Findings
of Fact
"In
reviewing the application and determining the merits of the application
the Board on the October 18, 1991 and December 13, 1991 hearings
heard evidence and considered the issues of safety and effectiveness
of the treatment modality utilized by the Applicant.
Most
drugs of abuse are removed from the body by detoxification and excretion
through the liver, kidneys, and the lungs. Although minute quantities
of some drugs may be found in sweat the amount represents a small
fraction of drug elimination.
The
Narconon drug treatment modality treats all drug addictions the
same. No scientific evidence was produced to show that all drug
addictions are properly treated in the same manner.
The
terms "patient," "student" and "client"
are used interchangeably in these Findings.
The
Narconon Program exposes its patients to the risk of delayed withdrawal
phenomena such as seizures, delirium and/or hallucinations.
The
Board has not considered any evidence of the beliefs or opinions
of any witness on matters of religion in making its findings of
fact. To the extent there may be some affiliation between Narconon
and any religion such affiliation has been totally disregarded by
the Board. The Board has not made its decision on certification
based upon any consideration of religion or religious affiliation.
The
Board concludes that the Applicant, Narconon International, has
the burden of proving that its program meets all requirements for
certification and specifically the burden of proving its program
is both safe and effective. Narconon has not sustained its burden
of proving its program is either safe or effective. However, regardless
of whether Narconon International has the burden of proof the Board
concludes there is substantial credible evidence, as found by the
Board, that the Narconon Program is unsafe and ineffective.
The
Narconon program requires its patients to sweat up to five hours
per day, seven days a week, for approximately thirty days. The rationale,
according to Narconon for the sweat-out is to rid the body of fat-stored
drugs and chemicals through sweat. However, there is no scientific
basis for the technique. Most drugs of abuse are removed from the
body by detoxification and excretion through the liver, kidneys
and (in some instances) through the lungs. Although minute quantities
of some drugs may be found in sweat, the amount represents such
a small fraction of drug elimination that no matter how much an
individual sweated through exercise or saunas, the clearance of
most drugs of abuse would not be significantly increased.
The
Narconon program includes the administration of high doses of vitamins
and minerals to the Narconon patient as part of their treatment.
The use of high amounts of vitamins and minerals in the amounts
described administered by Narconon can be potentially dangerous
to the patients of Narconon according to the more credible medical
evidence.
The
relationship between drug abuse and psychiatric disorders is well
established. Most drug abusers who enter residential drug treatment
facilities have high levels of anxiety, depression, hostility or
apathy. Further, a chemical dependency disorder may co-exist with
- or be secondary to - a specific psychiatric illness, such as schizophrenia
or major depression, which should be treated by established psychiatric
procedures. The Narconon program presents a potential risk to the
patients of the Narconon program that delayed withdrawal phenomena
such as seizures, delirium or hallucination that are occasionally
seen several days after cessation of drugs such as benzodiazepines
may be misinterpreted by Narconon's non-medical staff as the effect
of mobilizing the drug from fat during the sauna sweat-out procedure
period. There is also a potential risk that the reported re-experience
of the abused drugs' effect during the sauna sweat-out program may
be the result of misinterpreted symptoms of hyperthermia or electrolyte
imbalance since vital signs and serum electrolyte levels have not
been consistently monitored during the sweat-out procedures or when
a student is reporting the phenomena.
The
progress notes for the patients at Narconon do not consistently
evidence that vital signs are recorded every six hours in the detoxification
process; nor do the progress notes record fluid intake for detoxification
clients.
Discharge
summaries of patients at Narconon were not routinely completed within
fifteen days of the patient's discharge.
The
clinical records of patients at Narconon do not consistently reflect
the recording of vital signs every six hours for clients as required
under non-medical detoxification standards of the Department.
There
is credible evidence by way of witness testimony and review of Narconon
charts which reflect that there were patients who had psychiatric
problems who were taken off of their previously prescribed psychiatric
medication who did not do well and subsequently developed psychiatric
problems. This evidence indicates a lack of safety and effectiveness
in connection with the program.
Clients
of Narconon suffering from psychiatric illness, when taken off their
prescribed medications, did poorly in the Narconon program and were
placed in a segregated facility called "destem". This
practice endangers the safety, health and /or the physical and mental
well being of Narconon's clients.
Narconon's
program lacks any acceptable degree of quality control of the sauna
temperatures and treatment. Such a lack of control endangers the
safety, health and/or the physical or mental well being of its clients.
Narconon
hires former students to work at Narconon - Chilocco immediately
upon graduation and the former students work directly with the present
students. While former patients of drug and alcohol rehabilitation
clinics can be employed in such clinics after graduation, the former
patient's recovery from his addiction should be established with
more passage of time to ensure sobriety and to avoid putting patients
in contact with addicts who are not fully recovered. This practice
could negatively impact the safety and effectiveness of the program.
Narconon
does not maintain a sufficient level of follow-up of its students
after graduation, which impacts the effectiveness of the program
allowing for relapses and lack of recovery.
During
an on-site visit in November 1991 a student was found with a potentially
dangerous low level of potassium which could lead to cramps, (muscular,
skeletal problems) and cardiac arrhythmia.
The
vast majority of time spent in the Narconon treatment plan and course
work does not in any way relate to or involve education about drug
and alcohol abuse treatment, issues, and/ or addiction. The Narconon
treatment plan thus has deficiencies which render it ineffective.
The Narconon treatment plan is general in nature, applies categorically
to all students and is not individualized. The treatment plan also
lacks measurable individualized objectives which the students should
seek to achieve in the program. For instance, the treatment plan
sets a patient's objective as follows: "To have a clear mind."
This objective is essentially meaningless. In order for a bonafide
drug treatment plan to be effective it is essential to have individualized
measured objectives which Narconon's treatment plan lacks.
Part
of the Narconon treatment program involves touch assists between
patients. Touch assists involve massages between patients in rooms
by themselves. Narconon has both male and female patients who are
involved in the drug and alcohol rehabilitation program. This practice
of touch assists could likely lead to improper sexual contact between
drug addicts or alcoholics in the process of recovery. An accepted
standard in such programs is for the patients to keep their hands
to themselves. The practice of touch assists between male and female
patients who are recovering drug addicts or alcoholics in private
rooms renders the program unsafe in this respect.
The
discharge planning is not adequate and commences only very shortly
prior to discharge. This lack of discharge planning renders Narconon's
program ineffective.
Narconon
clients are counseled by Narconon staff that it is acceptable for
the client to drink alcohol after being discharged from the Narconon
program and if the client is incapable of being able to drink alcohol,
then this fact evidences the client's need for further treatment.
Such counseling endangers the client's safety, health and /or the
physical or mental well being, and is not in accord with acceptable
drug and alcohol counseling and treatment.
Narconon
employes staff inadequately educated and trained in the care and
treatment of drug and alcohol abuse clients. Such a practice endangers
the safety, health and/or the physical or mental well being of the
clients of Narconon.
Narconon
permits clients under treatment for drug and alcohol abuse to handle
and provide medications to fellow Narconon clients, to supervise
the sauna treatment of fellow Narconon clients, and to supervise
Narconon clients with psychiatric disorders. Such practices endanger
the client's health and safety and are not in accord with acceptable
drug and alcohol treatment.
There
is substantial medical literature which indicates that sauna therapy
may pose significant health risks to intravenous heroine addicts,
which is likely to be treated at Narconon, because such drug use
may impair normal physiological response and problems associated
with high temperature saunas which could be detected.
The
Narconon Program includes running to stimulate circulation followed
by prescribed periods in a sauna for up to 5 hours at extremely
high temperatures (i.e. 135° to 200° F) and as such endangers
the safety, health and/or the physical or mental well being of its
clients. Such a procedure exposes the client to the health hazards
of dehydration and heat injury. This sauna regime also creates a
risk of hyperthermia and electrolyte imbalance.
Narconon
restricts access by Narconon clients to their personal physicians,
family, attorneys, clergy and others by not permitting communications
except at limited and designated hours. such a practice may endanger
the physical or mental well being of Narconon's clients.
The
Narconon program fails to provide adequate follow-up and treatment
for Narconon clients demonstrating abnormal lab tests and other
medical problems. Such failures endanger the safety, health and/or
the physical or mental well being of the Narconon clients and is
not in accord with acceptable drug and alcohol care and treatment.
There
was no evidence that the Narconon staff inventoried and verified
the medications brought on to the campus by Narconon clients. such
a failure endangers the safety, health and/or the physical or mental
well being of Narconon's clients.
The
Board recognizes that Narconon has in the past few weeks adopted
many new policies. The evidence did not disclose adherence to many
if not all of these policies. There was no measurable and identifiable
compliance by Narconon to its newly adopted policies in the areas
of taking and recordation of vital signs, drug and alcohol instructions
to clients, handling of medications, withdrawal and discharge procedures,
lab testing, procedures for emergency medical supplies and others.
Narconon
clients are routinely administered clonidine. Narconon fails to
provide adequate supervision for clients prescribed this medication
given this drug's risks and potential for adverse consequences.
Such failure to adequately supervise endangers the safety, health
and/or the physical or mental well being of the Narconon clients.
The
vast majority of Narconon's course materials in its drug and alcohol
abuse program are not designed to educate and/or treat clients in
the area of drug and alcohol abuse. In addition, there was only
evidence of occasional lectures to Narconon clients in areas of
drug and alcohol abuse. As such, Narconon's program lacks sufficient
instruction and education in the area of drug and alcohol abuse.
There
is no credible scientific evidence that the Narconon program is
effective in the treatment of chemical dependency.
There
is no credible scientific evidence that exercise speeds up the detoxification
process.
Large
doses of niacin are administered to patients during the Narconon
program to rid the body of radiation. There is no credible scientific
evidence that niacin in any way gets radiation out of the patient's
body. Rather, the more credible medical evidence supports the existence
of potential medical risks to persons receiving high doses of niacin.
There
is no credible evidence establishing the safety of the Narconon
program to its patients.
There
is no credible evidence establishing the effectiveness of the Narconon
program to its patients.
Conclusions
Of Law
Any
finding of fact which should be included in the conclusion of law
such matters are included hereby by reference.
In
order for the Application to be granted by the Board it must be
shown by a preponderance of the evidence that the program is safe
and effective for the non-medical residential treatment of alcohol
and drug abuse.
Th
purpose of Mental health law in the State of Oklahoma is to provide
humane care and treatment of persons who require treatment for drugs
or alcohol abuse. Residents of the State of Oklahoma are entitled
to medical care and treatment in accordance with the highest standards
accepted in medical practice. 43A O.S. Supp. 1990, §1-102.
The
Narconon Chilocco program does not conform to the principles of
traditional chemical dependency treatment. The Board's conclusion
that the Narconon Chilocco program is non-traditional does not form
the basis, in any respect, for the Board's decision on the Narconon
application for certification.
No
scientifically well-controlled studies were found that documented
the safety of the Narconon program. There are potential dangers
from the use of non-medical staff who may be unable to interpret
the possibility of seizures, delirious, cardiac arrythmia, or hallucinations
that are phenomena associated with the cessation of drugs. There
is also a potential risk of the reported reexperience of the abused
drug effect during the sauna sweat out program may be the result
of misinterpreted symptoms of hyperthermia or electrolyte imbalance.
Moreover, the multiple findings of fact heretofore entered by the
Board establish that Narconon's program is not safe.
Drug
treatment program offered by Narconon Chilocco is an experimental
treatment and not proven safe or effective and is not in accord
with the highest standards accepted in medical practice as required
by statute.
No
scientifically wee-controlled independent, long-term outcome studies
were found that directly and clearly establish the effectiveness
of the Narconon program for the treatment of chemical dependency
and the more credible evidence establishes Narconon's program is
not effective. The Board determines that the Narconon Program is
not effective in the treatment of chemical dependency.
The
Board concludes that the program offered by Narconon Chilocco is
not medically safe.
The
Board has reviewed the proposed findings of fact and conclusions
of law submitted by the Department and Narconon. Any proposed finding
of fact and/or conclusion of law inconsistent with those entered
by the Board is denied.
Certification
is denied."
|