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About Me

Klaus Rose


I am a medical doctor by training and profession. After clinical training, I joined the pharmaceutical industry, as I wanted an international job. I was proficient in German, English, Italian, Spanish, and French. I started in a German company headquartered at the Swiss border. In parallel to clinical research on headquarter level, I became also Medical Director Switzerland. These days many Swiss physicians still felt more comfortable speaking in their mother languages German, French or Italian! Today, most speak English, but nevertheless, conversation in the mother tongue usually allows a more intensive conversation.

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Name
Klaus Rose


Profession
Medical Doctor


Birth Year
02 Nov 1953


Birth Place
Germany


Country
Switzerland

Career

I joined Novartis in Switzerland in 1997 and came across clinical studies in children. I was intrigued, also because our eldest daughter suffers from Sturge- Weber syndrome, which is serious and very rare. I became passionate about “pediatric drug development” and what the European Medicines Agency (EMA) called “Better Medicines for Children”. I became global head of pediatrics in Novartis 2001-2005 and got the same position in Genentech/Roche 2005-2009 (both companies are headquartered in Basel, Switzerland). After one more year in a regulatory company I became independent in 2011. I advised companies on European Medicines Agency (EMA) “pediatric investigation plans” (PIPs) and Food and Drug Administration (FDA) pediatric requests/demands.

Already in my early years, I saw that many regulatory pediatric studies were medically and scientifically questionable, but I did not get much further beyond this observation. Finally, I found the solution to the riddle in key documents of the American Academy of Pediatrics (AAP). Demanding separate pediatric studies began with observed toxicities of antibiotics in preterm newborns in the 1950s. Real, existing dangers of careless use of drugs in babies were exaggerated into alleged risks of all medications in all “children,” even those already physically mature. Initial justified concerns for babies have grown into a worldwide industry of “pediatric” studies that mostly are medically pointless and often even harmful. But they make perfect sense if you look at who benefits. The AAP and the FDA had become strong allies and managed together with other key players to convince lawmakers to reward pediatric drug studies with patent extensions. Such patent extension allowed companies to sell their patented drugs for 6 months long at a high price. But these patent extensions also gave pediatric researchers suddenly access to requests for advice and for conducting pediatric studies. Pediatric careers emerged in academic research, regulatory authorities, clinical research organizations, and pharmaceutical companies.


My Most Recent Publication

How Parents with a Sick Child Can Escape the Labyrinth of Lies, Hypocrisy, and False PromisesĀ 


Release Date

2021

Total Pages

240

Language

English

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Career Continued

The underlying blur in “pediatric drug development” is that the administrative definition of children is equated with an alleged physical distinction of adults and children by the verge of legal adulthood, the 18th birthday. A 16-years-old athlete is legally and administratively still a child with 16 years. But an athlete of 16 years that is taller and stronger than one or both parents is bodily no longer a “child”. And drugs treat the body, not somebody’s legal status.

I am publishing about this challenge with friends and colleagues in international peer-reviewed medical journals.1,2,3 My first medical textbook was released in 2020,4.1,4.2,5 the 2nd will be released in 2021.6 More are in the pipeline. Without expecting it, I came across the largest abuse of humans in medical research since the unveiling of inhuman studies in the USA in 1966,7,8 and the Tuskegee Study, which terminated in 1972.9 Before the COVID-19 pandemic, I regularly lectured at international conferences. My first online course will be on September 9 & 10, 2021.10 Face-to-face conferences will start again soon.

My focus has expanded from advising pharmaceutical companies to publishing, lecturing, advising clinicians, lawyers, patient advocacy groups, journalists, and more. I am open to suggestions. E-mailĀ  klaus.rose@klausrose.net or call +41 61 312 0510.

References as hyperlinks

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