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?

11 things we know about the expired vaccine scandal

by MICHAEL WOODHEAD
The expired vaccine 'shame' originating in Shandong has caused a huge outcry of concern in China and has prompted angry reactions from the very top leaders, including Li Keqiang. 

Here's what we know so far:

1. More than 2 million doses of expired or spoiled vaccine worth $88 million have been sold by a rogue Shandong wholesaler since 2011.

2. Between 12 and 25 different vaccine products were involved. They were Class 2 (non-essential/optional) vaccines such as rabies and Japanese encephalitis, which are distributed via private wholesalers rather than though the centralised buying system used for Class 1 (essential/state-funded vaccines). The vaccine products affected are said to include: 

• Rabies, Rabies immune globulin
• Varicella, 
• Haemophilus influenza B (Hib), 
• Pneumococcal polysaccharide vaccine (23-valent) 
• Meningococcal A/C vaccine 
• Influenza vaccine, 
• Hepatitis B vaccine

3. The mother and daughter team of rogue sellers have been arrested, along with 37 other suspects in Shandong. They are believed to have bought cheap vaccines that had expired or had not been stored or transported according to cold chain methods to ensure they remained viable. Three pharmaceutical companies have been investigated and one has had its manufacturing and distribution suspended. A further nine wholesalers are under investigation.

4. The National Health and Family Planning Commission and the China FDA say they are now "resolutely investigating the relevant departments" and actively tracking down where the vaccines have been sold to 24 provinces. Officials say each vaccine and recipient should be traceable by barcode and batch number. Authorities are now investigating the case at the behest of Premier Li Keqiang, who has called in law enforcement authorities and said there were obvious loopholes in the regulatory system for the supply and distribution of Class 2 vaccines.

5. The WHO say that there should be no major adverse effects in recipients of vaccines that have expired or not been handled according to the cold chain procedures - however the recipients may not have received an adequate immune response and would not be protected against the infections for which the vaccine was given. The WHO has urged the Chinese public to maintain faith in the immunisation system and it emphasises that vaccination programs have helped reduce China's high burden of infectious diseases.

6. The NHFPC says there have not been any notable spikes in vaccine related adverse effects but it is now checking figures - particularly for the Shandong area.

7. Chinese netizens are asking why the information was only brought to light in February 2016 when the authorities became aware of the problem in April 2015. This raises obvious questions of whether vaccines could have been traced and recalled before being given to unsuspecting patients.

8. There has been public outrage and 'vaccine panic', with many Chinese expressing scepticism about the quality of Chinese made and distributed vaccines and anger about the integrity of the medical safety surveillance and regulatory system. There are fears for vaccination rates may fall as the public lose faith in public vaccine programs.

9. Some of the more open media outlets have blamed China's lax approach to food and medicine safety on the authorities' lack of accountability and transparency and also the routine censorship of and control of 'bad' news. Caixin magazine ran a feature that harked back to a previous hepatitis B vaccine adverse events scandal from 2013, but the article was later deleted.

10. Some analysts have said that the Class 2 non-essential vaccine distribution system is ripe for corruption. It has minimal regulation and there are strong financial incentives for unscrupulous wholesalers and local disease control departments to collude to make commissions and backhanders off sales of unreliable vaccines.

11. China CDC director Wang Huaqing says that after a full investigation some children and adults may need to undergo repeat vaccinations to ensure they are covered against certain diseases. However he says the more widespread impact is likely to be on herd immunity levels in the population rather than individual risk of infection.

My January news blog ...

Regrettably, I am cutting back on my blogging about China medical news this year. I've been doing this for more than a year now, out of enthusiasm and my own personal interest in the area, but it's becoming too much of a burden on my time. And of course it is all unpaid. Unless there is a sponsor out there who wishes a regular stream of China medical news? After my day job doing much the same thing about Australian medical news I find it hard to sit down at home and do the writing for this blog. So from now on I shall probably only update the site about once a week. That is not enough to cover the many things happening in healthcare in China, but that's your lot. As they say in Yorkshire, you don't get owt for nowt.

This week I have been reading about how patients in Shanghai with chronic diseases will now be able to pick up their repeat prescriptions from community clinics instead of the big hospitals. It's a move intended to relieve the overcrowding at the tertiary hospitals and sounds like an obvious and sensible idea. Whether it will work or not depends on whether China's hospital-obsessed patients can be persuaded to show up at the low-status community clinics.

There are also moves to try curb China's high levels (approaching 50%) of caesarean section intervention in pregnancy. A feature article by Yang Wanli describes how some obstetricians in China are trying to persuade women to opt for natural birth. However, the barriers are a lack of available analgesia for women in labour and the industrial production-line mentality of China's hospitals.

Rural health is a major issue in China this month, with the State Council approving a plan to boost the rural medical workforce. The Council wants to see rural areas of China have qualified doctors replace the current 'barefoot' practitioners. However, well-meaning intentions will not fix the huge rural medical workforce problem in China. The simple problem is that university qualified doctors do not want to work in rural villages. The pay is pathetic, there is no status and the workload is high. As this article shows, the current rural medical workforce is mostly unqualified and often dangerously lacking in skills.

That's not to say that rural health is completely hopeless in China. There have been great achievements in some areas of public health such as immunisation and basic child health. However, as a major article by Chinese paediatricians the Archives of Diseases in Childhood shows, the next step for China is to try reduce the incidence of more complex diseases in children. China has done well in tackling the easily preventable causes of child disease, now it must turn its attention to the difficult stuff - the consequences of preterm birth, and the many congenital and metabolic diseases.

One problem with monitoring China's progress in child health is knowing whether or not the official  figures are true. Take measles vaccination for example. According to official reports, China has 95% measles vaccine coverage of infants. But when researchers analysed the causes of measles outbreaks in Hunan and Jiangsu that affected hundreds of children they found that the actual rates of measles immunisation more like 80%.

And finally, for those who put their faith in western healthcare companies helping improve the health of China, take a cautionary look at the sorry tale of GSK. A well regarded company in the west, GSK was the subject of high profile bribery allegations and a court case that jailed one of its British executives for  his role in the bribes to doctors and hospitals. Now the company is reported to be cutting the jobs of 1000 employees in China following the downturn in its business there (including a 60% drop in revenue).

Resisting the Japanese invader: the China success story against Japanese encephalitis

by Michael Woodhead
 As China cranks up its media hate campaign against its former enemy Japan, the country can actually celebrate victory in its war against another 'Japanese' invader from the 1940s: Japanese encephalitis. 

This mosquito borne viral disease used to cause about 200,000 cases of severe neurological illness in China every year at its peak in the 1960s and 70s - with about 30% patients dying and many of the survivors  left with lasting neurological disability as a result of the infection.

The name is misleading - the disease did not originate in Japan, but was first identified there in the 19th century. The infection was first recorded in China in the 1940s and became widespread in the 1960s - partly because of the breakdown in public health preventive activities during the chaos of Mao Zedong's Cultural Revolution.

A vaccine against the virus was developed in Japan in 1965, and China started manufacturing its own vaccine a few years later.  Writing in the journal PLOS Neglected Tropical Diseases, Dr Gao Xiaoyan and colleagues at the Chinese Centre for Disease Control and Prevention, Beijing, describe how Japanese encephalitis was brought under control in China.

The initial Chinese vaccine was only available in limited quantities and required many doses. It was expensive and was only available to privileged cadres and Party members, not to the peasants who were most at risk of the disease. With more than half the cases of Japanese encephalitis in the world, China continued to work on improving the vaccine and eventually developed one in 1988 that was more convenient and could be mass produced at relatively low cost, to make it affordable for public health use.

This vaccine was gradually made available at a cost of 1 yuan to rural residents, and was fully subsidised as a free vaccine after the year 2005. Since it was included in the "Expanded Program of Immunisation" this cheap and effective vaccine had reduced the incidence of Japanese encephalitis in China from 21/100,000 people to just a fraction of 1 per 100,000 - a remarkable achievement.

But the vaccine is not the only reason for the drastic reduction in Japanese encephalitis in China. Other public health measures were implemented by local health authorities to reduce mosquito breeding and transmission:  pig farms were moved away from villages,  sewage disposal was improved to reduce mosquito breeding, and mosquito breeding grounds in areas of static water were eliminated.

The threat from Japanese encephalitis has now been markedly reduced in the more prosperous eastern provinces of China but it remains a problem in the poorer parts of southwest China. Nevertheless, Chinese researchers say other developing countries can copy the Chinese model for eliminating Japanese encephalitis: low cost programs using inexpensive vaccine and anti-mosquito measures.

Most Chinese unwilling to pay for vaccines

by Michael Woodhead
Most Chinese people are unwilling to pay for vaccines to prevent common infections such as influenza and pneumonia, a study has found.
In a survey of more than 2600 people in three provinces, researchers from the China Center for Health Development Studies, Peking University asked whether people would be willing to pay the market price for influenza vaccine that costs 80 yuan ($12) and for a course of pneumococcal conjugate vaccine that costs 860 yuan ($138). Only 8% of people surveyed said they would pay for pneumococcal vaccine while 45% said they were willing to pay for influenza vaccine. The average price people were willing to pay was 60 yuan for influenza vaccine and 200 yuan for pneumococcal vaccine, according to the study in Vaccine.
Put another way, the number of people willing to have pneumococcal vaccine would increase from 8% to 25% if the price reduced from 860 to 400 yuan. The demand for influenza vaccine would increase from 45% to 70% if the price reduced from 80 to 40 yuan.
The researchers said the widespread unwillingness to pay for vaccines reflected their high price in China and the lack of any government subsidy. They said profit mark-ups on vaccines mark ups were high in China (as much as 43%) and they generally cost much more than in other countries.
"Our results suggest that both innovative vaccine pricing mechanism and expansion of financing sources are needed to alleviate economic barriers to self-paid vaccines," they concluded.

Four-fold rise in chickenpox shows China's one-dose varicella vaccination policy is not enough to prevent outbreaks

by Michael Woodhead
China needs to move from a one-dose to a two-dose varicella vaccination schedule because he current system is not preventing outbreaks of chickenpox, a study from Beijing has shown.
There have been more than 62 outbreaks of chickenpox (varicella) among children in the Fengtai district of Beijing since 2008 despite vaccination rates of over 80%, researchers have reported this month. They found that the number of varicella cases has increased fourfold in the district from
from 167 in 2008 to 622 in 2012. More than 60% of the cases were breakthrough infections in children who had been vaccinated, according to Dr Zhang Xue and colleagues at the Department of Epidemiology and Biostatistics, School of Public Health, Capital Medical University.
"These results indicated that in the Beijing Fengtai District, one-dose vaccination could not effectively protect the vaccination recipient from varicella infection or cut off the varicella transmission during the outbreak," they wrote.
Their study suggested that the efficacy of the varicella vaccine wanes after a few years, and in children with varicella, the average time since vaccination was six years, (76% of cases occurred more than five years after vaccination).
Varicella was also more common among children of migrant worker families, presumably because of lower vaccination rates and due to overcrowded living conditions.
The researchers said their findings showed that the single dose vaccine program introduced in 1997 was not sufficient to contain varicella in China.
"In summary, our study provides justification for implementing a two-dose varicella vaccination program in cities in China, such as Beijing, despite the presence of already-high vaccination coverage."

Hepatitis B vaccine in China: the unanswered questions

Commentary by Michael Woodhead

The deaths of 17 Chinese infants reported as having have followed hepatitis B vaccination are a tragedy that needs to be be fully investigated. When the first deaths occurred, the suspicion lay with a vaccine made by Shenzhen BioKangtai, with reports that certain batches of the vaccine were linked to the deaths of newborns in several provinces who had received vaccines with the specific batch number. Matters then became confused when reports were made of deaths of infants who had received other vaccines, including one made by a company called Beijing Tiantan. In all, 17 deaths have been officially reported in relation to hepatitis B vaccine.
When the first deaths were reported, the China Food and Drug Administration (SFDA) and the National Health and Family Planning Commission (NHFPC) ordered a halt to the use of the Biokangtai vaccine in China's newborn vaccination program and an investigation into the vaccine used.

After a rapid investigation of less than two weeks it has been announced that no problems have been found with the batches of Biokangtai's vaccine reportedly involved in the deaths and adverse reactions. The SFDA has also found no problems in the manufacturing, storage, transport or injection of the vaccine. Nevertheless, manufacturing permissions have been suspended for the three major manufacturers of hepatitis B vaccine, on the grounds that their facilities had not met the new GMP criteria for vaccine prodiction that came into effect on 1 January.
Post-mortem investigations into the infant deaths have also excluded the vaccine in nine cases, so far, and the other eight cases are waiting for autopsy results. Thus the hepatitis B infant vaccination campaign has quickly been given the all clear by the various authorities, and this verdict has been endorsed by the local branch of the WHO. The WHO representative rightly pointed out that the hepatitis B program was based on a good vaccine and prevented many cases of diseases and death every year. However, the announcement about the vaccine being safe was met with anger from some of the families of the children who died, and there has been disbelief on online forums about the "all clear" verdict from netizens who have little faith in monitoring of safety and quality of foods and medicines in China.

Despite the endorsement of WHO, there are still areas of doubt and unanswered questions in relation to the safety of China's hepatitis B vaccine and other child vaccine programs. First of all, if a vaccine was not responsible for the infant deaths, what was or were the real causes? With millions of newborns being vaccinated it is statistically probable that some natural infant deaths will co-incide with the time of vaccination. But the reports of 17 deaths in association with hepatitis B vaccination require in-depth investigation. Another question is whether it is possible to confidently rule out the vaccine as a possible factor in the cause of death. The investigations into the child deaths and into the vaccine quality and usage were done very quickly, raising questions about how thorough and comprehensive they were. There was also little transparancy about the process.
By comparison, when a similar series of vaccine-linked adverse events was seen in Australian infants given flu vaccine in 2010, authorities followed this up with several major inquiries. One inquiry was overseen by an independent clinician who examined the timeliness and appropriateness of the responses to the events. A second inquiry looked at the systems in place to monitor vaccine adverse events. A third inquiry looked into the vaccine manufacturing and quality issues. These separate inquires continued for months and in one case extended for more than a year. They concluded that a manufacturing anomaly had caused the vaccine batch for that year to be more 'reactive' than usual and to provoke more adverse effects. As a result, flu vaccine made by this manufacturer was banned from use in children, while products from other manufacturers continued to be allowed to be used. The other inquiries found that vaccine event monitoring and responses could have been better, and that information sharing had been poor and could be improved.

The recommendations from these inquiries were accepted by the Australian government, which has started to implement new vaccine monitoring and oversight systems. China could learn much from the Australian response to a series of vaccine related adverse events, to improve vaccine safety monitoring and response systems and to improve transparency in the whole process.
A clear and open response on the issue is needed from the Chinese authorities to maintain confidence in the safety of vaccination programs for children. It is not enough to point out that 15 million children receive the hepatitis B vaccine each year with the vast majority showing no ill effects and that the vaccine program prevents millions of cases of severe illness and death. Given the previous food and drug quality safety scandals seen in China - and the lack of public faith in the responses from the authorities - it is not surprising that there is now a crisis of confidence in the quality of China's food and drug products. Let us hope that vaccines do not become like milk powder, with parents only having faith in imported foreign brands for their newborns.

China reports 12th hepatitis B vaccine-related death

An infant in south China's Hainan Province died on Friday after receiving hepatitis B vaccine, local authorities said, bringing the total of such cases to 12 in the country.
Medical specialists are on their way to look into the cause of death in Lin'gao County in Hainan.
This is the third infant death linked to hepatitis B vaccines produced by the Beijing Tiantan Biological Products Co. Ltd.
Source: Peoples Daily

Experts defend hepatitis B immunisation programme after deaths

The hepatitis B vaccination program for newborns should stay in place despite the recent deaths of eight babies, medical experts said.
But expectant mothers are worried about the quality of vaccines as authorities investigate the cause of the deaths.
Jia Jidong, who leads the Liver Research Center at the Beijing Friendship Hospital, cited China's relatively high prevalence of the viral infection as a major reason for keeping the immunization program.
China reported a hepatitis B prevalence of more than 7 percent.
"We would have seen a relapse of the epidemic if the program was not well implemented,” he warned.

More details released on hepatitis B vaccine deaths and recall

An infant who became sick just minutes after a hepatitis B vaccination and died an hour later may be the fourth victim of vaccines produced by China’s largest hepatitis B vaccine supplier in the southern city of Shenzhen.
The deaths have triggered a nationwide suspension.
An official investigation is underway, while Biokangtai has not said where vaccines from the same batch as the Shenzhen baby received may have been sold.
Last Tuesday, the boy, born at 10:31am and apparently healthy, was given a vaccination six minutes later. At 10:39am, his face turned blue, his cries became faint and his breathing became rapid due to a lack of oxygen, Dr Yang Jinmin at the Nanwan People’s Hospital in Shenzhen, Guangdong Province, said.

Shenzhen Kangtai Hepatitis B vaccine withdrawn after four infant deaths

by Michael Woodhead
The China Food and Drug Administration (SFDA) has suspended the use of recombinant hepatitis B vaccine for children manufactured by Shenzhen Kangtai Biological Products (Shenzen Kangtai Shengwu Zhipin, 深圳康泰生物制品股份有限公司) after the four deaths were reported among children who received the vaccine. According to an announcement by the SFDA on 20 Dec, the four deaths were reported following vacination with batches of the company's vaccine in Hunan, Guangdong and Sichuan. The SFDA says an investigation into the cause of death is still underway and until the results of this investigation are available, the use of all batches of the vaccine is being suspended immediately, in the interests of child safety and safety of the infant vaccination program.

Hunan investigates hepatitis batches after two deaths

Health authorities of Hunan, central China, are investigating three cases of adverse reactions to hepatitis B vaccination, including two deaths.
A one-month-old boy died on December 6 in Hengshan County, two days after being vaccinated. Another eight months old died in Changning City on December 9, one day after vaccination for both hepatitis B and flu. A third newborn in Hanshou County showed a severe adverse reaction after being vaccinated on November 25, the Hunan Provincial Center for Disease Control and Prevention said Monday.

Elderly Beijingers miss out on free flu vaccine

by Michael Woodhead

Most elderly people in Beijing are failing to take advantage of the government’s program of free influenza vaccine each winter, research shows.

Only 44% of people over 60 had influenza vaccination during the seasons from 2008 to 2011, according to a survey of almost 2500 elderly Beijing residents published in the BMJ Open journal this week.

The vaccination rates over three seasons were consistently below 50%, which is well below the WHO target of 75% for annual seasonal influenza vaccination for the elderly, said Dr Zheng Yang and co-researchers from the Institute for Infectious Disease and Endemic Disease Control at the Beijing Center for Disease Prevention and Control (CDC).

The low uptake of flu vaccine occurred despite the government policy to offer the vaccine free of charge to all vulnerable populations including older people via community health centres, the researchers said.

Analysis of the figures showed that flu vaccination was more likely among people living in rural areas of Beijing, people with a lower level of education and those who perceived themselves to be unwell.

“Influenza vaccine coverage in Beijing still remains suboptimal. Further work needs to be undertaken to ascertain whether the method of distributing the vaccine is adequate and whether health professionals are appropriately promoting the vaccine,” the researchers concluded.

“ Education efforts should continue to highlight the need for the vaccine among individuals who are at risk from the disease and its associated complications,” they added.

Read the full study at: BMJ Open

Vaccine effective against China’s avian influenza A (H7N9)

by Michael Woodhead
A vaccine has been shown to be effective in humans against the new avian-origin influenza A (H7N9) virus that has already caused 137 cases and 45 deaths in China.

Australian and US researchers developed an A/Anhui/1/13 (H7N9) viruslike particle (VLP) vaccine that combines the HA and neuraminidase (NA) of A/Anhui/1/13 with the matrix 1 protein (M1) of A/Indonesia/5/05.

Writing in the NEJM they say avian influenza viruses have acquired mutations that could facilitate infection in mammals, which could pose a pandemic threat if the viruses become readily transmissible in humans. They have previously shown the efficacy of the vaccine in mice, and in a new study they have demonstrated the efficacy of the VLP vaccine in humans.

In a randomized, placebo-controlled clinical trial of the vaccine in 284 Australian adults two identical doses were given 21 days apart.

When followed up after a month, a strong immune response was seen in 81% of partcipants receiving 5 μg of vaccine with adjuvant. Significant increases in N9 neuraminidase-inhibiting antibodies occurred in 97.2% of recipients of vaccine with 60 units of adjuvant.

The VLP vaccine with adjuvant was associated with increased local and systemic reactions, but few of the reactions were severe, and no body temperatures exceeded 38.5°C.

The researchers from Novavax say the vaccine appears to be a good candidate for prevention of a pandemic  avian-origin influenza A (H7N9).

See the full report in: NEJM DOI: 10.1056/NEJMc1313186

China medical news roundup for Monday 18 November

Thousands of fake rabies vaccine doses may still be on the market

Almost 11,000 fake rabies vaccines brought into the eastern Shandong Province have yet to be found, some 10 days after the case was busted, Qilu Evening News reported yesterday.

According to the Ministry of Public Security, the suspect bought 12,000 fake rabies vaccines in the central Henan Province, and since 2009 has sold 10,800 in Shandong.

The fake shots are made from distilled water and vitamin K1.

Police say the suspect, surnamed Liu, bought vaccines at 0.8 yuan (13 US cents) each and resold them for 1 yuan to vendors in Shandong. In turn, they sold them to patients for 26 yuan each.

Health and drug authorities in Shandong Province started an investigation earlier this month after the suspect was held.

However, they don’t know where the fake rabies vaccines have gone.

Insiders warned they could flood the market as vaccination units are allowed to buy stocks independently.

This increases the risk of buying fake vaccines, compared to unified provincial-level purchases in the past.

As inspectors didn’t find fake rabies vaccines in legal vaccine trade companies, there is speculation that they were bought by unlicensed vaccination units or licensed vaccination units that didn’t check certification, said Zhang Jun, who works in the industry in Jinan, capital of Shandong.

There have been fake rabies vaccine cases across the country since 2005.

In 2009, a five-year-old boy in the Guangxi Zhuang Autonomous Region died 21 days after he was injected with a rabies vaccine which was later discovered to have been a fake.

Source: Shanghai Daily

Adenovirus implicated in severe infant pneumonia

Adenovirus is a critical pathogen that can cause severe respiratory infections even in immunocompetent children, researchers from Hangzhou have found.

In a study of children hospitalised with acute lower respiratory tract infection from 2006 to 2012 they found that infection due to adenovirus infection was infrequent but often caused severe outcome. In an analysis of 479 children with adenovirus infection, the incidence rate of adenovirus-associated acute lower respiratory tract infection peaked in the second six months of life.

Children with pneumonia accounted for 74% of the patients, and more than one-third developed severe pneumonia. Features of severe adenovirus-associated lower respiratory tract infection included persistent high fever with serious infective symptoms, and hepatic dysfunction was one of the most common complications. Mixed infection of atypical pathogens was common (19%).

 The researchers from concluded that “co-infection of adenovirus with atypical pathogens is common and that antibiotic treatment with azithromycin or erythromycin is necessary in patients with mixed infection of atypical pathogens.”

Full study at World Journal of Pediatrics

H6N1 poultry flu reported in humans for first time

The first report of human infection with a wild avian influenza A H6N1 virus has ben published by clinicians from Taipei.

Writing in the Lancet, researchers from the Taiwan Centres for Disease Control say the virus is one of the most common viruses isolated from wild and domestic avian species, but human infection with this virus has not been previously reported.

They publish a case history concerning a 20-year-old woman with an influenza-like illness who presented to a hospital with shortness of breath in May, 2013. An unsubtyped influenza A virus was isolated from her throat-swab specimen and was transferred to the Taiwan Centres for Disease Control (CDC) for identification.  The virus was identified as the H6N1 subtype, but the source of infection was not established. Sequence analyses showed the human case was very similar to chicken H6N1 viruses.

“These viruses continue to evolve and accumulate changes, increasing the potential risk of human-to-human transmission,” they comment.

“Our report highlights the continuous need for preparedness for a pandemic of unpredictable and complex avian influenza.”

Read the full study in The Lancet.

 

Chinese women fare worse after stroke compared to males

Neurologists in north east China have shown that women fare worse than men after a stroke.

Health-related quality of life was significantly worse for  adult females compared to males, according to a study carried out by Dr Wu Xiaoning and colleagues at the First Affiliated Hospital of Liaoning Medical University.

More than 400 stroke survivors were followed up six months after discharge from hospital.

Following stroke, improvements in physical functioning, bodily pain, vitality, social functioning, emotional role, and mental health in the SF-36 survey were significantly higher for men than woman.

Regression analyses confirmed that female sex was adversely associated with overall health status at discharge.

Female stroke patients were older than male stroke patients and were more likely to have transient ischemic attack and hypertension. Male stroke patients were more likely to have a history of smoking, heart disease and dyslipidemia, while female patients were less likely to achieve daily living independence.

“Our results demonstrate that sex has a significant impact on stroke outcome in Chinese individuals, wherein female stroke survivors are more likely to live a life of profound disability with poor self-care ability compared to male survivors,” the researchers concluded.

Read full study at: Journal of Clinical Neuroscience

Lung cancer increase seen in Beijing

Beijing municipal health authorities said on Friday that the number of lung cancer patients in the city has been rising over the last decade, without elaborating on what might have caused the rise.

The number of lung cancer patients per 100,000 people was 63.09 in 2011, compared with 39.56 registered in 2002, according to the Beijing Municipal Health Bureau, citing figures from the city's tumor prevention and treatment office.

In 2011, Beijing reported a total of 7,999 new lung cancer cases, accounting for 20.8 percent of the malignant tumor cases that year.

The bureau said lung cancer is the most common disease among male malignant tumor patients.

The statistics also showed that the lung cancer incidence rises as people age, and male patients outnumber female patients after the age of 35.

Health experts with the Beijing Cancer hospital said lung cancer is highly linked to lifestyle, noting that smoking is the top reason for the disease, followed by passive smoking and environmental pollution, such as air pollution.

People with respiratory diseases are more likely to contract lung cancer, the experts added.

Source: Xinhua

China medical news roundup for Wednesday 13 November

China alliance hopes to boost vaccine access

Eleven civic societies, including the China Medical Association, the China Medical Doctor Association, and the China Medical Women's Association, launched the China Alliance for Vaccines & Immunization on Friday to enhance Chinese and foreign children's access to vaccinations.

Despite tremendous progress in immunizing children worldwide, more than 20 million children do not receive essential vaccines globally, according to the World Health Organization.

China has a unique role to play in supporting global immunization efforts, said Lei Zhenglong, deputy director of the Bureau of Disease Prevention and Control at National Health and Family Planning Commission.

“Immunization requires continuous commitment and there are still challenges that we need to address for China’s immunization program”, he said, adding that immunization needs a joint effort beyond just government.

“Civic societies can leverage their diversity and flexibility to play a bigger role in the future,” he noted.

The alliance includes community organizations, professional associations, academic institutions and organizations representing affected population groups and will work to cultivate greater partnership in China and other countries, said Cheng Feng, vice-president of the Global Health Strategies initiative.

“The global community has a responsibility to reach all children, everywhere, with the vaccines they need, and China is an important part of such efforts,” he said.

Given its experience and expertise in immunization, China has an opportunity to draw from its success and help the world achieve goals for universal access to immunization, he added.

The alliance will also explore opportunities to promote the adoption of quality and affordable vaccines made in China, he said.

Last month, the first Chinese-made vaccine achieved WHO pre-qualification and met international standards for quality, safety and efficacy.

That status allows the Chinese manufacturer to sell its vaccine against Japanese encephalitis to international agencies to be used in low-income countries.

Source: China Daily

Infectious diseases kill 1200 Chinese a month

A total of 1,272 people died of infectious diseases on the Chinese mainland in October, the National Health and Family Planning Commission announced on Monday.

A total of 549,135 infectious disease cases were reported on the Chinese mainland last month, it said.

Among them, five cases of cholera were reported, but none resulted in death. Plague and cholera are categorized as Class A infectious diseases, the most serious category.

In addition, about 285,020 cases were identified as Class B infectious diseases. Hepatitis, tuberculosis, syphilis, dysentery and gonorrhea accounted for 95 percent of the cases in this category, the statement said.

It added that category C infectious diseases claimed 10 lives in October, with foot-and-mouth disease, infectious diarrhea and mumps reported most frequently.

Source: Xinhua

China’s family planning policy has improved child and maternal health 

On the 40^th anniversary of China population control program, National Health and Family Planning Commission spokesman Mao Qun-an said family planning had reduced population growth by 400 million people, greatly reducing stress on environment and society.

Family planning has ensured our rapid population growth has been effectively controlled, he said. China's birth rate has fallen from 33% in 1970 to 12% in 2012, half of the world average. Over the same period, women's total fertility rate dropped from 5.8 in 1970 to 1.6, reaching the same level of developed countries.

"China's population reproduction pattern has changed from a traditional high birth rate and infant mortality to a low birth rate and low infant mortality, Mao said.

Family planning effectively alleviated the pressure of population on resources and the environment. 

“If we had not implemented our family planning policy, China's population would by now have reached 1.7 to 1.8 billion, with a higher pressure on arable land, grain, water resources and energy,” he added.

Family planning also improved womens’ and childrens’ health and improved child development, Mao said. The policy improved prenatal and postnatal care, reproductive health services, universal adolescent sexual and reproductive health knowledge, and protected baby girl survival as well as promoting development rights and gender equality.

China had achieved outstanding results in terms of maternal and infant mortality, with mortality rates dropping significantly from 80 and 50 per 100,000 in 1991 to 24.5 and 10.3 per 100,000.

"The success of China's family planning practices, has ensured that the world 7,000,000,000 Population Day has been postponed for five years," said Mao. China family planning policy set an example for other developing countries to address population and development issues, and established China as a responsible populous country.

Source: Xinhua 

Two out of three Chinese don’t trust doctors

According to a survey published on Tuesday, 67 percent of people do not trust doctors' professional diagnosis and treatment

The survey, which sampled 252,283 people and was conducted by the survey center of the China Youth Daily, also showed that more than 87 percent of respondents expected to rebuild doctor-patient trust following recent assaults on medical workers in China..

Some 30.4 percent of respondents attribute current medical disputes to a lack of public welfare services, which should be provided by public hospitals, and 27.4 percent said negative news reports worsened such disputes, according to the survey.

Other reasons ranging from uneven distribution of medical resources, intensive physical workload, and the knowledge gap between patients and doctors are blamed for the loss of doctor-patient trust, the survey said.

On Oct 25, a doctor was stabbed to death and two others injured by a dissatisfied patient at a hospital in East China's Zhejiang province.

In the same week, a doctor in Guangzhou, capital of South China's Guangdong province, was beaten up by a patient's family members.

Violence against medical staff is on the rise, according to a previous sample survey by the Chinese Hospital Association conducted from Dec 2012 to July 2013.

The annual average number of assaults on doctors per hospital increased from 20.6 in 2008 to 27.3 in 2012, according to the survey, which polled staff and patients at 316 hospitals.

"Courses in medical colleges focus more on medical techniques, but there are few courses on communication," Wang Zhong, vice-head of Tsinghua University Hospital, was quoted by the newspaper as saying, adding that inadequate communication is the root of a majority of medical disputes.

Wang said that the assault of medical staff destroys hospital order and should be curbed and condemned as it brings panic to doctors, which ultimately results in decreased service by doctors.

Chinese Vice-Premier Liu Yandong pledged to curb assaults on medical workers at a meeting last week, noting that the government will launch a year-long campaign to enhance security arrangements at hospitals and improve coordination between hospitals and police.

Source: China Daily

China medical news roundup for Tuesday 12 November

Polio vaccine switch within two years

 China’s switch from live to inactivated polio vaccine will make the rare paralysis reaction a thing of the past.

Xia Maoqiu knows his son Yu Han is one in a million — he was diagnosed last year.

The 2-year-old is among the small number of children in China who have suffered a negative reaction to the oral polio vaccine, which has helped eradicate the disease.

Health specialists say only about a dozen cases of the condition — vaccine-associated paralytic polio — occur every year.

"According to the Health and Family Planning Commission, only one out of every 1 million children who take the vaccine has an abnormal response," Xia said.

His son, who is believed to be the first child in Sichuan province affected, received the oral vaccine at a clinic in Chongzhou in October 2011 but was back in hospital a month later with a fever.

"After he recovered and was back home, we noticed something strange during bath time," said Tu Tao, the boy's mother. "His left leg was turned inward and he was feeble. I asked him to walk a few steps, but he kept falling."

Unhappy with an initial diagnosis by local medics, Xia and Tu contacted the Chinese Medical Association in Chengdu, where experts confirmed the oral vaccine had caused the paralysis.

Since then, the toddler has undergone more than 1,000 acupuncture treatments, and the family has seen its savings of 200,000 yuan ($33,000) disappear, despite receiving 178,000 yuan in compensation from the Sichuan provincial government.

"Yet his leg is no better than when we discovered the problem," Xia said.

Although rare, China is working to make the condition a thing of the past.

The country has set a goal to introduce the inactivated polio vaccine, which does not pose a risk of paralysis, into its routine immunization program in two years, and officials say an application has already been filed with the State Food and Drug Administration for mass production and use of the first domestically made IPV.

"The oral vaccine has helped China eliminate polio, and now we're preparing to introduce IPV, which is in line with the international standard and can better protect against the polio infection," said Shen Qi, deputy director of the National Institutes for Food and Drug Control's Institute for Biological Product Control.

Worldwide, most polio vaccine in use is oral, yet more than 60 countries and regions have introduced IPV. Some only use IPV, while some use both.

"Eventually all use of OPV (the oral vaccine) will be ended in China and the world," Rodewald said. "However, there will be a few years in which both IPV and OPV are likely to be used together."

It is critical, he said, that polio vaccination coverage remains high in China, as it shares borders with Pakistan and Afghanistan, where polio remains endemic.

An outbreak of polio reportedly imported from abroad hit the Xinjiang Uygur autonomous region in 2011. Twenty-one cases were detected between August and October that year, killing one and leaving 17 people paralyzed, including eight children.

"That outbreak was the first to come from abroad since 2000, and the risk remains as viruses know no boundaries," warned Luo Huiming, deputy director of the Chinese Center for Disease Control and Prevention's National Immunization Program.

Che Yanchun, director of science and technology at the Chinese Academy of Medical Sciences' Institute of Medical Biology, said in February it applied for a license to produce and use IPV after clinical trials.

"To eliminate polio thoroughly, we can't depend solely on foreign products. We must have a homegrown IPV," she said.

However, Rodewald said China faces challenges in introducing an IPV.

The supply will need to be sufficient for all children to receive at least one dose, he said, while the increase in injections will put pressure on public health workers.

Shen at the Institute for Biological Product Control also said there is a cost implication. According to her, one dose of the oral vaccine costs less than 1 yuan, "but IPV is far more expensive."

Source: China Daily

China’s new health insurance scheme having positive impact – study

The Urban Resident Basic Medical Insurance (URBMI), launched in 2007 has had an appreciable positive effect on health service utilisation in China, a new study has found.

The scheme that aims to cover around 420 million urban residents in China significantly increased the likelihood of insured people receiving both inpatient and outpatient treatment, according to an evaluation by Dr Chen Gang of the Flinders Health Economics Group, Australia and colleagues at the National School of Development, Peking University.

The scheme increased the probability of using outpatient services in the past two weeks, although the insurance reimburses mainly against critical outpatient care.

However, based on data from the URBMI Survey from 2008–2011  the study also found that the insurance scheme did not reduce rates of people being refused hospitalisation based on financial difficulty.

“Given that it is still early days for the URBMI scheme, the positive effect on health services utilisation is appreciable,” the study authors concluded.

Read the full study at Pharmacoeconomics

Unlicensed Korean cosmetic surgeons work in Beijing

Eight plastic surgery hospitals in Beijing have claimed to have famous surgeons from South Korea on their staff, but 13 out of the named 14 surgeons are unlicensed, the Beijing News reported.
According to Qi Shiming, an official at the Beijing Municipal Health Bureau, most of Beijing's more than 260 plastic surgery hospitals tout the services of renowned surgeons from South Korea. The bureau recently published a list of Beijing's licensed plastic surgeons. From October of 2012 to October of 2013, only eight foreign doctors were registered in Beijing, of whom six were from South Korea.

Source: Global Times

China medical reforms – what’s ahead?

At the 18th National Congress of the Communist Party of China (CPC) last November, China pledged to advance the nation’s medical insurance system to one that covers the entire population, as well as establish a mechanism to provide insurance and aid in treating critical illnesses. As the Third Plenary Session of the 18th CPC Central Committee opened this Saturday, people are expecting the meeting will charter the next stage for China’s healthcare reform.

Since 2009, China has accelerated its reforms to make health care more accessible and affordable. By 2013, medical insurance covered 95 percent of the population, with 265 million people enrolled in the Basic Medical Insurance for Urban Employees (BMIUE), 271 million covered by the Basic Medical Insurance for Urban Residents (BMIUR) and 805 million enrolled in the New Rural Cooperative Medical Insurance Scheme (NRCMS).

As the Report of the 18th National Congress of the CPC pointed out, everyone should have access to basic medical and public health services. By 2015, the percentage of people covered by medical insurance will have increased by 3 percent.

Despite the universal coverage, public dissatisfaction with the health service is growing. We have seen a rising number of attacks on medical staff across China. According to figures from the Chinese Hospital Association, from 2008 to 2012, the number of incidents aimed at doctors and nurses per year increased from 20.6 to 27.3 on average in every hospital across China. Doctors and nurses are experiencing a crisis, and so is patient-doctor trust.

Violence has become an expression of the patients’ resentment over the high costs of treatment and medicine, as well as over corruption. The semi-marketization reform has left China’s public hospitals struggling to make ends meet. To boost salaries, doctors are forced to over-prescribe medicines and tests, and even receive grey incomes -- kickbacks from medicine companies.

In July this year, GSK’s China business was probed for allegations of bribing doctors to boost sales. In an effort to end their financial dependence on medicine, authorities have since last June started reforms at county-level public hospitals to wean hospitals away from medicine. Reforms are expected to be extended to all public hospitals by 2015.

As healthcare coverage has broadened, the share of patient spending has also declined dramatically. The NRCMS pays for 75 percent of in-patients’ costs once they are admitted to hospital and the BMIUR covers 70 percent. Yet challenges remain daunting as the high proportion of reimbursement may not be of much help to those patients suffering critical illnesses.

When addressing the 16th National Congress of the All-China Federation of Trade Unions on Oct. 21, Premier Li Keqiang emphasized the importance of establishing a critical illness coverage system. “There are 3 million people every year who can’t afford to pay for the bills when diagnosed with critical conditions despite the reimbursement,” he pointed out.

Serious health expenses dragging a household into poverty is nothing unusual, especially not among low and middle income families who are particularly vulnerable to critical illnesses. The Guiding Opinions on Providing Critical Illness Insurance for Urban and Rural Residents co-drafted by six Ministries was released at the end of last August. According to the Opinions, those insured by BMIUE, BMIUR or NRCMS will get at least half of the self-paid treatment expenses reimbursed once diagnosed with severe illness.

By the end of August 2013, 94 regions across 23 provinces had piloted the critical illness cover system and seven provinces had fully implemented the system, benefiting 210 million people. Patients with grave illnesses including uremia and cervical cancer have been reimbursed for 90 percent of the total costs in some regions.

In October, Russia announced that all Russians will enjoy free healthcare. The announcement aroused a debate over whether China can follow in Russia’s footsteps. Professor Zhou Zijun of School of Public Health, Peking University, opposed this idea. “Free healthcare for low-income groups is feasible, but free healthcare for all is impossible in China. It will put unbearable economic burdens on younger generations.”

When talking about the critical illness cover system, Li said, “To explore solutions for this problem, the government along with society and its individuals should work together.” As China’s healthcare reform rolls forward, the country’s total health expenditure has ballooned. Complete reliance on the government and public hospitals may not be an ideal option in China.

At the 18th National Congress of the CPC, China renewed its health policies and for the first time the Report explicitly stated, “We should encourage the development of private hospitals.” Fortunately, we don’t have to wait much longer to welcome a major breakthrough in this area.

On September 29, 2013, the China (Shanghai) Pilot Free Trade Zone was launched and the establishment of wholly foreign-owned medical institutions will be allowed within the Zone. Although the government is not making much bolder moves, it is still good news for China’s patients. It may still be too early to say that China’s public hospitals will be challenged, but at least we can expect more foreign funding will be poured into China’s medical sector. Now that the door has been opened, who knows what will come next?

Source: china.org.cn 

Hangzhou scientists make body parts with 3D bioprinter

Body parts in a Petri dish: scientists in Hangzhou say these could one day be the solution to the dire shortage of human organs available for transplant in China. Except for spouses and relatives, living donor organ transplants are banned in the country. But Professor Xu Ming'en and his team believe this 3D bioprinter might hold the key to a future of regenerative medicine, where new body parts can simply be printed to order. Dubbed Regenovo, it builds organs with cells made of a biological gel and layers them in much the same way as bricks and mortar in a wall. Eventually, says Xu, an organ prototype like this kidney emerges, a version that at this stage lacks blood vessels or nerves.

Says Professor Xu: "The materials we use all belong to a type of hyrdogel. That hydrogel is like gelatin or collagen which have the same physical property in our bodies. This stuff usually exists outside of our cell matrixes. So we extracted this material and we're using it in the printer. It's just like mud for some cells - it builds cells in the appropriate places, just like bricks. It's a meticulous process." The science is not new - teams in the United States have pioneered biomedical research, printing tissue for a variety of organs, from kidneys to livers. But a thriving organ production market is still a long way off. Xu says one of the main challenges is finding a way to engineer the artificial organs to interact properly with the rest of the body.

"It could take fifteen to twenty years before the 3D printer can print more complex organs, and that's because some important problems need to be solved. First, the materials that the 3D printer uses need to have a higher level of precision, and need to be able to print a larger variety of cells and create a more complex cell structure. We also need a considerable number of cells for the printing process. So, stem cell research can advance the 3D printer's development." And if they succeed, Xu and his colleague say millions will benefit, not just in China, but around the world.

Source: Reuters

Shanghai girl with rare tumour seeks foreign help

The parents of an 11-month girl, who was diagnosed with a rare brain tumor, are looking for help from abroad in an effort to save their child.

The girl, Yang Yang, suffers from atypical teratoid/rhabdoid tumor (AT/RT), a rare and aggressive form of cancer that occurs among children.

"Doctors at the Shanghai Children's Medical Center have told us that my daughter has only some months to live," said Yang Jing, the girl's mother. But she and her family are not about to give up.

The baby was first diagnosed with pneumonia at Renji Hospital in September and was transferred to Shanghai Children's Medical Center after her situation worsened with a facial paralysis.

On October 25, a Beijing doctor was invited to operate on Yang Yang and remove the tumor in her brain. The tumor's size was bigger than an egg and was bonded to the brain stem. Yang said her daughter needs urgent after-treatment but Chinese hospitals do not have the experience of treating the disease.

Doctors at Shanghai Children's Medical Center said they come across cases like this just once or twice a year.

Yang even went to Beijing where she visited five hospitals but it was all in vain.

"The hospitals either did not have any cases that were successful or simply did not haven't come across an AT/RT case," she said.

She corresponded with hospitals abroad and got feedbacks from University of Texas MD Anderson Cancer Center, St Jude Children's Research Hospital and Dana Frber Cancer Institute. But most of them wanted her to bring the baby to the US, which is expensive. The family has already spent 120,000 yuan (US$19,704) in the past two months.

"The ideal situation would be that my daughter receives the treatment in China with help from abroad," Yang said.

Source: Shanghai Daily

Enterovirus vaccine safe and effective against hand foot and mouth disease, Chinese trial shows

A trial conducted in Jiangsu has provided major step forward in the development of  a vaccine against enterovirus 71 - a member of the Picornaviridae family of viruses associated serious and fatal outbreaks of hand, foot, and mouth disease across Asia.
Published in The Lancet,  the results of a phase 2 trial of an enterovirus vaccine in more than 1100 infants and children in Jiangsu found that the vaccine had good immunogenicity and a low incidence of adverse effects.
The inactivated EV71 vaccine developed by Beijing Vigoo Biological used the EV71 strain was given in two doses a month apart, injected intramuscularly into the deltoid region in children aged 12—36 months and into the anterolateral side of thigh in infants aged 6—11 months.
The trial compared four different doses of vaccine, and all procuced  good antibody responses, with the best seen with an adjuvant 320 U formulation.
Antibody titres had significantly declined by eight months, suggesting a need for a booster shot. Generally, the vaccine had a good safety profile in all participants. Most reactions were mild or moderate and severe adverse reactions were uncommon.
Researchers say an enterovirus  vaccine is a public health priority because mortality rates with enterovirus 71 are as high as 82—94% in severe cases and the incidence of hand, foot, and mouth disease seems to be increasing across the Asia region
As a result of our findings, the adjuvant 320 U formulation has been selected for larger multicentre, randomised, double-blind, placebo-controlled trial in about 10 000 participants aged six—35 months.
Source: Lancet