This is a linkpost for /r/discussion/lw/nzi/80_of_data_in_chinese_clinical_trials_have_been/
The article misses the point. It doesn't talk about the significance of the story.
A better headline might be "The Chinese government decided that it's in their interest to be public about data fabrication by Chinese scientists."
Given that this comes right after the Chinese government decides that it makes sense to reduce red meat consumption in China, it's a sign of progress and good Chinese leadership.
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.
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.
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.
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."
Missing link: should point to Science Alert.
Article says the Chinese State Food and Drug Adminstration (CFDA or SFDA) conducted an internal review of the drugs currently pending approval, and found out that in more than 80%:
the data failed to meet analysis requirements, were incomplete, or totally non-existent. [Also], many clinical trial outcomes were written before the trials had actually taken place. [...] The report found that pretty much everyone involved was guilty of some kind of malpractice of fraud. [...] even third party independent investigators tasked with inspecting clinical trial facilities are mentioned in the report as being "accomplices in data fabrication due to cut-throat competition and economic motivation".
There's no matching news item on the SFDA site; it probably doesn't have an official version in English. The article linked relies on this and that.
Compare and contrast with Scott Alexander's idea of making the American FDA regulate less. Two ends of a spectrum? Different cultures and markets leading to different outcomes? Similar situations but better hidden in the American case?
Compare and contrast with Scott Alexander's idea of making the American FDA regulate less.
The FDA actually does regulate less than the CFDA in this case. The FDA doesn't disapprove 80% of the drug seeking approval for misbehavior.
If you look at the Ranbaxy case the FDA is quite bad at detecting data forgery of generics companies.
This raises some interesting questions.
If the end result is fraud and bad medicine, whether you regulate more or less, is that a reason to regulate less so money isn't wasted on mandatory fraudulent studies?
Regulation raises the the barrier of entry to selling medicine. Does this reduce the amount of fraud because it's harder to to sell completely untested medicine and there's at least some quality control by the regulator? Or does it increase the amount of fraud because once a drug costs huge amounts of money to develop and approve, companies are less willing to take a loss if they discover the drug doesn't really work, and so lie more?
Let's take New England Journal of Medicine. It's a journal that pretends to do peer review. It's the highest ranked journal in medicine. The New England Journal of Medicine endorsed the CONSORT guidelines on best practice in trial reporting.
Does the peer review mean that authors who submit papers to the journal get told to modify their papers to fulfill the standards laid out in the CONSORT guidelines? No, the top rated journal in medicine doesn't use peer review to make sure that the papers in their journal fulfill the standards that the journal endorsed.
What does the FDA do about such violations of scientific integrity? It doesn't care. The NHI doesn't even fund projects fighting it, so Ben Goldacre needed to get outside sources of money with the Laura and John Arnold Foundation (hedge fund billionaire money).
The problem with the FDA isn't that they regulate a lot but that they regulate in the interests of Big Pharma instead of regulating in the interest of the citizens.
Tort reform also seems to be important in the US context and the example that Scott brought. It wasn't just the FDA regulating but a company withdrawing their product to avoid getting sued.
Don't regulate efficiency. Regulate consistency of formulation, at most.
There are plenty of actors interested in efficacy. Really, everyone else involved.
Don't regulate efficiency. Regulate consistency of formulation, at most.
What's generally regulated is side-effects.
If you don't regulate truthfullness of published efficacy info, then companies will compete on advertising and bad studies to claim efficacy of their products. I don't think that would lead to a marketplace where non-experts could reach correct conclusions about efficacy.
I have no real idea about the efficacy of most non-regulated things I'm sold, from deodorants and toothpaste to computer software. It's just that with these things, the risk of occasionally buying something bad and learning not to use that anymore is acceptable. Not so with medicine.
I sent Derek Lowe yesterday an email about the story and he today published: http://blogs.sciencemag.org/pipeline/archives/2016/10/04/chinas-internal-drug-market-a-mess#comment-274193 His blog is generally one of the best places for serious discussion of a subject like this and various people comment.
Only 80%?
Still better than allowing diesel cancer to spread wildly in the population... that's going to be DDT of 21st century: looked miraculous at the first look, turned deadly Satan's invention. In the article, risks are admitted, but severity dismissed (hard to prove wrt.. DDT)
How do diesel exhaust fumes cause cancer?
When diesel burns inside an engine it releases two potentially cancer-causing things: microscopic soot particles, and chemicals called ‘polycyclic aromatic hydrocarbons’, or PAHs. According to Phillips, there are three possible ways these can cause cancer:
“Firstly, inhaled PAHs could directly damage the DNA in the cells of our lungs – leading to cancer.
“Secondly, the soot particles can get lodged deep inside the lungs, causing long-term inflammation, and thirdly this can increase the rate at which cells divide. So if any nearby lung cells pick up random mutations, this inflammation could, theoretically, make them more likely to grow and spread.
chemicals called ‘polycyclic aromatic hydrocarbons’, or PAHs
PAHs form when you cook meat over fire. Sure you don't want to start by forbidding that? :-/
Last i heard, the FDA doesn't actually care about efficacy, it only cares about process. It focuses on the formulation of studies, and fabrication and manufacturing processes. basically an ISO 9001 type certification.
I can't figure out how to edit the post description to include a summary paragraph. Help?
... Now the actual link is gone and I can't edit it back in! It's supposed to point here. Mods/admins, can you help? Here is a screenshot of what I see.