Patients may ask about a widely reported call from the Cochrane Collaboration for full disclosure of information about clinical studies leading to the approval of the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza) used to treat influenza.
The reviewers point out that data on oseltamivir from 8 trials of a 10-trial meta-analysis remain unpublished and were not available either from the studies' authors or the manufacturer. That meta-analysis "has been the sole publication" cited by the CDC in support of its treatment guidelines.
On the basis of drug company data submitted to government agencies, the reviewers estimate that 60% of patient data from oseltamivir's phase III trials "have never been published." Using such "regulatory information" rather than published journal studies, the reviewers estimate that oseltamivir showed "no evidence of effect" on hospitalization rates; there was not enough information available to assess the drug's effects on complications or viral transmission.
Saturday, January 21, 2012
Thursday, July 28, 2011
FDA Finds U.S. Drug Research Firm Faked Documents
WASHINGTON (Reuters) Jul 26 - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.
The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston.
The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.
"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.
It remains unclear which drugmakers have used Cetero's services to apply for regulatory approvals and the FDA is asking companies to identify such instances. The regulators said the measure is precautionary and the safety and efficacy of drugs already on the market are unlikely to be affected.
The FDA inspected Cetero in May and December last year and found falsified records about studies.
Specifically, in at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at Cetero facilities at that time, the FDA said in its May report.
The FDA also said at the time that Cetero might have "fixed" studies to get the desired result, or did not include failed results in their report.
"Cetero's May 2010 and December 2010 responses are inadequate because the scope of their internal investigation was far too narrow to identify and adequately address the root cause of these systemic failures," the regulators said.
Cetero was not immediately available for comment.
The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston.
The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.
"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.
It remains unclear which drugmakers have used Cetero's services to apply for regulatory approvals and the FDA is asking companies to identify such instances. The regulators said the measure is precautionary and the safety and efficacy of drugs already on the market are unlikely to be affected.
The FDA inspected Cetero in May and December last year and found falsified records about studies.
Specifically, in at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at Cetero facilities at that time, the FDA said in its May report.
The FDA also said at the time that Cetero might have "fixed" studies to get the desired result, or did not include failed results in their report.
"Cetero's May 2010 and December 2010 responses are inadequate because the scope of their internal investigation was far too narrow to identify and adequately address the root cause of these systemic failures," the regulators said.
Cetero was not immediately available for comment.
Friday, July 15, 2011
Screening Does Not Reduce Ovarian Cancer Mortality
Screening with transvaginal ultrasound and CA-125 measurement does not reduce ovarian cancer mortality, according to results from the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial published in JAMA.
Some 78,000 women aged 55 to 74 without histories of ovarian cancer were randomized to usual care, or to screening with annual transvaginal ultrasound for 4 years and annual CA-125 blood testing for up to 6 years. During roughly 12 years' follow-up, the primary endpoint — ovarian cancer mortality — did not differ between the groups.
Roughly 3000 women had false-positive results on screening, one third of whom had surgery (e.g., oophorectomy) as part of the diagnostic evaluation. Among these, the rate of major surgical complications was 21 per 100 procedures.
=Just wondering if transvaginal ultrasound and CA-125 measurement will decrease or stop. Cynics doubt it
Some 78,000 women aged 55 to 74 without histories of ovarian cancer were randomized to usual care, or to screening with annual transvaginal ultrasound for 4 years and annual CA-125 blood testing for up to 6 years. During roughly 12 years' follow-up, the primary endpoint — ovarian cancer mortality — did not differ between the groups.
Roughly 3000 women had false-positive results on screening, one third of whom had surgery (e.g., oophorectomy) as part of the diagnostic evaluation. Among these, the rate of major surgical complications was 21 per 100 procedures.
=Just wondering if transvaginal ultrasound and CA-125 measurement will decrease or stop. Cynics doubt it
Saturday, July 9, 2011
antidepressants dont work?
Abstract
Background: This paper examines the current status of research on the efficacy and effectiveness of antidepressants. Methods: This paper reviews four meta-analyses of efficacy trials submitted to America’s Food and Drug Administration (FDA) and analyzes STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted. Results: Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy. These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest. The STAR*D analysis found that the effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study authors with an apparent progressively increasing dropout rate across each study phase. Conclusions: The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.
Efficacy and Effectiveness of
Antidepressants: Current Status of
Research
H. Edmund Pigott a Allan M. Leventhal b Gregory S. Alter a John J. Boren b
a NeuroAdvantage, LLC, Clarksville, Md. , b Department of Psychology, American University,
Washington, D.C. , USA
Background: This paper examines the current status of research on the efficacy and effectiveness of antidepressants. Methods: This paper reviews four meta-analyses of efficacy trials submitted to America’s Food and Drug Administration (FDA) and analyzes STAR*D (Sequenced Treatment Alternatives to Relieve Depression), the largest antidepressant effectiveness trial ever conducted. Results: Meta-analyses of FDA trials suggest that antidepressants are only marginally efficacious compared to placebos and document profound publication bias that inflates their apparent efficacy. These meta-analyses also document a second form of bias in which researchers fail to report the negative results for the pre-specified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure as though it was their primary measure of interest. The STAR*D analysis found that the effectiveness of antidepressant therapies was probably even lower than the modest one reported by the study authors with an apparent progressively increasing dropout rate across each study phase. Conclusions: The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.
Efficacy and Effectiveness of
Antidepressants: Current Status of
Research
H. Edmund Pigott a Allan M. Leventhal b Gregory S. Alter a John J. Boren b
a NeuroAdvantage, LLC, Clarksville, Md. , b Department of Psychology, American University,
Washington, D.C. , USA
Wednesday, June 29, 2011
ncep 2004 guidelines
The NCEP’s 2004 guideline update garnered headlines by recommending lower targets for bad cholesterol, which would put more Americans on the drugs. But there was also a heated controversy in the medical community over the fact that 8 of the 9 experts on the panel had financial ties to industry. “The guideline process went awry,” says Michigan State’s Barry. He and 34 other experts sent a petition of protest to the National Institutes of Health, saying the evidence was weak and the panel members were biased by their ties to companies.
Sunday, March 20, 2011
Meta-Analysis Favors Pioglitazone in 'Real World' Settings
In an analysis of observational studies comparing pioglitazone versus rosiglitazone, pioglitazone emerges as the safer of the two.
Analyzing studies comprising over 800,000 patients with type 2 diabetes, researchers report in BMJ that use of rosiglitazone was associated with a "modest but statistically significant increase in the odds of myocardial infarction, congestive heart failure, and death compared with patients receiving pioglitazone in real world settings."
In 2010, the European Medicines Agency recommended withdrawal of rosiglitazone from the market, and the U.S. FDA placed restrictions on its use.
Editorialists ask why, despite the association with increased risks for heart failure and the availability of other agents, thiazolidinediones remain among the leading prescribed drugs in the U.S. That popularity, they conclude, "says much about how healthcare has become less about promoting patients' interests ... and much more about promoting other interests, including those of the drug industry."
Analyzing studies comprising over 800,000 patients with type 2 diabetes, researchers report in BMJ that use of rosiglitazone was associated with a "modest but statistically significant increase in the odds of myocardial infarction, congestive heart failure, and death compared with patients receiving pioglitazone in real world settings."
In 2010, the European Medicines Agency recommended withdrawal of rosiglitazone from the market, and the U.S. FDA placed restrictions on its use.
Editorialists ask why, despite the association with increased risks for heart failure and the availability of other agents, thiazolidinediones remain among the leading prescribed drugs in the U.S. That popularity, they conclude, "says much about how healthcare has become less about promoting patients' interests ... and much more about promoting other interests, including those of the drug industry."
Saturday, March 12, 2011
benicar ups cv death but lowers protein in urine in type 2 dbtcs
Olmesartan, an angiotensin-receptor blocker, delays the development of microalbuminuria in patients with type 2 diabetes and well-controlled blood pressure, but its use is associated with an increased risk of death from cardiovascular events, according to a New England Journal of Medicine study.
The ROADMAP trial, sponsored by the drug's manufacturer, randomized some 4500 diabetic patients with normoalbuminuria to daily olmesartan or placebo. In addition, participants' blood pressures were treated to maintain values under 130/80 mm Hg.
After a median 3-year follow-up, the olmesartan group showed a significant advantage over placebo in delaying time to onset of microalbuminuria (the primary outcome). However, fatal cardiovascular events were more common with olmesartan.
An editorialist writes that the finding of delayed microalbuminuria was not unanticipated. And given the increased cardiovascular mortality found with olmesartan, she asks why wouldn't other renin-angiotensin blocking drugs be prescribed if they are not associated with fatal complications?
The ROADMAP trial, sponsored by the drug's manufacturer, randomized some 4500 diabetic patients with normoalbuminuria to daily olmesartan or placebo. In addition, participants' blood pressures were treated to maintain values under 130/80 mm Hg.
After a median 3-year follow-up, the olmesartan group showed a significant advantage over placebo in delaying time to onset of microalbuminuria (the primary outcome). However, fatal cardiovascular events were more common with olmesartan.
An editorialist writes that the finding of delayed microalbuminuria was not unanticipated. And given the increased cardiovascular mortality found with olmesartan, she asks why wouldn't other renin-angiotensin blocking drugs be prescribed if they are not associated with fatal complications?
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