks FDA approval. Otherwise, every single hormone is available as an FDA-approved preparation manufactured by a pharmacutical company which, evil as they are, still maintain good quality control standards.

    The main reason BHRT is so popular in compounding pharmacies is because you pay a huge premium to get them custom mixed. They’re taking raw chemicals (purchased from those evil pharmacutical companies they rail against), mixing you up a poorly-controlled dose and selling it to you for three times the price of the FDA-approved, quality-controlled product that’s already available.

    Not to toot my own horn, but I substantially wrote most of the BHRT article on wikipedia and think it’s a pretty good representation of the mainstream opinion. There’s lots of great articles freely available in the references section.

  5. windriven says:

    I find myself in the uncomfortable position of asking: what’s the big deal? On the one hand woo in any form is to be resisted. But on the other, chelation seems to be among the more benign forms of woo out there.

    I am of the (perhaps totally unfounded) belief that IV chelation therapy must be prescribed by and administered under the supervision of a licensed physician. If not, anyone stupid enough to let Buffy the Toxic Metals Slayer stick a needle in their arm deserves what they get.

    That there is no good evidence supporting chelation therapy for anything other than acute heavy metals poisoning should be enough to warn all but the slack-jawed. That said, there are any number of mainstream medical procedures that are or have been used routinely without robust supporting science.

    I for one would much rather see chelation therapy remain the province of trained professionals – physicians and pharmacists – than go underground to be administered by the local hydrotherapy squirrel. Eventually, professional education and peer pressure should be enough to snuff the practice out.

  6. Robin says:

    @qetzal, in addition to pedsnurse’s examples, I’ve used an apothecary to have medication made into liquid for an elderly person who was having trouble swallowing due to neurological problems. Also, veterinarians sometimes recommend meds in transdermal form or tuna flavored paste for cats who refuse pills.

  7. @windriven:

    The problem is that most licensed physicians who do “chelation therapy” are Buffy the Toxic Metals Slayers. Look here for evidence that IV chelation is not one of the more benign forms of woo, and that there has been plenty of professional education and peer pressure over about 4 decades, but all it’s done is embolden the chelation quacks and teach them how to be politically savvy. Look here for a discussion of how they’ve co-opted professional “education” and other such trappings to further their cause. Look here and here for examples of how unprofessional those allegedly trained professionals are.

    The most popular chelation agent, Na2EDTA, was made illegal in the U.S. a couple of years ago, but it’s not clear if the practice has diminished much—no surprise, considering that many of the same crew administer IV hydrogen peroxide, which has never been legal.

  8. icewings27 says:


    “tuna flavored paste” YUM! I’m going to ask if I can get my next Rx compounded that way for me.

    On topic – My sister did some kind of chelation therapy to remove “toxic heavy metals” and also takes colloidal silver to supposedly heal everything from her bad back to her bad skin. I’m trying to educate her – I send her links to SBM frequently – but it boggles my mind that she’s trying to remove one kind of metal and swallowing another at the same time!

  9. @windriven:

    I almost forgot: chelationists have become very good at arguing that what they are doing is always about heavy metals poisoning (although not of the acute kind). They have been quite convincing to patients and politicians, even if not to scientists and other physicians. See the first link in my previous comment for a discussion with references (it’s under “Chelation Gains a User-Friendly Hypothesis”).

  10. vicki says:

    Icewings27: You might suggest that your sister find some pictures of the writer Evangeline Walton, whose skin had been badly discolored by colloidal silver. She might not have “bad skin” in the sense of acne, but blue skin is not very popular either.

  11. TsuDhoNimh says:

    My pharmacist dad used to compound various things – often with a different or no flavor for pediatric patients, custom dosages in ointments, to overcome specific administration challenges.

    He would not be happy to see the BHRT and chelationists taking over.

  12. Joe says:

    What kind of publication is Pharmacy Times? One would hope they were inundated with complaints over that drivel.

  13. Zetetic says:

    I have an old Navy buddy, a pharmacy officer, who retired and went to work for a designer compounding pharmacy in southern California. I’m not sure if they’re doing chelating agents but I guess they’ll mix up just about whatever you want.

    I have a question about compounding… Do custom combinations of drugs and strengths run afoul of individual FDA approvals? Wouldn’t it be somewhat akin to off-label use if compounding represents use of the drugs in different ways than what’s approved by FDA?

  14. Roger Kulp says:

    I have one of those rare cases of autism,that also has diagnoseable metabolic disease,along with it,in my case multiple defects of folate metabolism,I have 5,10 MTHFR deficiency

    I have MTRR deficiency

    As well as folinic acid responsive seizures,they’re not just for babies,and a couple of other metabolic conditions they are still working on diagnosing.I am only getting names on paper for all these things in the last year,after decades of undiagnoseable sickness,and a half a dozen or so times of nearly dying in hospitals,while doctors had no idea what was going on.

    I am finally starting to have some semblance of a normal life. High dose MB12,and folinic acid has been a big part of this. Believe it or not,it’s kind of hard to get this stuff,even if you have prescriptions.I have to get mine filled at two different compounding pharmacies,one where I live,in New Mexico,the other in Georgia. It is a little difficult to give yourself regular injections,if you have both sensory,and motor coordination problems like I do.

    I get my MB12 as a nasal spray.The first pharmacy I tried was that big one that sponsors the big antivax sites,and conferences.They charged me almost $200 for a bottle,that lasted a month.The other people,in Georgia,charge me $60 for a bottle that lasts two months.

    Compounding is one issue chelation is another.There needs to be some kind of outright ban on the use of all types of chelators on children,say twelve and under,unless it is an absolute life or death matter.While I do believe people can get very sick from mercury and metals,from amalgam fillings,these are usually adults.I would be willing to wager most of the chelators sold in the last twelve years,have been sold to parents for their autistic children.Many of them chelate their children for five,or ten years,and openly admit their children may need to be chelated for life.You know this business of chelating for Alzheimer’s,diabetes,and heart disease is just an outgrowth of the vaccine-thimerosal-autism stuff

    And this doesn’t even get into the questionable practices of the labs that do a lot of this testing for “metals” in the first place.

  15. daedalus2u says:

    Some years back some of the compounding pharmacies were putting out nicotine lolly pops and selling them over the counter (as I recall).

    From Sigma, nicotine is available for ~$6/gram; the nicotine in about 6 cartons of cigarettes.

  16. windriven says:

    @ Dr. Atwood

    Thank you for the reference sites. I stand corrected.

    I would like some additional perspective if possible. You said in the Medscape that:
    “Since the mid-1970s, court documents and newspapers have reported at least 30 deaths associated with IV disodium EDTA, most of it administered by ACAM members.”

    Do you have any idea how many infusions were conducted during that period? 30 out of 30,000 is pretty concerning. 30 out of 3,000,000 maybe not so much as there is always the possibility that there were other risk factors or even that Na2-EDTA was correlated but not causative.

    In any event you made the point convincingly that the therapy is pure nonsense. And of course IV infusion of anything carries some risk and should not be used recklessly.

    All of this leads me to a continuing problem I have with the apparent impotence of professional boards in dealing with physicians and pharmacists who stray deep into the weeds of sCAM. Dr. Novella was kind enough to send me some links that explain the problem but really do not excuse it. At some point the boards are going to have to man up and face the potential for litigation as a necessary risk or abdicate their ethical responsibility and accept the consequences to their profession and to the population of health care consumers.

  17. @windriven:

    I don’t know how many infusions were administered during that time. If you look at the same article linked above, you’ll see, under “The Risks for Na2EDTA Chelation and Supplements,” that

    the risk for a serious, but probably manageable, complication occurring at some time during a course of 20–30 infusions is in the realm of 1% to 5%; the risk for minor but annoying side effects is probably 5% to 20%; there is almost certainly decalcification of bone, because excreted calcium must be replaced from the body’s stores, but it may be quickly replenished from dietary sources and hence inconsequential – or perhaps not, especially in postmenopausal women. We simply don’t know. The risks for other long-term or subtle complications, some of which are discussed below, are also unknown.


    We have previously cited deaths associated with the chelation practice of H. Ray Evers. These were judged due to renal failure, congestive heart failure, and hypoglycemia. There is evidence that Dr. Evers could have prevented several deaths if he had identified and managed complications in a timely and competent fashion. The initial complications would nevertheless have remained. The only significant difference between the dosing of Na2EDTA in Dr. Evers’ cases and that of the TACT is that Evers gave infusions 5 times/week for 3–4 weeks, followed by an indefinite rest period, whereas the TACT gives 1 infusion/week for 30 weeks. That difference may explain Evers’ complications, but perhaps not: Dr. J. David Spence, one of the government’s expert witnesses, reckoned that over a 2-year period at Meadowbrook Hospital, Evers had treated about 600–700 patients with chelation. The incidence of serious complications on the basis of only deaths – as few as 13 or as many as 21 – was thus 1.8% to 3.5%, similar to the incidence of serious, albeit appropriately treated, complications reported by the trials cited above.

    We also know two more things: that the ACAM claims no deaths in 30+ years, which is false, and that the benefit of infusions is zero, thus making any risk unacceptable.

    I believe that if Na2EDTA is administered slowly enough, the risk of death is quite low, because acute hypocalcemia, the cause of most deaths, will not occur. Nevertheless, everyone in medicine knows that accidents can happen—which in this case means that IV infusions might proceed much faster than planned—and that since this is a reality, there is no justification for infusing an ineffective concoction that can be lethal if given too fast.

  18. windriven says:

    @ Dr. Atwood

    Thanks for your willingness to take the time to provide those citations. I truly appreciate it.

    “the risk for a serious, but probably manageable, complication occurring at some time during a course of 20–30 infusions is in the realm of 1% to 5%;”

    Even back in the days of ether and cyclopropane I don’t think that risk of general anesthesia was nearly that high and the benefits of a general are indisputable! If you’re going to be at ASA I’ll buy you a beer.

  19. Angora Rabbit says:


    In addition to Dr. Atwood’s references, tucked in his response are his comments about hypocalcemia. I hadn’t seen this discussed here yet, and maybe I missed it? Many of these chelators are not selective for cadmium, mercury, or whatever else the woo-meisters are peddling. EDTA* binds calcium quite nicely and EGTA binds magnesium very well. In fact we use these in molecular biology experiments to inactivate enzymes that could otherwise damage our assays. They have also been added to foods as preservatives, chelating metals to reduce oxidation and microbial growth. I can’t imagine how infusing them would somehow selectively remove the Hg/Cd/Pb etc without binding other divalent cations. This is why it needs to be done under controlled conditions with knowledgeable medical experts. I know a little bit about real medical chelation to remove lead from true poisonings, and it isn’t a trivial treatment.

    *There’s irony for you. The same woo-sters who complain about EDTA preservatives in food then turn around and inject themselves with the stuff to “detoxify.” I can’t rationalize it – it makes my head hurt.

    I once spent an uncomfortable several days with a woman who was so proud that she had paid a small fortune to have her mercury-laden fillings removed and was undergoing chelation therapy to remove all those nasty toxins. I think my tongue was shortened I had to bite it so hard. Sad, sad, sad, and I don’t know that she had that kind of $ to spend.

  20. I’ve heard from several sources that lead poisoning is still an issue in children, particularly in urban areas such as Detroit where up to 6% of young children have documented lead poisoning. I’m curious, when treating real cases of lead poisoning in children, is oral or IV chelation used in the standard of care? Is this something that would be supplied by a standard pharmacy, a compounding one?

    Sorry to ask remedial questions, I did do a google search but wasn’t coming across a satisfactory answer.

  21. WilliamLawrenceUtridge says:

    Roger Kulp’s comment seems to illustrate a general distinction both within compounding pharmacies and medicine/alternative medicine itself. The willingness to charge extra goes hand in hand with an unethical use of inappropriate and/or unproven treatments and flat-out dangerous advice.

    Compounding has a useful role, but that’s for needed customization. Most people don’t need their drugs delivered in a customized or unusual dosage/modality. It’s something that all pharmacists should be able to do if necessary, with a random distribution that probably doesnt’ require specialization. Getting custom compounding adds considerably to any risk of taking medication in the first place (dose too high or too low) and in the woo case, to no demonstrated benefit. It’s used as a profit-driver, like a chiropractor selling vitamins.

  22. WilliamLawrenceUtridge says:

    Zeteticon, in the case of BHRT, custom compounding is used as an outright runaround of the prohibition on estriol. In Europe it is a standard estrogen for vasomotor symptoms due to menopause, but in the US it was grandfathered in and now lacks approval for production as a full-on medication because the appropriate studies have been done. It’s possible it will never be approved there because it’s a nonpatentable, naturally-occurring compound and therefore most companies are unlikely to see significant profits. There’s some interesting/critical stuff on compounding in the following references. BHRT and compounding are so heavily intertwined that they’re usually considered synonymous but it’s really two separate ideas: hormones molecularly identical to endogenous ones, and customized compounding of said molecules. The latter may have an advantage since it permits transcutaneous rather than oral preparations (and dermal application may have advantages due to its avoidance of the liver) but really – most compounds you can get transdermal versions anyway direct from a pharmacutical company. Proponents of BHRT promote it as if it were risk-free because they’re “natural” but all drugs, including hormones, have side effects. Nature doesn’t care if you live or die.–%20Cirigliano.pdf

    The FDA also has some info on compounding in their paper on BHRT:

  23. Is everyone aware that comments are off for Sam Homola’s latest piece? Is this deliberate or an oversight?

  24. squirrelelite says:


    It looks like it is open for comments now.

    Evidently, this is some new quirk in the WordPress blog posting process. I noticed it on one of the last few blogs the other day, but it only lasted a few seconds before it opened for comments.

  25. MI Dawn says:

    @Roger Kulp: actually, chelation for arteriosclerosis, etc, has been going on much longer than chelation for autism. I can recall hearing about it when I was in nursing school in the 80’s (as a form of quack medicine, I might add…)

  26. Drat, I had a post here that was in moderation, now it’s disappeared.

    In short and without the link. I just wondered if chelation, used orally or IV, is standard of care in verified lead poisoning in children? Here in Michigan, Detroit is known as having a higher than average rate of lead poisoning, 6% in young children. If so, does that require a compounding pharmacy?

    I tried googling the topic, but didn’t find a good source.

  27. Chris says:

    Michele, it depends on the level of lead poisoning, due to the risks of chelation itself. The Mayo Clinic site used to have the levels listed, but it seems to have changed (something must have changed lately for reliable sources to change their pages). I only found a Wiki page which references a paper:

  28. TsuDhoNimh says:

    @ micheleinmichiganon I just wondered if chelation, used orally or IV, is standard of care in verified lead poisoning in children? …. If so, does that require a compounding pharmacy?

    If the levels are high enough, yes. But it’s Calcium EDTA, not sodium EDTA. That means it’s not sucking calcium out.

    The patient is hospitalized and blood levels of various things are carefully monitored during and after chelation to make sure it’s working as intended.

    There are also continuous 24-hour urine collections which the lab gets to test for excretion quantities (not single specimens, every drop of pee from one whole day is collected) to see how much of the load is being removed.

    Chelation is SERIOUS STUFF!

  29. Bogeymama says:

    Almost every pharmacy compounds on a daily basis, most at the request of dermatologists who order unique concentrations and combinations of many different ingredients. Diclofenac gels in varying strengths up to 10% are also very popular, and are also cheaper and safer compared to their oral counterparts. Compounding doesn’t always mean more expensive – raw ingredients come very cheaply in many cases. A pharmacy here compounds diaper cream that is cheaper than anything you can buy.

  30. Joe says:

    @Bogeymama on 05 Oct 2010 at 12:07 pm “Almost every pharmacy compounds on a daily basis, most at the request of dermatologists …”

    I was going to write something like that; however, I don’t know if the mixtures devised by dermatologists are justified. For example (in another situation), the American College of Ob/Gyn says the BHRT mixtures are not justified.

    If you can buy a “compounded” cream that is less expensive (and is safe, effective and well-preserved) compared to a commercial product- that sounds good. However, one wonders if the “compounded” product you mention is not, in fact, a commercial product that is bought in bulk. I have great respect for pharmacists and doubt that you can get their time so cheaply (their time is often (usually?) more significant than the price of raw materials). They are, at the same time, merchants who may offer good, commercial products at low cost.

  31. TsuDhoNimh – Thanks to you also for the answer.

    I was under the impression that some sort of drug treatment (a form of chelation or otherwise) was used in all cases of lead poisoning. I can see now that due to the risks it only appears to be used in the most severe cases.

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