nytimes.com/2024/04/15/heal...
this company apparently makes Imbruvica and is now being looked at ????
Maybe we should start writing letters to polit... - CLL Support
Maybe we should start writing letters to politicians or otherwise putting pressure on the goons who are "scrutinizing the Chinese"
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GettinThruIt
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Jm954Administrator
I can't get access to the article without taking out a subscription. Can you give us a better idea of what is said.
Lawmakers raising national security concerns and seeking to disconnect a major Chinese firm from U.S. pharmaceutical interests have rattled the biotech industry. The firm is deeply involved in development and manufacturing of crucial therapies for cancer, cystic fibrosis, H.I.V. and other illnesses.
one of those being Imbruvica.....also, try changing browsers and messing around a bit usually you can get one or two articles for free, I get it for free through my library subscription
Firm is called WUXI if I'm not mistaken.
Thanks, there has been some disquiet about the scrutiny and oversight that is imposed by theFDA on Chinese pharma companies.
The long and short of it is that the Chinese companies' processes and products are meant to be quality assured and checked by the FDA but apparently the FDA have to book appointments to go and see the paperwork etc months in advance and there are strong suspicions that much of the QA data is fraudulent and doesn't reflect reality. 
Thank you Jackie for a sensible and balanced response.
Curious to know why GettinThrult posted this comment and wondered if they have spent any time in China.
Colette
I just posted it because I came across it reading and it seemed relevant, especially as the vote to ban Tik Tok is coming up it seems like the China scare is fairly real. I haven't been, but am inclined to agree that the Chinese quality control is not great ....
But just posting a link, without context as to why, is actually against "the rules". Your title and sentence barely meet the criteria & do not give any context as to what the link is about, & why you think it's important.
I don't know about others, but no way am I going to click on some random Internet link without knowing what it's about. Even if it's in a locked post (and yours isn't) of this Forum.
Good point, I've seen an uptick in "shared" articles that are only a hypertext link. I think that another good thing to think about is to consider the information outlet and the relationship to the subject.
I don't feel that a media source that has say, business investments as a focus is great to tout the efficacy of a beloved new darling of the medicine world.
On the other hand, to report that the success of a particular drug is creating a demand, such that it is influencing the cost of a class of drugs to lower pricing among contenders for market share, benefitting patient access to drugs seems entirely germane to why one would post to begin with.
Now the second case, is only my opinion as to source veracity and intent, but not some sort of rule or policy.
Perhaps, someone read an article in an non-traditional source and that informed them about a drug, no problem asking a question about it; that actually protects and informs the community. However, to suggest a medicine from "Uncle Fred's Your Guess Is As Good As Mine" periodical isn't helpful in pursuing a trustworthy knowledge base for the forum. 🙂
Which is not the case here I think you’re referencing something else
You're right, only the first part, where I agree with Sofia. sorry 🙂
Fully concur. Thanks
I decided not to redo the whole thing but point taken
Isn't this the generic ibrutinib? Instead of brand name Imbruvica? Isn't Imbuvica manufactured by Catalent for the (former company) division AbbVie purchased? I understand it is co-marketed with Jannsen; AbbVie does the US, Janssen does elsewhere.
And does this article say that the FDA is having problems accessing this company's manufacturing facilities in the US for inspection purposes?
Chinese need to be scrutinized. Especially after covid.
I get the "whatever we can do wherever however" sentiment. Nonetheless, the idea of writing to politicians to further an issue without knowing anything more about competing issues than this one NYT article re scrutiny on China does not seem wise to me.
It would be premature and wasn’t a call to action really I wanted people to know about the issue but I can see I should have made the post differently … if Imbruvica becomes among one of the many drugs that is difficult to obtain in a year or two this article was the first indication .. I’m sure to anyone reading this comment that probably seems impossible so take it with a grain of salt
I think it's good to alert people to a potential problem down the pike and steps being taken now that might cause it. I'm not on imbruvica but would be horrible to be using ANY drug effectively that then becomes unavailable. I've often wondered about the quality of the meds from other countries -- not only in China but my impression is that a huge amount are made in India, and not always to our standards.
Well... addressing the original point.
There are likely reasons to be concerned. WuXi is one big maker of CLL drugs (ibrutinib), BeiGene makes a couple more (zanubrutinib, sonrotoclax) and both have strong Chinese ties/origin, though BeiGene is a bit of a hybrid ownership model.
Acalabrutinib is Astra Zeneca these days and venetoclax is an AbbVie / Genentech comarketing agreement. Pirtobrutinib is Eli Lilly. The CAR-T treatments are generally US or European. But... all the non-China manufactured drugs likely have precursor dependency on China at some point in the chemical supply chain anyway.
So US/China trade war (or shooting war) issues are potential impacts to a drug supply this board depends on.
I'm not sure whether we know enough to advocate for a solution, though. Yes, there are IP and skills migration/theft concerns. Yes, quality of manufacture and quality of China-conducted clinical trials are also concerns.
But... it's not like the US entities don't have access to the underlying information about drug composition and manufacture. I would guess we could re-create any missing drug manufacture, perhaps with some time lag, and knowing there are US stockpiles of some of the Chinese supplied medicines. And I'm not convinced that China has enough true research expertise to make shutting the rest of the world out a big concern just yet.
