January 13, 2010

Purpose and Target Audience
The purpose of this document is to provide information to state/local immunization programs regarding options for reporting certain criminal, fraud and abuse matters relating to the 2009 H1N1 influenza vaccine and ancillary supplies.

Background
The Centers for Disease Control and Prevention (CDC) continues to receive reports regarding charges, distribution and marketing irregularities involving the 2009 H1N1 influenza vaccine and ancillary supplies. CDC reviews any information provided and uses its best efforts to forward such reports to appropriate federal (and in some cases, state) regulatory and other agencies for their awareness and possible action.

What types of fraud and abuse may arise with respect to the 2009 H1N1 influenza vaccine and ancillary supplies?
* Charging for the 2009 H1N1 monovalent influenza vaccine
Note: 2009 H1N1 influenza vaccine doses are provided at no cost to providers by the Federal government. Patients may not be charged for the vaccine or ancillary supplies. However, administration fees may be charged.
* Requesting an out-of-pocket fee directly from the patient that is above the maximum regional Medicare allowable charge. The current Medicare administration reimbursement rates is available online.
* Selling 2009 H1N1 influenza vaccine or ancillary supplies provided by the Federal government
* Counterfeit vaccines

* Adulteration of vaccine
* Theft of vaccine
* Consumer fraud
* Marketing and advertising, often on websites or via the internet, including fraudulent product claims, bogus products, and implied endorsement by federal agencies (including use of federal government agency logos)
* Diversion, which includes situations where legitimate prescription drugs/vaccines are:
1. Entered into illegal channels (i.e., black market, illegal Internet sales, sales without prescription, etc.) and/or
2. Acquired or obtained by an illegal method (cargo/wholesale/manufacturer/ distributor theft, smuggling into the USA, illegal sale to unauthorized party without prescription, etc.).

What options exist for reporting suspected fraud and abuse issues related to 2009 H1N1 influenza vaccine and ancillary supplies?
State and local partners should follow any routine procedures they may have in place for notifying appropriate authorities of any suspected fraud or abuse matters. For example, allegations of charging for doses, or sales, of 2009 H1N1 vaccine should be directly reported to their State Attorney General’s Office. Any suspected criminal activity should be reported to appropriate state and local authorities, as well as to the Food & Drug Administration – Office of Criminal Investigations.

Below is a list of federal enforcement agencies, along with the criminal, fraud and abuse matters which fall under their purview. State and local partners may directly report criminal activity, fraud and abuse matters to relevant agencies.

1. Food and Drug Administration (FDA), Office of Criminal Investigations:
    * Scams or schemes involving efforts to market bogus vaccine or flu treatments;
    * Any potentially illegal vaccine-related activity such as theft, diversion, adulteration (misbranding), potential counterfeits, etc;
    * Marketing of fraudulent or bogus 2009 H1N1 products claiming to prevent or treat 2009 H1N1 influenza;
     *Implied endorsement of any 2009 H1N1 product by HHS/FDA and/or improper use of HHS/FDA logos on company websites or other marketing materials.

      Suspected criminal activity relating to FDA regulated products and the 2009 H1N1 flu virus may be reported directly to FDA-OCI.

2. Federal Trade Commission (FTC), Bureau of Consumer Protection:

Scams (especially via the internet or websites) including unsupportable product claims, false advertising, and fraudulent or bogus products, as well as implied endorsement by federal agencies and improper use of federal agency logos on company websites or other marketing materials

Complaints may be submitted directly to the FTC.
State and local partners may report any such matters which come to their attention directly to the CDC by sending an email to the CDC H1N1 Vaccine Fraud mailbox at H1N1FraudAbuse@cdc.gov. The email should include their contact information as well as a detailed description of the situation including when it occurred. CDC will review the information provided and will use its best efforts to forward these emails to one or more of the agencies listed above, and possibly to others as warranted, for their awareness and possible action.

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Opinion: Swine flu response drew criticism, but taught valuable lessons
COMMENTARY
By Dr. William Schaffner
msnbc.com contributor
 Dec. 29, 2009
By now many of us have gotten our doses of influenza vaccine. Now it’s time for a dose of influenza reality. Let’s acknowledge that flu virus is a living thing — and a pretty crafty one at that. Despite all our best efforts, sometimes flu will get the better of us. Depending on your personal experience, you may feel that was the case this year. But in my view, there are a lot of positives to take away from this year’s experience.

Positive No. 1: By the end of 2009, our influenza enterprise will have supplied almost 200 million doses of flu vaccine in the U.S. That will include about 110 million seasonal influenza doses and nearly that many pandemic H1N1 vaccine doses.

That number may feel inadequate this year because we were fighting on two fronts, having to deliver two different vaccines to somewhat different target groups. Meanwhile, we will have proved positive outcome No. 2: We have the capacity to produce more vaccine than the American public usually demands.

While we’re talking about public demand, let’s consider its impact, because that’s positive outcome No. 3: Public demand for vaccine is up this year — way up. Right now that means news reports of “shortages” as vaccine supply continues to roll out. But if we can sustain increased demand, we will achieve several important goals: We will protect more people through direct vaccination, we will protect more people by protecting those around them, we will keep more adults at work and more kids at school and we help ensure a better supply for the future.

Increased demand means increased supply. If the public accepts more vaccine, you can bet that the private sector will make it. For good or bad, that’s how our economic system works.

The law of supply and demand means manufacturers won’t make more product than they can sell — how can they justify spending on products to throw them away? It’s an American business standard; it works this way across all industries — cars, houses, clothes and yes, even vaccines.

Manufacturers responded quickly
But for the record, here’s positive No. 4: While manufacturers are private enterprises that need to consider profits, they’ve shown great flexibility and willingness to alter their plans and work to achieve goals established by our public health leaders. Companies readied themselves to switch from seasonal to pandemic vaccine production in the late spring and then made the change virtually overnight when asked to do so.

Manufacturers started the H1N1 process in May and vaccine delivery began in October. We all wish we could have as much vaccine as we need on the shelves the moment we need it. But in the case of vaccines, it doesn’t work that way.

Vaccines start from live material — viruses and bacteria that cause us great harm. It takes time to grow these live materials and then to render them incapable of causing any harm themselves. As a result, vaccines are probably the most well-tested and safest medical intervention we have. And to date, they’re the only intervention that has led to complete elimination of a disease from the planet. (It’s smallpox, in case the ailment doesn’t immediately come to mind).

While I could go on for a while with the positives, here is my last one, positive No. 5: Flu awareness has increased. The Department of Education has asked schools to participate in vaccination programs for our children. This is a tough task for our overburdened schools, but all indications are that they’re doing everything they can to be part of the effort. And that’s good because this particular pandemic flu can hit kids hard. But we also need to remember that seasonal flu also hits kids hard. School-aged children have the highest infection rates and infants and toddlers are hospitalized at rates similar to the elderly because of influenza.

Rising awareness among health workers
Awareness about the need to vaccinate health care workers also has increased. I particularly applaud any efforts to raise vaccination rates in health care workers. We have a duty to do no harm and to be there for our patients. When health workers don’t get vaccinated, we risk failing on two counts. To all those hospitals across the country that have made efforts toward universal health care worker vaccination, I say “Bravo!” We’ve made strides this year and we need to keep at it in the years to come.

Dealing with an unpredictable virus requires aggressive approaches like these. Rapid production of safe and effective H1N1 vaccines is evidence that our years of hard work and effort are paying off. We have acquired an impressive knowledge base, production capacity and vaccine delivery infrastructure. We are poised to make significant strides this year in the fight against seasonal influenza, but keeping this momentum means understanding — and taking — a dose of reality.

Dr. William Schaffner, chairman of the Department of Preventive Medicine at Vanderbilt University, is also president-elect of the National Foundation for Infectious Diseases.

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If someone in your home has it, you’ve got a 1 in 8 chance of getting sick

Dec. 30, 2009

How contagious is swine flu? Less than the novel viruses that have caused big world outbreaks in the past, new research suggests.

If someone in your home has swine flu, your odds of catching it are about one in eight, although children are twice as susceptible as adults, the study found. It is one of the first big scientific attempts to find out how much the illness spreads in homes versus at work or school, and who is most at risk.

The study was done by outbreak specialists from Imperial College London and from the U.S. Centers for Disease Control and Prevention. Results are in Thursday’s New England Journal of Medicine.

Swine flu has sickened an estimated one-sixth of Americans since the novel virus was first identified in April. The second wave of cases now seems to have peaked, and health experts do not know if another surge lies ahead.

People with swine flu are advised to stay home for at least a day after their fever goes away by itself to avoid spreading illness. That puts family members at risk, but who is vulnerable and to what extent has not been known.

60 percent of cases are kids
About 60 percent of swine flu cases have been in children, but researchers wondered: are they truly more likely to get swine flu, or just more likely to be taken to a doctor and tested for it? Are they more likely to spread the virus than adults are?

To find out, researchers studied infection patterns in 216 people with swine flu from around the United States (half of them children) and 600 people living with them.

Respiratory illnesses that researchers assumed were swine flu developed in 78 of the 600 household members, or 13 percent. However, 10 percent had symptoms more specific to flu.

That’s less than the “spread” rate during earlier flu pandemics in 1957 and 1968, when 14 percent to 20 percent of household members were infected. Less is known about spread in the 1918 pandemic, but households and lifestyles were very different then. In an ordinary flu season, the virus spreads to 5 percent to 40 percent of household members, various studies have shown.

Children were twice as susceptible to catching swine flu as adults were, and even more so if they were younger than 4, said one of the researchers, Lyn Finelli, surveillance chief for the CDC’s flu division.

“It fits with what I’m seeing clinically,” said Dr. James King, chairman of the American Academy of Family Physicians’ board of directors and a family medicine doctor in Selmer in western Tennessee. “Most of the people I’m seeing are people under 20, mostly kids,” he said.

Nearly three-fourths of households in the study managed to avoid spreading the illness to any family members.

In homes where the germ was transmitted, researchers found something unexpected: “People at all ages were just as likely to spread the virus,” Finelli said. “That was surprising, since we always think of kids as super-spreaders.”

The study was funded by several public and private health-related groups in England and the United States, including the Bill & Melinda Gates Foundation.

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COMPILED FROM REPORTS BY THE ASSOCIATED PRESS

Dec. 31, 2009

How contagious is the swine flu? Less than the novel viruses that have caused big world pandemics in the past, new research suggests.

If someone in your home has swine flu, your odds of catching it are about 1 in 8, although children are twice as susceptible as adults, the study found. It is one of the first big scientific attempts to find out how much the illness spreads in homes versus at work or school.

Results of the study — conducted by the Imperial College London and the U.S. Centers for Disease Control and Prevention — are published in today’s New England Journal of Medicine.

Swine flu has sickened an estimated one-sixth of Americans since April.

GUANTáNAMO DETAINEES: Court: Surveillance info can stay secret
A federal appeals court ruled Wednesday that professors and attorneys who represent Guantánamo Bay detainees cannot force the government to reveal whether an antiterrorism program eavesdropped on their conversations.

The National Security Agency and the Department of Justice had refused to comply with the plaintiffs’ 2006 Freedom of Information Act request.

The government had refused to confirm or deny the existence of any records obtained under the Terrorist Surveillance Program, authorized by President George W. Bush after the Sept. 11 attacks.

RADIO SHOW HOST: Limbaugh reportedly taken to hospital
Conservative radio talk show host Rush Limbaugh was taken to a hospital with chest pains on Wednesday, a Honolulu TV station reported.

Paramedics responded to a call from the hotel where Limbaugh is vacationing, KITV reported. The station, citing unnamed sources, said Limbaugh, 58, was taken to the Queens Medical Center in serious condition.

Spokeswoman N. Makana Shook said the hospital was unable to comment.

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PARIS — For each case of swine flu causing high fevers and crippling muscle pains there could be four others without major symptoms, French experts have reported.

Infection rates for the pandemic H1N1 virus in France, where the study was done, may be far higher than previously thought if these so-called “asymptomatic” cases — easily mistaken for a bad cold — are taken into account, according to a study posted online Monday.

The results suggest the same could apply to all the regions in the world where the newly-emerged virus has struck.

Researchers led by Xavier de Lamballerie, director of of the Emerging Viruses Unit of the University of Aix-Marseille, analysed data collected from blood samples given by more than 1,000 women getting regular check-ups during the first trimester of pregnancy.

The samples were collected from across the country over a two-week period at the end of November and early December, said the study, published in PLoS Currents: Influenza, a research-sharing platform vetted by flu experts.

Traces of the swine flu antibodies showed up in more than 10 percent of the women. It was not known how many had had severe flu symptoms.

Extrapolating to the entire male and female population of adults between 20 and 39 years old in mainland France, the researchers calculated that more than 1.7 million people in that age bracket would have been infected.

This figure is five times the number of patients of the same age who consulted a doctor with major flu symptoms over the three-month period up to the end of November, suggesting that four-in-five cases went unreported or — more likely — did not erupt into a severe influenza.

Experts say the H1N1 virus that first emerged in Mexico in March has almost entirely replaced the “normal” seasonal flu, a signature trait of flu pandemics in the 20th century as well.

“The number of people infected by the [swine] flu is higher than we would have estimated by counting up the reported cases,” said Lamballerie.

An “unusually high rate” of asymptomatic cases — much higher than for the seasonal flu — could explain this discrepancy, he said.

At the same time, he cautioned against concluding that it was not necessary to be vaccinated against the new flu strain.

“While it may be true that there are more people for whom the flu is less serious and asymptomatic, it is also true that there are more people who have serious or very serious forms of the disease” compared to the common flu, he told AFP.

He added that is was not even certain that being infected with the weakest form of virus provided protection against the more virulent ones, though preliminary evidence suggested as much.

The French Institute for Public Health Surveillance, which also participated in the study, cautioned against extrapolating the results to the entire French population outside the 20-to-39 age bracket.

Earlier studies from Mexico and elsewhere have indicated that older populations may have some in-built immunity to the swine flu, which is related to the strain that dominated up until the pandemic of 1957.

The World Health Organisation (WHO) said Tuesday that swine flu has killed at least 12,220 people worldwide.

The Americas, especially the United States and Canada, have been worst hit with at least 6,670 victims, while 2,422 confirmed fatalities have been reported in Europe, the WHO said.

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December 31, 2009

Women should avoid getting pregnant until after the swine flu pandemic is over, reports today’s Beijing News in its top headline.

In a government report published yesterday, the Ministry of Health advised that women who wanted to be pregnant now or in the near future should consider postponing their plans to avoid getting pregnant in the flu season.

According to the ministry, pregnant women who contract the disease, especially the overweight ones will face high risks to develop serious complications including miscarriage, premature birth, fetal distress, and stillbirth; death incidence is also higher among the pregnant women, who account for about 13.7% of the death toll caused by H1N1 flu.

The ministry announced that there were a total of 4,448 newly diagnosed H1N1 flu patients in the last week, among whom, 1,380 were hospitalized. Meanwhile, 93 patients who were diagnosed earlier died.

The ministry warned that with the Chinese new year approaching, increasing population movement will also increase the chances of catching the disease. People who have developed symptoms such as fever and respiratory infection should avoid contact with others.

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Questions to Ask Your Doctor
Here are a few questions to consider asking your health care provider about flu antivirals

* Do I need antiviral treatment if I have flu symptoms?
* When should I call back if I don’t feel better?
*What do I do if my child is prescribed oseltamivir and can’t swallow capsules? Click here for instructions on how to open capsules and mix the medicine with liquids.
Treatment Is Important for High Risk Groups
People in high risk groups should talk to their health care provider as soon as possible if they think they may have the flu because they have a greater chance of getting serious flu complications than other persons. Flu antiviral drugs can make you feel better, shorten the time you are sick, and prevent serious flu complications, especially if treatment is begun within 2 days of getting sick. Flu antiviral drugs must be prescribed by a physician.

Don’t Delay Treatment
If your doctor prescribed Tamiflu® (oseltamivir) or Relenza® (zanamivir) for you, don’t delay filling the prescription, and start taking the medication as soon as you get it. This way you will get the most benefit. It’s very important that antiviral drugs be started as soon as possible for the flu, ideally within 2 days of getting sick.

Don’t Confuse Tamiflu® (oseltamivir) with Theraflu®
Tamiflu® is the brand name and oseltamivir is the generic name of a prescription antiviral drug used to treat the flu and should not be confused with Theraflu®, which is an over-the-counter medication. Antiviral drugs are not sold over-the-counter. You can only get them if you have a prescription from your health care provider.

Side Effects of Flu Antiviral Drugs
The most common side effects of oseltamivir (Tamiflu®) are nausea and vomiting, which can also be symptoms of the flu. Nausea and vomiting can be minimized by taking the medication with food. The most common side effects of zanamivir (Relenza®) are dizziness, sinusitis, runny or stuffy nose, cough, diarrhea, nausea, or headache, also symptoms that can be due to the flu. Zanamivir may also cause wheezing and trouble breathing in people with lung disease; therefore, persons with a history of asthma or another lung disease should not be prescribed zanamivir.

Treatment May Be Needed Even if Test Results are Negative
Your health care provider may diagnose you with flu based on your symptoms and their clinical judgment or they may choose to use an influenza diagnostic test. Health care providers can use rapid flu tests (15 minutes or less) to test a specimen from your nose or throat in their offices. Unfortunately, these tests are less than perfect in telling who really has the flu. Therefore, you could still have the flu, even though your rapid flu test result is negative. Health care providers may prescribe antivirals if they suspect flu, even if the rapid flu test is negative.

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Spicy Indian curries could prevent swine flu and common cold just like any prescribed medicine available with the chemists, claim Russian doctors.

“You can strengthen immunity by consuming spicy food like curries, as spices like turmeric, ginger and cumin also posses excellent therapeutic effect,” an unnamed official of the Moscow [ Images ] anti-epidemics committee was quoted as saying by news agency RIA Novosti.

As panic grips Moscow residents over the spread of seasonal influenza and swine flue in the eastern parts of the country and neighbouring Ukraine, authorities are focusing on prevention and have ordered the use of masks at work place.

Besides the intake of spicy food, people have been advised to consume raw onions and garlic, which contain anti-viral properties.

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In findings that may lead to better ways to prevent and treat influenza and other viral infections, researchers report the discovery of a family of naturally occurring antiviral agents in human cells.

In experiments in human and mouse cells, the flu-fighting proteins prevented or slowed most virus particles from infecting cells at the earliest stage in the virus lifecycle. The anti-viral action happens sometime after the virus attaches itself to the cell and before it delivers its pathogenic cargo.

“We’ve uncovered the first-line defense in how our bodies fight the flu virus,” said Stephen Elledge, the Gregor Mendel professor of genetics and of medicine at Harvard Medical School (HMS) and a senior geneticist at Brigham and Women’s Hospital (BWH). “The protein is there to stop the flu. Every cell has a constitutive immune response that is ready for the virus. If we get rid of that, the virus has a heyday.”

“When we knocked the proteins out, we had more virus infection,” said geneticist Abraham Brass, an instructor in medicine at HMS and Massachusetts General Hospital (MGH), who led the study first as a postdoctoral fellow in the Elledge research group and then in his own lab at the Ragon Institute. “When we increased the proteins, we had more protection,” Brass said.

The native antiviral defenders are also crucial after the cells are infected, Brass and his co-authors found. In the cells, the proteins accounted for more than half of the protective effect of the interferon immune response. Interferon orchestrates a large component of the infection-fighting machinery.

“Interferons gave the cells even more protection, but not if we took away the antiviral proteins,” Brass said. The study is published online Dec. 17 in the journal Cell.

The potent interferon response is what makes people feel so sick when their bodies are fighting the flu or when receiving interferons as therapy. “If we can figure out ways to increase levels of this protein without interferon, we can potentially increase natural resistance to some viruses without all the side effects of the interferons,” Elledge said.

In the study, the surprisingly versatile antiviral proteins protected cells against several devastating human viruses – not only the current influenza A strains including H1N1 and strains going back to the 1930s, but also West Nile virus and dengue virus. While IFITM did not protect against HIV or the hepatitis C virus, experiments suggested the protein may defend against others, including yellow fever virus.

The researchers do not know how the antiviral proteins deflect this variety of viruses, which use different mechanisms of entry into the cell. The protein family, called interferon-inducible transmembrane proteins (IFITM), was first discovered 25 years ago as products of one of the thousands of genes turned on by interferon. Since then, not much else has been discovered about the IFITM family. Versions of the IFITM genes are found in the genomes of many creatures, from fish to chickens to mice to people, suggesting the antiviral mechanism has been working successfully for millions of years in protecting organisms from viral infections.

In Elledge’s lab, Brass began the study as a genetic screen to learn how the body blocks the flu. The researchers had previously run similar screens with hepatitis C virus and with HIV. In the screen, the researchers used small interfering RNA to systematically knock down one gene at a time by depleting the proteins the genes were trying to make. Then they examined what effect each blocked gene had on a cell’s response to influenza A virus.

The screen revealed more than 120 genes with potential roles in different stages of infection. Four of those genes, when knocked down, allowed for a robust increase in the infection of cells by influenza A virus. Of these four candidate “restriction factors,” the research team concentrated on the IFITM3 protein because of its known link to interferon and found two closely related proteins in the IFITM family with similar activity.

The most distinctive property of the first-line IFITM3 defense is its preventive action before the virus can fuse with the cell, said co-author and virologist Michael Farzan, associate professor of microbiology and molecular genetics at HMS and the New England Primate Research Center. “The virus is unable to make a protein in the cell to counteract the IFITM proteins, because the cell is already primed against the virus,” Farzan said. “To find something that hits the flu and hits it so close to the entry stage of the viral life cycle is really interesting and unusual among viral restriction factors.”

The researchers have more questions than answers about how the IFITM restriction factors actually work, but they are excited about the range of inquiry the discovery opens up. For example, variations in the protein from person to person may explain differences in people’s susceptibility to flu and other viral infections, as well as its severity, the researchers speculate.

And if scientists can understand the mechanism of action, they may be able to design new therapies with even better antiviral actions. The proteins themselves may be useful for defending against infections in animals, like birds and pigs, which might prevent the emergence of new, potentially more dangerous influenza A strains.

In another potential application, if IFITM3 has a role in the chicken embryos or canine cells used to make flu vaccines, inhibiting the proteins may speed up vaccine production, which has been an issue this year with the manufacture of the H1N1 pandemic vaccine.

The research was funded by the Howard Hughes Medical Institute, the Phillip T. and Susan M. Ragon Foundation, the National Institutes of Health, New England Regional Center of Excellence for Biodefense, Cancer Research UK the Wellcome Trust, and the Kay Kendall Leukaemia Foundation. BWH and MGH have filed a U.S. patent application for this technology that relates to the identification and use of host factors to modulate viral replication/growth.

Full Citation

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Date: 27 Dec 2009

The millions of people who benefit from the care and support that social care workers provide day in, day out see you as one of their most important assets and we are committed to protecting you and your families during the current swine flu pandemic.

“Many of the people you care for and support could become seriously ill if they catch swine flu. We fully support the swine flu vaccination programme – it will reduce the risk to staff, protect their colleagues and families and those they care for and support and help sustain services during the pandemic. The vaccination programme covers councils’ directly managed eligible frontline social care workers, as well as eligible independent sector workers and personal assistants to people receiving direct payments.

“It’s important that staff can make an informed decision about the vaccination and social care organisations will provide you with information to enable you to do this. The vaccine has been thoroughly tested and is entirely voluntary. We call on social care organisations to ensure that all eligible staff are given suitable and reasonable access to the vaccination during working hours to protect themselves, their families and those they care for and support from swine flu.

“While we recognise that the decision to be vaccinated is a personal matter, we encourage staff to protect themselves with the swine flu vaccine, in addition to the seasonal flu immunisation. It is your best defence against flu this winter.”

Source
UNISON

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