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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (4292)	4/17/2003 10:17:16 AM
From: Harold Engstrom	Read Replies (1) \| Respond to of 10345

The authors are right: there is a reason that MS trials take so long. 6 months and two doses will not show any clinical benefit other than MRI improvements. We will just have to wait for outcome of long-term studies. IMO, the letter to the editor lacks rigor.

To: Icebrg who wrote (4292)	4/17/2003 10:18:21 AM
From: Qualified Opinion	Read Replies (1) \| Respond to of 10345

Per Biogen's CC, Biogen is in discussions with the FDA about the possibility of filing an NDA for Antegren for MS during the beginning of 2004 and for Crohn's at the end of this year or the beginning of 2004.

To: Icebrg who wrote (4292)	4/17/2003 3:02:15 PM
From: Icebrg	Read Replies (1) \| Respond to of 10345

Natalizumab for Active Crohn’s Disease There was also an Antegren/Crohn's Disease letter in the current issue of NEJM. In this case the conclusion was actually positive for Antegren (if anything). Credit for this one goes to myself. to the editor: In the study by Ghosh et al. (Jan. 2 issue),1 a regimen of two infusions of natalizumab at a dose of 6 mg per kilogram of body weight was associated with higher remission rates than was placebo at several intervals, except at week 6 (the primary end point). The failure to demonstrate a difference may be due in part to chance and to the use of a small study sample. Randomization is supposed to ensure equal distribution of base-line characteristics that may confound a clinical trial. However, in this study, the randomization process assigned 63 patients to placebo and only 51 patients to two infusions of 6 mg of natalizumab per kilogram (a 19 percent difference). The authors attribute their failure to detect significant differences at week 6 to the unusually high remission rate in the placebo group. However, concomitant therapy with azathioprine or mercaptopurine was being given to a larger percentage of patients in the placebo group (35 percent) than in the group assigned to two infusions of 6 mg of natalizumab per kilogram (18 percent) (P=0.04). It appears that the shortcomings of randomization may have contributed to the reported null findings with regard to the primary study end point in this trial. Edward A. Lew, M.D., M.P.H. Elena Martinez Stoffel, M.D. Brigham and Women’s Hospital Boston, MA 02115 edward_lew@hms.harvard.edu 1. Ghosh S, Goldin E, Gordon FH, et al. Natalizumab for active Crohn’s disease. N Engl J Med 2003;348:24-32. the authors reply: We thank Drs. Lew and Stoffel for their discussion of base-line imbalances between the placebo group and the group receiving two infusions of 6 mg of natalizumab per kilogram and for their discussion of the potential effect of such imbalances on the analysis of the primary end point. Subrata Ghosh, M.D. Imperial College of Medicine London W1Z 0NN, United Kingdom s.ghosh@ic.ac.uk Tanya Palmer, B.Sc. Elan Pharmaceuticals Stevenage SG1 2FU, United Kingdom

To: Icebrg who wrote (4292)	4/22/2003 3:59:27 PM
From: Qualified Opinion	Read Replies (1) \| Respond to of 10345

Full article on Professor Peter Behan with link: Judge criticises expert witness for misrepresenting research findings Clare Dyer legal correspondent, BMJ A UK judge has strongly criticised an expert witness in a personal injury case, accusing him of misusing the works of others, misrepresenting his critics, and abandoning any claim to objectivity. Judge John Griffith Williams, recorder of Cardiff, sitting as a High Court judge, said that Peter Behan, emeritus professor of neurology at Glasgow University, "demonstrated a capacity to use his interpretation of the evidence to suit his purposes which conflicts with his duty to the court as an expert witness." Professor Behan was representing Christine Perry, a former post office worker who alleged that she developed multiple sclerosis as a result of falling over a mailbag at work. Ms Perry’s case is the latest in a run of cases brought by claimants who blame trauma for triggering multiple sclerosis. Whether it can do so in the case of susceptible individuals has long been a subject of medical controversy, but the current majority view is that trauma plays no part. Judge Griffith Williams accepted the evidence of the Post Office’s expert, Alastair Compston, professor of neurology at Cambridge University, that the injury experienced by Ms Perry was a chance coincidence unrelated to her multiple sclerosis. In his judgment, the judge said Professor Behan was "guilty of overstating his case, but of greater significance is my conclusion that he has put a gloss on the facts of this case to bring them within the criteria which he contends must be met." In Professor Behan’s report to the court, said the judge, he had misrepresented the conclusions of three papers on the relation between trauma and multiple sclerosis. In one study that said a particular mechanism was "possible," he had changed the word to "probable." He had described the only prospective study ever done as "atrocious," called the work of those who disagreed with him "rubbish" and "verbiage," and branded as "bunkum" Professor Compston’s view that multiple sclerosis is an autoimmune disease. The judge said that Professor Behan’s own study of 39 cases, in which he said that multiple sclerosis was precipitated or exacerbated by trauma to the cervical cord, had been turned down for publication by medical journals. The patients were not a random sample because they had all been referred for medicolegal reports. Judge Griffith Williams is not the first judge to criticise Professor Behan. Mr Justice Garland, who presided over a case in 2000 in which a driver, Robert Nixon, alleged he developed multiple sclerosis as a result of an accident in which a standard lamp fell on his car, detailed comments from several judges in a section headed: "Judicial views on Professor Behan as an expert witness." In 1997, Professor Behan appeared for a farm worker, John Hill, who successfully claimed he had developed chronic fatigue syndrome from exposure to organophosphates. The judge, Mrs Justice Smith, said of Professor Behan’s evidence: "Had [he] expressed himself with greater moderation and objectivity and had he not sought to misrepresent the effects of his research, my task would have been a great deal simpler." Mr Justice Garland said in his Nixon judgment that in the Hill case there was a lengthy argument over costs, "the outcome of which was that Professor Behan should not be remunerated for appearing as an expert witness." ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER. link:http://www.vaccinationnews.com/DailyNews/March2002/JudgeCriticizesExpert.htm