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Thu., Aug 06 2009 3:44pm (EDT)
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CDC Finds Swine Flu Tests Often Wrong
By Associated Press
Updated: 4 hours ago
A rapid test to diagnose swine flu is often wrong… that’s according to Atlanta based Centers for Disease Control and Prevention. 

A CDC study finds that swine flue tests come up inaccurate half the time.
It’s the first government study of how well the rapid tests work. 

Scientists looked at the product from three companies and found at least half of the time they’re inaccurate. And that they’re better at diagnosing seasonal flu. 

In the event a test comes back negative… the CDC recommends doctors order a more precise lab test and in the meantime prescribe medicines like Tamiflu.
 




Legal immunity set for swine flu vaccine makers

http://news.yahoo.com/s/ap/20090718/ap_on_he_me/us_med_swine_flu

By MIKE STOBBE, AP Medical Writer Mike Stobbe, Ap Medical Writer 
Fri Jul 17, 8:15 pm ET

ATLANTA � The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.

The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.

___

AP Medical Writer Lauran Neergaard contributed to this report from Washington.
 



Swine Flu Vaccine Fast-Tracked to September?
www.webmd.com/cold-and-flu/news/20090717/swine-flu-vaccine-fast-trackPanel: Skip Most Safety, Efficacy Tests to Get Swine Flu Vaccine in September
By Daniel J. DeNoon
WebMD Health News
Reviewed by Brunilda Nazario, MD
July 17, 2009 -- Pandemic swine flu vaccine should be fast-tracked, with vaccinations starting in mid-September -- soon after schools open.

That recommendation came today in a unanimous vote by the National Biodefense Safety Board (NBSB), an influential board of outside advisors to Health and Human Services Secretary Kathleen Sebelius.

 
Getting swine flu vaccine by September means skipping all but the most preliminary clinical tests of vaccine safety and effectiveness. But it means getting some 60 million to 80 million doses nearly at the same time the CDC expects the next wave of the pandemic to hit the U.S.

"We cannot wait beyond mid-August [to make a decision] if vaccine is to be in supply by mid-September," the panel's pandemic influenza working group states in its recommendations. "A critical goal is to have some [standalone] novel H1N1 vaccine available by mid-September 2009, should it be needed."

Why rush through a swine flu vaccine? The first wave of the swine flu pandemic is only just starting to ebb in the U.S. But the virus spreads quickly among children -- and the nation's schools begin opening in late August. "A second wave is likely to occur, as soon as fall 2009," the recommendations state. "Best estimates suggest that infection rates will be two to three times higher than expected with seasonal influenza. The second wave could peak in October, but we must anticipate onset as early as September."

Initial doses likely will go to those most severely hit by the pandemic so far: infants, toddlers, school-age children, pregnant women, and adults with risk factors for severe flu disease. Next week, the CDC's vaccine advisory board will recommend a priority list for exactly who will first get the vaccine. The NBSB recommendation puts into words a fear that government officials have so far expressed only privately. "Having vaccine only after the peak [of the pandemic] may be worse than having no vaccine at all: It incurs all of the risk and cost with no potential benefit," the recommendation reads.

The National Biodefense Science Board advises Sebelius on emergency preparedness for biological threats. Whether to act on the NBSB's decision is up to her -- and, ultimately, to President Barack Obama.

Why deploy a vaccine that hasn't completed safety and efficacy testing? Because we already have a lot of experience with similar vaccines, concluded the NBSB flu vaccine working group, led by University of Utah flu expert Andrew Pavia, MD.

Pandemic swine flu is a type A, H1N1 flu virus. For decades, a type A H1N1 vaccine has been part of the regular seasonal flu vaccine, and the new vaccine is made exactly the same way.

Fast-tracking the vaccine will mean guessing at the best dose, but that's an educated guess based on the well-established dosage for the seasonal H1N1 vaccine.

A more critical guess is whether people will be protected against the new flu bug with only one shot of vaccine. The NBSB working group suggests that previous exposure to H1N1 virus and H1N1 vaccine will prime virtually the entire population so that only one dose is needed -- even though the seasonal vaccine does not protect against pandemic swine flu.

Fast-tracking the vaccine would also mean deciding who's first in line. Robin Robinson, PhD, director of BARDA, the Health and Human Services agency responsible for the logistics of emergency medical supplies, says 60-80 million doses could be available in mid-September -- if vaccine makers start packaging their products in mid-August. Similar quantities would follow in each subsequent month until demand was met.

Voting members of the NBSB include experts from universities, the pharmaceutical industry, and medical groups. NBSB chairwoman Patricia Quinlisk, MD, MPH -- who was absent from today's telephone-based meeting -- is director of the Iowa health department. Non-voting members of the NBSB include representatives of the White House, the Health and Human Services Department, national security agencies, the FDA, and NASA.

  Novel Influenza A H1N1 (Swine Flu) Updates & Alerts

Consistent with national influenza surveillance programs, the Oklahoma State Department of Health will discontinue reporting individual case numbers of novel H1N1 influenza by county effective August 1, 2009.

(I wonder why? This and reports of swine flu being diagnosed over the phone leads me to believe this pandemic is made up.)

 As the new influenza virus has spread more broadly, the case numbers no longer reflect the true burden of disease and states are transitioning their surveillance efforts in preparation for the upcoming regular influenza season. Future surveillance information will provide more “snapshot” data on whether flu activity is increasing or decreasing, locations where more flu is being identified, and any indicators that the severity of illness is changing.

The Oklahoma State Department of Health (OSDH) and public health officials nationwide are tracking and investigating human cases of a new strain of influenza virus that originated in swine, but is now being spread person-to-person. Cases of this new H1N1 flu in Oklahomans can be determined by testing at the OSDH Public Health Laboratory. All positive test results are reported by county of residence with full case investigations limited to persons with more severe illness requiring hospitalization, pregnant women, or persons associated with facilities of special interest. These may include nursing homes, daycares, or healthcare facilities. Persons suspected or confirmed to have H1N1 influenza are advised not to go to work, school, or other public places until at least 24 hours after symptoms have resolved.

The purpose of the OSDH “swine flu” website is to report the number of laboratory-confirmed cases of the new strain of H1N1 flu in Oklahoma, provide fact sheets and other informational materials about the disease, and offer easy access to other links and resource documents of interest to specific audiences including healthcare professionals; faculty and staff at schools, colleges & universities; childcare workers; business leaders; and travelers.

Number of Reported Novel Influenza A H1N1 (Swine Influenza) Cases by County, Oklahoma* 
(as of July 29, 2009, 2:00 P.M. CST)