U. S. Department of Defense studying Church of Scientology Purification Rundown

dchoiceisalwaysrs

Gold Meritorious Patron
This is exactly what I'm afraid of. And a Narconon facility is not bias-free even in the absence of outright fraud.

Plus it will be so convenient for OSA to 'borrow photo copy paper' a well developed 'tech' in 'Operation Snow White'. oh..maybe they don't do that anymore they just copy server files these days.
 
I assume Severna Park Health and Wellness Center, a previous Narconon site, now a Hubbard detox site, gets the vast majority other than overhead taken out by the university. They run 50 vets thru purif (both experimental and control groups get the purif which is bogus in itself) - plus they pay rent for the study coordinator. I don't think the vets get anything. It said they are recruiting nearby so they don;t need to pay much for travel, if anything.

How much is the alleged religion being paid for the use of its tech in this review?

How much are the volunteer victims being paid to put their lives at risk?

Just when you think things might be getting a tad more rational... :omg:
 
Udarnik I am glad you have contacts at Albany, go for it. I wonder if they lied to the IRB.

Yeah, didn't finish the thread on WWP before I posted. This is a real trial (the only acceptable evidence is clinicaltrials.gov):

Holy shit I don't know how this got through the Institutional Review Board.

It is fully funded by the DoD, which really pisses me off on two levels. First, that Johnny-boy has the gall to ask for donations, and second that some shithead at the DoD was asleep at the wheel enough to give the go-ahead.

I know people at Albany. A lot of people. The IRB / ethics committee is going to hear about this.
 

dchoiceisalwaysrs

Gold Meritorious Patron
I have often wondered why institutions that are approached by the likes of Narconon for funding do not just direct them to the CofS? The CofS, with its IAS reserves could easily fund a full four or five year study under the auspices of the relevant IRB's - what an opportunity for Scientologists - imagine the world getting to know that the flabby con man was, in fact, brlliant and his 'detoxification" is the bees knees.

Scientologists always seem so reluctant in things like this - I wonder why?

Are you kidding? I was led to believe that those were reserved for private inurement. Maybe Janet Light could correct me on that if I am wrong? Is she out of the IAS+COS+RTC completely separate entities co-mingled RPF situated on INT base?
 

Lohan2008

Gold Meritorious Patron
The study design seems quite bogus. Both the "experimental" and "control" group get the purif, and get tested before and after. The only difference is that the "experimental" group gets the purif right away, while the "control" group has to wait 4-6 weeks before they start the purif. They also exclude people with psychiatric conditions.

I can't believe this got past peer review. ^ ditto

:banghead:
 

Udarnik

Gold Meritorious Patron
If anyone in the US wants to help out, writing your Congressman and / or Sentator to complain about vets being used as guinea pigs - and here is the real point - for a detox method that a) has no biochemical rationale or previous clinical study rationale and b) is based on the scientifically unsound assumption that toxins built up in fat are to blame for GWS - and that there are better ways to test this Proof-of-Concept study. If you feel really industrious, pointing out Hubbard's crazy shit might get some critical attention from a congressional staffer.

Here is a good reference to include.
 
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MrNobody

Who needs merits?
The description of the study is posted at http://www.albany.edu/ihe/gulf.htm

The study is taking place at Severna Park, a Narconon facility in Maryland. http://www.drug-detox-rehab.org/sta...yland_drug_detox_rehab_info~Severna+Park.html

The principal investigator is David O Carpenter, doesn't seem to be a $cilon - he could be the same David Carpenter that took the courses but it may be a common name. But his co-investigator is Kathleen Kerr, director of Narconon Canada.

The study design seems quite bogus. Both the "experimental" and "control" group get the purif, and get tested before and after. The only difference is that the "experimental" group gets the purif right away, while the "control" group has to wait 4-6 weeks before they start the purif. They also exclude people with psychiatric conditions.

I can't believe this got past peer review.

Oh, GREAT! I have always excellent results when I test myself. :faceslap:

Does the DOD really fund that :bs: ? Incredible.
 

Udarnik

Gold Meritorious Patron
The study design seems quite bogus. Both the "experimental" and "control" group get the purif, and get tested before and after. The only difference is that the "experimental" group gets the purif right away, while the "control" group has to wait 4-6 weeks before they start the purif. They also exclude people with psychiatric conditions.

I can't believe this got past peer review. ^ ditto

:banghead:

No, Lohan, crossover designs are quite common now that we have more sophisticated statistical techniques at our ready disposal made possible by good stats programs. I've helped deisign a few crossover types myself.

What I object to is the waitlist as a control with no active comparator.

Some of GWS is likely PTSD with psychological overtones. Just talking to someone and doing something, anything, is likely to lift the mood and thus the score on the rating instrument. A better comparison would be to have the waitlist group have regular medical attention and appointments. I know that waitlist is a common "placebo" in talk therapy trials, but doing nothing and knowing they are going to get something in the future is going to make them anxious and lower their scores. That is my issue with the trial design.
 
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Udarnik

Gold Meritorious Patron
How about the (USA) Surgeon General as well ??
http://www.surgeongeneral.gov/contactus/

Office of the Assistant Secretary for Health
http://www.hhs.gov/ash/contactus/contactus.html

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)

The surgeon general is a public health official, not a regulatory official. Don't waste his time, write to the FDA clinical trial oversight office:

Drug studies:
Call 301-796-3150
Fax 301-847-8748
Email: [email protected]
(Division of Scientific Investigations, Office of Compliance, CDER)

Note in any correspondence to the agency that up to 5000 mg Niacin is being used without any biochemical rationale or animal studies having been performed on exposures that high. No titration protocol was given in the clinicaltrials.gov website, leading me to think that they are just going to keep dosing up until the poor subject can't tolerate any more.
 

RandomCat

Patron with Honors
To help avoid/avert confusion, if this discussion continues here, it might help to better understand an oft-used phrase. :)

Here's the Wiki page about Gulf War Syndrome (GWS): http://en.wikipedia.org/wiki/Gulf_War_syndrome

As you'll see, this term was initially used to describe the ill-health symptoms experienced by soldiers who participated in the 1991 Gulf War.
Physicians (military and civilian) were still trying to 'get their act together' about how best to treat these people when US-led military conflicts occurred in Afghanistan and Iraq.

Soldiers who were stationed in these two countries and experienced ill-health symptoms were initially categorized as having GWS and treated with GWS-learned medical protocols, but physicians learned fairly quickly that the symptoms from the later 2 groups didn't exactly fit the existing definitions/treatment protocols.

More recently, physicians realized that the symptoms and illnesses reported by soldiers stationed in Afghanistan differ from those stationed in Iraq. What makes the task of separating the differences more difficult however, is that many soldiers were stationed in both Afghanistan and Iraq.
What makes the task most difficult, though, is that a majority of soldiers served multiple tours of duty in one or both places.
Ex.: Did Soldier X develop lung infections in Afghanistan, but only during his/her second tour, a time period when we see lung infections spike? Or did the lung infections develop because s/he already was diagnosed with early-stage COPD* during his/her tour in Iraq?

There exists true distinction between people who served in/around 1991 as having the GWS diagnosis, and those who, most unfortunately, came later.

At this point in time, using the term GWS as an umbrella term to discuss this awful topic on ESMB is reasonable enough. But when reading the US Army-generated bulletins, DoD policies, and other GWS-related medical literature, please note that in some documents GWS only means the 1991 group, not those who served later or in different places.
The US soldiers who served in Afghanistan and/or Iraq, along with their military and civilian physicians, don't all agree that GWS is the proper term for the illnesses from which they suffer. With so many overlapping ill-health symptoms reported by so many soldiers it's extremely challenging to all directly concerned, which almost guarantees that it's near-impossible for those not directly concerned.
What remains true, however, is that every reasonable person wants these people returned to good health. :)

By way of simple comparison, those here who were involved with the Los Angeles sea org in the 1970's have entirely different recollections than those who were in the Australian sea org in the 1990's.

Here's a single-post thread that will also help to better understand a portion of this topic: http://www.forum.exscn.net/showthread.php?34019-Book-Recommendations&p=879891&viewfull=1#post879891 It's a very long post, but if you read it all and then think a 'purif' will help in any way, please let me know.

JB (*COPD = Chronic Obstructive Pulmonary Disease)
The causes and symptoms of GWS are so vague, how can you tell if any treatment works?... What exactly are the toxins invoved? And can they be measured?
What symptoms in individuals have other causes (e.g. Aging. The person's genetic makeup). Could some symptoms be caused by post traumatic stress?

Even if a treatment does make some feel better, how do you effectively eliminate the placebo effect? [Control group(s) would have to be very well thought out.].
 

Udarnik

Gold Meritorious Patron
The causes and symptoms of GWS are so vague, how can you tell if any treatment works?... What exactly are the toxins invoved? And can they be measured?
What symptoms in individuals have other causes (e.g. Aging. The person's genetic makeup). Could some symptoms be caused by post traumatic stress?

Even if a treatment does make some feel better, how do you effectively eliminate the placebo effect? [Control group(s) would have to be very well thought out.].

Precisely. This is a garbage study on an ill-defined population, so they feel they will be more easily able to manipulate the results.

And they are right about that.
 

La La Lou Lou

Crusader
The causes and symptoms of GWS are so vague, how can you tell if any treatment works?... What exactly are the toxins invoved? And can they be measured?
What symptoms in individuals have other causes (e.g. Aging. The person's genetic makeup). Could some symptoms be caused by post traumatic stress?

Even if a treatment does make some feel better, how do you effectively eliminate the placebo effect? [Control group(s) would have to be very well thought out.].

Placebos do work on a small percent of people.

The way it works in CFS (Chronic Fatigue Syndrome) is that the immune system is working on anything and everything, tiny amounts of toxins therefore can have more effect than would on someone else. A patient would certainly know if he or she felt any improvement.
 

Udarnik

Gold Meritorious Patron
This study should have not been funded because it is based on an unsound theory that toxins remaining in the body from the gulf war in the '90s is the single thing responsible for this syndrome (not likely the case), and that these supposed toxins can remove by sweating (when the liver is by far the organ most responsible for this function, with the kidneys playing the part of dumping the metabolites). There are known risks with the large niacin doses and saunas are not safe for people with many conditions, so basically this study has not balanced risk with potential benefit properly.

This is a pilot study so is not blinded, but it has a control group which will have standard care while the test subjects go through the program, then the controls will go through the program (cross-over study). I am hoping that with reviews by the DOD, an independent IRB and 3 institutional IRBs, there are adequate safety measures. I said adequate, because the only safe way to do this program is to not do it.

The exclusion criteria on the clinicaltrials.gov site are: "Veterans who meet the inclusion criteria but have been diagnosed by a physician with (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple sclerosis, etc.) that are not associated with Gulf War service but can produce diverse symptoms similar to Gulf War Illness; (2) conditions that might interfere with respondents' ability to report symptoms (eg., psychiatric conditions or history of hospitalization for depression, alcohol or drug dependence; (3) pregnancy or unwillingness to use contraception." There will be a more detailed list in the protocol, and since there will be screening tests, it is likely that elevated liver enzymes will exclude some subjects (I hope so at least). Also, the consent should have a pretty comprehensive list of the risks, but I am concerned the risks will be played down because of investigator bias.

Before the study, after the 4-6 weeks of sauna, and 3 months later, these subjects will be tested with blood tests [comprehensive metabolic panel (electrolytes and enzymes such as liver, heart, ext), lipid panel, complete blood count with differential and thyroid panel], cognitive tests and the ever nebulous quality of life measure. There may also be stopping rules, but they may or may not be well chosen.

THere are usually a whole set of rules guiding dosing of the main study med and with known issues of high dose niacin, there are likely a list of when to reduce niacin to reduce and manage side effects.

I have a feeling that monitoring for toxicity and CV stress was a big part of why it took so long to get off the ground. However, the person doing the negotiation was the Principal Investigator, and it looks as if he is going to be in Albany while the staff administering the study will be in Maryland. Is there going to be an MD on site when this is going on? I have big concerns that the negotiated safety precautions in the protocol amendment are going to go out the window with the half-trained Scilons at the study center.
 

RandomCat

Patron with Honors
Placebos do work on a small percent of people.

The way it works in CFS (Chronic Fatigue Syndrome) is that the immune system is working on anything and everything, tiny amounts of toxins therefore can have more effect than would on someone else. A patient would certainly know if he or she felt any improvement.
The placebo effect can at times be very satistically significant, especially when the result are measured by 'how one feels'. e.g. If I remember correctly some control groups in the clinical trials for antidepressants showed about 30% of the individuals receiving the placebo said they felt better.
 

Udarnik

Gold Meritorious Patron
The placebo effect can at times be very satistically significant, especially when the result are measured by 'how one feels'. e.g. If I remember correctly some control groups in the clinical trials for antidepressants showed about 30% of the individuals receiving the placebo said they felt better.

That can be true in pain trials as well. But in those trials, the patient is getting a dummy pill. In this one, the "placebo" is a waitlist, which is not treatment at all, not even sham treatment. This will make even ineffective treatments look good, because the patients in the active will be having something done to them, even if it is ineffective, and will experience a placebo effect.
 

RandomCat

Patron with Honors
Precisely. This is a garbage study on an ill-defined population, so they feel they will be more easily able to manipulate the results.

And they are right about that.
Add to this, telling a group of people now in their 40's and 50's that the may have been exposed to something in 1990-1991 that could lead to all sorts of serious medical issues...
I'm about that age and I have some of these symptoms too (but I've never been to the middle east).
 
My understanding is that these wait list control group designs are used when the intervention is thought to be effective and the investigator doesn't want the control group to miss out, for example when prior research indicates treatment efficacy. That is not the case here.

No, Lohan, crossover designs are quite common now that we have more sophisticated statistical techniques at our ready disposal made possible by good stats programs. I've helped deisign a few crossover types myself.

What I object to is the waitlist as a control with no active comparator.

Some of GWS is likely PTSD with psychological overtones. Just talking to someone and doing something, anything, is likely to lift the mood and thus the score on the rating instrument. A better comparison would be to have the waitlist group have regular medical attention and appointments. I know that waitlist is a common "placebo" in talk therapy trials, but doing nothing and knowing they are going to get something in the future is going to make them anxious and lower their scores. That is my issue with the trial design.
 

RandomCat

Patron with Honors
That can be true in pain trials as well. But in those trials, the patient is getting a dummy pill. In this one, the "placebo" is a waitlist, which is not treatment at all, not even sham treatment. This will make even ineffective treatments look good, because the patients in the active will be having something done to them, even if it is ineffective, and will experience a placebo effect.
That's exactly the kind of thing I'm afraid might happen.

I suspect this would shoot down the study with any reputable peer review journal. But in the meantime, the COS would have their favorable​ research results... and they could blame the psychiatrists and bigots​ for dissing their project. :p
 
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