Introduction & History
Introduction
PLEASE NOTE- you will be asked to complete a short quiz at the start of your practical based on your online learning.
Botulinum Toxin is produced by Clostridium botulinum, a gram-positive anaerobic bacterium. The clinical syndrome of botulism can occur following ingestion of contaminated food, from colonization of the infant gastrointestinal tract, or from a wound infection. It is broke into 7 neurotoxin labelled as types A, B, C (C1 , C2), D, E, F, and G).
Although they differ, they are structurally similar. Human botulism is caused mainly by types A, B, E, and (rarely) F. Types C and D cause toxicity in animals only.
Types A & B are for local use and is a muscle relaxant, and aesthetics use to treat muscle lines.
To become fully active the molecule must dissociate into a heavy chain (100KDA) linked by a disulphide bond to a light chain (50KDA). It is this dual chain form of the molecule that causes the therapeutic benefit for the reduction in lines and wrinkles.
There are various botulinum toxins brands available to us on the market, and they all possess individual potencies & re constitution guidelines. Care is required to assure proper use and avoid errors. There are currently two different types of botulinum toxin commercially available in the United Kingdom – type A toxin (including the brands Botox®, Vistabel®, Dysport®, Azzalure® and Xeomin® and Bocouture®) and type B toxin (Neurobloc®).
Botulinum Toxin Type A is the wrinkle reducing injection treatment. These treatments were first licensed for cosmetic use in the early 2000’s. Botulinum Toxin Type A is also known as Botox®, which is actually a brand name supplied by Allergan. Vistabel® is manufacturerd by the same company.
Azzalure® and Dysport® are manufacture by Galderma Bocouture® and Xeomin® are manufactured by Merz Pharmaceuticals
All Botulinum Toxin Type A Toxin Brands are classified as POM’S (Prescription only Medication) and as such can only obtained by prescription from either a nurse or Doctor prescriber. Enhance Me Academy has access to a UK wide prescribers list.
The Advertising of ‘BOTOX’ / Wrinkle Relaxing Treatments
In January 2020 The Advertising Standards Authority and the Medicines & Healthcare Products Regulatory Agency have clamped down on the advertisement of Botox treatments in the UK after they found widespread, illegal marketing of the cosmetic procedure online.
Regulators have issued an enforcement notice to the cosmetics industry, calling for the “immediate” takedown of ads promoting Botox and other botulinum toxin injections on social media platforms.
Under advertising rules, promoting such procedures is prohibited. However, the ASA said it had found widespread flouting of the regulations on social media.
The watchdog is now launching a crackdown of paid-for ads, non-paid-for posts and influencer marketing, beginning with Instagram.
From 31 January, the ASA will use “monitoring technology” to discover problematic ads and flag them for removal to Instagram owner Facebook.
It will refer non-compliant sellers to the MHRA (Medicines and Healthcare Regulatory Agency) which has investigatory and enforcement powers. Advertising will now have to be of a soft nature, not advertising to the treatments directly & referring to appointments for treatment as ‘consultations’
HISTORY OF BOTULINUM TOXIN
Botulinum Toxin Type A has had quite a journey & transitional from a deadly toxin to one of the number one Anti-Ageing treatments in the world.
In the late 1700s in Europe an outbreak of a deadly illness from contaminated foods swept across the continent, fuelled partly by the poverty from the Napoleonic War that resulted in unsanitary food production. The main cause of food-borne illness at the time was from smoked blood sausages. Dr.Justinus “Wurst” Kerner (1786-1862), began a lifelong quest to uncover the mysteries of the poison. He was later considered to be the godfather of botulinum toxin Kerner’s intense research between 1817 and 1820, who identified and described the first accurate descriptions of botulism (a term coined in 1871 from the Latin botulus, meaning “sausage”). In 1822, he compared contaminated sausage ingredients and concluded that the toxin must occur in the fat, leading him to call the suspicious substance “sausage poison”, “fat poison’, or “fatty acid,” and published the first complete monograph of the “fatty toxin” from blood sausages. Kerner described the symptoms of botulism as follows: vomiting, intestinal spasms, mydriasis, ptosis, dysphagia, and respiratory failure. He recommended methods for the treatment and prevention of food poisoning. During animal and self experimentation, Kerner observed that the toxin developed under anaerobic conditions and was lethal in small doses. Since the effects of this blood poison were similar to atropine, scopolamine, nicotine and snake venom, Kerner surmised that sausage poison was likely biological in nature which considering microscopic pathogens had not yet been discovered at the time was considerably remarkable. Kerner interrupted signal transmissions within the peripheral and autonomic nervous system. Kerner suggested that small amounts of this sausage poison could be used to lower nervous system activity associated with movement disorders.
Biological Weapon of Warfare
During the first world war Germany unsuccessfully attempted to produce chemical and biological weapons. As World War II approached, the American government learned that the multiple countries were engaged in bio-warfare programs. President Franklin Roosevelt then ordered the US National Academy of Sciences to learn to use it as offensive and defensive biological weapon.
In 1946, Carl Lamanna and James Duff developed concentration and crystallization techniques for the toxin which were subsequently used by Dr Edward J. Schantz to produce the first Botulinium Toxin for human use (the basis of the later clinical product). The US Office of Strategic Services (OSS) developed a plan using Chinese prostitutes to assassinate high ranking Japanese officials via gelatine capsules containing the newly purified Botulinium Toxin The government abandoned the plan when test donkeys that received the capsules survived. Ironically, though Botulinium Toxin today is considered one of the deadliest poisons in the world, with just 1 gram it has the potential to kill 1 million people, however the toxin is not an ideal biological weapon, since large amounts need to be ingested and mortality rates vary.
In 1972, President Richard Nixon signed the Biological and Toxic Weapons Convention, effectively putting an end to all investigations on biological agents for use in war. Schantz took his research to the University of Wisconsin, where he produced a large amount of Botulinum Toxin A that remained in clinical use until December of 1997.
Human Experimentation
Clinical use of the toxin began in the late 1960s and early 1970s, when Dr. Alan Scott began experimenting with Botulinum Toxin Type A supplied by Dr.Schantz, on monkeys, with the hope that one of the compounds could be used for the nonsurgical treatment of strabismus in humans. Strabismus is the abnormal alignment of the eyes; the condition of having a squint.
Scott publishes his first studies proving that could weaken extraocular muscles in 1973 and postulated that the toxin could be potentially used for a wide variety of musculoskeletal disorders and spasticity, even before human studies were conducted. Scott received approval from the Food and Drug Association (FDA) in 1978 to begin testing small amounts of the toxin (then called Oculinum) in human volunteers; his landmark paper, published in 1980, showed that intramuscular injections of Botulinum Toxin Type A could correct gaze misalignment in humans.
In 1989, one year after manufacturer Allergan Inc acquired the rights to distribute Scotts Oculinum in the United States, Botulinum Toxin Type A was approved for the nonsurgical correction of strabismus, blepharospasm, hemifacial spasm, and Meige’s syndrome in adults, and clinical use expanded to include the treatment of cervical dystonia and spasmodic torticollis. Shortly thereafter, Allergan bought Scott’s company and renamed the toxin, Botox as it is widely referred to today.
Cosmetic Use
In the mid-1980s, Dr. Jean Carruthers, an opthalmologist in Vancouver, Canada, noticed that her patients injected with BoNTA for blepharospasm experienced a reduction in glabella rhytides, and discussed her findings with both Scott and her dermatologist spouse, Dr. Alastair Carruthers, who was attempting to soften the forehead wrinkles of his patients using soft-tissue augmenting agents available at the time. Intrigued by the possibilities, the Carruthers used the toxin experimentally in their receptionist’s forehead and subsequently published the first report of
Botulinum Toxin Type A for the treatment of glabellar frown lines in 1992. Other reports soon followed, including the first double-blind, placebo-controlled study for the treatment of hyperkinetic facial lines.