Research Paper on "FDA Health Policy on Intravesical Botox High"

Research Paper 10 pages (3065 words) Sources: 10

[EXCERPT] . . . .

FDA Health Policy on Intravesical Botox

HIGH PUBLIC DEMAND

The normal bladder sends nerve messages to the brain when the bladder is full (MD Guidelines, 2010). The brain responds by commanding bladder muscles to tighten or relax. Failure to transmit these messages causes a disorder called neurogenic bladder malfunction. It interferes with normal bladder control and the its function as a reservoir for urine. This disorder may result from trauma to the brain, spinal cord or congenital abnormalities. It is either flaccid or spastic. A flaccid neurogenic bladder is distended and constantly leaks small amounts of urine. A spastic neurogenic bladder is very distended and drives urine back to the kidneys. This asserts abnormal pressure and damages kidney tissues and, if prolonged, renders the bladder susceptible to infection. Risk factors include diabetes, multiple sclerosis, amyotropic lateral sclerosis, Parkinson's Disease, herpes zoster infections, and syphilis. Persons with neurological disorders, have had pelvic surgery or experienced trauma are more prone. Statistics say that incontinence occurs in 8.5% of women and 1.6% in men between 15 and 64 (Lansang as qtd in MD Guidelines). In the U.S., neurogenic bladder develops in 40-90% of persons with multiple sclerosis, 37-72% of those with Parkinson's Disease, ad 15% of those who have suffered stroke (MD Guidelines).

Non-neurogenic bladder malfunction is now known as overactive bladder or OAB

(Ellsworth & Kirshenbaum, 2010 p 29). OAB is common and affects 17% of both men and women 40 years old and older. It is characterized by the urgency to pass urine frequently and at night and difficult to defer. The condition suggests urodynamically demonstrable detrusor over-activity related to other forms of urethrovesical disorder. It has as yet no known cause. Urine is passed 8 or more a day. Persons suffering from OAB

often suffer a loss of self-esteem, guilt feelings, fear of being a burden to family and friends, and fear and embarrassment for the smell of urine. They often limit or reduce social activities and to places where bathrooms are accessible. At home, they use specialized underwear, protective bedding, and dark and thick clothes to hide these underclothes. Their condition leads to work absenteeism and decreased productivity, avoidance or limitation of physical activity and strained sexual relationships for fear or leakage or the odor of urine. OAB develops in 65% of men and 67% of women whose symptoms have definite effects on their daily lives. Medications are in clinical trials for disorders affecting components of bladder function, such as the urothelium, the afferent sensory nerve pathways and the central nervous system. On the other hand, expanded understanding of OAB has led to the approval of the neuromodulation therapy and the investigation of intravesical injection of botulinum toxin or botox (Ellsworth & Kirshenbaum pp 30-34).

Botulinum Toxin or Botox

Botox type A and type B are pure substances, derived from the gram-positive bacterium, clostridium botulinum, the most poisonous naturally occurring (AAD, 2005; Moore et al., 2005). They block muscular nerve signals and commonly used in small amounts to reduce wrinkles and facial lines. Botox was discovered by Professor Pierre Emile van Ermengem in 1897. It was first used in 1980 by dermatologic surgeons for cosmetic use in 1987. Of the 7 immunologically distinct sybtypes of the bacteria, 2 are clinically used. These are Botulinum -- A toxin or BTX-A, called Botox in the U.S., and Dysport in the UK. The bacterium was initially approved by the Food and Drug Administration in 1989 for strabismus and blepharospasm. Eventually, it was used for cervical dystonia, cosmesis, hypersecretory disorders and overactive muscle disorders. Although it has yet to approved by the FDA, botulinum toxin has been used to treat neurogenic and non-neurogenic detrusor over-activity, detrusor-sphincter dyssynergia or DSD, motor and sensory urge and chronic pain syndromes (Moore et al., AAD).

Schurch pioneered the use of BTX -- A on patients with neurogenic detrusor over-activity or DO (Moore et al., 2005). He injected 200 or 300 units into 21 spinal cord injury patients with DO and urge incontinence. After 6 weeks, 17 of them became completely continent. Improvements in bladder function and urodynamic parameters were found in 11 patients who were followed up at 16 and 36 weeks. A retrospective multi-center European study of 200 patients with the same condition achieved similarly significant increases in bladder capacity, reflex volume, bladder compliance and decrease in mean voiding pressures. Schurch compared two different doses of botox on 59 patients with the disorder. In 24 weeks, incontinence was rapidly reduced and sustained. Grosse, another researcher, studied the effect of repeat detrusor injections of botox on 66 patients. Cystometric capacity and reflex volume substantially increased with every injection. At the same time, reflex contractions significantly decreased. Repeat injections had the same effect as the first and revealed the absence of drug resistance (Moore et al.).

Most institutions currently administer between 100 and 300 units per treatment of both neurogenic and non-neurogenic detrusor over-activity (Moore et al., 2005). Grosse tested the effect of 100 to 150 units on 20 patients with non-neurogenic OAB. A follow-up after 14 months revealed no difference in the tidal volume voided, frequency and quality-of-life scores between the two groups. Schurch replicated the study on 59 patients with neurogenic urinary incontinence on whom he administered 200 and 300 units. Findings showed significant decreases in incontinence per week, detrusor pressure during contractions, and the number of hyper-reflexic detrusor contractions per week. Both groups also showed significant improvements in their quality of life. What remained was to determine the optimal dosage of the drug (Moore et al.).

Reported side effects have been rare as the doses are localized and way below the assumed fatal dose (Moore et al., 2005). But 2002 researches found two cases of generalized muscle weakness and the return of bladder spasticity after 2 months. Urinary retention is another potential complication, as further studies found. Repeat injections may also develop immune responses, which interfere with therapeutic efficacy. Contraindications include pre-existing neuromuscular diseases, such as myasthenia gravis, Eaton-Lambert syndrome, and amyotrophic lateral sclerosis. Botox is also contraindicated to breastfeeding or pregnant patients and those taking medications for neuromuscular weakness (Moore et al.).

Rationale

Botox therapy has been an increasingly favored alternative to chronic urologic conditions, such as DSD, neurogenic and non-neurogenic DOA and pelvic pain syndromes (Moore et al., 2005). For its low side effects and 6-12 months' duration of action, it is an appealing alterative to cumbersome conservative medical treatment and invasive surgery for the conditions (Moore et al.).

Research Support for Change

A review of Cochrane randomized or quasi-randomized controlled trials on neurogenic and idiopathic OAB in adults treated at least with one intravesical injection of botox (Duthie et al., 2008 p 1). The goal of the review was to compare the effectiveness of botox with other treatments for the same condition. Using strict inclusion criteria, 8 studies qualified. Most of these studies revealed the superiority of botox to placebo in terms of incontinence episodes, bladder capacity, maximum detrusor pressure and quality of life. Its beneficial effects were achieved with low doses of 100-150 units. These suggested stronger efficacy with higher doses of 300 units or more. The benefits appeared to quantitatively exceed the effects of intravesical resiniferatoxin (Duthie et al. p 2-4).

The efficacy of intravesical botox is, however, relatively recent (Duthie et al., 2008 p 5). Its rare side effects may be evident only with increased use and its long-term effects still largely unknown. Its length of action is likewise not yet determined. Several tests greater than 1 years are being conducted. Gousse (2005 as qtd in Duthie et al.) noticed an increase in voided volume with increasing treatments. It suggested a possible addictive effect from the six-monthly interval. Furthermore, not all studies examined quality of life and OAB is largely a disease of symptoms. Lastly, most investigated patients had neurogenic OAB. Thus, the results cannot be generalized to include those with idiopathic OAB. Intravesical botox holds a lot of promise as a therapy for OAB. But there exist too little data on its safety and efficacy in comparison with other therapies or placebo. So far, most of the evidence on its efficacy is still largely anecdotal. Studies on its adverse and long-term side effects were conducted only on a few participants. In addition, the optimum dose has yet to be determined (Duthie et al. pp 6-10).

Drug manufacturers conduct preclinical tests in the first 6-7 years of a product in search of therapeutic value (FDA, 2002). In this period, they complete the synthesis and purification of a drug and conduct animal testing. In a standard of 5,000 tested compounds, they choose 5 promising enough to file an Investigational New Drug or IND application. If the Food and Drug Administration or FDA -- and by an institutional board - approves it, the drug manufacturer gets a go-signal to begin the first phase of development. The IND stage consists of 3 phases. Phase I consists of clinical trials using health persons to determine the drugs basic properties and safety on humans.… READ MORE

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