Just because one doctor failed to follow the rules doesn't invalidate the entire field of psychiatry.
Scientology seems to be having a rough go of it lately, what with high-profile defections that include its leader's father and its founder's granddaughter. The organization also appears to be on the verge of losing Suri Cruise just as she's getting old enough to join in some of its special rituals. Even media titan Rupert Murdoch, well-acquainted with the attentions of conspiracy theorists and parliamentary inquiries alike, is on the record labeling Scientologists as "creepy, maybe even evil."
But Scientology is still heartily charging forth in its epic battle against the dark forces of psychiatry, sometimes scoring undeniable battlefield wins. Unfortunately, aided by unwitting state regulators and media, the Scientologists are slaying creaky old windmills, not the dragons they imagine. Founder L. Ron Hubbard considered the medical study and treatment of disordered thought, abnormal mood and bad behavior as something of a threat to the pseudo-scientific religion he devised to clear up all these matters. L. Ron baked in so much suspicion towards psychiatrists, I wonder if the group's founder wasn't concerned with what diagnosis shrinks might hand him if they ever got him on the couch.
Little wonder then that the Church of Scientology operates a subsidiary whose sole aim is to discredit and dismantle the field of psychiatry. The subsidiary flies by the benign moniker "Citizens Commission on Human Rights," which sounds like it might be a UN-affiliated NGO. The group incessantly employs classic propaganda techniques like trumpeting each instant of an errant psychiatrist as emblematic of the entire field. A favorite strategy is zeroing in on poorly funded government mental health facilities and blaming the clinicians who toil there for their lack of proper resources, rather than acknowledging the dearth of societal support for funding mental health care and the full array of community supports needed to deinstitutionalize the sickest patients. If anything, CCHR's campaigns undermine public support for mental health treatment, especially in countries with more unsophisticated representatives and gullible media.
When you watch self-congratulating CCHR videos cataloging shoddy conditions in the world's most underfunded and poorly managed mental health facilities over the years, Scientologists hope you'll accept their slippery logic that these events say something about the validity of psychiatry as a whole. Of course they do not, no more so than any case of medical malpractice in any field, in any country, brings down validity of medicine as a whole. Mental illnesses are disease processes rooted in biology still under research by medical scientists that require intervention by mental health clinicians who stay abreast of an evolving body of scientific knowledge. The auditing sessions and e-meters L. Ron prescribed bear no resemblance to this reality.
So you can see why any critically minded reader will want to know when Scientology is the driving force behind any given brouhaha. But readers of a recent four-article investigative series in the Austin American Statesman were instead informed that an enviably safe physical treatment was controversial as evidenced by the concerns of the humanitarians at CCHR, which was described only as "a mental health watchdog group." As the Statesman reported, CCHR succeeded in getting the Texas Department of State Health Services to investigate psychiatrist Allen Childs for conducting research without proper certification from his hospital's review board. Consumers of the newspaper series like the author of this article at the Austinist can be forgiven for getting the impression that a state hospital psychiatrist had actively experimented with a dangerous form of electrotherapy called Cranial Electrotherapy Stimulation (CES). Yet all public evidence suggests nothing of the sort occurred.
I do not believe that the Statesman or Texas officials knew they were also serving as functionaries in a Scientology campaign. If so I think that Scientology's role would have made its way into at least one of the four Statesman articles:
The articles report how CCHR complained to state officials about Dr. Childs publishing two studies (2005 and 2007) including patients from North Texas State Hospital without institutional review board (IRB) approval. Dr. Childs was working with a population of intellectually disabled adults prone towards violence that other state facilities couldn't treat, referring them to the North Texas facility because of its high-security behavior management unit. Dr. Childs realized that the CES treatment reduced the number of violent outbursts without any significant side effects, something medication couldn't do for these patients. He made CES part of his routine medical practice so as to use as little medication as possible. When he decided to report his experience to others, he should have gone to an IRB for the OK -- a panel of medical and community representatives who evaluate research designs for any potential risk to the participants. IRBs have the power to entirely veto projects or demand modifications to research protocols. Texas officials quickly found that no IRB approvals existed for Dr. Child's two papers, and their investigation snowballed from there. As reported in the final article, Dr. Childs resigned. He'd already wound down his practice at the hospital before this episode. He did not respond to the Statesman for comment (nor to the state inquiry, it appears).
The head of the University of Texas College of Pharmacy took a particular interest in the Statesman articles. Dean Lynn Crismon provided statistical and research design assistance for some of Dr. Child's CES research in the late 1980's and was shocked to read how his old associate had gone off the rails. His research back then included IRB approvals. But when I explained to Dr. Crismon that Scientology had successfully targeted his old research partner, their involvement instantly tempered his interpretation of the newspaper articles. A full time administrator now long after his brief association with Dr. Childs, Dr. Crismon went on to spend a significant portion of his research career evaluating methodologies for improving care in public mental health systems. He and his team were the sometime target of CCHR press releases that he believes distorted his record.
What provoked the ire of state hospital officials, the lack of IRB approval, was a bit of a moving target, Dr. Crismon pointed out. For most of Dr. Childs' career, IRB approval would not have been the standard for the type of research he was conducting. Dr. Childs was using a technology that had been FDA approved for over 30 years to treat depression, anxiety and insomnia and whose only known side effects (like headaches and tingling) are so rare, benign and self-limited they would be the envy of most pharmaceuticals. CES passed its most recent FDA safety review just this past March. Dr. Childs secured approval to use the device (marketed as Alpha Stim) from his hospital's therapeutics committee and by its ethics panel, then obtained proper consent from each patient before use. He went on to make this stimulator a part of his routine practice, finding that it helped lower aggression. So he started using it for that problem more and more. Other doctors followed suit.
This is a very common evolution in routine medical practice seen with any number of devices, procedures and medications. All doctors use treatments "off label." This isn't an experiment. Dr. Childs then decided to collect his cases and report about his success so other doctors could consider trying it themselves. There is no question that an IRB would have approved the study, in fact they most likely would have issued a "waiver." When a doctor is using his own clinical data and masking any information that could identify the individual patients involved, there is essentially no risk to the patients. A pro-active "experiment" is not occurring, only a review and synthesis of clinical records. The relevant federal regulation specifically excludes this type of work:
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
It didn't become the norm for clinicians to ask IRBs to vet this kind of publication until around the year 2000, according to Dr. Crismon, who has served on IRB's for 19 years including a period as chairman of the Texas Behavioral Health IRB. Today the University of Florida tells its staff that case studies with three or fewer patients need not go before its IRB. That number appears to be an internally developed rule of thumb; federal statutes don't include any such guidance. Dr. Childs's 2005 paper involved nine patients.
CES raised red flags for Scientologists because of the "electrical" aspect. Scientology considers electroconvulsive therapy (aka "electroshock") to be torture, and has a penchant conflating other electrical treatments with that therapy. ECT can send an entire amp of current through the brain. By contrast CES operates on the level of hundreds of microamps, over a thousand times smaller. Worn on each earlobe, you can walk about and do your business while having a CES treatment for thirty minutes or an hour. Users have full control to take it off at any time. I tried it on my back once a few years ago and didn't feel anything (it is no longer "cranial" stimulation when applied to the back, of course). It's powered by a 9-volt battery.
Cranial electrotherapy stimulation has not entered the medical mainstream despite its many decades on medical supply store shelves. Its second-class status becomes obvious on the principle manufacturer's website which features heavy direct-to-consumer appeals. CES isn't important enough to be discussed in medical schools, and seems to be embraced only quite spottily in psychiatry, neurology and related fields. Its unpopularity doesn't stem from any concerns about safety, however; the general impression is that there are other, more effective and well-studied treatments available (including full-bore electroconvulsive therapy). Ironically, considering Scientology's concerns, many clinicians have trouble believing a few microamps can do anything. By all accounts, Dr. Childs is one of the true believers, speaking at conferences across the country. I spoke with a neurologist who recalled one of his talks in the 1990s. Dr. Childs came off overly enthusiastic but sincere, I am told.
Despite its place in the nightmares of Scientologists everywhere, electricity is reaching a new heyday in medicine thanks to more sophisticated and targeted technologies like transcranial magnetic stimulation and deep brain stimulation, both recent FDA-approved technologies that offer more anatomical localization than CES. As electrical stimulators continue to miniaturize and start recharging over the air, a great many medical applications lie ahead in the next few decades.
So Dr. Childs conducted a study that nobody questions would have met perfunctory approval, had he only bothered to submit it. He did his work in an era when norms for this type of research were evolving. I think these facts should attenuate our condemnation of his actions, which should not be viewed through the perverted lens of Scientology's hate for the psychiatric profession, but rather as the error of an overzealous clinician committed to doing anything he can do help some of the most helpless people in the state psychiatric population. There were other misdeeds uncovered in the course of the investigation: Dr. Childs is accused of filming some of his patients without their consent and speaking judgmentally about their behavior in a talk accompanied by the video; he did not disclose in his second paper that he had become a consultant for the device company after the first paper. These are serious charges and there are no available facts that mitigate them. I have not seen the video, so the excerpts as reported are out-of-context. Was video consent ever obtained? Was Dr. Childs consulting for Alpha Stim at the time of his 2007 paper? Dr. Childs is not cooperating with the state (it seems) or granting interviews, so we don't know.
This collection of errors is certainly enough for state officials to demand Dr. Child's resignation, particularly if he is unwilling to defend himself. But just as important in the whole affair is the fact that the state of Texas and the Austin American Statesman were made unwitting players in a staged production by the Church of Scientology, some of the greatest showmen on earth. They'd like Dr. Allen Childs's mistakes to go towards discrediting the entire field of psychiatry. The true lessons in this tale are wholly different. I've spoken with three people who knew Allen Childs and all describe a sincere and passionate and perhaps rather excitable man. He made no secret of the fact that he was submitting his cases for publication, and he appears to have been simply ignorant of the need for IRB approval; perhaps his ignorance extended to his use of video as well. Could the state hospital have done a better job of educating its staff and supporting their research? Did the journals prompt Dr. Childs for certification of his IRB approvals?
I will not give Dr. Childs the benefit of the doubt while he is able yet unwilling to speak for himself. However, I do not see any evidence that he harmed patients beyond using their images in the video (as described). In fact the results he reports warrant further randomized, controlled investigation. The resignation of this well-meaning psychiatrist means little for the safety of his former patients, but it means a lot to Scientology. If CCHR's new strategy is to comb the psychiatric literature for instances where an IRB is MIA, psychiatry had better prepare for battlefield earth.
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Ford Vox, MD, is a physician, based in Atlanta, who specializes in caring for people with complex brain injuries. He has written for Newsweek, Slate, and the Los Angeles Times.