Trump and Roche and Davos = autism drug fasttracked

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You may have read about the US Food and Drug Administration (FDA) granting "Breakthrough Therapy" status to an autism drug developed by Swiss pharmaceutical company Roche:

https://www.disabilityscoop.com/2018/01 ... rug/24649/

What's not been reported in this context is that Roche chairman Christoph Franz has been lauding Trump and his administration and is actively lobbying US Secretary of Commerce Wilbur Ross, whom he met most recently last week at the World Economic Forum in Davos, which was also attended by FDA Commissioner Scott Gottlieb and Trump himself.

In German:
https://www.blick.ch/news/wirtschaft/ro ... 94422.html

In English:
https://www.nytimes.com/reuters/2018/01 ... trump.html

"Fears U.S. President Donald Trump could damage the drugs industry have not been realised and the administration's efforts to accelerate new medicine approvals will bolster the sector, the chairman of Swiss drugmaker Roche said. 'The US Food and Drug Administration (FDA) wants to trim the time it takes for drugs to be approved,' Christoph Franz told Swiss newspaper Blick in an interview published on Friday. [...] FDA Commissioner Scott Gottlieb, whom Trump brought in, aims to approve drugs based on very early data [...]. 'Fears that Trump would damage the pharmaceuticals branch have not been realised,' Franz, who was in Davos for the World Economic Forum meeting, told Blick in the interview. 'It's quite the opposite. We see new opportunities."

Swiss newspapers also reported on Saturday about a dinner Trump had held with business leaders, including heads of pharmaceutical companies, where they outdid themselves praising the new Trump-appointed head of the FDA for speeding up the drug approval process. This fasttracked autism drug is just a case in point.

In German:
https://www.bernerzeitung.ch/wirtschaft ... er-id=2521

In English:
https://www.statnews.com/2018/01/26/got ... ump-davos/

"at a dinner with European business leaders at the glitzy World Economic Forum on Thursday night, Trump had only praise for Food and Drug Administration Commissioner Scott Gottlieb, one of the administration officials to accompany the president to Davos. 'Scott Gottlieb, as you know, is a star,' he said. [...] His agency releases press releases at breakneck speed"

"Pharma gets seat at the table at private dinner with Trump at Davos"
https://www.statnews.com/2018/01/25/pha ... os-dinner/

Just some context.

Thanks for the info.

Seems cure-ism and overmedication are alive and well

The European Medicines Agency (EMA) will be holding an international awareness session for, among others, academia and NGOs. This sounds like it could be of interest to autistic people in the EU who wish to understand how the regulatory process for new medicines works, particularly now that Roche's autism drug was recently fasttracked by the FDA in the US. Hopefully, EMA will also inform about oversight of medical trials in the EU with regard to other pharmaceutical and/or genetic autism research.

Date: 8-9 March 2018
Location: European Medicines Agency, London, UK
Summary: "This two-day awareness session for international regulators , academia and non-governmental organisations (NGOs) will give an insight into how the European medicines regulatory network works, the role of European Medicines Agency (EMA), scientific aspects of EMA's work and its interaction with scientific experts. It will address topics including the role of experts and benefit-risk evaluation. It will also provide networking opportunities with academics, NGOs staff and regulators from and outside the European Union. The event will be broadcast live. EMA will publish further material after the event."

Registration deadline is 16 February, but they say the event is already fully booked and prospective participants will be placed on a waiting list. In any event, please consider following the live broadcast.

http://www.ema.europa.eu/ema/index.jsp? ... 058004d5c3