The Experts below are selected from a list of 1422 Experts worldwide ranked by ideXlab platform
Laura A Thoma - One of the best experts on this subject based on the ideXlab platform.
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weight variability of scored and unscored psychotropic drug tablets split by a uniquely designed tablet splitting device
Hospital Pharmacy, 2005Co-Authors: Robert J Nolly, Patrick Rodrigues, Laura A ThomaAbstract:Tablets of three psychotropic drugs were split using a uniquely designed tablet splitting device, the Tru-Cut Multi-Tablet Cutter, and evaluated for weight variation utilizing criteria based on the United States Pharmacopeia (USP) Uniformity of Dosage Units Content Uniformity Criteria. Whole tablets of Risperdal 2 mg and 4 mg, Paxil 20 mg and 40 mg, and Zoloft 100 mg were split by a device that positioned tablets in tablet specific disposable trays for splitting. Each half tablet weight was recorded utilizing a digital electronic balance. Weight variability was determined by comparing actual half tablet weight to theoretical half tablet weight and calculation of the relative standard deviation. Results showed half tablets of all drugs met the weight variation criteria resulting in uniform half tablet dosages as defined by the criteria.
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Weight Variability of Scored and Unscored Split Psychotropic Drug Tablets
Hospital Pharmacy, 2003Co-Authors: Sahar M. Rashed, Robert J Nolly, Lawrence Robinson, Laura A ThomaAbstract:The authors investigated the weight variation of split scored and unscored tablets of several dosages of three costly psychotropic drugs, using weight variation criteria based on the United States Pharmacopoeia 26 (USP) Content Uniformity of Dosage Units. Whole tablets of Paxil 20 and 40 mg, Risperdal 2 and 4 mg, and Zoloft 100 mg that had been split with a widely available device by pharmacy technicians in a managed care pharmacy were evaluated. Each half tablet weight was recorded using a digital electronic balance. Weight variability was determined by comparing actual half tablet weight to the theoretical half tablet weight and calculating the relative standard deviation. Results showed that weight variability occurred in half tablets of unscored tablets of Paxil 40 mg, Risperdal 2 and 4 mg, and scored tablets of Zoloft 100 mg. Half tablets of scored Paxil 20 mg tablets did not show weight variability, resulting in uniform half tablet dosages. The authors concluded that tablet splitting does not generally produce uniform and equal half tablet doses, and that split tablets should be evaluated using weight variation criteria before tablet splitting programs are initiated.
Mohamed H. Hamdan - One of the best experts on this subject based on the ideXlab platform.
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Serotonin Reuptake Inhibitor (Paxil) Does Not Prevent the Vasovagal Reaction Associated With Carotid Sinus Massage and/or Lower Body Negative Pressure in Healthy Volunteers
Circulation, 2002Co-Authors: Theodore S. Takata, Stephen L. Wasmund, Michael L. Smith, Jose A. Joglar, Kim Banks, Robert C. Kowal, Richard L. Page, Mohamed H. HamdanAbstract:Background— The purpose of this study was to assess the effect of the serotonin reuptake inhibitor paroxetine hydrochloride (Paxil, SmithKline Beecham) on cardiovascular reflexes. We hypothesized that Paxil prevents neurally mediated syncope (NMS) by attenuating the sympathoinhibition and vagotonia associated with a vasovagal reaction. Methods and Results— In a double-blind randomized study, 25 healthy subjects with a positive response to either carotid sinus massage (CSM) or lower body negative pressure (LBNP) received Paxil (20 mg/d) or placebo for 6 weeks. Arterial baroreflex sensitivity (BRS), muscle sympathetic nerve activity (SNA), baroreflex control of SNA, blood pressure, and heart rate responses to CSM and LBNP were measured at baseline and at 6 weeks. Nineteen subjects completed the study (Paxil, n=9; placebo, n=10). In the Paxil group, BRS decreased significantly compared with baseline (15.8±4.0 ms/mm Hg versus 11.0±2.6 ms/mm Hg, P=0.05); however, all 9 subjects continued to have a positive res...
Stan Kutcher - One of the best experts on this subject based on the ideXlab platform.
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Confusion, Concern, Self Interest and Science: The Recent SSRI and Youth Suicide Conflagration
Child and Adolescent Psychopharmacology News, 2005Co-Authors: Matthew R. Kutcher, Stan KutcherAbstract:In the late spring of 2003, a story of intrigue, corporate irresponsibility, suicide and profit greeted the public. On June 10, the British Broadcasting Corporation ran a headline story with the title, ‘Children Should Not Take Seroxat.’ The BBC story reported the details of a review of paroxetine (Paxil) in treating pediatric depression just completed by the United Kingdom’s Committee on the Safety of Medicine (CMS). The CMS review was initiated following the revelation that the manufacturer of Paxil, GlaxoSmithKline (GSK), had not released negative clinical trial data on the use of Paxil in child and adolescent depression. The CMS review had concluded that paroxetine caused a two–fold increase in suicidal thoughts and risk of self–harm behavior in patients under the age of 18. Proceeding from the initial CMS advisory a firestorm of controversy was initiated both within the medical community and the public. Here was a drug considered as a first–line treatment for depressed youth that was now said to increase the likelihood of self harm. The news story was made more compelling since the information that the drug may lead to increased harm and suicidal thoughts remained for a time concealed from physicians and the public alike by a big pharmaceutical company. The multinational controversy that was ignited by this advisory has served to focus global attention on issues related to drug and healthcare regulatory policy, and this debate, regardless of the merits of the CMS case has served to move ahead a number of positive reforms initiated through both legislative and voluntary measures, aimed at increasing the transparency and dissemination of all clinical–trial data.
Peter R. Breggin - One of the best experts on this subject based on the ideXlab platform.
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How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence
2016Co-Authors: Peter R. BregginAbstract:This is the second in a series of Special Reports on previously suppressed data con-cerning the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil(paroxetine) and its capacity to cause violence and suicide. The data were con-tained in a report that I wrote as a medical expert for a product liability suit against the manufacturer of Paxil, Lacuzong v. GlaxoSmithKline (GSK).1 After taking Paxil 10 mg for 3 days, Mr. Lacuzong drowned his two children and himself in a bathtub. The case was eventually ‘‘resolved’ ’ without the details of the settlement being made public. The drug company denied all allegations. My product liability report was based on numerous sources, most notably a 3-day trip to the drug company offices to examine its internal files concerning how Paxil was re-searched, developed, and marketed. Until these Special Reports, the information in these files had not been made public. Since the publication of my first special report concerning how the manufacturer of Paxil hid and manipulated data concerning Paxil-induced suicide (Breggin, 2006), the FDA and the drug company, GlaxoSmithKline, have issued statements confirming that depressed adults of all ages taking the antidepressant have an increased rate of suicidality compared to depressed adults taking placebo (Kraus, 2006). These adults with majo
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Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide
2016Co-Authors: Peter R. BregginAbstract:Shortly after the publication of my first special report in EHPP (Breggin, 2006a), the Food and Drug Administration (FDA) and the drug company GlaxoSmithKline (GSK) confirmed my basic conclusion that Paxil causes increased suicidality in adults (Kraus, May 2006). The GSK meta-analysis of all placebo-controlled clinical trials for Paxil dem-onstrated that adults of all ages with major depressive disorder suffered a 6.4 times increase in the rate of suicidal ideation and behavior compared to the controls receiving the sugar pill (0.32 % vs. 0.05%). In addition to increasing suicidality in depressed adults of all ages, Paxil also increased suicidality in young adults (ages 18–24) suffering from anxiety dis-orders. My product liability report demonstrated that the drug company had been hiding and manipulating the relevant data for many years prior to the recent publication of data showing that Paxil causes suicidality in adults. The product liability suit was brought by the wife of a man who drowned himself and their two children two days after beginning to take a daily 10-mg dose of the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil. Although GSK denied all al-legations, the suit was resolved to the satisfaction of the plaintiffs. My original produc
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SPECIAL REPORT Court Filing Makes Public My Previously Suppressed Analysis of Paxil’s Effects
2015Co-Authors: Peter R. BregginAbstract:In late 1999 I was asked by attorney Don Farber to be the medical expert in a productliability case brought by the family of Reynaldo Lacuzong against the drug companyGlaxo SmithKline (GSK) in California. Mr. Lacuzong was a machine operator with no prior history of serious mental illness, violence, or suicidality before he was prescribed a relatively small dose of 10 mg of Paxil (paroxetine). Almost immediately after starting the Prozac-like selective serotonin reuptake inhibitor (SSRI) antidepressant, he developed akathisia—an inner agitation accompanied by a compulsive hyperactivity—as well as other manic-like signs of irritability and anxiety. Antidepressant-induced akathisia is known to be associated with violence, suicide, psychosis, and an overall mental deterioration (Amer-ican Psychiatric Association, 2000, pp. 800–802). Depression with drug-induced agitation can produce similar results. On the third day of taking Paxil, Mr. Lacuzong drowned him-self and his two small children in a bathtub. As a medical expert, I was empowered by the court to examine hundreds of cartons of drug company files contained in GSK’s sealed record room. These files included Food and Drug Administration (FDA) correspondence and all of the company’s worldwide clinical trials and adverse drug reports for Paxil. On July 21, 2001, my report in the form of an affidavit was sent to the judicial arbitrato
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Drug Company Suppressed Data on Paroxetine-Induced Stimulation: Implications for Violence and Suicide
Ethical Human Psychology and Psychiatry, 2006Co-Authors: Peter R. BregginAbstract:This is the third special report in a series that has published observations and excerpts from my 1999 product liability report in the California case of Lacuzong v. GlaxoSmithKline, alleging that Paxil (paroxetine) caused a double murder and suicide. Shortly after the publication of my first special report in EHPP (Breggin, 2006a), the Food and Drug Administration (FDA) and the drug company GlaxoSmithKline (GSK) confirmed my basic conclusion that Paxil causes increased suicidality in adults (Kraus, May 2006). The GSK meta-analysis of all placebo-controlled clinical trials for Paxil demonstrated that adults of all ages with major depressive disorder suffered a 6.4 times increase in the rate of suicidal ideation and behavior compared to the controls receiving the sugar pill (0.32% vs. 0.05%). In addition to increasing suicidality in depressed adults of all ages, Paxil also increased suicidality in young adults (ages 18-24) suffering from anxiety disorders. My product liability report demonstrated that the drug company had been hiding and manipulating the relevant data for many years prior to the recent publication of data showing that Paxil causes suicidality in adults. The product liability suit was brought by the wife of a man who drowned himself and their two children two days after beginning to take a daily 10-mg dose of the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil. Although GSK denied all allegations, the suit was resolved to the satisfaction of the plaintiffs. My original product liability report was sealed as a part of the settlement, but subsequent events in another lawsuit against GSK in which I was also the plaintiff's expert enabled me to make it public (discussed in Breggin, 2006a). That case has recently been settled as well. My product liability report was based upon a 3-day trip to the offices of GSK in order to examine the company's complete library of documents relating to the development and marketing of Paxil. My initial report in EHPP focused on GSK's manipulation of data concerning Paxil-induced suicidality in adults (Breggin, 2006a). The second report in EHPP focused on how GSK hid data on drug-induced akathisia (Breggin, 2006b). Akathisia (psychomotor agitation) is very emotionally distressing and is known to cause suicide, violence, and an overall decline in the individual's mental condition (DSM-IV-TR, pp. 800-802). The current report focuses on the role of Paxil-induced central nervous system stimulation in causing violence and suicide and the manner in which GSK obscured or disguised the antidepressant's stimulating effects. Akathisia can be viewed as a form of central nervous system stimulation, and therefore this current report dovetails with the second report. In January 2005, the FDA compelled the manufacturers of antidepressants to include a great deal of new information about psychiatric adverse drug effects in their official labels. Closely paralleling observations I had been developing over more than a decade concerning the stimulating effects of these drugs (Breggin, 1991, 1997, 2001, 2003), the agency required the following observations to be placed on all antidepressant labels, including Paxil (Food and Drug Administration, January 26, 2005, p. 2): The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Note that the label change applies to both adults and children and to people given the medication for psychiatric or nonpsychiatric purposes. However, the drug company continued to maintain that there was no proof of Paxil causing suicide in adults until the recent publication of the results from the placebo-controlled clinical trials (Kraus, 2006). …
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How GlaxoSmithKline Suppressed Data on Paxil-Induced Akathisia: Implications for Suicidality and Violence
Ethical Human Psychology and Psychiatry, 2006Co-Authors: Peter R. BregginAbstract:This is the second in a series of Special Reports on previously suppressed data concerning the selective serotonin reuptake inhibitor (SSRI) antidepressant Paxil (paroxetine) and its capacity to cause violence and suicide. The data were contained in a report that I wrote as a medical expert for a product liability suit against the manufacturer of Paxil, Lacuzong v. GlaxoSmithKbne (GSK).1 After taking Paxil 10 mg for 3 days, Mr. Lacuzong drowned his two children and himself in a bathtub. The case was eventually "resolved" without the details of the settlement being made public. The drug company denied all allegations. My product liability report was based on numerous sources, most notably a 3-day trip to the drug company offices to examine its internal files concerning how Paxil was researched, developed, and marketed. Until these Special Reports, the information in these files had not been made public. Since the publication of my first special report concerning how the manufacturer of Paxil hid and manipulated data concerning Paxil-induced suicide (Breggin, 2006), the FDA and the drug company, GlaxoSmithKline, have issued statements confirming that depressed adults of all ages taking the antidepressant have an increased rate of suicidality compared to depressed adults taking placebo (Kraus, 2006). These adults with major depressive disorder suffered a 6.4 times increase in the rate of suicidal ideation and behavior compared to the controls receiving the sugar pill (0.32% vs. 0.05%). This metaanalysis of placebo-controlled clinical trials also focused on young adults who were prescribed Paxil for anxiety disorders as well as depression. In this broader diagnostic group, young adults (ages 18-24) who were given Paxil were also at increased risk for suicidality. Summarizing these data, Paxil increased suicidality in depressed adults of all ages and also in young adults with depression, dysthymia, panic disorder, generalized anxiety disorder, and obsessive compulsive disorder. The rates of Paxil-induced suicidality will be much higher in actual clinical practice where the drug exposure typically lasts much longer than 4-6 weeks, patient monitoring is much less thorough, multiple drugs often exacerbate adverse drug reactions, and many patients are already suicidal. By admitting that Paxil causes suicidality in adults, the FDA and GlaxoSmithKline confirmed observations I have been making in my publications and trial testimony for more than a decade (e.g., Breggin, 1997, 2001; Breggin & Breggin, 1994). The FDA and the drug company released their results within weeks after the publication of my initial special report in EHPP, which showed that the drug company had been suppressing the relevant data for many years (Breggin, 2006). My first Special Report, "Court Filing Makes Public My Previously Suppressed Analysis of Paxil's Effects," described how recent court proceedings made my product liability report available to the public despite previously successful efforts by GSK to suppress it. My initial Special Report provided excerpts from my product liability analysis concerning how the drug company manipulated data concerning Paxil-induced suicidality. For example, GSK's analysis of suicidality left out two attempted suicides and two completed suicides on Paxil, and exaggerated the number of suicidal acts on placebo. The company also reduced the apparent significance of suicide-related events by providing separate analyses of overdose, suicide attempt, and suicidality. It is more useful and meaningful to combine all suicide-related activities into one category, suicidality. For Special Report Part II, I have excerpted sections from my product liability report concerning how the drug company hid both the rates for Paxil-induced akathisia and the relationship between akathisia and suicidality. Akathisia is a drug-induced inner agitation or dysphoria that causes a person to feel compelled to move about. …
Meredith Wadman - One of the best experts on this subject based on the ideXlab platform.
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Paxil study under fire
Nature, 2011Co-Authors: Meredith WadmanAbstract:Trial researcher alleges paper exaggerated antidepressant benefits. "The contentious issue of drug-industry influence over medical-research writing erupted on the campus of the University of Pennsylvania in Philadelphia this week. A professor of psychiatry has alleged that several colleagues — including the chair of his department — allowed their names to be added to a manuscript while ceding control to the global pharmaceutical giant GlaxoSmithKline (GSK). The professor, Jay Amsterdam, also claims that the manuscript, written with an unacknowledged contractor paid by GSK, unduly promotes the company's antidepressant drug Paxil (paroxetine), the subject of the study. "The published manuscript was biased in its conclusions, made unsubstantiated efficacy claims and downplayed the adverse-event profile of Paxil," Amsterdam's lawyer wrote in an 8 July letter to the Office of Research Integrity (ORI), the body responsible for investigating research misconduct in US Public Health Service agencies and its grant recipients. The letter accuses the study's academic authors of engaging in scientific misconduct by allowing their names to be attached to the manuscript (C. Nemeroff et al. Am. J. Psychiatr. 158, 906–912; 2001), which has been cited more than 250 times. Documents accompanying Amsterdam's complaint are offered as evidence that "most if not all" of the authors were handpicked by GSK, working in conjunction with the medical-communications company Scientific Therapeutics Information (STI) in Springfield, New Jersey, to lend credibility to a result that Amsterdam says places Paxil in an overly favourable light." Language: en