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.

China's pharma companies take a stake in public hospitals. What could possibly go wrong?

by MICHAEL WOODHEAD
China's not-very communist health minister Li Bin wants to see hospitals turn to "social capital"(ie private investors). And it is slowly starting to happen. China's 'public' hospitals are currently in a strange place - they are essentially state-owned for-profit enterprises, but bound by an odd mix of rules and regulations that keep some prices in check and yet which allow rampant price gouging and overservicing in areas such as pharmaceuticals. Not for nothing are pharmacies know as the 'gold mine' of hospitals.

To try get rid of the obvious incentives for hospital doctors to overprescribe the government is currently phasing in a ban on drug commissions. They are trying to de-link income from drug sales and hospital revenue.

However it's not clear to me how this squares with the trend for China's pharmaceutical companies to go into partnership with hospitals, and essentially to become their operators. Take the recent deal by the Guangzhou Baiyunshan Pharmaceutical Group to invest in six hospitals in the obscure Shandong city of Jining. The joint venture covers six main hospitals with around 6000 beds and a total annual revenue of 2 billion yuan.

The local health department has 49% stake in the new Jining health provider company, while the pharma company has a 33% stake in return for 5 billion yuan investment. Other stakeholders include investment companies, with between 15% and 2% interests.

Analysts say the new joint venture will allow industrial groups to make profits from controlling supplies of pharmaceuticals as well as medical devices, supplies and equipment. I'm no health economist but I can't see how allowing a pharma company to own and operate all of a city's hospitals is good for the patient. Who decides which drugs are made available at the hospital - and what happens to the competitor products? Also what is to stop overservicing, as we have seen so evidently a problem in the current system?

As a commentator in Caixin magazine concludes:

"With deals like this we need to first be clear what is the purpose of the restructuring of public hospitals, and through the restructuring of what kind of results you want to achieve? These issues need further study and discussion. "

Drug resistant bacteria - just how much of a problem are they in a typical Chinese hospital?

by Michael Woodhead
With broad spectrum antibiotics easily available over the counter in China  - and the Chinese cultural expectation of an antibiotic as the magic bullet for every viral fever - it's not surprising that drug resistance is a major problem in the PRC. 
But just how common is the problem for a typical provincial hospital? The rather worrying answer is quite a big problem. A study carried out in the Liaocheng People's Hospital in Shandong has found that one in three bacteria samples obtained from around the hospital were multi-drug resistant. Researchers at the hospital took almost 10,600 microbial samples from around the hospital and found that  33.4% were multi-drug resistant pathogens such as ESBLs producing E. coli and A. baumannii. The blackspots for resistant bacteria were in surgical departments and the intensive care department. Samples obtained from respiratory and secretions were the greatest source of resistant bacteria. The obvious consequences of these multi-drug resistant bacteria are treatment failure, longer hospital stays, increased mortality, and higher hospitalisation costs. As the authors conclude, their findings show the need for much greater attention to antibiotic resistance, especially from respiratory cases and surgical wounds.

Six of the top medical news stories from China

1. China has a huge shortage of midwives, and would need a further 800,000 to meet the WHO standard of one for every thousand women of child-bearing age, according to a new report. Health officials say the problem will worsen as China adopts a two child policy.

2. Efforts to control pneumococcal disease and Haemophilus influenzae type b (Hib) in children by vaccination are failing due to low immunisation rates and delayed immunisation, a study from Shanghai shows. A review of vaccination records for 28,000 children up to the age of seven found that 51% had one dose of Hib vaccine and 11.4% had one dose of pneumococcal vaccine. Only 8.2% of children had Hib vaccine at the right time and only 0.5% had timely pneumococcal vaccine. Rates were particularly poor for migrant children, the study found.

3. Rates of hypertension have increased in China and yet treatment and control of the condition remain poor, according to researchers from Shandong. In a study of more than 4000 people they found that the incidence of hypertension increased from 2.9 per 100,000 people in 1991–1997 to 5.3 in 2004–2009 Antihypertensive treatment and control rates for hypertension were 5.7% and 1.7% in 1991–1997 and 19.9% and 7.6% in 2004–2009, respectively.

4. The rate of disabilities from road crashes in China has skyrocketed as the number of cars on the road has increased over the last two decades. The incidence rate for road traffic disabilities increased over time from 1.50 per 100,000 people in 1980 to 11.2 per 100 000 persons in 2005, according to Professor Zheng Xiaoying of the Institute of Population Research, Peking University.

5. Malaria is still a major problem in central China especially during floods and rainy periods of the summer. A study from Mengcheng County, Anhui found that there were 3683 malaria were notified during the study period of May to October 2007 Most of the cases occurred a week to a month after flooding and waterlogging. Public health action should be taken to control the potential risk of malaria epidemics after wet weather, the researchers from Shandong University said.

6. The recent outbreaks of H7N9 avian influenza also resulted in many mild and asymptomatic infections as well as severe life threatening cases, researchers from Guangdong have reported. Their surveillance program noted 21 cases of infection in Guangzhou, China in 2013 and 2014, of which several were mild or asymptomatic infection. Family clusters occurred, suggesting limited person-to-person transmission of the H7N9 virus, they said.

Human-to-human transmission of H7N9 reported in Shandong family cluster

by Michael Woodhead
A probable case of human-to-human transmission of H7N9 avian influenza has been reported by researchers in Shandong province investigating a family cluster of the infection.
A 36-year-old man who developed the infection in April last year in Zaozhuang seems to have transmitted the H7N9 virus to his four year old son, according to Dr Liu Ti and colleagues from the Shandong Provincial Center for Disease Control and Prevention. Writing in the journal BMC Infectious Diseases, they describe the case histories of the family cluster, and conclude that the son had no exposure to poultry as a source of infection but had prolonged contact with his sick father.
The father became infected with H7N9 avian influenza in mid April, possibly from being in proximity to poultry markets, they found. He had no close contact with poultry but there were poultry farms and markets in the area where he lived, the found. The "index case" developed a severe fever and sought medical help. His son became infected seven days later, but he had no exposure to poultry as he remained at home with his sick father before the father was hospitalised with pneumonia. The son had prolonged, close contact with his father, including eating together, and he also became infected with H7N9 and was hospitalised. Both father and son eventually recovered from H7N9 infection and were later discharged from hospital.
“The infection of the index case probably resulted from contact with environmentally contaminated material. For the son, the probable infection source was from the index case during unprotected exposure, but the possibility from the environment or other sources could not be completely ruled out,” the researchers said.
“Though it is difficult to ascertain the infectious source for the two cases, the emergence of H7N9 clusters requires urgent attention because of the possibility that a change in the epidemiological character could spread more easily among people,” they concluded.

Shandong's "Doctor QQ" dispenses online remedies for the housebound

In Shandong's Jinan city, Dr Li Lihua is encouraging his housebound patients to consult him first on QQ before trying to go to hospital. In October 2013, Dr Li set up his own doctor-patient commnity on the social media site QQ and now has 60 patients on his 'list'.
He encourages them to consult with him online for minor ailments and he says the QQ service offers them attention and confidentiality. The doctor in charge of the Shanxi Lu health station says this way he can help people avoid going to hospital and if they need to go to the hospital he can refer them to the most appropriate department and doctor.
One example was a web friend who asked about toothache - Dr Li tells him which antibiotic and anti-inflammatory medications to take, to avoid hot and spicy foods and to drink plenty of fluid.
According to the Qilu Evening News, Dr Li says this helps him to keep in contact with patients who otherwise would not get to see a doctor.

Medical care for rural elderly hampered by 'unfilial' shame and urban migration

Zhu Chengyu strolls around her countryside courtyard as a form of exercise. Old age and illness blight her daily life.
The 78-year-old woman, who lives in Zhuhe village of Dong'e County in eastern China's Shandong Province, has been admitted to hospital five times this year for asthma and heart disease.
Medical expenses costing thousands of yuan was partly covered by basic medical insurance. The remainder, around 2,000 yuan, was a large sum for Zhu.
She has no other source of earnings apart from a monthly pension of 65 yuan (10.5 US dollars) and an annual payment of 800 yuan, which she gets from renting her 2.5 mu (0.17 hectares) of crop land.
What worries Zhu most is when she becomes ill. Nobody is around to take her to hospital.
"My only son and his wife work as migrants in cities and seldom come back home," Zhu said. "I am left alone."

Chinese Alzheimers research may be example of academic 'black market'

by Margaret Munro
Some of Canada’s top brain specialists have apparently been duped by shady operators in China.
The Canadian doctors approved and recently published a scientific report on Alzheimer’s disease that came from a “flourishing” academic black market in China, according to a report released Thursday.
“China’s publication bazaar,” as it is described, allows unscrupulous scientists to pay big money — up to  $26,300 — to become authors of scientific papers they didn’t write.
They don’t do any experiments or research either, according to the report in the U.S. journal Science that adds a creative, if disturbing, twist to research misconduct.
“It’s new to me,” says Dr. Robert Chen, at the University of Toronto, who is now investigating the origins of the suspect Alzheimer’s report.
It surfaced last year in China’s “flourishing academic black market involving shady agencies, corrupt scientists and compromised editors — many of them operating in plain view,” according to Science. It says that several scientific papers advertised under “authorship for sale” by Chinese brokers and editing shops have later appeared in established journals — including the Alzheimer’s report published this year in the Canadian Journal of Neurological Sciences.

Cockroaches bred by pharmaceutical companies for hepatitis drugs

Wang Fuming spends 8 hours every day with cockroaches — millions of them. He even dines on them, fried, in the belief they can cure his stomach disease.
Although the insect incites feelings of disgust and dread for many people, the 43-year-old businessman in Shandong province has pinned high hopes on them.
Inside two concrete buildings near an elevated highway running through Jinan's Changqing district, Wang keeps as many as 10 million cockroaches in sheets of cartons that resemble battery cages on a hen farm.
Wang supplies cockroaches to pharmaceutical companies, who use them as medicinal ingredients. Scientists say certain parts of a cockroach can enhance a person's cardiovascular functions as well as combat hepatitis B.
The price of dried cockroaches, on average, reaches 150 yuan ($25) per kilogram and farms are steadily spreading in Shandong, Jiangxi, Yunnan and Sichuan provinces.
The largest farm, which occupies more than 2 hectares and has an annual production of more than 1 billion American cockroaches, is owned by a pharmaceutical company in Xichang, Sichuan province.
Source: China Daily

Chinese women with PCOS have high rates of hypertension and metabolic abnormalities

by Michael Woodhead

One in five Chinese women with Polycystic Ovarian Syndrome (PCOS) have hypertension, almost twice the rate of other women, a study from Shandong has found.

Women with PCOS also had abnormal lipid, insulin and glucose levels compared to women without PCOS according to a study conducted by Dr Shi Yuhau and co-researchers at the Reproductive Medicine Hospital Affiliated to Shandong University, Jinan.

The researchers studies 3396 women with PCOS and 1891 controls They found the prevalence of hypertension to be 19.2% in the women with PCOS, which was much higher than that in the controls (11.9%). After matching for BMI, the hypertensive PCOS group had significantly higher glucose, insulin, and lipid levels than the normotensive PCOS group; these differences were significant.

The researchers said the likelihood of long-term metabolic complications was high in hypertensive PCOS patients.

 “These findings underscore the importance of preventive strategies in women with PCOS in order to prevent hypertension,” they said.

“Cardiac risk factors associated with PCOS have public health implications and should drive early screening and intervention measures. Fasting lipid profiles and glucose examinations should be performed regularly. Treatment of the associated cardiovascular risk factors, including insulin resistance, hypertension and dyslipidaemia, should be incorporated into routine PCOS patient wellness care programmes. These results suggest that it is importance to control weight and blood pressure in women with PCOS in order to reduce their excess risk of future complications. “

Read the full study in: European Journal of Obstetrics & Gynecology and Reproductive Biology

Clinical research from China in the medical journals ...

In the Journal of Thoracic Diseases, Dr Xiao Kun and colleagues at the Department of Respiratory Medicine, PLA General Hospital, Beijing, evaluate prognostic indicators for  Community-acquired pneumonia in elderly patients. In their study of 240 patients they found that Pneumonia Severity Index scores were the best indicator in predicting different clinical outcomes of aged patients with CAP, when compared to testing for N-terminal pro B-type natriuretic peptide (proBNP) levels and three other scoring systems. They also found that systolic BP might be as a protective factor for prognosis of CAP.

Celecoxib may be an effective way of preventing the formation of joint adhesions, according to Shanghai researchers. In the journal Experimental and Therapeutic Medicine, 

orthopaedic surgeons from the Sixth Affiliated People's Hospital of Shanghai Jiaotong University report on an animal experiment in which they tested the inhibitory effects of celecoxib and ibuprofen given for 30 days on joint adhesions. Few adhesions were seen in the celecoxib treated animals, suggesting that the drug “may provide a novel and potent approach for their prevention,” they conclude.

In the same journal, cardiologists from the People's Hospital of Zhengzhou University, Henan report that Chinese patients with chronic heart failure have poor outcomes by international standards. Survival rates of 685 patients with chronic heart failure (HF) and reduced ejection fraction (HFrEF) were assessed during follow up of around 30 months.

 The fatality rate was 28%, with most due to pump failure 6% due to sudden deaths. The predictors of mortality were advanced age, BMI, NYHA functional class and lack of oral β-blockers at discharge.

“Patients with heart failure and reduced ejection fraction have poor prognoses in China, particularly those patients with an LVEF of ≤35%. Therefore, cardiologists should strive to improve the prognosis of HF among Chinese patients and focus on the importance of the practical application of HF diagnosis and treatment guidelines,” the researchers said.

In the European Spine Journal, bone specialists from Jinan Military General Hospital, Shandong, show that the most important risk factors for recurrent fractures after vertebroplasty are osteoporosis and treated level at the thoracolumbar junction. In a one year follow up study of 175 patients who underwent vertebroplasty for first-time and single-level osteoporotic vertebral fractures. They found that recurrent fractures developed in 37 (21%) of patients. Higher fracture rates were seen in pateints higher BMD T-score, and treated vertebrae located in the thoracolumbar junction.

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

More than one in 20 Chinese at risk of gout

About 7% of Chinese people living in urban areas have high blood levels of uric acid that put them at risk of gout, a Shandong study shows. 
A study of 4,218 adults in the Jinan area found that hyperuricemia (serum uric acid ≥416 μmol/L in men and ≥357 μmol/L in women) was present in 6.4 % of men and 2.1 % of women overall. The prevalence of hyperuricemia was greater in urban (6.7 %) than in rural areas (1.7 %) of Jinan city. High uric acid levels were associated with hypertriglyceridemia and high serum creatinine level and also significantly associated with male sex, urban residence, hypertension, obesity, and hypercholesterolemia.
Source: Rheumatology International

Shandong rural residents to have family doctors

More than 130,000 rural residents in Zibo's Zhangdian district, Shandong province, will be able to have family doctors and receive free home visits starting next month. According to a recently launched healthcare program, the local government is working to establish family doctor teams composed of licensed general practitioners, nurses and rural doctors in all 120 villages of the district. The teams will establish personalized health files and provide free treatment and medical advice for residents who have signed up with them. They are also required to make at least two house calls a week for people above 65 years old, children younger than 6 years old, pregnant women, as well as those suffering from chronic diseases and mental disorders. Shandong launched the rural family doctor medical service last month, which is expected to cover 20 percent of the villages in the province by the year's end, according to Qiu Bingyu, deputy head of the provincial bureau of health. "Most people in Chinese rural areas don't like going to hospital and having regular health checks, so it is very necessary to provide the service in those areas," said Chou. So far, the model has been implemented in villages across the cities of Linyi, Jining, Zibo, Binzhou, Yantai and Qingdao. The family doctors in Jining alone have visited more than 162,000 rural residents and diagnosed nearly 30,000 cases of disease. Read more: China Daily