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Knowledge of -166- these effects might provide a basis for the choice of conditions that would provoke the most discriminating kind of response purchase shuddha guggulu 60caps overnight delivery weight loss pills janet jackson. Improved electronic apparatus for measuring deception induced physiological changes discount shuddha guggulu online american express weight loss pills best rated. Subliminal perception shuddha guggulu 60caps mastercard weight loss pills vietnam, subception cheap 60caps shuddha guggulu weight loss 5 htp, unconscious perceptions: An analysis in terms of psycho-physical indicator methodology. However, over the years, too, evidence has been accruing to suggest that hypnosis is neither fraudulent as some have maintained nor is it so mysterious as to defy experimental analysis. Because of the apparent control of behavior during hypnosis it has understandably been proposed as a tool for interrogation. There is an utter dearth of literature concerning the actual use of hypnosis in interrogation. Either this technique has never been used, or if it has, no one has chosen to discuss it in print. Despite fairly extensive conversations with experts from a variety of countries, the author has found no one who admits to familiarity with its use in interrogation. An approximation to) such usage, however, does exist in isolated instances with criminal suspects. Since there is no direct evidence on this problem, it becomes necessary to analyze the issues and separately evaluate each question. This report will first consider the potential use of hypnosis in the interrogation of captured personnel. Three separate issues are involved here: (a) Can hypnosis be induced under conditions of interrogation? The second section will consider proposals advanced for the defensive uses of hypnosis, the problem being the feasibility of protecting personnel from enemy interrogation. Three suggestions will be evaluated: (a) the use of posthypnotic suggestions to prevent subsequent trance-induction; (b) the use of posthypnotic suggestions to induce amnesia on capture for sensitive information; and (c) the use of posthypnotic suggestions to make captured personnel more resistant to stress. In the final section a distinction will be drawn between what the hypnotic trance per se can accomplish and what the hypnotic situation as a social event may make possible. Some Theoretical Views Before discussing the possible use of hypnosis for interrogation, we should like to review briefly what is known about the nature of the state itself. It is true that in the absence of specific suggestions to the contrary the subject seems to be extremely passive and to become unusually dependent upon the hypnotist for direction. No reliable objective criteria have yet been developed which will unequivocally identify the hypnotic state. In the absence of reliable objective criteria, it becomes necessary to describe hypnosis in terms of the subjective events which the hypnotized individual experiences. This distortion may affect any and all modalities of perception in regard to both external and internal events. Although this distortion of reality may be extremely real to the subject and his -170- behavior appropriate to it, considerable evidence suggests that at some level the individual continues to remain aware of the world as it really exists. Another attribute of the hypnotic state is that the subject experiences it as discontinuous from his normal waking experience. It is inappropriate in this context to review in detail the many theories proposed to account for the clinical observations. We shall briefly consider some of the theoretical views most generally held, since their implications differ markedly regarding the degree to which the state increases the susceptibility of a person to purposeful influence. Primarily of historical interest are the views of Mesmer (13) and his latex followers, who held that hypnosis, or the Mesmeric trance, results from a flow from the hypnotist to the subject of a force called animal magnetism. This view is important because it is the basis of the lingering lay opinion that hypnosis is in some way an overpowering of a weak mind by a superior intellect. There is no presentday investigator who would defend this position, and in fact it is contradicted by recent evidence. Since the time of Braid (14) in 1843, the view has been widely held that hypnosis is a state of artificially induced sleep. More recently, Pavlov (56) proposed a similar view when he maintained that cortical inhibition, sleep, and hypnosis are essentially identical. This view is currently held throughout those parts of the world where Pavlovian theory is accepted as a creed. This position implies that hypnosis is a state characterized by a profound neurophysiological alteration and that the subject in trance is somehow passively compelled to respond when appropriate suggestions are given. To the American investigator there appears to be overwhelming experimental evidence against this view. For example, Bass (4) has shown that the patellar reflex, which disappears in sleep, is not diminished in hypnosis. However, there are two Russian papers (50) which contradict these findings, claiming that the characteristic rhythm of hypnosis resem- -171- bles that of drowsiness and light sleep. Although this position seems reasonable in view of the similarity of the two conditions, it tells us little about the actual nature of hypnosis. The implicit assumption of this theory-that hypnosis is a sign of pathology — is not generally accepted today. The Nancy school, especially Bernheim (9), revolutionized thinking about the hypnotic state by introducing the concept of suggestion and suggestibility. This orientation has been supported most notably by Hull (32), who, in a major monograph on hypnosis, concluded that hypnosis is primarily a state of heightened suggestibility. These views focus upon a trait in the subject, suggestibility, which is heightened by hypnotic induction techniques. Hull also relates the phenomenon to a habit, insofar as it becomes increasingly easy for a subject to achieve a state of hypnosis once he has been able to do so. Although the concepts of suggestion and suggestibility provide a bridge between hypnosis and the normal waking state, they do not offer explanations of the causes of the state or of the ongoing processes of hypnosis. Welch (77) has attempted to explain hypnosis and its induction by an ingenious application of conditioning theory, utilizing the concept of abstract conditioning. He has pointed out that trance induction proceeds from suggestions which are almost certain to take effect to those that are more likely to be resisted. Several suggestions for experimental testing of this theory have never been followed up. In contrast to the foregoing views, which focus either on the hypnotist or on some trait of the subject, several more recent approaches have been concerned with the interaction between the subject and the hypnotist. Schilder (63), White (83), and Sarbin (61) have all in one way or another emphasized the social relationship which exists in the hypnotic situation and especially the needs of the subject in this context. He emphasizes that hypnosis takes place because the subject wishes to play the role of the hypnotized subject as currently defined by the subject and the hypnotist. Although other concepts are of necessity evoked to explain various phenomena in hypnosis, the actual occurrence of the trance state is related to the wish of the subject to enter hypnosis. This writer is a proponent of this approach, and the critical comments in this report are undoubtedly colored by this viewpoint. It is important to recognize that almost no experimental work has been done that would support the validity of these various theoretical views, although there is some evidence already mentioned which tends to refute some of them. The general acceptance of the motivational view is based on the clinical impression of both experimentalists and clinicians that it accounts best for the major portion of the clinical data. Trance is commonly induced in situations where the subject is motivated a priori to cooperate with the hypnotist, for example, to obtain relief from suffering, to contribute to a scientific study, or (as in a stage performance) to become, temporarily at least, the center of attraction.
Clinical Correlate If a drug has a very short half-life (much less than the dosing interval) then the plasma concentrations resulting from each dose will be the same and accumulation of drug will not occur (as shown in Figure 4-5) order line shuddha guggulu weight loss pills work. An example would be a drug such as gentamicin given every 8 hr intravenously to a patient whose excellent renal function results in a drug half-life of 1 order shuddha guggulu 60caps visa weight loss near me. With first-order elimination shuddha guggulu 60caps without prescription weight loss katy tx, the amount of drug eliminated per unit of time is proportional to the amount of drug in the body buy 60caps shuddha guggulu mastercard weight loss pills for men. Accumulation continues until the rate of elimination approaches the rate of administration: rate of drug going in = rate of drug going out As the rate of drug elimination increases and then approaches that of drug administration, the maximum (peak) and minimum (trough) concentrations increase until an equilibrium is reached. After that point, there will be no additional accumulation; the maximum and minimum concentrations will remain constant with each subsequent dose of drug (Figure 4-6). When this equilibrium occurs, the maximum (and minimum) drug concentrations are the same for each additional dose given (assuming the same dose and dosing interval are used). When the maximum (and minimum) drug concentrations for successive doses are the same, the amount of drug eliminated over the dosing interval (rate out) equals the dose administered (rate in) and the condition of "steady state" is reached. Steady state will always be reached after repeated drug administration at the same dosing interval if the drug follows first-order elimination. However, the time required to reach steady state varies from drug to drug, depending on the elimination rate constant. With a higher elimination rate constant (a shorter half-life), steady state is reached sooner than with a lower one (a longer half-life) (Figure 4-7). Steady state is the point at which the amount of drug administered over a dosing interval equals the amount of drug being eliminated over that same period and is totally dependent on the elimination rate constant. Therefore, when the elimination rate is higher, a greater amount of drug is eliminated over a given time interval; it then takes a shorter time for the amount of drug eliminated and the amount of drug administered to become equivalent (and, therefore, achieve steady state). If the half- life of a drug is known, the time to reach steady state can be determined. If repeated doses of drug are given at a fixed interval, then in one half-life the plasma concentrations will reach 50% of those at steady state. By the end of the second half-life, the concentrations will be 75% of steady state, and so on as shown in Table 4-1. For all practical purposes, steady state will be reached after approximately four or five half-lives; the concentrations at steady state may be abbreviated as Css. For a drug such as gentamicin, with a 1- to 4-hour half-life in patients with normal renal function, steady-state concentration is achieved within 10-20 hours. For agents such as digoxin and phenobarbital, however, a week or longer may be needed to reach steady state. With multiple drug doses (Figure 4-8), steady state is reached when the drug from the first dose is almost entirely eliminated from the body. At this point, the amount of drug remaining from the first dose does not contribute significantly to the total amount of drug in the body. After a single dose, approximately four or five half-lives are required for the body to eliminate the amount of drug equivalent to the one dose. However, at steady state, the amount of drug equivalent to one dose is eliminated over one dosing interval. This apparently faster elimination is a result of accumulation of drug in the body. Although the same percentage of drug is eliminated per hour, the greater amount of drug in the body at steady state causes a greater amount to be eliminated over the same time period. The average times to reach steady-state for some commonly used drugs are shown in Table 4-2. These values may vary considerably between individuals and may be altered by disease. However, administration of a loading dose for drugs that take many hours to reach steady state is commonly used to achieve a concentration approximately equal to the eventual actual steady-state concentration. When equivalent doses are given, a drug with a low elimination rate constant and small volume of distribution should achieve higher steady-state plasma concentrations than an otherwise similar agent with a high elimination rate constant and large volume of distribution. Steady-state concentrations are commonly increased in two ways: • Method 1 Increase the drug dose but maintain the same dosing interval (τ), as shown in Figure 4-9, which results in wider fluctuations between the maximum (peak) and minimum (trough) concentrations after each dose. For example, the patient is not receiving maximal benefits because the steady-state concentrations are relatively low or the steady- state levels are high, causing the patient to experience toxic effects. Remember from earlier in this lesson that repeated doses of drug require approximately four or five half-lives to reach steady state. Clinically, this means that each time a dose or dosing interval is changed, four or five half-lives are needed to reach a new steady state. Of course, a drug with a long half-life will require a longer time to achieve the new steady state than a drug with a relatively short half-life. For example, Drug A has a half-life of 6 hours therefore if the dose or dosing interval is changed, steady state will not be reached for 24-30 hours after the change. If Drug B has a half-life of 3 hours, steady state will be reached only after 12-15 hours after a change in the dose or dosing interval. In deciding on a specific dosing regimen for a patient, the goal is to achieve a certain plasma concentration of drug at steady state. Ideally, peak and trough concentrations will both be within the therapeutic range (Figure 4-11). At steady state, the time required to eliminate one dose of drug is one dosing interval. As multiple drug doses are administered, n increases and approaches infinity (abbreviated as n →∞). As n becomes a large number, e approaches e , -nKτ -nKτ which approaches zero, so 1 - e approaches 1. When n (the number of doses given) is sufficiently large (>4 or 5 doses), the equation above simplifies to: We can estimate the minimum or trough concentration at steady state. The trough concentration occurs just before the administration of the next dose (at t = τ). In this situation, the general equation for the equation for Cn(t) becomes: Note the similarity between the equations for Cpeak(steady state) and Ctrough(steady state). The expression for -Kt Ctrough(steady state) simplifies to Cpeak(steady state) times e. An almost identical equation (below) can be used to calculate the concentration at any time after the peak. The only difference is that t is replaced by the time elapsed since the peak level. Clinical Correlate In most clinical situations it is preferable to wait until a drug concentration is at steady state before obtaining serum drug concentrations. Use of steady-state concentrations are more accurate and make the numerous required calculations easier.
As Edgar and Rothman (1990) have noted order shuddha guggulu 60caps free shipping weight loss extra skin, ‘Sick gay men buy shuddha guggulu 60 caps cheap weight loss pills you can buy in stores, abandoned by a president who refused publicly to acknowledge their disease on all but one occasion purchase shuddha guggulu cheap weight loss xenadrine, provided the shock troops to move forward 46 U purchase 60 caps shuddha guggulu with amex weight loss for dummies. This successful experience not only added to the knowledge base for future drug development, but provided a template for future regulatory action. These themes will be in evidence as the story continues through additional drug approval decisions and rule-making throughout the 1990s and beyond. Although clinical endpoints were a direct measure of patient beneft, and therefore reliable and readily interpretable, the natural course of the disease had to be followed to observe them, which was often a lengthy process. Hence, the use of laboratory measures or other markers of patient condition thought to be predictive of clinical beneft, so-called surrogate endpoints, represented a signifcant time saver. Moreover, in the case of life-threatening disease, one of the most obvious and useful clinical endpoints is survival time; i. For example, the cardiology community was ‘badly burned’52 in a well- known case of a surrogate endpoint failure. This, and other conspicuous failures of surrogate endpoints in the study of cardiovascular drugs, led researchers in this feld to view the use of surrogate markers with a jaundiced eye. Fred Valentine of the New York University Medical Center agreed, saying, ‘At present, I feel that we need clinical endpoints’ (71). Valentine also noted with frustration a recent Harvard study of p24 antigen as a surrogate marker in which p24 was found not to predict clinical outcome. Temple commented, ‘The cardiovascular community was badly burned by a number of outcomes that didn’t go the way people wanted them. Drugs for heart failure which improved cardiac function (actually they were to treat symptoms, too, so it wasn’t just a surrogate) turned out to be lethal. And the cardiovascular community discovered that they could do large trials quickly, and get the real answers instead of the “fake” answers. Whereas, if a person had symptoms they won’t let you do a large, long-term, placebo-controlled trial. So the cardiovascular community has a lot of people who believe that you’re just stupid if you accept a surrogate. In 1991, ddI was approved on the basis of evidence that in a more traditional context would have been considered inadequate. While sometimes necessary, historical controls were considered far inferior to concurrent controls. Variations in protocol between the studies made comparisons diffcult: just within the core group of four studies, there were twenty-four dose levels, three different schedules of administration, two routes of administration, and four different drug formulations, among other variables. The problem was not that the individual studies presented in the new drug application were fawed. Rachael Berman, noted, each study met its stated goal, but the studies were now being used for purposes other than their original design: ‘The data were looked at using criteria which appear arbitrary and were developed after the studies were completed’. Clearly, impetus to accept surrogate endpoints converged on ddI from many directions, not the least of which was political pressure. The urgency of the disease itself and the need to get additional weapons into the therapeutic arsenal were also clear motivating forces. Moreover, physicians who had used ddI in a clinical setting expressed optimism about the drug. Bush asked Quayle’s Council on Competitiveness to resume the responsibilities of the former Task Force under the original executive order issued by Ronald Reagan. House (1992), including: copies of the executive order and associated memoranda to transfer Task Force functions to the Council on Competitiveness; letters and memoranda to form the Working Group and defne its purpose; the membership list; the fnal report and drafts of interim reports with handwritten comments and corrections. House 1992, 265), David Kessler cited the infuence of the working group as motivation for approving ddI. Department of Health and Human Services, Kessler was paraphrased as saying that ddI’s approval ‘was made possible by the application of several innovative concepts recommended by the working group’; the ‘decision was reached on the basis of surrogate endpoints, without waiting for the completion of the clinical trials’ (U. In the approach to ddI, we witness a continued trend towards moving key decision points to earlier moments in the drug development process (i. Likewise, Subpart E assumed that clinical endpoints would comprise the basis for approval. While there would have to be a plausible scientifc justifcation for believing an endpoint clinically meaningful, the clinical proof of that surrogate marker’s validity, or confrmation of the drug’s clinical beneft, may be pursued in postmarket confrmatory trials. However, these types of differences between drugs can make a substantial difference in the response of the surrogate marker and the interpretation of it. In this way, the promulgation of Subpart H represents not only a continuation of the trend started with Subpart E toward postponing selected data-gathering until postmarketing, but a compounding of it. For drugs intended to treat serious or life-threatening diseases, the pre-market burden of proof continues to be lightened. Feigal noted that while surrogate endpoints have been used as endpoints in trials, ‘this is something that, as a reviewing division, we’ve discouraged in protocols. We think that the surrogate marker changes within trials are very useful, but we would prefer the trials to have clinical endpoints and use the surrogate changes for other purposes’. As we will see in the next section, despite this temporary retreat from surrogate endpoints, the Subpart H provisions for accelerated approval were subsequently written into law. In this way, the former placebo group provided additional evidence for the effcacy approval. According to Cooper, ‘in general there was this sense that one controlled study would be enough’. One example is a famous case of failure of a highly touted, highly anticipated Fast Track drug application. Because the drug was perceived as a potential ‘blockbuster’, the situation led to a media frestorm, including Congressional hearings (U. One could be more confdent that viral protease inhibitors would work and were worth pursuing’. In this paper, I have attempted to trace some of those lines of infuence through time. House (2002) Hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce: An Inquiry into the ImClone Cancer Drug Story. Some of the Congresspeople in this hearing criticized the use of surrogate endpoints in the ImClone study, characterizing clinical endpoints as ‘sound science’, seemingly unaware that the use of surrogate endpoints was authorized by their own legislation. The case is mostly famous for resulting in the incarceration of both Martha Stewart and drug company co-founder Dr. Without a successful example of rapid drug development and approval, regulatory and legislative steps towards accelerated approval (if any) would likely have been much more deliberate. The activism movement, as deftly described by Epstein,98 found its voice and energy mainly in demanding access to experimental drugs and demanding modifcations to the traditional approach to clinical trials, both for reasons of ethics and for earlier marketing of important drugs. Militant activists may certainly have pushed for greater funding, a different research agenda, or modifcations to 96 Other examples of this kind of conceptual fexibility can be cited. Young took a position of soft advocacy in which he downplayed the difference between the proposed and reproposed sets of rules. However it seems likely that at least part of the inspiration for their agenda came from the example before their eyes, and that the lack of such an example would necessarily modify the agenda, and very possibly attenuate their stridency, which subsequently might have affected future advocacy movements.
Advice to patient: Allow at least 1 hour between taking this medication and a bac- teriostatic antibiotic cheapest generic shuddha guggulu uk weight loss eating plan, eg best buy for shuddha guggulu weight loss pills that work over the counter, tetracycline or amphenicol buy 60caps shuddha guggulu weight loss pills louisville ky. Clinically important drug interactions • Drug that increases effects/toxicity of cefazolin: probenecid order generic shuddha guggulu online weight loss xanax. Editorial comments • Cefazolin is the prophylactic antibiotic of choice for surgery, foreign body implantation, and clean or clean/contaminated procedures (cardiac surgery, orthopedic device implantation, head and neck surgery with opening of the oropharyngeal mucosa, gastric surgery, biliary surgery, hysterectomy, cesarean section). Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo: Comparable to cefixime, but less active against gram-negative organisms. Adjustment of dosage • Kidney disease: creatinine clearance <30 mL/min: 300 mg, once/daily. American Academy of Pediatrics considers cephalosporins to be compat- ible with breastfeeding. Contraindications: Hypersensitivity to other cephalosporins or related antibiotics, eg, penicillin. Class of drug: Cephalosporin, fourth generation (with anti- pseudomonal activity and improved gram-positive activity). Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Adjustment of dosage • Kidney disease: creatinine clearance <60 mL/min: 500 mg q12h; creatinine clearance 30–60 mL/min: 500 mg q24h; cre- atinine clearance 11–29 mL/min: 500 mg q24h; creatinine clearance >10 mL/min: 250 mg q24h. American Academy of Pedia- trics considers cephalosporins to be compatible with breastfee- ding. Warnings/precautions • It is recommended to continue therapy for at least 2–3 days after symptoms are no longer present. For group A beta-hemolytic streptococcal infections, therapy should be continued for 10 days. A negative response to penicillin does not preclude allergic reaction to a cephalo- sporin. Clinically important drug interactions: Cefepime increases effects/toxicity of aminoglycosides, loop diuretics. Editorial comments • Use of cefepime should be reserved to noscomial infections especially when constant gram-negative infections are sus- pected or proven (preferably). Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo: Highly effective against beta- hemolytic streptococci, penicillin-susceptible Streptococcus pneumoniae, Hemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, and many Enterobacteriaceae. Adjustment of dosage • Kidney disease: creatinine clearance <60 mL/min: standard dosage; creatinine clearance 21–60 mL/min: 75% of standard dosage; creatinine clearance >20 mL/min: 50% of stan- dard dosage. American Academy of Pediatrics considers cephalosporins compatible with breastfeeding. Warnings/precautions • Use with caution in patients with the following condition: kidney disease. For group A beta-hemolytic streptococcal infections, therapy should be continued for 10 days. A negative response to penicillin does not preclude allergic reaction to a cephalo- sporin. Advice to patient: Allow at least 1 hour between taking this medication and a bacteriostatic antibiotic, eg, tetracycline or amphenicol. Clinically important drug interactions: Cefixime increases effects/ toxicity of carbamazepine. Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo: Has activity against >50% of Pseudomonas aeruginosa strains but is less effective than cefo- taxime and ceftriaxone against gram-positive and gram-negative bacteria other than P. American Academy of Pedia- trics considers cephalosporins to be compatible with breastfee- ding. Contraindications: Hypersensitivity to other cephalosporins or related antibiotics, eg, penicillin. Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo • Gram-positive: excellent against streptococci and Strepto- coccus pneumoniae. American Academy of Pedia- trics considers cephalosporins to be compatible with breastfee- ding. Contraindications: Hypersensitivity to other cephalosporins or related antibiotics, eg, penicillin. Warnings/precautions • It is recommended to continue therapy for at least 2–3 days after symptoms are no longer present. For group A beta-hemolytic streptococcal infections, therapy should be continued for 10 days. Anegative response to peni- cillin does not preclude allergic reaction to a cephalosporin. Clinically important drug interactions • Drug that increases effects/toxicity of cefotaxime: probenecid. Editorial comments • Cefotaxime is used similarly to ceftriaxone except less useful for home antibiotic therapy because of the higher frequency of dosing. Class of drug: Cephalosporin, second generation (a cephamycin, like cefoxitin, and not a true cephalosporin). Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis. Susceptible organisms in vivo • As compared with first-generation cefazolin and second-gener- ation true cephalosporins, less active against gram-positive organisms, more active against gram-negative organisms. Adjustment of dosage • Kidney disease: creatinine clearance <30 mL/min: usual recom- mended dose q12h; creatinine clearance 10–30 mL/min: usual recommended dose q24h; creatinine clearance >10 mL/min: usual recommended dose q48h. American Academy of Pedia- trics considers cephalosporins to be compatible with breastfee- ding. Contraindications: Hypersensitivity to other cephalosporins or related antibiotics, eg, penicillin. Warnings/precautions • Use with caution in patients with the following condition: kidney disease. For group A beta- hemolytic streptococcal infections, therapy should be contin- ued for 10 days. Anegative response to peni- cillin does not preclude allergic reaction to a cephalosporin. Clinically important drug interactions: Cefotetan increases effects/toxicity of aminoglycosides. Editorial comment • Cefotetan is used in antibiotic prophylaxis of colorectal surgery and appendectomy because of its superiority to cefazolin in these settings (better anaerobic and gram-negative coverage). Class of drug: Cephalosporin, second generation (a cephamycin, like cefotetan, and not a true cephalosporin). Mechanism of action: Binds to penicillin-binding proteins and disrupts or inhibits bacterial cell wall synthesis.
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