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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The Great Leap Fraud: China’s wake-up call on scientific misconduct and fake science on Science Friction – ABC RN (Natasha Mitchell | September 2018)0

Posted by Admin in on October 6, 2018

You’ve heard of fake news, but what about fake science? The shocking, shady world of the modern scientific marketplace. A special for ABC RN’s China In Focus series featuring Ivan Oransky of Retraction Watch and guests.

China’s president wants to turn the country into a scientific superpower, but mass retractions by scientific journals of papers penned by Chinese scientists has exposed a major problem for China and for science globally.

It’s home to a thriving black market for fake papers, fake peer reviews, and beyond.

But is China alone?

Listen to the interview and read more and this discussion piece

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.

Read the rest of this discussion piece

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.

Read the rest of this discussion piece

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.