BEWARE RESEARCH FRAUD CPNSEQUENCE: ' Chinese courts call for death penalty for researchers who commit fraud'' - Health Resource International West Africa (HRI)

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Monday, 26 June 2017

BEWARE RESEARCH FRAUD CPNSEQUENCE: ' Chinese courts call for death penalty for researchers who commit fraud''

C ourtesy of WAME we share,

' Re: [WAME-L] Chinese courts call for death penalty for researchers who commit fraud

'----according to the Nature article on the topic (https://www.nature.com/articles/n-12286656 ), the death penalty could be invoked AS A RESULT OF RESEARCH FRAUD specifically if people die from exposure to a drug approved because
of fake data: "Under that law, if the approved drug causes health problems, it can result in a 10-year prison term or the death penalty, in the case of severe or fatal consequences. Even if the drug is not approved and even if no one is harmed by an approved drug, those who break the law by submitting fake data may face three years in prison."



China has a serious problem--the article says, "A hint of the depth of the problem came after the China Food and Drug Administration (CFDA) in 2015 ordered companies to re-evaluate 'the authenticity, integrity and compliance of clinical trial data' in pending applications for new drugs. The agency told them that if CFDA examiners later found violations, the companies would not be able to submit other drugs for approval. More than 80% of the applications were voluntarily withdrawn, according to CFDA documents. One-quarter of the remainder was subsequently rejected because of problems with authenticity."

The penalty doesn't appear to be an idle threat: "In 2007, China executed the former head of its drug agency for accepting bribes to approve medicines, some of which ended up killing people."

Oransky and Marcus state in their StatNews article (https://www.statnews.com/2017/06/23/china-death-penalty-research-fraud/): "A scientist who cheats on a drug study could, at least in theory, jeopardize the health of the people who take that medication, with potentially fatal consequences." Unfortunately the case of Vioxx highlights the potential risks: although Merck never admitted fault, they settled $4.85 billion in lawsuits over undisclosed cardiovascular risks (http://www.npr.org/templates/story/story.php?storyId=5470430 ). .Margaret Winker, MD  Trustee, WAME''

Africa Center for Clin Gov Research & Patient Safety
@ HRI West Africa Group - HRI WA
Consultants in Clinical Governance Implementation
Publisher: Health and Medical Journals 
8 Amaku Street Housing Estate, Calabar
Cross River State, Nigeria
Phone No. +234 (0) 8063600642


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