PandemicPrep.Org

By Maggie Fox, Health and Science Editor Maggie Fox, Health And Science Editor

Nov. 12, 2009

WASHINGTON (Reuters) – H1N1 swine flu killed an estimated 3,900 Americans from April to October, including more than 500 children, U.S. health officials said on Thursday.

Better data than was previously available shows the flu pandemic has infected an estimated 22 million Americans and put 98,000 in the hospital, the U.S. Centers for Disease Control and Prevention said.

Children account for 8 million of the infected, 36,000 of those hospitalized and 540 deaths.

“We think the 540 number is a better estimate for the big picture that we are getting out there,” the CDC’s Dr. Anne Schuchat told reporters.

About 82 U.S. children die in an average flu season. The CDC said H1N1 has produced the worst flu season in the United States since 1997, when current measurements started.

“What we are seeing in 2009 is unprecedented,” Schuchat said,” Schuchat said.

The CDC said doctors need to treat severe cases quickly with antiviral drugs such as Tamiflu, made by Roche AG, Relenza, made by GlaxoSmithKline or for especially grave hospitalized cases, peramivir, made by BioCryst.

Schuchat stressed the pandemic was not worsening but noted that it takes time to gather data on flu cases and deaths. The count released on Thursday is not an actual reckoning of deaths but an extrapolation based on detailed data from 10 states.

CDC’s previous estimate of U.S. flu deaths was 1,200.

In an average flu season, about 36,000 Americans die and 200,000 are hospitalized with 90 percent of deaths and hospitalizations among people over 65.

With H1N1, 90 percent of those infected and seriously ill are younger adults and children.

Schuchat said the pandemic would likely continue through the winter and early spring. “We have a long flu season ahead of us,” she said.

Most confirmed flu cases are H1N1 and about 30 percent of people who show up at the doctor’s office and are actually tested for influenza turn out to have flu, as opposed to some other infection.

I want to apologize to our loyal readers for no newsletter over the past few weeks. So let’s review what has been happening and make sure you are up to date. 

 Current Situation:

• Outbreaks on college and university campuses across the country have surged again after declining. Most cases continue to be mild, according to the American College Health Association. The number of school closings across the country continues to rise, as reported by the US Department of Education.
  

• The CDC reports that 48 states now report widespread flu activity. Although we haven’t reached the peak yet, flu activity has already exceeded what we have seen in some of the worst flu seasons. Pneumonia and influenza rates continue to rise.
  
• The WHO reports that there is widespread disease across the northern hemisphere. Mexico is seeing more flu cases now than they saw in the initial outbreak in April/May. Europe is experiencing an unusually early flu season with wide spread cases. A huge outbreak in the Ukraine is causing a big problem for that country. They are estimating that there have been 500,000 cases since mid-October with 24,000 people hospitalized (the country only has 48 million people).
  
• Vaccine Update:
  
  • Supply of H1N1 vaccine continue to be a problem in the US. As we wrote about earlier, there are significant delays in shipment of vaccine from manufacturers. This is due to the difficulties in growing the virus in eggs, which is part of the manufacturing process.
    
  • Although the US Government had originally predicted that we would have 60-80 million doses by this point, only 38 million have been shipped.
    
  • Vaccine delay has impacted vaccination programs in states across the US and has eroded the confidence in public health initiatives, according to several state health representatives. The Alabama Health Department testified to congress that they don’t expect to receive adequate vaccine to immunize their high priority groups until the end of December or January.
    
  • Around the world, millions of people have received the vaccine and it is proving to be a very safe vaccine.
    
  • Since vaccine campaigns started in October, only 1/3 of parents who tried to get their children vaccinated have been successful.
    

         Disease Update:

o    99 % of the subtyped flu that is tested is the new novel H1N1. Those areas that had seen some early seasonal flu strains circulating, have seen that drop off significantly.

         More Mask controversy

o    In the continuing discussion of masks, the original study done in China and reported here last month showing that N-95 masks were much more protective than surgical masks has been “re-analyzed” and now is much less conclusive. Due to some changes in the statistical analysis done, N-95’s still show some benefit but the study numbers make the difference not statistically significant.

         President Obama declares a National Emergency (on October 26th)

o    This was not unexpected and it allows HHS Secretary Sebelius to waive or modify certain provisions in Medicare, Medicaid, Child Health Insurance Program (CHIP), EMTALA and HIPAA programs. It also allows hospitals to respond to this crisis easier. 

         Medications

o    There has been a shortage of liquid Tamiflu and the government has released about 300,000 bottles of liquid Tamiflu from the National Strategic Stockpile. There are also directions for compounding liquid Tamiflu on the CDC website that pharmacists can use.

o    The government issues emergency use authorization for IV Perimivir and Zanamivir for critically ill patients that don’t respond to Tamiflu. A few cases were recently presented on a conference call and they had good results.

         First cat to catch H1N1

o    Iowa has reported that a house cat has been documented with the novel H1N1 infection after two of its three owners were sick with flu. This is the first time a cat has been documented to have the disease. Prior to this, infections were only documented in humans, pigs, birds and ferrets.

         No more kissing in Turkey

o    Last week, the health minister in Turkey advised all Turks to avoid kissing anyone for the next 5 months.

by The Associated Press

CHICAGO October 28,

The number of students staying home sick with the flu is multiplying nationwide and normally quiet school nurses’ offices suddenly look like big city emergency rooms, packed with students too ill to finish the day.

The federal government has urged schools to close because of the swine flu only as a last resort. But schools are closing by the dozens as officials say they are being hit so hard and so fast by the H1N1 virus that they feel shutting down for a few days is the only feasible option.

“There was nothing else we could do,” said Michael Frechette, the superintendent of Connecticut’s Middletown Public Schools where a middle school closed for the rest of the week after 120 students stayed home sick Monday and another 25 were sent home by noon. “The only way to stop that transmittal was to keep the kids home for the rest of the week.”

At least 351 schools were closed last week alone — affecting 126,000 students in 19 states, according to the U.S. Education Department. So far this school year, about 600 schools have temporarily shut their doors.

The number of closures this year appears on target to surpass the roughly 700 schools closed last spring when the swine flu outbreak first hit.

“This is scary,” said Kathryn Marchuk, a nurse whose son attends St. Charles East High School outside Chicago, which closed for three days last week after about 800 of its 2,200 students called in absent. “So many people are sick. It’s just everywhere.”

Many school officials said they were afraid the virus would spread faster if they stayed open.

“Students are in such close proximity (to each other) and they’re in two or three classrooms a day at two or three different desks,” said Donna Lovell, director of pupil personnel for Berea Community Schools in Kentucky, which closed for four days last week after 20 percent of its students called in sick. “It’s an incubator situation.”

Whether it is all effective is debatable, with some experts saying that closing schools merely spreads the number of cases over a longer time.

But school officials like Frechette disagree, saying students who get sick this week while they’re at home cannot infect nearly as many people as they were if they were walking the hallways of schools.

“Nobody’s at school so they’re not infecting each other,” he said. Besides, he said, “kids are dying (and) it’s just four days.”

With such a surge of sick students, many schools are also scrambling to come up with ways to keep kids on top of their studies.

The U.S. Education Department recommended districts and schools provide ill students with remote learning opportunities such take-home assignments or posting homework and class lessons on the Internet.

Though some schools are doing that — including Keigwin Middle School in Middletown, Conn., where assignments are posted on its Web site and students are asked to read 20 minutes a day — others say assigning sick students homework is a wasted effort.

“If you want to make a kid really hate school … the most effective thing you could do is to make them do their homework and school work when they have a fever and are not feeling well,” said Nancy Kalish, an education writer who co-authored a book, “The Case Against Homework.”

Jim Blaney, a spokesman for the district that includes St. Charles East High, said that although parents or healthy students could come to the school to pick up books, the days the school was closed were not the time to push ahead with lesson plans.

“We wanted the kids to get healthy, stay home, rest,” he said.

Though there is no way to know how many children actually had swine flu, the deaths so far of roughly 1,000 people in the U.S. — some of them children, including a 14-year-old in Ohio and another in Illinois this month — have cast a shadow on school districts.

“We’re a small community where everybody pretty much knows everybody,” said Jon Hussman, a principal in Culdesac, Idaho, a town of fewer than 500 residents. “(And) when you have the possibility of death in that community, that’s something you want to avoid.”

The way Steve Bianchetta sees it, there is no incubator like a high school, a view that helps explain why the central Illinois superintendent closed Watseka High School for two days last week after a third of the school’s 330 students were absent.

“They’re not as hygienic as the younger kids,” he said. “They hold hands, they drink out of each other’s sodas.”

Some officials say another reason for shutting down was that sick kids were still showing up.

Closing school “took the pressure off,” said Katy DeSalvo, whose daughter, Amy, a 17-year-old senior at St. Charles East had been home sick and worried that missing school would hurt her grades. “She wants to go to Duke (and) all the kids, particularly the higher-achieving kids, want to go back. And they’d infect everybody.”

Some districts closed even for small numbers of sick students. In Traverse City, Mich., the school district closed every one of the 18 schools even though the number of absentees at some was not close to 20 percent.

“It was in the best interest to do so,” said Jayne Mohr, the associate superintendent for the 10,000-student district. “You could see it spreading, making its way across the 300-square mile district.”

Not everyone believes shutting down is the best option.

Some children, especially in low-income districts, depend on schools for free lunch and parents can’t always take off work to stay at home. Plus, shutting school doesn’t always keep kids from spreading the virus.

“If kids were isolated in their homes it may help,” said Julie Pryde, administrator in Illinois’ Champaign-Urbana Public Health District. But “kids congregate at malls, at each other’s homes, they go to movies — and that is not helpful.”

Flu.Gov Oct. 24, 2009

On October 24, 2009, President Obama signed a proclamation declaring the 2009 H1N1 influenza pandemic a National Emergency to facilitate our ability to respond to the pandemic by enabling – if warranted – the waiver of certain statutory Federal requirements for medical treatment facilities. In particular, this proclamation is aimed at providing HHS the ability to waive legal requirements that could otherwise limit the ability of our nation’s health care system to respond to the surge of patients with the 2009 H1N1 influenza virus.

Authority

Section 1135 of the Social Security Act [42 USC §1320b–5] permits the Secretary of Health and Human Services to waive certain requirements for healthcare facilities in response to emergencies.  Two conditions must be met for the Secretary to be able to issue such “1135 waivers”:  first, the Secretary must have declared a Public Health Emergency; second, the President must have declared an emergency or major disaster either through a Stafford Act Declaration or National Emergencies Act Declaration.  If these conditions are met, then the Secretary may waive or modify Federal requirements as listed in section 1135.  After the Secretary invokes section 1135, healthcare facilities may petition for 1135 waivers in response to particular needs, and only within the geographic and temporal limits of the emergency declarations.

Under Section 1135:

The Secretary will issue waivers or modifications under section 1135 for specific requirements to match the specific situational needs. The requirements that may be waived include certain requirements related to Medicare, Medicaid or the Children’s Health Insurance Program (CHIP), the Emergency Medical Treatment and Labor Act (EMTALA), and the Health Insurance Portability and Accountability Act (HIPAA).  These requirements provide important protections for patients during normal day-to-day operations, but they may impede the ability of healthcare facilities to fully implement disaster operations plans that enable appropriate care during emergencies.  For example, requirements under the Emergency Medical Treatment and Labor Act (EMTALA) prohibit hospitals from sending an individual to an off-campus location for an appropriate screening.

• Waivers are permitted only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period.  The “emergency area” and the “emergency period” are the geographic area, in which, and the time period, during which, the dual declarations exist.  For this event, the emergency area is nationwide and the emergency period begins on October 23, 2009, and will last through duration of the declared Public Health Emergency for 2009 H1N1 influenza.  HIPAA waivers are subject to special time limits as discussed below.   
  
• Permitted actions include the waiver or modification of conditions of participation, other certification requirements, and program participation requirements for health care providers, pre-approval requirements; waiver of sanctions for certain directions or relocations and transfers that otherwise would violate EMTALA; waiver of sanctions related to Stark self-referral prohibitions; modifications to deadlines and timetables for the performance of required activities; and waiver of sanctions and penalties arising from noncompliance with certain HIPAA privacy regulations.
  

Examples of waiver requests:

• Hospitals request to set up an alternative screening location for patients away from the hospital’s main campus (requiring waiver of sanctions for certain directions, relocations or transfers under EMTALA).
  
• Hospitals request to facilitate transfer of patients from ERs and inpatient wards between hospitals (requiring waiver of sanctions under EMTALA regulations).
  
• Critical Access Hospitals requesting waiver of 42 CFR 485.620, which requires a 25-bed limit and average patient stays less than 96 hours.
  
• Skilled Nursing Facilities requesting a waiver of 42 CFR 483.5, which requires CMS approval prior to increasing the number of the facility’s certified beds.
  

Past instances where the Secretary invoked the Section 1135 waiver authority for recent disaster events include:

• Hurricane Katrina (2005)
  
• Hurricanes Ike and Gustav (2008)
  
• North Dakota flooding (2009)
  

Q:  Why declare a National Emergency for the 2009 H1N1 pandemic now; why can’t we wait until a hospital or region needs these 1135 Waivers?

A:  The H1N1 epidemic is moving rapidly.  By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly.  When the Secretary of HHS invokes section 1135, HHS has in past practice accepted requests from affected healthcare facilities, providers, and/or States for specific waivers or modifications.  HHS will be requiring such requests in connection with this emergency and will need to process such requests quickly.  Adding a potential delay by requiring HHS to  wait for a National Emergency Declaration before it could issue necessary 1135 waivers is not in the best interest of the public, particularly if this step can be done proactively as the President has done.  

Q:  Do 1135 waivers affect State laws or regulations?

A:  Under section 1135, only certain Federal requirements relating to Medicare, Medicaid, CHIP, and HIPAA may be waived or modified as listed in section 1135.   An 1135 waiver does not affect State laws or regulations. 

Q:  Has the authority to grant 1135 waivers been granted before?

A:  Yes, there are several instances where 1135 Waiver authority has been granted under the Stafford Disaster Relief and Emergency Assistance Act (as opposed to the National Emergencies Act) to help healthcare facilities cope with large patient burdens.  Recent examples include Hurricane Katrina (2005), Hurricanes Ike and Gustav (2008), and the North Dakota flooding (2009).  The Secretary was also prepared and able to invoke the 1135 waiver authority in connection with the 56th Presidential Inauguration (2009) in the event that 1135 waivers became necessary.

Q:  Specifically, what will this National Emergency Act (NEA) Declaration enable?  What will 1135 waivers allow hospitals to do if a waiver is requested and granted?

A:  An NEA Declaration fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers.  Healthcare facilities that receive specific waivers or modifications under section 1135 will be able to continue to provide care even if they are out of compliance with certain Medicare, Medicaid and CHIP requirements. 

Q:  How does the President’s National Emergency declaration under the National Emergencies Act differ from a Stafford Act declaration?  How does the request process for assistance under the Stafford Act differ from the request process for 1135 waivers?

A:  Presidential proclamation of a national emergency under the National Emergencies Act and a Presidential declaration of an emergency or major disaster under the Stafford Act are distinct and separate declarations.

The National Emergencies Act allows the President to issue a proclamation to invoke particular emergency authorities as needed. The President’s proclamation that the 2009 H1N1 influenza pandemic constitutes a national emergency fulfills the second of the two conditions required for the Secretary of HHS to be able to grant 1135 waivers.  The President’s proclamation coupled to the HHS Secretary’s prior public health emergency declaration for 2009 H1N1 influenza enables the HHS Secretary to issue waivers or modifications under section 1135 of the Social Security Act for certain Medicare, Medicaid, CHIP, and HIPAA requirements as discussed above.  The President’s proclamation does not trigger a Stafford Act declaration or provide financial or other resources.

In general, when an incident overwhelms or is anticipated to overwhelm State resources, the Governor may request Federal assistance, including assistance under the Stafford Act.  The Stafford Act authorizes the President to provide financial and other assistance to State and local governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts following Presidential emergency or major disaster declarations under the Stafford Act.  The Stafford Act is triggered by a Presidential declaration of a major disaster or emergency under that Act, when an event causes damages of sufficient severity and magnitude to warrant Federal disaster assistance to supplement the efforts and available resources of States, local governments, and the disaster relief organizations in alleviating the damage, loss, hardship, or suffering. 

Most incidents are not of sufficient magnitude to warrant a Presidential declaration.  However, if State and local resources are insufficient, a Governor may ask the President to make such a declaration.  Ordinarily only a Governor can initiate a request for a Presidential emergency or major disaster declaration.  In extraordinary circumstances, the President may unilaterally declare a major disaster or emergency.  In order to assist States in assessing impacts and evaluating the need for Federal assistance in a pandemic influenza, FEMA has developed a fact sheet for requesting Stafford Act assistance from the Federal government: http://www.fema.gov/pdf/emergency/pandemic_influenza_fact_sheet.pdf. 

As noted above, the H1N1 epidemic is moving rapidly.  By the time regions or healthcare systems recognize they are becoming overburdened, they need to implement disaster plans quickly.  The President’s proclamation of a national emergency under the National Emergencies Act, coupled to the HHS Secretary’s prior public health emergency declaration for 2009 H1N1 influenza will allow the Secretary of HHS maximum flexibility to issue waivers or modifications under section 1135 of the Social Security Act nationwide as needed.  The process for requesting specific waivers or modifications under section 1135 is discussed below.  As the 2009 H1N1 pandemic evolves, if State and local resources become insufficient, then states may request assistance under the Stafford Act through the usual Stafford Act process.

Q:  Is the HIPAA Privacy Rule suspended during a national or public health emergency?

A:  No.  The HIPAA Privacy Rule is not suspended during a national or public health emergency. However, the Secretary of HHS may waive sanctions and penalties against a covered hospital that does not comply with certain provisions of the HIPAA Privacy Rule under the Project Bioshield Act of 2004 (PL 108-276) and section 1135(b)(7) of the Social Security Act. 

Specifically, the Secretary of HHS may waive sanctions and penalties against a covered hospital that does not comply with the following provisions of the HIPAA Privacy Rule: (1) the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care (45 CFR 164.510(b)); (2) the requirement to honor a request to opt out of the facility directory (45 CFR 164.510(a)); (3) the requirement to distribute a notice of privacy practices (45 CFR 164.520); (4) the patient’s right to request privacy restrictions (45 CFR 164.522(a)); and (5) the patient’s right to request confidential communications (45 CFR 164.522(b)).

Q:  When and to what entities does the HIPAA 1135 waiver granted in response to the 2009 H1N1 influenza pandemic apply?

A:  The HIPAA waiver only applies to hospitals nationwide that have instituted a disaster response plan and for up to 72 hours from the time the hospital implements its disaster response plan.  In addition, hospitals may only operate under such a HIPAA waiver during the emergency period beginning on October 23, 2009 through the duration of the HHS Secretary’s public health emergency declaration for 2009 H1N1 influenza.  

When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.  HIPAA waivers are only effective if taken in a manner that does not discriminate among individuals on the basis of their source of payment or their ability to pay.   

Regardless of the activation of an emergency waiver, the HIPAA Privacy Rule permits disclosures for treatment purposes and certain disclosures to disaster relief organizations. For instance, the Privacy Rule allows covered entities to share patient information with the American Red Cross so it can notify family members of the patient’s location.  See 45 CFR 164.510(b)(4).

Learn More:  * Visit the weblink below for information on sharing information in emergency situations. http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/emergency/katrinanhipaa.pdf

Q:  When and where are 1135 waivers (not related to HIPAA) in effect?

A:  The Secretary may issue specific waivers or modifications under section 1135 only to the extent they ensure that sufficient health care items and services are available to meet the needs of Medicare, Medicaid, and CHIP beneficiaries in the emergency area during the emergency period.  The “emergency area” and the “emergency period” are the geographic area, in which, and the time period, during which, the dual declarations exist.  For this event, the emergency area is nationwide and the emergency period begins on October 23, 2009, and will last through duration of the declared Public Health Emergency for 2009 H1N1 influenza.  HIPAA waivers are subject to special time limits as discussed above.

Q:  What are practical implementation steps States and Individual Healthcare Providers need to consider?

Determining if Waivers Are Necessary

In determining whether to invoke an 1135 waiver (once the conditions precedent to the authority’s exercise have been met), the Assistant Secretary for Preparedness and Response (ASPR) with input from relevant HHS Operating Divisions will determine the need and scope for such modifications.  Information considered includes requests from Governors’ offices, feedback from individual healthcare providers and associations, and requests to regional or field offices for assistance.

How States or Individual Healthcare Providers Can Ask for Assistance or a Waiver

Once an 1135 Waiver is authorized, health care providers can submit requests to operate under that authority or for other relief that may be possible outside the authority to either the State Survey Agency or CMS Regional Office.   Requests can be made by sending an email to the CMS Regional Office in their service area, or by calling the State or CMS Regional Office.  Email addresses are listed below.  Information on your facility and justification for requesting the waiver will be required.

Review of 1135 Waiver requests

CMS will review and validate the 1135 waiver requests utilizing a cross-regional Waiver Validation Team.  The cross-regional Waiver Validation Team will review waiver requests to ensure they are justified and supportable. 

Implementation of 1135 Waiver Authority

Providers must resume compliance with normal rules and regulations as soon as they are able to do so and, in any event, the waivers or modifications a provider was operating under are no longer available after the termination of the emergency period.

Federally certified/approved providers must operate under normal rules and regulations, unless they have sought and have been granted modifications under the waiver authority from specific requirements.

Frequently Asked Questions

Further information on the 1135 Waiver process can be found at:  http://www.cms.hhs.gov/H1N1/

Questions regarding 1135 that are not addressed at the above website can be sent to the following mailbox:  Pandemic@cms.hhs.gov  

Missourians can call a new toll-free number for information about the H1N1 flu.

The number, 1-877-FLU-4141 (1-877-358-4141), will be answered 24 hours a day, seven days a week.

H1N1 Flu InfoLine specialists will answer questions about flu symptoms, when to seek medical care and the new H1N1 flu vaccine, now available at locations throughout the state. Medical professionals will be available to assist with the calls.

The Missouri Department of Health and Senior Services is urging Missouri residents to get the H1N1 vaccine as it becomes available in their community.

Pregnant women, children and young adults are most at risk of contracting the H1N1 flu, so they will be given priority to receive the vaccine first. Studies show that older people are less at risk because they appear to have some degree of resistance to the virus.

The vaccine comes in an inhalable aerosol mist form, and an injectable form. The mist version of the flu vaccine can be used by healthy children and adults ages 2 through 49. Because it contains live virus, the flu mist is not appropriate for pregnant women, children under 2 years old or anyone with an underlying health condition such as asthma. Those groups should receive an H1N1 flu shot.

According to health department officials, adequate supplies of the flu vaccine will be available for the high risk groups. As additional shipments of the vaccine arrive in Missouri, flu shots or mist should be available to everyone who wants them.

H1N1 flu symptoms include fever, cough and sore throat. The majority of cases are relatively mild to moderate and do not require medical treatment. Most people with the H1N1 flu can recover at home. They should drink plenty of fluids, take fever-reducing medication, and stay home and rest.

Pregnant women and people with underlying health conditions who think they might have the flu should contact their health care provider.

In addition to the vaccine, basic flu prevention practices can help control the spread of the flu:

* Wash your hands frequently with soap and water.

* Cover your coughs and sneezes with a tissue or the inside of your elbow, not your bare hands.

* Avoid touching your eyes, nose and mouth.

* Stay home when you are sick, especially if you have a fever. Remain at home until 24 hours after your fever is gone without the use of fever-reducing medication.

For more information about the flu, go to the state health department’s web site at http://www.dhss.mo.gov/> www.dhss.mo.gov. To learn more about obtaining the H1N1 flu vaccine, Missourians should call their local health department.

The H1N1Flu InfoLine is sponsored by the Missouri Department of Health and Senior Services.

Officials prepare for a surge in H1N1 cases

By Michael D. Shear and Rob Stein
Sunday, October 25, 2009

President Obama has declared H1N1 swine flu a national emergency, clearing the way for his health chief to give hospitals wider leeway in how they handle a possible surge of new patients, administration officials said Saturday.

The president granted Health and Human Services Secretary Kathleen Sebelius the power to lift some federal regulations for medical providers, including allowing hospitals to set up off-site facilities to increase the number of available beds and protect patients who are not infected.

Obama said in the declaration that the “rapid increase in illness . . . may overburden health-care resources.” White House officials played down the dramatic language, saying the president’s action did not stem from a new assessment of the dangers the flu poses to the public.

Instead, officials said the action provides greater flexibility for hospitals that may face a surge of new patients as the virus sweeps through their communities. The declaration allows Sebelius to waive certain requirements under Medicaire and Medicaid, privacy rules and other regulations.

“The H1N1 is moving rapidly, as expected,” White House spokesman Reid Cherlin said Saturday. “By the time regions or health-care systems recognize they are becoming overburdened, they need to implement disaster plans quickly.”

The Centers for Disease Control and Prevention reported on Friday that the flu was spreading widely in at least 46 states and had already caused the hospitalization of at least 20,000 Americans. More than 1,000 deaths have been attributed to the virus and more than 2,400 additional deaths were probably associated with it, officials said.

Emergency rooms across the country are seeing increasing numbers of patients. At least one hospital in Tennessee and another in Texas recently set up tents in their parking lots to screen those suspected of having swine flu; those tents did not require waivers because they were used for screening, not treatment.

In an e-mail, James G. Hodge Jr., a professor of health law and ethics at Arizona State University, wrote that Obama’s declaration is “much more than a formality.”

“Broader powers of the federal government are now authorized to respond to the emerging outbreak,” Hodge wrote. “In short, the stakes just got raised with this proclamation.”

Cherlin said the waivers, which would free hospitals from some regulations that guide their behavior during normal operations, may be granted only to health-care facilities that request them. “Adding a potential delay while waiting for a National Emergency Declaration is not in the best interest of the public, particularly if this step can be done proactively as we are doing here,” he said.

Public health experts praised the move, saying it was an important precautionary step that could help hospitals and other first responders care for large numbers of sick people as the outbreak continues.

“We know a number of hospitals are already experiencing high but manageable loads. It’s not a stretch to imagine that hospitals could be strained,” said Jennifer Nuzzo of the University of Pittsburgh’s Center for Biosecurity. “It’s a just a precautionary move, so if need be we can focus on the care of patients rather than focus on administrative hurdles. In disasters, you often don’t have the time or luxury to keep the paperwork in order. You want hospitals focusing on patients.”

Others agreed, likening the move to getting plows and salt supplies ready before a large snowstorm.

“You get ready — make sure everything is battened down,” said Arthur Caplan, a University of Pennsylvania bioethicist.

But Caplan said he was concerned that the dramatic language could create unnecessary anxiety, in the same way that the World Health Organization’s progressive elevation of pandemic alerts last spring caused widespread concern.

Obama’s declaration could sharply increase demand for the vaccine, which is becoming available much more slowly than originally expected.

“I’ve already gotten a couple of calls from people today asking, ‘Where can I get the vaccine?’ whereas yesterday it was, ‘I don’t want that vaccine,’ ” Caplan said. “I’m worried about people getting panicky and the vaccine being diverted away from those who need it most.”

David P. Fidler, a professor of law at the University of Indiana, said that “the declaration has political implications in that it will intensify scrutiny of the federal government’s preparedness and response for this kind of event.”

“I also wonder whether the increasing impact of H1N1, coupled with the presidential declaration, will make the U.S. move more slowly in sharing the H1N1 vaccine it promised to donate to developing countries . . . especially in light of all the problems being experienced with access to the vaccine in the U.S. now and for the foreseeable future,” Fidler wrote in an e-mail.

Health authorities are especially concerned about pregnant women, young adults and children. At least 95 children have already died from the virus, far more than usually die during an entire typical flu season.

Although officials had hoped at least 40 million doses of vaccine would be available by this time, production problems have delayed the federal government’s ambitious inoculation campaign. Only about 16 million doses have become available.

By HENRY C. JACKSON, Associated Press Writer Henry C. Jackson, Associated Press Writer

Oct. 19, 2009

WASHINGTON – At least one pig from Minnesota has tested positive for the H1N1 virus, the U.S. Department of Agriculture said on Monday, the first case of a pig contracting the virus in the United States.

Agriculture Secretary Tom Vilsack said in a statement that USDA officials have begun to reach out to U.S. trade partners and international organizations to emphasize that H1N1, also known as swine flu, cannot be contracted by eating pork products.

“We have fully engaged our trading partners to remind them … that there is no scientific basis to restrict trade in pork and pork products,” Vilsack said. “People cannot get this flu from eating pork or pork products. Pork is safe to eat.”

The USDA’s National Veterinary Services Laboratories confirmed the presence of H1N1 after an initial test suggested that as many as three pigs may have had the virus. USDA is continuing to conduct tests to confirm other potential positive tests from the pig samples.

The original samples were taken as a part of a university research project from pigs shown at the Minnesota State Fair between Aug. 26. and Sept. 1.

USDA officials have said that the pigs did not show signs of sickness, and officials suggested they likely contracted the virus from some of the nearly 1.8 million people who visited the fair.

Officials also said the infection of a so-called show pig doesn’t indicate an infection of commercial herds because show pigs are in separate segments of agriculture than the swine industry.

Agriculture officials have expected H1N1 to find its way to domestic pigs this year. Herd infections were already reported in Canada, Australia, Argentina, Ireland, the United Kingdom and Norway. A hog vaccine for the virus is being developed but isn’t yet available.

By LAURAN NEERGAARD, AP Medical Writer Lauran Neergaard, Ap Medical Writer

10-16-09

WASHINGTON – Swine flu is causing unprecedented illness for so early in the fall — including a worrisome count of child deaths — and the government warned Friday that vaccine supplies will be even more scarce than expected through this month.

Federal health officials said 11 more children have died in the past week because of the virus.

Manufacturer delays mean 28 million to 30 million doses, at most, will be divided around the country by the end of the month, not the 40 million-plus that states had been expecting. The new count from the Centers for Disease Control and Prevention means anxiously awaited flu-shot clinics in some parts of the country may have to be postponed.

It also delays efforts to blunt increasing infections. Overall, what CDC calls the 2009 H1N1 flu is causing widespread disease in 41 states, and about 6 percent of all doctor visits are for flu-like illness — levels not normally seen until much later in the fall.

The Centers for Disease Control and Prevention says about half of the child deaths since September have been among teenagers.

And overall for the country, deaths from pneumonia and flu-like illnesses have passed what CDC considers an epidemic level. About 6 percent of all doctor visits are for flu-like illnesses, levels not normally seen until later in the fall.

The CDC’s Dr. Anne Schuchat (SHU’-kit) says, “These are very sobering statistics.”

This new strain is different from regular winter flu because it strikes the young far more than the old, and child deaths are drawing particular attention. Eighty-six children have died of swine flu in the U.S. since it burst on the scene last spring — 43 of those deaths reported in September and early October alone, said CDC’s Dr. Anne Schuchat.

That’s a startling number because in some past winters, the CDC has counted 40 or 50 child deaths for the entire flu season, she said, and no one knows how long this swine flu outbreak will last. Half of those early fall child deaths are among teenagers, also surprising as preschoolers are thought to be most vulnerable.

“These are very sobering statistics,” Schuchat said.

Also in contrast to regular winter flu, swine flu sometimes can cause a very severe viral pneumonia in otherwise healthy young adults, the World Health Organization warned Friday.

Typically, influenza weakens people so they’re vulnerable to bacterial pneumonia, especially those over age 65. But the new H1N1 can dive deeper into the lungs, in “small subsets” of patients who go into respiratory failure within days, said WHO medical officer Dr. Nikki Shindo.

“Do not delay the treatment,” she said as WHO ended a three-day meeting of 100 international flu specialists gathered in Washington.

The new swine flu strain also may have hit some pigs at the Minnesota State Fair in late August, animals possibly infected by some sick 4-H students. If the infection is confirmed, it wouldn’t be a surprise: A sick farm worker first infected pigs in Canada last spring, and herds have been hit in Australia and Argentina, too. The virus doesn’t spread to humans who eat pork.

Fortunately, most people recover from the new strain with simple at-home care, just as with the regular flu. While there aren’t precise counts, states have reported more than 2,000 deaths from pneumonia or flu-like illnesses to the CDC since Aug. 30. And Schuchat said other tracking systems show those deaths have reached the level that each year is used to declare an influenza epidemic, months early.

As of Wednesday, states had ordered 8 million of the 11.4 million doses of swine flu vaccine the government has ready to ship. Just over half of the vaccine now available is in shot form and the rest as a nasal spray. First in line for scarce H1N1 vaccine are supposed to be pregnant women, anyone age 6 months to 24 years, health care workers and people under 65 with flu-risky conditions.

CDC’s Schuchat urged patience, saying eventually enough vaccine will be here for everyone who wants it: “I know this is frustrating for people.”

Regular winter flu kills 36,000 Americans a year, and around the country some clinics aren’t getting shipments of seasonal vaccine as quickly as expected either, as manufacturers juggle the extra work. About 82 million doses of seasonal vaccine have been shipped, and 114 million eventually will arrive, enough for typical demand, Schuchat said.

Also Friday, judges in New York granted temporary restraining orders blocking mandatory flu vaccinations for health care workers who argued they should have a choice. In addition to New York, many hospitals nationwide have mandated shots for their employees this year so they don’t infect patients or have to miss work.

Even though swine flu is all that’s circulating here now, the regular winter flu that targets older adults has hit other countries along with the new H1N1. South Africa packed in two distinct flu seasons in one winter. WHO’s Dr. Vivek Shinde said the extremely early swine flu start in the Northern Hemisphere increases the chance that those countries, too, will get a double-whammy, making it important not to skip the seasonal shot.

“There is a lot of winter left between now and April,” he told the WHO meeting.

Mon Sep 21, 6:38 pm ET

WASHINGTON (Reuters) – Influenza can help trigger heart attacks and may account for a 35 percent to 50 percent rise in heart attack deaths during flu season, British researchers reported on Monday.

While a flu vaccine can prevent these deaths, fewer than half of the most vulnerable heart patients in Britain actually get a flu vaccine every year, however, they said.

“We believe influenza vaccination should be encouraged wherever indicated, especially in those people with existing cardiovascular disease,” Charlotte Warren-Gash of University College London and colleagues wrote in the journal Lancet Infectious Diseases.

“Further evidence is needed on the effectiveness of influenza vaccines to reduce the risk of cardiac events in people without established vascular disease.”

Warren-Gash and colleagues reviewed 39 studies conducted between 1932 and 2008 on the potential links between flu and heart deaths.

All the studies that covered entire populations showed a rise in deaths due to heart disease or heart attacks when influenza viruses were circulating, they found.

Seasonal influenza kills about 250,000 to 500,000 people a year, a figure that experts came up with by carefully monitoring confirmed flu deaths in a small area, counting excess deaths during influenza season over large populations, and consolidating both calculations.

Warren-Gash’s team found the proportion of excess influenza deaths that were due to heart disease ranged from 35 percent to 50 percent.

Four out of eight studies showed people who were vaccinated from seasonal influenza were less likely to have a heart attack they found.

But in Britain, only 47 percent of people with chronic heart disease, asthma, diabetes or other conditions who are supposed to get a flu shot did last year.

Countries now are gearing up to vaccinate hundreds of millions of people against the pandemic H1N1 swine flu and people with chronic heart disease are at the top of the list of those who should get one.

By MARIA CHENG, AP Medical Writer Maria Cheng, Ap Medical Writer Mon Sep 21, 8:48 pm ET

LONDON – Heart patients who catch the flu may have more to worry about than just a fever or the sniffles: the virus could also spark a heart attack, new research shows.

Amid the global outbreak of swine flu, experts say it’s crucial that heart patients get vaccinated against both regular flu and swine flu to avoid medical problems. Doctors said swine flu isn’t any more dangerous than regular flu, but it’s important for heart patients to get vaccinated because more flu viruses will be circulating this year.

British researchers analyzed 39 previous studies of heart patients and found a consistent link between flu and heart attacks. Up to half of all unexpected flu deaths were due to heart disease, the researchers found.

The study was published online Tuesday in the British medical journal, The Lancet Infectious Diseases.

“The message here is so strong and so logical that it’s hard for us to ignore,” said Dr. Ralph Brindis, vice president of the American College of Cardiology. “If we can convince cardiac patients to get a flu vaccine, that could ultimately save lives.”

Only about one-third of heart patients in the U.S. regularly get vaccinated.

Doctors have long known that flu viruses can worsen existing medical conditions and that heart patients are especially vulnerable during flu pandemics. Flu viruses cause inflammation in the body, usually in the lungs. But they can also cause swelling in the heart itself or in the coronary arteries, which could lead to dangerous clots breaking off and causing a heart attack.

Once heart patients get the flu, they are also more vulnerable to complications like pneumonia and other infections.

“We know influenza vaccine is effective in preventing influenza and therefore in theory, ought to be effective in preventing the complications of influenza,” said Andrew Hayward of University College London, one of the study authors. He said two of the studies analyzed showed heart patients who got a flu shot had fewer heart attacks than those who didn’t.

Hayward said flu viruses might merely act as triggers for heart attacks in cardiovascular patients.

“Influenza may be bringing forward an event that might have happened anyway,” he said, adding there is evidence that when the virus peaks, so too do heart attacks.

Experts are unsure whether the study results apply to otherwise healthy people with no history of heart disease. But they say flu viruses could potentially trigger heart attacks in people with no apparent heart disease, if they have risk factors like high blood pressure or are overweight.

For heart patients, doctors said the evidence is clear.

“Flu has too often been off the radar screen,” said Dr. Harlan Krumholz, a spokesman for the American Heart Association and professor of medicine at Yale University. “But flu is as important to think about as cholesterol or blood pressure.”