Search

THE TYPICAL SCIENTIFIC PAPER GOES THROUGH a curious metamorphosis on its way into the scientific literature. It is written on a computer, printed out and submitted to a journal on [...]

The article reports on the plan of University of Tokyo's Institute of Medical Science in Japan to overhaul efforts to educate researchers on ethics rules and tighten internal review and compliance procedures. In addition to the said plan, scientific journals are getting stricter about the documentation of human studies that have undergone ethics review. It is learned that periodic educational efforts in raising everyone's awareness of clinical research ethics guidelines are not sufficient. It is also noted that journals should require and publish a description of the approved experimental protocols that would help keep researchers from getting approval for one experiment and doing another. It would also protect human subjects and keep scientists honest.

The article reports that sex and gender are missing in COVID-19 data in the U.S., pointing out that most clinical trials do not report results by sex, as of July 2021. Topics include the paper published in "Nature Communications" which noted that only eight out of 45 COVID-19 randomized controlled trials reported the impact of sex or gender, the lack of attention to sex effects as indicated in several studies and the why suggesting a sex difference where one might not exist can be harmful.

The article offers information on a paper related to protection of a rodent's brain after a stroke from a drug presented by Ulrich Dirnagl, director of the Center for Stroke Research at Charité University Medicine in Berlin. It discusses the animal research and its effects on human drug studies by clinical trials. It informs that researchers need stricter safeguards and better statistics to ensure that the research performed by them is solid.

The article reports that Norwegian oncologist Jon Sudbø, admitted this week through his attorney to falsifying data in three seminal papers published by top medical journals. The revelations have put on hold a multimillion-dollar oral cancer prevention trial, sponsored in part by the U.S. National Cancer Institute. The fraud is all the more unsettling given the recent fabrications by South Korean researcher Woo Suk Hwang in stem cell science. The papers reported that 26 of 27 individuals with aneuploid mouth lesions having abnormal numbers of chromosomes, developed aggressive oral cancer and were more likely to die of the disease than were those with other types of lesions. An immediate casualty of the fraud may be a 360-person trial of the anti-inflammatory Celebrex, along with another drug, in healthy people with aneuploid mouth lesions. Two reports were published in the March 20, 2005 issue of the "Journal of Clinical Oncology" and the October 15, 2005 issue of the journal "The Lancet."

The article informs that when the "New England Journal of Medicine" (NEJM) last week released a scathing editorial asserting that a study on the firm Vioxx had omitted safety data, the episode became the latest chapter in the efforts of medical journal editors to keep what they consider misleading drug studies from their pages. A string of similar cases have prompted journals to tighten requirements of authors, ask increasingly pointed questions before publishing, and require that clinical trials be publicly registered before papers are reviewed. The latest case came to light when Gregory Curfman, an NEJM editor, was deposed on November 21 in the third Vioxx lawsuit. Curfman learned from a Merck & Co. Inc. memo of three unreported heart attacks, which he realized had been deleted from a paper comparing the gastrointestinal effects of Vioxx with those of the anti-inflammatory naproxen, says Karen Pedersen, an NEJM spokesperson. In an e-mail to Science, Bombardier said that she and the other authors are preparing a reply to NEJM and declined to comment until that's complete. In a statement, Merck denied any wrongdoing, asserting that the three heart attacks occurred after the study's prespecified completion and thus did not warrant inclusion.

The article discusses tumor analysis research documented in 2006 by a Duke University genetics group and questions raised about data integrity and the validity of the resume of one of its authors, Anil Potti. Growth of the controversy stimulated by a summer 2010 report on possible fraud in Potti's resume led Duke officials to cancel clinical trials using techniques described in the research paper.

Information about several papers discussed at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) held March 5-8, 2012 on HIV prevention research is presented. Topics include the combination of failures and successes that have led to insights into HIV prevention and cures, such as a clinical trial testing a prevention intervention, called pre-exposure prophylaxis (PrEP), which gives anti-HIV drugs to uninfected people.

This article reports that Europe's biggest HIV research organization, the 49 million dollars French National Agency for Research on AIDS and Viral Hepatitis has a new director. Jean-François Delfraissy, a clinician at the forefront of HIV research and treatment since the early 1980s and most recently director of internal medicine at Bicêtre Hospital in Paris, has authored more than 200 papers and played a key role in many clinical trials, including the first one to show the effectiveness of AZT against mother-to-child transmission of HIV. He has also promoted ANRS's recent expansion into hepatitis B and C research. Joep Lange, past president of the International AIDS Society, who predicts that Delfraissy's accessible style will help foster international collaborations. Delfraissy succeeds Michel Kazatchkine, who in February became the French government's ambassador in the fight against AIDS.

Current Clinical Trials (CCT), AAAS's entry into electronic publishing, has hooked up with The Lancet in what is billed as a pioneering adventure in 'parallel publication.' According to the agreement, [...]