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Formed primarily by the bcl-2 protein family. As a regulator of cell survival, the bcl-2 family of proteins plays a pivotal role in the etiology and progression of cancer and in the development of acquired resistance to anticancer treatment. Bcl-2, expressed in hematological or solid-tumor types, is a key regulator of apoptosis by slowing or preventing cell death. A decrease in apoptosis promotes carcinogenesis. Antisense compounds are small, chemically modified, single strands of deoxyribonucleic acid DNA ; that are complementary to specific target messenger ribonucleic acid mRNA ; sequences. Protein is produced by the translation of genetic information from mRNA. Antisense RNA binding triggers degradation of the mRNA, which prevents production of the target protein i.e., bcl-2 ; . Bcl-2 overexpression blocks the release of cytochrome C, which activates caspases, reduces the efficacy of cancer therapy, and thereby promotes survival of cancer cells. Bcl-2 antisense profoundly decreases bcl-2 production in tumors and unblocks the pathway of programmed cell death triggered by cancer therapy.1 Inhibiting bcl-2 production may potentiate the pro-apoptotic effects of anticancer agents. Bcl2 antisense can target several molecular targets, including CD20 + sites on B cells involved in NHL. Clinical phase I studies showed that bcl-2 protein concentrations could be safely reduced in lymphoma cells in patients receiving antisense therapy. The next step was to add conventional anticancer therapy. Trials involving patients with follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia are expected to commence shortly. These studies will use antisense therapy for five days to reduce the bcl-2 protein in patients who will then receive anticancer therapy. For mantle cell lymphoma, the anticancer therapeutic agent might be rituximab, because lymphoma cells express high amounts of CD20 + antigen in addition to bcl-2 protein. pulmonary function. To date, 13 patients have been treated and many patients experienced a partial, durable remission of disease. Patients continue to be recruited, and a possible combination with other known drugs that have been used to treat lymphoma is under consideration.
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The lower compliance with DNR orders is probably associated with events occurring during invasive procedures. A written protocol for managing DNR orders and a formal procedure for receiving DNR status information, as they suggested, would clearly help minimize the problem. However, radiologists should also make every effort to communicate with patients or the next of kin ; about the possible complications of invasive procedures. This communication should whenever possible ; go beyond the usual informed consent to involve discussion of different scenarios, including what the patient might consider an acceptable resuscitation measure. This should not replace the communication between the patient and his or her primary physician about code status; rather, it would complement that discussion and help clarify DNR orders related to an invasive procedure. It could also help establish a closer relationship among the radiologist, the patient, and his or her family and assist the radiologist, when an emergency arises, to provide the level of care that is in accordance with the patient's wishes. No note on the chart can describe and clarify the patient's wishes for resuscitation better than can the patient. Eleftherios Mylonakis, MD The Miriam Hospital Providence, RI 02906.
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Statement of Need Cardiovascular disease CVD ; affects more than 70 million Americans annually, with cardiovascular CV ; events, such as myocardial infarction, accounting for approximately 40% of all US mortality. Although CVD is the leading cause of death in the United States, with a total economic burden of more than $400 billion per year, hypertension alone is the most common risk factor for CVD and the most frequent basis for a visit to a primary care provider. In addition to hypertension, common risk factors for CV events eg, dyslipidemia, diabetes, physical inactivity, and smoking ; are consistent among all age groups and ethnicities. However, patients at highest risk for CV events often have multiple risk factors, including diabetes, atherosclerosis, and previous CV events. Clinical studies have demonstrated the efficacy of numerous antihypertensive drug classes, including diuretics, beta blockers, calcium channel blockers, angiotensin-converting enzyme ACE ; inhibitors, and angiotensin II receptor blockers ARBs ; , in blood pressure control and CV prevention. However, despite the burden of CVD and the effectiveness of antihypertensive therapy, studies have found that 65% of.
In respect of the appointments during 2003 excluding that of 10 October ; and in February 2004, Dr B stated: "I do not recall [Ms A] mentioning abdominal pain . and I would have examined her abdomen if she had done." On 11 March 2004, Ms A visited Dr B. She stated: "Same pain. Same complaints. But now unbearable. [Dr B] finally examines me for the first time since Nov 2002. He said he could do nothing about my pain other than pills and waiting lists. I begged him for help. I was crying in agony. Everything hurt." Dr B recorded: "Some pain upper abdomen recently." Following a physical examination of Ms A, he queried the possibility of a mass on the left side of her abdomen and arranged an urgent scan, sending the referral on the same day. Paradex was prescribed for pain. Dr B recalled: "11 March 2004 . [Ms A] complained of upper abdominal pain, more on the right side and some back pain. She had been taking more Ranitidine than usual. Her abdomen looked distended and there was a suggestion of a mass on the left side. A urine sample was tested and was normal. I thought that she had a lower abdominal mass and sent an urgent requisition for an abdominal ultrasound to [the first public hospital], which was sent that day. Later that week, she was seen at an After Hours Clinic and admitted to [the first public hospital]." 13 March 2004 Ms A presented to the Emergency Department at the first public hospital, where she was admitted. After transfer to the second public hospital on 16 March 2004, she had a laparotomy, 4 a left salpingo-oophorectomy, 5 and removal of a 14.7kg ovarian cyst. In response to my provisional opinion, Ms A stated: "I would like to express that I do agree ovarian cysts are difficult to diagnose in [their] early stages, however with all the symptoms, unable to lay on stomach, increased heartburn, large stomach, wiggly feeling in stomach, Mltilium not helping, inability to eat a meal, constant toilet, frequent bowel movements, back pain, severe stomach pain perforation of stomach ; , side pain, months of stomach pressure, difficulty to breathe, skinny limbs along with talking about diets, juicing vegetables and exercise which were not working, I know this cyst should not [have] gone past Oct 2003. I only visited [Dr B] approx two three times a year for the last 10 years, until the cyst appeared then visiting 8 times within the next 17 months and
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Anxiously to get their hands on proven, safe, and effective drugs, the fear is that this digestive disease will be lost again in the current cacophony between congress, the FDA, the drug industry, and litigations. When one mentions irritable bowel syndrome, it is quickly eut wt w m e'hah e h t issues. Or, if the discussion turns to heartburn with motility-like symptoms of bloating, nausea, abdominal discomfort, and fullness after a few bites of food, then all are familiar with these digestive problems. These commonly occurring motor problems of the digestive tract, irritable bowel syndrome, and dyspepsia, are in the same family of neurological dysfunctions of the digestive system. While these neurological dysfunctions of the gut don'j tn t r they can also tu ed h progress to digestive failure. For the upper digestive system, the plight of this group of mainly young women have been invisible and been left out of the loop for serious research and development for new drugs. Three million Americans suffer from gastroparesis. But the story gets worse. One hand is all it takes to count the medical treatments available for treating gastroparesis. Called prokinetic or pro-motility drugs, these medications enhance the emptying power of the stomach and help to relieve symptoms. All of the current medications used to treat this debilitating digestive disease have been borrowed from other medical uses. One drug that was being developed by Janssen Pharmaceutical, and which this patient ppli cu cli "w "was domperidone or Motilium. This medication had ou t n received full approval by the FDA, only to be overturned. No doubt the blow-up of another blockbuster drug, cisapride or Propulsid, may have had something to do with the ` eleventh hour' FDA denial of domperidone. Domperidone, for those who respond to this medication, allows patients with gastroparesis to be able once again to eat and sleep because symptoms are effectively subdued. Without do pr oeptn s y p nausea, vomiting and abdominal m e dn, aet sm t s pain m y sa nei "n r " hlsi ling weight loss. a ecleoh o t f ntt n o a This form of nutrition relies upon a tube placed from the outside of the abdomen, entering into the small intestine for liquid feedings. Domperidone is approved worldwide and has been in use for patients with gastroparesis for over 20 years. It is safe and effective, but did not make the cut with the FDA. What does that leave? American patients have to rely upon three older drugs for the treatment of their gastroparesis, and the safety record of these drugs does not stack up to that of domperidone.
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Except for small quantities of controlled substances for acute injuries, dental work, etc., only the designated Sole Provider or Alternate will prescribe, countersign, or telephonically authorize a controlled substance prescriptions for a patient in the program. 2 ; Providers must notify the Sole Provider or Alternate if a patient assigned to the Sole Provider Program attempts to obtain a controlled substance. Either a telephone call or an electronic mail message to the Chief, Department of Pharmacy is the suggested method of notification. The Chief, Department of Pharmacy will forward all notifications to the SPS for review. 3 ; On at least a quarterly basis, a member from the SPS will query all Sole Providers regarding their patients' progress, the appropriateness of their controlled substance usage, as well as their other pharmaceutical care needs. 4 ; The Sole Provider will attempt to arrange for a similar continuum of care when the patient relocates to another geographical area. The Sole Provider must inform the SPS of any pending moves so the DCCS can contact the gaining MTF's DCCS to coordinate the hand-off process. 5 ; The SPS will administer the Sole Provider Program and will report to the P&T Committee as required. g. RWBAHC's Pharmacy personnel will not dispense prescriptions for controlled substances to a Sole Provider patient unless they are written by, or approved by, their Sole Provider or by the designated Alternate. h. Disengagement and Appeals: 1 ; Disengagement, whether through problem resolution, noncompliance, PCS, or ETS, must be reviewed by the SPS. On a case-by-case basis, the SPS will determine if any follow-up action is needed. Recommendations, if any, will be referred to the P&T Committee for approval. 2 ; Sole Providers and Alternates will provide as much and
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The present report is based on data available in the Central Registry by October 25, 2006. At that time more than 750 reporting physicians from 39 countries had contributed cases to the Central Registry. Countries that had been active are listed in Table 1. Table 1 Countries that have contributed with pregnancies reported to the Central Registry of EURAP and
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N the Western world today, it is possible for a child with hemophilia receiving adequate treatment to live a near normal life. An accurate diagnosis is quickly established, the family is educated on the management, and the child is put either on prophylactic factor replacement or on-demand replacement given at home. With this type of treatment most children with hemophilia apart from the small number who develop inhibitors ; can go to school, enjoy sports, and expect to have minimal or no joint bleeding.1 This level of treatment is expensive. In Sweden, for example, it costs US$ 100, 000 per year to provide prophylactic factor replacement for one child with hemophilia. However, the cost of providing prophylaxis for all children with hemophilia in the country represents only 0.2% of the national health budget.2 This is not the case in most developing countries where the government does not have the resources to buy the necessary quantities of coagulation factors in the face of more urgent health priorities and hardly any patients can afford to pay for their own treatment even for on-demand home therapy. In this situation hemophilia is managed by using every available option that does not require expensive treatment products.
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Epithelial Caco-2 TC7 ; cell monolayers. Pharmaceutical Research 16, 625632. Artursson, P Ungell, A.L. & Lofroth, J.E. 1993 ; , Selective paracellular permeability in two models of intestinal absorption: cultured monolayers of human intestinal epithelial cells and rat intestinal segments. Pharmaceutical Research 10, 11231129. Artursson, P 1990 ; . Epithelial transport of drugs . in cell culture. I. A model for studying the passive diffusion of drugs over intestinal absorptive Caco-2 ; cells. Journal of Pharmaceutical Sciences 79, 476482. Rubas, W., Jezyk, N. & Grass, G.M. 1993 ; . Comparison of the permeability characteristics of a human colonic epithelial Caco-2 ; cell line to colon of rabbit, monkey, and dog intestine and human drug absorption. Pharmaceutical Research 10, 113118. Chadwick, V .S., Phillips, S.F. & Hofmann, A.F. 1977 ; . Measurements of intestinal permeability using low molecular weight polyethylene glycols PEG 400 ; . II. Application to normal and abnormal permeability states in man and animals. Gastroenterology 73, 247251. Conradi, R.A., Hilgers, A.R., Ho, N.F. & Burton, P 1991 ; . The influence of peptide structure on .S. transport across Caco-2 cells [see comments]. Pharmaceutical Research 8, 14531460. Conradi, R.A., Hilgers, A.R., Ho, N.F. & Burton, P 1992 ; . The influence of peptide structure on .S. transport across Caco-2 cells. II. Peptide bond modification which results in improved permeability. Pharmaceutical Research 9, 435439. Gres, M.C., Julian, B., Bourrie, M., Meunier, V ., Roques, C., Berger, M., Boulenc, X., Berger, Y. & Fabre, G. 1998 ; . Correlation between oral drug absorption in humans, and apparent drug permeability in TC-7 cells, a human epithelial intestinal cell line: comparison with the parental Caco-2 cell line. Pharmaceutical Research 15, 726733. Yamashita, S., Tanaka, Y., Endoh, Y, Taki, Y., Sakane, T., Nadai, T. & Sezaki, H. 1997 ; . Analysis of drug permeation across Caco-2 monolayer: implication for predicting in vivo drug absorption. Pharmaceutical Research 14, 486491. Lennernas, H., Nylander, S. & Ungell, A.L. 1997 ; . Jejunal permeability: a comparison between the Ussing chamber technique and the single-pass perfusion in humans. Pharmaceutical Research 14, 667671. Artursson, P & Magnusson, C. 1990 ; . Epithelial . transport of drugs in cell culture. II. Effect of extracellular calcium concentration on the paracellular transport of drugs of different lipophilicities across monolayers of intestinal epithelial Caco-2 ; cells. Journal of Pharmaceutical Sciences 79, 595600 and
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Next step was to develop strategic plans for each of these disease areas, based on questions such as: What is the ultimate medical need? What is out there in terms of external development opportunities? And what do we have in our pipeline? Once we had arrived at our ten disease areas, that made it easier for us to cut back projects that looked interesting but didn't fit into these areas.
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Establish a clear treatment framework e.g., a treatment contract ; with explicit agreements about the following: Goals of treatment sessions e.g., symptom reduction, personal growth, improvement in functioning ; When, where, and with what frequency sessions will be held A plan for crises Clarification of the clinician's after-hours availability Fees, billing, and payment.
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Review all medical record documentation, regardless of time period, to determine if the member was provided diabetes education. The audit tool contains seven topics specific to diabetes. If the record contains specific notation that the member was educated on one of these topics, check ; YES b ; Documentation can include referral to a diabetes management class, a nutritionist, or other external resource. If the record contains documentation of education in another topic than those indicated, check the "Other" category and indicate what was documented in the record.
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Abbreviations: MMP-2, matrix metalloproteinase-2; DMEM, Dulbecco's modified Eagle's medium; DLT, dilactitol tyramine; HBSS, Hanks' balanced salt solution. Correspondence: John E. Kaplan, Ph.D., Department of Physiology and Cell Biology A-134 ; , Albany Medical College, 47 New Scotland Avenue, Albany, NY 12208-3479. Current address of Stanley F. Penc: Developmental and Newborn Program, Childrens Hospital, Harvard Medical School, Boston, MA 02115. Received December 19, 1997; revised May 11, 1998; accepted May 12, 1998.
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