Question:

Large amounts of crossposting. Reams of articles. Both signs of a control freak.

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> ->Large amounts of crossposting. > ->Reams of articles. > ->Both signs of a control freak. > Hey – should you be posting all the headers from this stated control > freak? They are x-no-archived!

       I only do that  a selected few posts meet       certain criteria

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> Poor Ralphy boy.. he still has not figured out who owns this NG

yoo doo. – Hide quoted text — Show quoted text ->->Large amounts of crossposting. >->Reams of articles. >->Both signs of a control freak. >Hey – should you be posting all the headers from this stated control >freak? They are x-no-archived! > — > Psychiatry is to Science > as Astrology is to Astronomy

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Volume 1, Number 1 — Summer 1996 INTERNATIONAL JOURNAL OF PSYCHOPATHOLOGY, PSYCHOPHARMACOLOGY AND PSYCHOTHERAPY ISSN: 1088-6710 Hanky-Panky in the Pharmaceutical Industry. Seymour Fisher, Ph.D. Center for Medication Monitoring Department of Psychiatry & Behavioral Sciences University of Texas Medical Branch Galveston TX 77555-0441 ABSTRACT This paper reprints three essays that were originally distributed on the Internet, to the Psychopharmacology Forum of InterPsych, in the latter half of 1995. Part I is a factually based account of how a pharmaceutical company unethically intervened in the publication of a scientific article reporting clinical results inimical to that company’s interests. A follow-up Part II offered additional documentation of drug companies’ influence on academic research, and further raised questions as to the industry’s pervasive influence on the training of young physicians. Part III revealed some of my thinking behind the hope that the public can be aroused to bring moral pressure on the pharmaceutical industry. Cite as: Fisher S Hanky-Panky in the Pharmaceutical Industry. Int J Psychopath Psychopharmacol Psychother 1996, 1 (1). URL http://www.psycom.net/ijppp.v1n1.html PART I (First posted on the Internet in late July 1995) Does the pharmaceutical industry want clinicians and patients to learn more about possible side effects of newly marketed drugs? I think the time has come to make public just one egregious example of how individual drug companies can influence the publication of clinical research results that are not in their best financial interests. (I also have documented instances of how insidiously the pharmaceutical industry can influence publication of other manuscripts and even NIH support of research projects dealing with adverse drug reactions of newly marketed drugs. But that’s another story for, perhaps, another time.) First, however, for those who do not know me, I’d like to point out that I have nothing to gain personally by going public with this issue. I’m just about 70 years of age, and my academic credentials and career don’t need any embellishing (a brief resume can be found in "Who’s Who in America"). Next, I urge you to read the article on "Postmarketing Surveillance by Patient Self-Monitoring: Preliminary Data for Sertraline versus Fluoxetine" in the July, 1995 issue of the Journal of Clinical Psychiatry (1995;56:288-296). This paper is based on large-scale data indicating that many adverse reactions known to be induced by fluoxetine (Prozac) were being reported with even greater frequency by sertraline (Zoloft) patients; the tables also include suggestions to the clinician for age and gender patient types most at risk. Zoloft is manufactured by Pfizer Incorporated (Roerig Division). The manuscript was accepted for publication on May 12, 1994. On December 8, 1994 the Editor wrote me to say that he had become "concerned that our largely clinician readership might interpret the results more literally than our investigator colleagues. This apprehension led me to draft the accompanying commentary, which I would like to publish along with your article." Although none of the journal’s three reviewers who had originally recommended publication voiced this apprehension, the Editor’s proposed commentary was entitled "What will this drug do to me, doctor?", and tacitly implied that our results and conclusions might be spurious. I replied to this letter on December 20, showing that most of the substantive criticisms he raised in his proposed commentary were simply not valid, suggesting instead that the research results along with the article’s carefully qualified discussion of the results should be able to speak for themselves. Letter from the Editor dated December 30: "I have revised and (I hope you will agree) ’softened’ some of my comments. I hope you will be more comfortable with the current draft." His revised commentary included sentences such as "It would be simplistic and premature, however, to treat this report as gospel and conclude that in reality sertraline produces a higher frequency of unwanted reactions than does fluoxetine." And the final paragraph was to be: "The report by Fisher et al. is thought- provoking and can frame hypotheses for additional testing. The actual incidence of side effects of these two SSRIs will become clearer with time and additional study." (Similar caveats were actually included in the discussion section of the article, but without the pejorative flavor of the proposed Editorial.) By February of 1995, when we had not yet received page proof nine months after acceptance of the article, I phoned the editorial office for information. I was told it was scheduled for the May issue. However, in April when we had still not received either page or galley proof, and when a follow-up phone call elicited the information that the publication date was now postponed until July, I undertook a quickie "research project." This led to a letter I wrote to the Editor on May 1, in which I expressed the view that publication of his proposed Commentary would be grossly unfair unless I was also given the opportunity to respond to the Editorial. What follows was my proposed rebuttal: COMMENTARY ON "What will this drug do to me, doctor?" In this issue, an article by Fisher (Fisher S, Kent TA, and Bryant SG, 1995) presents data from more than 2,700 fluoxetine and sertraline patients using a well-validated postmarketing surveillance method developed to signal possible adverse drug reactions (ADRs). The preliminary results indicated that many adverse reactions known to be induced by fluoxetine were being reported with substantially greater frequency by sertraline patients. The article is accompanied by an Editorial Commentary (Gelenberg AJ, 1995), admonishing readers not to "conclude that in reality sertraline produces a higher frequency of unwanted reactions than does fluoxetine." Certainly this could be a premature conclusion to draw. But a legitimate question can be raised as to why this particular paper is being singled out when the implied "conclusions" in more than 90% of the papers published in this Journal and in other psychiatric journals are also generally subject to alternative interpretations, not all of which may be equally plausible. The Editor notes that a bias could have been introduced because we relied "on a comparatively small percentage of volunteers [almost 20%] out of an approached population." But all postmarketing surveillance studies use only a minute sample of the total population of interest (Baum C and Anello C, 1989). The more salient question is whether there is reason based on empirical evidence to believe that the final selected samples favor one drug group over the other. If selection causes a bias in our method, we should not have been able to detect in our validation studies so many of the commonly accepted ADRs for various drugs (Fisher S, 1995; Fisher S, Bryant SG and Kent TA, 1993). However, it is always possible in any postmarketing surveillance method that volunteer subjects (including physicians who are urged to report possible ADRs to the FDA) or even medical record samples could introduce a bias. Similarly, although the Editor questions "whether this technique is well suited for comparing incidences of adverse events between a newer and an older agent," he also acknowledges that results from our past studies along with the statistical controls used in the data analyses suggest that what we were seeing in this sertraline study is not simply a "newer drug" phenomenon. So, again, why the red-flag editorial? A review of 119 articles published in this Journal from July 1993 through April 1995 (excluding supplements, monographs, and the October 1994 issue, which was unavailable) offers some clues. The mean article length was slightly less than six pages (skewed upward by a few longer papers); the mean publication lag, defined as the number of months between the date of acceptance and the published issue date, was eight months — for which most authors are grateful to the Editor. Only two of the 119 articles were not published until 11 months after acceptance, and none had a lag of one year or more. There was no relationship between the length of an article and the publication lag. While some issues of the Journal included a "commentary" on a specific paper, none of them were signed by the Editor. In fact, a cursory search through issues dating back to 1990 found only one previous Editorial, which also focused on adverse drug reactions (Gelenberg AJ, 1992). Yet, our sertraline paper not only prompted an Editorial, but publication was delayed more than a year after it was formally accepted on May 12, 1994. During the past four years of the 10-year development of our postmarketing method [continuously supported by the National Institute of Mental Health along with other nonpharmaceutical funding sources], we have became acutely aware of the fact that, once a new drug has been marketed, many pharmaceutical companies clearly do not want their drugs to be carefully monitored for possible ADRs — in particular, not by any method that can systematically and sensitively compare possible ADR profiles. The Editor of this Journal is to be commended for having the courage to publish our sertraline/fluoxetine paper, but one cannot help wonder to what degree external pressures may have contributed to both the publication delay and the need for a cautionary Editorial. Presently, the ultimate clinical preference for one psychopharmacological agent over another is mainly determined not so much by true differences in therapeutic efficacy (most antidepressants in most situations are about equally effective) but by presumed … read more »

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