This is a follow-up blog post by Clay Jones and Grant Ritchey, who wrote about the use of dental appliances in the management of tourette syndrome way back in the Olden Times (June 2016). Because we will refer to the above post often, and because we make a ton of shillbucks for every click on one of our articles, we encourage you to read (or re-read if you’re a star SBM pupil) our earlier piece multiple times in order to appreciate this post in its entire context.
The story so far
A couple of years ago, we wrote an article about how some dentists claim that they can successfully manage the signs and symptoms of Tourette Syndrome (TS). We covered in some detail the current concepts of the etiology and pathogenesis of the condition; while much is still unknown, we know more than what many outliers would have us believe. That being said, there is no shortage of charlatans willing to take advantage of the gaps in our knowledge by filling them with all manner of pseudoscientific false hope. And while we expressed our wish that dental appliances could benefit those with TS, we registered our skepticism and called for rigorous oversight and accountability for those dentists who claim to treat TS and have called for future research in this area.
Specifically, we singled out a new (at the time) campaign by an organization called , founded by a sports radio personality called Craig Carton. After Carton kicked off the charity with a sizable donation, the organization went into full fundraising mode to sponsor research into a proprietary dental appliance to present to the TS community. This research was to be conducted under the auspices of the highly respected University of Tennessee College of Dentistry, with the Grand Poobah Dean of the school Dr. Timothy Hottel himself acting as the Principal Investigator!
The study design was abysmal. It involved having 65 patients use a placebo device for one week, during which they would rate their tics, then wear the study device for several weeks. You heard that right. All subjects will know that they are wearing the study device, and it wasn’t disclosed what either the placebo device or the therapeutic devices was, or how they differed in their design. The study is uncontrolled and unblinded, practically designed to be positive for the many reasons we discussed in our previous post on the subject.
There was a lot of marketing noise associated with TicTocStop: from Camp Carton (more on that later), to an appearance by Carton and (then Chief Medical Director of TicTocStop Inc.) on TV show, to extravagant celebrity golf tournaments. It struck us as consistent with the kind of marketing commonly seen with bogus free energy machines or juice cleanses, and we wondered if the fundraising was the primary goal and the study just a prop. With all that money rolling in and with some solid scientific research underway, what could possibly go wrong?
Things are possibly going wrong
For over a year after our post, we heard nothing from Drs. Balanoff or Hottel regarding the progress of their research. Accordingly, Grant sent out an email on August 23rd, 2017:
Dear Dr. Hottel and Dr. Balanoff,
I hope this email finds the both of you well. I am writing to follow up on your TicTocStop research project I inquired about 15 months ago. What has transpired since our last correspondence? Has the study begun, and if so, is there any preliminary data or conclusions that you can share at this time?
Thank you for your dedication to helping those with Tourette Syndrome, and I look forward to hearing from you.
That very day, Dr. Balanoff responded:
Thanks for reaching out. The study did start and is now complete. We are in the process of preparing a paper for a peer reviewed journal. I don’t have much more to share but I should have a lot to share very soon.
William L. Balanoff, DDS, MS, FICD
Chief Medical Director TicTocStop, Inc.
Great news! We could only assume that the results were positive, but since we didn’t know the details of the study design (other than they were hoping to enroll 65 participants and any results of improvement would be self-reported), we could only speculate. But regardless, we would hear from them “very soon.”
We waited. Grant learned dental Swahili (thanks Rosetta Stone®-Dental Edition!) and Clay completed the first act of his one-man play (“a triumph of the human spirit!” – Clay’s mom). Still, no news. We waited some more.
Hearing nothing for months, we revisited the situation a couple of weeks ago, wondering what had happened and why the promised study had not yet materialized. Clay first did a little Googling on his Commodore 64 and stumbled upon a from September 7, 2017 (two weeks after Grant’s email exchange from a few months ago) which alleged (among other things):
Internal Revenue Service records show the Tic Toc Stop nonprofit has raised more than $1 million since Carton — who was — founded it in 2013 to “fight against Tourette Syndrome.”
Intrigued, Grant emailed Drs. Balanoff and Hottel on April 20th of this year.
Dear Dr. Balanoff and Dr. Hottel,
I am writing to follow up on your study on the use of oral appliances in the management of Tourette Syndrome. The last I heard, it sounded like the paper was close to being published, but to date I haven’t seen whether or not it has been. If it has, can you direct me to the article or send me a copy?
As you know, in 2016 my colleague Dr. Clay Jones and I wrote an article on the Science Based Medicine blog about oral appliances and TS in general and the TicTocStop campaign specifically. We were skeptical of the claims made by dentists who treat TS and of the methods of the TicTocStop campaign, but remained hopeful that some good science would be done to add to the body of knowledge of TS management, even if the results were negative.
We are aware of the allegations against TicTocStop founder Craig Carton, and we would like to get your thoughts on how this turn of events affects you and your research. Will you continue with the project? Dr. Hottel, will you need to distance yourself and your University from the project from a public relations standpoint? I realize that the controversy surrounding the charity doesn’t affect the science of whether oral appliance therapy may or may not be effective with TS; there are many layers to it. What are the plans for your research moving forward?
Thank you for your kind attention to this matter. Dr. Jones and I are planning to write a follow up post to our original one and I want to make sure I accurately report all sides of the issue. The blog gets almost two million readers each month, and fair and accurate science reporting is a responsibility we both take very seriously.
Within the hour, Grant had received a response from Dr. Balanoff (who interestingly no longer had the title of Chief Medical Director, TicTocStop on his signature line).
Thanks for reaching out. The research has been submitted for publication. I will be happy to share the article once I know that it has withstood the review process and is ready for publication.
Thanks again for your continued interest.
William Balanoff, DDS, MS, FICD
Full speed ahead! It looks like we’re going to get that groundbreaking paper after all! We were nervous that mentioning the controversy surrounding Craig Carton would cause a defensive reaction in them, but neither did we want to avoid the issue. To his credit, Dr. Balanoff responded quickly and professionally.
We dug further. We stayed up late nights furiously inserting our Fortran punchcards into the Private-investigator-detective mainframe computer that Steve Novella keeps in his basement. We learned that Dean Hottel had been by the Tennessee Board of Dentistry at least a month before Grant’s and Balanoff’s 2017 email exchange, although this was not disclosed by either of them in their correspondence. The notes from the minutes of the Board meeting (on page 7 in the link above if you’re curious) simply stated “Update from School of Dentistry – Dean Hottel was placed on indefinite suspension” with no further explanation. Shortly thereafter, the University of Tennessee announced the appointment of an interim Dean of the College of Dentistry.
We dug even furtherer. It turns out that Dean Hottel has been accused of from the TicTocStop charity:
Timothy L. Hottel, Dean of the College of Dentistry at The University of Tennessee Health Science Center reportedly received $340,000 from TicTocStop, Inc., for the ‘Clinical Study on Use of Oral Appliances in Mitigating Severity, Frequency of Motor and Vocal Tics.’
And while we acknowledge that a blog post is not solid evidence by any stretch, and perhaps it was just a grant for the study and he didn’t personally profit from it, it raises serious ethical questions, especially since apparently he is no longer affiliated with the research project. Moreover, the author of the blog also questions whether , a summer camp for kids with TS, even exists at all. That accusation seems a little far-fetched to us, what with all the , but in light of everything else that Craig Carton allegedly did, it’s certainly a story worth pursuing in our opinion.
To summarize, we have a former radio host and a dental school dean who have quietly disappeared from the Tourette’s stage and may be in some sort of legal and ethical hot water. Meanwhile, the former Chief Medical Director of TicTocStop who promised a peer reviewed paper any time now has left us empty handed. Last but not least, the Tourette Syndrome community is left disappointed at yet another empty promise for an effective treatment.
Why did you just tell us all that?
Do you mean apart from gloating and proudly saying “We told you so?”
No, it’s because this highlights an enormous problem with the promotion of medical and dental treatments – whether they are new drugs, procedures, or in this case, a prosthetic intervention. Too often, commercial entities either throw up sham “studies” to support their claims or bypass the scientific process altogether in a rush to get their product to market. Or if they do perform “legitimate” research and don’t get the results they want, they deliberately ignore the results and don’t submit the paper for publication.
While we can’t go on record by saying this is definitely the case with TicTocStop, we were suspicious of them two years ago, and nothing they’ve done since has convinced us otherwise. In fact, the more we look at the whole set up, the shadier it appears to be. Originally on Dr. Balanoff’s website, the focus of the study design didn’t appear to be geared toward an effective treatment for TS, rather it was merely to get the requisite FDA approval for marketing to dentists, dental labs, and potential customers. There is no blinding, the cohort size is too small to be of significance, and the treatment time is only of a few weeks’ duration, hardly enough time to judge efficacy. And as the investigators said on The Doctor’s show, “what we are selling is hope.”
But the really interesting thing is that just as we were writing this post Dr. Balanoff took down all of his references of and associations with TicTocStop as well as the outline of his study design. On his new website (he kept the same URL), he is now promoting an appliance for TS called the T.A.G. appliance. Our hunch is that it is the same appliance as before, but just rebranded. He will probably still use the same shoddy study he has been conducting for years to promote his gadget to dentists, dental labs, and vulnerable people with TS.
This is very suspicious and has a taint about it. The intrigue deepens.
Just like any alternative medicine treatment or therapies not shown to be effective, patients can spend a lot of money chasing hope and they can waste precious time on ineffective cures instead of getting the care they need. There are ways to combat that however, one of which is the .
The AllTrials Initiatve
According to their website, “AllTrials is an international initiative of Ben Goldacre, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense about Science and is being led in the US by Sense About Science USA, Dartmouth’s Geisel School of Medicine and the Dartmouth Institute for Health Policy & Clinical Practice. The AllTrials petition has been signed by 93310 people and 739 organisations.”
The codified in a set of ethical principles for human experimentation in 1964. Drafted by the World Medical Association, it asserts that every investigator has an obligation to report the findings of his or her clinical trial, even if those results are negative, unexpected, or is contrary to the interest of the investigator. The AllTrials Initiative supports the registration of any clinical trial prior to the initiation of that trial. Furthermore, trials that have already begun (or are completed) should also be registered retrospectively. This assures that the nature of the experiment cannot be modified during or after the research, and that the investigator(s) cannot after the fact. ClinicalTrials.gov is the world’s largest register for clinical trials, and there is no valid excuse for researchers not to do so.
The next step is to report findings. This is a brief summary of the trial’s results, and becomes part of the public record for all to see. An audit published in 2012 found that only a fifth of trials registered on ClinicalTrials.gov had reported results within one year of completion and different research found that trials which produced negative results are twice as likely to remain unreported than positive trials. According to AllTrials, publication of all results will reduce reporting biases and help researchers and policy-makers produce more reliable systematic reviews of the safety and effectiveness of medical interventions. Following the summary, a full report is submitted. Quoting the AllTrials website:
Full reports sometimes contain narrative descriptions of adverse events experienced by trial participants. This information is important to understanding the trade off between risks and benefits of a treatment. These paragraphs may contain identifiable patient information which may need to be redacted. These paragraphs should be available on request to researchers who provide a protocol of their study plan, with no reasonable request refused by the academic or company who authored the report.
By having these standardized recommendations publicly available, “phantom” research projects, , and can be reduced. There is transparency and accountability of all researchers, be they corporate, institutional, or governmental. The public is well served, and the body of knowledge in any given area is increased.
Conclusion: Sometimes it’s hard being right
The TicTocStop debacle is a sad lesson in greed, fraud, and the betrayal of trust. When we wrote the original SBM post almost two years ago, we expressed our skepticism and doubts about TS dental appliances due to biological implausibility and a lack of any good evidence in the area of dental appliances and TS. Even so, we assumed the best motives and intentions of the investigators and sent our best wishes to them for their efforts. After all, wouldn’t it be wonderful if a simple dental appliance could manage the symptoms of TS without drugs or surgery? Clay could get some relief from his condition and Grant could help others do the same.
But alas, because of The TicTocStop player’s actions, more money was wasted and more hopes were dashed. Hopefully going forward, researchers will use AllTrials or the ClinicalTrials.gov site to register their research projects. Perhaps Institutional Review Boards (IRBs) and ethics committees will in time require these steps, forcing investigators to be proactively transparent and agree to publish all results, regardless of outcome. This will protect the public in ways that aren’t being done today. As President Ronald Reagan stated: “Trust, but verify.”
Clay and Grant will be giving a presentation on this topic at NECSS on July 13th in New York City. We will expand on this article and bring everyone up to date on this still unfolding story. We might even do an interpretive dance if the tip jar is full enough. Tickets are still available at NECSS.org, and we hope to see you there!