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Can animal studies substitute for human studies in approving drugs destined for human use? Read the sound science evidence in our January 2004 issue. |
| Reference Manual On Scientific Evidence | |
| 10 Myths About Expert Witnesses | |
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Read the groundbreaking research on the possible link between sildenafil citrate and aggressive behavior. Write to us about your own experiences with sildenafil and contribute to this important ongoing research. Neurological, Psychological, and Aggressive Disturbances with Sildenafil by Harry A. Milman and Suzanne B. Arnold. Ann Pharmacother. 2002 Jul-Aug;36(7-8):1129-34. BACKGROUND: Anecdotal reports and case studies have described psychological disturbances and aggressive behavior in some men taking sildenafil. In the course of assisting the defense in a trial in which a man was alleged to have committed rape and in which sildenafil was implicated, a mechanistic hypothesis was formulated by the first author for central nervous system (CNS) adverse effects associated with the use of sildenafil. OBJECTIVE: To examine whether there was any scientific information available to suggest a possible mechanism for or an association between exposure to sildenafil and aggressive behavior. METHODS: The scientific literature on sildenafil, nitric oxide (NO), and the NO-cyclic-guanosine monophosphate (cyclic-GMP) signaling pathway was reviewed. Adverse event reports that referenced sildenafil and were filed with the Food and Drug Administration Adverse Event Reporting System between January 4, 1998, and February 21, 2001, also were examined. RESULTS: Published studies reported that sildenafil crosses the blood-brain barrier, that it exerts various biochemical and physiologic effects in the brain, and that it affects information processing. Other published reports indicated that phosphodiesterase type 5 (PDE-5), NO synthase, and guanylyl cyclase are present at highest activities in areas of the brain responsible for behavior, sexual drive, and emotion, and that NO modulates aggression and sexual behavior in male mice. In addition, 274 adverse event reports designated sildenafil as the primary suspect of various neurologic disturbances, amnesia, and aggressive behavior. DISCUSSION: Evidence has been presented for an association between sildenafil and various CNS adverse effects, including aggressive behavior. Whether sildenafil causes these effects by inhibiting PDE-5 in the brain, accumulating cyclic-GMP, decreasing NO, and affecting cell-cell signaling and modulation of aggressive behavior requires further investigation. CONCLUSIONS: It is recommended that, before prescribing sildenafil for erectile dysfunction, clinicians should caution their patients and their partners on the possibility of neurologic, emotional, or psychological disturbances; amnesia or loss of consciousness; or aggressive behavior.
Reference Manual on Scientific Evidence The Federal Judicial Center in Washington, D.C. has published the revised, second edition of its Reference Manual on Scientific Evidence. The Manual, as Fern Smith, Director of the Center, notes in the preface to this new edition, assists "federal judges in recognizing the characteristics and reasoning of ‘science’ as it is relevant in litigation." This is not merely a re-printing of the 1994 Manual; several new chapters have been added. In a concise and very readable Introduction, U.S. Supreme Court Justice Stephen Breyer reviews the increasingly important role scientific evidence plays in litigation and the corresponding challenges trial courts must meet if science is to "find a warm welcome . . . in our courtrooms." The first edition of the Manual was published in 1994 largely as a result of the landmark 1993 Supreme Court case on expert testimony, Daubert v Merrell Dow Pharmaceuticals; in a new chapter by Margaret Berger, law professor at the Brooklyn Law School, "The Supreme Court’s Trilogy on the Admissibility of Expert Testimony," she helpfully summarizes Daubert as well as two subsequent cases, 1997's General Electric Co. v Joiner and 1999's Kumho Tire Co. v Carmichael. A likewise welcome addition to this revised Manual is "How Science Works" by David Goodstein, a professor of physics at the California Institute of Technology, who discusses the philosophy and practice of Science. New reference guides on medical testimony and engineering are also included, which should assist judges in their review for cases involving nonscientific expert testimony. One of the more requested portions of the first edition--the Reference Guides--remain but have been updated with new cases and additional material. The Reference Guide on DNA Evidence, however, has been completely revised to take account of the rapid changes that the last six years have seen in this field. To make room for these changes and additions, some of the material in the first edition on court-appointed experts has been condensed and rearranged into a new chapter, "Management of Expert Evidence," written by William W. Schwarzer, U.S. District Judge for the Northern District of California, and Joe Cecil, director of the Judicial Center’s Scientific Evidence Project. The Reference Manual on Scientific Evidence is a welcome resource for a firm grounding in the complexities of science in the courtroom. An electronic version of the Manual may be downloaded off the Internet by pointing your browser to: |
MTI REVIEW INDEX Hypoglycemia: Driving Under the Influence Read how low blood sugar can lead to an unjustified DUI --with sound science in easy to understand language and actual case reports Psychological Autopsies: Can the Dead Testify? Scientific Misconduct: Science and Lies Without the Video Tape Carcinogens: Living With Cancer Causing Agents DUI and .08 BAC: It's in the Blood? Of Mice, Men and Genomics: New Technologies and Toxic Testing Sick Building Syndrome: A House on Haunted Hill? Cosmeceuticals:..The Make-up of an Uncertain Future? The NAAQS Particulates: Running on Toxic Fumes? Toxic Rx: Prescription for Error? Water Toxins: ... Pfiesteria Hysteria Toxic R&R: Relevance and Reliability... Endocrine Disruptors: To Be or Not To Be
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SBS--House on Haunted Hill II October 2003
It is that time of year when the air gets a bit of a chill and our thoughts begin turning to the cozy comfort of indoors. However, sometimes the comfort we hope to receive turns into medically unexplained symptoms of Sick Building Syndrome that can indeed haunt us forever. In October of 1999 you may recall our article entitled Sick Building Syndrome: House on Haunted Hill or Chicken Little Goes to Washington in which we covered some of the basics of this haunting syndrome. Since 1999 we believe much has happened in this area to warrant an update for our readers.
Sick Building Syndrome (SBS) is one of many syndromes that are defined largely on the basis of unexplained symptoms rather than specific medical signs. In fact, scientists are still trying to sort out and categorize the various syndromes such as SBS, chronic fatigue syndrome, multiple chemical sensitivity (MCS), Gulf War Syndrome, and the like. Some of these conditions overlap with explained conditions such as asthma, which often leads to sharp debate over the relationship of such symptoms and syndromes to environmental exposures. And yet in some areas such as toxic molds some progress has been made in linking the symptoms to the syndrome. For example, last year HR 5040 The United States Toxic Mold Safety and Protection Act (now HR 1268) was introduced in Congress, which may become law at some future date.
Of course, it is not only scientists that have difficulty identifying some of these syndromes; it is often even more difficult for attorneys to know if they have a real case of SBS. At MTI this is one of our specialty areas and by using sound science we can help our clients identify a legitimate case of SBS. Additionally, in our research occasionally we run across an article that goes beyond the medical jargon that we believe can be especially helpful to our attorney readers. One such article, Identifying and managing adverse environmental health effects: Taking an exposure history describes the issues involved in terms of the needs of physicians who are treating patients who complain of a myriad of symptoms and uses an example of an actual SBS case. This timely and informative article is available free online at http://www.cmaj.ca/cgi/content/full/166/8/1049.
After rereading our newsletter and this very helpful article we hope you will
think of MTI for your next case involving SBS or any of the chemically -related
syndromes. Our professional staff, made up of researchers, doctors, and scientists,
is the absolute best and we have many years of experience in providing sound
science to our attorney clients, regardless of which side of the toxic tort
spectrum their case falls.
Contact us. We would like to hear from you!
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