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Grassley asks FDA to probe Glaxo's Paxil communication.(Ethics)(Brief article)
- Article from:
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Adverse Event Reporting News
- Article date:
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June 17, 2008
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Copyright informationCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Sen. Chuck Grassley (R-IA) has asked FDA to dig in on the data that GlaxoSmithKline submitted to the agency about the antidepressant Paxil to determine if the company concealed risk of suicide for users of the drug, "The Wall Street Journal" reported June 12.
Grassley pointed out in a letter to the agency and HHS Secretary Michael Leavitt that the U.K. recently concluded that GSK withheld safety information in its submission for approval in Europe; he wants FDA to investigate whether the company did the same in the U.S. as well.
In Grassley's statement on the Senate floor June 11, he spoke of how drug companies conceal unflattering data. "I don't mean that they ...
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L-arginine beneficial in preeclampsia.(Literature Review &...
Townsend Letter: The Examiner of Alternative Medicine;
October 1, 2007 ;
Gaby, Alan R.;
297 words
......L-arginine group and 25 days in the placebo group (p < 0.006). The mean duration of...L-arginine group and 34.8 weeks in the placebo group (p = 0.14). The dose of antihypertensive...L-arginine group and in 13% of those in the placebo group (p < 0.05). The incidence of ...
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Nitric Oxide May Curb Neonatal Brain Damage.
OB GYN News;
June 1, 2000 ;
JOHNSON, KATE;
560 words
......or compromised blood flow. Babies in the placebo group were delivered by elective cesarean section...as many low 5-minute Apgar scores in the placebo group; six babies in the placebo group scored less than 7, compared with only...
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Drug is okd for AIDS patients // Test group here hails good news
Chicago Sun-Times;
September 20, 1986 ;
Howard Wolinsky;
582 words
......was a lot of happiness, even in the placebo group," which been taking dummy pills. "I...ARC and participant in the study's placebo group, couldn't wait to get home yesterday...eight the placebo. One patient in the placebo group died but none died in the group receiving...
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Desmopressin Effective for Nocturia Treatment.
Internal Medicine News;
August 1, 2001 ;
FINN, ROBERT;
546 words
......the desmopressin group and 3% for the placebo group, he reported. Nocturnal urine output...83 minutes longer than it was in the placebo group. Overall, 29 (35%) of the patients...compared with only 1 patient (2%) in the placebo group. Dr. Philip van Kerrebroeck of University...
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Use Oral Desmopressin Judiciously for Nocturia.
OB GYN News;
August 1, 2001 ;
FINN, ROBERT;
564 words
......the desmopressin group and 3% for the placebo group. Nocturnal urine output decreased significantly...83 minutes longer than it was in the placebo group. Overall, 29 (35%) of the patients...compared with only 1 patient (2%) in the placebo group. Dr. Philip van Kerrebroeck of ...
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Vical Licensee AnGes MG Report Positive Results.
M2 Presswire;
June 18, 2007 ;
787 words
......potential ethical issues against the placebo group subjects. AnGes is ending the trial...dosing, showed 30.8 improvement in the placebo group and 70.4 improvement in the treatment...the AMG0001 group compared with the Placebo group. Yesterday, an IDMC (Independent Data...
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Caffeine and naps only slightly helpful to night shift...
Clinical Psychiatry News;
February 1, 2005 ;
Mulcahy, Nicholas;
404 words
......nap/caffeine treatment group and the placebo group. Alertness and performance did not...and naps did help somewhat. Only the placebo group had a worsening of RT10 from shift...end. Additionally, at shift end, the placebo group's RT10 was worse than that of the caffeine...
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Zoladex Before Ablation Leads to Better Outcomes.
OB GYN News;
April 1, 2001 ;
Worcester, Sharon;
296 words
......goserelin acetate group and 26% in the placebo group. At 1 year, the rates were 35% and...goserelin acetate group and 14% in the placebo group. There was a reduction in the amenorrhea...treatment group as much easier than in the placebo group. Patients in the goserelin acetate...
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Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis...
PR Newswire;
June 18, 2007 ;
787 words
......potential ethical issues against the placebo group subjects. AnGes is ending the trial...dosing, showed 30.8 improvement in the placebo group and 70.4 improvement in the treatment...the AMG0001 group compared with the Placebo group. Yesterday, an IDMC (Independent Data...
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Glucasamine sulfate supplementation reduces symptoms of OA in...
Dynamic Chiropractic;
January 1, 2002 ;
Meschino, James;
176 words
......revealed by radiographs, whereas the placebo group had progressive joint space narrowing...symptoms worsened slightly in the placebo group, compared with improvement of symptoms...small and equivalent to that of the placebo group. The conclusion drawn by these researchers...
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rhTSH-Stimulated ^sup 131^I Therapy in Large Goiters
The Journal of Nuclear Medicine;
August 1, 2007 ;
Anonymous;
274 words
......was reduced from 170 to 121 mL in the placebo group and from 1 5 1 mL to 72 mL in the rhTSH-pretreat...retained ^sup 131^I thyroid dose in the placebo group, no such relationship was noted in...more adverse effects (pain) than the placebo group. At 12 months, goiterrelated ...
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Ultralow-dose estradiol and BMD in postmenopausal women.(Tips)
American Family Physician;
August 1, 2005 ;
Walling, Anne D.;
787 words
......in the treatment group than in the placebo group. After one year, BMD in the lumbar...treatment group and by 0.5 percent in the placebo group. Differences also were significant...treatment group and decreased in the placebo group. Differences remained significant at...
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Controversy About Lack of Placebo Group Decline in Alzheimers Clinical...
U.S. Newswire;
July 28, 2008 ;
787 words
......trials. In Alzheimer trials, if the placebo group does not worsen over the course of...Multiple Studies Reveals Process to Ensure Placebo Group Decline Lon S. Schneider, MD, professor...worsening over the course of the trial. Placebo group sample sizes less than 100 had a 37...
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Research capsules
Pharmaceutical Representative;
January 1, 2002 ;
Anonymous;
608 words
......group (133 hours) compared with the placebo group (141 hours).This improvement was more...resolution, compared with 37% of the placebo group. DIAPEP277 Phase II study data published...reduction of insulin production in the placebo group, and an increase in the active treatment...
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Paxil fails to aid in major depression.(Behavioral Pediatrics)
Pediatric News;
July 1, 2006 ;
Splete, Heidi;
321 words
......paroxetine (Paxil) and -23.38 in a placebo group. The randomized, double-blind, multi-cent...aged 7-11 years, compared with the placebo group (39% vs. 13%), which suggests a lower...the treatment group compared with the placebo group, the researchers said. The incidence...
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