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Also best colospa 135mg, 32% will suffer significant cognitive decline buy discount colospa, as measured by a score of less than 24 on Mini-Mental State Examination cheapest generic colospa uk. This suggests that mania has a poorer prognosis and represents a more severe disruption of the central nervous system function purchase colospa overnight. Summary and recommendations of a report of a working party of the Royal College of Physicians. Anxiety Disorders Oliaku Eneh Definition The psychological symptoms of anxiety comprise of fear, worry, nervousness, tension, apprehension, irritability, difficulty concentrating and insomnia. The physical symptoms include increased heart rate resulting in palpitations, breathlessness, light headedness and dizziness, nausea, tremor, dry mouth, sweating, abdominal discomfort that may progress to diarrhoea and frequent micturition. Patients may have a tendency to alleviate their symptoms by abusing alcohol and prescribed medications, especially benzodiazepines. Most psychiatric disorders in the elderly have co-morbid anxiety and many elderly people get very anxious about the multiple health conditions they are faced with, resulting in the under-recognition and under-treatment of primary anxiety disorders. Epidemiology The prevalence of most anxiety disorders falls with age and is higher in women than in men. This gender difference is less pronounced in the elderly and the majority of cases are longstanding with onset in young adulthood and middle age. Overall prevalence in the elderly ranges from 5-10%, the highest rates are found in the community with phobic disorders presenting the most while panic disorders present the least. Aetiology As with other psychiatric disorders, many factors come to play in the development of anxiety disorders in the elderly. Physical illness- there is an association between anxiety disorders and increased mortality and physical morbidity from cardiovascular, respiratory and gastrointestinal complaints. This is further confounded by the physical symptoms of anxiety with some important physical disorders presenting with anxiety symptoms and vice versa. In the majority of elderly people, the investigations and treatment of physical illness is frightening and may provoke anxiety disorder in vulnerable individuals. Psychosocial stressors- evidence shows that anxiety is associated with low socioeconomic status. Adverse life events especially if they are threatening in nature are known to precipitate anxiety. In addition, individuals may also develop late life vulnerability to anxiety when faced with challenges if they were previously exposed to early adverse experience such as parental loss. In contrast to late life depression, phobic disorders in the elderly are not associated with the lack of confiding relationships; rather it is believed that in some cases the presence of close relationships may maintain phobic avoidance (Lindesay, 1996) because in a bid to protect and support the patient, families and other home based services invariably encourage the housebound approach and may thereby worsen the situation. Drug induced- A variety of drugs have been implicated in the onset of anxiety symptoms. They include: - Thyroxine - Antidepressants - Anticholinergics - Sympathomimetics 963 - Steroids - Alcohol - Caffeine In addition, withdrawal symptoms from psychotropic medications can also precipitate anxiety symptoms (Rodda ea, 2008). Co-morbidity with other psychiatric illness- - High levels of anxiety are often found in elderly patients in the early stages of dementia. Recent studies revealed that different genes showed evidence for association with specific types of anxiety disorders, such as panic disorder, social phobias or generalised anxiety disorder (Academy of Finland, 2008). Specific anxiety disorders and their clinical features Phobic disorder Phobia occurs commonly in the elderly with increasing frailty and prevalence ranges from 0. These disorders provoke clinically significant levels of distress and disability due to high levels of anxiety. They are usually heralded by a traumatic event usually of a physical nature and may have had a public manifestation. However, in spite of the complete resolution of the physical event, the psychological impairment persists. There are 3 main types of phobia: Agoraphobia- prevalence in the elderly is estimated to range from 1. These individuals may be rendered housebound because many are terrified by the thought of collapsing and being left helpless in public. It can occur with or without panic attacks but always causes anxiety symptoms during the situation. This fear may spiral out of control if there is no obvious escape route and embarrassment is perceived. Consequently the individual learns to avoid these situations and this avoidance in turn reinforces the fear. Fear can also occur merely in anticipation of the anxiety-provoking situation and symptoms are not better explained by another mental or physical disorder. Specific phobias- fear is experienced only in the presence of a particular object or situation. Onset is usually in childhood and prevalence in the elderly is estimated to range from 3. Anxiety is restricted to the presence of the specific phobic object or situation, all other diagnostic criteria are similar to those of social phobia. Panic disorder Panic attacks and panic disorder are rare and symptomatically less severe in the elderly, estimates of prevalence ranges from 0. However, the prominent physical symptoms of panic disorder may result in patients being referred instead to cardiologists, neurologists and gastroenterologists. In one study of cardiology patients with chest pain and no coronary disease, one third of those aged 65 and over met the criteria for panic disorder. Several attacks occur within a period of one month and symptoms are not better explained by another psychiatric or physical disorder. Panic attacks are often co-morbid with other psychiatric disorders, particularly depression, and it may be severe enough to mask depressive features. In addition the condition should not meet the criteria for other anxiety disorders, psychiatric or physical disorders. Onset in old age is rare, the majority starting before the age of 25 and usually running a chronic fluctuating course into old age especially if left untreated. Obsessional symptoms may appear at any age following head injury or cerebral tumour. The individual recognizes them as originating from his own mind but is unable to resist them despite repeated attempts at doing so. Compulsion is the irresistible urge to perform an act repeatedly despite the futility of that action. Insight is usually fully intact and the patients usually regard these symptoms as unreasonable and are distressed by them so much so that their functioning is impaired to a greater or lesser degree. Obsessions and or compulsions should last at least two weeks and not arise as a result of another mental disorder. The experience of the event is sometimes regarded as “near death” for the individual and might actually have involved the death of another person. Symptoms begin within six months of the event and should be present for more than a month, are severe enough to cause distress and impair functioning. Heightened emotional arousal in the form of exaggerated startle response, hypervigilance, emotional numbness, insomnia, irritability and poor concentration that were not there prior to the incident. Older persons who are frail have a greater tendency to feel threatened than their younger counterparts. Acute stress reaction This happens when symptoms of anxiety occur in response to extreme physical or psychological trauma. The risk of developing this disorder is increased if physical exhaustion or organic factors are also present as in the elderly. It is usually of brief duration, onset is within a few hours and it lasts only hours or days. Patient is initially ‘dazed’ with associated reduction in attention and consciousness, inability to comprehend stimuli and disorientation. This is followed by either withdrawal from the situation or agitation and severe distress, depression, anger and despair. The preceding event is a life changing one that is associated with significant subjective distress and emotional disturbance. The major difference is that the anxiety that follows lasts longer and emanates from difficulty in adjusting to the prevailing situation. Onset of symptoms is within one month of the event and duration is usually less than six months. Brief (< one month) or prolonged mild depressive reaction might accompany the anxiety symptoms.

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It is grounded in a public health model for addiction involving nicotine to be ignored in that addresses system and service coordination; the course of treating addiction involving health promotion and prevention colospa 135mg, screening and alcohol or other drugs buy generic colospa on line. Accordingly buy genuine colospa, when early intervention; treatment and recovery; and treating addiction colospa 135mg low cost, it is critical to recognize the resiliency supports to promote social integration 4 high rates of co-occurrence of different and optimal health and productivity. Treating the disease of occurring medical, including mental health, addiction involves addressing not only the problems exist and allow for the development of 10 specific object of the addiction, but the an appropriate and specific treatment plan. Assessment tools, as distinguished from screening tools, are meant to determine the The bottom line is that addiction is an illness that presence and severity of a clinical condition and we are able to treat and manage, if not cure, should parallel, at least in part, established ‡ provided that we focus on the person with the diagnostic criteria for the disease. Assessments addiction, the family and the community--a tools also might examine social, family and 8 holistic approach to a sprawling problem. President Child Mind Institute A comprehensive assessment helps to create the foundation for effective treatment that is * § 12 individualized and tailored to the patient. Assessment The assessment should gather information about many aspects of the individual including the Once a patient has been screened for risky use physiological, behavioral, psychological and and identified as requiring professional services social factors that contribute to the patient’s beyond a brief intervention, a physician-- substance use and that might influence the working with other health professionals--should 13 treatment process. For example, in addition to perform a comprehensive assessment of the determining the patient’s health status, the stage patient’s medical, psychological and substance 14 and severity of the disease and the family use history and current health status, present history of addiction, the assessment should symptoms of addiction, potential withdrawal determine personality traits such as syndrome and related addictive behaviors. This temperament; family and social dynamics; the thorough assessment is a necessary precursor to extent and quality of the patient’s family and treatment initiation and must involve a trained 9 social support networks; prior treatment physician. The assessment should utilize attendance and response to previous treatment reliable and valid interview-based instruments 15 experiences; and the patient’s motivation and and biological tests as needed. It is * important that assessment instruments also offer Despite the distinction between screening and some degree of cultural sensitivity and that they assessment tools, the term screening often is used to 17 subsume the concept of assessment or are age and gender appropriate. Furthermore, while there is some overlap between screening or assessment procedures used to identify risky substance use and methods † used to diagnose a clinical addiction, a formal See Appendix H for some examples of assessment diagnosis of addiction should be based on the instruments used by practitioners and researchers to demonstration of specific symptoms included in the help make these diagnoses. The treatment plan Cessation of Use should articulate clearly the treatment goals and particular interventions aimed at meeting each of Tobacco. The plan should be monitored and for most persons going through it, is not unsafe revised as needed should the patient’s status or and does not require medical monitoring. Patients undergoing smoking cessation may experience certain withdrawal symptoms The comprehensive assessment also should including cravings, irritability, impatience, result in a detailed and thorough written report, hostility, anxiety, depressed mood, difficulty which should be incorporated into the patient’s concentrating, decreased heart rate, increased health record, that: 21 appetite and sleep disturbances. The calming effect many smokers feel when smoking usually  Provides a clinical diagnosis and identifies is associated more with the relief of nicotine the particular manifestations and severity of withdrawal symptoms than with the effects of the disease; the nicotine itself. Withdrawal symptoms can commence in as little as a few hours after the  Identifies factors that contribute to or are last dose of nicotine, peak within a few days, related to the disease; and either subside within several weeks or, in 22 some cases, persist for months. Detoxification itself addresses smokers: using nicotine patches to maintain a intoxication or withdrawal but is not treatment 20 baseline serum nicotine level along with the gum of addiction. In most cases, cessation of use is or lozenges to produce a boost of serum nicotine the necessary first step to formal treatment 27 levels periodically. Examine the patient and determine if symptoms are acutely present-- Alcohol and Other Drugs. Some patients with ideally using standardized instruments to ‡ 35 addiction involving alcohol and other drugs can measure the severity of withdrawal --and reduce and ultimately cease substance use documenting vital signs and other physical without medical supervision, particularly if they manifestations of withdrawal. Assess for † are not physically dependent on the substances the presence of co-occurring medical and involved, the disease is not advanced and they mental health conditions and determine, have sufficient personal supports to help them through the use of drug testing, which through the cessation process. Assist patients through For patients who demonstrate physical withdrawal to re-establish a state of dependence on a substance, cessation of use on physiological stability with or without the 37 their own may be unsafe and medically use of medications. Detoxification occurs when toxic substances that come from the ingestion of alcohol or other Alcohol Detoxification. In alcohol drugs are removed from the body via detoxification services, the cessation of alcohol metabolism through the liver and excretion ingestion in an alcohol-tolerant individual is 30 coupled with certain medications to help prevent through the kidneys. Medically-assisted detoxification aims to reduce the risk of the dangerous effects that may accompany discomfort and potential physical harm for alcohol withdrawal. Withdrawal from alcohol 31 typically takes up to seven to 10 days, but with patients who are experiencing withdrawal. During the first six to 48 assistance of medical professionals and may hours of withdrawal from alcohol, symptoms involve the use of pharmaceutical therapies to may include anxiety, nausea, agitation and 40 guide people safely through withdrawal. More severe Medical professionals may collaborate with symptoms can include hallucinations and 41 supportive, non-medical personnel or with seizures. Detoxification is an important and often usually appears two to four days after the last 42 necessary prerequisite to effective acute drink. It should serve as the catalyst for entry into the treatment system but 34 does not itself constitute treatment. The medication’s be more severe in persons who have undergone ability to treat seizures, the minimal potential for prior multiple episodes of alcohol withdrawal, a misuse, the significant potential to treat mood † 44 process known as the kindling effect. Benzodiazepines, which have calming, sedating effects, have been shown to prevent the onset of Opioid Detoxification. A large oxycodone, withdrawal symptoms are not life review study found that whereas threatening, but they can be extremely 56 benzodiazepines are more effective than uncomfortable and must be managed 57 placebos at treating seizures in patients going effectively to prevent relapse. Opioid through alcohol withdrawal, there is no evidence withdrawal symptoms can include abdominal that they are more effective than other pain, muscle aches, agitation, diarrhea, dilated medications used to treat alcohol withdrawal pupils, insomnia, nausea, runny nose, sweating 58 syndrome or that particular benzodiazepines are and vomiting. Benzodiazepines generally last from seven days to several 59 commonly used to treat the anxiety and agitation weeks. Because medical complications can symptoms associated with alcohol withdrawal develop, patients must undergo regular ‡ 47 48 include diazepam, chlordiazepoxide, monitoring including physical examinations, a 49 lorazepam and oxazepam. Abrupt discontinuation of opioids, benzodiazepines commonly are prescribed for especially for a patient who has developed alcohol withdrawal on an outpatient basis where physical dependence on the drug, typically is not patients’ drinking may not be monitored recommended; instead, in the case of such 51 adequately. Another cautionary note is that dependence involving prescription opioids, the benzodiazepines have addictive potential in their patient is tapered or weaned off the opioid § 61 own right; therefore, their use must be medication. Kindling leads to a worsening of withdrawal symptoms with each § attempt at alcohol detoxification. The use of a tapering dose calculator can help in ‡ Diazepam also may relieve muscle spasms and this process and can be accessed online at: seizures associated with alcohol withdrawal. Detoxification develops addiction involving these drugs; these also can be achieved using specific medically- symptoms are not life-threatening and generally prescribed opioids that have less potential for are less severe than those associated with †† 69 misuse (methadone or buprenorphine) and then withdrawal from alcohol or opioids. Buprenorphine detoxification to assist in stimulant withdrawal 71 can be dispensed or prescribed for illicit or is limited. A vaccine to treat addiction prescription opioid withdrawal in any outpatient involving cocaine and ease withdrawal ‡‡ 72 setting by qualified physicians who have the symptoms currently is being tested. While use of these vaccine’s place in the cocaine detoxification 73 medically-prescribed opioids can result in process and how it can be implemented safely. In the elderly, there is a risk of falls and myocardial infarctions during * 77 It is not restricted when prescribed for pain benzodiazepine withdrawal. It is ‡ Becoming qualified to prescribe and distribute common for people detoxifying from buprenorphine involves an eight-hour approved program in treating addiction involving opioids, an †† agreement that the physician/medical practice will During withdrawal from stimulants, there is a risk not treat more than 30 patients for addiction of depression or negative thoughts and feelings that involving opioids with buprenorphine at any one time may lead to suicidal thoughts or attempts. Drugs under investigation for this purpose include Physicians who meet the qualifications are issued a modafinil, propranolol and bupropion; these waiver by the Substance Abuse and Mental Health investigations are of off-label uses of approved drugs. For patients deemed a danger benzodiazepine detoxification extend over a to themselves or others, medically-managed period of weeks or months--tapering the patient intensive inpatient treatment or emergency off the drugs over time. Another option for hospitalization in a psychiatric facility is 86 detoxification from benzodiazepines is to recommended. For patients with mild or prescribe a different drug from the class, one moderate withdrawal symptoms, outpatient with a longer half-life, such as detoxification can be just as effective as 81 chlorodiazepoxide or clonazepam. Detoxification can take place in a variety of settings including the Acute Care patient’s home (monitored and managed by trained clinicians), physicians’ offices, non- Effective, clinical treatments for addiction hospital addiction or mental health treatment include a significant and growing range of facilities, urgent care centers and emergency pharmaceutical and/or psychosocial therapies departments, intensive outpatient and partial delivered by qualified health professionals. Due hospitalization programs and acute care inpatient to the complex nature of addiction and its * 82 settings. Patients extent to which addiction co-occurs with a broad should be placed in the least restrictive setting range of other health problems, effective 83 possible. Beginning in the 1970s, there was a medically-managed acute treatment protocols movement toward medical ambulatory also should address both co-occurring disorders detoxification, primarily for alcohol, that and patients’ nutrition and exercise maintained high safety and efficacy profiles while 89 requirements. The ability to continue to meet life managed care companies and other responsibilities as well as relatively lower costs organizations to appropriately match patient 84 are advantages of outpatient detoxification. The primary substance involved in the addiction, the severity of the symptoms and particular Pharmaceutical Therapies patient characteristics (e. For 91 component of addiction treatment, particularly for patients who are highly motivated to adhere * † 92 Such as acute care general hospitals, acute care to the medication regimen.

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Although thalidomide showed no toxicity need for the drug; (d) indirect injury order colospa in united states online, where the to laboratory animals when tested by Ciba and drug interferes with mental or physical functions order genuine colospa on-line, Chemie Grunenthal 135mg colospa visa, potentially irreversible per- resulting in collateral injuries; (e) interactions colospa 135 mg on line, ipheral polyneuritis was soon identified in patients where ingesting the drug in the context of other following long-term use of thalidomide. Symptoms drugs or foods causes injury; (f) inefficacy, where included burning pain in the feet, cramping pain the drug fails to perform its intended function; in the calves, loss of ankle and knee reflexes, and and (g) socially adverse effects, where a drug (usu- tingling hands (Crawford 1994). Other reported ally an antibiotic) is overused by a population of toxicity symptoms included severe constipation, patients, resulting in the rise and spread of resistant dizziness, hangover, loss of memory, and hypoten- microorganisms (Dukes et al 1998). In the 1950s, though, until it became clear that the reports on neurotoxi- it was not common practice for drug companies to city were valid and that, in addition, thalidomide test new drugs on pregnant animals (Ferguson was adversely affecting unborn children. This was shocking news about a care it owed to all potential consumers of the drug, popular drug that was, at the time, marketed including the then-unborn plaintiffs. This claim, throughout Europe and Asia as a mild, safe seda- too, was questionable, however, in light of the con- tive and anti-emetic; alarmingly, thalidomide was temporaneous Hamilton v. In addition to phocomelia, proving that thalidomide was the teratogenic cause thalidomide babies suffered from spinal cord for each plaintiff given the spontaneous risk of defects, cleft lip or palate, absent or abnormal ex- abnormality inherent in human embryonic develop- ternal ears, and heart, renal, gastrointestinal or ment (See Ferguson 1992). One German physician even testified tributable to thalidomide (Sherman 1968; see also that, in his opinion, the injuries sustained by the 6 7 Szeinberg 1968 ; see also Flaherty 1984 ). Instead, thalidomide focused the at- cidence of fertility disturbances after puberty tention of lawmakers and scientists on the potential (Duker et al 1998). Also ignoring the on the unborn plaintiff liability doctrine that origin- dearth of scientific proof of efficacy, the American ated with the thalidomide cases. This chapter has provided a brief overview of the Although the two-generation limitation excluded doctrinal framework of products liability law that a relatively few plaintiffs outright, the most import- is applied in pharmaceutical injury cases. This ful, regulatory means by which defective products burden of proof created difficult logistical prob- can be removed from the market and negligent lems, because of the two to three decade delay be- manufacturers can be censured. In Report of 8 Distillers advertized thalidomide as a treatment for morning- the 13th European Symposium on Clinical Pharmacological sickness that could be given `with complete safety to preg- Evaluation in Drug Control. Tice, (1948), where the plaintiff was shot in the induced Injury a Reference Book for Health Professions and eye by one of two negligent hunters who had shot in his Manufacturers. The doctrine is now memorialized in the Second Dutton (1988) Worse than the Disease: Pitfalls of Medical Restatement of Torts: `Where the conduct of two or more Progress. The theory is that secret protection has no statutory lifespan; pro- the patentee has suffered an injustice in that the tection lasts as long as divulgation is prevented. This exchange of monopoly To promote the progress of science and the useful for divulgation is at the core of the patent arts by securing for limited times to authors and concept. Failure of the inventor to fully dis- inventors the exclusive rights to their respective close an invention has led to patent invalida- writings and discoveries. Although the subject matter to be protected Since they are a form of monopoly, and because largely dictates what type of protection is available monopolies have been subject to abuse (e. Another severe limitation out risk of being back-engineered, then the on patent rights is simply prohibiting the grant of innovator should consider not seeking a patent at patents on certain types of inventions. Al- the secret is inadvertently revealed, or when some though their numbers are diminishing, many coun- analytical tool is developed which allows back- tries have allowed only limited patent protection on engineering of the invention. In the area of pharmaceuticals; typically, what can be patented is pharmaceuticals, trade secret protection is not the processes to synthesize the compounds, but not likely to be sought by the innovator, since a new on the compounds per se. Two types of pharmaceutical tage if they were to grant compound per se protec- inventions, however, are often kept as trade secrets: tion, because they do not have the in-house manufacturing process improvements, and screen- infrastructure to invent/patent such compounds ing assays. The subtleties of this essentially the more desirable chair without an accommoda- economic debate are beyond the scope of this dis- tion with the other. Patents as described above between the first patentee and are limited geographically, temporally, and by the the manufacturer, does not protect the manufac- rights of others. However, he cannot make such a chair naturally occurring articles, scientific principles, because there is already a patent which, very and some inventions related to atomic energy and broadly, claims a chair having a flat sitting surface nuclear material. The since (a) it may be very difficult to prove that a first patentee has the right to exclude others, includ- particular process is being used by the alleged in- ing the later patentee, from making a four-legged fringer; and (b) other manufacturing processes may chair with a flat sitting surface, but it cannot itself have been developed which do not infringe. In this case, the manufacturer can chemical entity and a pharmaceutically acceptable attempt to negotiate a license from the first pa- carrier or two chemical entities), life forms (e. Two types of invention that tend to with multiple substituents on a core structural fail the utility test are perpetual motion machines element, but which does not specifically show the (the Patent and Trademark Office wants to see now-claimed compound. The matter is made worse by the organ- references cited against the applicant teaches an ization of patent applications, which are usually alkyl group at the same position of 4±7 carbons, drafted by first stating the background of the in- the second reference teaches 10±15 carbons, and vention, which may include a description of the the latest reference teaches 20±30 carbons). It should not be too surprising that an Exam- It brings in such secondary considerations as the iner, presented with both a statement of a problem commercial success of the invention, that there and the solution to the problem, would respond by was a long-felt need in the art, the failure of others concluding that the solution is obvious. Failing to convince by mere argumentation, shown the solution to a trivial geometric puzzle, the applicant may choose to introduce tangible which of course, up to that moment, had com- evidence, which is typically in the form of a signed pletely baffled us. Note that, The first and most important of these treaties is the since the rejection is based on what is disclosed in Paris Convention for the Protection of Industrial the prior art, the applicant can use what is disclosed Property of 1883. If the application is applicant and the Examiner, usually in the form successfully prosecuted, the applicant is then of written communications, which results in granted a patent by each of the designated coun- granting or denying the grant of a patent), or by tries; i. There is also a great economic is the simplest, since there is only one filing, one advantage to this arrangement, since the applicant prosecution, and essentially one set of allowed need only file one application to stop the prior art. If there is an adverse decision, or if decision-making process within a pharmaceutical the subject matter of the application is no longer of company varies from organization to organization interest, there are no translation costs. If an invention requires such a cell, However, the maximum advantage, in both time the applicant cannot meet the obligation to disclose and cost, results from deferring national filing until the invention in a patent specification; i. If the applicant no way to put the invention in the hands of the decides to defer national filing to 30 months, he/she public without also giving the cell to the public. A solution to this patentability (novelty, obviousness, and utility) as problem is to make a restricted deposit of the cell they apply to the claims, and possibly comments on in a public depository, which will provide an acces- other matters. Prosecution of each application is Treaty resolves these issues by providing a list of then handled by each country independently of approved depositories throughout the world and what any other country may be doing with a cor- one set of deposit conditions, including restricted responding application. The inventor need make only one deposit of that country, the Written Opinion cannot con- under one set of rules to enable the invention, and trol, and there can be a broad range of reactions the public gets disclosure of the invention under from the national patent offices to the Written certain restricted conditions prior to patent grant. Therefore, the 20 year patent has a ject matter or that there is some fundamental error slightly longer (by about 1 year) patent life than the in the first application, e. Rather, are still in prosecution, but it can also occur if one many of these are just the first of a string of related has already been granted and a patient has issued. Ultimately, a decision is made by a panel of invention, thus leveling the international playing Administrative Patent Judges as to which party is field. Each type of biotech invention pre- Issue Fee is paid and the patent is granted) or the sents it own technological difficulties, which must Examiner issues a Final Rejection, to which the be resolved using whatever tools are available when response is an Appeal. In these About 9±10 months after filing the application, a countries, when the Examiner decides there is pa- decision is made by the Patent Committee about if, tentable subject matter, the allowed claims are Pub- where, and how to foreign file the application, lished for Opposition. That there are so many effective standards must be set for clinical research, to treatments available for the cure or control of so which all interested parties should adhere. How- many diseases is largely the outcome of decades of ever, procedures must also be in place if fraud is research, stretching throughout the second half of suspected, despite the existence of these standards. However, there is still a very Within the pharmaceutical industry, the standards long way to go to master many diseases, including needed for the conduct of clinical research already cancers, psychoses, dementias and many others, exist, and have been adopted by all regulatory which are currently untreatable. Clinical research bodies licensing medicines, international pharma- must therefore continue, including genetic and bio- ceutical companies, and contract research organiza- technological research, recognizing that the welfare tions. Research fraud distorts the beginning of this chapter are therefore in place, database on which many decisions may be made, there is no such harmonization when it comes to possibly adversely affecting the health of thousands dealing with fraud and misconduct in the context of of others. Indeed, even within Europe there rifyingly dangerous; if licensing decisions were to be is as yet no agreed attitude towards tackling the made based on efficacy and safety data that are problem. Fortunately able aspect of clinical research must be tackled if we there is no strong evidence that such a sequence of are to achieve and maintain confidence in scientific events has yet occurred, but the importance of the integrity and in the clinical research process. Extrapolating this to the rest of the worldÐ trials to determine the thalidomide effect, but had and there is no evidence that the incidence of fraud at least accurately observed its toxicity. It took a decade to data being generated is fraudulent, where investi- demonstrate publicly that such studies did not gators are making up some of the data to be sub- exist, and almost another decade (1996) before mitted to a company andÐworst of allÐmaybe McBride was publicly denouncedÐall of which exploiting their patients in the process. This definition of an eminent public figure whose reputation was includes all of the components of fraud: the such that it was unthinkable that he might be tell- making-up of information that does not exist, and ing lies. Furthermore, this case demonstrates the intending to do so flagrantly in order to deceive messianic complexoccasionally seen in fraudsters, others into believing that the information is true. Adjuvant Breast and Bowel Project, regarding a The first example is that of John Darsee, a re- number of multicenter clinical studies on breast search cardiologist, first at Emory University, then and bowel cancer. He pleaded guilty to 13 counts of commit- have had to be retracted from the prestigious jour- ting `acts derogatory to the honour and dignity of nals in which they first appeared.

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