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"States scrape up bird flu drug funds" USA Today

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    Posted: August 09 2006 at 3:47pm

States scrape up bird flu drug funds

Posted 8/8/2006 11:01 PM ET

By Julie Schmit, USA TODAY
Some states are scrambling to find money to pay for anti-flu drugs, so orders from states may fall short of the federal government's goal of stockpiling enough to treat 25% of the population in a flu pandemic.

States had to indicate by last week how many anti-virals they intended to buy and stockpile through a federal contract that makes the drugs available to states at a discount. States must confirm those numbers by Dec. 29 to be sure to get a federal subsidy covering 25% of their cost.

North Carolina asked the federal government to reserve its full allotment of 884,000 anti-virals. However, in a July 31 letter to federal officials, the state said it was "impossible to make an accurate estimate at this time," about what it would buy, given the "uncertainty regarding the availability of state funding" and whether other entities in the state could help pay.

At least 43 states have told the federal government they intend to purchase their full allotments or have asked for them to be reserved. Others have also warned that funding is uncertain.

Colorado, Montana, Connecticut, Nebraska and North Dakota have said they are unlikely to buy full allotments. Colorado officials fear the drugs may not work very well if a bird flu pandemic eventually hits. Other states say buying the drugs is not the best use of limited public health and pandemic resources.

Arizona and Oklahoma have reserved their full allotments and are seeking partners, such as local health districts and tribal governments, to share the cost. They'd get "a lot more bang for the buck," buying at the federal price than on the open market, says Arizona state epidemiologist David Engelthaler. If Arizona bought its full amount, the $8 million tab would gut its ability to prepare hospitals for a pandemic, he says.

The federal government plans to buy 44 million anti-viral courses for the states this fiscal year (which ends Sept. 30) and next, enough to cover 17% of the population. It wants states to buy 31 million more courses, to reach 25%. A course treats one person.

The plan has critics, including health advocacy organization Trust for America's Health. It warned earlier this year that cash-strapped states may not follow through on full anti-viral purchases. "Where you live should not dictate the level of protection," says spokeswoman Kim Elliott. The federal government should pay the full freight, TFAH says.

Under the federal contract for state purchases, one course of Tamiflu costs $19 and one of Relenza costs $22, about one-third to one-fifth the Internet retail price. States pay 75%; the federal government pays 25%. If states buy all 31 million treatments, their cost will be roughly $465 million.

States can order the drugs at the discounted price until mid-2008. After Dec. 29, the federal government may reallocate unused subsidy money to other states that want to buy more than their allotted amounts, says William Raub, a senior official at the Department of Health and Human Services.

Bird flu has killed 135 people in nine countries in Asia, the Middle East and the Republic of Djibouti in Africa since 2003. The virus has not shown it can spread easily among humans, but there's fear that if it starts to, it could spark a pandemic, because humans have no immunity to the virus and there are no proven vaccines.

Anti-virals Tamiflu and Relenza cut the severity of regular flu and may improve survival for bird flu victims, the World Health Organization says.

For now, North Dakota has told the federal government it intends to buy 44,000 of the 66,000 courses allotted to it. But it may not buy any through the federal program, says Tim Wiedrich, the state's chief of emergency preparedness.

Emergency use only

HHS says the drugs must be used only for a pandemic. They have a five-year shelf life. States may have to throw out what they buy if there is no pandemic. North Dakota wants the freedom to use some to treat regular flu before they expire. It's exploring whether it can get a bulk discount on its own. HHS says letting states use pandemic supplies for regular flu would take future sales away from Roche and GlaxoSmithKline, which sold the drugs at a discount for pandemic use only. "Their annual market could disappear," Raub says.

Federal stockpiles may be kept beyond the drugs' five-year shelf life if testing by the Food and Drug Administration or Department of Defense shows they are effective longer, Raub says. As of now, state stockpiles are not eligible for shelf-life extension, he says.

The Aug. 1 deadline for states to inform HHS of their intentions will help drugmakers plan production. Roche makes Tamiflu, the No. 1 anti-viral, and GlaxoSmithKline makes Relenza. Tamiflu is expected to fill the bulk of the stockpiles.

Roche says it's filling orders on a first-come, first-served basis, except for those from countries where there have been bird flu outbreaks.

Roche will fill federal and state stockpiles concurrently, says spokesman Terry Hurley. It also has enough capacity to deliver all 81 million stockpile courses in 2007, he says. That won't happen, though, if state and federal orders aren't placed in time.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 09 2006 at 6:27pm

Tamiflu, Relenza, Relenza, Tamiflu ....

It's strange that federal, state and local professional emergency managers can't get beyond the magic bullet that will save the day.

These antivirals may reduce the initial symptoms of an infected person if it is taken in the correct dosage for the correct length of time.

The virus mutation that does go H2H may not be effected by these antivirals. May as well take M&Ms.

Stocks of food, water, and lots of MASH units would be real pandemic preparation.

81 million courses of Schlamafu. Feh!

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 10 2006 at 5:21am
This is a 4 page article from Medical Economics re
 Avian Flu ; is your practice ready ?
 Determine who's first in line for vaccines.
page 3
 Educate Patients . page 2
 Plan to refocus your practce when a pandemic strikes.
 Click your curser over power points to view .
 No 5 on second power point
 Don't prescribe antiviral medicines so patients can stockpile them .
 Thought it was best to post this here after reading the above . Hmm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 11 2006 at 2:03am
 page 3 of the link  advice for Doctors in private practice includes list they determined of who will be vaccinated first.
Jul 21, 2006
By: Robert Lowes
Medical Economics
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Pages | 1 | 2 | 3 | 4

Stock up on supplies. To cope with a surge of influenza patients, you'll need extra hand-hygiene supplies such as alcohol-based handrubs, tissues, gloves and gowns as well as masks for both clinicians and patients. Surgical masks for patients cost as little as seven cents a piece. Disposable N95 respirator masks, which offer more protection, are pricier at $1 each, but won't bankrupt you. Although it's not recommended, if you reuse your own N95 mask in a pinch, wash your hands before you put it on and after you take it off. Also, keep the N95 mask covered, perhaps with a cheap surgical mask, to prevent contamination.

Determine who's first in line for vaccines. By all accounts, vaccine supplies will be scarce at the start of a pandemic, so they'll be doled out judiciously. Two HHS advisory committees have recommended a priority list (at that will help you determine how much vaccine you'll need to order.

Aside from people who make vaccines and antiviral drugs, healthcare workers who deal directly with patients have the highest priority for vaccinations. The second group includes patients 65 years and older with at least one high-risk condition for influenza such as diabetes or emphysema, anyone from 6 months to 64 years with at least two high-risk conditions, and anyone over 6 months who's been hospitalized for pneumonia, influenza, or a high-risk condition. Individuals in this second group account for roughly 18 percent of patients in a typical primary care practice, according to Jonathan Temte.

Following this group are other tiers of patients, such as pregnant women and patients 65 and older with no high-risk conditions. There's a somewhat different ranking for antiviral drugs. Moreover, priority lists could change depending on which individuals wind up to be the most susceptible to an actual pandemic virus.

Plan to refocus your practice when a pandemic strikes. Be prepared to notify high-risk patients that they need to be vaccinated, assuming vaccines are available. To minimize the spread of a virus, postpone nonessential office visits like physicals and well-baby visits, and triage incoming phone calls and electronic messages to determine who really needs to be seen in person. Consider making house calls to infected patients to avoid bringing them into the office. If possible, don't admit patients to the hospital, where they're more likely to catch the pandemic virus, says internist John Mitas.

By taking these steps, you'll also organize yourself for other threats, notes retired Army Col. Jeffrey Elting, medical director for bioterrorism response coordination for the Washington, DC, hospital association.

"We've experienced monkeypox and SARS," says Elting, an FP. "We have Hantavirus outbreaks from time to time. You also have to consider terrorists who may resort to smallpox or some other agent.

"Preparing for an influenza pandemic blends together with other infectious-disease efforts."

Besides, thinking ahead is never a waste of time.

"Federalizing" vaccines—will it save more lives?

Physicians' ability to combat an influenza pandemic will hinge on how quickly they get their hands on vaccines and antiviral medications.

To speed things up, the Bush administration has set out to expand the nation's capacity to produce influenza vaccine so that within six months of an outbreak, there'd be enough for the entire population. One way is to create vaccines through cell cultures as opposed to the slower, more cumbersome method of growing them in chicken eggs. HHS has awarded $1 billion in contracts to drugmakers to put this technology into high gear.

Pages | 1 | 2 | 3 | 4

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Post Options Post Options   Thanks (0) Thanks(0)   Quote jknoel Quote  Post ReplyReply Direct Link To This Post Posted: August 11 2006 at 8:50am

In my opinion, the HHS recommendations for vaccine and anti-viral distribution aren't worth looking at.  For the most part, they are missing the big picture on what categories spread flu around the most and how to stop its transmission.  And they are pushing anti-virals for 2 reasons: 1) it really is the only medical intervention you can give if there are no vaccines and 2) it's an election year.

And read this abstract of an article I found on PubMed for a project i am doing:

Both influenza A virus surface glycoproteins, the haemagglutinin (HA) and neuraminidase (NA), interact with neuraminic acid-containing receptors. The influenza virus A/Charlottesville/31/95 (H1N1) has shown a substantially reduced sensitivity to NA inhibitor compared with the A/WSN/33(H1N1) isolate by plaque-reduction assays in Madin–Darby canine kidney (MDCK) cells. However, there was no difference in drug sensitivity in an NA inhibition assay. The replacement of the HA gene of A/WSN/33 with the HA gene of A/Charlottesville/31/95 led to a drastic reduction in sensitivity of A/WSN/33 to NA inhibitor in MDCK cells. Passage of A/Charlottesville/31/95 in cell culture in the presence of an NA inhibitor resulted in the emergence of mutant viruses (delNA)whose genomes lacked the coding capacity for the NA active site. The delNA mutants were plaque-to-plaque purified and further characterized. The delNA-31 mutant produced appreciable yields (C106 p.f.u./ml) in MDCK cell culture supernatants in the absence of viral or bacterial NA activity. Sequence analysis of the delNA mutant genome revealed no compensatory substitutions in the HA or other genes compared with the wild-type. Our data indicate that sialylation of the oligosaccharide chains in the vicinity of the HA receptor-binding site of A/Charlottesville/31/95 virus reduces the HA binding efficiency and thus serves as a compensatory mechanism for the loss of NA activity. Hyperglycosylation of HA is common in influenza A viruses circulating in humans and has the potential to reduce virus sensitivity to NA inhibitors.

Basically, it says that in a lab, they got a flu virus to mutate so that it doesn't need its neuraminidase to release from a cell.  Granted it may be a long shot, but these same mutations could in theory happen in a clinical setting with the wide use of Tamiflu and Relenza making them completely ineffective.
The only way to grow is to take a chance.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 12 2006 at 10:21pm

Flu vaccine problems possible this fall

Jul 10th - 6:20am
The FDA would not identify the contaminant but agreed with Sanofi that the problem appeared unlikely to prevent Sanofi Pasteur from making its 50 million doses. That amount is about 40 percent of the 120 million total flu shots expected for the United States this year.

"With regard to the upcoming influenza season, we are confident that we will meet our manufacturing goal of approximately 50 million doses of influenza vaccine for the U.S. market," said Sanofi spokesman Len Lavenda. "... The amount of material impacted is minimal relative to our overall manufacturing capacity, and none of this material has been or will be used in the manufacture of this year's vaccine."
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 13 2006 at 10:14am
The yearly flu and a mutated H5N1 that has gone H2H2H is like apples and oranges.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 13 2006 at 2:00pm

"The yearly flu and a mutated H5N1 that has gone H2H2H is like apples and oranges."

Do you mean to compare a yearly Low Path AI?  with a mutated High Path AI?

" apples and oranges."

I don't agree.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Guests Quote  Post ReplyReply Direct Link To This Post Posted: August 13 2006 at 6:32pm
Apples and oranges - their not the same. The yearly flu is an ongoing mutation of the 68 virus. An Avain Infuenza virus that mutates into H2H is different. After the H2H pandemic passes, the yearly flu will be an ongoing mutation of the Avian virus.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote rickstooker Quote  Post ReplyReply Direct Link To This Post Posted: August 13 2006 at 8:19pm
I agree that this emphasis on Tamiflu and Relenza is pathetic.

It represents a true CYA mentality -- because they have no other "aproved" treatment
for avian influenza.

Yet they don't know how much Tamiflu is enough to effectively stop H5N1,
since it's much stronger than seasonal flu.

It must be started within two days of the onset of symptoms, but
that's a problem in Asia and African countries where bird flu is
infecting people now.

During a pandemic, everybody with the sniffles will want it immediately,
but it either won't be available, or managing the administration of
tablets every 12 hours for 5 days will be a nightmare.

Yet there are alternative treatments that could well fight the virus
better than H5N1 -- though with no guarantees.

Nobody in mainstream medicine or government dares to go out on a limb
to recommend stockpiles of Vitamn C, zinc and selenium.

If your mother takes government stockpiled Tamiflu and still dies, you
can't sue because the doctor did what the establishment agrees is the
best current medical treatment.

If a doctor injects your mother with Vitamin C and she still dies, somebody
will sue and win.

CYA -- the lawyers win no matter what.
Richard Stooker

How to Protect Yourself and Your Family From Bird Flu
avian flu protection
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