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Dramatherapy, da nce movement thera py, art therapy, music therapy ; Arts Therapies are forms of psychotherapy that make use of artistic media as a vehicle for non-verbal and or symbolic communication. Arts therapists encourage people to express and deal with feelings and emotions through the arts, i.e. music, visual arts, drama and movement dance. A `holding' environment is valued and encouraged by establishing a clienttherapist relationship in order to achieve personal and or social therapeutic aims appropriate for the individual. People can join individual and or group therapy for different reasons, some of which may include the need to express emotions, build self-esteem and self-confidence, release stress and anxiety and clarify life choices and options available. The aims and objectives of groups are negotiated with the group members. Safeguards 1. Registration with arts therapies professional associations. It is importan t to check that the therapist is a registered member of arts therapies professional associations. It is the role of the professional organisation to ensure that the therapists are qualified at a postgraduate level in validated University based training courses minimum qualifications a Diploma and or Masters ; , are under regular clinical supervision and take part in continuing professional development. Each arts therapy is regulated by their professional body and governed by their Code of Ethics. There are four arts therapies professional associations: Dramatherapists: British Association of Dramatherapists BADth. Designed and run for women, by women, The Retreat seeks to make your annual screening mammogram personal and comfortable. When you enter The Retreat you're welcomed into a relaxing atmosphere. Our health care colleagues are warm, personal and compassionate. Private changing rooms are connected directly to the mammography room. Comfortable cloth capes are provided, rather than the often-used paper ones. During the mammogram, your female technologist stays with you the entire time and explains each step. At The Retreat, our focus is always on you, for example, drug information.

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7 Many health policies seem to have a paternalistic component. This is the case whenever the effectiveness of an intervention is evaluated on other grounds than what is communicated by individuals through their actions, i.e. on ad hoc grounds. However, given the potential problems with individuals' decision-making ability, such approach can be justified. But this requires one to believe in a model that is distinct from the standard homo economicus model of economics. Human interaction Problems in understanding the value of treatments emphasize the role of health professionals. One thing that makes the health production process special is the physician-patient relationship. This was observed already by Arrow 1963 ; , who motivates health institutions through the principalagent problem between a physician, a patient, and an insurer. However, if patients or physicians ! ; fail to fully understand the situation, it is questionable whether the principal-agent framework does full justice to the physician-patient relationship.8 While human interaction seems important in health related decision-making, it is difficult to tackle in the standard economics framework. Let us consider some examples. There are typically many recommendations a physician may justifiably give to a patient from the same verifiable data. Because of this, the physician cannot avoid deciding of how much to reveal and which way to manipulate the patient. To cooperate with the physician, the patient must trust that the physician uses his authority in favor of him. Therefore, trust plays a central role in a well functioning physician-patient relationship. Since altruistic people are presumably more trustworthy than others, altruism has been thought as an important character of physicians see Ma in this volume ; . But trust without substance - e.g. possibility to punish or reward has no meaning in economics. Thus it seems that to analyze physician-patient relationship, one must go beyond the standard economics framework. While it is easy to see why a patient departures from the rational man paradigm, physicians are not perfect either. They take actions on the basis of rules of thumb, stereotypes e.g., believe that certain kind of patients do not comply with recommendations ; , common practice, the need to "do something" the physician feels he cannot send the patient home without even a worthless recommendation ; , the patient's expectations e.g., prescribe antibiotics just because it is what the patients asked ; . From the perspective of economics, it is far from clear how one should organize the incentives of a boundedly rational physician? A good example of why the standard economics approach is insufficient is the "treatment effect". It is easy to figure out reasons why it not only matters what the treatment is but also how it is provided. Anxiety, procrastination, suspiciousness, and denial are common features of patient's decision making.9 How and when such states of mind show up may be sensitive to the treatment strategy. More generally, the success of human interaction can be sensitive to the motives, or suspected motives, of individuals. Human interaction is hard to capture in a standard economics framework. One of the key principles in economic modeling is that only the outcomes matter. This rules out all kinds of treatment effects. Of course one could try to enlarge the model to capture also the unmodeled payoff consequences. However, it is safe to argue that there is not rich enough model that could ever approximate all.
Pramide or the disturbing cardiac arrhythmias seen with cisapride. Low dose antidepressant medication may both decrease anxiety and decrease visceral hyperalgesia, which is the physiologic process contributing to pain experienced in this condition. Most patients respond to a program, which includes evaluation, acknowledgement, explanation, support, normalization, and medication. Various forms of relaxation therapy would seem logical for these teens in particular, but some children prone to this syndrome are less likely to slow down enough to use these less dramatic initiatives. CME.

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Relieving Symptoms Reflux of gastric acid not only depends on acid production, but also on the ability of acid to reach the esophagus. Drugs that effectively reduce this "backward" flow of acid have been sought for years. If they prove to be effective at reducing the reflux of acid to normal, drugs suppressing gastric acid may not be needed. Although bethanechol has been used to reduce reflux for years, its rate of adverse events e.g., blurred vision and abdominal cramping ; limits its usefulness. Metoclopramide and cisapride increase LES pressure. Metoclopramide 10 mg 4 times day appears to produce effective heartburn relief in patients with mild GERD. The frequency of heartburn relief is similar to that seen with prescription doses of H2RAs, but less than that seen with PPIs. Healing Esophagitis Esophagitis healing with prokinetics is similar in frequency to normal doses of prescription H2RAs. For patients with esophagitis with a Savary-Miller Class I or II, about 5080% will heal after 812 weeks of treatment. Efficacy depends on the severity of the lesions with more severe esophagitis such as those with Class III or IV having a lower healing rate. When the studies using prokinetics are reviewed, the efficacy is clearly better in patients with mild esophagitis. Recommendations on the Role in Managing GERD Prokinetics when used alone are not especially effective in treating more severe lesions such as erosive esophagitis. However, both metoclopramide and cisapride enhance the esophagitis healing rate of H2RAs and PPIs. Direct head-to-head comparisons of metoclopramide and cisapride have not been done, but the extrapyramidal and central nervous system side effects of metoclopramide have limited 9 Gastroesophageal Reflux Disease.
Introduction: In cases of trauma, infection and tumor, it is often necessary to instrument the upper cervical spine. Though in general pedicle screws in C2 are safe, potential injury to the vertebral arteries is present. Owing to this risk, translaminar screws into C2 have been used. The aim of our study was to investigate the stability in the in vitro cadaveric spine across C2-C3 when instrumented with translaminar or pedicle screws at C2. Methods: Eight fresh frozen human cadaver cervical spines C1 C5 ; were potted at C1-2 and C5. Pure moments in increments of 0.3Nm to a maximum of 1.5 Nm were applied in flexion, extension, right and left lateral bending, and right and left axial rotation. Each specimen was tested sequentially in 3 modes: 1. ; Intact, 2. ; C2 pedicle screws-C3 lateral mass fixation PS ; 3. ; C2 translaminar-C3 lateral mass fixation TL ; . The sequence of fixation testing was randomized. Motion was tracked with reflective markers attached to C2 and C3. Results: Instrumentation showed significantly less motion than the intact spine in all directions and with all loads over 0.3Nm. Though there was no significant difference between PS and TL fixation, generally PS fixation was associated with less motion than TL screws. Conclusion: When pedicle screws in C2 are contraindicated or inappropriate, translaminar screws in C2 would potentially offer a safe and stable alternative for posterior instrumentation and propulsid.

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Mention may be made, as examples and without implied limitation, of analgesics, such as aspirin, paracetamol, ibuprofen, tramadol, codeine, dextropropoxyfene, buprenorphine, benorilate and morphine; antispasmodics, such as phloroglucinol; agents used in gastroenterology, such as cisapride, domperidone and metopimazine; agents for combating motion sickness, such as dimenhydrinate; antimigraines, such as dihydroergotamine and sumatripan.

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Specifically, the approved product labeling for prilosec states that clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibiotics, that clarithromycin is contraindicated in patients receiving cisapride, or pimozide who have pie-existing cardiac abnormalities or electrolyte disturbances, and that clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate and clemastine!

And injury in May 1991. was then treated at the Accident and Ernergency Department without hospitalization . He sustained a laceration over the right eyebrow and was conscious and alert throughout . Neurological observation was stable. An evening fever f, figure 11 ; occurred after admission and lie had cough with whitish sputum . Cefuroxirne was started on 24.8.1991 . Indornethacin was also started on 26 .8 .1991. for left knee pain and right foot pain. The fever subsided on 27.8.1991 . Chest X-ray revealed a coin lesion over right middle zone and he was subsequently transferred to a chest hospital for observation on 10.9 .1991 . He was readmitted to the geriatric ward on 14.9.1991 from the chest hospital because of disorientation, neck rigidity, tremor and fever . Tuberculous meningitis was subsequently diagnosed and his condition irnproved after ariti-tubercuWus treatment . Review of the hospital record showed that he had been put on inclornethacin at a close of 25rng four times a clay from 26.8W1 till 10.9.1J91. After oral administration in man, cisapride is rapidly and completely absorbed, but its absolute bioavailability is 40 to due to an extensive intestinal metabolism and to an hepatic first pass effect. Peak plasma levels are reached within 1 to 2 hours. The better bioavailability is reached when the intake takes place 15 minutes before meals. Ciapride is mainly metabolized through cytochrome P450 3A4; it is mainly metabolized by oxydative NCPMP 24844 02 53 and clopidogrel.

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Catastrophic health care events: implications for pricing i would view these as different approaches to similar problems, although i must say, without being sycophantic, that i was truly impressed with what dave was doing yesterday and cloxacillin.
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Happening before the patient is given a medical evaluation. In a memory assessment clinic, the physician is supported with the information cognitive testing results and family concerns ; needed to make an accurate diagnosis and the family is supported by having someone with the time to listen to those concerns and direct them to find information and or services that could assist them. Blood work or a CAT scan may be needed to rule out medical reasons for the patient's symptoms, so it may take a second visit to the clinic to receive a diagnosis. While many people with MCI or early dementia may initiate their own diagnosis and care, for some it will be up to another family member to alert the physician. It's helpful if a trusted family member or friend makes the appointment and accompanies the person to that appointment. On the day the person is to be seen, be sure to bring along items that will support the person during the testing glasses and hearing aids ; . Also bring a list of current prescriptions and over the counter medications that the person takes. Be ready to answer questions like, "What symptoms have you noticed? When did the symptoms appear? Are there other persons in the family who have had AD?" If the diagnosis turns out to be AD another irreversible dementia, the Alzheimer's Association will be there to answer your questions and to provide support. Call us at 608-232-3400 or 800-272-3900, for instance, astemizole.

Within our geographical boundary are three prisons. The inmates of these prisons are also potentially patients of this Trust and require healthcare provision. The responsibility for commissioning of health services provided in the prisons will move away from the Home Office to the NHS by April 2006. We will assume these responsibilities from April 2005, which presents us with substantial additional challenges. I have been, therefore, very keen to get acquainted with the places, people and issues well in advance of our statutory take over date. At the end of August I and other Directors undertook a tour of HMP Blakenhurst and HMP Brockhill. At the end of a long day we were left with an extremely positive picture of the healthcare provision and the prison regime. HMP Blakenhurst is a male remand prison and HMP Brockhill is a women's prison. We were met everywhere by committed and sensitive professionals, all very aware of the challenges and issues of the healthcare of the people in their care. The prisoner population of both establishments is, in terms of the prison service generally, very transient and the majority of inmates are very troubled. We are currently preparing for the assumption of these new responsibilities within the PCT. Graham Vickery Chairman and danocrine. However, a may 2007 study in the new england journal of medicine states that the popular drug may raise a patient’ s chance of having a heart attack, or suffer a heart-related death, because cisapride suspension.
Variable 2 weeks 4 weeks 8 weeks baseline 2 weeks 4 weeks 8 weeks weeks 1-2 weeks 3-4 weeks 5-8 placebo n 159 ; 15 18 30 cisapride n 163 ; 21 22 40 omeprazole n 161 ; 59 71 76 value and ddavp. Table 1. Continued Day 5 7000 76.9 N A 1.7 41.4 * 69.0 * N A 521 * 5.9 * 105 * N A N 5.8 2.9 1.00 N A 867 72 0.1 * 100 N A N 133 4.1 Chloride mEq l ; Calcium mEq l ; Admission 104 9.3. Children who see their mothers physically abused may often suffer their own emotional and behavioral problems in response, new study findings show. : today.reuters news newsarticle x?type healthNews&storyid 2006-01-04T172238Z 01 KNE462493 RTRUKOC 0 US-ABUSE-CHILDREN-HEALTH and stimate.

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Small Intestinal Transit Disorders A number of small intestinal transit disorders have been described in dogs and cats, including enteritis, post-surgical pseudo-obstruction, nematode infection, intestinal sclerosis, and radiation enteritis. Vomiting and diarrhea are the most important clinical signs associated with these disorders. Overgrowth of small intestinal bacteria, a common sequela to disordered motility, contributes to these clinical signs. Transit disorders associated with mechanical obstruction should always be differentiated and treated appropriately. Delayed transit associated with functional disorders should be managed with dietary modification low fat diets ; and prokinetic agents cisapride, tegaserod, or metoclopramide ; . Tegaserod, a new 5-HT4 partial agonist, has recently been reported to normalize intestinal transit in opioid-induced bowel dysfunction in dogs. Colonic Motility Disorders History Constipation, obstipation, and megacolon may be observed in cats of any age, sex, or breed, however, most cases are observed in middle aged mean 5.8 years ; , male cats 70% male, 30% female ; of Domestic Shorthair 46% ; , Domestic Longhair 15% ; , or Siamese 12% ; breeding. Affected cats are usually presented for reduced, absent, or painful defecation for a period of time ranging from days to weeks or months. Some cats are observed making multiple, unproductive attempts to defecate in the litter box, while other cats may sit in the litter box for prolonged periods of time without assuming a defecation posture. Dry, hardened feces are observed inside and outside of the litter box. Occasionally, chronically constipated cats have intermittent episodes of hematochezia or diarrhea due to the mucosal irritant effect of dehydrated feces. Physical Examination Colonic impaction is a consistent physical examination finding in affected cats. Other findings will depend upon the severity and pathogenesis of constipation. Dehydration, weight loss, debilitation, abdominal pain, and mild to moderate mesenteric lymphadenopathy may be observed in cats with severe idiopathic megacolon. Colonic impaction may be so severe in such cases as to render it difficult to differentiate impaction from colonic, mesenteric, or other abdominal neoplasia. Cats with constipation due to dysautonomia may have other signs of autonomic nervous system failure, such as urinary and fecal incontinence, regurgitation due to megaesophagus, mydriasis, decreased lacrimation, prolapse of the nictitating membrane, and bradycardia. Digital rectal examination should be carefully performed with sedation or anesthesia especially in those cats with recurring bouts of constipation. Pelvic fracture malunion may be detected on rectal examination in cats with pelvic trauma. Rectal examination might also identify other unusual causes of constipation, such as foreign bodies, rectal diverticula, stricture, inflammation, or neoplasia. Chronic tenesmus may be associated with perineal herniation in some cases. A complete neurologic examination with special emphasis on caudal spinal cord function should be performed to identify neurologic causes of constipation, e.g. spinal cord injury, pelvic nerve trauma, and Manx sacral spinal cord deformity. Differential Diagnoses Several authors have emphasized the importance of considering an extensive list of differential diagnoses e.g. neuromuscular, mechanical, inflammatory, metabolic endocrine, pharmacologic, environmental, and behavioral causes ; for the obstipated cat. A review of published cases, however, suggests that 96% of cases of obstipation are accounted for by idiopathic megacolon 62% ; , pelvic canal stenosis 23% ; , nerve injury 6% ; , or Manx sacral spinal cord deformity 5% ; . A smaller number of cases are accounted for by complications of colopexy 1% ; and colonic neoplasia 1% colonic hypo- or aganglionosis was suspected, but not proved, in another 2% of cases. Inflammatory, pharmacologic, and environmental behavioral causes were not cited as predisposing factors in any of the original case reports. Endocrine factors obesity, n 5; hypothyroidism, n 1 ; were cited in several cases, but were not necessarily impugned as part of the pathogenesis of megacolon. Pathogenesis The pathogenesis of idiopathic megacolon has been historically attributed to a primary neurogenic or degenerative neuromuscular disorder. While it seems clear that a small number of cases 11% ; result from neurologic disease, the vast majority 90% ; of cases have no evidence of neurologic disease. Some of the.
Fig. 14 Comparative lipophilicity of drugs shown in different colors: dark blue, highly lipophilic; light blue, slightly lipophilic; black, neutral; red, slightly hydrophilic; brown, highly hydrophilic Molecular Modeling Pro and decadron.

Assessing and Planning for Youth Friendly Services, Part 1 2 hours ; Instructions: 1. Ask participants to work individually or in teams, if from the same facility or region. 2. Using Participant Handout 6.8 ask participants to assess their facilities based on the characteristics identified. 30 minutes ; 3. Using the Action Plan attached Participant Handout 6.9 ; , individuals or teams should discuss strategies for enhancing or improving any area scoring below a 3. Ask them to select three priority areas to begin working on and complete the action plan. A sample is attached. 45 minutes ; 4. Option - Divide participants into groups. Assign one of the health facility case studies to each group. Give each member a copy of the case study. Point out that the description of the facility and community may not answer all of the questions group members may have, so they should also indicate where more information is needed. This might also be the case in a true assessment where records may not be kept up to date or where information is not available. ; 20 minutes ; 5. Using the checklist in Participant Handout 6.8 each group should reach consensus on the scores for each YFS characteristic. 40 minutes ; 6. Ask the groups to select three priority areas to begin working on and complete the action plan. A sample is attached. 1 hour ; 7. Option Conduct an actual site visit of a local health facility. This needs to be arranged in advance for a time that is least intrusive to facility staff but also where you are likely to see adolescent clients. A maximum of 5 participants should visit each site. 8. Participants should decide in advance their roles in the assessment process. One person can be assigned to each task, i.e. observing provider client interaction, reviewing client records, etc. The process should begin with an introduction to the staff and or head matron. It should end with an on-site debriefing or an invitation to the head matron or his her designee for a debriefing on the following day. Their parents both with c8sapride travelers concerning swallowed.

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Date: 12 01 97ISR Number: 3003007-4Report Type: Expedited 15-DaCompany Report #971121-008013188 Age: 82 YR Gender: Female I FU: I Outcome Dose Death ORAL ORAL Hyponatraemia 10 MG, TID, ORAL Buflomedil 15O MG, QD, ORAL Propafenone 300 MG, QD Zopiclone 7.5 MG, ORAL Paroxetine 20 MG, ORAL Macrogol ORAL Gaviscon ORAL 22-Aug-2005 Page: 4 10: 49 SS ORAL SS ORAL SS ORAL SS ORAL SS SS ORAL Professional Cisapdide SS ORAL PT Duration Hyperglycaemia Hypokalaemia Foreign Health Haldol Risperidone PS SS ORAL ORAL Report Source Product Role Manufacturer Route.

Table 3. Immunohistochemistry Results NK lymphomas Case no. CD2 CD3 CD4 CD5 CD7 CD8 CD16 CD30 CD34 CD43 CD45Ro CD56 CD57 CD68 CD79a MAC383 Chloroac Ki67 TIA1 Perforin Granz. B P70 P140 NKG2A LIR1 CD94 P58.1 P58.2 I II III and propulsid. Intraluminal pressure in the colon. Itopride, cisapride and mosapride were applied to the serosal. The net cost savings of this change was the 1996 drug topics redbook cost of acarbose at $4 05 a month, minus the cost of decreased doses of cisapride $3 64 a month ; , discontinued sorbitol $1 63 a month ; , and decreased doses of glipizide $3 00 a month ; , or a savings of $9 62 per month.

Cisapride treatment, in symptomatic infants as a group, significantly reduced the RI Table 3; Fig 1; Wilcoxon signed rank test, P .017 ; . The number of episodes 5 minutes 24 hours ; was also significantly reduced P .026 ; . No significant effect was seen on the total number of refluxes 24 hours ; or duration of the longest episode. Eight infants 33% ; showed no decrease in RI after a week on cisapride therapy Fig 1; Table 4 ; . Three of these infants improved after cisapride dose was increased from 0.09 to 0.25 mg kg dose every 6 hours Table 5 ; . Cisqpride was discontinued in 3 infants because of prolonged QTc. Three infants had no follow-up. Only 1 infant infant 19; Table 5 ; showed no improvement with increased dose. As director of diversity for Perini Building Co., Lorrinda Gray-Davis works to include more women and minority business owners in the company's projects. In her role, Gray-Davis oversees Perini's diversity development staff and their efforts to recruit minority and women-owned suppliers and contractors to work on their projects. Perini Building Co. works for a number of companies and government organizations that require women or minority-owned companies to participate in their projects. Gray- Davis' job is to ensure women and minorityowned business leaders are educated about the industry and are qualified to work with Perini on its projects. She developed a program that creates mentoring opportunities for less established minority and women-owned suppliers and contractors with more established firms. Gray-Davis' work has garnered her recognition within the business community. The Grand Canyon Minority Supplier Development Council Inc. named her 2005 Corporate Advocate of the Year. She`s also active in the business community. She serves on the board of directors of the Grand Canyon Minority Supplier Development Council, and is a member of the Arizona Hispanic Chamber of Commerce, the Women's Business Enterprise Council and the Associated Minority Contractors of America. Further, she has been active in promoting the participation of women and minorities in the sport of drag racing and helped Frank Pedregon become the first Hispanic owner of a NASCAR team through the Drive for Diversity program. Name drugs by omitting from their computations of Best Price statutorily and contractually required information. For example, defendants omit from their rebate calculations, cash, for instance, cisapride withdrawn. Medication reviews HMRs and RRMRs ; can alert GPs and pharmacists to many problems. The review can also help solve the problem by looking at medication alternatives. For all information on medication reviews, call the Division's Dr Jenny Gowan, 8480 4611. 's opinion, cisapride is only minimally efficacious therefore no safety risk is acceptable.

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Radiology. 2005 Jun; 235 3 ; : 992-48. CT sign of brain swelling without concomitant parenchymal hypoattenuation: comparison with diffusion- and perfusion-weighted MR imaging. Na DG, Kim EY, Ryoo JW, Lee KH, Roh HG, Kim SS, Song IC, Chang KH. Department of Radiology, Seoul National University College of Medicine, Seoul National University Hospital, 28 Yongon-dong, Chongno-gu, Seoul 110-744, Korea. dgna radiol.snu.ac.kr Radiology. 2005 Jun; 235 3 ; : 1072-7. Multistage ethanol sclerotherapy of soft-tissue arteriovenous malformations: effect on pulmonary arterial pressure. Shin BS, Do YS, Lee BB, Kim DI, Chung IS, Cho HS, Kim MH, Kim GS, Kim CS, Byun HS, Shin SW, Park KB. Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Kangnam-Ku, Seoul, 135-710 Korea. Lab Chip. 2005 Aug; 5 8 ; : 845-50. World-to-chip microfluidic interface with built-in valves for multichamber chip-based PCR assays. Oh KW, Park C, Namkoong K, Kim J, Ock KS, Kim S, Kim YA, Cho YK, Ko C. Bio Lab, Samsung Advanced Institute of Technology, P.O. Box 111, Suwon 440-600, Korea. MrOhio Samsung Lab Chip. 2005 Jul; 5 7 ; : 739-47. A serpentine laminating micromixer combining splitting recombination and advection. Kim DS, Lee SH, Kwon TH, Ahn CH. Department of Mechanical Engineering, Pohang University of Science and Technology POSTECH ; , San 31 Hyoja-dong Namgu, Pohang, Kyungbuk 790-784, Korea. Lab Chip. 2005 Jun; 5 6 ; : 657-64. Magnetic force-based multiplexed immunoassay using superparamagnetic nanoparticles in microfluidic channel. Kim KS, Park JK. Department of BioSystems, Korea Advanced Institute of Science and Technology, 373-1 Guseong-dong, Yuseong-gu, Daejeon 305-701, Korea. Thorax. 2005 Aug; 60 8 ; : 701-3. Dendriform pulmonary ossification in patient with rare earth pneumoconiosis. Yoon HK, Moon HS, Park SH, Song JS, Lim Y, Kohyama N. Division of Pulmonary and Critical Care, Department of Medicine, College of Medicine, Catholic University of Korea, Seoul, Korea.
Stephen Barlas is a freelance writer based in Washington, DC, who covers issues inside the Beltway. Send ideas for topics and your comments to sbarlas verizon . tra, G. D. Searle ; , and cisapride Propulsid, Janssen ; posed unresolved safety problems. After reading the GAO report, one is left wondering whether the CDER "reorganization"--moving a bureaucrat up a few notches and giving him a new title--is enough to cure what ails the CDER drug safety surveillance operation. Was this simply a matter of rearranging the deck chairs on the Titanic? It is clear that the FDA needs more than a reorganization to emerge from the clouds darkening the skies over its offices in Rockville, Maryland. To start with, the ODS needs more resources. In fiscal year 2005, the ODS spent $26.9 million and employed 106 staff members; by contrast, the OND spent $110.6 million and had a staff of 715. The GAO report portrays a "Keystone Cops" relationship between the two offices. Each office has its own confusing methods of operation, complicated by a revolving door at the top. The ODS has had eight directors in 10 years. The ODS director acknowledged to the GAO that his shop apparently uses the equivalent of a pencil and sheet of paper to keep track of evolving drug problems. He is developing a tracking system, apparently its first organized one, which is now being tested; it is expected to become operational sometime in 2006. CDER director Steven K. Galson, MD, has said that the reorganization will remove the ODS from the OND, where it suffers from subservience. The name of the ODS will be changed, and it will be placed directly under his name on the organizational chart. However, this has not yet taken place. When that happens, it is not clear how Dr. Seligman will fit in. Will a new ODS director be appointed? Will Dr. Seligman assume that job? No one knows. The FDA's shortcomings will not be cured internally. It will take congressional direction, which has been in precious shor t supply. Senator Charles Grassley R-Iowa ; introduced an FDA drug safety review reform bill in April 2005 with great fanfare. It contained some good ideas, even though it wasn't particularly radical or far-reaching. But even that mild bit of legislative remedy has been stuck in the Capitol Hill medicine cabinet. There have been no hearings on that bill, and it has gone nowhere. The House Appropriations Committee did include an amendment in its FDA budget bill for fiscal 2007, passed in midMay 2006, which gives the agency the authority to require drug companies to complete postmarketing clinical trials. The GAO report points out that the FDA can do that now only in limited circumstances. But whether that amendment survives in the final FDA appropriations bill is anyone's guess. Neither that amendment nor the Grassley bill addresses postmarketing communications with pharmacists. The FDA's MedWatch system is supposed to update pharmacists with safety alerts and monthly safety labeling changes. Even CDER admits that the program needs to be strengthened. CDER has asked the White House Office of Management and Budget for permission to send a survey to users of MedWatch asking for suggestions on how to improve the communications process. The GAO recommended several other improvements it would like to see made at CDER. Those recommendations did not include promoting current staffers or creating new offices. Systemic changes are needed, and they have been needed for a long time. s.

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