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Gentium S.p.A. "Gentium" or "the Company" ; is a biopharmaceutical company focused on the research, discovery, development, and manufacturing of drugs to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Gentium's founding company received approval in 1986 to sell a drug called Defibrotide in Italy to treat deep vein thrombosis DVT the indication was changed in 1993 to both treat and prevent vascular disease with risk of thrombosis. Currently, Gentium is developing Defibrotide for a variety of uses, including to treat and prevent hepatic veno-occlusive disease VOD ; , a condition in which some of the veins in the liver are blocked as a result of toxic cancer treatments, such as chemotherapy. A severe form of VOD with multi-organ failure MOF ; is a potentially devastating complication with a survival rate after 100 days of only approximately 20%. There is no drug approved by the U.S. FDA or European regulators to treat or prevent VOD; thus Defibrotide could become an important product should it receive approval and reach the market. Due to the historically low survival rate and lack of treatments for this condition, there is an immediate need for a drug to treat VOD with MOF. Gentium's application for FDA Fast Track designation for Defibrotide to treat VOD with MOF occurring after stem cell transplantation SCT ; by means of injection was approved in May 2005. The Fast Track designation program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Reasons for Gentium being granted Fast Track are summarized in Table 6. At this point, the approval process for Defibrotide for this use remains dependent upon the successful completion of clinical trials.
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Resistance after 120 minutes of myocardial ischemia measured by the flowmeter and the degree of reduction in regional myocardial reflow to the ischemic area measured by the microspheres. That is, the increase in resistance was greater than one might have predicted based on the reduction in reflow to the ischemic area. However, despite this discrepancy, both the flowmeter and the microsphere measurements demonstrated that Isordil did not prevent the reduced reflow phenomenon. Whether another coronary vasodilator such as nitroglycerin or an even larger dose of Isordil might possess the ability to prevent the reduction in the reflow phenomenon and the increase in left anterior descending coronary artery vascular resistance in the heart is presently uncertain. The potential application of this information to clinical settings is currently unknown. The data obtained in this study do identify an increase in left anterior descending coronary artery vascular resistance and a significant reduction in reflow to the subendocardial portion of the ischemic region of the left ventricle after 120 minutes of myocardial ischemia. The increase in coronary artery vascular resistance can be prevented and the reduction in reflow to the subendocardial portion of the ischemic region can be modified by hypertonic mannitol. Whether this same reperfusion abnormality occurs in patients with ischemic heart disease, and, if it does, whether it can be modified by pharmacological or physiological intervention s ; is uncertain, but this subject is one that deserves investigation in the future. References.
P H I Single-chamber right ventricular pacing may be producing many new cases of heart failure by causing ventricular dyssynchrony. New evidence for this hypothesis came from a study with more than 23, 000 paced patients and controls, showing that patients with pacemakers were 44% more likely to have heart failure HF ; death or hospitalization than matched patients without pacemakers, Ronald Freudenberger, M.D., reported at the annual meeting of the International Society for Heart and Lung Transplantation. "This is the first population-based study to show that right ventricular pacing in patients without heart failure is bad, " said Dr. Freudenberger, director of the heart failure and transplant cardiology program at Robert Wood Johnson Medical School in New Brunswick, N.J. Indications of a link between single-chamber pacing and HF have also been seen in the results from several recent intervention studies. "The way we've practiced cardiac pacing for the last 3 decades must be abandoned, " said Michael O. Sweeney, M.D., director of cardiac pacing and implantabledevice therapies at Brigham and Women's Hospital in Boston. Although Dr. Freudenberger stressed that his findings do not prove that singlechamber pacing causes HF, the results are suggestive enough that physicians should immediately minimize their use of singlechamber right ventricular pacing as much as possible. One way is to set pacing rates so that patients are paced only when their heart rates make pacing necessary, he told this newspaper. It's also possible that right-atrial pacing may avoid producing the dyssynchrony and QRS-interval widening that is probably causing HF in patients who have right ventricular pacing. But superior safety of right-atrial pacing must still be proven in prospective studies. One such study, led by Dr. Sweeney, is testing "the first new mode of cardiac pacing in 35 years, " using a device that provides "managed ventricular pacing." This device can produce either dual- or singlechamber pacing, depending on conduction activity. When normal conduction is present, it automatically switches to pacing the right atrium only, minimizing right ventricular pacing. This study, being done at about 100 centers in the United States, Canada, and Europe, is on track to finish enrollment this year and produce results in 2007, Dr. Sweeney told this newspaper. The case-control study involved more than 3 million patients discharged alive from 85 acute-care hospitals in New Jersey during 1997-1999. Records for these patients were in the Myocardial Infarction Data Acquisition System. In this database were 11, 426 patients who had received pacemakers for the first time and had no record of HF either at the time of pacemaker implantation or in the prior year. A group of 11, 656 control patients without pacemakers or HF were selected from the same database. The controls were matched with the pacemaker and ocuflox.
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A test is not a psychological X-ray, nor does it necessarily reveal hidden conflicts and forbidden wishes. Psychological tests must meet three criteria: 1 ; Reliability, 2 ; Standardization, and 3 ; Validity. Tests are used by a variety of professionals, including psychologists, special-education teachers, guidance counselors, psychiatrists, speech therapists, nurses and engineers. Psychophysical tests should require evaluation of the subject's appearance and condition, ability to follow instructions, as well as balance and coordination. These types of tests are called Divided Attention Tests, for they require the subject to concentrate on more than one thing at a time, dividing the subject's attention between mental and physical tasks. Studies have shown that a person who is under the influence of an alcoholic beverage may be able to perform one of these tasks but rarely both. If under the influence of an alcoholic beverage, people are likely to make certain predictable errors while attempting these tasks. Since the mid 1970's, the National Highway Traffic Safety Administration NHTSA ; , with the cooperation and assistance of the law enforcement community, has conducted research that resulted in the development of a battery of three standardized field sobriety tests: Horizontal Gaze Nystagmus, Walk and Turn and the One Leg Stand to assist police officers in detecting impaired drivers. The program, which was previously termed the Improved Sobriety Testing, was validated in laboratory and field studies conducted by the Southern California Research Institute. These tests were initially developed by the Los Angeles Police Department and the methodology of conducting these tests is included in the NHTSA course "DWI Detection and Standardized Field Sobriety Testing." In 1986, the Advisory Committee on Highway Safety of the International Association of Chiefs of Police IACP ; passed a resolution which recommended that law enforcement agencies adopt and implement the field sobriety testing program developed by NHTSA. As the program grew, it be Continued on page 11!
Figure 1. Twenty-four hour bladder diary types of intake. Excessive caffeine consumption, for example, can create or exacerbate overactive bladder symptoms, and drinking after dinnertime can lead to increased nocturia. The bladder diary also serves as a good reference to gauge the success of whatever treatment has been instituted as time passes. Patients, who are discouraged because they still leak after taking a medication for three months, may be reassured when it is noted that their number of incontinent episodes has been decreased from six to two per day. PHYSICAL EXAMINATION. When a patient is scheduled for an appointment she should be given or sent.
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