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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Top Chinese rabies vaccine maker ordered to stop production over forged data – FiercePharma (Angus Liu | July 2018)0

Posted by Admin in on September 28, 2018

China’s drug regulator just pulled a manufacturing permit for the country’s second-largest maker of rabies vaccines over data falsification, marking the latest episode in China’s drug safety scandal.

During an inspection, China’s State Drug Administration found Changchun Changsheng Life Sciences forged production records for its Vero cell-based rabies vaccines. The agency immediately moved to revoke the company’s GMP license tied to the vaccine—just three months after its issuance—and dispatched a team to investigate the incident on site, according to a Sunday statement (Chinese).

In its announcement filed to Shenzhen Stock Exchange, the Changchun, China-based company said it has started recalling all unexpired rabies vaccines, even though the batches under question weren’t released to the market, and it hasn’t received any adverse event report related to the quality of the vaccines through years of monitoring.

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Let the Sun Shine into the Medical Ivory Tower – The Hastings Center (Adriane Fugh-Berman | September 2018)0

Posted by Admin in on September 25, 2018

In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family Physician. Before it was published, I was surprised to receive a communication asking me to disclose the fact that I had written a textbook on dietary supplements. It had not occurred to me to disclose the publication of my then decade-old book, but I certainly should have, and I was impressed that the publication had actually checked up on me.

Would that more journals would follow AFP’s example. A joint New York Times and ProPublica investigation found that Jose Baselga, the chief medical officer at Memorial Sloan Kettering Cancer Center in New York, failed to disclose payments from pharmaceutical and health care companies in more than 100 articles he authored in medical journals. Between August 2013 (when Federal Open Payments disclosures began) and 2017, nine pharmaceutical and medical device companies paid Dr. Baselga almost $3.5 million.

Dr. Baselga has been on the board of directors of Bristol Myers Squibb and Varian medical systems, which sells radiation equipment to Memorial Sloan Kettering, among other clients. Dr. Baselga has been a consultant to Astra Zeneca, Eli Lilly, Novartis, and Roche/Genentech and an advisor to many pharmaceutical companies, diagnostics companies, and start-ups. He has presented favorable opinions about drugs made by companies that paid him– including drugs that other researchers found ineffective or unsafe. According to the Times article, Dr. Baselga called the results of a Roche trial of taselisib, a P13K inhibitor “incredibly exciting” at a meeting of the American Society of Clinical Oncology; Roche, the manufacturer, considered the drug so disappointing they scrapped further development.

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Australian Code for the Responsible Conduct of Research (2018)0

Posted by Admin in on September 23, 2018

The Australian Code is the Australian national reference for research integrity. The document was issued by the National Health and Medical Research Council, Australian Research Council and Universities Australia.

The Australian Code discusses eight core principles, 13 institutional responsibilities and 16 research responsibilities. At launch it was complemented by the Guide to Managing and Investigating Potential Breaches of the Code, 2018 (the Investigation Guide). Two more guides are expected by the end   of 2018, with the remaining guides expected early 2019.

The eight-page 2018 version is a significant change from the 2007 version (which was 39 pages). It represents a movement away from detailed strict standards on research integrity matters to general principles that must inform institutional policies, processes and resources.

Japanese university revokes PhD following a retraction – Retraction Watch (Ivan Oransky | September 2018)0

Posted by Admin in on September 22, 2018

Tokyo Women’s Medical University has stripped a researcher of her PhD, following the retraction of a paper — for data duplication — that was based on her thesis.

This September 2018 case from Japan is another ‘good’ example of what HDR candidates are risking when they cheat in their work. We included links to a few other similar items.

The August 30th announcement notes that a degree was revoked on July 20. The announcement does not name the researcher, but refers to degree number 2881, which corresponds to Rika Nakayama’s PhD. The university describes carelessness and errors, but not misconduct.
Here’s a rough Google translation of the announcement:

The thesis which became the application paper is based on the case which was handled at the off-campus facility to which the person belongs. Duplication of case data occurred due to carelessness of the person during the preparation of the paper. Those who created the paper with data duplication applied for a degree, and a degree was approved. Duplication of case data was discovered when this paper was investigated by random monitoring of the facility. That person did not take the form of correction but undertook the withdrawal procedure of the paper from the journal. In recognition of the fact that the dissertation application paper was withdrawn, we decided to cancel the degree award.

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