Danish participants in a medical research project were never informed of its commercial interests.
While the project with the involvement of Facebook CEO and billionaire Mark Zuckerberg is tipped to become an international success, Danish experts have slammed it as a violation of data protection and a "bad deal for Denmark."
Some 263 Danish women who participated in a public research project and gave blood samples at the State Serum Institute (SSI) every week throughout their pregnancy have been surprised to learn that they were in fact part of an undisclosed US business enterprise, Danish Radio reported.
The blood samples, originally intended to track neurotransmitters during pregnancy, were sent to the US and formed the basis of a blood test that can predict premature birth, which many expect to become a worldwide success. The American research centre involved was founded by Facebook billionaire Mark Zuckerberg and is now the co-owner of the invention. The participants were never informed of the commercial interests of the research project.
"I feel that my trust and my good intentions have been abused", Mary Petersen, one of the women who participated in the research project, told Danish Radio.
Undisclosed Commercial Interests
While the research project was approved by a Science Ethics Committee, the SSI failed to notify it about all of the analysis methods the US side had to carry out or the commercial interests of the project.
According to Kent Kristensen, associate professor of health law at the University of Southern Denmark, the research project was thus approved on the wrong basis and in violation of a law intended to protect participants in health research.
The hundreds of blood samples were sent to Stanford University without a so-called data processor agreement having been entered into, which ensures that the data is not misused. Without a data processor agreement, the samples were transferred illegally in violation of the rules on data protection, according to Kent Kristensen.
'Bad Deal for Denmark'
In 2017, Mads Melbye and his US research colleagues applied for a patent that would allow them to make money on the blood test based on the data from the pregnant Danish women. The research centre that filed the application with the US Patent Office and is now in charge of commercialising the test, was founded by Facebook billionaire Mark Zuckerberg. It is called Chan Zuckerberg Biohub, named after Mark Zuckerberg and his wife, Chan.
Professor Kim Østergaard from Copenhagen Business School, an expert in contract law, estimated that the Chan Zuckerberg Biohub has gained the most control over the blood test and stands to earn the most from it. He also called it a "bad agreement for Denmark". By contrast, the SSI assured that "from a market point of view [the organisation] receives a fair share of the income", and that the test will be "made available cheaply in Denmark.”
In California, Mads Melbye and his American colleagues also founded a private company. The company is called Mirvie and in 2018 received around $70 million in start-up capital from private investors and entered into a pre-agreement with Chan Zuckerberg Biohub. In 2018, Mads Melbye owned about a fifth of the company. His American research colleague, the daily manager of Chan Zuckerberg Biohub, had the same stake, Danish Radio reported.
According to the SSI, Melbye didn't tell the institute about his financial interest in the pregnancy project. At the request of the Ministry of Health and the Elderly, Mads Melbye sold his shares last year and withdrew from the company, according to Danish Radio.
In the aftermath of these revelations, Melbye resigned this summer. While Melbye personally rejected making any mistakes, the State Serum Institute regretted not properly informing the participating women about all the aspects of the study.
You can read this article as it originally appears at Sputnik here.
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