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

Tuesday, June 30, 2009

Consumers Action Alert: against rBGH

We recently had a great victory when Kathleen Sebelius, then Governor of Kansas, vetoed a bill that would have restricted rBGH-free labeling on dairy products. She's since become the Secretary of the Health and Human Services Department, which gives us a great opportunity for her to take even bigger action on protecting consumers from rBGH. Can you thank Sebelius for her leadership on this issue and ask her to re-examine the approval of rBGH?

Now that Kathleen Sebelius is in charge of HHS, she directly oversees the Food and Drug Administration, which handled the approval of rBGH. When rBGH was originally being approved, there were many concerns around the research that was being used, and the revolving door appointments of people like Mike Taylor, who worked for both Monsanto and FDA.

Mike Taylor was a former attorney for Monsanto who went to work for FDA, where he helped draft FDA's policy declaring that genetically engineered foods are "generally regarded as safe." He also wrote the policy that exempted genetically engineered foods from being labeled. This was all during the time that Monsanto's genetically engineered hormone rBGH was being approved at FDA. After these policies were written, Taylor left FDA and eventually went back to work for Monsanto.

Now is the time for FDA, under Sebelius' leadership, to re-examine the use of rBGH. Over 30 countries, including all of the European Union, Canada, Japan, Australia and New Zealand banned the use of the hormone from the animal welfare concerns alone. There are still significant human health concerns surrounding the use of rBGH as well.

Consumers across the country have rejected milk that's been produced with rBGH, and it's time to end its use once and for all. Please take action now to ask Secretary Sebelius to stand up for consumers on this issue.

Click on title above to go to the "Food & Water Watch" site to take action;

http://action.foodandwaterwatch.org/t/741/p/dia/action/public/?action_KEY=1170


Thanks!


Sarah, Alex, Noelle and the Food Team
Food & Water Watch
goodfood(at)fwwatch.org

Biologics Exclusive a Boon to BigPharma but an Affront to Free Enterprise

Obama backs 7-year exclusivity for biologics By Tracy Staton

The Obama administration is throwing its weight behind a shorter exclusivity period for biologics. These products should be open to generic competition after seven years, the administration said, rather than the 12 to 14 years branded drugmakers have lobbied for, Bloomberg reports. That's a "generous compromise" upward from the five years proposed by at least one Congressional leader.

"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs," Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, wrote to Rep. Henry Waxman, who is working on legislation that would allow the copycat biologic meds.

As you know, current law doesn't allow copycat forms of biologic meds, even after their patents have expired. There's long been a movement to open up a so-called "regulatory pathway" for biosimilar meds, but those efforts have gained real traction recently as legislators hunt for any and every way to save money on healthcare. Branded drugmakers, generics firms, insurance plans, politicians and plenty of others have opinions about just how generic biologics should work. The debate has only just begun.

Related:

Biotech Drugs Need Only 7 Years Protection, U.S. Says (Update2)

Share | Email | Print | A A A


By Catherine Larkin

June 25 (Bloomberg) -- Biologic drugs should be subject to generic competition in the U.S. after seven years, the Obama administration said, calling it a “generous compromise.”

Access to cheaper copies of medicines made by Amgen Inc., Roche Holding AG and other biotechnology companies is “a key element” in reducing health-care costs, White House officials said in a letter to Representative Henry Waxman obtained today by Bloomberg News. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Waxman proposed only five.

Americans spend more than $60 billion a year on biologic drugs to treat cancer, rheumatoid arthritis and other serious illnesses at a cost of as much as $200,000 for each medicine, Ernst & Young estimates. Unlike conventional pills, biologics can’t be copied even after patents expire. Patient groups, payers and generic drugmakers have battled biotechnology companies for more than two years over how to allow competition.

“Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” wrote Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, in the letter dated yesterday.

Obama has urged lawmakers to rein in record health-care spending, expand coverage to the 46 million uninsured and modernize record-keeping. His proposed budget in February called for legislation allowing generic biologics after a period “generally consistent” with the 1984 law that provides five years of protection to most conventional pills and seven years of protection to so-called orphan drugs for rare diseases.

Health-Care Overhaul

Waxman, a California Democrat and chairman of the House Energy and Commerce Committee, sent a letter to Obama earlier this month asking him to discuss the potential savings from generic biologics and what can be done to prepare the Food and Drug Administration to regulate this new category of products.

The White House is conducting “a serious review of FDA’s existing authorities” to ensure that the agency can quickly take on the role of approving generic biologics once legislation is passed, DeParle and Orszag wrote to Waxman.

Generic biologics may be included as part of the Senate health committee’s plan to overhaul the $2.5 trillion U.S. health-care system, but lawmakers haven’t agreed to specific details for their proposal. The panel passed a bipartisan bill in 2007 that called for 12 years of exclusivity.

Advertising Effort

Drug-plan managers today began an advertising campaign urging lawmakers to reject proposals that would delay generic competition when biotechnology companies make “minor changes” to their formulas. The ad is sponsored by the Pharmaceutical Care Management Association, a Washington-based trade group representing Medco Health Solutions Inc., CVS Caremark Corp. and other companies that coordinate drug benefits for employers.

The U.S. lags behind Europe, where Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, Novartis AG’s Sandoz division, of Basel, Switzerland, and Hospira Inc., of Lake Forest, Illinois, have won approval for copies of three biologic drugs.

Amgen, of Thousand Oaks, California, and Genentech, a unit of Swiss drugmaker Roche, are the largest U.S. makers of biologics. They say their medicines can’t be replicated like conventional pills produced through chemical synthesis because of complex manufacturing and finished products that have slight variances.

Amgen Comment

“Without a fair and sustainable cycle of investment and returns in innovative R&D, biotech discovery will be stifled,” said David Polk, a spokesman for Amgen, in an e-mail today. “We look forward to working with Congress on legislation which strikes a necessary balance.”

The Biotechnology Industry Organization, a Washington-based trade group, has backed a measure from Representative Anna Eshoo, a California Democrat, that would set a high bar for approving generics and only after a brand-name product was on the market for 12 to 14 years.

Generic biologics may be sold at a 10 percent to 30 percent discount, allowing for “substantial consumer savings” without eroding market share for brand-name drug companies, the Federal Trade Commission said in a June 10 report.

Amgen’s Epogen for anemia and Neupogen to boost white blood cells after chemotherapy will probably be among the first biologics copied in the U.S., Ronny Gal, an analyst at Sanford C. Bernstein & Co. in New York., said in a Feb. 24 presentation. Both drugs already have competition in Europe.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: June 25, 2009 17:37 EDT


http://www.bloomberg.com/apps/news?pid=20601202&sid=aXuk6lNlI_Jw

Tamiflu Resistant Swine Flu Reported

INFLUENZA A (H1N1) - WORLDWIDE (78): TAMIFLU RESISTANCE, DENMARK
****************************************************************
A ProMED-mail post

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


Date: Mon 29 Jun 2009
Source: BBC News [edited]



Experts have reported the 1st case of swine flu that is resistant to
Tamiflu [oseltamivir], the main drug being used to fight the pandemic.
Roche Holding AG confirmed a patient with H1N1 influenza in Denmark showed
resistance to the antiviral drug. David Reddy, company executive, said it
was not unexpected given that common seasonal flu could do the same.

The news comes as a 9 year old girl has become the 3rd to die in the UK
with swine flu. It is understood from her doctors at Birmingham Children's
Hospital that she had underlying health conditions. (Bloggers Note: ALWAYS they say that, but the truth is ambigious here, as there are other reports that the disease is effecting (and killing) mostly young, healthy people.) It is not yet known whether swine flu contributed to her death. (We we ever know?)

Meanwhile, the Department of Health has announced a big jump in the number
of patients in England confirmed with swine flu, up 1604 since Friday [26
Jun 2009], taking the UK total so far to 5937. A Health Protection Agency
spokeswoman stated that: "Routine sampling in the UK has shown that there
is currently no resistance to oseltamivir or zanamivir." Experts have been
using Tamiflu, also known as oseltamivir, in a bid to stop the H1N1
spreading in communities. If taken early, it ensures that symptoms are mild
and reduces the chance of a victim giving the illness to someone else.

This 1st reported case of resistance developed in a swine flu patient
taking Tamiflu. Mr Reddy stressed that there were no signs of a
Tamiflu-resistant strain of H1N1 circulating in the community. This is in
contrast to seasonal H1N1 flu, where a Tamiflu resistant strain emerged
last year [2009] and is now widely circulating. Experts fear if this were
to happen, it could render Tamiflu ineffective [in treatment of the swine
flu H1N1 virus infection].

Another antiviral drug, called zanamivir or Relenza, made by
GlaxoSmithKline, is also effective against swine flu. The UK government has
been stockpiling these antiviral drugs and currently has enough to treat
half of the population, with a contract to bring that up to 80 per cent as
soon as possible. Supplies of flu vaccine have also been ordered, and the
1st doses could be administered in the autumn [2009].

A spokeswoman for the Health Protection Agency said: "The Health Protection
Agency continues to watch for antiviral resistance and will be carrying out
regular sample testing throughout this outbreak. We have been monitoring
antiviral drug resistance since the beginning of this outbreak. Routine
sampling in the UK has shown that there is currently no resistance to
oseltamivir or zanamivir." Virologist Professor John Oxford said: "I'm not
surprised about this finding. The question is whether it is going to
spread. We will soon know the answer."

--
communicated by:
ProMED-mail

[According to the European Influenza Surveillance Scheme Weekly Electronic
Bulletin of 26 Jun 2009 (), all seasonal A(H1N1)
viruses tested have been sensitive to oseltamivir and zanamivir but
resistant to M2 inhibitors, although elsewhere Tamiflu resistance has been
observed in A H1N1 seasonal viruses. The emergence of Tamiflu-resistant 209
swine-origin A H1N1 influenza virus is not unexpected in view of the
widespread and somewhat indiscriminate use of the drug in the treatment of
what is still a relatively mild disease. It remains to be seen whether the
Tamiflu-resistant virus will spread in Europe and beyond and appear
independently elsewhere. It is presumed that the Tamiflu-resistant virus
isolated in Denmark remains sensitive to the alternate neuraminidase
inhibiter Relenza. - Mod.CP]

[see also:
Influenza A (H1N1) - worldwide (77): case count 20090627.2338
Influenza A (H1N1) - worldwide (76): comments on 1918 virus (03) 20090625.2309
Influenza A (H1N1) - worldwide (74): susp. origin 20090624.2303
Influenza A (H1N1) - worldwide (73): case count, epidemiology 20090622.2288
Influenza A (H1N1) - worldwide (72): case count, epidemiology 20090619.2261
Influenza A (H1N1) - worldwide (70): risk factors 20090619.2260
Influenza A (H1N1) - worldwide (69): other viral infections 20090618.2254
Influenza A (H1N1) - worldwide (68): southern hemisphere 20090618.2253
Influenza A (H1N1) - worldwide (65): antivirals in pregnancy 20090616.2224
Influenza A (H1N1) - worldwide (64): case count, pandemic 20090616.2221
Influenza A (H1N1) - worldwide (62): Egypt, Lebanon 20090611.2150
Influenza A (H1N1) - worldwide (62): Egypt, Lebanon 20090611.2150
Influenza A (H1N1) - worldwide (60): Egypt (Cairo) 20090608.2117
Influenza A (H1N1) - worldwide (59): Worldwide 20060608.2117
Influenza A (H1N1) - worldwide (58): USA, Africa 20090607.2109
Influenza A (H1N1) - worldwide (57): Brazil, USA 20090605.2090
Influenza A (H1N1) - worldwide (55) 20090603.2056
Influenza A (H1N1) - worldwide (47): China, epidemiology 20090526.1962
Influenza A (H1N1) - worldwide (45) 20090525.1951
Influenza A (H1N1) - worldwide (42) 20090523.1929
Influenza A (H1N1) - worldwide (39) 20090521.1903
Influenza A (H1N1) - worldwide (37) 20090520.1893
Influenza A (H1N1) - worldwide (34) 20090518.1863
Influenza A (H1N1) - worldwide (31) 20090516.1835
Influenza A (H1N1) - worldwide (29) 20090515.1824
Influenza A (H1N1) - worldwide (26) 20090514.1798
Influenza A (H1N1) - worldwide (23) 20090511.1764
Influenza A (H1N1) - worldwide (21) 20090510.1749
Influenza A (H1N1) - worldwide (19) 20090509.1733
Influenza A (H1N1) - worldwide (17) 20090508.1722
Influenza (H1N1) - worldwide (15) 20090507.1709
Influenza A (H1N1) - worldwide (13) 20090506.1695
Influenza A (H1N1) - worldwide (11): coincident H3N2 variation 20090505.1679
Influenza A (H1N1) - worldwide (09) 20090504.1673
Influenza A (H1N1) - worldwide (07) 20090503.1658
Influenza A (H1N1) - worldwide (05) 20090503.1657
Influenza A (H1N1) - worldwide (03) 20090501.1646
Influenza A (H1N1) - worldwide (02): case counts 20090430.1638
Influenza A (H1N1) - worldwide 20090430.1636
Influenza A (H1N1) "swine flu": worldwide (07), update, pandemic 5
20090429.1622
Influenza A (H1N1) "swine flu": worldwide (06) 20090429.1614
Influenza A (H1N1) "swine flu": worldwide (05) 20090428.1609
Influenza A (H1N1) "swine flu": worldwide (04) 20090428.1601
Influenza A (H1N1) "swine flu": worldwide (03) 20090428.1600
Influenza A (H1N1) "swine flu": Worldwide (02) 20090427.1586
Influenza A (H1N1) "swine flu": Worldwide 20090427.1583
Influenza A (H1N1) virus, human: worldwide 20090426.1577
Influenza A (H1N1) virus, human - New Zealand, susp 20090426.1574
Influenza A (H1N1) virus, human - N America (04) 20090426.1569
Influenza A (H1N1) virus, human - N America (03) 20090426.1566
Influenza A (H1N1) virus, human - N America (02) 20090425.1557
Influenza A (H1N1) virus, human - N America 20090425.1552
Acute respiratory disease - Mexico, swine virus susp 20090424.1546
Influenza A (H1N1) virus, swine, human - USA (02): (CA, TX) 20090424.1541
Influenza A (H1N1) virus, swine, human - USA: (CA) 20090422.1516
Influenza A (H1N1) virus, swine, human - Spain 20090220.0715]

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


*##########################################################*
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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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Monday, June 29, 2009

Sanofi's Lantus linked to cancer risk

Sanofi's Lantus linked to cancer risk
By Tracy Staton

The rumors came true: European studies released over the weekend suggest a link between cancer and Sanofi-Aventis' diabetes treatment Lantus. Word of a possible safety problem with Lantus leaked out last week, spurring some stock analysts to downgrade the company and investors to sell off their Sanofi stock.

The data is far from conclusive, as their publisher, the European Association for the Study of Diabetes, points out. Two of the bigger database analyses found an increase in cancer risk--especially breast cancer--among Lantus patients compared with those using other forms of insulin. One of the smaller studies found no statistically significant link, while the smallest found no link at all. "Our study does, however, arouse an urgent suspicion," one of the authors told Reuters, "which should have consequences for the treatment of patients."

Sanofi defended Lantus's safety, saying that clinical trials found no cancer link--and pointed out that clinical trials do remain the "gold standard" of drug research. The company plans a conference call later today at 1 p.m. Eastern, which will be aired as an audio webcast at its site (see below for the link). "Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance arising from 24 million patient-years of experience, Sanofi-Aventis stands behind the safety of Lantus," Sanofi CMO Jean-Pierre Lehner said in a statement. "We consider that the results of these patient registries are not conclusive."

But a lack of ironclad evidence doesn't mean Lantus sales won't suffer. (Need we remind you about the infamous Avandia meta-analysis?) A Societe Generale analyst has already churned out numbers: Marietta Miemietz predicts that Lantus sales may only reach $4.78 billion by 2012 now, compared with a previously expected $7 billion or more, Bloomberg reports. "We expect Lantus to remain commercially available, but expect controversies to ensue, with a likely negative impact on the franchise," Miemietz said in a note to investors. And with Lantus expected to be a key driver of Sanofi revenue as patents expire on its other big drugs, the company has plenty to worry about. How can it fight back? Tune in this afternoon to see what Sanofi is planning.

- read the Sanofi release
- find the link to the company webcast
- read the Wall Street Journal story
- see Bloomberg's coverage
- get more from Reuters

ALSO: Shares in Novo Nordisk rose over 5 percent Monday after the drugmaker said it hasn't seen any cancer risks for any of the three insulin analogues it markets, distancing itself from the worries surrounding a diabetes treatment from French rival Sanofi-Aventis. Report

Related Articles:
Lantus worries drag on Sanofi stock
Sanofi-Aventis - Biotech Market Share Report
Sanofi profits leap; Wyeth results flatten

Read more about: Pharma Stocks, drug safety, Sanofi-Aventis, Lantus


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

Another Big-Pharm Goes Bio(Tech)

Sources: Novartis in talks to buy Elan assets

By John Carroll Comment | Forward

Novartis appears ready to cherry pick some of Elan's prime assets, if it can come to terms on the details. Citing sources, The Sunday Times in London reported that the pharma giant is in talks to buy Elan's interest in Tysabri--which it markets with Biogen Idec--as well as its development programs for Alzheimer's.

The Irish biopharma company has been seeking a partner for months now, with reports of its on-and-off merger talks capturing headlines periodically. In Sunday's report, the source said that the complexity of a negotiation over buying specific assets would likely push any prospective deal signing "some way off."

Citigroup Global Markets was brought in at the beginning of the year to see if it could help arrange a merger, alliance or some minority investment. And Elan said earlier this month that a strategic transaction was in the offing. At one time or another, however, Elan has reportedly been in talks with BMS, Pfizer and Lundbeck, but no deal was ever finalized with any of them.

- read the report from RTT News
- read the story in the Guardian

Related Articles:
Source nixes rumors of Elan-BMS merger talks
Is BMS eyeing Elan?
Lundbeck CFO squelches Elan takeover buzz
Elan's stock rises on rumor of Lundbeck bid

Read more about: Elan, Novartis

US Pig Farmers Destroying Pigs & US Compensating Them?

Pig carcasses slop across I-235 on-ramp

BY JOE RODRIGUEZ
The Wichita Eagle

You probably would've believed this story when pigs fly.



Oops.

A truck spilled several pig carcasses over a west Wichita highway ramp Wednesday, causing a traffic headache — and a big stink — for nearly two hours.

One hundred degrees. Near rush hour. Talk about bad timing.

Authorities said that a driver transporting the carcasses made the turn on the ramp at about 3:45 p.m. Because of the steepness of that ramp, the driver spilled several carcasses, according to the Kansas Highway Patrol.

But the patrol said the driver didn't realize he spilled the pigs, and kept on driving.

In the meantime, authorities closed the ramp to clean up the mess — made worse, the patrol said, by the extreme heat.

"The heat probably didn't help the smell much," said a patrol dispatcher.

It was so bad that a police officer working the scene said he nearly got sick.

Not to worry, though. Authorities said the spilled carcasses caused no health risks.

Just a big mess.

The cleanup work was done by crews from the Kansas Department of Transportation, according to spokesman Tom Hein.

Hein didn't know how many carcasses there were. It was difficult to determine, he said.

KDOT workers scooped up the carcasses and treated the ramp "to help absorb some of the moisture that was left" from the carcasses, Hein said.

By 5:30, the highway ramp was back open.

The pigs were taken to a pit, where they were dumped.

And quickly covered.

Bloggers Note: And where did all these dead little piggies come from, and how did they meet their ends, and why buried in a pit instead of a rendering plant? Could it be American pig farmers are destroying their (unmarketable) pigs and is the gov't (US) is paying the vig?


http://www.kansas.com/nl/weird/story/867065.html

U.S. Food Production "most elite" and "safest" in the World? Is Trent Loos Loos-ing his Mind?

Or, "Who is the Loo-ney one now?"

Loos tells the world American Food Production Safest in the World
(doent he read the latest U.S. news and reports about all the livestock disease, food contamination and recalls?)

Challanges "Chipotle's food integrity

(not exactly an un-biased opinion, and what is the "product" that he says animal lovers and those concerned with food safety are allegedly "pushing?" But he is right about those free-ranging fowl - what omnivores they are!)

--------------------Article

By Trent Loos / Updated: 2009-06-29 10:50:36

Chipotle Mexican Grill is misleading American consumers and financially benefiting from a "feel good, no guilt" marketing message that in fact is untrue. As a sixth-generation U.S. farmer, I have personally provided daily care for more than one million farm animals in my lifetime.

Unlike that which is portrayed in Chipotle's marketing campaign, modern agriculture and confined animal agriculture are sustainable. Anyone attempting to tell you otherwise is probably trying to sell you on his or her product, and I suggest you double-check his or her integrity and true objectives.


On behalf of today's food producers I have asked Chipotle to immediately refrain from using the phrase "food with integrity" out of concern for the future of the American farmer as well as the American consumer. I am urging that consumers and farmers not frequent Chipotle establishments until the company is willing to change its ways and stop being disingenuous about its motives.


While long troubled by Chipotle's messaging, I am taking action after viewing the June 16 segment on Nightline in which Chipotle owner Steve Ells was openly and publicly talking about his company's commitment to producing "food with integrity" while pigs in the background could be seen drinking from puddles that likely contained their own urine, feces and other possible contaminants and bacteria.


As a kid, we raised pigs out in the hills, and in those mud holes, pigs exhibited their 'piggy-ness.' Compared to today's modern confinement pork production system, where comprehensive manure management plans are in place to protect the environment, our system of 30 years ago was not good for the environment in any shape or form. Trees still do not grow in the area where our pigs once roamed.


I also am concerned with the chicken served in Chipotle restaurants. In the Nightline segment, Ells pointed out that the free-range chicken served in his company's restaurants comes from chickens only fed vegetarian diets. I still, today, have free-ranging hens on my farm, and they eat a vast number of insects and any dead animal carcass that might accidentally show up. So, I am telling you that there is zero integrity in a man who states that his chickens only eat vegetarian diets if they come from free-range conditions. This is just not possible.


While the United States of America is indeed a country where one has the choice to reject the science and technology that have been the success story of American agriculture I want Ells to know that America's farmers and ranchers will no longer stand back and allow Chipotle or any food company to mislead consumers about the accomplishments of the livestock industry over the past 50 years and how the planet, society and our animals have benefited greatly from those.


I have been at every level in animal agriculture, and I can tell you that modern agriculture, through confinement housing, has taken our nation's food system to the most elite in the world. Today's farmers produce the safest, most wholesome supply of food with fewer resources impacted than at any time in recorded history.


Commentary by Trent Loos,
founder of Faces of Agriculture
Loup City, NE



http://www.joplinindependent.com/display_article.php/tloos1246294236

Sunday, June 28, 2009

BigPharma Getting Bigger; Buying Up BioTech / Merck's BioInvest

Merck acquires biosimilars in $130M pact
February 12, 2009 — 10:38am ET | By John Carroll

Merck signaled its clear intent to get aggressive about the biosimilar business with this morning's announcement that the pharma giant is buying Insmed's portfolio of follow-on biologics for $130 million in cash. Merck's BioInvest will take over the development of INS-19 and INS-20, both intended to mimic existing biologics that prevent infections in cancer patients receiving chemotherapy. INS-19 is in late-stage trials while INS-20 is in early-stage development.

In what may become a pattern for similar deals, Merck is paying $10 million down and the other $120 million when the deal closes. There are no milestones in the deal. Merck is also buying a 50,000-square foot manufacturing facility in Boulder, CO in the pact. Insmed, meanwhile, plans to continue to develop its protein therapies.

"Insmed's pipeline of follow-on biologic candidates presents the opportunity to expedite Merck's entry into the biologics marketplace as well as providing unique manufacturing resources and an experienced team of protein experts," said Frank K. Clyburn, senior vice president and general manager Merck BioVentures. "This agreement represents a strong strategic fit for Merck as we aggressively expand and advance our portfolio of developmental follow-on biologics."

Like other pharma companies, Merck has opted to get aggressive about developing follow-on therapeutics. Unlike traditional small molecules, there is no regulatory pathway established in the U.S. to develop biosimilars. But lawmakers have signaled their intent to take on the issue this year. And with big pharma companies jumping into the game, BIO may find itself up against some heavyweight lobbying efforts in Congress.

- check out the Merck release
- read the AP report

Related Articles:
Merck priority for 2009: Dealmaking
Merck willing to consider major buyout
Merck CEO open to big-time M&A
Merck to create biotech unit


http://www.fiercebiotech.com/story/merck-acquires-biosimilars-130m-pact/2009-02-12?utm_medium=nl&utm_source=internal

Thursday, June 25, 2009

"Hamster" Virus cripples (BigPharma)Genzyme plant



"Hamster" Virus cripples (BigPharma)Genzyme plant

By George Miller

With its manufacturing plant out of commission being decontaminated, Genzyme has said the virus causing the contamination might have come from an unnamed vendor.

The plant, just outside Boston, is used to make Cerezyme and Fabrazyme, treatments for Gaucher disease and Fabry disease, respectively. It is expected to be closed until late July, according to the Boston Globe.

The Globe was among many news outlets providing extensive, ongoing coverage of the closure, despite the difficulties of explaining bioprocess complexities to a lay audience. In one report, it included an interactive of the manufacturing process containing a surprising amount of detail for a daily newspaper.

The virus strain, Vesivirus 2117, probably interfered with the growth of the Chinese hamster ovary cells used in biologics production, says a company announcement. It was likely introduced through a nutrient used in the manufacturing process.

The virus is known to Genzyme: It was the cause of declines in cell productivity at two of the company's plants last year, including the currently disabled facility.

Company shares dropped 7 percent following the event. Genzyme said existing supplies will need to be rationed.

Related Article:
Genzyme plant goes idle for sanitizing
FDA cites "objectionable conditions" at Genzyme plant

Gov't Bails Out Failing BioTech Firm with 35M Contract

Facing angry creditors, Protein Sciences wins $35M contract
By John Carroll

A day after creditors went to federal court in a bid to push the financially shaky vaccine maker Protein Sciences into bankruptcy liquidation, the company won a $35 million federal contract to push a faster and more efficient approach to making pandemic vaccines.

The bulk of the $11.7 million that the creditors are demanding is owed to Emergent Biosolutions, which lent the company $10 million to help seal a buyout deal. But the acquisition deal fell apart, leaving executives on both sides engaged in an angry round of accusations and counter-accusations.

Andrew Pollack at The New York Times asked the government if officials were entrusting the country's pandemic defenses to "a financially shaky or untrustworthy company." But an official at HHS says that audits demonstrated that Protein Sciences is financially healthy enough to do the work.

Daniel Abdun-Nabi, the president of Emergent, tells the Times that a forced bankruptcy wouldn't destroy Protein Sciences' technology. That could be acquired by a company like, say, Emergent.

From the NY Times;

Vaccine Maker Facing Possible Bankruptcy Wins Contract

By ANDREW POLLACK
Published: June 23, 2009
A small biotechnology company facing possible bankruptcy and liquidation has been awarded a $35 million federal contract to develop a faster way to make vaccines for pandemic influenza.

The award of the contract to the Protein Sciences Corporation of Meriden, Conn., was announced on Tuesday by the Department of Health and Human Services. But only a day earlier, creditors filed a petition in federal bankruptcy court in Wilmington, Del., seeking to force Protein Sciences into bankruptcy and liquidation, saying they were owed $11.7 million.
Almost all of that money is owed to Emergent BioSolutions, a vaccine company in Rockville, Md., that lent Protein Sciences $10 million last year in advance of the pending acquisition of virtually all the assets of Protein Sciences by Emergent. The acquisition deal fell apart, and Emergent sued Protein Sciences and its top executives, accusing them of fraud and breach of agreements.

The series of events raises questions about whether the government is entrusting part of the nation’s influenza defense to a financially shaky or untrustworthy company. Conversely, the award of the contract could put Emergent into an uncomfortable light for trying to force into bankruptcy a company with promising vaccine technology.

Robin Robinson, director of the branch of Health and Human Services that will administer the contract, said the government had spent months doing “two very thorough financial audits” of Protein Sciences. “It was determined that they were healthy enough to go forward with development of this vaccine,” he said.

Health authorities are scrambling to come up with enough vaccine to protect the world’s population against the recently declared pandemic of swine flu, which has killed more than 230 people worldwide and sickened more than 52,000. They are worried that the death toll from the strain might rise sharply this winter.

“I can’t imagine what legitimate purpose can be served by trying to close the company,” Daniel D. Adams, the chief executive of Protein Sciences, said in an interview on Tuesday. Mr. Adams said that Emergent’s suit was without merit and that its actions were making it difficult for Protein Sciences to attract new investors.

But Daniel J. Abdun-Nabi, president and chief operating officer of Emergent, said that bankruptcy “doesn’t destroy the product, and it doesn’t destroy the technology.” It might result in the technology’s being sold to a stronger company, like his own or others, he said. Emergent, which makes the anthrax vaccine used by the armed forces, says it has been more than patient in giving Protein Sciences a chance to pay back the loan.

Protein Sciences is one of several small companies trying to make influenza vaccines by methods that are faster than growing them in chicken eggs, the technique now generally used.

Instead of growing whole viruses, Protein Sciences produces just a protein from the virus and it does so in genetically modified insect cells.

The company, which is privately held, has already applied to the Food and Drug Administration for approval of a seasonal flu vaccine. And last week, Mr. Adams said, the company made its first 100,000 doses of a vaccine against the new swine flu.

The federal contract will help Protein Sciences develop its technology and obtain F.D.A. approval. It can be extended up to five years for a total cost of $147 million.

If the technology is proved safe and effective and is licensed by the F.D.A, the contract calls for Protein Sciences to establish domestic manufacturing capacity, to provide a finished vaccine within 12 weeks of the onset of a pandemic and to produce at least 50 million doses of a pandemic flu vaccine within six months.

Mr. Robinson of Health and Human Services said that for the current pandemic, the Protein Sciences vaccine might be used as a backup to those being supplied by larger companies.

See Also, "Studies Show & Doctors Agree, Ignore Pandemic, Say no to Tamiflu (vaccines);

A ProMED-mail post

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


Date: Fri 19 Jun 2009
From: Julian Tang



Some follow-up comments on the question posed by
Dr Rau in the ProMED-mail post titled: Influenza
A (H1N1) - worldwide (67): comments on 1918
virus, archive number 20090618.2251.
-----------------------------------------------------
I think Dr Rau has raised a valid point, and one
that I have also commented on previously (1);
i.e., it is difficult to assess how accurate the
estimated number of deaths due to the 1918
influenza A(H1N1) virus can be -- especially
without any laboratory confirmation of the causal
agent. The influenza virus was only formally
discovered in 1933 by Smith and colleagues (2),
so before that it would have been difficult to
definitively relate the cause of death to this
unknown pathogen.

Mathematical modellers tend to argue that the
number of excess deaths in what we now know are
fairly predictable influenza seasons (at least in
temperate countries) are almost certainly due to
influenza. Admittedly this may be more true
nowadays because we can control the other causes
of death with clean water, effective sanitation,
modern medicine and vaccination programmes.
However, in 1918, many of these excess deaths
(the death certificates would hardly have been
very accurate at that time) may have been due to
other infectious agents such as TB, cholera,
typhoid (many of which may have gone undiagnosed
in the community and may have presented with
flu-like illness) and bacterial pneumonias. As
pointed out in several recent articles (3,4),
secondary bacterial infection may well have been
the direct cause of death during this 1918
pandemic -- particularly since penicillin was
also not available as a recognised antibiotic
then either. In fact, this also raised the more
philosophical question of exactly how do you
define the cause of death? In such cases,
influenza becomes just a contributing factor,
perhaps like any other lung condition that may
predispose to bacterial infection. So how
meaningful is the stated cause of death on any of
the death certificates during that time?

The oft cited paper on the Copenhagen data (5)
again suffers from the limitations noted above --
that no definitive diagnosis of influenza could
have been made in any of the cases at that time,
since the virus itself had not been discovered
yet. It's quite amazing how one study on the data
from the 1918 pandemic from one city has created
such concerns about the so-called 'lethal 2nd
wave', which may be totally irrelevant to the
modern society in which we now live, with modern
medicine (reducing case fatality rates -- when
widely accessible), influenza vaccination (which,
admittedly, still has a poor uptake rate), rapid
modern travel (perhaps most important, which may
disseminate the virus to multiple locations
worldwide providing rapid herd immunity -- as we
are seeing now with the new H1N1/2009 virus).

In fact, in their abstract, the authors of this
article actually state that the rapid spread of
the milder summer wave may have protected against
a higher mortality in the following fall wave.
So, if we are using the conclusions of this paper
to guide current public health policy with this
new influenza A(H1N1/2009) virus, to provide
greater protection against any potentially more
"lethal fall wave," it seems that we should allow
this current, relatively mild A(H1N1/2009)
influenza virus to disseminate as widely as
possible and not attempt to contain it at all
with isolation/quarantine or the widespread use
of oseltamivir (Tamiflu).
But how likely are
governments and public health teams to follow
such a suggestion? Probably not very.

Conclusions
-----------
The Copenhagen summer wave may have been caused
by a precursor A/H1N1 pandemic virus that
transmitted efficiently but lacked extreme
virulence. The R measured in the summer wave is
likely a better approximation of transmissibility
in a fully susceptible population and is
substantially higher than that found in previous
USA studies. The summer wave may have provided
partial protection against the lethal fall wave".
(5)

Perhaps, some comment from the authors of this
paper would be useful to clarify things.

References
----------
(1) Tang JW. Pandemic influenza forecasting: does
past performance indicate future performance? Am
J Infect Control. 2008 Sep;36(7):466-7.
(2) Smith W, Andrewes CH, Laidlaw PP. A virus
obtained from influenza patients. Lancet 1933;
222: 66°V68.
(3) Morens DM, Taubenberger JK, Fauci AS.
Predominant role of bacterial pneumonia as a
cause of death in pandemic influenza:
implications for pandemic influenza preparedness.
J Infect Dis. 2008 Oct 1;198(7):962-70.
(4) Brundage JF, Shanks GD. Deaths from bacterial
pneumonia during 1918-19 influenza pandemic.
Emerg Infect Dis. 2008 Aug;14(8):1193-9.
(5) Andreasen V, Viboud C, Simonsen
L.Epidemiologic characterization of the 1918
influenza pandemic summer wave in Copenhagen:
implications for pandemic control strategies. J
Infect Dis. 2008 Jan 15;197(2):270-8.

--
Communicated by:
Dr Julian W Tang PhD, MRCP, FRCPath
Consultant/ Virologist
Division of Microbiology/Molecular Diagnostic Centre
Department of Laboratory Medicine
National University Hospital
5 Lower Kent Ridge Road
Singapore 119074



[Another relevant factor might be the therapeutic
interventions available at that time. See for
example: Aspirin in the 1918 pandemic, Tsunetoshi
Shimazu, British Medical Journal, 17 June 2009;
338 b2398
.
- Mod.CP]

INFLUENZA A (H1N1) - WORLDWIDE (74): SUSPECTED ORIGIN

INFLUENZA A (H1N1) - WORLDWIDE (74): SUSPECTED ORIGIN
***********************************************
A ProMED-mail post

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


Date: Tue 23 Jun 2009
Source: New York Times [edited]



Contrary to the popular assumption that the new swine flu pandemic
arose on factory farms in Mexico, federal agriculture officials now
believe that it most likely emerged in pigs in Asia, but then
traveled to North America in a human. But they emphasized that there
was no way to prove their theory and only sketchy data underpinning it.

There is no evidence that this new virus, which combines Eurasian and
North American genes, has ever circulated in North American pigs,
while there is tantalizing evidence that a closely related "sister
virus" has circulated in Asia.

American breeding pigs, possibly carrying North American swine flu,
are frequently exported to Asia, where the flu could have combined
with Asian strains. But because of disease quarantines that make it
hard to import Asian pigs, experts said, it is unlikely that a pig
brought the new strain back West. "The most likely scenario is that
it came over in the mammalian species that moves most freely around
the world," said Dr. Amy L. Vincent, a swine flu specialist at the
Agriculture Department's laboratory in Ames, Iowa, referring, of
course, to people.

The 1st person to carry the flu to North America from Asia, assuming
that is what happened, has never been found and never will be,
because people stop carrying the virus when they get better.
Moreover, the officials said, the chances of proving their theory are
diminishing as the virus infects more people globally. It has now
reached more than 90 countries, according to the World Health
Organization. Since some of those people will inevitably spread it to
pigs, its history will become impossible to trace. "To tell whether a
pig is newly infected by a human or had the virus before the human
epidemic began really can't be done," said Dr. Kelly M. Lager,
another Agriculture Department swine disease expert.

The highly unusual virus -- which includes genetic bits of North
American human, avian and swine flus and Eurasian swine flu -- has
not been detected in any pigs except those in a single herd in Canada
that was found infected in late April 2009. A carpenter who worked on
the farm after visiting Mexico had been thought to have infected the
herd. But in mid-June 2009, Canadian health agencies said he was not
to blame. The whole herd was culled, and the virus has not been found
elsewhere in Canada, as it would have been if it were endemic, since
American and Canadian laboratories test thousands of flu samples to
help the pork industry develop vaccines.

But a sample taken from a pig in Hong Kong in 2004 was recently found
to have a virus nearly matching the new flu. That flu, which had 7 of
the new flu's 8 genome sequences, was noted in an article in Nature
magazine on 11 Jun 2009, which called it a "sister virus."

Scientists tracking the virus's lineage have complained that there is
far too little global surveillance of flu in swine. Public databases
have 10 times as many human and avian flu sequences as they do
porcine ones, said Dr. Michael W. Shaw, a scientist in the flu
division of the Centers for Disease Control and Prevention, and there
are far fewer pig flu sequences from Asia than from North America and
Europe, and virtually none from South America or Africa. "Something
could have been going on there for a long time, and we wouldn't
know," Dr. Shaw said. But national veterinary officials said they
knew of no close relatives of the new virus in the large private
North American databases either. That makes it most likely, they
said, that it has been circulating in Asia.

The new virus was 1st isolated in late April 2009 by American and
Canadian laboratories from samples taken from people with flu in
Mexico, Southern California and Texas. Soon, the earliest known human
case was traced to a 5-year-old boy in La Gloria, Mexico, a rural
town in Veracruz. Because that area is home to hog-fattening
operations with thousands of pigs in crowded barns near lagoons of
manure, opponents of factory farming were quick to blame the
industry. In May 2009, the Mexican government said it had tested pigs
on the Veracruz farms and found them free of the virus. Smithfield
Foods, an owner of the farms, and the National Pork Producers
Council, the industry's lobbying arm, were quick to publicize that
announcement. But outside veterinary experts still disagree on
whether those tests proved anything. According to Smithfield, Mexican
government veterinarians tested snout swabs taken on 30 Apr 2009 and
blood samples stored since January 2009. But since the human outbre!
ak in Veracruz is believed to have started in February 2009, many
veterinary experts said testing pig snouts for live virus in April
2009 proved nothing. Any pig sick in February 2009 would have long
since recovered and, since hogs are usually slaughtered at 6 months
old, many of those alive in early February 2009 would be bacon by
April 2009. But Dr. Greg Stevenson, an expert in swine diagnostics at
Iowa State University, said that since flu could persist in a large
herd for months, "if it had been there in February 2009, it would
probably still be there at the end of April 2009."

The blood tests -- in which scientists look for antibodies formed in
response to a previous infection -- present a different set of
problems. Antibodies are much harder to tell apart from one another
than viruses are. A pig that had the new H1N1 flu would come up
positive on an antibody test. But so would a pig that had the regular
H1N1 swine flu that has circulated since 1930, or even a pig that had
been vaccinated against the earlier H1N1 flu, and all the Smithfield
pigs routinely get flu shots. The company said vaccinated pigs could
be distinguished from previously ill pigs because illness produced
more antibodies. But outside experts were skeptical. An antibody test
specific enough to identify only the new flu strain "would take
months to develop, at a minimum, and would require considerable R & D
expertise and technology," said Dr. Christopher W. Olsen, a swine flu
expert at the University of Wisconsin's veterinary medical school.

The governor of Veracruz has asked the National Autonomous University
of Mexico to do its own investigation of industrial hog farming in
his state; the work is expected to take months. Carlos Arias, the
biochemist leading the team, said he hoped to test all the swab and
tissue samples stored by the farms and the national veterinary laboratory.

[Byline: Donal G. McNeil Jr.]

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[This analysis is highly speculative, but it does identify some of
the difficulties inherent in attempts to determine the origin of the
novel 2009 (swine-origin) A (H1N1) influenza virus, and it provides a
review of some current attempts to determine the role of this virus
in disease in pigs globally. - Mod.CP]

[see also:
Influenza A (H1N1) - worldwide (73): case count, epidemiology 20090622.2288
Influenza A (H1N1) - worldwide (72): case count, epidemiology 20090619.2261
Influenza A (H1N1) - worldwide (71): comments on 1918 virus (02) 20090619.2262
Influenza A (H1N1) - worldwide (70): risk factors 20090619.2260
Influenza A (H1N1) - worldwide (69): other viral infections 20090618.2254
Influenza A (H1N1) - worldwide (68): southern hemisphere 20090618.2253
Influenza A (H1N1) - worldwide (67): comments on 1918 virus 20090618.2251
Influenza A (H1N1) - worldwide (66): new strain, sequence analysis
20090617.2235
Influenza A (H1N1) - worldwide (65): antivirals in pregnancy 20090616.2224
Influenza A (H1N1) - worldwide (64): case count, pandemic 20090616.2221
Influenza A (H1N1) - worldwide (63): case count, pandemic 20090611.2166
Influenza A (H1N1) - worldwide (62): Egypt, Lebanon 20090611.2150
Influenza A (H1N1) - worldwide (61): PCR test 20090610.2139
Influenza A (H1N1) - worldwide (62): Egypt, Lebanon 20090611.2150
Influenza A (H1N1) - worldwide (60): Egypt (Cairo) 20090608.2117
Influenza A (H1N1) - worldwide (59): Worldwide 20090608.2117
Influenza A (H1N1) - worldwide (58): USA, Africa 20090607.2109
Influenza A (H1N1) - worldwide (57): Brazil, USA 20090605.2090
Influenza A (H1N1) - worldwide (56): case counts 20090605.2089
Influenza A (H1N1) - worldwide (55) 20090603.2056
Influenza A (H1N1) - worldwide (54): dynamics 20090601.2038
Influenza A (H1N1) - worldwide (53): case counts 20090531.2025
Influenza A (H1N1) - worldwide (52): seasonal vaccine 20090530.2010
Influenza A (H1N1) - worldwide (51): dynamics 20090529.1999
Influenza A (H1N1) - worldwide (50): swine immunity 20090528.1987
Influenza A (H1N1) - worldwide (49): case counts 20090528.1984
Influenza A (H1N1) - worldwide (48): case counts 20090527.1972
Influenza A (H1N1) - worldwide (47): China, epidemiology 20090526.1962
Influenza A (H1N1) - worldwide (46): case counts 20090526.1960
Influenza A (H1N1) - worldwide (45) 20090525.1951
Influenza A (H1N1) - worldwide (44): case counts 20090525.1945
Influenza A (H1N1) - worldwide (43): case counts 20090523.1931
Influenza A (H1N1) - worldwide (42) 20090523.1929
Influenza A (H1N1) - worldwide (41): case counts 20090522.1921
Influenza A (H1N1) - worldwide (40): case counts 20090521.1906
Influenza A (H1N1) - worldwide (39) 20090521.1903
Influenza A (H1N1) - worldwide (38): case counts 20090520.1895
Influenza A (H1N1) - worldwide (37) 20090520.1893
Influenza A (H1N1) - worldwide (36): case counts, amended 20090519.1882
Influenza A (H1N1) - worldwide (35): case counts 20090518.1867
Influenza A (H1N1) - worldwide (34) 20090518.1863
Influenza A (H1N1) - worldwide (33): case counts 20090517.1848
Influenza A (H1N1) - worldwide (32): case counts 20090517.1845
Influenza A (H1N1) - worldwide (31) 20090516.1835
Influenza A (H1N1) - worldwide (30): case counts 20090516.1831
Influenza A (H1N1) - worldwide (29) 20090515.1824
Influenza A (H1N1) - worldwide (28): case counts 20090515.1822
Influenza A (H1N1) - worldwide (27): case counts 20090514.1800
Influenza A (H1N1) - worldwide (26) 20090514.1798
Influenza A (H1N1) - worldwide (25): case counts 20090513.1785
Influenza A (H1N1) - worldwide (24): case counts 20090512.1772
Influenza A (H1N1) - worldwide (23) 20090511.1764
Influenza A (H1N1) - worldwide (22): case counts 20090511.1759
Influenza A (H1N1) - worldwide (21) 20090510.1749
Influenza A (H1N1) - worldwide (20): case counts 20090510.1741
Influenza A (H1N1) - worldwide (19) 20090509.1733
Influenza A (H1N1) - worldwide (18): case counts 20090509.1728
Influenza A (H1N1) - worldwide (17) 20090508.1722
Influenza A (H1N1) - worldwide (16): case counts 20090507.1715
Influenza A (H1N1) - worldwide (15) 20090507.1709
Influenza A (H1N1) - worldwide (14): case counts 20090507.1702
Influenza A (H1N1) - worldwide (13) 20090506.1695
Influenza A (H1N1) - worldwide (12): case counts 20090505.1681
Influenza A (H1N1) - worldwide (11): coincident H3N2 variation 20090505.1679
Influenza A (H1N1) - worldwide (10): case counts 20090504.1675
Influenza A (H1N1) - worldwide (09) 20090504.1673
Influenza A (H1N1) - worldwide (08): case counts 20090503.1660
Influenza A (H1N1) - worldwide (07) 20090503.1658
Influenza A (H1N1) - worldwide (06): case counts 20090502.1654
Influenza A (H1N1) - worldwide (05) 20090503.1657
Influenza A (H1N1) - worldwide (04): case counts 20090501.1648
Influenza A (H1N1) - worldwide (03) 20090501.1646
Influenza A (H1N1) - worldwide (02): case counts 20090430.1638
Influenza A (H1N1) - worldwide 20090430.1636
Influenza A (H1N1) "swine flu": worldwide (07), update, pandemic 5
20090429.1622
Influenza A (H1N1) "swine flu": worldwide (06) 20090429.1614
Influenza A (H1N1) "swine flu": worldwide (05) 20090428.1609
Influenza A (H1N1) "swine flu": worldwide (04) 20090428.1601
Influenza A (H1N1) "swine flu": worldwide (03) 20090428.1600
Influenza A (H1N1) "swine flu": Worldwide (02) 20090427.1586
Influenza A (H1N1) "swine flu": Worldwide 20090427.1583
Influenza A (H1N1) virus, human: worldwide 20090426.1577
Influenza A (H1N1) virus, human - New Zealand, susp 20090426.1574
Influenza A (H1N1) virus, human - N America (04) 20090426.1569
Influenza A (H1N1) virus, human - N America (03) 20090426.1566
Influenza A (H1N1) virus, human - N America (02) 20090425.1557
Influenza A (H1N1) virus, human - N America 20090425.1552
Acute respiratory disease - Mexico, swine virus susp 20090424.1546
Influenza A (H1N1) virus, swine, human - USA (02): (CA, TX) 20090424.1541
Influenza A (H1N1) virus, swine, human - USA: (CA) 20090422.1516
Influenza A (H1N1) virus, swine, human - Spain 20090220.0715
2008
----
Influenza A (H1N1) virus, swine, human - USA (TX) 20081125.3715
2007
----
Influenza A (H2N3) virus, swine - USA 20071219.4079
Influenza, swine, human - USA (IA): November 2006 20070108.0077]
....................................................cp/msp/dk

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Wednesday, June 24, 2009

Obombas Health Care Reform: It's a win-win deal, but Big Pharma wins Biggest

By Tracy Staton

Everyone's a winner with the pharma industry's $80 billion in concessions to healthcare reform. Or so analysts are saying. Political types claim President Obama's reform plans got a jump-start from the government's deal with drugmakers. Washington-watchers say the powerful special-interest group AARP pulled one over on drugmakers, which have resisted the group's efforts to close the so-called Part D donut hole. (The industry wanted to help low-income seniors, specifically, while AARP wanted help for all seniors, the Wall Street Journal reports.)

But to hear pharma analysts talk, it's the industry itself that gained most from the deal. Originally, Congressional leaders wanted drugmakers to give up $130 billion in savings. Pharma got away with $80 billion, about 38 percent less. An estimated $30 billion of that amount goes to the donut hole, but drugmakers could recoup part of that, provided the 50 percent branded-drug discount spurs more seniors to stick with name-brand meds rather than switch to generics.

"Roughly 20-25 percent of Medicare D patients reach the donut hole, and the majority of them either stop or switch their medications," Deutsche Bank analyst Barbara Ryan said in a research note (as reported by Reuters). "Therefore, pharma may be providing discounts for branded drugs which will primarily represent incremental demand."

Plus, the deal gives drugmakers some ammo to fight off less-attractive proposals. Repeal the DTC tax break? Not so fast. Direct government price negotiation? Not apart from Medicaid. "Healthcare reform, for the pharmaceutical sector at least, now doesn't stand there as being open-ended, with a worst-case scenario of virtually everything going to generics," one healthcare fund manager told Reuters. "That's no longer the case; you can move on and manage it from here." We'll have to wait and see whether Big Pharma cuts back on lobbying expenses next quarter; so far this year, the industry has ploughed millions into pushing its own reform agenda.

- see the WSJ Health Blog post on AARP
- read the Reuters analysis
- check out some calculations at Seeking Alpha
- get the numbers on pharma lobbying from BNet Pharma

Related Articles:
Drugmakers pledge $80B to health reform
Pharma offense is best reform defense
Read pharma's lips: No public plan
Bayer pharma chief laments pricing pressures
Drugmakers hike prices to boost revenues

Read more about: analysts, Medicare Part D, Medicare, healthcare reform

Monday, June 22, 2009

Rumsfield, Regan, Behind the Aspertane Lies



The Lethal Science Of Splenda - A Poisonous Chlorocarbon
From Dr. Betty Martini, D.Hum

Bettym19@mindspring.com
By James Bowen, M.D.
5-8-5

James Bowen, M.D., A physician, biochemist, and survivor of aspartame poisoning warns about yet another synthetic sweetener, Splenda.

Historical background on Aspartame (Nutri-sweet) "The FDA denied approval of aspartame for 16 years, then caved in to political/economic pressure when Don Rumsfeld, CEO of the manufacturer, was brought to Washington by Ronald Reagan. A new FDA Commissioner was appointed to approve it then became a consultant for NutraSweet's public relations firm for $1,000/day on a 10 year contract. Forthcoming has been a global epidemic of disability and death. One might expect FDA to be more cautious next time, yet FDA approved the toxic chlorocarbon Splenda without hesitation and without any long term testing on human subjects."

HAWAII -- The chemical sucralose, marketed as "Splenda", has replaced aspartame as the #1 artificial sweetener in foods and beverages. Aspartame has been forced out by increasing public awareness that it is both a neurotoxin and an underlying cause of chronic illness worldwide. Dr. James Bowen, Researcher and biochemist, reports:

"Splenda/sucralose is simply chlorinated sugar; a chlorocarbon. Common chlorocarbons include carbon tetrachloride, trichlorethelene and methylene chloride, all deadly. Chlorine is nature's Doberman attack dog, a highly excitable, ferocious atomic element employed as a biocide in bleach, disinfectants, insecticide, WWI poison gas and hydrochloric acid.

"Sucralose is a molecule of sugar chemically manipulated to surrender three hydroxyl groups (hydrogen + oxygen) and replace them with three chlorine atoms. Natural sugar is a hydrocarbon built around 12 carbon atoms. When turned into Splenda it becomes a chlorocarbon, in the family of Chlorodane, Lindane and DDT,

"It is logical to ask why table salt, which also contains chlorine, is safe while Splenda/sucralose is toxic? Because salt isn't a chlorocarbon. When molecular chemistry binds sodium to chlorine to make salt carbon isn't included. Sucralose and salt are as different as oil and water.

"Unlike sodium chloride, chlorocarbons are never nutritionally compatible with our metabolic processes and are wholly incompatible with normal human metabolic functioning. When chlorine is chemically reacted into carbon-structured organic compounds to make chlorocarbons, the carbon and chlorine atoms bind to each other by mutually sharing electrons in their outer shells. This arrangement adversely affects human metabolism because our mitochondrial and cellular enzyme systems are designed to completely utilize organic molecules containing carbon, hydrogen, oxygen, nitrogen, and other compatible nutritional elements.

"By this process chlorocarbons such as sucralose deliver chlorine directly into our cells through normal metabolization. This makes them effective insecticides and preservatives. Preservatives must kill anything alive to prevent bacterial decomposition."

Dr. Bowen believes ingested chlorocarbon damage continues with the formation of other toxins: "Any chlorocarbons not directly excreted from the body intact can cause immense damage to the processes of human metabolism and, eventually, our internal organs. The liver is a detoxification organ which deals with ingested poisons. Chlorocarbons damage the hepatocytes, the liver's metabolic cells, and destroy them. In test animals Splenda produced swollen livers, as do all chlorocarbon poisons, and also calcified the kidneys of test animals in toxicity studies. The brain and nervous system are highly subject to metabolic toxicities and solvency damages by these chemicals. Their high solvency attacks the human nervous system and many other body systems including genetics and the immune function. Thus, chlorocarbon poisoning can cause cancer, birth defects, and immune system destruction. These are well known effects of Dioxin and PCBs which are known deadly chlorocarbons."

Dr. Bowen continues: "Just like aspartame, which achieved marketplace approval by the Food and Drug Administration when animal studies clearly demonstrated its toxicity, sucralose also failed in clinical trials with animals. Aspartame created brain tumors in rats. Sucralose has been found to shrink thymus glands (the biological seat of immunity) and produce liver inflammation in rats and mice.

"In the coming months we can expect to see a river of media hype expounding the virtues of Splenda/sucralose. We should not be fooled again into accepting the safety of a toxic chemical on the blessing of the FDA and saturation advertising. In terms of potential long-term human toxicity we should regard sucralose with its chemical cousin DDT, the insecticide now outlawed because of its horrendous long term toxicities at even minute trace levels in human, avian, and mammalian tissues.

"Synthetic chemical sweeteners are generally unsafe for human consumption. This toxin was given the chemical name "sucralose" which is a play on the technical name of natural sugar, sucrose. One is not the other. One is food, the other is toxic; don't be deceived."

Dr. Bowen also calls attention to another seldom recognized and deadly permanent effect of these chemicals: "Aspartame, sold as NutraSweet, Equal, E951, Canderel, Benevia and under other names, is a hypersensitization agent which causes Polychemical Sensitivity syndrome. Chlorocarbons strongly induce uncurable hypersensitivity diseases which are now becoming rampant." (James Bowen, M.D.)

Doctor Bowen has spent 20 years researching artificial sweeteners after his use of aspartame resulted in being diagnosed with Lou Gehrig's disease. Dr Bowen's intention is to warn the world of the toxicity of tabletop poisons like aspartame, Splenda and Neotame.

For more information on aspartame and Splenda click on the Aspartame Information List on http://www.wnho.net. Dr. Bowen can be seen in the movie "Sweet Misery: A Poisoned World" For the movie call 1 818 349 8822 or email cori@soundandfuryproductions.com See how aspartame was approved by clicking on http://www.soundandfury.tv/pages/Rumsfeld2.html

Aspartame and Splenda Toxicity Centers,
http://www.holisticmed.com/aspartame
Aspartame and brain tumors cases for litigation contact Dr. Betty Martini at Bettym19@mindspring.com or 770 242-2599. Currently taking states New York, New Jersey, Madison County, Illinois and Mississippi

A medical text, Aspartame Disease: An Ignored Epidemic by H. J. Roberts, M.D. presents, 1038 pages of aspartame horrors. http://www.sunsentpress.com or 1 800 827 7991

Russell Blaylock, M.D., has published Excitotoxins: The Taste That Kills on the
subject, http://www.russellblaylockmd.com

Dr. Betty Martini says "the controversy rages over Splenda (sucralose). Is it safe and natural like sugar or is it a chlorinated hydrocarbon? As lawsuits fly, consider the chemistry of this artificial compound."

"The FDA denied approval of aspartame for 16 years, then caved in to political/economic pressure when Don Rumsfeld, CEO of the manufacturer, was brought to Washington by Ronald Reagan. A new FDA Commissioner was appointed to approve it then became a consultant for NutraSweet's public relations firm for $1,000/day on a 10 year contract. Forthcoming has been a global epidemic of disability and death. One might expect FDA to be more cautious next time, yet FDA approved the toxic chlorocarbon Splenda without hesitation and without any long term testing on human subjects."

Dr. Betty Martini
MISSION POSSIBLE INTERNATIONAL,
9270 River Club Parkway, Duluth, Georgia 30097
http://www.wnho.net and http://www.dorway.com
770 242-2599
Bettym19@mindspring.com



http://www.rense.com/general65

FDA on Splenda, "Splendid Lies"



The Problem with Splenda

As more and more people are becoming obese there are more people looking to substitute their favorite foods with those that are not as calorie packed but taste just as good. Many have found that artificial sweeteners are the way to go, with Splenda being the latest and supposedly greatest in a long line of products. It’s true; this artificial sweetener does taste better than those of the past, but is it worth it? Splenda is packaged well and has been marketed beautifully, but there is some scientific data that suggests that Splenda is not nearly as kind to your body as real, calorie packed sugar is.

Artificial Food Products

It seemed as though Splenda was the dieter’s dream and so many of us are reluctant to admit that artificial sweeteners and other man made products simply are not good for us. The problem is that the only safe foods are those that actually come from the earth, not those that have to be chemically produced or changed to create the product. In fact it appears as though chemically altered substances may take a toll on our health and the health of our children. For this reason, you should not consider Splenda, which is basically a sugar free chemical substance, a product that you want to buy.

Is Splenda Better than Aspartame?

The availability of Splenda came on the heels of disappointment of many as we found out the dangers associated with aspartame.(Go here to see a history FDA approval of Aspartame; http://exposingfdanusda.blogspot.com/2009/06/rumsfield-regan-behind-splenda-lie.html

Aspartame penetrates the blood brain barrier, meaning it can enter the brain and create toxins that can literally damage the brain. Many diet conscience people turned to Splenda because they didn’t want to experience neurological side effects that aspartame can and does cause. We don’t yet know what the long term affects of Splenda usage will be, but we do know that it is not a naturally occurring sugar product, in fact it is a chemical substance, and that fact speaks volumes. The fact is we aren’t sure yet if Splenda is any better for your body than aspartame. The question is are you willing to take the chance?

Splenda: To Buy or Not to Buy?
For the longest time NutraSweet was the biggest seller of all of the artificial sweeteners, but when research uncovered the data about what aspartame does to the brain and the body on a whole many people were disgusted and worried about their health. Splenda seems like a great option because it is manufactured by a well known brand, Johnson & Johnson, and it also tastes much more like sugar than anything else that has been on the market in the past. Splenda is also marketed as being made from real sugar, making it an obvious choice for those that are looking for a sugar substitute. Splenda has another attractive feature, which is that it is heat stable, meaning people who are trying to cut calories from their diet or individuals, such as diabetics, can enjoy more of their favorite foods without the calories and carbohydrates associated with real sugar.

What Do We Already Know About Splenda?
While we do not yet have long term studies on the side effects of Splenda, we do know that Splenda and other blends of chemical sweeteners appear to be causing problems. Those that use the substances gain weight, experience sleep disturbances, have problems with sexual functions, as well as an increased risk of cancer! In addition it appears as though Splenda and other artificial sweeteners are causing an increase in Multiple Sclerosis, Lupus, diabetes, and many different degenerative diseases. In short, Splenda and similar sweeteners are hurting the very people that the product is marketed toward: those that do not want to gain weight and those that cannot freely consume real sugar!
A lot of researchers are concerned about the chlorine in Splenda. Those that created Splenda have openly stated that there is chlorine in Splenda, which is not a big deal because chlorine is usually used in combination with other elements. Chlorine is not harmful to the body because it is usually absorbed and flushed away like everything else. The problem with Splenda is that those that are in the know have admitted that only about 15% of Splenda is actually absorbed by the body. What this means is that the creators of Splenda cannot actually tell us how much chlorine has been left in the body! The fact is, any element that is being left in the body in undetermined amounts can cause problems, and there is no doubt that the chlorine that you are taking in through Splenda is causing problems for your body.

Don’t Be Fooled by Sweetener Blends
Many artificial sweetener users are turning away from aspartame and sucralose or Splenda and are turning toward the sweetener blends that they are finding in products, assuming that these are somehow safer. These sweetener blends are simply mixtures of the harmful substances. The reason that these substances are often used together is that they can reproduce the real sugar taste better than they can alone.
When consumers ingest these sweetener blends they are not only getting the side effects of one sweeter, they are getting them from all of the sweeteners used. In addition, who knows what sort of toxins could be produced by the mixture of the products? It’s already been stated that you cannot excrete all of these sweeteners or the chemicals in them, imagine how many toxins you have floating around your body right now!

Is Anything Safe Anymore?
Sugar is still safe, and though it does tend to pack the calories into every sugary spoonful it can’t cause any more weight gain than is already being caused by the artificial sweeteners out there. The difference between sugar and the artificial products is that sugar satisfies the body, but the artificial sweeteners actually trick your body and make you hungrier, causing you to consume more calories than you would have otherwise. Seems like a vicious circle, doesn’t it? Be sure when you buy sugar not to buy the altered sugar products as these can be detrimental to your health.
The sweeteners that you probably just want to scratch off of your safe to use list are aspartame, acesulfame-K, neotame, sucralose, and alitame. Sucralose and Alitame both have FDA approval pending. A sweetener known as Cyclamate lost its FDA approval back in 1970, though it is currently up for approval again. There is and probably always will be more sweeteners in various stages of development as well as FDA approval.
In addition to sugar you can also safely consume saccharin and stevia. Saccharin is actually a complex sugar extract that comes from a plant that originated in China. The FDA has reported that neither saccharine or stevia has ever caused cancer! This is more like it!

Weight Gain and Ceasing the Use of Artificial Sweeteners
If you consume artificial sweeteners because you want to lose weight, you might want to know that researches cannot find any evidence that the sugar substitutes actually help consumer’s lose weight. These chemicals, in many circumstances, often stimulate the appetite so it could be working against you. Simply limit the amount of food that you are taking in and making better food choices will be a more straight forward way to lose weight and healthier, too!
When you stop using these sweeteners you will probably notice a huge change. Children are often the most noticeably different when artificial sweeteners are pulled from their diet. Many depressed and aggressive children become more balanced and enjoyable to be around. Many researchers also attribute many mental illnesses or behavioral problems to the over use of chemicals in our diets.
The way to identify what does and does not have Splenda or any other artificial sweeteners is to read labels. When you get in the habit of checking labels you can better your life and the lives of all of your family members. Even diabetics can find better ways to eat and drink rather than take in these harmful chemicals, it’s simply about making better food choices for everyone.
With more than 3,000 products on the market today with just Splenda in them, reading labels will really help you cease using these products. While we don’t know for sure what long term use of Splenda will mean, it’s better to quit while you’re ahead than wait and see based on initial research and the case histories associated with similar products.

http://www.splendainfo.com/dangers-side-effects-splenda-artificial-sweetener"

Saturday, June 20, 2009

New Report: Swine Flu Killing the Young & Healthy



INFLUENZA A (H1N1) - WORLDWIDE (70): RISK FACTORS
*************************************************
A ProMED-mail post

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


Date: Thu 18 Jun 2009
Source: Google news,The Canadian Press report [edited]



Risk factors for severe swine flu a wide umbrella under which many stand
----------------------------------------------------------------------
Whether speaking of a 58-year-old man or a 38-year-old woman, or a
little boy of 9, officials announcing swine flu deaths are almost
always quick to note "underlying health conditions" may have
contributed to the fatal outcome. Asthma, heart disease, diabetes,
maybe even obesity are among the conditions used to help explain why
swine flu infection is hospitalizing and killing younger people,
people who would be expected to make a full recovery from seasonal
flu.

It could create the impression that only the sickly are dying from
the new H1N1 flu virus -- a claim no one is making. To the contrary,
many, including the World Health Organization, say between one-third
and one-half of swine flu deaths have occurred in people who were
previously healthy. But how healthy is previously healthy? The answer
depends on who you ask.

Dr Anand Kumar is a critical care specialist who has been treating
swine flu cases in embattled intensive care units (ICU) in several
Winnipeg hospitals. He says a small portion of the ICU patients look
like flu's typical victims, people with health conditions know to be
badly exacerbated by a bout of influenza. But more are younger and --
until they got sick -- healthier than flu patients hospitals
typically see during a regular influenza season. "For the most part,
these young, relatively healthy people aren't marathon runners or
anything like that," he admits. "They're normal people.... If you
asked them 'Are you healthy?' they'd say 'Yeah, pretty healthy."'

Dr Michael Gardam, head of infectious disease prevention and control
for Ontario's public health agency, believes the constant refrain of
"underlying conditions" bespeaks a sort of wishful thinking, an
attempt to explain away the unusual age range of the people the new
virus is sending to hospital or to the morgue. "That's the story that
I think people haven't really registered," says Gardam. "We're
clinging to these 'Oh, they had underlying illness, therefore it's
OK."' "But ... I would argue that the 30-year-old with mild asthma --
how big of an underlying illness is that compared to again the
80-year-old person with bad lung disease from smoking, who's got
heart disease? That's the usual group that unfortunately gets really
sick with flu, not this healthy adult group." You'll find little
argument that this virus, at this time, is causing more severe
disease in people far younger than those normally hospitalized and
killed by flu or its complications in a typical flu season.

"This is not a disease of older adults. There's no question," says Dr
Allison McGeer, an influenza expert with Toronto's Mount Sinai
Hospital. "For people under 50, this is a significantly more severe
disease than seasonal flu. For people over 50, it's much better," she
notes. But are the people under 50 who are being badly hit by the
virus specimens of perfect health or are many of them already shaded
by the broad umbrella known as "pre-existing health conditions?" How
you view a condition like asthma -- seen in 41 per cent of the
hospitalized cases in New York City -- may influence how you answer
that question. "A lot of that is about labelling people," McGeer
admits. "Half of me doesn't want you to think you're diseased if you
have asthma, and the other half of me wants you to get your flu
vaccine because you're at increased risk." "How do you walk that
line?"

Year in and year out, public health authorities get plenty of
evidence many people who have some health issues plunk themselves
firmly on the "healthy" side of the divide. Scans of people with
asthma, diabetes and other conditions, and women who are pregnant
forego the flu shots public health officials urge them to get,
suggests Dr Scott Harper, an influenza expert with New York City's
Department of Health. New York City has had one of the biggest swine
flu outbreaks to date. As of Tuesday [16 Jun 2008], more than 700 New
Yorkers have been hospitalized with swine flu and 23 people in the
city have died from infections. With those kinds of numbers, one
might expect to see patterns emerge. But Harper says in fact the
department believes that many of the health conditions known for
years to increase the risk posed by flu are being seen in the people
suffering serious disease with swine flu. "The majority of deaths
that are being seen have well recognized underlying health risks," he
insists. "Those that don't may have and we just haven't seen them
yet. And then we may also find new risk factors, but they have not
yet been adequately described analytically to be able to say it's a
legitimate risk factor."

One such potential new risk factor is obesity. An early study from
the US Centers for Disease Control suggested it may be contributing
to poor outcomes in people who contract the new H1N1. The WHO is
concerned about that possibility. "Obesity is now a huge global
problem," says Dr Nikki Shindo, an expert with the WHO's global
influenza program. "And if obesity is a risk factor, then I would be
very much worried about some of the populations that are living with
obese conditions." Four of the people who died in New York City were
obese. Still, Harper says it's too soon to say whether that's a risk
factor in and of itself, or if some of the things that go
hand-in-hand with obesity -- like early heart disease, like diabetes
-- are the real risk factors. Teasing out that answer will be tough
but necessary, he says, noting that knowing who is truly at the most
risk from this virus will dictate who stands where in the queue for
swine flu vaccine once it becomes available and who should get
priority access to antiviral drugs.

[Byline: Helen Branswell]

--
Communicated by:
ProMED-mail Rapporteur Mary Marshall

[In the absence of clearly defined risk factors it remains reasonable
to assume that older people have some degree of protection due to
earlier exposure to an immunologically similar agent. In which case
it would be appropriate to give younger age groups priority for
vaccination with a swine-origin A (H1N1)-type vaccine when available,
and to continue vaccination of older age groups with seasonal
influenza vaccine if still available. - Mod.CP]

[The article above is a timely discussion on the issue of identifying
risk factors associated with more severe disease in this current wave
of influenza A (H1N1). One factor that should be highlighted when
discussing any comparisons with prior pandemic influenza patterns is
that it has been 41 years since the last influenza pandemic (the
"Hong Kong flu" in 1968), and much has changed in the interval since
the last pandemic in terms of basic health conditions. For example
there has been an observed pandemic of obesity, so that if obesity
has always been a risk factor for more severe disease with influenza
infection, the number of individuals at risk may have crossed a
threshold now allowing the "tip of the iceberg" to be large enough to
be seen. Another change has been an increase in morbidity and
mortality due to asthma in many countries. In the USA prevalence
rates of asthma have increased since 1978 (in table 7 of the American
Lung Association 2005 report on 'Trends in asthma morbidity and
mortality,' the reported asthma prevalence rates per 1000 population
in the 18-44 year old age group went from 29.0 in 1982 to 56.9 in
1996. For full report with all tables and analyses, see
).

For the reverse side, in studies addressing risk factors for
influenza among children, asthma has fairly consistently been
identified as a key risk factor for disease and co-morbidity among
hospitalized cases (see refs 1 and 2 below). Pregnancy has been
observed to be a risk factor of serious disease in many viral
infections, so it is not surprising that it is showing up as a risk
factor for serious disease in this present pandemic. Excess deaths
were observed among pregnant women in the 1918 pandemic and the 1957
pandemic (see refs 3 and 4.) Widelock, Csizmas, and Klein present an
analysis of the excess mortality among pregnant women in New York
during the 1957 pandemic period when compared with the same influenza
periods in 1958, 1959, and 1960.

This moderator has been leaning towards the question of "how healthy
are those who are reportedly healthy" or are there underlying
conditions that had not previously been identified in the reportedly
"otherwise healthy" individuals who have had severe disease
associated with influenza A (H1N1) infection? Having worked in major
inner city emergency rooms in a large urban center in the USA, it was
not uncommon for individuals to present with later stage severe
disease associated with chronic illnesses that had previously not
been identified, yet had most likely been present for a significant
amount of time prior to presentation to the health sector. Often it
was co-morbidity with an acute disease that precipitated presentation
to the emergency room where the "underlying disease" was then
identified.

As for the observation that there is more disease and more serious
disease attributable to influenza A (H1N1) infection among younger
age groups, the explanation for this observation may either reflect a
cross over immunity in older age groups from previously circulating
H1N1 influenza viruses, or it may reflect the bias that the initial
age group affected were younger ages, and these cohorts have greater
co-mingling to facilitate transmission among them, or most likely, a
combination of both. A study on serum cross reactive antibody
response to the novel influenza A (H1N1) virus after vaccination with
seasonal influenza vaccine revealed at baseline, cross-reactive
antibody was detected in 6-9 percent of those aged 18-64 years and in
33 percent of those aged greater than 60 years (see ref 5 below),
demonstrating that the younger age groups were more uniformly
susceptible to infection with influenza A (H1N1). Given this
observation it appears prudent to include younger age groups in
vaccination activities, but with only one third of older age groups
with cross reactive antibodies, they should also be included as
targeted for vaccination activities. Hence, a significant challenge
for vaccine production.

This is the 1st time that pandemic influenza activity has been
subjected to such intense scrutiny under a myriad of different
microscopes (both literally and figuratively) in a prospective manner
and the medical community is there validating and disproving many
previous "observations" and "theories." There is a lot to be learned,
and as each answer becomes available, new questions arise.

References
----------
1. Samransamruajkit R, Hiranrat T, Chieochansin T, Sritippayawan S,
Deerojanawong J, Prapphal N, Poovorawan Y: Prevalence, Clinical
Presentations and Complications among Hospitalized Children with
Influenza Pneumonia. Jpn J Infect Dis., 61(6): 446-9, 2008. Available
from
.
2. Gordon A, Ortega O, Kuan G, Reingold A, Saborio S, Balmaseda A,
Harris E: Prevalence and Seasonality of Influenza-like Illness in
Children, Nicaragua, 2005-2007. Emerg Infect Dis [serial on the
Internet]. 2009 Mar [date cited]. Available from
.
3. Widelock D, Csizmas L, Klein S: Influenza, Pregnancy, and Fetal
Outcome. Public Health Rep 1963; 78: 1-11 Available from
.
4. Gall SA: Influenza and current guidelines for its control. Infect
Dis Obstet Gynecol 2001; 9: 193-5. Available from
.
5. Serum Cross-Reactive Antibody Response to a Novel Influenza A
(H1N1) Virus After Vaccination with Seasonal Influenza Vaccine. MMWR
Morb Mortal Wkly Rep 2009 May 22; 58(19): 521-4. Available from
. - Mod.MPP]

[see also:
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Influenza A (H1N1) virus, swine, human - USA (02): (CA, TX) 20090424.1541
Influenza A (H1N1) virus, swine, human - USA: (CA) 20090422.1516
Influenza A (H1N1) virus, swine, human - Spain 20090220.0715
2008
----
Influenza A (H1N1) virus, swine, human - USA (TX) 20081125.3715
2007
----
Influenza A (H2N3) virus, swine - USA 20071219.4079
Influenza, swine, human - USA (IA): November 2006 20070108.0077]
...................................cp/mpp/mj/lm

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