Botox ® - What is it used for? Botox ® - Can anything bad happen?

Botox ® - Looking toward the future.

Botox ® - What is it?

Botox, which is the trade name for botulinum toxin, is produced by a bacterium that has been identified for hundreds of years. Professor Emile Pierre van Ermengem, from Belguim, first identified the bacterium Bascillus botulinus in 1895 (DasGupta). From there, it was later renamed Clostridium botulinum, and is now known as botulinum type A, or Botox. C. botulinum

Before it's positive medical benefits were discovered, C. botulinum was (and still is) "the most poisonous biological substance known" (Munchau 161). Even in extremely small amounts, botulinum toxin can lead to what is called botulism - a condition that eventually paralyses the body systems, including the autonomic nervous system. Botulism can only occur two ways - either by being infected with spores that can then produce and release the toxin into the body, or through ingesting a food product infected with the toxin (Cherrington).

Make no mistake, the risk of death via botulinum toxin is still quite real, and cases of botulism are still reported in the United States every year (Vangelova). Botulism-causing bacteria (C. botulinum) and their spores are found nearly everywhere imaginable. The spores can be found in dirt, or in sediment around marine life. Accordingly, spores can be found on the surface of fruits, vegetables, and seafood (Vangelova). To be clearer, the spores themselves are not harmful - it is the toxin that is produced as the bacteria begin to grow (Vangelova).

The toxin binds to nerve endings where they are joined with muscles, which ends up preventing nerves from signaling for muscles to contract (Vangelova). Weakness begins to occur, followed by complete paralysis of the muscle(s). The complete body is affected, from the brain down. One of the most serious is the paralysis of the respiratory functions, preventing the person from breathing on their own. Recovery, if possible, can be a long process, while waiting for the damaged nerve endings to regrow.

Historically, botulism was a devastating condition before the medical advancements of today were around. There were no respirators or ventilators, causing the death rate of botulism between 1910 and 1919 to be 70% (Vangelova). The rate was right below 10% in the 1980s, and the 1990s saw the rate of death drop to around 2% (Vangelova).

When speaking of botulism, there are three types of botulism poisoning which are being considered. Firstly there is the rare wound botulism, in which an infection is caused by toxins produced in an infected wound. Food-borne botulism is obviously when food is consumed that is contaminated with the C. botulinum toxin itself.

The most prevalent type of botulism poisoning is called infant botulism, in which C. botulinum spores geminate and grow inside the intestine of an infant.

Infant botulism is impossible to prevent, because it is not the toxin that is ingested, but the spores, which are present everywhere. The spores seem to take advantage of the underdeveloped intestinal systems present in infants. Though quite serious, infant botulism is typically not fatal. In nearly twenty-years, 1976-1993, there were only 1,206 confirmed cases of infant botulism, with all cases in children less than a year old (Vangelova). Thankfully, the death rate in infant botulism is less than 2%, and there can usually be a full recovery (Vangelova). The baby might have to remain on a ventilator or respirator for months because the horse serum derived antitoxin has not been deemed medically safe for use on infants.

The symptoms of botulism are somewhat vague, causing misdiagnosis in earlier stages. Symptoms may include weakness, partial or full paralysis, fatigue, even trouble swallowing (which relates back to paralysis) and dry mouth (Vangelova). Again, the randomness of the symptoms must cause some doctors to misdiagnose, which might skew numbers of reported cases.

Presently, as stated before, the only "cure" for botulism is the use of an injected "antitoxin" made from a serum in horses (Vangelova). This injection, if the botulism is caught early enough, can prevent the toxin in the body from attaching to nerve endings (unless it has already done so). By neutralizing the toxins that have not yet attached to nerve endings, some damage can be prevented. There are some serious life-threatening side effects associated with the injections, like anaphylactic shock, which is a severe allergic reaction that can actually cause death as well.

Part Two: Botox ® - What is it used for?

So how in the world did the most deadly biological substance become something that is being tested for the treatment of wrinkles, migrane headaches, stroke and multiple sclerosis? Once the toxin was actually isolated, or purified, by Dr. Herman Sommer in the 1920s, the study of the toxin became them main focus of researchers (DasGupta). With the studies came the eventual discovery that there could be positive uses of the toxin.

The first major breakthrough happened in the 1950s, when the toxin's ability to temporarily paralyze an overactive muscle when injected into the muscle (Schantz). Dr. Vernon Brooks is credited with having made that discovery. The toxin actually blocks the release of acetylcholine from the motor nerve endings, which in turn causes the temporary paralysis (Coffield).

In the 1960s, further testing was done, this time on monkeys. Dr. Alan Scott tested the botulinum toxin type A to see if the toxin might be a possible treatment for a condition...

Dystonia, according to the Dystonia Medical Research Foundation's website, is a disorder that is neurological, and causes involuntary muscle contractions, which in turn can cause other parts of the body to be forced into painful movements (DMRF). Because of that study's results, the F.D.A. eventually approved the study of botulinum toxin type A in humans, in 1978 (Schantz).
After that, it seems the results have been endless and positive. 1989 is when the first botulinum toxin type A was marketed to treat dystonia in patients aged twelve and older (Schantz).

Because of the clinical success of the toxin, now known as Botox ®, further research has been done that have found a multitude of uses. Included in these uses are:

Disorders caused by overactivity of muscles for which treatment with botulinum toxin A is established

Ophthalmological disorders

Concomitant misalignment

Primary or secondary esotropia or exotropia

Nonconcomitant misalignment

Paralytic strabismus (III, IV, VI nerve palsy, internuclear ophthalmoplegia, skew deviation)

Duane's syndrome

Restrictive or myogenic strabismus

Movement disorders

Idiopathic focal dystonias

Craniocervical (torticollis and isolated head tremor, blepharospasm, oromandibular dystonia, lingual dystonia, laryngeal dystonia)

Other focal dystonias (writer's cramp, occupational cramps such as musician's cramp)

Tardive dystonia

Hemifacial spasm/post-facial nerve palsy synkinesis

Examples of overactive muscle conditions for which treatment with botulinum toxin A has been tried

Ophthalmic disorders

Disorders of ocular motility (nystagmus and oscillopsia)

Thyroid disease (upper eyelid retraction, glabellar furrowing)

Therapeutic ptosis for corneal protection

Movement disorders

Secondary dystonia

Tic disorders (simple tics, Tourette's syndrome, dystonic tics)

Temor (essential, primary writing, palatal, cerebellar)

Painful spinal myoclonus

Parkinson's disease (freezing of gait, off period dystonia, severe constipation)

Cephalic tetanus, stiff man syndrome, neuromyotonia

Muscle stiffness, cramps, spasms

Spasticity

Multiple sclerosis

Stroke

Traumatic brain injury

Cerebral palsy

Spinal cord injury

Neuromuscular disorders

Myokymia

Neurogenic tibialis anterior hypertrophy with myalgia

Benign cramp-fasciculation syndrome

Pain

Headache (tension type, migraine, cervicogenic)

Backache (neck, lower back)

Myofascial pain

Tennis elbow

Ear, nose, and throat disorders

Oromandibular disorders (bruxism, Masseter hypertrophy, temporomandibular joint dysfunction)

Pharyngeal disorders (cricopharyngeal dysphagia, closure of larynx in chronic aspiration)

Laryngeal disorders (vocal fold granuloma, ventricular dysphonia, mutational dysphonia)

Stuttering with glottal blocks

Disorders of pelvic floor

Anismus

Vaginismus

Anal fissures

Detrusor-sphincter dyssynergia

Cosmetic applications

Wrinkles, frown lines

Rejuvenation of ageing neck

Other disorders for which botulinum toxin A has been tried

Overactivity of smooth muscles

Oesophageal disorders (achalasia, diffuse oesophageal spasm, oesophageal diverticulosis)

Sustained sphincter of Oddi hypertension

Gastric pyloric spasms

Hypersecretion of glands supplied by cholinergic sympathetic or parasympathetic neurones

Ptyalism

Increased tearing

Hyperhidrosis (axillary, palmar, gustatory)

Intrinsic rhinitis

The preceding table was taken from A. Munchau's article "Uses of botulinum toxin injection in medicine today" from the British Medical Journal. Complete source listing can be found in bibliography.

Botox® has been used widely since the F.D.A. first approved it. From its initial treatment of eye conditions associated with dystonia, uses for nearly every condition under the sun have been tested. What has Botox® in the media, however, is the cosmetic use of the injections, to paralyze muscles in the face, which in turn cause a decrease in the appearance of wrinkles. The effects can last for up to three or four months, causing the patient to have to return for more injections. Botox® parties have jumped into the scene, where a plastic surgeon will attend a gathering of friends, much like the Tupperware parties of the past. Ironically, in the article by Luba Vangelova "Botulinum Toxin: A Poison that Can Heal," which was published in the F.D.A. Consumer Magazine in 1995, the F.D.A. put a stern warning at the end of the article discouraging Botox® from being used as wrinkle therapy. In their November 18, 1994 Federal Register Notice, the F.D.A. went so far as to "denounce (d) the promotion of such unapproved use as 'an egregious example of promoting a potential toxic biologic for cosmetic uses.'" (Vangelova) Clearly, their tune has changed, as the cosmetic use of Botox® has since been approved by the F.D.A. this year.

Part Three: Botox® - Can anything bad happen?

Obviously, Botox® is a toxin. As pointed out…