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Safety testing

Did you know that the Institute does years of safety testing on all our new psychotherapy techniques and psycho-immunology disease treatments? Yup, we do, and in fact the Institute’s certified therapist program and clinic structure was designed specifically for just this purpose when Frank and I (Grant) founded the Institute back in the late 1990s. 
As we write this, we are in the middle of a huge wave of safety testing 7 new psycho-immunology treatments on a variety of pathogens - with more coming. It is an exciting time for us as we move this new technology into the world. 
But at this point, many people might be wondering “why would any new psychotherapy treatments even need safety testing? After all, there are no drugs or surgeries involved, so aren’t they intrinsically safe? And anyway, isn’t personal growth from any psychological healing always a good thing?”

Mistaken assumptions
Unfortunately, as Mark Twain was said to say, “What gets us into trouble is not what we don't know. It's what we know for sure that just ain't so.” People naturally enough assume that psychological techniques are interacting only with one's immaterial thoughts and emotions, and base their beliefs about safety testing on that idea. However, what people don't know is that effective psychological techniques work by interacting with actual, physical intracellular ('subcellular') biological systems and pathogens. And this 'psychobiology' phenomenon is where the potential problems lie. In other words, effective psychological techniques physically modify the interior workings of the cell. And in some cases, trigger unexpected physical, biological subcellular symptoms (as well as emotional issues and in rare cases, something called 'spiritual emergencies'). 
This is exactly the same issue that drug companies also face when creating new drugs. The biological complexity of people is so large (and not well understood) that you just can't fully predict what will happen. So drug companies have to test, test, and test to be sure that some unexpected metabolic pathway or drug reaction doesn't cause (more) problems for the patient. 
But let's stop for a moment. Before we go any further, please don't confuse existing therapies with new, untested experimental therapies. Before you run screaming from your local therapist, remember that here we're talking about new, untested, experimental therapies that need safety testing. Trauma therapies like EMDR, TFT, EFT, WHH, TIR, and so on have decades of use behind them, and their problems and solutions are pretty well understood. In the few cases where problems arise (which is why clients read and sign informed consent forms), the therapist generally knows what to do about them. It's a lot like taking your car to a licensed car mechanic. OK, hopefully that helps clear up any confusion!

How we safety test - larger and larger groups
Obviously, a psychological process designed for humans has to be tested on humans (as poor little lab rats are notoriously bad at following verbal directions!) So, how do you test in as safe a way as possible?
You can think of the testing protocol as four concentric circles that expand out from the center. 
Preclinical study: The inner-most circle holds the few (typically 3-4) members of the basic research team who derive the treatment. If they notice any problems, they revise the process until it looks both safe and effective. This stage can take from months to years, even decades, as we solve the causes of diseases of unknown etiology, and work out easy, effective treatments. In engineering terms you can think of this as the 'proof of principle' stage, or in drug development terminology, the 'preclinical research phase'. 
Phase 1: On the next ring out are the members of the applied research team. This is a relatively small group of about 6 people. They test the process on themselves under the eagle eyes of the research group members. At this point we look for safety and if applicable also efficacy. In engineering terms, you can think of this as the prototype stage; in software terms, the alpha testing; and in drug development terminology, the 'phase 1 clinical trial'. 
Phase 2: If all goes well, both in terms of safety and efficacy, we move onto the next ring out, that of large scale testing. This is composed of 12 to 20 (or more, depending on the process) of our trained, certified therapists who volunteer for this testing. In engineering terms, this would be the pre-production stage; in software terms, the beta testing; and in drug development terms, the 'phase 2 clinical trial'. As in any clinical medical drug trial, this part of our testing is very time consuming as it requires juggling lots of testing volunteers, test results and scheduling. 
Phase 3: If all goes well, the process is then released to further cautious testing by our clinic staff with real clients in a controlled and closely monitored setting. In engineering terms, this would be the first production runs, and in terms of drug development, the phase 3 clinical trial. 
Phase 4: After about 6-12 months in our clinics (depending on the number of clients), we release it to our certified private-practice therapists for use with their clients. In engineering terms, this would be product release (crossing your fingers that the product don't get returned). In drug development terms, this would correspond to releasing a drug on the market (approval by FDA, EMA or similar) for any licensed physician to prescribe to patients with the exact diagnose that the drug has been developed to treat. (Note, some physical disease processes we keep at the clinic level, as we deem them requiring more medical knowledge than psychotherapists have.) 
Publication: Finally, after another 2 years on average to get more and more experience with the process, we publish. At this point, we make sure what we write is not going to cause harm, as people with absolutely no experience in trauma will be reading it, and possibly experimenting on themselves. We have to balance between being useful and being harmful. 
From start to finish, this testing usually takes about two years (excluding the delay to publish), and takes about a man-year of our staff time per process (not including the publication time). Obviously, with such a tiny staff, we have to be pretty careful on which diseases we want to put into our testing pipeline. 

What do we look for in safety testing?
In safety testing, we're looking for unexpected or rare problems (either physical or emotional). The nice thing about psychobiology processes is that they work fast. Clients are generally done in about 1-2 hours, which means if there is a problem it generally shows immediately while still working with the therapist. This makes problems a lot easier to spot, as we have an immediate 'before and after' experience to gauge by. Occasionally, a problem only shows up over time. As people's lives are filled with all sorts of issues that arise and go away like street noise (e.g., they get fired, they fight with their spouse, etc.), we look for anything new or unusual, especially if a pattern shows up in several people. Fortunately, this long-term type of problem is very rare, but we still carefully watch out for this remote possibility. That's a reason we always safety test over a period of months, just in case. 
As a practical example, let's look at our old Silent Mind Technique (SMT) for 'mind chatter' or 'hearing voices' (ICD code F44.1) for the unusual side effects ('safety issues') that we found. Surprisingly, after treatment some people immediately feel lonely without their mind chatter! This is easily dealt with by the therapist who knows ahead of time to watch for it. A somewhat more delayed problem can show up when the client tries to sleep. Their mind has become so silent that the client is now more aware of pre-existing tinnitus. It's just like being in a bar when everyone leaves, and now you notice the refrigerator noise. An even slower-to-arise problem can show up in a couple's relationship. To a spouse, it can feel as if the client is suddenly more remote or distant than they were because they no longer interact in all the same old dysfunctional, unconscious ways. Knowing it might happen ahead of time makes their adjustment to the new dynamic go much more smoothly. These problems turn out to be intrinsic with getting rid of the fungus that causes voices; these are the sorts of things we sometimes find when we safety test, albeit most processes have no safety issues, delayed or otherwise.
Let's take a look at an example that has more overt biology content. Our psycho-immunology treatment for 's-holes' (ICD code F60.8) has just finished its phase 2 safety testing as I write this blog. This process eliminates the sensation of 'sucking holes' along the midline of a person's body. This common disease gives a person the constant feeling of needing attention, love or admiration. The treatment is in two parts: one to get rid of the amebic infection that gives the sucking sensation; the other to get rid of the structural vulnerability along the person's midline that led to the opportunistic infection there. The bad news is that healing either one gets rid of the presenting symptoms. The safety problem showed up in the order of healing, during our phase 1 (alpha) testing. If the midline vulnerability is fixed first, we find the ameba moves and overgrows over the entire subcellular structure. And it now becomes difficult to treat the ameba, because the presenting symptom is gone, so there is no easy way to verify success. Once we realized this was happening, the solution became obvious. We start with the ameba step, and make sure the s-hole symptoms are fully gone. Then we do the midline vulnerability step, which also has a different, unique sensation outcome to measure success. If a client quits before finishing, which can easily happen as healing trauma isn't fun, the client is no worse off than when they started, or if they skip the second step, they only miss the even better improvement they would have gotten if they had continued. 

The elephant in the living room - suicide
The biggest potential risk of any therapy, be it trauma therapy or anything else, is stimulating suicidal feelings in some clients. Since no one really understands why people get suicidal, avoiding this problem is very problematic. Looking at the entire field of psychotherapy, the statistics are grim - on average, half of all therapists have one client suicide, a quarter have two suicide, and it goes up from there. 
Clients and their families often naively expect a therapist to be able to fix their suicidal clients. After all, they are trained therapists, right? That's their job! Sadly, there is no good fix for this problem. This situation is similar to a person who has cancer and goes to a doctor. The doctor's job is to fix it, right? That's what they are paid to do! Sadly, there are limits to the current technology, which may not be obvious or it may be hard to accept. 
We deal with this issue in two ways. First, none of our processes are used or tested on suicidal clients (a 'pre-existing condition'). And secondly, when we do safety testing, we really watch out for it just in case of the remote possibility that it can trigger this problem in some susceptible people. By the end of safety testing, a given process would have been tried on several dozens of people over a long enough period of time to judge that it is very safe to use for a larger audience.

The dark side of humans and of the internet
This issue around safety testing is a hard one to fathom. I (Kirsten) am now going to speak from my own personal experience as a drug research scientist to give you some more perspective between drug research and our institute (ISPS) psycho-immunology. When a medical company hires a new research scientist, a contract is signed agreeing to strict confidentiality not only during the time of employment but for years after. For the most part this confidentiality ensures that a research scientist who changes job from one company to a competitor company does not boost the new company with detailed knowledge around drugs being developed by the former company - in other words the confidentiality agreement is an attempt to secure the intellectual property and future income of a company. If a former research scientist does not conform he/she can be prosecuted and the major damage done is one of monetary value. Leaking drug development confidential information is almost never a safety issue for a medical company because safety and efficacy testing of drugs follow strict laws governed by medical agencies around the world (such as FDA and EMA).
Similar to the medical industry, researchers, clinic staff, and therapist working with our institute sign contracts agreeing to strict confidentiality around anything that we have not yet published. The reason for this you might think is the same as the one mentioned above - to protect the intellectual property and future income of the institute. This however is only partially true. The main reason is safety!! In contrast to medical drug development, the safety testing that we do is not mandatory and is not governed by a regulating authority but put in place by the institute (ISPS) because we want our clients to get safe treatments that are effective and easy to follow. As you can see, if a person involved in our work leaks their knowledge around a treatment that has not been released for therapists to use, it is similar to 'releasing' a drug to the market before it has been through all the clinical safety and efficacy testing phases. It is very problematic and it is a potential risk for anyone who uses the leaked treatment protocol on themselves or others.   
We have seen highly bizarre behaviors in some therapists who have worked with us in the past. Over a decade ago, we had one therapist who had access to our untested, proprietary and restricted basic research experiments and used them on clients, charging lots of money - and leaving over a dozen people in bad places emotionally and physically (volunteer therapists in the institute spent all their time for a full year helping these people solve their activated issues). Twice, we've had volunteer staff therapists take our restricted, untested experimental work and published it online - breaking their confidentiality agreements. (Fortunately the websites where our material was released eventually have been shut down.) In both of those cases, these therapists were desperate to feel important. Sadly, the perpetrators actually knew people would be harmed with these untested processes, but simply didn't care. During safety testing, we've also seen some therapist testers take the test process and use it on their family, clients or friends (during the safety testing phase), directly ignoring their written and verbal agreement not to do so. This is particularly stupid, as not only is the material potentially unsafe, in some cases was not even an optimized final process. It makes one wonder if they secretly hate their loved ones. 
By now, you know we test the heck out of our processes for years, require our therapists to use informed consent with clients, and we have published textbooks with chapters on safety. But you would not guess this from some of the bizarre online posts we see on our YouTube channel and Amazon textbooks. For example, in one case where we found out who was doing it, a student's boyfriend got dumped, decided we were to blame, and for months put really strange warnings up on our YouTube channel. Another anonymous person claimed on our Amazon book reviews that we're killing our clients in job lots. Apparently nobody noticed all the corpses piling up, so they felt obligated to let the world know. Sigh... 
Even though the institute has developed many treatments for various bizarre behaviors - we still get surprised and puzzled by what we see when it comes to safety and confidentiality.

The outcome is safe and effective techniques
We hope you've enjoyed this quick tour of our safety testing on new techniques and processes. In this blog post, we've focused on the need and methodology for safety testing; now let's look from a bigger perspective at the results of safety testing. If we do find a problem, we iterate and change the protocol until the safety issue is gone, or if the issue is intrinsic, figure out how to handle it appropriately (as in the SMT example of loneliness after one's voices are gone). Fortunately, the new generation of psychobiology and psycho-immunology techniques that we are testing have shown themselves to be amazingly robust and free of problems. These techniques are true breakthroughs, allowing us to eliminate many tremendously painful or disabling psychological and physical problems easily and quickly that were previously totally intractable or incurable. What an amazing time to be alive!

Below are some useful references if you'd like more in-depth information.

Summary information on our website:
This is an in-depth training video for our own therapists.

In our textbooks
Subcellular Psychobiology Diagnosis Handbook (2014). 
     ⁃ Chapter 2: Primary cell pathogens - symptoms and safety, pg. 15-25.
     ⁃ Chapter 6: Risks, informed consent, and ethical issues, pg 77-101.
     ⁃ Chapter 13: Spiritual emergencies and related problems, pg. 265-275.
     ⁃ Appendix 4: Informed consent form, pg 291-298.

Peak States of Consciousness, volume 2 (2008). 
     ⁃ Appendix A: A partial list of safety issues, pg. 451-454.

The Basic Whole-Hearted Healing Manual (2004). 
     ⁃ Special topics, pg. 135-142. 
     ⁃ Spiritual emergencies, pg. 143-162. 
     ⁃ Clients not to work with, pg. 161-163. 
     ⁃ Ethical issues, pg. 169. 

Other references:
Responsible Research: A systems approach to protecting research participants (2003) by D. Federman, K. Hanna, L. Rodriguez (ed.), National Academy of Sciences.

From the desks of
Dr. Kirsten Lykkegaard, Director of Research
Dr. Grant McFetridge, Emeritus
Hornby Island, Canada
April 14, 2024

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