A Study of 58,000 Patients
David R, Hawkins, M.D.
Tardive Dyskinesia is a critical clinical problem in psychiatry
today and almost every issue of every professional journal carries
at least one article devoted to the subject. In general, the incidence
is reported to be on the average of between 10 and 25% of patients
on neuroleptics, and the recovery rate is reported to be about
50% patients who develop this neurological disorder.
T.D. has presented the profession with whole variety of practical
as well as theoretical problems. It also presents an ethical as
well as a medico-legal dilemma for the practitioner. If he withholds
neuroleptic medication the patient's psychosis may progress or
re-emerge, and psychotic behavior and self-destruction in all
its forms may occur. If the patient commits a crime, or suicide,
or is overtly destructive, the physician may be sued for malpractice
for failing to institute proper treatment. If he places the patient
on medication and T.D. develops, he may be sued for causing the
T.D. Many private clinicians are currently solving the problem
by refusing to treat patients who require antipsychotic drugs,
but physicians such those who work in hospitals and state institutions
are caught in an insoluble conflict situation. Even if a truly
effective treatment eventually is found, the illness will still
have already been present with all its risks, Until recently,
knowledge about T.D, was limited primarily to the profession and
the unfortunate victims of the disorders. Recently, however, in
November of 1983, there was a three day nation-wide documentary
program devoted to T.D. aired on CBS television and the public
was exposed to viewing some severe cases plus the news that one
million dollar malpractice awards were being won by T.D. victims.
The program included a moralistic denunciation of the profession
which "should have known better than to prescribe anti-psychotic
drugs" by a Monday morning quarterback critic. The program deliberately
promoted emotionalism and sympathy in the viewer and indignation
at the guilty culprit, the practicing physician, together with
the strong suggestion to sue for a million dollars. The full impact
of this widely televised program is yet to be felt by the profession,
but numerous lawsuits are currently in preparation as an immediate
aftermath, Once the legal precedent has been set, the door is
open to a mass of lawsuits, The TV documentary estimated, based
on incidence and prevalence, and the number of patients who need
anti-psychotic drugs, that within a year one million Americans
will have developed T.D. The medico-legal potentiality of this
is awe inspiring, to say the least.
Over the past 20 years there has been much work done to clinically
investigate the value of high dosage vitamins as an adjunct in
the treatment of schizophrenics and other perceptually disordered
psychotic conditions. There was much discussion, argument and
political dissension about this approach, which first arose at
a time in the 1950s and '60s when psychiatry was previously psychoanalytically
oriented and there was little knowledge about the relationship
between nutrition and brain chemistry. Orthomolecular psychiatry
developed out of the inquiry as to whether therapeutic nutrition
favourably affected psychotic disorders or not, There were conflicting
reports in all the literature and the Issue was never settled
to general satisfaction. The end result was that those who believed
that nutrition helped their patients continued to use high dosage
vitamins in treating their schizophrenic patients,
During the late 1960s, the 1970s and early 1980s, well over a
hundred thousand psychotic patients were on high dosages of vitamins
as well as the standard treatment of anti-psychotic drugs. These
were primarily long term patients who were on neuroleptics and
on mega-vitamins for years, many for as long as 20 years and more,
There is thus a very large patient population group that has been
treated by a large number of physicians over a period of many
years distributed throughout the entire country under very diverse
family, ecological and socio-economic conditions.
By the late 1970s it was clear from the psychiatric literature
and professional meetings that T.D. was becoming an increasingly
frequent clinical development in patients who were solely on neuroleptic
drugs, At the North Nassau Mental Health Center in Manhasset Long
Island, New York, we had been treating large numbers of schizophrenics
since the mid-1960s with anti-psychotics, plus megavitamins and
sugar free diets. (We reported our results and techniques primarily
in the book Orthomolecular Psychiatry published with Prof. Linus
Pauling as Co-editor.) We noticed that none of our patients either
in private practice, the hospital or the clinic had developed
overt T.D. We searched through our case loads over the years and
there was not a single case of clinically apparent T.D. amongst
the 15,000 schizophrenic patients we had treated over the past
15 years. Together with Dr. Charles Tkacz we presented a report
at the Academy of Orthomolecular Psychiatry Meeting in May, 1981,
and published it in the Journal of Orthomolecular Psychiatry in
1981.1 We thought that it would be overlooked in a sub-speciality
journal of limited circulation so notices were placed in Psychiatric
News to bring it to the attention of the profession at large.
Perhaps the fact that we had NO cases of T. D. in 15,000 patients
presented a credibility problem, as many clinicians probably thought
that we ought to have some, at least! It was decided to enlarge
the study to include a much wider patient population so as to
include the clinical observations of many more physicians and
Institutions. This was done in December, 1983.
One hundred clinicians were contacted who were known to have large
practices which included prescribing megavitamins along with neuroleptics
in the treatment of schizophrenic patients. They were scattered
throughout the United States and Canada and had been using megavitamins
in their practice for an average of at least 10 years or more,
Twenty physicians stated that they did not use neuroleptics; and
the remaining 80 physicians reported on the number of cases they
had treated over the last 10 years and the incidence of overt
T.D. in their practices.
The average dose of megavitamins was 3 grams daily of Vitamin
B3 (of either Niacin or Niacinamide) plus 3 grams of Vitamin C,
plus 600 mg of B6 and often Vitamin E 600 IU was included. Nutramega
was the brand formulation most often prescribed which contained
the megadoses in capsule form). This was divided into 1/3 the
daily dose at each meat (3 capsules 3 times daily of the most
frequently used formulation.)
The results of the study were as follows: 69 physicians treated
a total of 41,972 patients without a single case of T.D. 11 physicians
treated a total of 16,070 patients and reported collectively 26
cases Thus, 80 clinicians treated a total of 58,042 patients with
an incidence of 0.045% T.D. (In this reporting, only cases of
overt clinically observable T.D. are reported).
The 26 cases of T.D. who were reported among the 58,000 patients
have as yet not been studied and so it is still unknown whether
they were bona-fide T.D. or not. (As one clinician put it "Everything
that shakes is now called T.D. - but we saw
movement disorders years before the antipsychotic drugs".) Also,
it is not known whether those 26 patients actually took the prescribed
megavitamins or not. It could also be argued that the cases of
T.D. were under reported. This would mean that the symptoms were
not noticed by the patient or his family nor by the treating physician
or his assistants (many of the reporting physicians practice in
groups and clinics with large staff and patients are seen by a
multiplicity of professionals). To help clarify this problem,
there is amongst this large patient population a sub-group of
1,000 patients whom I personally treated over a 10 year period
in the hospital and all of whom had a neurological examination
by an attending neurologist on the staff of the Brunswick Hospital.
All of these patients were on neuroleptics, all were markedly
psychotic and the majority were consequently on high doses of
antipsychotics. All of these patients had a neurological work-up,
including EEG and psychological testing, and were examined by
an internist as well as at least one other psychiatrist, Over
the ten year period no patient developed clinical T.D.,
With evidences of T.D. being reported of 10% to 50%, we should
have expected between 6,000 to 20,000 cases of TD. in this study
of 58,000 patients. Even if there were a 100% error in the reporting
of cases (i.e. 52 cases instead of 26), there would still only
be a remarkably low incidence of 0.1%!
Summary
A study of the practices of 80 physicians over a 10 year caseload
of 58,000 patients treated with antipsychotic drugs plus high
dosage vitamins, reveals a total of only 26 patients developing
Tardive Dyskinesia, This Is an incidence of less than 0.05%. This
is a remarkable finding in view of currently reported rates of
10% to as high as 60%. The data are strongly suggestive that the
prescribing of high dosage Vitamins B3, C and B6, along with neuroleptic
drugs, provides almost 100% protection against the development
of this dread neurological disorder which is reportedly irreversible
in 50% of those patients in whom it develops.
References