DanArmak comments on 80% of data in Chinese clinical trials have been fabricated - Less Wrong

6 Post author: DanArmak 02 October 2016 07:38AM

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Comment author: DanArmak 02 October 2016 05:54:18PM 0 points [-]

I assume the Chinese government can't just deprive its citizens of legal medicine altogether. Either (1) enough things remain approved and enough new things keep being approved to satisfy the market for the really important remedies. Or (2) the rich will import European/American/Japanese/etc. approved medicine (which I've heard they already do to a large extent), and the poor will buy unauthorized local medicine on the black market (or unauthorized supposed imports), and be worse off than today.

But if you declare >80% of local medicine bad, and also create a huge uncertainty as to what's bad and what isn't (presumably they haven't retested all previously approved medicine), I find it hard to believe scenario 2 won't happen. And it doesn't seem to be in the Chinese government's interest if they want to improve the state of local medicine. At least not in the short to medium term.

I'm confused, and I don't think I'm seeing the whole picture.

Comment author: ChristianKl 02 October 2016 06:49:40PM *  2 points [-]

The Chinese used to be very lax about approving medicine. They changed and decided to have higher standards that declare 80% of the medicine to be bad. This means that in the future Chinese companies that want to get new drugs on the market have to do things differently.

But if you declare >80% of local medicine bad

They are declare >80% of "1,622 clinical trials for new pharmaceutical drugs currently awaiting approval" to be bad. That doesn't mean that they take existing drugs off the market.

I'm confused, and I don't think I'm seeing the whole picture.

It's difficult to see the whole picture because the "journalists" don't really care to investigate what's happening and the information is only available between the lines. Currently there's likely strong back-door fighting going on in China.

I'm not sure to what extend this affects the approval of Big Pharma drugs that have FDA approvals. The article unfortunately doesn't speak about it.

Over the long-term it's likely a goal of the Chinese government to raise their quality standards in a way that China can export drugs to the West.

Comment author: DanArmak 03 October 2016 12:14:53AM 0 points [-]

They are declare >80% of "1,622 clinical trials for new pharmaceutical drugs currently awaiting approval" to be bad. That doesn't mean that they take existing drugs off the market.

One problem is that consumers might decide >80% of all previously approved drugs are bad, but they don't know which, so they can't trust any of them. Chinese pharma revenues will drop as everyone who can will use drugs imported from abroad. Gray markets providing bulk medicine imports will flourish, but the buyers who can afford to use them should beware of fraudulent merchandise and of plain misunderstandings and mistranslations.

Comment author: ChristianKl 03 October 2016 02:39:10PM *  1 point [-]

One problem is that consumers might decide >80% of all previously approved drugs are bad, but they don't know which, so they can't trust any of them.

It likely wasn't an easy decision. At the same time I don't think there was trust in the trials to begin with that they could destroy.

Chinese pharma revenues will drop as everyone who can will use drugs imported from abroad.

There are approved drugs from Western companies that can be legally brought in China. I think this Crackdown focuses more on Chinese companies.

Googling brought me to an article:

CFDA has united with more than 25 other government agencies for a coordinated crackdown on drug producers that engage in dishonest activities. The initiative is part of the government’s contentious social credit scheme, which aims to monitor the corporate integrity of companies active in China. [...] The plan is to use these powers to more forcefully punish wrongdoers. Companies that get on the wrong side of CFDA could be cut off from government financial support and procurement programs. A negative credit score could also cause a company to be subject to more rigorous tax assessments, encounter barriers when applying for customs certificates or suffer many other difficulties intended to punish their behavior.

This is highly political. If you look at Chinese policies like the One-Child policy there was also collateral damage.

Just imagine what would happen in the US if either Clinton or Trump would say: "The IRS should be extra tough on those Big Pharma companies that are dishonest."