No Tamiflu or Relenza, for Children, Studies Say

INFLUENZA PANDEMIC (H1N1) 2009 (28): CHILD TREATMENT
****************************************************
A ProMED-mail post

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


Date: Mon 10 Aug 2009
Source: The Daily Telegraph online [edited]



[NB: This analysis refers to the use of oseltamivir [Tamiflu] in children
exposed to seasonal influenza virus infection but is included in the
influenza pandemic (H1N1) thread because of its relevance to the current
practice regarding the use of neuraminidase inhibitors in the treatment of
children exposed or potentially exposed to pandemic flu. - Mod.CP]

Children should not be given the antiviral drug Tamiflu [oseltamivir] for
swine flu [influenza pandemic (H1N1) 2009 virus infection] because its
harms outweigh any benefits, and the government should review its policy on
dealing with the pandemic, researchers have said.

The antiviral drugs Tamiflu and Relenza [zanamivir] reduce the length of
time children are ill with flu by about one day and can cause vomiting as a
common side effect, Oxford researchers found. Vomiting is more dangerous in
children than in adults, as it can rapidly lead to dehydration and
admission to hospital, they said.

Also, the drugs had little or no effect on asthma flare-ups, ear infections
or the likelihood of a child needing antibiotics, meaning on balance the
medicine does more harm than good in otherwise healthy children, the
authors said. It comes after research last week showed that Tamiflu reduced
the length of flu in adults by just half a day.

Together, these findings will question whether the government's policy of
stockpiling enough antiviral drugs for 80 per cent of the population was a
waste of money. The exact cost of the stockpile has been kept secret for
"commercial reasons" but is expected to run to tens of millions of pounds.
Countries around the world have stockpiled around 50 million doses of
Tamiflu, made by Roche, for use during a flu pandemic.

Tamiflu has also been linked to side effects such as insomnia and
nightmares in children. Dr Matthew Thompson, a GP and senior clinical
scientist at Oxford University and Dr Carl Heneghan, a clinical lecturer at
Oxford University, said the findings review of 7 research studies should
prompt the Department of Health to reconsider its policy. The study,
published online in the British Medical Journal, reviewed trials where
children aged between one and 12 were either given Relenza or Tamiflu to
treat seasonal flu or where one of their family had flu and they were given
medicine to stop them becoming ill. The researchers said although the
studies were carried out on seasonal flu, the findings are relevant to the
current swine flu outbreak.

The drugs may still be of some benefit for children who have underlying
conditions such as cystic fibrosis or whose immune system is compromised
because they are being treated for leukaemia, for example, but there was
not enough evidence to be conclusive about this, the researchers said. Dr
Thompson said the government's current policy of giving Tamiflu to all
symptomatic people was "inappropriate."

GPs are using their clinical judgment and providing antivirals to severe
cases of flu, but the National Pandemic Flu Service is handing out the
drugs to anyone who fits the criteria for having a flu-like illness. Data
from the Health Protection Agency has suggested only one in 4 of those with
symptoms will actually have swine flu.

The Flu Service handed out 150 000 doses of Tamiflu in its 1st week as
cases peaked at around 110 000 in 7 days. Dr Thompson said: "Reserving
these antiviral drugs for children who are more likely to have
complications may be a more sensible strategy and would take some of the
pressure off the current public demand for antivirals." Dr Heneghan warned
that prescribing the drugs so widely will encourage flu to become resistant
to the medicine. He said: "Going forward, we have a treatment which is
ineffective because we've given it to everybody." He also warned that
people were relying on Tamiflu, also known as oseltamivir, "like a magic
bullet," and this meant that serious complications of swine flu could be
dismissed in those on the drug. Parents should treat flu in children with
paracetamol and rest but watch carefully for complications and contact
their GP if they are worried, the authors said.

The research trials which were reviewed have been available for over a
year, and the government could have carried out its own study in this
before the outbreak of swine flu began, they said. The findings also showed
that when using antiviral drugs in children who have been exposed to flu
but do not yet have symptoms, as preventive treatment, they were of limited
use. They found 13 children need to be treated to prevent one case, meaning
onward transmission was only reduced by 8 per cent.

Government data released on 30 Jul 2009 suggested that by then, one in 77
children aged between one and 4 had already had swine flu along with one in
95 of those aged between 4 and 14.

Norman Lamb, Liberal Democrat health spokesman said: "An urgent review must
be carried out into whether the benefits of prescribing certain antiviral
drugs are worth the risks when it comes to our children's health. "Parents
will now need urgent guidance and reassurance about what exactly they
should be doing to look after their children. This is even more crucial
given that health experts are predicting a surge in swine flu cases this
autumn [2009]."

Sir Liam Donaldson, the government's chief medical advisor, said: "This is
a good research team, and their report is welcome. However, the study is
limited in its scope, tentative in its conclusions and not directly
comparable to the current situation. It reviewed a very small number of
past clinical trials on seasonal flu, not the current H1N1 pandemic flu
strain. Antivirals are the only available weapon, albeit imperfect, against
the virus until a vaccine is developed and ready for use. Like all drugs,
they can have side effects in some people."

A Department of Health spokesman said: "The BMJ review is based on seasonal
flu and not swine flu. As the authors note, the extent to which the
findings can be applied to the current pandemic is questionable; after all,
we already know that swine flu behaves differently to seasonal flu, and
past pandemics have hit younger people hardest. Whilst there is doubt about
how swine flu affects children, we believe a safety-first approach of
offering antivirals to everyone remains a sensible and responsible way
forward. However, we will keep this policy under review as we learn more
about the virus and its effects. For those who experience severe symptoms,
the best scientific advice tells us that Tamiflu should still be taken as
soon as possible; and to suggest otherwise is potentially dangerous. If
people are in any doubt about whether to take Tamiflu, they should contact
their GP."

A spokesman for Roche, which makes Tamiflu, said: "Data ... show that in
otherwise healthy children (under 12s) who had fever plus either cough or
head cold symptoms, Tamiflu treatment, started within 48 hours of onset of
symptoms, significantly reduces the time to alleviation on illness by 1.5
days compared to placebo. As with all medicines, healthcare professionals
need to weigh up the benefits against the risk of any side effects."

The latest figures have suggested the 1st wave of the swine flu outbreak
has peaked [in the UK], with officials saying around 30 000 new cases were
diagnosed in the week ending 1 Aug 2009, but a 2nd wave is still expected
later in the autumn. So far, 36 people with swine flu [in the UK] have died.

[byline: Rebecca Smith]

--
communicated by:
ProMED-mail rapporteur Mary Marshall

[The reference for the BMJ article is: Matthew Shun-Shin, Matthew Thompson,
Carl Heneghan, Rafael Perera, Anthony Harnden, and David Mant.
Neuraminidase inhibitors for treatment and prophylaxis of influenza in
children: systematic review and meta-analysis of randomised controlled
trials BMJ 2009;339:b3172, doi: 10.1136/bmj.b3172 (Published 10 Aug 2009)
. -
Mod.CP]

[see also:
Influenza pandemic (H1N1) 2009 (27): Viet Nam, patient data update
20090809.2819
Influenza pandemic (H1N1) 2009 (26): update 20090807.2801
Influenza pandemic (H1N1) 2009 (25): Australia, UK, updates 20090806.2784
Influenza pandemic (H1N1) 2009 (24): global update 20090805.2766
Influenza pandemic (H1N1) 2009 (23): (China, Taiwan), co-circ. H3N2
20090802.2713
Influenza pandemic (H1N1) 2009 (22): Australia (NSW), swine 20090801.2698
Influenza pandemic (H1N1) 2009 (21): vaccine priorities 20090730.2669
Influenza pandemic (H1N1) 2009 (20): Peru, 33 percent asymptomatic
20090730.2668
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (08): pandemic origins 20090718.2559
Influenza pandemic (H1N1) 2009 (06): case reporting 20090717.2553
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (04): pandemic origins 20090715.2527
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505
Influenza pandemic (H1N1) 2009 (02): obesity risk factor 20090711.2482
Influenza pandemic (H1N1) 2009 - Viet Nam: patient data 20090708.2450]

....................cp/msp/sh



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Big Pharma readies $150 to Help Obombas' Health Plan

msnbc.com

OBAMA'S PLAN HELPED
BY DRUG INDUSTRY -


Drugmakers have funneled more money to Democrats in recent years,
a trend that began soon after they gained control of Congress.
CNBC.com reported that, among presidential candidates,
Obama was number one, current and former, in contributions
received from pharmaceutical companies and health care
companies at $636,000 through the end of April, 2008.
Sen. Hillary Clinton is second at $568,000. Sen. John
McCain has taken in $173,000.

"The White House and allies in Congress are well aware of the effort by Pharmaceutical Research and Manufacturers of America, a somewhat surprising political alliance, given the drug industry's recent history of siding with Republicans and the Democrats' disdain for special interests.
"The campaign, now in its early stages, includes television advertising under PhRMA's own name and commercials aired in conjunction with the liberal group, Families USA.

"Numerous people with knowledge of PhRMA's plans said they had been told it would likely reach $150 million and perhaps $200 million. They spoke on condition of anonymity, saying they were not authorized to divulge details."

"So now we know why the president wants everyone to make nice in the healthcare
debate. His White House has cut a deal with Big Pharma that smells like the same old
rotten politics that candidate Obama regularly denounced and promised to end. The
drug industry agrees to deliver $80 billion in future savings and the president promises
the government will not use its awesome purchasing power to negotiate
lower drug prices." - Aleternet, Aug 8, 2009

"At the same time, the drugmakers are counting on the White House to block efforts by House Democrats to extract more than $80 billion from their industry in the legislation.

"The partnership is complicated because many Democrats in both the House and Senate oppose key goals of the drug industry. Liberals, in particular, favor the importation of prescription medicine from Canada and other countries. They also want the government to have authority to negotiate directly with companies for lower drug prices under Medicare."
"While the White House and Democrats benefit from PhRMA's help, they seem reluctant to discuss it openly."

Any health care bill that makes it to Obama's desk is
expected to "extend health insurance to the nearly 50 million
who now lack it." How? All Americans will be forced to buy
health insurance by mandate. That would mean a huge
new pool of potential customers for drug companies
and other health care providers.

Obama's plan helped by Big Pharma, to the tune of $150 million to $200 million or more - what are your comments?

Greg Dempsey

Voice of the People
======
Drugmakers ready $150 million for Obama plan
Boost would halt efforts to derail health-care overhaul

updated 11:17 a.m. PT, Sat., Aug 8, 2009

WASHINGTON - U.S. drugmakers stand ready to spend $150 million to help President Barack Obama overhaul health care this fall, according to numerous officials, a staggering sum that could dwarf attempts to derail Obama's top domestic priority.

Additionally, the industry is the major contributor to Healthy Economy Now, which recently completed a $12 million round of advertising nationally and in several states. The ads were made by firms with close ties to Democrats and the White House and generally reflected the administration's changing rhetoric on health care.

In an interview, Ken Johnson, senior vice president of PhRMA, said, "We will have a significant presence over the August recess, both on television and newspapers and on radio, but we have not finalized details for our fall campaign."

Ron Pollack, executive director of Families USA, said the partnership with the deep-pocketed drug industry is one of mutual self-interest, even though the two groups disagree on numerous issues. "We want to achieve coverage for everyone. For PhRMA, this would improve volume for prescription sales because everyone" would have better access to medicine, he said.

That, in turn, has created an incentive to offer concessions to the White House and lawmakers in hopes of shaping the bill, rather than simply opposing it.

Drugmakers were the first group to reach agreement with the White House and Senate Finance Committee Chairman Max Baucus, a Montana Democrat, announcing several weeks ago that they would absorb $80 billion in costs over a decade.

Even before the announcement, according to several individuals, the White House sought help from PhRMA in passing legislation.

Now, with the legislation under attack, the industry is providing key support during August as Republicans work to inflict a high-profile defeat on the president.

A significantly more ambitious advertising effort by PhRMA is expected to begin near Labor Day.

Jim Messina, a deputy White House chief of staff who is deeply involved in the administration's health care effort, brought Democratic senators up to date recently on the help PhRMA, labor unions and other outside groups are providing.

House Speaker Nancy Pelosi, a Democrat from California, has been critical of drug manufacturers, and Rep. Henry Waxman, also a California Democrat and chairman of the Energy and Commerce Committee, said several weeks ago the House was not bound by PhRMA and Baucus' agreement.

By the White House tally, overall advertising so far by PhRMA and other supporters of the bill has swamped efforts by opponents. Republican strategists concede it would be extremely difficult to match an effort of the size PhRMA is planning.

For comparative purposes, 2008 Republican presidential candidate John McCain was limited to spending $84 million a year ago when he accepted government funding for his fall campaign.

Independent calculations show Healthy Economy Now has spent about $12 million on three ads that ran nationally and in 17 states and the District of Columbia.

----------------------------------------------------------

The messages meshed with the White House's changing rhetoric. An ad that began in mid-June said patients would be able to choose their own doctors. Another, launched in mid-July, focused on consumer protections, including a ban on insurance companies denying coverage due to pre-existing medical conditions.

To make the ads, the group hired GMMB, a political consulting and advocacy advertising firm with close ties to the White House and Senate Democrats, as well as AKPD, top White House strategist David Axelrod's former firm.

Jeremy Van Ess, a spokesman for Health Economy Now, said the decisions were made by the organization, and not at the White House's request.

"Absolutely not. ... It's no secret in Washington that these two firms we had are the best out there," he said.

PhRMA/Families USA spent about $5.7 million in nationwide advertising for the two months ending Aug. 9, according to information compiled by a different organization.

Two weeks ago, the drug industry added another weapon to its arsenal, launching a series of ads under its own name in a few key states at a cost of about $1 million so far.

Among them is Nevada, where the industry has purchased time through Labor Day to air commercials thanking Senate Majority Leader Harry Reid for his efforts to pass health care reform. Reid's public approval is weak in the state, although he does not yet have a Republican opponent for 2010.

When PhRMA became the first big health care provider to agree to accept reductions as part of legislation, Obama made the announcement at the White House with the head of AARP in attendance. Billy Tauzin, the former Republican congressman who is head of PhRMA, was not invited.

More recently, Reid omitted the drugmakers from a list of outside interests trying to help pass legislation.

The drug industry's campaign is the culmination of a broader shift it has undertaken. A few years ago, the industry hired Steve McMahon, a longtime Democratic strategist, to oversee its political advertising.

msnbc.com

White House Confirms: Deal With Big Pharma Bars Price Negotiations

Ryan Grim
ryan@huffingtonpost.com | HuffPost Reporting

Updated: 08- 7-09 09:59 PM

Kicking William Schatner to the curb,....

In closed-door negotiations with President Obama and his top aides throughout the spring, Big Pharma offered its support for comprehensive health care reform and pledged to cut $80 billion in costs over the next ten years. Just exactly what Obama promised in return wasn't made public and was the subject of intense debate on Capitol Hill Thursday, as senators wondered aloud if the White House had tied their legislative hands.

Earlier in the week, there were reports that Obama had promised to oppose any congressional attempt to exact further money from the massive pharmaceutical industry, which would include allowing Medicare to negotiate for lower prices or import cheaper drugs from Canada -- two major priorities for congressional Democrats.

In a Thursday meeting with Senate Democrats, some of those present thought the White House backed off that deal. The administration has now stepped in to clear up its position: Congress can vote to do those things -- just not as part of the health-care overhaul legislation.

The White House said on Friday that drug price negotiations did not specifically come up in talks with Big Pharma. Because such negotiations would take the deal past $80 billion, however, they're off limits, as is reimportation of cheaper drugs from Canada.

White House spokesman Reid Cherlin confirmed that despite Thursday's uncertainty the deal outlined in the New York Times still stands.

Of course, as the White House acknowledges, senators are free to push for drug-price negotiations or reimportation, but they may have to do so without administration support and, certainly, in the face of Big Pharma opposition.

Several senators, including Sherrod Brown (D-Ohio) and Bernie Sanders (I-Vt.), pledged to go after PhRMA no matter what the White House said.

Ken Johnson, PhRMA's senior vice president, told the Huffington Post the drug lobby has been in touch with the White House the last few days but that he couldn't talk about the specifics of the deal. "It's been a trying 48 hours," he said.

He did, though, talk about PhRMA's principal goal of the negotiations that led to the deal. "We made it very clear - and again, I'm not talking about the agreement - but we made it very clear that with respect to health care reform, the line in the sand for us was price control," Johnson said.

The deal only applies to the health care reform bill itself, meaning the White House could back Senate Democratic attempts to push for more savings from drug makers in separate, future legislative attempts, a White House aide said.

The truce over, the two parties will then battle it out. "The only thing I can say is we'll do what we always do. We'll roll up our sleeves and fight them one fight at a time," said Johnson.

For the White House, it's critical to keep the drug lobby either neutral or in its camp, given the muscle that the pharmaceutical industry is able to flex. PhRMA is watching the administration closely to make sure it sticks to its deal.

"I'm going to be as honest as I can be. I'm keeping my eye on the ball... We have made an $80 billion commitment toward improving patient care and we're sticking to it," said Johnson. "Obviously there have been some discussions [in the last few days]. But it's important for everyone to take a step back and a deep breath right now. All of these reports as to what's in the agreement and what's not detract from the more important goal of making sure every American has access to high quality and affordable health care and services."

As long as the drug makers and the White House are allies, PhRMA would rather not focus on the specifics of the deal. "Every day we spend talking about he-said/she-said is a day we lose talking about why health care reform is good for America," said Johnson. "We are doing everything we can to make certain comprehensive reform is enacted this year. We're on board."

This story was updated to reflect the fact that, according to the White House, drug price negotiations did not specifically come up in negotiations, but are ruled out because they would take the deal past $80 billion.

--------------------------

http://www.huffingtonpost.com/2009/08/07/white-house-confirms-deal_n_254408.html

H1N1 Virus Mutated in Lab: Resistant to Relenza

INFLUENZA VIRUS - RELENZA RESISTANCE LABORATORY MUTATION
*********************************************
A ProMED-mail post

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


Date: Tue 4 Aug 2009
Source: The Age [edited]



Relenza-resistant flu virus mutation found
------------------------------------------
The H1N1 flu virus has mutated into a form resistant to the
Australian-developed antiviral drug Relenza. Researchers said the
mutation posed little threat to humans yet: the virus was not a
strain of swine flu virus [Influenza pandemic (H1N1) 2009 virus] or
bird flu [avian influenza H5N1) virus], and it was found only in the
lab [i.e., only after propagation of patients' samples in the
laboratory], not in patients. There are no known strains of
Relenza-resistant influenza in humans. In contrast, virtually all the
flu cases in the US and Europe last year [2008], much of Australia's
seasonal flu and even a few cases of swine flu have proven resistant
to the other leading antiviral drug, Tamiflu.

A team at North Melbourne's WHO Collaborating Centre for Reference
and Research on Influenza analysed 391 influenza A(H1N1) viruses
found in humans in Australasia and South-East Asia between 2006 and
2008, before the spread of swine flu [i.e., the isolates screened
were all seasonal influenza viruses - Mod.CP]. 9 of the viruses had a
previously unseen mutation that made them 300 times more resistant to
zanamivir (sold as Relenza), according to results reported in the
Journal of Virology [see below].

The mutation was not found when the specimens were taken from
patients, only later when the viruses multiplied in the lab. "That
could mean there were very low levels of this mutation in the
patient," said Dr Ian Barr, one of the researchers involved and
deputy director of the WHO centre. "We wouldn't say it's a clinical
problem, but it's an interesting finding. We know [the mutation] can
survive, and it's stable."

The recent spread of Tamiflu-resistant A(H1N1) viruses showed that
antiviral-resistant viruses could spread rapidly and travel widely
around the world, the study authors warned. A spokeswoman for Biota,
which developed Relenza, said the discovery was "not clinically
relevant, because it's an in vitro discovery -- there's no evidence
that this mutated virus has infected patients." A spokeswoman for
Relenza manufacturer GSK said the "clinical significance is yet to be
determined." GSK announced a week ago that it planned to triple
production of Relenza in the face of the spread of swine flu
[influenza pandemic (H1N1) 2009] virus infection and rising demand
from government stockpiles.

Last week Japan identified its 3rd case of Tamiflu-resistant swine
flu, making a total of 6 worldwide. Scientists have warned that the
massive worldwide use of Tamiflu since the outbreak of swine flu
could hasten the spread of resistant mutations. No Relenza-resistant
swine flu has yet been found.

[Byline: Nick Miller]

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[The research refered to in above newspaper article is published in
the Journal of Virology:

Ref: Zanamivir-Resistant Influenza Viruses with a Novel Neuraminidase Mutation.
J Virol. 2009 Jul 29. (Epub ahead of print)

---------------------------------------------------------------------------
Authors: Hurt AC, Holien JK, Parker M, Kelso A, Barr IG.
At: The WHO Collaborating Centre for Reference and Research on
Influenza, 10 Wreckyn St, North Melbourne, Victoria 3051, Australia;
Monash University, School of Applied Sciences, Churchill, Victoria
3842, Australia; Structural Biology Laboratory, St. Vincent's
Institute of Medical Research, Fitzroy, Victoria 3065, Australia;
Department of Biochemistry and Molecular Biology, Bio21 Molecular
Science and Biotechnology Institute, The University of Melbourne,
Parkville, Victoria 3052, Australia.

Abstract: "The neuraminidase inhibitors zanamivir and oseltamivir are
marketed for the treatment and prophylaxis of influenza, and have
been stockpiled by many countries for use in a pandemic. Although
recent surveillance has identified a striking increase in the
frequency of oseltamivir resistant seasonal A(H1N1) viruses in
Europe, USA, Oceania and South Africa, to date there have been no
reports of significant zanamivir resistance among A(H1N1) viruses or
any other human influenza viruses. We investigated the frequency of
oseltamivir and zanamivir resistance in circulating seasonal A(H1N1)
influenza viruses in Australasia and South East Asia. Analysis of 391
A(H1N1) influenza viruses isolated between 2006 and early 2008 from
Australasia and South East Asia revealed 9 viruses (2.3 percent)
which demonstrated markedly reduced zanamivir susceptibility and
contained a previously undescribed Gln136Lys (Q136K) neuraminidase
mutation. The mutation had no effect on oseltamivir susceptibility,
but caused approximately a 300-fold and a 70-fold reduction in
zanamivir and peramivir susceptibility, respectively. The role of the
Q136K mutation in conferring zanamivir resistance was confirmed using
reverse genetics. Interestingly, the mutation was not detected in the
primary clinical specimens from which these mutant isolates were
grown, suggesting that the resistant viruses either occurred in very
low proportions in the primary clinical specimens or arose during
MDCK cell culture passage. Compared to susceptible A(H1N1) viruses,
the Q136K mutant strains displayed greater viral fitness than the
wildtype virus in MDCK cells, but equivalent infectivity and
transmissibility in a ferret model."

In view of the relatively restricted clinical use of Relenza relative
to the more easily administered Tamiflu, it is not surprising that a
Relenza-resistant mutant has yet to be isolated directly from
seasonal or pandemic influenza virus infected patients. It is likely
that in time the Q136K mutation will appear be recovered directly
from patients as a consequence of increased clinical use of Relenza. - Mod.CP]

[see also:
2007
----
Influenza B virus, neuraminidase inhibitor resistance 20070404.1143
2001
----
Influenza virus, neuraminidase inhibitor resistance (02) 20010928.2372
Influenza virus, neuraminidase inhibitor resistance 20010926.2350]
....................cp/ejp/dk

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Update: Bad News for Rumsfeld; Swine Flu Tamiflu Resistant

WHO holds 2 billion people could catch H1N1

Click on title above to read more about the Rumsfeld / Tamiflu Connection;
http://www.nowpublic.com/world/tamiflu-scandal-gilead-sciences-donald-rumsfeld-connection
-------------------------------------------
Health officials raised the alarm about a strain of swine flu that is
resistant to the Tamiflu treatment as the virus claimed more lives on
Tuesday [4 Aug 2009], with Viet Nam reporting its 1st fatal case.
India and South Africa both reported their 1st deadly cases of the
A(H1N1) virus late Monday [3 Aug 2009]. Maria Teresa Cerqueira, head
of the Pan-American Health Organization office in La Jolla,
California, said a Tamiflu-resistant mutation of A(H1N1) [the
Influenza pandemic (H1N1) 2009 virus] had been found around the
US-Mexico border in El Paso and close to McAllen, Texas. Experts had
gathered in La Jolla, California, on Monday to discuss responses to
the outbreak, and warned that resistant strains were likely emerging
because of overuse of antivirals like Tamiflu. "In the United States
Tamiflu is sold with a prescription, but in Mexico and Canada it is
sold freely and taken at the 1st sneeze. Then, when it is really
needed, it doesn't work," said Cerqueira late Monday. Cases of
A(H1N1) that were resistant to the anti-viral medicine have now been
found in the United States, Canada, Denmark, Hong Kong and Japan.

As the northern hemisphere autumn approaches, and with it the onset
of seasonal flu, the WHO is working with drug companies to ensure
vaccines to cope both with H1N1 and seasonal flu will be available.
WHO spokeswoman Fadela Chaib said the agency hoped to give an update
on its vaccine plans later this week. Leading flu vaccine makers
include Sanofi-Aventis, Novartis , Baxter, GlaxoSmithKline and Solvay.

Novartis has started human testing of H1N1 swine flu vaccine
candidates while Sanofi-Aventis, the world leader in flu shots, will
commence within days, company officials said on Tuesday [4 Aug 2009].
The launch of clinical trials is a key part of a widening programme
of work being undertaken by big pharmaceutical companies as they
prepare for mass vaccination from next month. GlaxoSmithKline, the
other "big 3" flu vaccine supplier, said it would initiate clinical
studies later this month. Healthcare officials are relying on a
vaccine to contain the spread of disease, providing a potential sales
windfall for those companies that are able to deliver quickly and in
large volume.

Australia's CSL has so far been the fastest commercial operator,
after starting its 1st clinical trials in Australia 2 weeks ago. Now
others are catching up. "We started a little over a week ago,"
Novartis spokesman Eric Althoff said by telephone from Basel. Benoit
Rungeard, product communications director for Sanofi Pasteur, the
vaccines division of the French drugmaker, told Reuters his company
would start "in the coming days or next week." Althoff said
Swiss-based Novartis was conducting its clinical trials in a number
of countries, including the United States, Britain and Germany, and
was testing both single and booster, or repeat, doses of vaccines.
Novartis, in common with other manufacturers, will also compare
vaccines with and without adjuvants -- ingredients that boost the
immune system response. AstraZeneca, whose MedImmune unit makes
smaller amounts of a flu vaccine that is sprayed into the nose rather
than injected, said it would start clinical trials in the United!
States around 17 Aug 2009.

Meanwhile, a Taiwanese biotech company on Tuesday [4 Aug 2009]
started mass production of a swine flu vaccine before even completing
clinical trials, in a bid to get a jump before the start of the
winter flu season. Adimmune Corp, the island's only human vaccine
manufacturer, said it was starting production at its plant in central
Taichung. The company is due to deliver 5 million doses of A(H1N1)
influenza vaccine before the end of October [2009], according to the
purchase contract it has signed with the government, said deputy CEO
and president Ignatius Wei. The company says it has completed some
animal trials of the vaccine, but will only begin human trials in
September -- sparking criticism about the risks of manufacturing an
as-yet unproven product. But Huang Li-min, a doctor at National
Taiwan University Hospital who will oversee the human trials, says
Adimmune is taking a calculated risk. "They have to do so... they are
racing against time," Huang told AFP, referring to the upcoming start
of flu season. "There may be a risk for the company, but the risk is
small to an experienced company," he said.

--
Communicated by:
ProMED-mail Rapporteur SusanBaekeland

[The interactive HealthMap/ProMED map is available at:
- CopyEd.EJP]

[see also:
Influenza pandemic (H1N1) 2009 (23): (China, Taiwan), co-circ.
H3N2 20090802.2713
Influenza pandemic (H1N1) 2009 (22): Australia (NSW), swine 20090801.2698
Influenza pandemic (H1N1) 2009 (21): vaccine prioriities 20090730.2669
Influenza pandemic (H1N1) 2009 (20): Peru, 33 percent
asymptomatic 20090730.2668
Influenza pandemic (H1N1) 2009 (19): Viet Nam, H1N1, H5N1 (susp) 20090728.2655
Influenza pandemic (H1N1) 2009 (18): 1st case? 20090725.2631
Influenza pandemic (H1N1) 2009 (17): neurologic complications 20090723.2606
Influenza pandemic (H1N1) 2009 (16): Argentina, sequencing 20090723.2604
Influenza pandemic (H1N1) 2009 (15): Canada (AB) swine workers 20090723.2603
Influenza pandemic (H1N1) 2009 (14): case count 20090722.2599
Influenza pandemic (H1N1) 2009 (13): comments 20090722.2598
Influenza pandemic (H1N1) 2009 (12): antivirals 20090722.2597
Influenza pandemic (H1N1) 2009 (11): vaccine issues 20090722.2595
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (09): UK, pig stockman 20090718.2560
Influenza pandemic (H1N1) 2009 (08): pandemic origins 20090718.2559
Influenza pandemic (H1N1) 2009 (07): Argentina, swine, alert 20090718.2557
Influenza pandemic (H1N1) 2009 (06): case reporting 20090717.2553
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (04): pandemic origins 20090715.2527
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505
Influenza pandemic (H1N1) 2009 (02): obesity risk factor 20090711.2482
Influenza pandemic (H1N1) 2009 - Viet Nam: patient data 20090708.2450]
...................cp/ejp/dk

*##########################################################*
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Monkey Kidneys Used in Swine Flu Vaccines!

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Dear NaturalNews readers,

NaturalNews Tip of the day (from Mike):

Water is, of course, crucial for good health, but a lot of the "processed" city water available in the world today isn't very "wet" water. You can drink all you want and still not feel adequately hydrated. The BEST water of all is the water that's stored in plants. To really hydrate, drink fresh, living juices of water-rich plants like apples, celery, carrots, cucumbers, citrus fruits etc.

Yesterday's story on the dead monkey kidneys being used in flu vaccines shocked a lot of people ( http://www.naturalnews.com/026779_swine_flu_patents_vaccines.html). Lots of questions have been raised, so I'm addressing some of the more common concerns in a follow-up commentary published today at:

(Click on title above to go there)
http://www.naturalnews.com/026788_vaccines_health_pandemic.html


I'll also be spending 30 minutes (or so) discussing this story in more detail on a live teleconference (this Thursday evening) sponsored by the NaturalNews Moxxor team. No registration required, just call in Thursday evening at 6pm Pacific or 9pm Eastern: (US) 712-432-1001 and use Access Code 443153357#

I'll be on the call with Jonathan Landsman, discussing the swine flu vaccine and more. (Hopefully the call will stay connected this time. We had a glitch the last time we tried this, but we've worked out a better backup solution in case the Ecuador bandwidth doesn't cooperate...)

We've published another big story today about how prostate cancer screening actually harms men. This is a must-read story for anyone with a prostate!

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Today's Feature Stories:

Health Ranger Teleconference to Explain African Monkey Virus Vaccine Patent Finding
(NaturalNews) Yesterday's story about the African Green Monkey virus harvesting and vaccine patents still has many people scratching their heads. It's really difficult to grasp the real story that's emerging here: That a key vaccine ingredient production...


Prostate Cancer Testing Doesn't Help, It Harms Men
(NaturalNews) If you are a man, you've probably had the fear of prostate cancer drilled into you -- along with the idea that it is critical to your health, and probably your life, to have regular prostate cancer screenings. But two just released large...


He Shou Wu is the Most Amazing Longevity Herb of All
Out of about 10,000 Chinese medicinal plants only about 60 belong to the class of Superior Tonic Herbs. Out of these 60 herbs He Shou Wu is the most amazing longevity tonic of all. It is widely used in Chinese herbal medicine as a tonic to...


Pre-Birth Vitamin D Levels Determine Your Health for Life
In the nature versus nurture debate, scientists often talk about genetics versus environmental factors in health. One environmental factor that has been getting a lot of attention lately is Vitamin D- and with good reason. Vitamin D is turning...


Fish Oils Reduce Size of Cancer Tumors
(NaturalNews) The omega-3 essential fatty acid known as docosahexaenoic acid (DHA) is more effective at reducing the size of breast cancer tumors than the chemotherapy drug cisplatin, and can also reduce that drug's harmful side effects, reports a new...


Detox Symptoms are Often What Medical Folks Call Disease
People who understand body cleansing, understand what detoxification symptoms are. Medical professionals understand the symptoms that make up what we call disease. But the odd thing is that most detoxification symptoms are also the symptoms...


Magnesium Deficiency Linked to ADD and ADHD in Children
Our children are born into a world where conditions like Attention Deficit Disorder (ADD) and Attention Deficit Hyperactivity Disorder (ADHD) are diagnosed at an escalating rate. These conditions are often hastily medicated while parents...


Comfrey Promotes Healing of Wounds
Comfrey has been used as a healing herb since 400 BC. Its word means "grow together" in Latin. Its safest uses are external, and possess excellent ability to heal sores, burns, and other topical wounds due to its ability to multiply and regenerate...


Frederic Patanaude Part I: Raw Food Motivations and Mentors
This interview is an excerpt from Kevin Gianni's Rawkathon, which can be found at http://www.Rawkathon.com. In this excerpt, Frederic Patanaude shares on raw food motivations and mentors. Rawkathon with Frederic Patanaude. Frederic...





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Senate OKs $125 Billion USDA, FDA Budget

8/5/2009 10:45:00 AM

WASHINGTON—The U.S. Senate approved a $125 billion budget for the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) to increase funds for farm subsidies and food safety.

As reported by Bloomberg News, FDA spending would increase by 15 percent to $2.35 billion. Combined, the funds allotted for both agencies would increase 11 percent from the current fiscal year. The measure resembles the $123.8 billion bill passed by the House of Representatives on July 9. The Senate version outlines conditions under which a ban on cooked chicken imported from China may be lifted; the House legislation continues the ban.

The two versions of the budget will be reconciled by a House-Senate negotiating panel before a final plan can be submitted for another vote.

http://www.foodproductdesign.com/news/2009/08/senate-oks-125-billion-usda-and-fda-budget.aspx

Justice Department and USDA to Hold Public Workshops to Explore Competition Issues in the Agriculture Industry

Oh Boy. What does the DOJ have to do with the USDA? Oh yeah, thats right. The DOJ will be the "compliance and enforcement" arm of the New BigAgs & Big-Pharmas.

Workshops Will Promote Open Dialogue on Legal and Economic Issues in the Agriculture Industry


WASHINGTON, Aug. 5 /PRNewswire-USNewswire/ -- Attorney General Eric Holder and Agriculture Secretary Tom Vilsack announced today that the Department of Justice and the U.S. Department of Agriculture (USDA) will hold joint public workshops to explore competition issues affecting the agriculture industry in the 21st century and the appropriate role for antitrust and regulatory enforcement in that industry. These are the first joint Department of Justice/USDA workshops ever to be held to discuss competition and regulatory issues in the agriculture industry.


The joint Department of Justice/USDA workshops will address the dynamics of competition in agriculture markets including, among other issues, buyer power (also known as monopsony) and vertical integration. They will examine legal doctrines and jurisprudence and current economic learning, and will provide an opportunity for farmers, ranchers, consumer groups, processors, the agribusinesses, and other interested parties to provide examples of potentially anticompetitive conduct. The workshops will also provide an opportunity for discussion for any concerns about the application of the antitrust laws to the agricultural industry.


The goals of the workshops are to promote dialogue among interested parties and foster learning with respect to the appropriate legal and economic analyses of these issues, as well as to listen to and learn from parties with real-world experience in the agriculture sector.


"Maintaining a robust agricultural sector is crucial to the strength of the American economy and to who we are as a nation," said Attorney General Holder. "Through the dialogue established in these workshops and, ultimately through our actions, we are committed to ensuring that competition and regulatory actions benefit all American consumers and businesses."


"It is important to have a fair and competitive marketplace that benefits agriculture, rural economies and American consumers," said Agriculture Secretary Vilsack. "The joint workshops between the Department of Justice and USDA will allow a dialogue on very important issues facing agriculture today."


The first workshop will be held in early 2010. While some of the workshops may be held in Washington, D.C., others will be held regionally. The Department of Justice and USDA are soliciting public comments from lawyers, economists, agribusinesses, consumer groups, academics, agricultural producers, agricultural cooperatives, and other interested parties.


"For the first time ever, farmers, ranchers, consumers groups, agribusinesses and the federal government will openly discuss legal and economic issues associated with competition in the agriculture industry," said Christine A. Varney, Assistant Attorney General in charge of the Department of Justice's Antitrust Division. 'This is an important step forward in determining the best course of action to address the unique competition issues in agriculture."


The Department of Justice and USDA are interested in receiving comments on the application of antitrust laws to monopsony and vertical integration in the agricultural sector, including the scope, functionality and limits of current or potential rules.


The Department and USDA are also inviting input on additional topics that might be discussed at the workshops, including the impact of agriculture concentration on food costs, the effect of agricultural regulatory statutes or other applicable laws and programs on competition, issues relating to patent and intellectual property affecting agricultural marketing or production, and market practices such as price spreads, forward contracts, packer ownership of livestock before slaughter, market transparency, and increasing retailer concentration.


The public and press are invited to attend the hearings. Additional information about the date, time and location of the workshops will be provided at a later date. Interested parties should submit written comments in both paper and electronic form to the Department of Justice no later than Dec. 31, 2009. All comments received will be publicly posted. Two paper copies should be addressed to the Legal Policy Section, Antitrust Division, U.S. Department of Justice, 450 5(th) Street, N.W., Suite 11700, Washington, D.C. 20001. The Department's Antitrust Division is requesting that the paper copies of each comment be sent by courier or overnight service, if possible. The electronic version of each comment should be submitted to agriculturalworkshops@usdoj.gov. Detailed agendas and schedules for the workshops will be made available on the Antitrust Division's web site at www.usdoj.gov/atr.






SOURCE U.S. Department of Justice


--------------------------------------------------------------------------------



http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/08-05-2009/0005072599&EDATE=

HazMat crews respond to spill at the U.S.D.A. Soil Research Lab

8/5/09

Posted: Aug 05, 2009 7:46 PM EDT Wednesday, August 5, 2009 7:46 PM EST

Posted by Karin Slyker | email

LUBBOCK, TX (KCBD) - More than two dozen employees are safe after an emergency evacuation Wednesday.

Emergency officials tell NewsChannel 11 that a gallon of ammonium hydroxide spilled at the U.S.D.A. Soil Research Lab, located at 3810 4th Street.

Hazmat crews remained on scene for more than an hour cleaning up the caustic substance - used in soil research.

©2009 KCBD NewsChannel 11. If you're planning a trip through Clovis, New Mexico on Friday, August 7th, be aware that the Clovis Police Department will be out in force.


http://www.newschannel10.com/Global/story.asp?S=10855639

SWINE FLU IS NOT THE BIGGEST DANGER, IT IS THE VACCINE

-IMPORTANT PL

Tue Aug 4, 2009 7:53 am (PDT)


http://www.davidicke..com/content/view/25191
FLU IS NOT THE BIGGEST DANGER ....

... IT'S THE VACCINE

We are told that the drug companies and the World Health Organisation have been working at fever pitch to develop a vaccine for the 'new' swine flu strain known as H1N1, but ... wait for it ... Baxter International filed a patent for the H1N1 vaccine on August 28th 2008. Click here to read ....

Baxter Vaccine Patent Application US 2009/0060950 A1 says:

'... In particular preferred embodiments the composition or vaccine comprises more than one antigen ... such as influenza A and influenza B in particular selected from of one or more of the human H1N1, H2N2, H3N2, H5N1, H7N7, H1N2, H9N2, H7N2, H7N3, H10N7 subtypes, of the pig flu H1N1, H1N2, H3N1 and H3N2 subtypes, of the dog or horse flu H7N7, H3N8 subtypes or of the avian H5N1, H7N2, H1N7, H7N3, H13N6, H5N9, H11N6, H3N8, H9N2, H5N2, H4N8, H10N7, H2N2, H8N4, H14N5, H6N5, H12N5 subtypes.'

The patent was published in March 2009, a month before the virus was released in Mexico in April, but it was filed seven months before this 'new strain' was officially known about. It is the most blatant set-up you could ever see.

'Past swine flu outbreaks have been spread from pigs to humans, who then passed the flu on to other humans. However, with A-H1N1, there have been no reported infections of pigs. In fact, according to the Centers for Disease Control and Prevention (CDC), A-H1N1 has gene segments from North American swine, bird and human flu strains and a segment from Eurasian swine flu.'

*********************************************************************************************************************************

Another Big Pharma corporation involved is Novartis in Switzerland. Chief executive, Daniel Vasella, is a regular attendee of the secretive Bilderberg meetings that I have long exposed in my books. The Bilderberg group , named in Jane Bürgermeister's FBI submission, is the creation of the Rothschild dynasty and has been administered for decades by people like David Rockefeller and Henry Kissinger.

It answers to a Rothschild secret society in Britain called the Round Table. This was first headed by the Rothschild agent, Cecil Rhodes, who plundered southern Africa on the family's behalf .. Vasella attended the last Bilderberg meeting last May, just as the swine flu scare was being engineered, and bingo, his company comes up with the vaccine.

Food Industry Next "Big-Oil"

Click on title above to see why;

House Neuters Health Care Bill in Favor of BigPharm

House neuters comparative effectiveness
By Tracy Staton Comment | Forward

A House committee has defanged comparative effectiveness. In an amendment added to the healthcare reform bill, lawmakers stipulate that the government can't use the research to dictate care. As you know, drugmakers had feared that the head-to-head studies would be used to favor lower-cost treatments over branded meds. If this amendment sticks, that won't happen.

According to Reuters, the Senate is also working on comparative-effectiveness provisions in its version of healthcare reform. Finance Chair Max Baucus supports creating a not-for-profit to conduct the research, but it would be a no-no to issue any medical practice guidelines or insurance-coverage recommendations based on the studies. So maybe those expensive lobbying efforts have borne fruit after all.

Of course all this is subject to change, and with Congress going into recess, we'll see a barrage of information and misinformation in the media. Interested parties on all sides will be spinning the news with a vengeance. The Senate Finance Committee won't even vote on its package till after the break. So everything is still up for grabs.

- read the Reuters story
- check out the Wall Street Journal update

Related Articles:
Economy, gov put squeeze on pharma
Will comparative data lead to coverage denied?
PhRMA: Compare drugs first, cost second
Stimulus gives $1.1B to comparative studies
Comparative effectiveness bill hits Senate

Read more about: healthcare reform, comparative

Pesticides to Blame for Honey Bee Die-Off

COLONY COLLAPSE DISORDER, APIS - USA: MULTIPLE CAUSES SUSPECTED
****************************************************
A ProMED-mail post

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


[1]
Date: Wed 29 Jul 2009
Source: Environment News Service (ENS) [edited]



Scientists untangle multiple causes of bee colony disorder
----------------------------------------------------------
A microscopic pathogen and pesticides embedded in old honeycombs are
2 major contributors to the bee disease known as colony collapse
disorder [CCD], which has wiped out thousands of beehives throughout
the United States and Europe over the past 3 years, new research at
Washington State University (WSU) has confirmed.

Working on the project funded in part by regional beekeepers and
WSU's Agricultural Research Center, entomology professor Steve
Sheppard and his team have narrowed the list of potential causes for
colony collapse disorder. "One of the 1st things we looked at was the
pesticide levels in the wax of older honeycombs," Sheppard said.
Using combs contributed by US Department of Agriculture, Sheppard
found "fairly high levels of pesticide residue." Bees raised in those
hives "had significantly reduced longevity," he said. One easy
solution is for beekeepers to change honeycombs more often. In
Europe, for example, apiarists change combs every 3 years. "In the
US, we haven't emphasized this practice and there's no real consensus
about how often beekeepers should make the change," said Sheppard.
"Now we know that it needs to be more often."

Many researchers are investigating colony collapse disorder because
domestic honeybees are essential for a variety of agricultural crops
in the United States. Beekeepers truck their hives cross country to
pollinate almond groves in California, field crops and forages in the
Midwest, apples and blueberries in the Northeast, and citrus in
Florida. Unlike other diseases that have plagued bees in the past,
colony collapse disorder does not kill bees within the hive. It
leaves a hive with a few newly hatched adults, a queen, and plenty of food.

Another aspect of Sheppard's work, which is being conducted by
graduate student Matthew Smart, focuses on the impact of a
microsporidian pathogen known as _Nosema ceranae_, which attacks
bees' ability to process food. Beekeepers have considered it to be
"the smoking gun" behind colony collapse disorder. "_N. ceranae_ was
only recently described in the US, the 1st time in 2007," Sheppard
said. "But while no one really noticed, it has spread throughout the country."

But in a 2007 study, Jeffery Pettis, who heads the US Agriculture
Department's Bee Research Laboratory, and colleagues reported that
_N. ceranae_ had been in the United States for at least 10 years.
Smart surveyed numerous bee colonies in both the Pacific Northwest
and in California, and found _N. ceranae_ to be very widespread.
Sheppard's earlier research found _N. ceranae_ to be a tough bug to
battle. Of 24 hives checked in early 2008, _Nosema_ build-up was high
in a majority of the bees sampled.

Beekeeper Eric Olson of Yakima, Washington said he treated a hive
with a mega-dose of the antibiotic fumagillin. "That should have
caused the _Nosema_ to either disappear or at least go down," he
said, "but the levels went up." "What it basically does is it causes
bees to get immune-deficiency disorder. So it's actually causing the
bees to almost get a version of HIV," said Mark Pitcher, president of
Babe's Honey and the biggest beekeeper in Saanich on Canada's
Vancouver Island. Pitcher told the "Saanich News" that once the bees'
immune systems are compromised, they become susceptible to dying from
a wide range of causes, including chemicals once used to protect the
bees from parasites such as _Varroa_ mites.

Last summer [2008], researchers at Pennsylvania State University
found unprecedented levels of fluvalinate and coumaphos -- pesticides
used in the hives to combat varroa mites -- in all honeycomb and
foundation wax samples. They also found lower levels of 70 other
pesticides and metabolites of those pesticides in pollen and bees.
The Penn State researchers worked with the National Science
Laboratory of the US Department of Agricultural Marketing Service
that already tests commodities such as milk and fruits and vegetables.

"When we began doing this work, honey was not regularly analyzed, and
bee pollen was not a commodity and so was not analyzed," says Mullin.
"We decided to go with the types of screening the lab does for milk
and apples which look at over 170 pesticides. Now, honey is included
in the commodities to be analyzed." All of the bees tested showed at
least one pesticide and pollen averaged 6 pesticides with as many as
31 in a sample."

"We do not know that these chemicals have anything to do with colony
collapse disorder, but they are definitely stressors in the home and
in the food sources," says Penn State's Dr Maryann Frazier.
"Pesticides alone have not shown they are the cause of CCD. We
believe that it is a combination of a variety of factors, possibly
including mites, viruses, and pesticides."

While beekeepers will have a difficult time controlling pesticide
exposure outside the hive, the Penn State researchers tested a method
for reducing the chemical load in beeswax. Using gamma radiation from
a cobalt 60 source housed at Penn State's Breazeale Reactor, they
irradiated the sheets of beeswax that beekeepers use as the
structural foundation for the bees to build their combs. They used
radiation levels at the high end of that used to irradiate foods and
found that in the wax, irradiation broke down about 50 percent of the
acaricides, pesticides that kill mites.

--
Communicated by:
ProMED-mail


******
[2]
Date: Thu 30 Jul 2009
From: Jose and Sandy Villa [edited]


Re: multiple causes of bee colony disorder
------------------------------------------
The thought has crossed my mind on a number of occasions that a
trained epidemiologist, an outsider to the small club of researchers
and beekeepers in the US, would find the issue of CCD quite a dream
to try to sort out from a 'history of science' and politics
perspective. Here are some summary thoughts to captivate your
intellect (assuming you have some interest): [Now that is a
challenge! - Mod.MHJ]

First of all, CCD is poorly identified as a real syndrome. A
committee tried to come up with a list of symptoms to describe what
some first saw or heard reported in the fall of 2006. Later, some of
the members of the committee changed the definition to make it more
expansive (which to me sounds like making the syndrome fit the
evidence). Even worst, the definition of distribution and impact is
based on self-reporting. No one at our lab has ever seen it and we
are perhaps the most field oriented group in the country.

Second, CCD in my view is still idiopathic (although a group in
Montana has been claiming for months that they are about to describe
a single causative new organism). Despite a good amount of research
from a number of teams, a paper in Science, a lot of analytical
chemistry work, the best approximation is that "it" is likely a
combination of factors (assuming CCD is a unique syndrome). No one
has found a single cause; no one has followed Koch's postulates.

Third, beekeepers lose colonies in variable but significant numbers
nationwide and make up for it by "divisions." Some years are worse
than others. Unusual "disappearances" of colonies have been reported
through the decades and no single cause has been found. In my view,
the main explanations for the current spikes in colony mortality are
the parasitic varroa mite, poor weather, and nutrition, in that order
(with the possibility of pesticide poisoning for the most unusually
high mortalities).

In terms of what the report from the Sheppard lab in Washington State
claims, the issue of pesticides (particularly illegally applied
miticides) could explain the spotty but very high mortalities that
some claim to have experienced the fall of 2006. The pictures of
colonies with CCD with a handful of live adult workers, a queen, and
very large areas of immature bees fit a pesticide poisoning more than
anything else. One of the symptoms, the lack of interest by
opportunistic lepidopterans and coleopterans in the remains of CCD
"deadouts" also jumps at me as an overdose of a miticide/insecticide
rather than a pathogen. In terms of _N. ceranae_, the timing of CCD
does not coincide with the appearance of _N. ceranae_.

What makes the nationwide fascination with CCD even more bizarre is
the fact that beekeepers are reporting colonies in better shape this
year (2009) than in a long time......

This is a very quick overview of what I see from an unofficial
perspective. You can find a lot of the reports, press releases, and a
few papers archived at a site at Penn State with the acronym MAAREC
[Mid-Atlantic Apiculture Research & Extension Consortium at
] in case you want to 'Google' it. I
would gladly clarify or discuss any of the above if you are interested.

--
Jose Villa
Baton Rouge, LA
USA


[Our thanks to my apiarist friend, neighbour, and colleague, Jose
Villa for his valuable insights and the challenge he has set us
epidemiologists ... a very fair one. Pragmatically I test for "causal
factors," which when corrected result in a decrease in disease
incidence, whatever the statistical significance, and Koch not
withstanding. Apropos, many years ago I discovered that any r-square
association had to be greater than 0.1 to be worth investigation
because I routinely found that, for example in the 1967-68 FMD
epidemic 10 percent of farms on the Welsh Border had "black & white
dogs" (that is, Border Collies) and FMD, ditto FMD and well water as
opposed to piped water. These '10 percenters' come up all the time.
Plus it is rarely cost-effective to correct them even when they are
real. - Mod.MHJ]

[see also
2008
----
Colony collapse disorder, apis - Germany: chemical ban 20080613.1868
2007
----
Colony collapse disorder, apis - USA: (FL) 20071026.3490]
...................................mpp/mhj/mj/mpp

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Va. Labworker Infected w/ SmallPox

VACCINIA, LABORATORY-ACQUIRED - UNITED STATES OF AMERICA: (VIRGINIA), 2008
**************************************************************************
A ProMED-mail post

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


Date: Thu 30 Jul 2009
Source: MMWR 31 Jul 2009 / 58(29);797-800 [edited]



Laboratory-Acquired Vaccinia Virus Infection -- Virginia, 2008
--------------------------------------------------------------
Vaccinia virus (VACV) is the live viral component of smallpox
vaccine. Inadvertent exposure to VACV can result in infection, and
severe complications can occur in persons with underlying risk
factors (e.g., pregnancy, immunodeficiencies, or dermatologic
conditions) (1). The Advisory Committee on Immunization Practices
(ACIP) recommends smallpox vaccination for laboratory workers who
handle nonhighly attenuated VACV strains or other orthopoxviruses
(e.g., monkeypox, cowpox, or variola) (2). On 8 Jul 2008, the CDC was
notified by a Virginia physician of a suspected case of inadvertent
autoinoculation and VACV infection in an unvaccinated laboratory
worker. This report describes the subsequent investigations conducted
by the Virginia Department of Health and the CDC to identify the
source of infection and any cases of contact transmission. Of the
patient's 102 possible contacts, 7 had underlying risk factors for
developing serious vaccinia infection. Investigators found no
evidence of contact transmission and, based on the results of
molecular typing, further concluded that the patient had been exposed
to a VACV strain that had contaminated the seed stock from the
laboratory where the patient worked. This case underscores the
importance of adherence to ACIP vaccination recommendations for
laboratory workers and use of safety precautions when working with
nonhighly attenuated VACV (3).

Case Report
-----------
On 5 Jul 2008, a man in his twenties who worked in a laboratory at an
academic institution in Virginia went to a local urgent care clinic.
He reported swelling of cervical lymph nodes and pain and
inflammation of his right earlobe associated with purulent discharge
beginning 2 Jul 2008, followed on 3 Jul 2008 by a feverish feeling
and swelling of his left eye with no change in his vision. The
patient was prescribed cephalexin for presumed bacterial infection
and prednisone for swelling. However, on July 6, his symptoms
worsened, and he went to a hospital emergency department. The patient
was given bacitracin for his eye and discharged. That night, he noted
pustular lesions at similar stages of development on his right ear
and left eye ( see image in the original text), and also on his
chest, shoulder, left arm, and right leg.

On 7 Jul 2008, the patient returned to the emergency department with
increasing eye pain and mild photophobia and received a diagnosis of
right auricular/pinnal cellulitis and suspected periorbital
cellulitis. Prednisone was discontinued, and he was admitted to the
hospital for treatment with intravenous vancomycin, ceftriaxone, and
pain medications. The same day, an ophthalmology consultation was
obtained for left-sided severe preseptal cellulitis, confirmed by
computed tomography scan. Biopsy of the conjunctival lesion revealed
acute necrotizing conjunctivitis. Slit lamp examination revealed no
apparent corneal abrasions and a clear anterior chamber in the left
eye, with slight loss of visual acuity. Because the patient's eye
infection appeared consistent with keratitis, ceftriaxone was
discontinued, vancomycin was continued, and the patient was started
on piperacillin/tazobactam and clindamycin.

On 8 Jul 2008, an infectious disease physician who was consulted
raised the possibility of suspected VACV infection, among other more
common viral or bacterial etiologies, because of histopathologic
changes noted in the patient's eye specimens. The consulting
physician elicited from the patient that he worked in a cancer
research laboratory that handled mice infected with VACV. The
physician contacted the CDC, which contacted the Virginia Department
of Health. Upon further investigation, the patient was determined to
have worked with VACV during 29-28 Jun 2008, 4-6 days before symptom
onset. This information was inconsistent with the patient's statement
during his initial interview on admission the previous day, when he
said he recalled last working with VACV in mid-May. Specimens from
the patient's eye, ear, arm, and chest were sent to the Virginia
Laboratory Response Network. The patient met the CDC surveillance
case definition for ocular vaccinia (1).

On 9 Jul 2008, a computed tomography scan revealed worsening of the
left preseptal infectious process with intraorbital involvement. On
10 Jul 2008, pending receipt of viral testing, 800 mg acyclovir was
administered to the patient intravenously. After receipt of
diagnostic testing results, vaccinia immune globulin was not
administered because the patient was improving. The patient went on
to make a full recovery and returned to his laboratory work in August 2008.

Laboratory Analysis
-------------------
On 9 Jul 2008, the Virginia Laboratory Response Network tested lesion
scrapings from the patient using real-time polymerase chain reaction
and detected the presence of nonvariola orthopoxvirus DNA signatures.
The CDC subsequently confirmed the VACV infection. However, molecular
typing of VACV from the patient specimens, performed at the CDC,
indicated that the patient was infected with a strain (VACV Western
Reserve strain) that differed from the VACV strain reportedly used in
the laboratory's experiments (the recombinant construct OVA-vac).
Because the patient and laboratory VACV strains did not match,
investigators had to consider the possibility that the patient might
have acquired his VACV infection from another source, most likely
within the institution's laboratory complex.

Additional VACV specimens were collected both from the laboratory in
which the patient worked and from other laboratories in the academic
institution's research complex, and an investigation was launched to
identify the source of exposure. The CDC analyzed samples of all the
virus stocks used at the academic institution and detected a
contaminant virus in the OVA-vac stock from the laboratory in which
the patient worked that closely resembled the VACV strain isolated
from the patient.

Occupational Health Investigation
---------------------------------
During 4-5 Aug 2008, investigators interviewed 3 persons separately
regarding experiments performed at the laboratory during June and
July: the patient, the laboratory director, and a student who worked
with the patient during 26-28 Jun 2008, when the patient's exposure
to VACV was thought to have occurred. Although the academic
institution's occupational health clinic annually provided education
on workplace safety and offered smallpox vaccination to all
laboratory workers who handled nonhighly attenuated VACV strains or
other orthopoxviruses, neither the patient nor the student had plans
to be vaccinated. The laboratory director was not up-to-date with his
VACV vaccination (last vaccinated >10 years previously).

Representatives of the occupational health and biosafety team at the
academic institution were interviewed to review their biosafety,
VACV-use, and vaccination policies for laboratory personnel.
Investigators found that safety protocols were in place. However, as
a result of this incident, changes in laboratory procedures regarding
VACV were made. Before the incident, the academic institution offered
VACV counseling and vaccination only to personnel who specifically
requested vaccination, even if the employee's written work profile
indicated VACV use. As a result of the incident, the academic
institution now offers counseling and education to all personnel with
occupational exposure to VACV. Vaccination is then offered to
laboratory workers without medical contraindications, and a
declination form is completed for laboratory workers who decline the
vaccine. In addition, changes have been made to the academic
institution's laboratories to better reflect CDC biosafety recommendations (4).

Contact Investigation
---------------------
Recognizing that inadvertent transmission of VACV can occur through
contact with lesion exudates, investigators interviewed the patient
to identify his potential close contacts from 2 Jul 2008, when
symptoms began, through the period he was hospitalized. A close
contact was defined as any person with direct physical contact with
the patient or his linens, trash, or clinical specimens. Initially,
102 persons with possible exposure to the patient's lesions were
identified: 8 personal contacts, 12 laboratory workers, and 82
hospital workers.

A total of 55 (54 percent) of the 102 possible contacts were
identified as potentially having contact with the patient's lesion
exudates and were interviewed by the Virginia Department of Health or
members of the institution's infection control staff regarding
symptoms of possible VACV infection (e.g., fever, malaise, myalgia,
and lymphadenopathy) and risk factors for severe infection. These 55
close contacts included 8 personal contacts, 12 laboratory workers,
and 35 hospital workers. All were asked to report any symptoms or
illnesses for 14 days after their exposure. 7 of the 55 (4 personal
contacts and 3 hospital workers) had risk factors for severe
infection (i.e., pregnancy, immunodeficiencies, or dermatologic
conditions). However, no secondary VACV infections were detected.

[Reported by: E Davies, MPH, L Peake, MD, D Woolard, PhD, C Novak,
MD, Virginia Dept of Health; K Hall, MD, RT Leonard, PhD, R Allen,
PhD, Virginia. M Reynolds, PhD, W Davidson, MPH, C Hughes, MPH, V
Olson, PhD, S Smith, MS, H Zhao, MD, Y Li, PhD, K Karem, PhD, I
Damon, MD, PhD, Div of Viral and Rickettsial Diseases, National
Center for Zoonotic, Vector-Borne, and Enteric Diseases; A MacNeil,
PhD, A Roess, PhD, EIS officers, CDC.]

MMWR Editorial Note
-------------------
In 1972, routine childhood vaccination against smallpox was halted
because of a declining probability of smallpox importation, reduced
likelihood of spread following importation, and occasional untoward
side effects of vaccination (5). In 2003, members of the military,
selected health-care workers, public health personnel, and 1st
responders began receiving smallpox vaccinations as part of
bioterrorism preparedness (6). From 1972 to 2003, laboratory workers
were the only group recommended for periodic smallpox vaccination in
the United States. ACIP currently recommends smallpox vaccination at
least every 10 years for laboratory workers who handle cultures or
animals infected with nonhighly attenuated VACV or other
orthopoxviruses (e.g., monkeypox, cowpox, or variola)* (7).

Laboratory-acquired VACV infections are not nationally notifiable
conditions but often are reported to CDC when virus confirmation is
required for diagnosis. These laboratory-acquired infections
typically occur in unvaccinated workers (2). During 2005-2007, 5
cases of laboratory-acquired VACV infection were reported to the CDC
(1). No known contact transmission of VACV was reported from these
laboratory-acquired infections; however, instances of contact
transmission of VACV from smallpox vaccinees to close contacts,
including children and intimate partners, has occurred (8). Adherence
to ACIP recommendations by laboratorians often is dependent on
interpretations of the risks for VACV laboratory exposure by
laboratory directors (who might not be fully aware of the pathogenic
properties of VACV in humans), concerns over adverse events
associated with vaccination, and the extent of VACV education
provided to laboratory workers (2). After the incident described in
this report, VACV laboratory procedures were changed, and counseling
and education was extended to all laboratory workers with
occupational exposure to VACV.

Laboratory-acquired exposure to VACV can be associated with a high
inoculum and can occur through a route (e.g., ocular) with a high
risk for complications (9). In the event of an exposure, the affected
body part should be washed immediately; eyewash protocols should be
followed for ocular exposure. The laboratory worker should then
report the incident to the laboratory director or to the occupational
health clinic. Depending on the timing and circumstances of the
exposure and status of the inoculated site, administration of
postexposure vaccination, vaccinia immune globulin, or antivirals
might be indicated to attenuate adverse clinical outcomes associated
with VACV infection (7).

Clinicians should maintain a high index of suspicion for VACV
infection when evaluating vesiculopapular rashes in patients who are
laboratory workers handling nonhighly attenuated VACV strains or are
their close contacts. Suspected cases of VACV infection should be
reported to state or local health departments for diagnostic
guidance. Further characterization of viruses can be performed at
specialized reference laboratories such as the poxvirus laboratory at
the CDC. Contact VACV transmission is uncommon (5.9 cases per 100 000
vaccinations) (3,6,10), and infection control measures are effective
in preventing such transmission (7); therefore, contact
investigations should be limited to persons who might have had
contact with lesion exudates, whether or not they have risk factors
for severe VACV infection.

References
----------
(1) CDC. Surveillance guidelines for smallpox vaccine (vaccinia)
adverse reactions. MMWR 2006;55(No. RR-1).
(2) CDC. Laboratory-acquired vaccinia exposures and infections-United
States, 2005-2007. MMWR 2008;57:401-4.
(3) Sepkowitz KA. How contagious is vaccinia? N Eng J Med 2003;348:439-46.
(4) US Department of Health and Human Services, CDC, National
Institutes of Health. Biosafety in microbiological and biomedical
laboratories. 5th ed. Washington, DC: US Department of Health and
Human Services, CDC, National Institutes of Health; 2007. Available at
.
(5) CDC. Supplement: collected recommendations of the Public Health
Service Advisory Committee on Immunization Practices. MMWR 1972;21.
(6) CDC. Secondary and tertiary transfer of vaccinia virus among U.S.
military personnel-United States and worldwide, 2002-2004. MMWR 2004;53:103-5.
(7) CDC. Recommendations for using smallpox vaccine in a pre-event
vaccination program: supplemental recommendations of the Advisory
Committee on Immunization Practices (ACIP) and the Healthcare
Infection Control Practices Advisory Committee (HICPAC). MMWR
2003;52(No. RR-7).
(8) CDC. Household transmission of vaccinia virus from contact with a
military smallpox vaccinee-Illinois and Indiana, 2007. MMWR 2007;56:478-81.
(9) Lewis FM, Chernak E, Goldman E, et al. Ocular vaccinia infection
in laboratory worker, Philadelphia, 2004. Emerg Infect Dis 2006;12:134-7.
(10) Neff JM, Lane JM, Fulginiti VA, Henderson DA. Contact
vaccinia-transmission of vaccinia from smallpox vaccination. JAMA
2002;288:1901-5.

--
Communicated by:
ProMED-mail


[Laboratory-acquired exposure to VACV can be associated with a high
inoculum and can occur through a route (e.g., ocular) with a high
risk for complications [see reference (9)].

Smallpox vaccination is no longer recommended (in the USA) for
laboratory workers handling highly attenuated poxvirus strains
because these strains either are unable to replicate or replicate
poorly in mammalian host cells and, therefore, do not create
productive infections in healthy persons. Clinicians should maintain
a high index of suspicion for VACV infection when evaluating
vesiculopapular rashes in patients who are laboratory workers
handling nonhighly attenuated VACV strains or are their close contacts.

Adherence to ACIP recommendations by laboratorians often is dependent
on interpretations of the risks for VACV laboratory exposure by
laboratory directors. In the light of this incident a good case can
be made for compulsory vaccination of all laboratory workers employed
in laboratories using any strain of VACV. It is a matter of concern
that the molecular typing of VACV from the patient specimens,
indicated that the patient was infected with a strain (VACV Western
Reserve strain) that differed from the VACV strain reportedly used in
the laboratory's experiments (the recombinant construct OVA-vac).
This is indicative of a general laxity in the handling of viruses in
the laboratory concerned. - Mod.CP]

[see also:
Smallpox vaccination, adverse events - USA: prog. vaccinia 20090520.1886
2007
----
Rabies-vaccinia infection from oral vaccine - USA 20010825.2010
2000
----
Vaccinia virus infections - Russia: WHO confirmation 20000620.1008
Vaccinia virus infections - Russia (Far East) 20000619.0996
1998
----
Vaccinia recombinants, risk management: RFI 19980819.1658]
......................mpp/cp/ejp/mpp

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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.
************************************************************
Become a ProMED-mail Premium Subscriber at

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Send all items for posting to: promed@promedmail.org
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