What Botox Is In Detail - Research Paper Example

Abstract, page 3 Introduction, page 4 The Reason For This Study, page 5 Thesis, page 5 Method, page 6 Literature Review and Discussion, page 6 Conclusion, page 12 References, page 14 Abstract This article discusses in detail what Botox is, its possible toxic effects and various uses by the medical profession, both to treat medical conditions and for cosmetic purposes. Also mentioned is the possibility of side effects, both long and short term, and the ways in which Botox treatments are regulated, or not, as well as who should be allowed to provide treatments using this potent product. It is concerned with the regulations around administration and how these vary considerably from place to place, not just internationally, but within the individual states which make up the United States of America, where its use is controlled by the Food and Drug Administration, the organization there first allowed its use only for certain medical conditions, rather than for cosmetic use. Introduction Botox is the brand name for the protein based neurotoxic substance produced by Clostridium botulinum, a bacterium (FDA Office of Women’s Health, 2007). It is basically a naturally occurring muscle-paralysing poison. Until recent times it was known only as a source of food or other poisoning, which, if there was enough of the toxin present, caused paralysis, and could be fatal. This can be after consuming infected food or by ingesting the spores in foods such as honey, or if the spores entered the body through a wound. These bacteria then multiply within the body (Department of Health, State Government of Victoria, 2012). In recent times Botox is used, both medically and cosmetically (Lipham, 2008), to produce effects which are considered to be positive. In the United Kingdom alone roughly one million Britons receive treatments using Botox or dermal fillers each year (Daily Mail, 2010). In the article ‘Botox injects meaningful improvements into QOL’ (October, 2011), the author describes various ways in which Botox can be used to improve the quality of life. There has been research into the bacterium for over a hundred years according to Allergan.com (2012) and it is one of the most frequently researched medications. The product was first approved for use in 1990 and is used for a variety of conditions such as overactive bladder (Nissan, 2011; Rohrsted et al., 2012), and in bladder infections (Yokoyama et al., 2012); bilateral vocal cord synkinesis (Dray, 2012); several eye conditions, urinary incontinence caused by conditions such as multiple sclerosis and as a preventive in cases of severe and chronic migraine (Rothrock, 2012; Coppola et al., 2012). It is also used in cases of major muscle spasm, as in children with cerebral palsy (Jimenez-Shahed, 2012) and resultant hypertonia (Fehlings et al., 2012). It helps with severe post–operative pain, as explained by Smoot et al. (2011). More recently it has been used for problems with jaw tension (BOTOX® Treatment for Jaw Tension and TMJ, 2012), although it is admitted that this is not yet covered by medical insurance, and that not all dentists are trained in its use. Skin Medical (2012) describes how it can be used to prevent tooth grinding. Eye surgery can apparently also benefit, as described by Okumus et al. (2012), where it can be used instead of anaesthesia. Kean (2012) describes how it can be used to positively deal with even severe musculoskeletal pain. Blake et al. (2012) describe how it can be used in children with CHARGE disorder in order to deal with their excessive salivation, and Doft et al. (2012) discuss the treatment of hyperhidrosis, that is the excessive secretion of sweat, especially in the axillary area. Despite all these medical uses, it is of course used as a cosmetic, because its use removes frown lines and other signs of aging, and it is as a cosmetic substance that most people think of it (May & Triggle, 2008). According to the American Food and Drug Administration (2011): “At this time, Botox Cosmetic, made by Allergan Inc. of Irvine, Calif., is the only type of botulinum toxin approved by FDA to temporarily soften the frown lines between the eyebrows.” The Reason For This Study Clostridium botulinum toxin is obviously very potent. It is also very widely used. In 2008, sales reached $315.5 million in one quarter, and that was just for the producers. There should, therefore, be adequate guidelines for its use. There is, however, no one qualification for providers (Baxter, 2012). Also, there have been reports paralysis following the use of ‘potent, unapproved botulinum toxin’ (U.S. Food and Drug Administration, 2011). Thesis Botox is a very toxic substance, and food poisoning caused by it can be fatal. There can also be severe side effects from its medical or cosmetic use. It is being used in people of all ages, including children too young to make their own decisions. There should, therefore, be sufficient safe guards for its use. Method This thesis will be explored and argued using a literary search using search terms such as Botox, Clostridium botulinum, safeguards, cosmetic uses, etc. These findings will then be discussed. Literary Review and Discussion The literary sources seem to be in agreement that there is no qualification for those who administer Botox. This is perhaps because it has been found to have so many different uses; Botox was originally approved for medical use in the late half of 1980s for the treatment of certain conditions caused by spasms of muscles as occurs in dystonia (involuntary muscle contractions) and strabismus (crossed eyes or lazy eye), also blepharospasm, that is uncontrollable blinking, and spasmodic torticollis or uncontrolled neck movement. By 2002, the FDA approved Botox for the removal of frown lines which occur between the eyebrows. Now, in 2012, it is widely used to treat other areas such as forehead wrinkling and to treat the crow’s feet which form over time at the corners of the eyes. Use is also influenced by the fact that people are willing to pay high prices for treatment, such is the modern trend to continue to look young for as long as possible. However, instead of looking for a qualified practitioner, clients/patients are merely told to seek out a reliable person and that it should be administered, if not by a doctor himself, under the supervision of a named doctor. Rules about who and where the substance can be administered, as well as who is legally responsible, vary considerably from place to place. In Ohio, according to Goulder (2008), a nurse can administer the drug, but only in a physician’s office. Goulder explains that the nurses do receive special training. The reader is left wondering if the doctor is present, or is required to be so, and also who is technically legally responsible, the nurses involved presumably being employees. Nurses would be well advised to find out beforehand their legal position, as accidents can occur even in the best regulated situation, where great care is taken by those involved. The situation varies from state to state, with many state legislatures requiring that the physician carries out the procedure himself. In Ohio not only can the nurses give the medication, they are actually the ones who decide dosage. Some feel that this is not a nursing responsibility, but nurse who refuses to carry out treatments would presumably be disadvantaged in the employment market, if they declined to carry out the procedures which are very lucrative. Goulder explains that physicians charge an average fee of $492 per treatment, and of course most patients, whether seeking medical or cosmetic help, will return after a few months for follow-up treatment. Dr. Michael Sullivan, a plastic surgeon operating in Ohio, was unhappy with the decision to allow nurses to give the injections (quoted by Goulder, 2008). Dr. Sullivan was concerned about possible side effects such as bruising, drooping and muscle weakness. He is quoted as saying: “We’re going to hear of more and more complications and potentially deaths, because more and more physicians want to get out of insurance medicine and look at Botox and fillers and some of these quick procedures as a way to create a lucrative practice.” In his 2012 article, Jimenez-Shahed describes how Botox contains complex proteins causing antigenity, that is its use can result in the production of antibodies. Another problem which can occur, according to Benecke (2012), is when the body gradually develops an immunity to the substance and it no longer has the desired effect. Goulder (2008) mentions how a number of people are suing the producers of the Botox, Allergan, claiming that it has caused injury or even fatalities to their relatives and he states that in February 2008 the American Food and Drug Administration reported that the drug was linked to: “Adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.” Cooper (2007) does, however, point out that there is continued research into Botox use, so it is possible that difficulties will eventually diminish. It is not just physicians and cosmetic surgeons who take the responsibility for giving Botox injections. In many American states dentists are allowed to do so, although for medical rather than cosmetic reasons (Academy of General Dentistry, 2012). The diagram below shows what a mixed picture there is among the dental community. Is this an adequate way to deal with such a dangerous product? Mention is made in the article of the controversy about the subject, especially in view of the lucrative demand among an aging population. They argue that dentists already provide many cosmetic services such as the use of tooth whiteners and veneers, and also that they are skilled in dealing with the muscles around the mouth and such things as problems with the jaw. Figure 1. American State Dental Boards Activity Concerning Botox (2012). The diagram does not reveal differences from state to state. In most places, dentists are allowed to use the drug to treat conditions such as temporomandibular disorders, and sialorrhea or excessive salivation. In Florida, just to take one instance, the board has no policy of its own, but relies on the rules of the Medical Board. In Oregon, the Academy of General Dentistry (2012) reports that only ‘oral and maxillofacial surgeons with specific training’ are allowed to administer these injections. The writers also point out that in both the United Kingdom and Canada dentists are allowed to administer the drug, although according to Skin Medical (2012), “Botox can only be prescribed by a doctor or qualified prescribing clinician.” However, being a doctor does not necessarily imply knowledge of Botox or how to use it. The Daily Mail (2010) reports that in the United Kingdom many medical companies allow their employees to administer the substance after the briefest of training using an orange for practice. Such people may be able to give perfect injections, but how do they deal with side effects, especially serious ones? The Academy of General Dentistry (2008, par. 4) claims that Botox is an extremely safe substance and that problems only occur when overdoses as high as 10 to 50 times the usual dose are used, and that there have been less problems than with the use of local anaesthetics. Yet the Daily Mail article (2010, 14th September) claimed that there is an estimated one in twenty who find themselves suffering from complications such as lumpy skin and drooping of the eyelids, as well as more serious difficulties. In the same article, surgeon Andrew Vallance-Owen, speaking on behalf of the Independent Healthcare Advisory Services (IHAS) Working Group, is quoted as having said: “We are appalled by the sheer volume of bad practice within the industry but there is also a lot of good clinical practice and we are convinced that the great majority of providers are 100 per cent behind improving patient safety.” Despite this statement, and that given above by the Academy of General Dentistry already mentioned, Misra quoted by Derbyshire, 2002) believes that Botox is being administered “ahead of clear scientific evidence.” Yet, in the same year Van Hoven, on behalf of Allergan the manufacturers, stated that: “Botox is currently used in over 70 countries and there has been no evidence to date of any long-term safety concerns associated with the treatment.” She went on to claim that: “As with any pharmaceutical product, there are potential side-effects. Side-effects that can occur are known to be minor and of a temporary nature, including headache, respiratory infection, temporary eyelid droop, nausea and flu syndrome.” Yet, as pointed out earlier, individuals and their families are claiming in the courts that side effects can be very serious indeed, often because of misuse, in that excessive amounts are being administered in some cases. Hudson (2012) admits that there is the possibility of a long list of side effects, which she claims are minor, and which will diminish when the drug leaves the body after about six months, and many fade away after about a week. As with many other articles on this topic, however, the author claims no medical qualifications. In this case, the article also has at least one factual error in that it states that the FBI (sic) approved the drug in 1990. Botox is used to treat particular parts of the body. It can, however, travel to other areas of the body, and produce problems there. For this reason, the FDA has ruled (2009, April, as quoted by Singer) ) that this, and similar drugs, must carry stringent warnings on their containers. They would presumably not have done this without evidence to support their action, despite the claims of the producers, Allergen. Despite the problems, new forms of Botox continue to be developed as in Pagan and Harrison (2012) who describe the use of incobotulnum toxin A first used in Germany in order to alleviate inappropriate muscular movement. Usage has altered over time, and today, to most members of the public, Botox is simply a beauty treatment. According to Safer Cosmetic Surgery (2012), the use of Botox in beauty salons must be banned. The writer describes how the president of the British Association of Aesthetic Plastic Surgeons (BAAPS) has warned that in the public eye, and perhaps among practitioners, there is some confusion and blurring of the line between cosmetic procedures and beauty treatments. He feels that this means that it is most important that really effective regulations be introduced in order to prevent ‘back street’ clinics from causing actual harm to the clients who put their trust in them. According to Pearce (2007), “While Botox is a prescription drug that can be obtained only by a doctor, anyone — from a hairdresser to an osteopath — is allowed to inject it “under the guidance of a doctor.”” The relevant phrase there “under the guidance of a doctor” needs much more definition if the public are to receive the protection to which they are entitled. Conclusion This substance has now been in use for a generation or more, and has been studied for four times that long, yet remains controversial. Statistically, there are very few problems if the substance is used correctly and in the right dosages. However, Botox has gradually moved away from its purely medical uses towards cosmetic or beauty uses, and so regulation should move with this. This should be obvious to all those physicians concerned who presumably will know about possible difficulties, and who after all do not want to be taken to court. It is, of course, possible that Botox suffers from a bad press as the same substance can produce possibly fatal consequences if ingested or if it gets into wounds. There is, however, obviously a need for a definitive form of training in its use, dosages and prescribing, whether by physicians, surgeons, nurses or dentists, and whether for a medical or cosmetic condition, as well as careful checking that only approved Botox is available for use. It has been necessary to include in this study not just scholarly medical articles, but also to quote regulations as well as including input from the media, and from the manufacturers because Botox, and its administration, crosses the boundaries between medical use and cosmetic ones. Money is an important factor in this story. The Singer (2009) article, for instance, was published in the Business section of the New York Times, rather than under a scientific or medical heading. Where profits are concerned, there will always be those who sail close to the wind. There must be general legislation, rather than the present position where every state makes its own rules, or even fails to do so. Also, too often those with a financial interest are on the relevant boards which make the regulations. The public expect and deserve adequate protection. There will always be those who react adversely to a drug, as well as those prepared to break rules, and of course possible mistakes, but that does not take away the responsibilities of the medical profession and the drug administrations to do their best to prevent such incidents. Botox is obviously an effective and efficient treatment in many cases and so can be legally used in an increasingly wide variety of conditions, including purely cosmetic ways, but it does require both care and regulation, for the protection of the public who demand its use without having the necessary knowledge to understand the possible implications. The FDA insists on warnings on packaging, but how many patients actually see the packet, or if they do, get the chance to read what it says? References Figures Figure 1. American State Dental Boards Activity Concerning Botox. ( 2012). AGD Transcript, Academy of General Dentistry. Retrieved from http://www.agd.org/education/transcriptnews/?PubID=47&IssID=901 Other References Academy of General Dentistry. (2012). Botox use by dentists. AGD transcript. Retrieved from http://www.agd.org/education/transcriptnews/?PubID=47&IssID=901 Baxter, R. (2012). Who is Qualified to Inject Botox? The important thing is first to recognize that Botox... Retrieved from http://www.realself.com/question/botox-injections-who- qualified-administer-them Benecke, R. (2012, January 01). Clinical relevance of botulinum toxin immunogenicity. Biodrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy, 26(2), 1-9. Blake, K. D., MacCuspie, J., & Corsten, G. (2012, January 01). Botulinum toxin injections into salivary glands to decrease oral secretions in CHARGE syndrome: prospective case study. American Journal of Medical Genetics. Part A, 4, 828-831. Botox being injected by ‘practitioners’ with less than half a day’s training. (2010, September 14). Retrieved from http://www.dailymail.co.uk/health/article- BOTOX® Treatment for Jaw Tension and TMJ. ( 2012). Retrieved from http://www.docshop.com/education/dermatology/injectables/botox/jaw-tension Botox injects meaningful improvements into QOL. (2011, October 01). Pharmacoeconomics & Outcomes News, 640, 10. Botox (onabotulinumtoxinA). (2012). 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