Red-Wine Researcher Charged With 'Photoshop' Fraud Robert Lowes

January 13, 2012 — A University of Connecticut researcher known for touting the health benefits of red wine is guilty of 145 counts of fabricating and falsifying data with image-editing software, according to a 3-year university investigation made public Wednesday. The researcher, Dipak K. Das, PhD, is a director of the university's Cardiovascular Research Center (CRC) and a professor in the Department of Surgery. The university stated in a press release that it has frozen all externally funded research in Dr. Das's lab and turned down $890,000 in federal research grants awarded to him. The process to dismiss Dr. Das from the university is already underway, the university added. Dr. Dipak K. Das A university special review board (SRB) found evidence of research fraud in 2 dozen published papers dating back to 2002 as well as 3 grant applications. The university said it has notified 11 journals that published the studies of its findings. The publications include The American Journal of Physiology — Heart and Circulatory Physiology and the Journal of Molecular and Cellular Cardiology. Some of the studies asserted that a substance in red wine called resveratrol promoted heart health. "We have a responsibility to correct the scientific record and inform peer researchers across the country," said Philip Austin, interim vice president of health affairs at the University of Connecticut. The review board findings "point to a pervasive attitude of disregard within the CRC for commonly accepted scientific practices in the publication and reporting of research data," its report stated. "Given the large number of irregularities discovered in this investigation...the SRB can only conclude that they were the result of intentional acts of data falsification and fabrication, designed to deceive." The review board report stated that the US Office of Research Integrity (ORI) tipped off the university in 2008 about alleged fraud involving a 2007 article in Free Radical Biology and Medicine coauthored by Dr. Das titled "Redox regulation of resveratrol-mediated switching of death signal into survival signal." The ORI is now conducting its own investigation of Dr. Das, according to the university. Other members of the CRC played a part in the research fraud, and they are under investigation as well. "No Resemblance to Any Legitimate Experiment" The exact nature of the alleged fraud involves images of "blots" obtained through gel electrophoresis that were featured in article figures. Most of the figures presented Western blots, designed for studying proteins. Using Photoshop software as a forensic tool, the review board determined that dozens of images bore evidence of inappropriate manipulation by "photo imaging software." The most egregious examples were pasted-up "artificial blots" that "bear no resemblance to any legitimate experiment" and represent total fabrications. The board also found examples of background erasure, image duplication, and images having been spliced together. The board noted that splicing various blot images together can serve a legitimate purpose but that researchers must precisely describe the manipulation that they perform. Such explanations were lacking in articles coming out of Dr. Das's laboratory. The review board report stated that as head of the lab and senior author of all but one of the tainted articles, Dr. Das "bears principal responsibility for the fabrication and/or falsification that occurred." Furthermore, the evidence "strongly suggests" that Dr. Das was directly involved in faking images for publication. Some of that evidence was pulled from his personal computer. Accused Researcher Cites "Racial Hatred" The report quoted Dr. Das as saying he does not know who prepared the figures that appeared in the journal articles. It stated that he has provided "no substantive information" that could explain the research irregularities. An exhibit in the report contains what the board called Dr. Das's response to the investigation. In a document dated July 30, 2010, Dr. Das said the accusations against him are part of a campaign to rid the university health center of the "Indian community." "I became the Devil for the Health Center, and so did all the Indians working for me," he wrote. "The evidence for conspiracy and racial hatred is overwhelming." He also alleged that the stress of battling the university administration led to a brain hemorrhage and stroke. Medscape Medical News did not receive a reply to an email sent to Dr. Das at his university email address. A company called Resveratrol Partners, which markets a resveratrol-based dietary supplement called Longevinex, said yesterday in a press release that "Dr. Das is attending a scientific conference in India and has not been able to respond to the allegations." The Web site of Resveratrol Partners highlights some of Dr. Das's studies on the cardio benefits of resveratrol. In yesterday's press release, Resveratrol Partners managing partner Bill Sardi said that Dr. Das does not have any business relationship with the company and that other researchers have confirmed the value of Longevinex. Medscape Medical News © 2012 WebMD, LLC Send comments and news tips to news@medscape.net.

Relenza and Tamiflu Questioned

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.

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

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.

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."