Autism, A Killer App., And A Drug Of Choice

11 Nov

Below is the content from the post of a guest blogger Do’C invited onto Autism Street recently. It concerns the death of Tariq from chelation and the spurious claim that his death was simply down to a bad choice of drugs. I have shut comments off on this post. Please go to Autism Street to comment.

Part One: A Drug Of Choice

Reading here and there on web, one may notice people still scratching their heads about why Dr. Kerry used the drug he did to treat Tariq Nadama. Science blogger, Orac (Respectful Insolence), did an excellent job explaining why there is no right or wrong drug in this case, but there is another bit – Dr. Kerry quite likely used the drug he did, because this is the drug specified in the EDTA chelation “protocol” published by the American College for Advancement in Medicine, a chelation proponent organization.

When CDC scientist Mary Jean Brown recently said “No medical professional would ever have intended to give the child Disodium EDTA”, she was likely unaware of what’s often referred to as the ACAM protocol.

Roy Kerry is a member of ACAM.

The American College for Advancement in Medicine (aka ACAM) is the chelation proponent organization related to the protocol described below.

Protocol citation:
Rozema TC.The Protocol for the Safe and Effective Administration of EDTA and Other Chelating Agents for Vascular Disease, Degenerative Disease, and Metal Toxicity.
The Journal of Advancement in Medicine. 1997;10(1):5-100.

Note: ACAM’s journal is apparently no longer known as The Journal of Advancement in Medicine, and is now known as Clinical Practice of Alternative Medicine.

The protocol is republished in: E Cranton Ed. A Textbook of EDTA Chelation Therapy. 2nd Edition Hampton Roads (2001).

The ACAM protocol for so-called “EDTA” chelation therapy specifically prescribes the use of Endrateâ„¢, the disodium salt of EDTA. Endrateâ„¢ lowers blood calcium. More information about Endrateâ„¢ Edetate Disodium Injection USP safety and professional prescribing is available at this link. Examples of specification of the use of Endrateâ„¢ (DISODIUM EDTA) for so-called “EDTA” chelation therapy within the ACAM protocol include:

P. 9 I. OVERVIEW OF EDTA CHELATION THERAPY

[…EDTA is an abbreviation for the compound Ethylene Diamine Tetraacetic Acid. The form approved by the FDA for the treatment of lead poisoning is calcium EDTA. (1,2,3,4,5) The form of EDTA used to treat atherosclerotic conditions, on the other hand, is disodium EDTA, for reasons that will become apparent later. (6,7,8,9) EDTA chelation therapy is part of a comprehensive therapeutic program for the treatment of atherosclerosis. Other components include nutritional and dietary recommendations, oral nutritional supplements, an exercise program, a stress management program, if necessary, and medication, if necessary. On rare occasions, surgical intervention may be beneficial, but the vast majority of patients can be effectively managed without surgical intervention.

P. 10 II. PROTOCOL OBJECTIVES
[…The purpose of this treatment protocol is to assure maximum clinical efficacy and patient safety in the use of Ethylene Diamine Tetraacetic Acid, (otherwise known as EDTA or disodium Edetate or the disodium salt of Ethylene Diamine Tetraacetic Acid), and other chelating agents in a comprehensive therapeutic approach to the treatment of arteriosclerosis, atherosclerosis, and other disorders in which chelating agents have been shown to be beneficial. A knowledge of biochemistry, pharmacology and the basic clinical sciences is assumed. This protocol is also intended to establish international standards for the safest and most effective use of chelation therapy in a comprehensive multi-modality treatment program. In this protocol the use of the term EDTA will refer to the disodium form of the molecule as distinguished from the calcium disodium or magnesium disodium forms. Where appropriate, these other forms of EDTA will be identified as such. Written and oral examinations are offered periodically by the American and International Boards of Chelation Therapy (ABCT-IBCT), to assure that sufficient comprehension of this discipline has been attained.

P. 11 III. CHEMISTRY AND PHARMACOLOGICAL ACTIONS OF EDTA

A. Chemical Structure
The EDTA discussed in this protocol is the disodium salt of EDTA. It occurs as a white crystalline powder, soluble in water, slightly soluble in alcohol and mildly acidic. (10)

pp. 43-45 3. Supplies and Equipment

e. Disodium EDTA (Ethylene Diamine Tetraacetic Acid), NOT the calcium-disodium salt), is readily available in the United States in 20 ml (3 gram) vials, and is best tolerated without a chemical preservative.

Part Two: Confusion

The protocol clearly indicates Endrateâ„¢ is the drug to be used. Elsewhere, and especially in information readily available to the public, this is unclear and often confusing. ACAM, for all its reassurance about the safety of so-called “EDTA” chelation therapy, rarely identifies Endrateâ„¢ by its proprietary or generic name as the drug prescribed by their members according to the protocol – rather ACAM apparently refers to the drug as “EDTA.” For example, a recent ACAM press release announced a new program to credential chelationists:

The next twelve months will be a most important time for the staff and membership of the American College for Advancement in Medicine (ACAM). With the help of Applied Measurement Professionals, Inc. of Lenexa, Kansas, ACAM will be undertaking the development, validation, and administration of a national program for use in credentialing individuals as Certified Chelation Therapy Practitioner (CCTP). Chelation therapy is currently used as a treatment for blocked blood flow in arteries (atherosclerosis) by administering ethylenediamine tetraacetic acid (EDTA), a man-made amino acid, into the veins. While EDTA has been used in the past to treat lead toxicity, EDTA also “chelates” calcium, a component of atherosclerotic plaque. This therapy has been employed to improve blood flow through previously narrowed blood vessels, help restore lost bodily function and reduce pain.

This is unusual because there is no drug named “EDTA”. In fact, it ‘s not necessarily clear that the compound exists except as a disodium or calcium disodium salt. This brings up an important point: Endrateâ„¢ is trade name for the disodium salt of EDTA, and Versenate is the trade name for the calcium disodium salt of EDTA. Versenate is labeled for treatment of lead poisoning; because it contains calcium (unlike Endrateâ„¢), Versenate binds with lead preferentially, and leaves calcium alone. More information about Calcium Disodium Versenate (Edetate Calcium Disodium Injection USP) safety and professional prescribing is available at this link.

It’s also unusual that physicians would use the generic term “EDTA” when there is a possibility that doing so might increase the likelihood of confusing Endrateâ„¢ with Versenate. Sound-alike drug names are widely known to be a serious threat to patient safety. Several organizations work to prevent situations in which drugs have similar sounding names, as does the Food and Drug Administration. The sentence “While EDTA has been used in the past to treat lead toxicity, EDTA also “chelates” calcium, a component of atherosclerotic plaque” conflates Endrateâ„¢ and Versenate into a single product – “EDTA.”

This is precisely what not to do. In fact the CDC recently reported a two year-old child died after the unintentional administration of Endrateâ„¢ instead of Versenate. Source: Deaths Associated with Hypocalcemia from Chelation Therapy – Texas, Pennsylvania, and Oregon, 2003–2005. MMWR Weekly. March 3, 2006 /
55(08);204-207.

The “Position Paper on EDTA Chelation Therapy” published by the American College for Advancement in Medicine is sort of baffling. “Disodium magnesium EDTA” is used once, while “EDTA” is used 25 times. The following passage exemplifies the confusion because it seems to suggest Endrateâ„¢ and Versenate are one and the same thing, called “EDTA”.

Ethylenediaminetetraacetic acid (“EDTA”) is a synthetic amino acid first used in the 1940’s for treatment of heavy metal poisoning. It is widely recognized as effective for that use as well as certain others, including emergency treatment of hypercalcemia and the control of ventricular arrhythmias associated with digitalis toxicity.

In point of fact, Versenate was “first used in the 1940’s for treatment of heavy metal poisoning” and is currently labeled for use in treatment of lead poisoning. On the other hand, Endrateâ„¢, the drug specified in the protocol, is indicated for use in “emergency treatment of hypercalcemia and the control of ventricular arrhythmias associated with digitalis toxicity.”

The assertion below is misleading because it refers to the use of Versenate to treat lead poisoning in children, yet the ACAM protocol appears to direct physicians to use Endrateâ„¢ while apparently emphatically directing them not to use Versenate.

Whenever chelation is used in its widely-accepted role to combat lead poisoning, the dosages given even to children are administered much more rapidly than those administered to adults under this protocol.

How peculiar is it that that ACAM’s telephone number is 800-532-3688 or 800-LEAD-OUT? What’s the point of this?

Part Three: Safety In Death

Broad claims of safety are made for so-called “EDTA” chelation therapy in the ACAM position paper. For example:

The Food and Drug Administration determined that EDTA chelation therapy was safe prior to approving the Investigational New Drug protocol for the ongoing double-blind placebo-controlled studies.

It may (or may not) be true that FDA determined “EDTA chelation therapy
was safe” preparatory to beginning research subject to an Investigational New Drug application, but it’s undoubtedly true that a “safe” drug doesn’t carry a “black box warning” on its label. Endrateâ„¢, however, does:

WARNING The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

The position paper emphatically argues that “restriction to FDA package insert guidelines is inappropriate” with the obvious implication that the use of Endrateâ„¢ for so-called “EDTA” chelation therapy is simply an off-label use of the FDA-approved drug Endrateâ„¢, and as such ought not be restricted. While it’s generally true that FDA doesn’t regulate the off-label use of marketed drugs by physicians, it’s not clear that the use of Endrate in so-called “EDTA” chelation therapy is an “off-label” use. The drug label includes a contraindication warning physicians that Endrateâ„¢ “is not indicated for the treatment of generalized arteriosclerosis associated with advancing age.” Under what circumstances is a contraindicated use an off-label use?

The ACAM position paper incorporates a long quote by JAMA editor John Archer supporting the right of physicians to use approved drugs for off-label or unlabeled indications, ostensibly to hammer the argument home. Ironically, FDA assistant commissioner Stuart Nightingale wrote a response to Dr. Archer in a subsequent issue of the journal and used the example of Endrateâ„¢’s contraindication for use in arteriosclerosis to make the point that physician freedom was not absolute. Archer agreed with Dr. Nightingale in his reply. Source: Nightingale SL. The FDA and drug uses: Reprise. JAMA.1985;253:632.

The claim that there have been no fatalities is difficult to accept in the face of evidence to the contrary:

The safety of this therapy, when properly administered, is not an issue. It is estimated that over 500,000 patients nationally have been safely treated with this therapy by physicians utilizing the protocol developed by the American College for Advancement in Medicine. No reported fatalities have occurred in the United States when the ACAM protocol has been followed.

Following the deaths of fourteen people treated with Endrateâ„¢ in so-called “EDTA” chelation therapy the federal government sued to enjoin a notorious chelationist from all use of the drug – Source: United States v. An Article of Drug*** Diso-tate, et al. It might be objected that this physician used a higher dose than that specified by the ACAM protocol, but the report of expert medical reviewer J. David Spence, M.D. identified the dose used as 3 g. (p. 3), the same dose indicated in the protocol, and in the FDA-approved label for Endrateâ„¢ – Source.

There are other deaths associated with the use Endrateâ„¢ in so-called “EDTA” chelation therapy in addition to these fourteen patients. For example, in March of 1995 Jerry Osuch died the day after receiving his tenth session of so-called “EDTA” chelation therapy as the patient of Dr. Neil Ahner, a physician with “board certification” in chelation therapy, and a member of the ACAM board of directors.

On February 25, 1992 Louis Labbe died following so-called “EDTA” chelation therapy administered by Dr. Daniel Roehm. According to the Sun-Sentinel:

Labbe’s case outraged Dr. Stephen Nelson, then a Broward associate medical examiner. Nelson complained to the state’s medical licensing board that, given the gravity of Labbe’s illness, Roehm should have hospitalized him on his first visit. The Florida Board of Medicine agreed. In June 1992, a three-member panel found probable cause to believe Roehm’s care of Labbe fell below accepted standards. Roehm’s medical records “failed to demonstrate that the doctor even understood how serious and how sick this patient was and how important it was to get some intensive care and some aggressive therapy,” argued Larry McPherson, a state health care agency attorney. The state went on to accuse Roehm of gross malpractice in treating Labbe. Roehm relinquished his medical license in July 1993 to avoid further board action against him. He died in 1996.

Source (for both Osuch and Labbe): They wanted to look better, feel better. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-11.

The survivors of Susan Alexander, a 56-year-old woman who died in 2002, filed suit against Progressive Medical Group (PMG), several of its staff members, and Metametrix (a laboratory that offers nonstandard tests). The suit accused the defendants of negligence, fraud, racketeering, and wrongful death. According to the complaint, Ms. Alexander’s heart stopped beating during chelation therapy for alleged lead poisoning that had been diagnosed with a fraudulent test – Source.

On October 31, 1993, the man identified as “W.L.H” died during a course of treatment with Endrateâ„¢ for so-called “EDTA” chelation therapy prescribed by Dr. Eleazar Kadile – Source.

Part Four: What About Autism?

How is it possible for former president and long-time ACAM member Ralph Miranda, M.D. to make like a statement like the following after the death of Tariq Nadama?

“If the child’s death is tied to chelation therapy, it would be the first associated with the procedure since the 1950s”, said Dr. Ralph Miranda of Greensburg. Miranda is the former president of the American College for Advancement in Medicine, a group that sets clinical practice and education standards for chelation and other, similar therapies.

Source: Boy dies during autism treatment. Karen Kane and Virginia Linn. Pittsburgh Post-Gazette. 2005-08-25.

Inconsistent statements about the safety of Endrateâ„¢ and confusion over the identity of the drug used in so-called “EDTA” chelation therapy tends to cast doubt on the integrity of ACAM and its members and their commitment to provide accurate, factual information to the public. Patients considering so-called “EDTA” chelation therapy would do well to remember the case brought by the Federal Trade Commission charging ACAM with “false advertising over promotion of chelation therapy.” This brief synopsis is taken from the FTC press release announcing the consent agreement on December 8, 1998:

ACAM, based in Laguna Hills, California, is an association comprised principally of physicians who administer traditional and complementary/alternative medical therapies including chelation therapy. ACAM promotes chelation therapy in brochures and promotional materials and by maintaining a Web page on the Internet. Chelation therapy involves the intravenous injection of a prescription drug, ethylene diamine tetra acetic acid (EDTA), which is approved by the Food and Drug Administration for the limited use of ridding the human body of excess heavy metals.

According to the FTC’s complaint detailing the charges, ACAM’s advertisements and promotional materials for chelation therapy contained such statements as:

Chelation therapy is a safe, effective, and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery;

Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms; and

Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy.

Through the use of such statements, the FTC alleged, ACAM has represented that EDTA chelation therapy is an effective treatment for atherosclerosis, and that ACAM possessed and relied upon a reasonable basis when making the representations.

The FTC charged that the representations are false and misleading because ACAM did not possess and rely upon a reasonable basis to substantiate the claims – Source.

Six years later in response to the death of Tariq Nadama, ACAM issued a press release in which they invite the public to believe so-called “EDTA” chelation therapy is safe on the basis of the safety and efficacy of “EDTA” for treatment of lead poisoning. ACAM apparently forgot to mention they’re referring to Versenate – the drug their protocol apparently directs physicians NOT to use for so-called “EDTA” chelation therapy. ACAM asserts, “millions of infusions have been administered … without any deaths being noted.” Nevertheless deaths have occurred.

However, it is important to note that IV EDTA is an FDA approved treatment for lead toxicity in children and adults, with an excellent track record for safety. Millions of infusions have been administered over the last 30 + years, without any deaths being noted, when used in accordance with established guidelines. These guidelines were developed by experts in the field and include the intravenous administration of Magnesium Disodium EDTA.

ACAM asserts that, “Chelation Therapy has been clinically helpful for many autistic children who have evidence of heavy metal burdens, and have an impaired ability for detoxification.”

Shouldn’t ACAM explain to the scientific community and to the public why we should believe that lowering blood calcium would lead to clinical improvement in autistic children?

Shouldn’t ACAM explain to the scientific community and to the public why we should believe Endrateâ„¢ would be safe and effective in removing “heavy metals” – like the implied mercury – when the pharmacology of Endrateâ„¢ is sufficiently well known to permit experts to conclude Endrateâ„¢ doesn’t bind effectively bind and remove mercury. In simple terms, if Endrateâ„¢ doesn’t get to the places where mercury accumulates in the body, how would it bind and remove it?

Shouldn’t ACAM provide evidence to the scientific community and to the public proving that “many autistic children … have evidence of heavy metal burdens” (bona fide experts using valid laboratory tests have been unable to do so)?

Shouldn’t ACAM provide evidence to qualified specialists in pediatrics and toxicology that autistic children can be diagnosed with an “impaired ability for detoxification” and explain how correcting this impairment would lead to clinical improvement?

Is it possible that the parents of Tariq Nadama had no idea what they might really be getting into when their son was brought to the U.S. for chelation therapy that turned out to be a fatal attempt to treat him?

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