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.

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

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