Showing posts with label safety. Show all posts
Showing posts with label safety. Show all posts

Monday, 28 March 2016

Week 2 of the vaccine scandal: latest developments


by MICHAEL WOODHEAD
It is quite remarkable that in the middle of the second week of the scandal around distribution of dud vaccines there has been no comment whatsoever from China's health minister Li Bin. In fact the response from the Chinese government could be summed up as an attitude of "Crisis? What crisis?"

The official line has been to focus on the perpetrators - the illegal wholesalers and distributors in Shandong -  and to avoid any analysis of how things could go so badly wrong - and what the Chinese public should do about it all.

It seems clear that the government has been 'harmonising' (deleting and censoring) media and online articles and social media discussions relating to the vaccine scandal. The media articles that originally drew attention to the crisis have been removed, and instead replaced with bland assurances from officials that the matter is being investigated and all should be well.

Most of the permitted coverage has been along the lines of the WHO China response, namely:

  • The dud vaccines are unlikely to cause any adverse effects even if not handled according to the cold chain.
  • Most of the vaccines have already been used, and there have been no reports of spikes in adverse events.
  • The illegal distribution is being investigated and the perpetrators brought to justice.
That's it.

There has been no response to important questions such as:
  • How many people received dud vaccines and have any of them acquired diseases because of poor immune protection?
  • What are the most frequent and potentially most severe diseases covered by the dud vaccines?
  • What needs to be done to trace/follow up/test and re-vaccinate those who have received dud vaccines?
  • How can the public be reassured that vaccines currently in the system are not duds? Batch numbers? Locations?
These are just a few of the fundamental questions that any professional and competent medical regulator such as the FDA would be asking. And yet in China there has been no such response. There have been some vague reassuring statements from the China FDA, but no detailed information about the scale of the problem and how it will be addressed.

Once again the "SARS hero" Dr Zhong Nanshan has been given airtime to comment. Speaking at a national influenza conference in Hainan (unfortunate timing) Dr Zhong said there was no need to doubt the quality of Chinese made vaccines and no reasons for panicked parents to seek foreign vaccines or to go to places such as Hong Kong for vaccinations. He also said (quite rightly) that he hoped the vaccine scare would not undermine China's immunisation program, which has markedly reduced or eradicated diseases such as measles, whooping cough, polio and hepatitis B in China.



Fine words, and not to be disputed, but there is a need for more leadership on this issue if public faith in the public vaccination system is to be restored. As I've said before, trust is not easily won and it is a two-way street. If the government does not trust the public with information - if it closes down the communication channels and deletes articles about the vaccine problems then it will just encourage the public to turn to the rumour network.

On a wider level there is little hope for a robust medical and healthcare safety system when there is a culture of punishing those who speak out. In other countries there has been grudging acceptance by authorities that transparency and accountability are needed in clinical matters to ensure safety. Staff have to feel confident that they can speak out - and also feel that it is their duty to do so, rather than feel intimidated or a false sense of loyalty to persons or organisations. In China under Xi Jinping there is currently a major crackdown on those who are outspoken or who dare to question "the core".

And so at the end of March we find that China is facing its biggest health safety crisis since the melamine in milk saga of 2011. And yet if you turn to the medical forums such as DXY.cn there is no discussion and no advice there. They have presumably also been 'harmonised'. A week ago when the scandal first became public, the Deputy director of the Department of Immunology at Peking University Professor Wang Yue expressed shock at the safety implications of the dud vaccine trading.

"This is murder" he said, referring tho the likelihood of people dying from vaccine preventable diseases.

The article has now been taken down.

It's important for Li Bin to show some leadership and act swiftly to restore the public's faith in China's vaccination system. If not, vaccines may become like China's milk formula industry - untrusted, shunned and encouraging consumers to turn to expensive alternative 'grey market' suppliers.

Meanwhile, here are some links to articles of interest:

SARS hero Zhong Nanshan reassures on the vaccine problem, urges public to maintain faith in China's vaccine program

Propaganda Ministry directive: "Don't hype the news on illegal vaccines"

VOA article on the vaccine articles that have been removed and the vaccine keywords that have been blocked on social media

Netizens claim that China's propaganda ministry is highlighting news about Japan's war crimes as a distraction from discussion about vaccine scandal

Hong Kong media raise fears that vaccines may be the new milk powder - will mainland 'raiders' flood Hong Kong to buy up good quality vaccines?

Monday, 20 April 2015

Are Chinese hospitals safe? Fear of blame and shame is common, but the overall safety climate is good

by MICHAEL WOODHEAD

China may not have as many ambulance-chasing lawyers as the US, but healthcare staff live in fear of making mistakes because of a culture of blame and shame. Not so much "Better Call Saul" as "Better Keep Quiet".

While in the west there is now an attempt to make healthcare staff be more open and transparent in reporting medical mistakes, it seems like China has a long way to go in overcoming cultural barriers to admitting to errors. In a survey of 1272 healthcare staff at Shanghai hospitals, researchers found that there was a high level of fear of being blamed and fear of being subject to shame. Almost three quarters of staff said they would be disciplined if found making a mistake and 42% thought that asking for help was a sign of incompetence. A similar proportion of staff - 42% - thought that telling others about mistakes was embarrassing, and 40% of thought that it was better to not report errors in the hope that nobody would notice the mistake.

Worryingly, work pressure was also a major factor in mistakes - and covering them up - with about 60% of staff saying that with higher workloads, management forced them to work faster and taking shortcuts that might negatively affect patient safety. About 40% of hospital staff said they had witnessed a coworker do something that appeared to be unsafe in patient care in the last year and one in three staff admitted they had done something that was unsafe for patient car.

The fear of blame and shame phenomenon appears to be an Asian and Chinese concept. The 40-70% levels of 'blame and shame' fears seen in the study were much higher than the 5% rates seen in U.S. hospitals. As the authors note:

"Chinese society tends to be more collective than the Western society, which is called “familial collectivism” People admitting mistakes do not only embarrass themselves but also embarrass the team. Thus, [healthcare] workers may be reluctant to admit to making mistakes in China."

Interestingly, doctors had the highest levels of  “fear of shame” and the researchers said this chimed with the finding that Chinese doctors do not believe that “human error is inevitable”,  - in other words, Chinese doctors feel they must act like gods and be seen to be infallible - whereas admitting a mistake would be a sign of incompetence. This is consistent with “fear of shame” being particularly high among physicians. The Confucian ethic was also seen in the high levels of fear about reporting mistakes made by more senior staff that endanger patient safety.

Nevertheless, the overall safety climate in hospitals was no worse than that seen in the US, with 15% of staff giving 'problematic' responses to safety questions. As the authors said, Chinese healthcare workers are only likely to report mistakes and safety issue when they feel psychologically safe and do not have to fear being blamed and shamed.

The findings are published in BioMed Central.