Botulinum toxin (BTX) has been used at Baylor College of Medicine
Movement Disorders Clinic in the treatment of dystonia and related
disorders since 1983. Its safety and efficacy has been established,
partly as a result of the pioneering work at the Movement Disorder
Clinic, Baylor College of Medicine. The first double-blind, placebo
controlled trial of BTX in cranial-cervical dystonia was conducted at
Baylor and the findings were used to obtain the initial approval for
BTX by the Food and Drug Administration.

Dystonia is a neurologic condition manifested by involuntary
contractions (spasms) of muscles producing twisting, squeezing or
pulling movements and abnormal postures. Examples of dystonia include
blepharospasm (spasms of eyelids causing involuntary eye closure),
cervical dystonia or torticollis (spasms of neck muscles causing
twisting and other movements of the neck, abnormal head posture, and
neck pain), laryngeal dystonia or spasmodic dysphonia (spasms of
vocal cords causing a strained or breathy voice), oro-mandibular
(mouth and jaw spasms) dystonia, and task-specific dystonias
(writer's cramps). In addition to dystonias, BTX has been used also
to relieve other focal spasms, such as hemifacial spasms, tremors,
tics, spasticity, and other movement disorders. At Baylor's Movement
Disorders Clinic, BTX has been also used to treat muscle contraction
(tension) and migraine headaches, excessive drooling (sialorrhea),
excessive sweating (hyperhidrosis), and other conditions for which
BTX has been found to be effective. Studies involving thousands of
patients have demonstrated the usefulness and safety of BTX
treatments in these conditions.

BTX is a protein that acts by binding to certain nerve endings thus
preventing the release of the neurotransmitter acetylcholine. An
injection of BTX into the muscle blocks transmission of impulses from
the nerve to the muscle causing local and temporary weakness of the
target muscle. This process, called "chemodenervation", provides
effective relief of dystonias and other disorders manifested by
abnormal and unwanted muscular contractions or abnormal secretions.
The onset of improvement is often noted within a few days after
injection and the benefits usually wear off after 3 to 6 months at
which time a repeat injection is needed. Because BTX acts only
locally without spreading into the circulation, it does not usually
cause any systemic reactions. Most patients obtain safe and
substantial relief, but a few experience side effects after the
treatment. Except for occasional temporary feeling of generalized
malaise and weakness, nearly all other side effects are confined to
the injected body part. Injections into the eyelids, for example, may
result in transient local swelling, droopy eyelids, blurring of
vision, and tearing. Injections into the neck muscles may cause
temporary neck weakness or pain and difficulties with swallowing.
Swallowing problems as well as chewing, speech and voice difficulties
may also result from injections into the jaw and vocal cord muscles.
Injections into the arm or hand muscles may cause temporary weakness
of fingers and hands. These side effects are usually mild, occur
infrequently, and most resolve in a few weeks without any specific
treatment. If swallowing problems occur, it is advisable to change to
a soft or liquid diet. Of course, any troublesome side effects should
be reported to the treating or primary care physician.

BTX treatments do not represent a cure, but they usually provide
satisfactory relief of symptoms that can be maintained by repeating
treatments when the effects of previous BTX injections begin to wear
off. Rarely, some patients become unresponsive to the treatment
because they develop blocking antibodies. Such immunoresistance is
quite uncommon and occurs only after repeated treatments, usually
with relatively high doses or when injected more frequently than
every 2-3 months. There are several ways that the presence of
immunoresistance can be detected. The simplest and least expensive
way is to inject small amounts of BTX into the medial portion of
right eyebrow. If the eyebrow is weakened by the injection and one
week later the patient is unable to contract the muscle on that side
while frowning, this indicates that the patient does not have
blocking antibodies – no immunoresistance. Besides this unilateral
brow injection (UBI) BTX antibodies can be also detected by a mouse
bioassay. This test involves sending a frozen blood serum to
Northview Pacific Laboratories, 2800 7th Street, Berkeley, CA 94710
(Tel: 510-548-8440), along with a check for about $200. When the
blood sample is forwarded to the Northview Pacific Laboratories by
physicians other than those at Baylor College of Medicine, it is
important that you are identified as a patient at Baylor College of
Medicine and that the results are forwarded to us.

Patients who have become immunoresistant as a result of BTX
antibodies no longer respond to subsequent injections with the same
type of BTX-A, but may respond to other types of BTX. In December
1989, after extensive laboratory and clinical testing of BTX-A
(BOTOX©, Allergan Pharmaceuticals, California) the Food and Drug
Administration (FDA) approved this biologic as a therapeutic agent in
patients with strabismus, blepharospasm and other facial nerve
disorders, including hemifacial spasm. In December 2000, the FDA
approved BOTOX© and BTX-B (MYOBLOC™, Solstice Neurosciences, Inc,
California) as a treatment for cervical dystonia. In 2002, FDA also
approved BOTOX© for treatment of frown lines between the brows and in
2004 BTX was approved for severe underarm sweating (hyperhidrosis).
Approval for spasticity, headaches and other indications is still
pending. The procedure requires specialized skills and, therefore,
only some centers are performing this treatment. The average cost of
the medication will range from about $400 (for patients with
blepharospasm who receive an average of 80 units) to about $1,500
(for patients with cervical dystonia who receive an average 250
units) per visit. These charges merely represent estimates and the
actual cost of the medication depends on the exact dose required to
treat the specific condition and will be determined at the time of
the visit and. In addition to these charges for the medication
(BOTOX© or MYOBLOC™), there is a separate $500 fee for the
chemodenervation procedure (injection). To cover the cost of the
medication and our overhead, we require that all charges for the
medication and for the procedure must be paid or a documentation of
pre-approval is presented before the treatment visit.

We are genuinely concerned about the cost of the BTX treatments and
we are trying to keep the cost as low as possible. Because BTX is
approved by the FDA (at least for some indications), many insurance
carriers and Medicare provide reimbursement for the cost of the drug
and the chemodenervation procedure. The following codes should be
used for filing claims:

Joseph Jankovic, M.D.