Problems in Chinese clinical trials

I came across this story some weeks ago, and have been wondering why it hasn’t received more widespread coverage in the science-sphere and in the news.

80% of data in Chinese clinical trials have been fabricated

A Chinese government investigation has revealed that more than 80 percent of the data used in clinical trials of new pharmaceutical drugs have been “fabricated“.

The report uncovered fraudulent behaviour at almost every level, and showed that some pharmaceutical companies had hidden or deleted records of potentially adverse side effects, and tampered with data that didn’t meet their desired outcomes.

In light of the findings, 80 percent of current drug applications, which were awaiting approval for mass production, have now been cancelled.

The investigation, led by the Chinese State Food and Drug Administration (SFDA), looked at data from 1,622 clinical trials for new pharmaceutical drugs currently awaiting approval. The applications in question were all for Western medicine, not traditional Chinese medicine.

The SFDA found that the more than 80 percent of the data failed to meet analysis requirements, were incomplete, or totally non-existent.

The lack of general coverage worried me, as this seems like a major story, so I decided to try to dig deeper into the story before writing about it.

This proved to be wise, as the first reports wasn’t as complete as one could have wished.

CFDA: reports of clinical trial data fraud ‘not fact based’

The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”

According to this article, most of the trials were voluntarily withdrawn during a self-examination process, and were thus not found to be fraudulent by the CFDA. Another article adds a bit more details:

Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity

China’s Food and Drug Administration (CFDA) has opened investigations into 11 clinical trial sites and contract research organizations (CROs) as part of a data verification drive initiated last year. The regulator suspects the sites and CROs generated fraudulent clinical trial data to support 27 new drug applications.

CFDA released details of the investigations as part of a breakdown of the numbers associated with the self-audit of drug applications by organizations seeking approval in China. Of the 1,622 applicants asked to carry out the self-examination in July 2015, 1,193 organizations withdrew their submissions voluntarily after receiving the regulator’s request. CFDA allowed applicants to withdraw their filings without facing punishment. As 193 of the applicants were exempt from clinical trials, the withdrawals amount to 83% of all the submissions that went through the self-audit.

The regulator is seeking to dispel reports all of the applications were withdrawn because their data were fraudulent. While CFDA acknowledges some of the applications included false data, deliberately or by mistake, others were withdrawn because of more prosaic failings. Some of the withdrawals were triggered by recognition of failures to comply with good clinical practices (GCPs). Others were a result of the clinical trial data falling short of what is needed to demonstrate the safety and efficacy of a medicine

So, it seems like it is overstating it to claim that over 80% of all Chinese clinical trials contained fraudulent data.

It does, however, seem like one could make the claim that there have been found widespread problems with the data in Chinese trials – either through self-examination or through official data verification – otherwise, why would so many results be voluntary withdrawn?

I am happy to see that the Chinese authorities are following up with investigations into clinical trial sites and contract research organizations.

 

 

A reversal of roles in India

India is a country with a huge problem with inequality between the rich and the poor. If you look at the list of countries by inequality-adjusted HDI, India appears as number 99 on the list. Much of this is caused by the caste system, but other related factors, such as widespread nepotism and corruption also plays in.

In an attempt to root out the problems of unaccounted wealth and corruption, Prime Minister Narendra Modi has scrapped the 500 and 1000 rupee notes overnight. People in possession of such notes, have to deposit them in banks by the end of December (though I have seen news reports, that indicate that the exchange might continue after this). Of course, the tax department is keeping a keen eye on these deposits, and any unaccounted money will be hit with taxes and a heavy fine.

Not everyone in India thinks this approach is the right one, but it does look like it has some effect:

For the first time in India, the rich beg the poor to help them

Driver Rahul Sharma, 25, remembers the exact day when his employer turned from a wolf into a lamb. It was November 9 when his employer called him  beta  – Hindi for “dear” – for the first time. The maid was asked to give him a cup of tea, for the first time.

“I was shocked at his sudden niceness. It went on for two days,” said Sharma. For the past three years, his New Delhi-based employer has been abusive, bad-tempered, and imperious, often demanding that he turn up for work at 6am after finishing work at midnight.

“He didn’t even bother to remember my name. When he wanted to summon me, he’d call out ‘driver!’,” Sharma said.

“On the third day, the penny dropped. He asked me to deposit 250,000 rupees ($4900) in my bank account on his behalf so that he could get rid of his black money.”

According to the article, a lot of poor people employed by rich Indians, are getting approached by their employers in order to help them whitewash their money. This certainly indicates that there is some kind of effect. I am cynical enough to think that the rich people will find ways around the barriers (if nothing else, then through bribery), but in the process, there might be some benefits for the poor.

 

 

Lazy linking

A few links to things I have come across recently

3 Men Arrested in Plot to Bomb Kansas Aparment Complex, Mosque Following Presidential Election

Three members of a southwest Kansas militia dubbed the “Crusaders” were arrested Friday on charges stemming from a plot to attack a housing complex that houses a mosque in Garden City, Kan.

It is hardly a surprise that right-wingers are a genuine terrorist threat in the US, and it is good to see that the law enforcement are aware of this, and can stop them before they can effectuate their plans.

 

Parkinson’s researcher with three retractions heads to court on Monday

On Monday, Parkinson’s researcher Caroline Barwood will head to court in Brisbane, Australia, following a probe at her former institution, the University of Queensland (UQ).

Barwood was granted bail in November, 2014 — charges included  that she “dishonestly applied for grant funds,” and fabricated research that claimed a breakthrough in treating Parkinson’s disease, according to The Guardian. In March, Bruce Murdoch, a former colleague of Barwood’s at UQ, pleaded guilty to 17 fraud-related charges, and received a two-year suspended sentence after an institutional investigation into 92 academic papers.

It is fairly rare that scientists are facing trial after having fabricated research, probably because it can be difficult to be sure whether they actually fraudulently fabricated their result. In cases like this, where there were claims of breakthroughs in an area, giving people false hope, I think it is important for there to be a legal follow up.

 

Taking Trump voters’ concerns seriously means listening to what they’re actually saying

Donald Trump’s supporters deserve to have their concerns taken seriously.

If the media and commentators in 2016 can agree on nothing else, it’s this. It’s a bit of an odd meme. I can remember literally no one in 2012 dwelling on the importance of taking the concerns of Mitt Romney voters seriously, even though they made up a considerably larger share of the population than Trump supporters. No one talks about taking the interests of Hillary Clinton supporters, a still larger group, seriously.

But Trump supporters, a smaller group backing a considerably more loathsome agenda, have received an unprecedented outpouring of sympathy, undertaken as a sort of passive-aggressive snipe at unnamed other commentators and politicians perceived to not be taking their concerns seriously.

…

But there’s something striking about this line of commentary: It doesn’t take the stated concerns of Trump voters, and voters for similar far-right populists abroad, seriously in the slightest.

…

In the primary, though, the story was, as my colleague Zack Beauchamp has explained at length, almost entirely about racial resentment. There’s a wide array of data to back this up.

UCLA’s Michael Tesler has found that support for Trump in the primaries strongly correlated with respondents’ racial resentment, as measured by survey data. Similarly, Republican voters with the lowest opinions of Muslims were the most likely to vote for Trump, and voters who strongly support mass deportation of undocumented immigrants were likelier to support him in the primaries too.

We see the same in Denmark, where we always hear about how the voters for the xenophobic Danish Peoples’ Party (Dansk Folkeparti) have a lot of concerns which we should take serious, but when you listen to what the actual supporters say, it is all about foreigners and getting rid of them.

 

Male members form a barrier for women joining the corporate boards

Slate reports on PwC’s 2016 Annual Corporate Directors Survey, and points out something important.

Male Corporate Board Members Aren’t Stoked About Adding Women to Their Ranks

Much has been made over gender diversity on corporate boards in recent years. Study after study after study has shown that companies perform better when they have women on their boards of directors; it’s fair to assume that even the most crotchety, least woke board member would admit that gender diversity is an admirable goal, in theory.

Or is it? According to a new survey of 884 directors of public companies, 10 percent of current board members think the ideal number of women on a corporate board is somewhere between 20 percent of the board and zero. Zero! One in 10 directors mulled over the prospect of sharing a conference table with women and thought, “I could tolerate zero women, or maybe a very tiny proportion of women, but that is absolutely it.”

Every time the subject of women in corporate boards come up, there are always someone who claims that women have equal opportunity, and that there is no need for quotas or other measures to get more women into corporate boards. This study clearly shows that this is nonsense – there is an significant number of existing members of the boards that are actively against more women on the boards, so they form a barrier for women to join.

And don’t expect that corporate boards are swayed by evidence. As Slate stated, there are many studies that show that companies perform better when they have women on their boards of directors, but this doesn’t convince the male members

diversity-male-female-opinions

Source of the figure.

Given the weight of the evidence, the clear correct answers to the questions is “very much”, yet a majority of men doesn’t think this is the case.

Birds in nerdery

I love it when someone who is nerdy in one area, applies their nerdiness to more mainstream nerdery.

A good example of this, is this article by Peter Cashwell

Why that American Robin Cameo in ‘The Hobbit’ Wasn’t an Error

In this article, Peter Cashwell argues that it is fully acceptable that an American Robin appeared in The Hobbit movies, since it is a fantasy setting, which isn’t meant to mirror Earth exactly. I have known Peter Cashwell online for close to 2 decades, and his nerd credentials regarding mainstream nerdery (comics, sci-fi etc.) can’t be disputed. When it comes to birds, he has written the brilliant The Verb: To Bird about birding.

Speaking of birds, and popular culture, Peter Cashwell’s article for some reason made me think of this piece of brilliance:

Estimating the Airspeed Velocity of an Unladen Swallow by Jonathan Corum

Here Jonathan Corum answers the ancient question, what is the airspeed velocity of an unladen swallow?

Support Skepticon

Every year the awesome crowd of Skepticon is putting together a free skeptic conference in the middle of no-where (or rather Springfield, Missouri).

It is free for the participants, but unfortunately, it still costs money to put up a conference. This year, the fundraising has been going slow, and now there is only a month left to raise the final money they need to put on an awesome program.

So, if you have some spare money, consider throwing some in the direction of Skepticon.

I am planning on going to the conference, so if you are there, come and say hi.

Music with a message

I think this band is trying to tell us something

For the record: I quite like black metal, but I found this video/song funny, and thought I’d share.

NPR reports on suicides in Greenland

As some of you might know, the Kingdom of Denmark (or the Danish Realm) is formed by three autonomous countries – the Faroe Islands, Greenland, and Denmark.

This has not always been the case – the Faroe Islands and Greenland was considered part of Denmark since the forming of the Kalmar Union in 1397, and didn’t become autonomous until 2005 and 2009 respectively. As a step towards becoming autonomous, both the Faroe Islands and Greenland received home rule – though in Greenland’s case, it didn’t have until 1979.

Before 1979, Greenland had been a colony of Denmark-Norway for centuries until 1953, where it was turned into a county in Denmark.

At the same time as Greenland was turned into a county, a lot of well-meaning Danes attempted to modernize the Greenlandic Inuits, making them less dependent upon seal hunting and fishing.

Some of the measures done in these attempts have since become known to the general public – most notable the story of the 22 kids that were taken from their parents in Greenland and put into foster care in Denmark, resulting in them loosing their language and culture. This is similar to things that has happened to indigenous people in Australia and Canada.

Such a forced modernization always have a negative effect on the local population – a negative effect that goes on for generations.

This receives very little coverage in Denmark.

Now, however I see that NPR has an article in Danish about the suicide rate in Greenland – a suicide rate that, at least partly, can be traced back to the policies of Denmark in Greenland.

Selvmord i Grønland: Det er ikke mørket, som dræber dig

There is also a version in English: The Arctic Suicides: It’s Not The Dark That Kills You

It is depressing that it takes a foreign newsmedia to cover a serious problem in a country that is part of the Kingdom of Denmark, but unfortunately, the Danish media doesn’t seem to cover such subjects.

I guess Biden is not a Trump fan

ABC has uploaded a speech by Vice President Joe Biden, where he talks about Donald Trump. The description doesn’t say where and when it was given, but it was clearly after the first presidential debate.

I think the speech is pretty powerful, and could help move some doubters – either to not vote Trump or to vote Clinton.

What’s interesting, is that Biden’s speech is mostly about Trump’s one-liners (“because I’m smart”, “that’s called good business”), which demonstrates once again that the biggest liability for the Trump campaign is Donald Trump

Calling their bluff

I am spending some of my Sunday working, and as a treat to myself, I’ve bought myself some chocolate frogs.

Chocolate frogs in bags Chocolate frogs on plate

I think we all know to avoid colorful frogs, so these are clearly signaling to me that they are dangerous. I think it is a bluff though, and will not fall for it!