Quackwatch being sued by "Doctor's Data", a laboratory that caters to chelation therapists

Quackwatch is being sued by "Doctor's Data", a laboratory that caters to chelation therapists. See the post "Why Doctor's Data Is Trying to Shut Me Up" by Stephen Barrett, MD at this link.

(I have no connections to either Quackwatch or "Doctor's Data", and do not know Dr. Barrett. However, this case caught my eye.)

From a law firm, Augustine, Kern and Levens, Ltd. of Chicago:

Dear Dr. Barrett:

It has recently come to the attention of our client, Doctor's Data, Inc., an Illinois corporation, that you have, on a continuing basis, harmed Doctor's Data by transmitting false, fraudulent and defamatory information about this company in a variety of ways, including on the internet and in other publications. Doctor's Data is shocked that you would intentionally try to harm its business and its relationship not only with doctors but also with the public. Doctor's Data has also learned that you have apparently conspired with and encouraged individuals to seek litigation against it, and have filed false complaints at various government and regulatory agencies against Doctor's Data.

"It is never libelous," you have said, "to criticize an idea." However, you have gone way beyond the idea stage, and our client will not tolerate it. You apparently have carried on this conduct in an intentional manner and with the assistance of others. It is clear that you have a specific intent to harm Doctor's Data, and this conduct must stop immediately.

We demand that you cease and desist any and all comments regarding Doctor's Data, which have been and are false, fraudulent, defamatory or otherwise not truthful, and make a complete and full retraction of all statements you have made in the past, including those which have led in some instances to litigation. Such comments include, but are not limited to, those made in your article entitled, "How the 'Urine Toxic Metals' Test Is Used to Defraud Patients," which you authored and posted on Quackwatch.com. "The best evidence for reckless disregard," you have written, "is failure to modify where notified." Consider this notice to you that if you do not make these full and complete retractions within 10 days of the date of this letter, in each and every place in which you have made false and fraudulent, untruthful or otherwise defamatory statements, Doctor's Data will proceed with litigation against you and any organizations, entities and individuals acting in common cause or concert with you, to the full extent of the law, and will seek injunctive relief and monetary damages, both compensatory and punitive.

Doctor's Data is a CLlA-certified company in full compliance with all state and federal regulatory and CLlA standards, and your false, fraudulent, defamatory and otherwise untruthful comments have been made to intentionally damage Doctor's Data, Inc. This conduct will no longer be tolerated and if the retractions are not made as written above, the lawsuit shall be filed imminently.

Very truly yours,

Algis Augustine

Dr. Barrett of Quackwatch replied:

Dear Mr. Augustine:

Thank you for your letter of June 4th in which you accuse me of "transmitting false, fraudulent and defamatory information" about Doctor's Data. Your letter asks me to:

Cease and desist any and all comments regarding Doctor's Data, which have been and are false, fraudulent, defamatory or otherwise not truthful. and make a complete and full retraction of all statements you have made in the past.

Make . . . full and complete retractions within 10 days of the date of this letter, in each and every place in which you have made false and fraudulent, untruthful or otherwise defamatory statements.

I take great pride in being accurate and carefully consider complaints about what I write. However, your letter does not identify a single statement by me that you believe is inaccurate or "fraudulent." The only thing you mention is my article about how the urine toxic metals test is used to defraud patients: (http://www.quackwatch.org/t). The article's title reflects my opinion, the basis of which the article explains in detail.

If you want me to consider modifying the article, please identify every sentence to which you object and explain why you believe it is not correct.

If you want me to consider statements other than those in the article, please send me a complete list of such statements and the people to whom you believe they were made.

Thank you,

Stephen Barrett, MD

To which the response was predictable, resulting in this:

On June 18th, Doctor's Data filed suit against me [Barrett], the National Council Against Health Fraud, Inc., Quackwatch, Inc., and Consumer Health Digest, accusing us of restraint of trade; trademark dilution; business libel; tortious interference with existing and potential business relationships; fraud or intentional misrepresetation; and violating federal and state laws against deceptive trade practices. (On June 29th, Consumer Health Digest was dropped as a defendant.) The complaint asks for more than $10 million in compensatory and punitive damages. The suit objects to seven articles on my Web sites:

• How the Urine Toxic Metals Test Is Used to Defraud Patients
• CARE Clinics, Doctor's Data, Sued for Fraud
• Be Wary of CARE Clinics and the Center for Autistic Spectrum Disorders (CASD)
• Three brief articles in Consumer Health Digest:
  • Slate article blasts the urine toxic metals test
  • Shady clinic and lab under legal assault
  • "Autism specialists" sued
• Laboratories Doing Nonstandard Laboratory Tests

My personal opinion of "offbeat practitioners"

Barrett also writes:

Very few people provide the type of information I do. One reason for this is the fear of being sued. Knowledgeable observers believe that Doctor's Data is trying to intimidate me and perhaps to discourage others from making similar criticisms. However, I have a right to express well-reasoned opinions and will continue to do so. If you would like to help with the cost of my defense, please follow the instructions on our donations page.

This seems like a case of legal intimidation and may be a case for Senator Grassley's whistleblower hotline (whistleblower@finance-rep.senate.gov).

Finally, as a Medical Informatics specialist once called "Doctor Data", I find the company name "Doctor's Data" for a company in this business ironic indeed.

-- SS

Death by Chelation, Revisited

Regarding the latest report in the Pittsburgh Post-Gazette about the 5-year old boy who died after receiving disodium EDTA to treat his autism:

Roy Poses was absolutely correct that Dr. Mary Jean Brown, the CDC’s “expert in chelation therapy,” missed the real point of the tragedy: that the child was a victim of quackery, not merely of “medical error.” The truth is even more disturbing than that, however. Dr. Brown may have been technically correct that if calcium-disodium EDTA had been used instead of disodium EDTA, the child would likely not have died of hypocalcemia (though he might have died of another complication; calcium-disodium EDTA is also a dangerous drug). But this was not a simple case of mistaken drug identity, or "look-alike/sound-alike medications," as Dr. Brown supposed. Disodium EDTA is the form of EDTA preferred by the major advocacy group for all implausible uses of "chelation therapy," the American College for Advancement in Medicine (ACAM)*—the same organization that the FTC had cited in 1998 for “false or misleading” claims regarding “chelation therapy” and atherosclerosis.

The reason for that preference seems to be that when EDTA was first being pushed as a miracle cure for atherosclerosis (‘60s-‘70s), its purported mechanism was to leach calcium from plaques. That claim, which can still be found in pro-chelation literature, has largely given way to the theory that chelation works as an anti-oxidant by removing heavy metals such as mercury, lead, copper, and iron. Both of these theories are implausible on stoichiometric and physiological grounds. The disodium form of EDTA persists as the ACAM-recommended preparation, not only for atherosclerosis but for arthritis, Alzheimer’s, Parkinson’s, psoriasis, high blood pressure, scleroderma, cancer, macular degeneration, and more. The rationale for “chelation therapy” in autism, according to advocates, is that the disease is caused by mercury poisoning—mainly from childhood immunizations. This claim is not supported by epidemiologic studies

Dr. Brown might be disturbed to learn that disodium EDTA is the form used in the current, $30 million, Phase III "Trial to Assess Chelation Therapy" (TACT), jointly sponsored by the National Center for Complementary and Alternative Medicine and the National Heart, Lung, and Blood Institute. The reason that NIH investigators chose the more dangerous form of EDTA is that it was “recommended by the American College for Advancement in Medicine” Curiously, it’s almost impossible, merely by looking on the NCCAM website, to discover which salt of EDTA is used in the TACT. Except in the well-hidden RFA (Request for Applications), only “EDTA” is named, without reference to cations.

Thus most descriptions of the TACT are similar to this one posted by the NIH: “EDTA…is approved by the U.S. Food and Drug Administration (FDA) for use in treating lead poisoning and toxicity from other heavy metals. Although it is not approved by the FDA to treat coronary artery disease, some physicians and alternative medicine practitioners have recommended EDTA chelation as a way to treat this disorder.” On the contrary, disodium EDTA has not been approved by the FDA for the treatment of lead poisoning, but only for the emergency treatment of hypercalcemia and dig-toxicity (and for these purposes it is considered obsolete).

The NIH language implies that disodium EDTA for any other purpose is merely “off-label” and is safe, which is what chelationists and their influential champions assert (see p.2 of this slow-loading document). But this is misleading, because the FDA has specifically contraindicated disodium EDTA for atherosclerosis, and a “black box” warning states: “The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measure associated with this type of therapy.” Thus the numerous unapproved uses of disodium EDTA, prescribed by that strange subculture of practitioners who preach “detoxification” as a near-panacea, do not meet FDA standards for off-label use. On p. 37 of the TACT protocol, version 2, NIH investigators refer to such practitioners as “prominent experts.”

Perhaps unbeknownst to Dr. Brown, her statements would seem to challenge the NIH to explain why it would expose human subjects to a drug that the CDC considers highly dangerous, when a less dangerous substitute is readily available. The larger question is why the NIH would expose 2300 human subjects in a Phase III study of a treatment that has yet to successfully graduate from Phases I or II, and that has not been substantially studied in animals. Federal Code states: “Phase III studies…are performed after preliminary evidence suggesting effectiveness of the drug has been obtained…” The Declaration of Helsinki states: “Medical research involving human subjects must…be based on a thorough knowledge of the scientific literature…and on adequate laboratory and, where appropriate, animal experimentation.”

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