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voluntarily withdrawn, according to CFDA documents.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''
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
Cross River State, Nigeria
Phone No. +234 (0) 8063600642
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