EXPOSING the FDA and the USDA - Broad Casting here the things that they would prefer us NOT to know about our FOOD & DRUGS & Farming.

Wednesday, July 14, 2010

EFSA initiates re-evaluation of feed additives

The Bullshit Report: http://worldpoultry.net/news/efsa-initiates-re-evaluation-of-feed-additives-7696.html

14 Jul 2010

The FEEDAP Panel has completed a re-evaluation of the safety and efficacy of Cylactin, a feed additive used in diets for chickens for fattening.
Cylactin is a microbial feed additive based on a strain of lactic acid bacteria (Enterococcus faecium), which has had a history of use with both animals and humans. The initial assessment showed that the strain of lactic acid bacteria used in this product is more resistant to kanamycin than most other strains of Enterococcus faecium. Following a thorough review of the data, including the full genome sequence the Panel concluded that the antimicrobial resistance was not acquired; therefore, the risk that the bacteria might transfer kanamycin resistance to other organisms is not a cause for concern.

The Panel concluded that Cylactin is effective as a feed additive used for chickens for fattening and that there is no evidence that its use results in adverse effects for the target animals, human health or the environment.

The European Food Safety Authority’s FEEDAP Panel is re-evaluating all feed additives currently on the market, authorised under the previous regulatory framework, and in line with current EU legislation on feed additives for use in animal nutrition. The aim of the work is to ensure that all feed additives in Europe are re-assessed following the same, up-to-date guidelines taking into account the newest scientific developments.

EFSA has already received more than 30 feed additive applications for re-evaluation. In addition, the FEEDAP Panel is continuing to assess new additives submitted for authorisation in the EU, or new uses for additives already authorised. To date EFSA has evaluated more than 200 feed additive applications.

The Truth: Not even getting into the cruelty aspect of factory farmed chickens, in feeding antibiotics and growth hormones that promote faster growth and fatter chickens, made to grow so quickley and so obese that oftentimes their legs cant even hold them up, but more on that following this eye-opening report on moden poultry production from the UK;


FDA: Rule to ensure egg safety goes into effect

13 Jul 2010

The US Food and Drug Administration says that as many as 79,000 illnesses and 30 deaths due to consumption of eggs contaminated with the bacterium Salmonella Enteritidis may be avoided each year with new food safety requirements for large-scale egg producers.
The new food safety requirements became effective on 9 July, 2010, through a rule for egg producers having 50,000 or more laying hens – about 80% of production. Among other things, it requires them to adopt preventive measures and to use refrigeration during egg storage and transportation.

Large-scale egg producers that produce shell eggs for human consumption and that do not sell all of their eggs directly to consumers must comply with the refrigeration requirements under the rule; this includes producers whose eggs receive treatments such as pasteurization. Similarly, those who transport or hold shell eggs must also comply with the refrigeration requirements by the same effective date.

Egg-associated illness caused by Salmonella is a serious public health problem. Infected individuals may suffer mild to severe gastrointestinal illness, short-term or chronic arthritis, or even death. Implementing the preventive measures would reduce the number of Salmonella Enteritidis infections from eggs by nearly 60%.

“Preventing harm to consumers is our first priority,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “Today's action will help prevent thousands of serious illnesses from Salmonella in eggs.”

The rule requires egg producers with fewer than 50,000 but at least 3,000 laying hens whose shell eggs are not processed with a treatment, such as pasteurization, to comply with the regulation as of July 9, 2012.

Producers who sell all their eggs directly to consumers or have less than 3,000 hens are not covered by the rule.
Under the rule, egg producers whose shell eggs are not processed with a treatment, such as pasteurization must:
• Buy chicks and young hens only from suppliers who monitor for Salmonella bacteria
• Establish rodent, pest control, and biosecurity measures to prevent spread of bacteria throughout the farm by people and equipment
• Conduct testing in the poultry house for Salmonella Enteritidis. If the tests find the bacterium, a representative sample of the eggs must be tested over an eight-week time period (four tests at two-week intervals); if any of the four egg tests is positive, the producer must further process the eggs to destroy the bacteria, or divert the eggs to a non-food use
• Clean and disinfect poultry houses that have tested positive for Salmonella Enteritidis
• Refrigerate eggs at 45 degrees F during storage and transportation no later than 36 hours after the eggs are laid (this requirement also applies to egg producers whose eggs receive a treatment, such as pasteurization).

To ensure compliance, egg producers must maintain a written Salmonella Enteritidis prevention plan and records documenting their compliance. Egg producers covered by this rule must also register with the FDA. The FDA will develop guidance and enforcement plans to help egg producers comply with the rule.

The new rule is part of a coordinated strategy between the FDA and the USDA’s Food Safety and Inspection Service (FSIS). The FDA and the FSIS will continue to work closely together to ensure that egg safety measures are consistent, coordinated, and complementary.


Saturday, July 10, 2010


A ProMED-mail post
ProMED-mail is a program of the
International Society for Infectious Diseases

Date: 9 Jul 2010
Source: The New York Times [edited]

Tainted Dairy Products Seized in Western China
Two years after a national health scare over
melamine-tainted milk products rocked China's
dairy industry and called food safety here into
question, inspectors in western China's Qinghai
Province have seized 76 tons of dairy ingredients
laced with the same industrial chemical, the
state-run Xinhua news agency reported Friday [9
Jul 2010].

The seizure appeared to involve products that had
escaped a nationwide recall of dairy foods after
the 2008 scandal, which killed at least 6
children and sickened 294 000 others.

Inspectors in Gansu Province 1st discovered
contaminated samples of milk powder brought to
them for testing by a worker at the Dongyuan
Dairy Factory in adjacent Qinghai Province.
Qinghai officials later found 64 tons of raw
dairy products and 12 tons of finished goods were
tainted with melamine, some at up to 559 times
the legal maximum.

Both the factory owner, 54-year-old Liu Zhanfeng,
and the production manager Wang Haifeng, 37, were
taken into police custody, Xinhua said. Officials
said most of the contaminated material was
destined for Zhejiang Province, near Shanghai.

Melamine, which is used in concrete, fertilizer
and plastics, mimics protein in certain
food-quality tests, and Chinese manufacturers had
added the chemical to ingredients used in infant
formula, chocolate, pet and animal feeds and
other products to make them appear more
nutritious. When eaten in sufficient quantity,
however, melamine can cause permanent kidney
damage. [And in pets kidney failure and death. It
is likely the same in all monogastric animals,
which includes humans. - Mod.TG]

A year before the 2008 scandal, pet foods
contaminated with Chinese-supplied melamine
killed dozens of dogs in the United States and
Africa and forced recalls of nearly 90 brands of
pet food.

In January [2010], inspectors in southern China's
Guizhou Province pulled dairy products out of
local stores after discovering melamine in
products shipped there from Shanghai and 3 other
provinces. Xinhua reported on Friday that
officials in Jilin Province, in northeastern
China, had confiscated more than 1000 packages of
milk powder after finding tainted products in a
market on 22 Jun 2010. Officials have since begun
inspecting dairy plants across the region.

In all the recent cases, the contaminated
products appear to be leftovers from the 2008
recall. Inspections at that time found excessive
melamine in the products of 22 dairy companies,
or 1 in 5 dairy manufacturers.

Government officials here vowed to crack down on
food-safety violations in the wake of the 2007
and 2008 melamine incidents, which damaged the
reputation of Chinese food exports worldwide. The
government ordered sweeping changes in food
inspection last year, writing new rules and
placing the existing patchwork of food regulatory
bodies under a single authority, the National
Ministry of Health.

But food safety procedures still need
improvement, and corrupt manufacturers and
growers still use bribery and corruption to
escape scrutiny.

"The Chinese government has enormously and
effectively responded with new laws and new
regulations, and tries to implement this as soon
as it can," Rio Praaning Prawira Adiningrat,
secretary general of the Public Advice
International Foundation, said in a telephone
interview. "But the sheer size of Chinese economy
and the number of people makes it virtually
impossible to check everything." The foundation
works in China on food safety issues.

Mr. Praaning praised the government's commitment
and willingness to discuss its problems openly,
adding, "I think they are absolutely doing the
best they can."

The melamine scandal erupted in late 2008,
however, only after government officials
suppressed word of widespread poisonings so as to
avoid sullying China's international image during
the Beijing summer Olympics.

On Wednesday [7 Jul 2010], a southern China
newspaper reported that one father who launched
an online crusade for food safety after his child
died from melamine poisoning had been sentenced
to one year in a labor camp for "re-education," a
form of punishment often handed out to dissidents
who incur official disfavor.

The Guangzhou-based Southern Metropolis Daily
said that the father, Tang Lin, lost his
one-year-old son in August 2008 after the infant
was poisoned by tainted infant formula made by
the Sanlu Group, then China's biggest dairy. The
company went bankrupt after the poisonings became

After local authorities in Chongqing city, a
central China metropolis, refused to compensate
him, Mr. Tang took his grievances online to a
popular chat service called QQ. He was arrested
on 19 May 2010, his wife told the newspaper, and
apparently was sent to the labor camp shortly
afterward for "posing a threat to public security
by scare-mongering" the newspaper stated.

Police documents made public this week say Mr.
Tang told online forum members that "he would go
to extremes" to publicize his son's death and
that "there will be news reports."

[Byline: Michael Wines]

Communicated by:

Date: 9 Jul 2010
Source: Associated Press [edited]

China finds more milk items tainted with melamine
Chinese authorities have found dairy products in
at least 3 provinces tainted with an industrial
chemical that killed 6 babies and sickened
hundreds of thousands more in 2008, state media
said Friday [9 Jul 2010].

The discovery suggests toxic milk [products]
remains a lingering danger in China despite a
crackdown 2 years ago that saw dozens arrested
and 2 people, a dairy farmer and a milk salesmen,

Some of the recently found milk was
melamine-tainted powder that state media said was
likely stockpiled instead of destroyed 2 years

Melamine is added to watered-down milk to make it
appear rich in protein in quality tests that
measure nitrogen, found in both the melamine and
protein. Health problems from the chemical
include kidney stones and kidney damage. [And
death - Mod.TG]

In June 2010, authorities found 64 tons of raw
materials for making milk powder and 12 tons of
finished powder tainted with melamine at a
factory in the far western province of Qinghai,
the official Xinhua News Agency said. In a
separate case, they said they seized about 1000
packets of tainted milk powder in the
northeastern province of Jilin.

Xinhua said the owner and a production manager
from Dongyuan Dairy Factory in Qinghai have been
detained after tests showed some of their
products had 500 times the legal limit for
melamine. The contamination was initially
discovered because Dongyuan sent samples of the
powder, which they had purchased from Hebei
province, to a lab for testing so they could
figure out how much to dilute it before selling
it, Xinhua said, citing police.

The report said some of the material was believed
to be old powder that should have been destroyed
in 2008 amid a crackdown on tainted milk.

Xinhua said Dongyuan had already sold some of the
tainted goods to businesses in Jiangsu and
Zhejiang provinces -- a supply chain that
suggests melamine-tainted milk products could
still be available in many parts of the country.

In Zhejiang, about 3 tons of Dongyuan milk powder
was used to make ice cream and other products,
but most of it was still being processed and had
not entered the market, Xinhua quoted a
provincial food safety official as saying.

The Xinhua report didn't say whether there were
any reports of people getting sick from the

The phone at the Dongyuan factory rang unanswered Friday.

China's Administration of Quality Supervision
Inspection and Quarantine did not immediately
respond to a faxed request for comment.

China ordered tens of thousands of tainted milk
products burned or buried after more than 300 000
children were sickened and at least 6 died from
the contamination. But, crucially, the government
did not carry out the eradication itself.

In January 2010, authorities announced toxic
dairy products had been found in Shanghai and the
provinces of Shaanxi, Shandong, Liaoning and
Hebei, prompting a 10-day emergency crackdown
with inspection teams fanning out to 16 provinces.

Zhang Zhongjun, a representative for the U.N.'s
Food and Agriculture Organization in Beijing,
said the latest discovery highlights China's
ongoing struggle to step up food safety.

"We think the situation is improving but there
are still some problems," Zhang said. He said
many manufacturers are small-scale operations
with little food safety awareness and numerous
agencies handle enforcement, creating confusion
that lets some offenders slip through the cracks.

Associated Press researcher Zhao Liang contributed to this report.

[Byline: Alexa Olesen]

Communicated by:

Date: 9 Jul 2010
Source: XinhuaNet [edited]

Melamine tainted milk re-emerges in northwest China plant
Food safety authorities have seized 64 tonnes of
raw dairy materials contaminated with the toxic
chemical, melamine, in a dairy plant in northwest
China's Qinghai Province, the provincial quality
watchdog said. Tests of samples of the milk
powder showed up to 500 times the maximum allowed
level of the chemical, said the quality watchdog
in Gansu Province, where the contaminated milk
powder was 1st discovered.

Police traced the source of the milk powder to
Dongyuan Dairy Factory, in Minhe County in
neighboring Qinghai Province. Another 12 tonnes
of processed milk powder products, also tainted,
were also seized.

About 38 tonnes of the raw materials were
purchased from north China's Hebei Province, the
source of the toxic baby formula scandal that
brought down the Sanlu dairy company in 2008,
police said.

It is possible that traders had bought tainted
milk that was supposed to be destroyed after the
2008 scandal, planning to process and resell it,
said Wang Zhongxi, deputy chief of the quality
control bureau in Gansu.

An employee of the Dongyuan Dairy Factory, Liu
Xiping, sent 3 samples of milk powder for testing
by Gansu's quality control bureau for melamine
content test on 25 Jun 2010. The bureau called
the police after test results showed the samples
had excessive levels of melamine.

A police investigation found the plant wanted to
know the melamine content of the raw dairy
materials they bought so as to dilute the
melamine level in the milk powder before sale.
Police have detained the owner and production
director of the factory.

Milk powder produced in the plant was mainly sold
in east China's Zhejiang and Jiangsu provinces.
Only a small amount was sold in Qinghai.
Zhejiang's food safety commission said Friday
they had seized 3 tonnes of Dongyuan milk powder
in food processing factories in the province.

The tainted milk powder, in 25-kg packages, was
mainly used to produce dairy products like
ice-cream, said the commission. Most of the
contaminated milk powder was still being
processed and had not entered the market, it said.

Meanwhile, in Jilin City of northeast China's
Jilin Province, authorities were testing samples
of milk powder suspected of having excessive
levels of melamine, the city's industry and
commerce bureau said Thursday [8 Jul 2010]. The
bureau has seized more than 1000 packages of milk
powder, produced in the neighboring Heilongjiang
Province, from a store after a random test found
one of them had a high melamine content on 22 Jun
2010. However, it did not say when the test
results would come out.

Jilin's provincial quality control bureau said
Thursday it would start a general check on dairy
products in the province on Friday.

Some milk producers have added the industrial
chemical to products to fool protein content
tests. The practice caused the deaths of at least
6 Chinese babies in 2008 and left another 300 000
infants ill.

A dairy farmer and a milk salesman were executed
November last year [2009] for their roles in the
scandal which also resulted in the bankruptcy of
state-owned dairy producer Sanlu.

Sanlu's general manager, Tian Wenhua, was given a
life sentence in January 2009 on charges of
producing and selling fake or substandard
products. Altogether 21 people were convicted in
connection with the scandal.

[Byline: Pliny, editor]

Communicated by:

[Melamine is an organic base chemical most
commonly found in the form of white crystals rich
in nitrogen. It is widely used in plastics,
adhesives, countertops, dishware, and
whiteboards. Symptoms and signs of melamine
poisoning are irritability, blood in urine,
little or no urine, signs of kidney infection,
and high blood pressure. Melamine causes kidney
stones and other urinary tract problems in lab
animals. It also causes kidney failure and death

In 2007, melamine was found in wheat gluten and
rice protein concentrate imported from China and
used in the manufacture of pet food in the United
States. This caused the death of a large number
of dogs and cats due to kidney failure (see prior
ProMED-mail post Pet food fatalities, pets - USA,
Canada, Mexico (03): melamine 20070330.1099).

According to the United States Food and Drug
Administration (FDA) regulations the presence of
melamine is considered adulteration. Adulterated
foods are not acceptable for marketing or
consumption. In China, where adulteration has
occurred, melamine has also been added to
increase the nitrogen content of the milk (its
apparent protein content) after water was added
to raw milk to increase its volume.

According to the report from the Ministry of
Health of China dated 22 Sep 2008, there had been
more than 53 000 cases identified, of which 13
000 were hospitalized, and 104 infants were in
serious condition.

In January 2009, a court in China sentenced 2 men
to death for their role in making and selling
milk tainted with melamine. At least 6 children
died and nearly 300 000 fell ill after drinking
the toxic dairy products in 2008 (see prior
PRO/MBDS post Infant kidney stones - China (06):
WHO, timeline 20080922.2990).

In general the melamine has been added to
powdered milk products, including such things as
powdered infant formula to be mixed at the home.

The solubility of melamine in water is 3.1 grams
of melamine per liter of water at 20 deg C [68
deg F], so it is possible to add it to liquid

While melamine can be added to liquid milk
products, melamine is not naturally found in milk
and does not pass through a cow/sheep/goat/horse
into the liquid milk. However, ruminant animals,
such as cattle, are better at utilizing non
protein nitrogen as a nutrient in their feed. -

[see also:
Melamine, milk products - China (02) 20100202.0352
Melamine, milk products - China 20100105.0048
Melamine contaminated food products (09): worldwide ex China 20081130.3770
Melamine - USA (02): traces in infant formula 20081127.3738
Melamine contaminated food products (08): worldwide ex China 20081120.3658
Melamine - USA: alert 20081116.3619
Melamine contamination, animal feed (04): China 20081114.3598
Melamine contaminated food products (07): worldwide ex China 20081114.3587
Melamine contaminated food products (06): worldwide ex China 20081105.3480
Melamine contamination, animal feed (03): China 20081031.3433
Melamine contaminated food products (05): worldwide ex China 20081030.3425
Melamine contaminated food products (04): Worldwide ex China 20081027.3391
Melamine contamination, animal feed (02): China 20081020.3326
Melamine contaminated food products (03): Worldwide ex China 20081020.3324
Melamine contaminated food products (02): Worldwide ex China 20081004.3129
Melamine contaminated food products - Worldwide ex China 20081002.3107
Melamine contamination, animal feed: RFI 20081001.3097
Infant kidney stones - China (03): melamine 20080917.29151
Infant kidney stones - China (02): Gansu, milk, melamine 20080912.2856
Fish mortality - South Africa: melamine?, RFI 20070612.1919
Contaminated pet food - China: melamine 20070430.1403
Pet food fatalities, pets - USA, Canada, Mexico (03): melamine 20070330.1099]

ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
Donate to ProMED-mail. Details available at:

Visit ProMED-mail's web site at .
Send all items for posting to: promed@promedmail.org (NOT to
an individual moderator). If you do not give your full name
name and affiliation, it may not be posted. You may unsub-
scribe at .
For assistance from a human being, send mail to:

Thursday, July 8, 2010


A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Fri 2 Jul 2010
Source: Examiner.com [edited]

On 1 Jul 2010, Tri-Union Seafoods announced a recall of Chicken of
the Sea 12 ounce cans of solid white tuna packed in water, citing
that a production error caused some issues with proper sealing. The
FDA has specific guidelines on canned foods and the sealing process
and the tuna recalled did not meet those standards.

These products were distributed in 10 states including Wisconsin,
Nebraska, Utah, Pennsylvania, New York, Maine, Colorado, Indiana,
California and Oregon. The distribution dates were in February and
May [2010]. The 12 ounce Chicken of the Sea solid white tuna packed
in water has a upc code of 4800000262, "Best By Date 2/10/2014" and
product code 7OA1E ASWAB, 7OA2E ASWAB, 7OA3E ASWAB, 7OA4E ASWAB,
7OA5E ASWAB, 7OAEE ASWAB, or 7OAFE ASWAB. The best by dates and
product code numbers are imprinted on the bottom of the cans. No
other Chicken of the Sea products are affected by this recall.

There have been no reports of sickness identified with the
consumption of this product.

Canned food with loose seals can spoil quickly and has the potential
to cause sickness. Although rare, botulism can sometimes be found in
improperly sealed canned foods and according to an FDA fact sheet on
botulism, canned fish has been identified as a food that is commonly

[Byline: Vanessa Houk]

Communicated by:

[Because of the potential severity of botulism, ProMED-mail posts
such recalls even if, as in this case, there are no human cases
associated with the food products. Most of the food recalls (as in
these cases) are related to defective preparation procedures, which
could, but not necessarily do, result in the germination of viable
spores of _Clostridium botulinum_. - Mod.LL]

[see also:
Botulism, uneviscerated fish - USA: ex Norway, risk, recall 20100208.0427
Botulism, baby food, uneviscerated fish - USA: risk, recall 20091020.3599
Botulism, home canned green beans - USA: (WA) 20090310.0990
Botulism, uneviscerated fish - USA (02): risk, recall 20090228.0827
Botulism, uneviscerated fish - USA: (NY, NJ) risk, recall 20090120.0247
Botulism, dessert sauces - USA: risk, recall 20090126.0343
Botulism, human, home canned green beans - USA: (OH) 20080919.2947
Botulism, native foods - USA: (AK) 2007 20080811.2472
Botulism, tea concentrate - USA: (MT, AZ) risk, recall 20080618.1903
Botulism, pesto - USA: risk, recall 20080429.1474
Botulism, canned bean salad - USA: risk, recall 20080229.0821
Botulism, olive oil dip - USA: risk, recall 20080204.0448
Botulism, fish - USA: (NY, NJ, MD), risk, recall 20080124.0299
Botulism, canned beans - USA (03): risk, bean salad recall 20080122.0264
Botulism, canned beans - USA: risk, expanded recall 20080109.0117
Botulism, canned soup - USA: (PA) recall, RFI 20080103.0030
Botulism, foie gras - France: risk, recall 20080102.0016
Botulism, canned food: aerosol risk 20080101.0008]

ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
Donate to ProMED-mail. Details available at:

Visit ProMED-mail's web site at .
Send all items for posting to: promed@promedmail.org (NOT to
an individual moderator). If you do not give your full name
name and affiliation, it may not be posted. You may unsub-
scribe at .
For assistance from a human being, send mail to:

Wednesday, July 7, 2010


A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Tue 6 Jul 2010
Source: Pan American Health Organisation (PAHO), Regional Update,
Pandemic (H1N1) 2009 [edited]

Regional Update, Pandemic (H1N1) 2009
The information contained within this update is obtained from data
provided by Ministries of Health of Member States and National
Influenza Centers through reports sent to the Pan American Health
Organization (PAHO) or updates on their web pages.

Weekly Update

- In North America, acute respiratory disease activity remained low.
- In the Caribbean, Jamaica reported an increasing trend in acute
respiratory disease
- In Central America, El Salvador and Panama reported increasing
trends in acute respiratory disease. Panama reported a high intensity
of acute respiratory disease and moderate impact on health care
- In South America, Colombia reported an increased trend of acute
respiratory disease.
- In EW 22-25, Panama reported a sharp increase in the number of
influenza A/H3 viruses and influenza A not subtyped. Argentina (EW
24) and Chile (EW 25) continue to report a predominance of RSV
[respiratory syncytial virus].
- 54 new confirmed deaths in 5 countries were reported; in total,
there have been 8516 cumulative confirmed deaths in 28 countries of
the region.

I - Evolution of the pandemic
North America
In the United States, in EW 25, the proportion of outpatient
consultations for influenza-like illness (ILI) continued to remain
below the national baseline. All the sub-national surveillance
regions reported the proportion of ILI to be below their
region-specific baseline. The proportion of deaths attributed to
pneumonia and influenza was below the epidemic threshold. No
influenza-associated pediatric deaths were reported this week.

Influenza activity was reported as widespread in Jamaica, regional in
Cuba, and localized in Dominica. Trends of acute respiratory disease
were reported as increasing in Dominica, unchanged in Jamaica, and
decreasing in Cuba. All countries reported low/moderate intensity of
acute respiratory disease and low impact of acute respiratory disease
on health care services.

Jamaica, in EW 24, reported an unchanged SARI (severe acute
respiratory illness) and ARI (acute respiratory illness) rate as
compared to the previous week, remaining slightly above the national

Central America
Influenza activity was reported as widespread in Costa Rica, regional
in Nicaragua and Panama, and no activity in El Salvador. El Salvador
and Panama reported increasing trends in acute respiratory disease,
while Costa Rica and Nicaragua reported unchanged and decreasing
trends, respectively. All the countries reported low/moderate
intensity of acute respiratory disease, except Panama, which reported
high intensity. Costa Rica and El Salvador reported low impact of
acute respiratory disease on health care services, while Nicaragua
and Panama reported moderate impact.

In EW 24, Costa Rica reported a slight increase in SARI
hospitalizations and increased trends in confirmed pandemic cases in
5 of the provinces, especially in Alajuela, Heredia, and Puntarenas.

In EW 24 and 25, Panama reported an increased number of cases of
seasonal influenza (H3N2) in the province of Panama and some pandemic
influenza cases in the northern province of Chiriqui.

South America

Bolivia and Colombia reported regional influenza activity. Colombia
reported an increasing trend in acute respiratory disease, and
Bolivia reported a decreasing trend in acute respiratory disease.
Both countries reported low/moderate intensity of acute respiratory
disease, and low impact on health care services.

In EW 25 in Bolivia, at the national level, the number of SARI cases
decreased compared to the previous week, remaining within the endemic
channel. In the northern department of Pando, the number of SARI
cases was above the epidemic threshold.

In EW 24, Peru reported an increase in the number of confirmed
pandemic influenza cases in the southern region during the last 4 EW,
especially in the department of Arequipa.

In EW 24, Venezuela reported a decrease of 7.7 percent in the number
of acute respiratory disease cases, as compared to the previous week,
and an increase of 1.7 percent in the number of pneumonia cases, with
the highest percentage in the 1-4 year age group.

Southern Cone
Brazil and Chile reported regional influenza activity. The trends in
acute respiratory disease were reported as decreasing in Brazil and
unchanged in Chile. Both countries reported low to moderate intensity
of acute respiratory disease and low impact on health care services.

In Argentina, between EW 21-23, the number of hospitalizations among
children under 5 years of age with acute lower respiratory infection
has remained stable, after an increase of 122 percent between EW

In Chile, nationally, consultations for ILI remained low and within
the endemic channel. At the regional level, one region (Tarapaca)
reported high ILI activity, one reported moderate ILI activity, 10
regions reported low ILI activity, and 4 regions reported no ILI
activity. The percentage of consultations for pneumonia out of the
total number of consultations increased by 2 percent, especially
among children under 15 years of age.

[The remaining sections of this document, "II - Description of
hospitalizations and deaths among confirmed cases of pandemic (H1N1)
2009," and "III - Viral circulation," contain maps, graphs and
tabulated data. Interested readers should access the original pdf
file via the URL at the top of this report to view these sections and
the references for the data in part I. - Mod.CP]

Communicated by:
ProMED-mail Rapporteur Marianne Hopp

[see also:
Influenza pandemic (H1N1) (48): India 20100706.2249
Influenza pandemic (H1N1) (47): WHO update 107 20100704.2223
Influenza pandemic (H1N1) (46): India, monsoon 20100630.2177
Influenza pandemic (H1N1) (45): WHO update 106 20100626.2142
Influenza pandemic (H1N1) (40): WHO update 104 20100612.1970
Influenza pandemic (H1N1) (30): WHO update 20100417.1250
Influenza pandemic (H1N1) (20): China, update 20100303.0702
Influenza pandemic (H1N1) (10): PAHO update 20100121.0240
Influenza pandemic (H1N1) (01): China, 2009 20100105.0040]

ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
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Tuesday, July 6, 2010

Cleveland Clinic finds high Avandia cardio risk

July 5, 2010 — 9:32pm ET By George Miller

Researchers have turned to a second meta-analysis of existing clinical trials to address the question of cardiac safety in users of the GlaxoSmithKline diabetes drug Avandia. Their finding: "an unfavorable benefit-to-risk ratio."

The new meta-analysis, conducted by Steven Nissen (the cardiologist who launched the Avandia controversy with the first meta-analysis three years ago) and Kathy Wolski of the Cleveland Clinic, represents the "most robust available approach" for determining the drug's cardiovascular safety, and it provides a means of overcoming limitations in the first study. The current findings are published in a late June online version of the Archives of Internal Medicine, in time for this month's meeting of the FDA advisory committee considering whether to remove rosiglitazone from the market.

The Cleveland Clinic researchers note the absence of any large, definitive rosiglitazone cardiovascular outcomes trials. The 2009 Record study funded by GSK--which evaluated the drug for cardiac outcomes and regulation of glycemia in diabetes--was limited by low event rates, researchers say, and considered inconclusive.

The current study analyzes myocardial infarction and cardiovascular mortality for 56 randomized trials involving 35,500 subjects. Nissen and Wolski used a study-level meta-analysis to find that the odds ratio for myocardial infarction was in fact "significantly increased," but without evidence of an increase in cardiovascular mortality.

The researchers began by considering for the meta-analysis some 200 clinical trials that they found by scouring GSK's Avandia trial registry as well as MEDLINE and FDA listings. The select 56 all include a randomized comparator group, similar treatment duration, and more than 24 weeks of drug exposure. Of the 56, 15 reported no myocardial infarctions; 30 reported no cardiovascular mortality.

The trials without events were excluded in the primary prespecified analysis. But they were included in an alternative analysis, which yielded a similar hazard. The findings are consistent with prior meta-analyses conducted by GSK, the FDA and most independent investigators, the researchers say.

Related Articles:
GSK's Avandia trial faces recruitment battle
FDA may halt Avandia-Actos trial on safety concerns

Read more: Cleveland Clinic finds high Avandia cardio risk - FierceBiotechIT http://www.fiercebiotechit.com/story/cleveland-clinic-finds-high-avandia-cardio-risk-again/2010-07-05?utm_medium=nl&utm_source=internal#ixzz0sv4p2pPa


Monday, July 5, 2010


A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

Date: Sat 3 Jul 2010 11:28 AM
From: Ramon Noseda [in Spanish,
trans. Mod.MHJ, edited]

[Re: ProMED-mail Anthrax, human, livestock, 2009 - Argentina 20100702.2207]
[In response to some queries about percentages, Dr Noseda replied:]

The reported 85 964 cattle vaccinated (16.8 percent) were in the
county (partido) of Azul, which carries some 510 524 head. These were
registered vaccinations as part of the targeted Anthrax Control and
Surveillance programme in that county.

There is no national vaccination registry for anthrax and so the
national coverage can only be guessed at. It is believed to be
potentially approx. 25 percent of all cattle at risk. There are some
53 million cattle in the country and the annual production of anthrax
vaccine is 11 058 500 doses.

Dr Ramon Noseda
Laboratorio Azul Diagnostico SA
Av 25 de Mayo 479
(B7300FXE) Azul - Pcia Bs As

[The major national production of high quality beef is from the
pampas of Buenos Aires Province. And this province also has the best
soils for anthrax spore survival. Therefore it is extremely important
to have a proactive and effective anthrax control and surveillance
programme in this county where historically most anthrax has been
seen. It is succeeding and each year there are fewer outbreaks. When
they occur it usually involves cattle which had not been vaccinated
in spite of the advice given to the owner. Unfortunately as the
incidence falls, owners think their stocks are no longer at risk. We
see the same problem each year on the Canadian prairies and in the
Dakotas and north west Minnesota. - Mod.MHJ]

[see also:
Anthrax, human, livestock, 2009 - Argentina 20100702.2207
Anthrax, human, livestock, 2008 - Argentina 20090612.2179
Anthrax, human, livestock, 2007 - Argentina 20080528.1731
Anthrax, human, livestock - Argentina: 2006 20070519.1590]
ProMED-mail makes every effort to verify the reports that
are posted, but the accuracy and completeness of the
information, and of any statements or opinions based
thereon, are not guaranteed. The reader assumes all risks in
using information posted or archived by ProMED-mail. ISID
and its associated service providers shall not be held
responsible for errors or omissions or held liable for any
damages incurred as a result of use or reliance upon posted
or archived material.
Donate to ProMED-mail. Details available at:

Visit ProMED-mail's web site at .
Send all items for posting to: promed@promedmail.org (NOT to
an individual moderator). If you do not give your full name
name and affiliation, it may not be posted. You may unsub-
scribe at .
For assistance from a human being, send mail to:

Sunday, July 4, 2010

Big Pharma caught spying on the WHO

From WikiLeaks

December 10, 2009

By Kaitlin Mara (Intellectual Property Watch)[1]

Confidential documents related to the World Health Organization Expert Working Group on innovative financing for research and development surfaced today, revealing the group’s thinking as well as pharmaceutical industry thinking about the WHO process. The documents immediately raised concern about possible undue access to the process by industry; the WHO told Intellectual Property Watch the industry group was not supposed to have the documents.

The documents appear to have come from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and include draft reports on innovative financing mechanisms from the working group as well as an analysis by the IFPMA on the reports’ contents. They were released on Wikileaks, a website that anonymously publishes sensitive documents.

”IFPMA was not supposed to have working drafts of the expert working group in their possession and they were not given these documents,” said Precious Matsoso, director of Public Health Innovation and Intellectual Property (PHI) at the WHO, under whose auspices the expert working group falls. “It was understood by the working group that its report is intended for the director general and” WHO members, she added.

Public health advocates reacted strongly to the leaked documents. “The IFPMA document confirms much of what had been feared,” that there is “a larger WHO strategy to protect the status quo, particularly as it relates to intellectual property issues,” said James Love, the director of Knowledge Ecology International, a non-profit group focussed on transparency in policymaking and which has been advocating for prize funds, a biomedical R&D treaty, and other initiatives to fund R&D.

An introductory letter included with the documents addressed to the Public Health Advocacy Committee at IFPMA says “the overall result [of the working group’s report] is in line with most of the industry positions on this matter,” but says that “there is still room for them to introduce new language” as the documents date from before the final working group meeting concluded on 2 December.

The Expert Working Group’s “comparative analysis of innovative financing proposals for health R&D,” available from Wikileaks here [pdf], divides aspects of drug development into six categories and then lists the ideas from “least likely” to “most likely” to work.

The six categories are: fundraising, research and development capacity building in developing countries, basic research and product discovery, product development, manufacturing and distribution, and efficiencies.

The leaked documents are all available from Wikileaks here.

Expert Analysis

The draft reports available on Wikileaks do not contain final recommendations. These will be available only in the final report, expected to be released this week (IPW, WHO, 7 December 2009). Instead, it contains an analysis of all proposals made thus far, through two calls for advice from the public, and ranks them on efficacy and feasibility.

Within “fundraising,” proposals considered “least likely to work” include diverting existing resources to health, reducing tax evasion and havens, levying new charges on services or access rights. A proposal for a “Green IP” system (IPW, Inside Views, 27 June 2008) is currently “too hard to operationalise” but some elements could potentially be useful.

Most likely to work include new indirect taxes, for example on internet users; voluntary private contributions, new donor funds, and taxes on pharmaceutical profits. Taxing pharmaceutical profits is estimated to generate only USD 160 million versus, for example, a potential USD 2 billion from internet taxes.

On building research capacity, specific recommendations are not made, but the report says there is a lot of potential in this idea as innovative pharmaceutical development is often done in commercial ventures and, in developing countries, “commercial targets often have significant overlap with public health targets,” as local markets demand treatment for neglected diseases.

On basic research, prize systems and prize funds for completed drugs, as well as a “health impact fund,” are deemed least effective, as is the idea of a biomedical R&D treaty. “Endstage prizes” and the treaty were also seen as not particularly beneficial for product development. Prizes have been advocated as a solution to R&D financing problems by several health advocacy NGOs (IPW, Public Health, 12 February 2009).

Deemed more effective in incentivising research were funding for product development partnerships, grants to companies working on neglected diseases, and prizes for reaching “milestones” (such as those provided by Innocentive). Similar incentives were considered beneficial for product development.

Prizes were seen as possible incentives for manufacturing and distribution, though “likely only for diagnostics” as opposed to vaccines or medicines.

“Absolutely Fair Towards the Industry”

The draft report, the IFPMA said, is “absolutely fair” regarding industry concerns, using “real figures” on the cost of drug and vaccines developments and containing “many references to the importance of intellectual property … to achieve further innovation.”

As far as streamlining the current R&D system, which the report calls “unwieldy,” removing data exclusivity was seen as less effective compared to harmonising medicine regulatory systems and “pre-competitive platforms” for R&D.

The IFPMA analysis raised two major concerns.

The first relates to proposed taxes on the pharmaceutical industry, which the IFPMA document says “places the burden of the R&D … exclusively on industry and reinforces the negative image of pharmaceutical profits.”

“Operationalising this proposal may lead to companies increasing prices to compensate which would be counterproductive,” it adds. Further, it is not certain to be acceptable by all partners “as the tax should be imposed on the whole pharmaceutical sector, generic included.”

The second area of concern is drug-purchasing mechanism UNITAID’s proposed patent pool, and in particular its structure for royalty payments to IP owners. These payments would be determined based on the “therapeutic benefits and the affordability of royalities in particular countries,” the analysis says, adding that this “does not follow past or current patent pool structures” and emphasising that voluntary participation should be an “essential prerequisite.”

A UNITAID board meeting on 14-15 December will review an expert study on the patent pool, which the UNITAID board agreed in principle to establish in July 2008. In May 2009, the board instructed the organisation’s secretariat to prepare an implementation plan. An expert team analysed a range of issues and its report, completed in November, clearly recommends the implementation of the pool, sources told Intellectual Property Watch.

The IFPMA analysis also called for vigilance regarding the potential use of open source systems.

NGOs: Documents “A Step Backwards”

Love said the expert working group process was “a step backwards” and “evidence of a deeper problem in WHO regarding the influence of the pharmaceutical industry, and its philanthropic supporter, the Microsoft founder’s Gates Foundation.”

”This is a very disturbing set of documents,” said Sarah Rimmington, from nongovernmental organization Essential Action’s Access to Medicines Project. She added that the report “embraces the status quo and rejects the feasibility of almost every single important proposal aimed at truly solving these complicated problems.”

Kaitlin Mara may be reached at kmara@ip-watch.ch.

As published in Intellectual Property Watch. Thanks to Kaitlin Mara and IP Watch for covering this material. Copyright remains with the aforementioned.

Source documents:
Big Pharma inside the WHO: confidential analysis of unreleased WHO Expert Working Group draft reports, 8 Dec 2009

Retrieved from "http://www.wikileaks.org/wiki/Big_Pharma_caught_spying_on_the_WHO"
Categories: Analyses | United States | 2009 | 2009-12 | CommercialViews