Jul 02 2010
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?
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 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].
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?
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.
- 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.
- 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.
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