A few weeks ago I posted an article about bogus diagnostic tests. I cited Doctor’s Data, Inc. (DDI), as “a company with a long history of dubious offerings.” I also wrote:

You can’t help but have noticed that many of the links in this post are to articles on Quackwatch. That’s because the site is chock full of useful information about bogus tests, far more than can be found elsewhere. There you will find a more comprehensive list of bogus tests than I’ve mentioned here, and a larger list of laboratories peddling them. You’ll also find an article on “Dubious Genetic Testing” co-authored by the Quackwatch founder, Stephen Barrett, and our own Harriet Hall, and an article about bogus “biomedical treatments” for autism showing that—surprise!—Doctor’s Data and Genova Diagnostics are major players there, too.

I stand by all of those statements. It turns out that Doctor’s Data is not pleased that Dr. Barrett has so thoroughly blown the company’s cover.

As he describes on Quackwatch, about a month ago Dr. Barrett received this letter from a representative of the 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’s reply included this:

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… 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.

Rather than sending Dr. Barrett such a list, the firm replied:

Dr. Barrett,

You have been making false statements about Doctor’s Data and have damaged this company’s business and reputation, and you have done so for personal gain and your own self-interest, disguised as performing a public service. Your writings and conduct are clearly designed to damage Doctor’s Data. If you don’t retract your false claims and issue a public apology, the lawsuit will be filed.

Today is June 14th, which is the deadline that was in our letter of June 2nd. Because you responded, you have until Thursday, June 17th, to post your retractions. If you do so and show good faith immediately, this will be taken into account in proceeding.

Jeff Levens
Augustine, Kern and Levens, Ltd.

Once again, Dr. Barrett asked the firm to cite the purported false statements:

Dear Mr. Levens:

My letter asked you to identify the claims that you believe are false. You have not identified a single sentence that you believe is inaccurate. Since you have failed to do so, I have no choice but to assume that you cannot. My offer remains open, as it is to anyone who is criticized on any of my sites. If you identify anything that you consider inaccurate, I will seriously consider what you say and act accordingly.

Thank you,

Stephen Barrett, MD

The result was predictable:

On June 18th, Doctor’s Data filed suit against me, 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 misrepresentation; and violating federal and state laws against deceptive trade practices…The complaint asks for more than $10 million in compensatory and punitive damages.

It also asks the court to prohibit Dr. Barrett and others from exercising their freedom of speech:

WHEREFORE, DOCTOR’S DATA, INC., Plaintiff, prays that this court enter an order granting Doctor’s Data a permanent injunction; direct them to remove or delete all disparaging statements and remarks pertaining to Doctor’s Data from these or any web sites under their control; and prohibit them from publishing these or any other or additional such remarks on blogs, the aforesaid websites, or any other web sites pending the outcome of this litigation.

Sounds eerily similar to the Simon Singh case in the UK. The U.S., of course, has libel laws that are far more protective of freedom of speech than those in the UK; but any lawsuit at all, no matter how unfounded, is burdensome to the defendant, who must spend considerable time and money on his defense. Thus a corporation with means can easily cripple an individual such as Stephen Barrett, who realizes no “personal gain”  from what he writes on Quackwatch and lives on little more than a modest retirement pension. Roy Poses, referring to Scot Silverstein’s post over at Health Care Renewal about this lawsuit, observed:
 

Note that the Quackwatch publications which the suit addressed included one that simply described a lawsuit (filed by others), and another that simply summarized an article in Slate (written by others). Sounds like a SLAPP to me. 

Scot himself wrote:

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

Dr. Barrett is well aware of this, but he is not about to surrender:

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.

Yes, it is true that very few people or places provide the type of information that he does. That’s why I linked to so many of his articles from my own recent post. You can’t find that kind of information on virtually any mainstream website that claims to give reliable information about “complementary and alternative medicine”: not on WebMD, not on InteliHealth, not on the NCCAM website—even though most people would probably expect to find it in those places, if they were aware of it at all. You won’t find on any of those sites, for example, that being “a CLlA-certified company in full compliance with all state and federal regulatory and CLlA standards” is no guarantee against peddling bogus diagnostic tests.

Dr. Barrett needs both money and publicity to fight this. Please go here to donate money. Please spread this story around and keep plugging at it. Let’s turn this into an opportunity to expose both the sordid reality of present-day quackery and the perversion of law that the suit represents, exactly as has now happened in the Simon Singh case.

Editor’s note: It’s still a holiday weekend in the United States. I had considered simply taking the day off altogether, particularly since I’m busily working on my talk for TAM8–which (holy crap!) is in a mere three days–but then I figured today’s a good time to resurrect a “classic” (if you will) post that I wrote a few years ago, dust it off, and post it. I decided to do this mainly because I had been planning on bringing this post to SBM at some point right from the very beginning of SBM.

Regular readers of this blog are probably familiar with a certain homeopath named Dana Ullman. So persistent is he in his pseudoscientific arguments for the magic that is homeopathy that fellow SBM blogger Kimball Atwood once postulated a humorous law he dubbed the Dull-Man Law:

In any discussion involving science or medicine, being Dana Ullman loses you the argument immediately…and gets you laughed out of the room.

Kimball then pointed to a number of studies that Ullman likes to cite ad nauseam that supposedly “prove” the efficacy of homeopathy. One study Kimball didn’t mention, however, is a favorite of Ullman’s, one he likes to trot out time and time again. Specifically, it’s a study of homeopathy in the ICU that was published, in all places, in Chest, a respectable journal that, as you might expect, is dedicated to research on diseases of the chest, such as chronic obstructive pulmonary disease (COPD), cardiac disease, and basically any disease that manifests its pathology in the chest, although it primarily deals with critical care. I first learned of this study way back in 2007 from Dr. R. W., who at the time commented quite aptly that the article impressed him with just how far into the medical mainstream woo has penetrated, while retired doc also expressed his dismay.

Although I do feel a bit guilty not providing you with more original peerless prose pontificating on medical pseudoscience that you know and (hopefully) love, this article is constantly trotted out by homeopaths, even five years later, and that makes it worth updating an older post from another source. So here’s the abstract:

Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients.

Michael Frass, MD; Christoph Dielacher, RN; Manfred Linkesch, MD; Christian Endler, PhD; Ilse Muchitsch, PhD; Ernst Schuster, PhD and Alan Kaye, MD. Chest. 2005;127:936-941.

* From the Ludwig Boltzmann Institute for Homeopathy (Drs. Frass, Endler, and Muchitsch), Vienna, Austria; II Department of Internal Medicine (Mr. Dielacher and Dr. Linkesch); Department of Medical Computer Sciences (Dr. Schuster), University of Vienna, Vienna, Austria; and Department of Anesthesiology (Dr. Kaye), Texas Tech University Lubbock, TX.

Background: Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD.

Methods: In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homöopathie-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded.

Results: The amount of tracheal secretions was reduced significantly in group 1 (p < 0.0001). Extubation could be performed significantly earlier in group 1 (p < 0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 ± 1.61 days vs 7.68 ± 3.60 days, p < 0.0001 [mean ± SD]).

Conclusion: These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.

Holy homeopathy, Batman! Does this study mean that homeopathy actually works for critically ill patients in the ICU? Not so fast there, Robin. Let’s take a look.

First off, the title is interesting. Note how the word “homeopathy” or “homeopathic” does not appear. In fact, no derivative of the word “homeopathy” appears anywhere in the abstract. True, the Ludwig Boltzmann Institute for Homeopathy is mentioned in the institutional affiliations, but that would be easily missed by someone perusing the abstract. It’s almost as though the writers were trying to get this in under the radar. After all, most doctors don’t know much about homeopathy, which means that they don’t know much about what a “30C” dilution is or that such a dilution dilutes a substance to the point where there almost certainly isn’t a single molecule left.

First a word about the methods: Apparently in homeopathy lore, potassium dichromate is useful for treating thick respiratory secretions. On what basis, I don’t know. From where I come from, potassium dichromate is a nasty chemical; it’s a powerful oxidizing agent. Indeed, it’s sometimes used to clean laboratory glassware, although I never used it for that. It’s also used in photography and screen printing. It’s pretty toxic stuff and can cause a nasty dermatitis. Given all that, it’s a good thing that this stuff was diluted to nonexistence before being administered to patients sublingually (under the tongue)! If it weren’t, it could have caused some damage.

This all makes me wonder how this study ever got past the Institutional Review Board (IRB). After all, if there’s active ingredient left over, then the study would be proposing to give a toxic substance to patients on ventilators in an ICU. If the investigators made it very clear to the IRB that the dilution would be such that there would be no potassium dichromate left, then the IRB should have asked about the ethics of giving both experimental groups what is, in essence, a placebo. More disturbing is that the investigators stopped the administration of ?-agonist bronchodilators to these patients before they were started on placebo or treatment, in order “to avoid any potential influence and/or interaction.” Again, if there is potassium dichromate in the homeopathic remedy, then why did the IRB allow the investigators to administer it in the first place with no supporting evidence, either in clinical or animal models, that it might have an effect? If there is no potassium dichromate in the homeopathic remedy, then stopping effective medications in both study groups strikes me as unethical. In fact, the investigators essentially admit that it is diluted to nothing:

In homeopathic concentrations, potassium dichromate acts primarily by its mucolytic properties. In this study, we used a preparation of C30, which is equivalent to a potentiation of 30 dilutions, in which each of the 30 dilution steps is followed by subsequent vigorous succussions. Therefore, the above-described toxic effects were eliminated. In addition, the original orange-red color disappeared during the preparation. Onset of action may vary from patient to patient but is generally observed within 24 to 48 h.

What “above described toxic effects,” you ask? None, really. The investigators didn’t describe any potential toxic effects from potassium dichromate until the discussion section. Apparently, the reviewers didn’t read this study too carefully (which is, of course, one possible explanation for such woo making it into a journal with an impact factor of 4.008). Be that as it may, let’s look at the patient characteristics, shall we?

First, there were only 25 patients in each group, which is a pretty small number for anything other than a pilot study. You have to remember that, when studies are small, spurious results are more likely to occur. At first glance, the patient characteristics in this table appear pretty well balanced. At first glance. Actually, this is a good example of when statistical nonsignificance doesn’t necessarily mean clinically nonsignificant. For one thing, the stage of COPD in the control group was higher than that of the treatment group (1.20 ± 0.5 versus 1.08 ± 0.4, p=0.178). This seems very odd, because both groups are listed as having mild COPD by this criteria, given that the COPD stages run from 0 to 3, with 0 being normal lung function and 1 being the least severe. If the average COPD stage for each group was close to 1, then why did the patients have such difficulty coming off the ventilator? Something’s odd there, since the mean FEV1 (forced expiratory volume in 1 second) was 54.0 ± 5.3% in the potassium dichromate group and 52.4 ± 5.5% in the control group, both of which are very close to the range of stage 2 COPD (FEV1 between 35% and 49%). In other words, it would seem that most of the patients were bad stage 1 patients.

A more interesting difference, however, and potentially more likely to influence the results of the study comes when you look at the number of patients who were on home oxygen before being hospitalized and developing respiratory failure. In the control group, 9/25 patients were on chronic home oxygen, whereas in the potassium dichromate group, only 5/25 were on home oxygen. Leaving aside that both numbers seem very high for two groups whose COPD scores are 1.2 or below given that it’s usually patients with stage 3 COPD who require home oxygen, it is clear that the control group had nearly twice the number of patients who were on home oxygen before admission. This seems inconsistent with a small difference in the COPD score, and the low COPD scores seem inconsistent with such severe exacerbations. After all, the definition of stage 1 COPD is:

Often minimal shortness of breath with or without cough and/or sputum. Usually goes unrecognized that lung function is abnormal.

Essentially no patients with stage 1 COPD need home oxygen. Ditto stage 2 COPD, which is defined:

Often moderate or severe shortness of breath on exertion, with or without cough, sputum or dyspnea. Often the first stage at which medical attention is sought due to chronic respiratory symptoms or an exacerbation

By the measurements listed, the average patient in both groups had at worst slightly worse than stage 1 COPD, which makes it odd indeed that 36% and 20% of the control and potassium dichromate groups, respectively, were on home oxygen. Let’s just put it this way. Needing home oxygen is a good marker for one of two things: either more severe COPD or other concurrent lung conditions. Those four extra patients on home oxygen could potentially account for the longer time to extubation and longer length of stay in the hospital in the control group. We can’t tell if they do or not because the data isn’t presented in such a way to allow us to do so. It’s possible that the differences in patients on oxygen before admission made a difference. It’s also possible that this is just a spurious result from a relatively small study. Or, it’s possible that it might be correct and there might really be an effect, but this latter scenario is unlikely given the flaws in the study and the fact that no homeopath has yet explained a mechanism by which something like homeopathic potassium dichromate might do a single thing to eliminate secretions–or anything else, for that matter.

The bottom line is that, contrary to Dana Ullman’s representation of this study as slam-dunk evidence of the efficacy of homeopathy, it’s nothing more than a very questionable study in which it is unclear whether the treatment and control groups were truly comparable. The homeopaths’ conclusion would be hilarious were it not so sad that such woo has found its way into otherwise reputable journals:

The present study suggests that potassium dichromate C30 may be able to minimize the amount of tracheal secretions and therefore to allow earlier extubation when compared to placebo. Since the potentiation (dilution and vigorously shaking) of the study drug beyond the Avogadro number imposes no interaction with the patient’s metabolism, and due to the low cost of the drug, its use in the ICU may be beneficial, minimizing morbidity and mortality. Studies give some insight into the potential way of action of homeopathically prepared drugs. Cluster-cluster aggregation phenomena in aqueous solutions of fullerene-cyclodextrin conjugates, ?-cyclodextrin, sodium chloride, sodium guanosine monophosphate, and a DNA oligonucleotide revealed that there are larger aggregates existent in dilute aqueous solutions than in more concentrated solutions.²⁰ In another study, ultra-high dilutions of lithium chloride and sodium chloride (10-30 g cm^-3) have been irradiated by x-rays and gamma-rays at 77 K, then progressively rewarmed to room temperature. During that phase, their thermoluminescence has been studied and it was found that, despite their dilution beyond the Avogadro number, the emitted light was specific of the original salts dissolved initially.

This is the first scientific study of the effect of potassium dichromate on tracheal secretions. While the mechanism of potentized (diluted and vigorously shaken) drugs still remains subject to research, several articles describe its clinical usefulness. The effect may be best explained by cybernetics, which means that the information of the homeopathic drug acts consensually on the regulator. Thereby, the body regains its original property to regulate physical parameters.

First off, it’s nice to see that the investigators essentially admit that diluting above Avogadro’s number eliminates any trace of the compound. It is, however, unclear why they brought up ultrahigh dilution solutions irradiated at 77 Kelvin (or -196° C) and then rewarmed. First off, 10 to 30 molecules per cc is an incredibly concentrated solution in homeopathic terms. Second, homeopaths don’t cool their solutions down to the temperature of liquid nitrogen, irradiate them, and then slowly rewarm them, making me doubt very much the relevance of the experiment to anything that homeopaths do. But the part about cybernetics cracks me up. That one was clearly pulled out of someone’s hat (or perhaps out of their nether regions); yet it got by the reviewer.

As much fun as I have deconstructing such studies, hoping in vain for a good study but inevitably being disappointed, it is still disconcerting to see this sort of study published in Chest. More disturbing still is that an IRB allowed such a study of a useless medication on intubated ICU patients with COPD. It just goes to show that peer review is not perfect. It may remain the best bulwark against pseudoscience, but it’s only as good as the reviewers, and it’s not a foolproof guarantee against pseudoscience. As you can see from this study, it’s making its way into even the ICU, which is one place where evidence-based medicine should rule supreme and in which there should be no place for woo or quackery. What I fear is that, as more and more pseudoscience and non-evidence-based woo invades medical school, the dividing line between evidence-based medicine and woo will blur even more, and, as the older generations of physicians retire, the newer generation, who has been exposed to woo in medical school, will be less willing or able to call a duck a duck when they see it. Quack quack.

REFERENCE:

Frass, M. (2005). Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients Chest, 127 (3), 936-941 DOI: 10.1378/chest.127.3.936

Back in January, the Connecticut Board of Chiropractic Examiners held a four-day hearing to decide whether chiropractors must, as a part of the informed consent process, (1)warn patients about the risk of cervical artery dissection and stroke following neck manipulation and (2) give patients a discharge summary listing the symptoms of stroke.¹ On June 10th, the Board of issued a written opinion that stroke or cervical artery dissection is not a risk of cervical spine manipulation, so no warning is necessary. Presumably, although it is not specifically mentioned in the decision, no discharge summary is required because, if there is no risk of a stroke after neck manipulation, what would be the point?

Background

Janet Levy and Britt Harwe are two Connecticut women who suffered strokes resulting from neck manipulation by chiropractors. That’s not just their lay opinion, it’s the opinion of their respective treating physicians, right there in the medical records.

Each decided that some good should come of their unfortunate situations, so each formed a non-profit and began warning patients of the risk of stroke following manipulation. Victims of Chiropractic Abuse, Levy’s organization, put giant ads on the sides of busses in Bridgeport, CT., much to the chagrin of the folks at the University of Bridgeport. Within the hallowed halls of the University (Go Purple Knights!) is a College of Chiropractic, a College of Naturopathic Medicine, and the Acupuncture Institute. The chiropractors demanded that the ads be taken down, which got exactly nowhere.

Some chiropractors also began harassing Levy and Harwe, calling them Nazis and KKK members, for example, and threatening their personal safety and that of their families.(What is it with the pseudoscience crowd and calling people Nazis? Perhaps, having used up their entire supply of imagination creating their nostrums, they are reduced to these tired tropes.) The FBI recommended Levy and Harwe have one of the harassers arrested, which they did, and that calmed things down for a while.

Levy and Harwe knew that most chiropractors were not warning patients on their own, so they pushed for a state law requiring them to do so. After a great deal of effort they got before the state legislative Public Health Committee with the help of Sen. Len Fasano. At the committee hearing a compromise was reached between the proponents for a required warning and the chiropractic faction.

Sen. Fasano described this agreement in his testimony at the hearing before the Chiropractic Board:

I proposed legislation to the Public Health Committee, which legislation sought that some sort of informed consent be given by chiropractors to patients upon the … manipulation of the neck.

There were numerous discussions on both sides of that legislation, if I may, and it was sort of determined that perhaps the best way of handling this would be what we call a Take Away Form, where, for the first time that you [are] treated [with] the manipulation of a neck, the chiropractor would give you a Take Away Form, which discussed the risks and, also, symptoms, should you have some issues with respect to a stroke. These are the things you look at, and you should seek treatment right away.

However, it was impressed upon Senator Harris, [who] is Chairman of the Public Health Committee and myself, as the proponent, that rather than putting [it] in a state statute, the better way of doing this is to allow this Board [of Chiropractic Examiners] to govern itself, and, as a result, the matter was not pressed forward at the senate ….

Both sides agreed that a Take Away once a year upon the manipulation of the neck is reasonable, however, we did not put [it] in [a] state statute, because we believe it was better governed by the policing body [i.e., the Board].

(From Levy, I learned that she lived up to her part of the agreement, which was to take down her ads and not speak out against chiropractic while the matter was before the Board for consideration.)

Upon questioning by one of the attorneys, Sen. Fasano reiterated his understanding that “the chiropractors and the victims were coming to this Board in unison to ask for a Declaratory Ruling.” Sen. Fasano confirmed that this was Sen. Harris’s understanding as well. But by the time of the hearing, it was clear to Sen. Fasano that the chiropractors had no intention of living up to their end of the bargain and that they were dead set against any sort of discussion of the risks with patients and against giving patients a list of stroke symptoms to take home.

The Hearing

The hearing began with a bang on January 5th when the Connecticut Chiropractic Association and the Connecticut Chiropractic Council made a motion to disqualify the only public member of the Board participating in the proceeding, Jean Rexford, because they thought she might be in cahoots with one of the stroke victim organizations. This allowed the lawyers to warm up their vocal cords. By the end of almost 30 pages of transcript on this topic alone they were in fighting form. The chiropractors lost round one and Rexford remained to become the only dissenting vote in the Board’s ruling.

I attended the first two days of the hearing and it was clear to everyone from the get-go that the chiropractors would fight tooth and nail against a rule requiring any disclosure of risk. It was one of those “kumbayah” moments in chiropractic history when a temporary truce is declared in their internecine war and chiropractic organizations of all stripes circle the wagons.

This was no better exemplified than by the fact that J. David Cassidy, D.C., Ph.D., Dr.Med.Sc., lead author of the study, “Risk of Vertebrobasilar Stroke and Chiropractic Care,” Spine 33 (2008) S176-S183 [the “Cassidy study”] was required, in order to testify, to appear as a representative of the International Chiropractors Association (ICA), the organization of the super-straight-Daniel-David- Palmer- Innate-Intelligence chiropractors. I’ll bet he doesn’t put that on his C.V.

Here’s the testimony of George Curry, D.C., Chairman of the Board of ICA’s state affiliate, the Connecticut Chiropractic Council, describing the ICA’s beliefs:

Chiropractic science, as taught in the chiropractic curriculum in an accredited chiropractic college, involves the scientific aspects of the study of the human body and the science of detection and correction of the vertebral subluxation complex.

The art refers to the particular technique that a Doctor of Chiropractic would choose to reduce or correct a subluxation, and the philosophy is the where by [sic] or rationale that someone would investigate the spine as a cause of ill health.

The very basis upon which the profession was founded was that the body is a self-healing, self-regulating mechanism and has inherent recuperative powers, and that if those recuperative powers are interfered with, then it could cause of a loss of health.

Dr. Cassidy should hope and pray that this hearing transcript never, ever gets into the hands of an attorney who is preparing to cross-examine him.

Dr. Cassidy was plopped down into the middle of the hearing as a witness for the chiropractors, even though no one had listed him as a witness, as was required, prior to the hearing. This is why he had to pretend to be speaking for the ICA, as they were allowed to substitute him for the previously listed ICA witness. Apparently, we had done enough damage that the chiropractors felt they needed to bring in the man himself to defend his study.

The problems with the Cassidy study were explained on SBM  in an excellent post by Dr. Crislip (which, this being Dr. Crislip, also discusses hangings, The Who v. Motorhead, and being over age 50). The study’s hypothesis is that the association between chiropractic care and stroke can be explained by patients going to the chiropractor for headache and neck pain caused by a pre-stroke vertebral artery dissection. In other words, the pre-existing dissection causes the stroke, not the chiropractor’s twisting the patient’s neck. Dr. Crislip slices and dices the study nicely to show how this conclusion is not supported by the data.

So what did the chiropractors say, under oath, about the need for informed consent regarding neck manipulation and stroke? To quote one chiropractic witness (which is pretty much to quote them all, as their testimony on this point varied little): “There is no scientific evidence of a cause and effect relationship between a chiropractic neck treatment and a subsequent stroke.” That’s right — “no scientific evidence.”

Irony of ironies! The profession that has studiously avoided the scientific method for over 100 years suddenly discovers the value of science. A sort of jailhouse conversion, if you will.

And how did they know this? The Cassidy study. Even though the Cassidy study says, right there on page S181, that “[o]ur results should be interpreted cautiously and placed into clinical perspective. We have not ruled out neck manipulation as a potential cause of VBA strokes.” (Emphasis added.)

In another big dose of irony, decades of case reports of stroke following neck manipulation introduced into evidence were dismissed by one chiropractor, who testified that these constituted mere anecdotal evidence. This from the profession for which anecdotal evidence, dressed up as “clinical experience,” repeatedly trumps scientific plausibility.

I was permitted to give testimony before the Board as a “lay witness” on behalf of the non-profit Campaign for Science-Based Healthcare. My testimony consisted of channeling the post by Dr. Crislip and another post by Dr. Hall about how chiropractors and their trade associations were misrepresenting the study’s results to the public.

I also quoted from two neurology texts which addressed the anatomical aspects of cervical manipulation and artery dissection, both concluding that manipulation could indeed cause dissection:

The extracranial VA (vertebral artery) is also susceptible to traumatic injury because of its encasement in the bony part of the cervical canal. Either spontaneously or after minor trauma from neck manipulation, the VA may be injured, and dissection with luminal compromise and clot embolization may occur. This is a common cause of stroke, especially in younger patients without other vascular risk factors.

Samuels, Office Practice of Neurology (2nd ed. 2003), 372. (Emphasis added.)

Dissection of the extracranial carotid and vertebral arteries accounts for approximately 80% to 90% of all cervicocephalic dissections…. The vertebral artery is most mobile, and most susceptible to mechanical injury, at the C1-C2 level, as it leaves the transverse foramen of the axis and abruptly turns to enter the intracranial cavity …. The C1-C2 site is involved in one half to two thirds of all vertebral artery dissections and in 80% to 90% of rotation-related dissections.

Mohr, Stroke: Pathophysiology, Diagnosis, and Management (4th ed. 2004), 1059. (Emphasis added.)

Also testifying for “our side” was the indefatigable Canadian pediatrician and chiropractic critic, Dr. Murray Katz. If you are not familiar with Dr. Katz’s work, suffice it to say that chiropractors like Dr. Katz every bit as much as anti-vaxers like Dr. David Gorski. He undermined the Cassidy study’s methodology and hammered on the susceptibility of the vertebral and carotid arteries to injury from manipulation.

Three survivors of stroke after manipulation and three relatives of patients who died also testified. You could hear a pin drop.

The most compelling aspect of their testimony was how remarkably similar each story was to the others:

• the nonsensical reasons for having neck manipulation (sore shoulder, “maintenance care,” lower back pain);
• the youth of the victims, all under 45 years old, one only 20 years old;
• symptoms of stroke appearing within minutes to hours after manipulation;
• clueless chiropractors who had no idea what was going on while their patients were experiencing stroke symptoms, and who gave their patients ridiculous advice (toxins were being released, take Advil) or did nothing at all instead of sending them straight to the hospital;
• the patients’ and emergency doctors’ frustrations at not being able to figure out the source of the patients’ symptoms — the patients were not connecting symptoms with manipulation because they had not been informed of the risk of stroke;
• the “aha!” moments of hospital doctors when they learned their patients had undergone chiropractic manipulation;
• the lingering neurological deficits of the patients who survived and the devastation suffered by the victims and their families.

There could have been no better summation for the victims and their allies than the testimony of Douglas Fellows, M.D., chairman of Diagnostic Imaging and Therapeutics at the University of Connecticut Health Center, a member of the Connecticut Medical Examining Board, and himself a former physical therapist who had used cervical manipulation in his practice. He appeared in support of the Medical Examining Board’s previously filed statement urging that patients be informed of the risk of stroke following manipulation.

Dr. Fellows confirmed the Medical Board’s opinion that vertebral artery dissection can be caused by cervical manipulation. He also testified that, although the risk of stroke and death were remote in the procedures he performs as an interventional radiologist, he always tells patients of this possibility. In response to a question from a Chiropractic Board member — which contained the assertion that “we haven’t established any causality. At most, we’ve established a temporal relationship” — he replied:

We don’t know what the risk is, as far as the percentage risk, but it’s the harm that we worry about, the potential, the devastating effect of paralysis or death, and that’s what we do [referring to warning his patients of the risk of stroke from certain procedures, even thought the risk is remote].

The Decision

Although the Board had previously voted 4-1 against the necessity of a warning, the written “Declaratory Ruling Memorandum of Decision” was not issued until June 10th.

In its decision, the Board correctly stated that, under Connecticut law, “[t]he materiality of a risk is determined by weighing the benefits of a procedure, against the frequency and severity of the potential harm.” But, this being chiropractors, who simply discard facts not fitting their paradigms, that was the last mention of “benefits” and “severity.” From then on, the decision focused solely on “frequency.”

The Board relied heavily on the Cassidy study in making its decision that “the evidence is sufficient to establish that a stroke or cervical arterial dissection is not a risk or side effect of a joint mobilization, manipulation or adjustment of the cervical spine performed by a chiropractor.”² It is worth repeating that the study itself states “[w]e have not ruled out neck manipulation as a potential cause of some VBA strokes.” However, the Board explained this away by noting that “Dr. Cassidy credibly testified ‘this is a study that raises real doubt about the association being a risk …’” In fact, according to Dr. Cassidy’s testimony, he’s become so doubtful he has absolved himself from a previous admission that he caused a patient’s stroke by manipulating her neck.

The Board went on to explain that “[s]tatistically, what scant evidence exists of the incidence of stroke following a … manipulation … of the cervical spine was found primarily in persons under age 45. As provided in the Rothwell study, ‘it remains to be explained why an association between chiropractic manipulation and [vertebrobasilar accident] was observed only in the young. If an association were to exist, one would expect that it would exist regardless of age.’”

If only the Connecticut Board of Chiropractic Examiners had read Science-Based Medicine before issuing its ruling!
Dr. Crislip, who has answered many questions here recently, had an answer to this very question months ago in his SBM post on the Cassidy study.

In the over 45 age group, strokes due to chiropractic could be lost in the sea of strokes due to other reasons, and since we do not know if there were a dissection or blood clot as a cause of strokes, it is hard to conclude that there were no extra strokes from chiropractic. The study was not powered to determine the rare event of a chiropractic event against the background to usual stokes in the elderly. The mean age in this study was 63 ….

Young people should not have any stroke. In the young, vertebral artery dissection is a common cause of a rare event. It is also the worry from chiropractic neck manipulation. If you could find an effect of chiropractic, it would be in the young. And they do. The people who have an increase in stroke are those under age 45. And it is a big association: odds ratios from 3 to 12.

The association is most noticeable in the first 24 hours after seeing a chiropractor. Usually if you rip an artery it is symptomatic right away. Again, we do not know if these people had dissection or not. We only know they had stroke of some sort, within a day after seeing a chiropractor. One would predict that if there were an association between chiropractic and stroke you would most easily find it in the young and the effect would be most noticeable in the first day or so after the chiropractic visit.

And this article confirms this association.

I even cited to Dr. Crislip’s post in my brief and provided a link! So much for Board’s self-proclaimed “careful and thorough review of all of the testimony and documentary evidence.”

And speaking of said “careful and thorough review,” the decision did not explain how Board managed to avoid the basic anatomy of the human neck, which strongly suggests that twisting it forcefully is really not a good idea.

The Board did allow that “the evidence is sufficient to establish that spinal manipulation on persons who are having an acute stroke or cervical arterial dissection is not within the standard of care.” Well, that’s certainly a relief!

The Board also said that a chiropractor who wanted to “discuss these issues” [presumably, the non-existent stroke risk] with a patient could do so without being in violation of the standard of care.

So, even though the Cassidy study says that patients with headache and neck pain can be presenting with vertebral artery dissection, and that there is no screening procedure to determine whether patients presenting with headache or neck pain are at risk of VBA stroke, chiropractors should feel free to manipulate the neck without warning of the risk of stroke. Why didn’t the Board decide that the evidence they find so compelling dictated the much safer option of not using manipulation on anyone with headache or neck pain?

Post-hearing

What does this ruling mean?

Unfortunately, young people will continue to have debilitating strokes and some will die following cervical manipulation.

But the fight was not for naught. Many TV viewers saw scary videos of necks popping at the hands of chiropractors during media coverage of the hearing. Awareness of the risk of stroke was raised — not everyone believes the chiropractors when they deny it. “Our side” got great press.

Janet Levy can resume her bus ads in Bridgeport. Sen. Fasano will again introduce legislation making chiropractors inform their patients of risk. It failed this year but he vows to re-introduce it next year. And Levy has just filed suit in Connecticut against two state chiropractic organizations citing them for, among other things, failure to warn patients of the risk of stroke following manipulation.

The Board’s declaration that there is no risk of cervical artery dissection and stroke following manipulation is a finding of fact and not binding on the courts. As is their ruling that informed consent does not require a warning. Under Connecticut law, whether a warning of risk is required is determined by the “reasonable patient” standard, that is, what would a reasonable patient consider important in making his decision whether to undergo a particular procedure. One of the very purposes of the reasonable patient standard is to prevent practitioners from setting low standards and then claiming they’ve abided by their profession’s standard of care. Imagine the chiropractor sued for failure to warn who erroneously thinks he’s been inoculated against malpractice claims by following the Board’s ruling. Surprise!

As a matter of fact, the hearing transcript and videotape are now in the hands of plaintiffs’ personal injury attorneys, who will mine it for useful information. A couple of years ago the American Justice Society (formerly known as the Association of Trial Lawyers of American) started a chiropractic interest group (that is, interest in suing chiropractors for personal injury). The section collects and distributes such information for AJS members.

The chiropractors may have won this battle, but they could be losing the war.

Notes

1. The Petition for Declaratory Ruling filed by the Connecticut Chiropractic Association, which set this proceeding into motion, used the term “cervical artery dissection” in describing the risk of cervical manipulation at issue before the Connecticut Board of Chiropractic Examiners. The Board also used the term “cervical artery(ies)” in its ruling and otherwise during the proceeding, as did some of the other participants. “Cervical artery” is an imprecise term as there is no such anatomic structure. Apparently, its use refers collectively to the vertebral and carotid arteries.
2. At least I think that is the Board’s decision, as it is repeated several times and is made “Finding of Fact” number 3 in the Memorandum of Decision. But the Board also states a couple of times, once in its actual “Order” at the end of the written decision, that the “evidence is insufficient to conclude that stroke or cervical artery dissection is a risk or side effect of” cervical spine manipulation. Deciding that the evidence is sufficient to establish there is no risk is quite a different thing than deciding the evidence is insufficient to establish there is a risk.

Some Universities have more cachet than others. On the West coast it is Stanford that has the reputation as the best. There is Oxford, Yale, MIT, and maybe Whatsamatta U. I would wager that in most people’s mind the crème de la crème is Harvard. Harvard is where you find the best of the best. If Harvard is involved, a project gains an extra gobbet of credibility. Brigham and Women’s Hospital also has a similar reputation in the US as one of the hospitals associated with only Harvard and the New England Journal of Medicine. Premier university, premier hospital, premier journal.

So if Brigham and Women’s Hospital and Harvard Medical School are offering continuing medical information (CME) for acupuncture, there must be something to it, right? A course called “Structural Acupuncture for Physicians” must have some validity.

Brigham and Women’s Hospital, which is a teaching affiliate of Harvard Medical School, includes the Oscher Clinical Center for Complementary and Integrative Medical Therapies. The Oscher center offers acupuncture, yoga, chiropractic and a variety of other modalities including craniosacral therapy.

There are few things, in a world of alternative nonsense, as nonsensical as craniosacral therapy .

A craniosacral therapy session involves the therapist placing their hands on the patient, which they say allows them to tune into what they call the craniosacral system. The practitioner gently works with the spine and the skull and its cranial sutures, diaphragms, and fascia. In this way, the restrictions of nerve passages are said to be eased, the movement of cerebrospinal fluid through the spinal cord is said to be optimized, and misaligned bones are said to be restored to their proper position.

Cranial Sacral therapists think they can improve the flow of spinal fluid flow by gently massaging the skull. Really. I can’t make this stuff up. I operate under the assumption that you can judge a person by the company they keep, although guilt by association is problematic in medical institutions. Programs are often started in hospitals for financial reasons without the benefit of scientific or medical input. It is one of the many prices we pay in the US for a for-profit medical system. But if there is a institution whose scientific standards are such that they allow craniosacral therapy, well, they lose a major chunk of credibility. As the saying goes, you lie down with pigs, you come up smellin’ like garbage.

On the other hand, it would be much easier to participate on committee work. The Pharmacy and Therapeutics committees in which I participate spends significant time evaluating the literature to decide how best to utilize new drugs and therapies. If only we offered craniosacral therapy: I would never have to justify a treatment based on science and reality again. So now I realize, sadly, that Brigham and Women’s and, by extension Harvard, has questionable scientific standards, or, if they have standards, they apply them selectively.

The brochure states

This unique course provides practical, hands-on training in acupuncture. The training program is designed to bring together Eastern and Western views of health and disease into a result-oriented acupuncture style. You will learn to evaluate and treat patients using modern Japanese acupuncture techniques that link classical Chinese theory to concrete, understandable clinical diagnostic and treatment techniques.

Whenever I hear about the Eastern views of health and disease I always think of General Westmoreland in the movie “Hearts and Minds.” I know, cheap shot. But an Eastern heart attack is different from a Western heart attack how?

What, I wonder, is a “result-oriented acupuncture style.” Since acupuncture has little, if any, efficacy, it cannot have therapeutic results. Maybe the key word is style. There is style and there is substance. I suppose they could be suggesting that the acupuncture they are teaching will only look like it is working?

Style probably refers to the type of acupuncture, as in Kiiko Style acupuncture. Like the kung fu movies I watched as a teen, there are various acupuncture styles that need to compete in a winner take alltournament, to determine once and for all whose acupuncture is strongest.

Modern Japanese acupuncture differs from Chinese acupuncture in that they use finer needles that are not placed as deeply. Japanese acupuncture does seem to share one feature with Chinese acupuncture, at least to judge from the videos of the procedure I can find searching YouTube: a complete lack of understanding of sterile technique. I you want to get the willies watch a video on acupuncture, Japanese or otherwise. Barehanded, no hand washing, the practitioner touches the area to be pierced, no alcohol wipe is used, and the junction of needle/skin is manipulated. The Kiiko style, to judge from the photographs on the website, does not include gloves. These videos should be entitled “How to transmit infectious diseases.”

I assume they will use sterile technique at the course, since “emphasis is given to “hands-on” point location and needling techniques based upon palpatory feedback” although one cannot be sanguine in regards to a hospital system that uses craniosacral therapy. Germ theory is, after all, just a theory.

The didactic portion of the course will focus on bridging the gap between acupuncture practice and science. The scientific basis of acupuncture and the methodological problems with acupuncture research is presented as part of the discussion of specific clinical conditions throughout the course.

That will be an interesting discussion. Since the acupuncture literature, as discussed at length on this blog, is such that the best studies show no effect and the science is only barely applicable to acupuncture and pain treatment, it would be fun to be a fly on the wall and see how they ‘bridge the gap” for the justification of the covered uses: Pain Control, Hormonal Imbalances, OB/GYN Problems, GI Disorders, Scar Treatments, Structural and Orthopedic Problems, Cardiac and Vascular Disorders, Autoimmune and Autonomic Disorders, Mood Disorders, Myofascial and Neuroanatomic Treatment.

Not only will they be teaching Japanese acupuncture and classic Chinese acupuncture, but also auricular acupuncture and the German Microsystem approach (MAPS: Mikro-Aku-Punkt-Systeme). That last one

… is based on the Somatotopic fields comprising of specific points of correspondence in the Auricle (Ear), Scalp, Oral Cavity etc. A micro system is like a Map of the body — somatotope or a cartography of the whole organism similar to the homunculus discovered in the sensory motor cortex of the brain. Each of the Micro system points have a clearly defined correlation to and interrelation with a particular organ or function…For Example EAR Acupuncture is one such Micro-system. It was discovered by the french doctor Nogier who decoded the functional correspondences of the respective ear points. The punctual cartography of the Ear resembles an upside down embryo.

MAPS is apparently the result of the unholy mating of acupuncture and phrenology.

I am surprised they did not include Korean Hand Acupuncture, foot acupuncture and tongue acupuncture. They are leaving out three key styles of acupuncture. One wonders how six styles of acupuncture can all be valid, share similar physiology, and be supported by the same science, given their differences. I suppose it is like asking which is the valid style of astrology: Indian, Western, or Mayan. It is a trick question. They are all nonsense.

The best constructed study to date on acupuncture demonstrated that sham acupuncture by twirling toothpicks on the skin is arguably more effective and definitely has fewer side effects when compared to ‘real’ acupuncture. I can use quotes with the best of them. I wonder it they will pass out a box of toothpicks. Since twirling toothpicksgives similar results with fewer complications, one wonders how they justify teaching acupuncture styles that are less efficacious and more dangerous than toothpicks. Can you ethically offer an equivalent therapy with more side effects than a known competitor?

Let’s see, cost of the class: $6650. For that kind of cash, who needs ethics? That’s right, if you are a Harvard-affiliated hospital you can charge the cost of two loaded, top-of-the-line MacBook Pros to teach magic. I bet they get it. “Harvard-trained acupuncturist” would look great on a business card and provide instant credibility. A quick google finds practitioners whose websites mention the Harvard course for their training. Premium price for premium nonsense.

I am only disappointed they did not charge ten dollars more. $6660. Now there’s a number.

As the web page for the Oscler center says

The market for complementary and integrative medicine is vast and shows no sign of diminishing. This trend must be guided by scientific inquiry, clinical judgment, regulatory authority, and shared decision-making. – Dr. David Eisenberg.

The market. Not the need. The market. It is depressing when good institutions promote worthless nonsense.

Next time I read the NEJM and see an article from Harvard or Brigham and Women’s, I will not be as accepting of the result as I was in the past. They have lost some of their credibility with me. It is sad. Great institutions can have feet of clay. At least there are still institutions you can believe in. Mom. Apple Pie. Baseball. Go Barry Bonds.