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Lost In Translation: H1N1 Flu Warnings In Foreign Lands

I’m grateful to for bringing us this H1N1 warning sign from Thailand:

Top 10 Things To Know About The H1N1 Flu

We have been inundated with so much information about the 2009 H1N1 that it’s hard to keep it all straight. Here’s my top ten list of what’s most important to know, much of it coming from the website of the Centers for Disease Control and Prevention, which has done a spectacular job of providing timely and useful information:

1) What is the 2009 H1N1 Flu (Swine Flu)?

Different from the typical seasonal influenza virus, this is a new type of flu virus that appeared in Mexico in April, 2009 and soon spread to the United States and around the world. It contains a combination of genetic material found in influenza viruses that infect humans, birds, and pigs.

On June 11th the World Health Organization (WHO) declared a phase 6 pandemic – its highest alert level. On July 16th the WHO called the pandemic the fastest moving pandemic ever.

2) Why are people concerned about the 2009 H1N1 pandemic?

Over the past century, three major pandemics have swept through the world and caused severe illness and death. The most devastating by far was the influenza pandemic of 1918, which killed 40-100 million people worldwide and 500-750,000 Americans at a time when the U.S. population was only about 100 million. The 1957 “Asian flu” caused about 70,000 deaths when the U.S. population was about 170 million. The last pandemic, in 1968, killed about 34,000 out of 200 million Americans.

3) How does the 2009 H1N1 influenza compare to the typical seasonal flu?

Because the 2009 H1N1 virus is new, most people – especially children and young adults – have little or no immunity against it. It is spreading more quickly than the usual seasonal flu but seems to be somewhat milder – though still capable of causing severe illness and death. The typical seasonal flu affects 15-60 million Americans, leading to more than 200,000 hospitalizations. Annual deaths range from 17,000 to 52,000 annually, averaging about 36,000.

The elderly are especially at high risk of seasonal flu, with over 90% of deaths occurring in patients over 65. In contrast, 2009 H1N1 has preferentially affected young adults and children while older patients appear to have some immunity. Only 18% of deaths from H1N1 have been in patients over 65.

It’s estimated that between April and June, more than a million Americans became ill from 2009 H1N1; the CDC stopped reporting individual cases on July 24th, 2009. While the vast majority of cases have been relatively mild, as of September 3rd there were 593 deaths and 9,079 hospitalizations in the United States and territories.

For both the regular flu and the 2009 H1N1, certain groups are at increased risk for complications once infected – children under 5, pregnant women, and patients with underlying medical conditions such as suppressed immune systems, asthma, diabetes, neurological disorders, kidney problems, and heart disease as well as adults over age 65.

4) What Can We Expect This Fall?

Flu virus tends to die down over the summer because it survives better when the weather is cold and dry than warm and humid. That’s why during our summer the H1N1 virus spreads to the Southern Hemisphere, where it’s winter. But the virus never really went away in America and is now surging much earlier than with the regular seasonal flu.

In August, a panel of experts prepared an extensive report for President Obama about the virus. While warning that the exact impact of H1N1 was impossible to predict, the panel outlines a “plausible scenario” that included 60-120 million infected Americans, as many as 1.8 million hospital admissions, and 30-90,000 deaths. Others, including the CDC, have suggested that these estimates are a “worst case scenario.”

Unfortunately, the influenza virus is famously unpredictable and the above “plausible scenario” could be way off in either direction. Although the virus is relatively mild now, it can quickly change on its own through mutation and become more deadly. Another way of changing is if two different viruses happen to infect the same cell at the same time. The two different strains could then trade genetic material. Hypothetically, the 2009 H1N1 that is currently sensitive to the antiviral medication Tamiflu could become resistant to Tamiflu if it combines with last year’s seasonal flu strain which was 99 percent resistant to the drug. Fortunately, until now the virus has been stable genetically and it remains sensitive to Tamiflu and Relenza.

5)What are the symptoms of the 2009 H1N1?

The symptoms are very similar to those seen with the regular seasonal flu: fever, headache, fatigue, cough, sore throat, runny nose, and aches and pains. In addition, there may be gastrointestinal symptoms such as nausea, vomiting, and diarrhea.

6) How can you catch H1N1?

Just as with the regular seasonal flu, the virus enters your body through your nose, mouth, or eyes. People infected with H1N1 shed virus starting a day before symptoms begin and lasting up to a week or longer in some patients. An uncovered cough or sneeze in a patient with influenza can send infectious virus-filled droplets into the air. If you touch a surface that’s infected with flu virus and then touch your mouth, nose, or eyes, the virus can enter your body and cause infection.

7) How do you prevent the seasonal flu and 2009 H1N1?

The most effective way is through vaccination – assuming you are in a group for which immunization is appropriate. The CDC recommends vaccination with both the regular seasonal flu vaccine, which is already being given, and the 2009 H1N1 vaccine once it becomes available around mid-October. So far, the 2009 H1N1 vaccine has been shown to be safe in adults; the CDC told me this week that studies in children and pregnant women should be done within about 2-3 weeks. Health officials want to vaccinate at least 159 million Americans. Experts predict there will eventually be enough vaccine for all Americans who want it. But only about 45 million doses are expected to be available with the first batch in mid-October.

Those on the priority list to get the 2009 H1N1 vaccine include pregnant women, people in close contact with infants 6 months and younger, health care workers, those ages 6 months to 24 years, and people ages 25 to 64 with serious conditions that put them at high risk for complications from flu.

Experts stress the importance of covering your mouth with a tissue when you cough or sneeze. Wash your hands often with soap and water or an alcohol-based hand cleaner. Remember: you don’t get flu from virus that’s only on your hands; you get it when you touch your face and give the virus a way to enter your body. Avoid close contact with sick people. And if you are sick with the flu, the current CDC recommendation is to stay home for at least 24 hours after your fever is gone without the use of fever-reducing medication. In some situations, the use of a face mask may be indicated, especially to try to prevent flu in patients at increased risk for complications;
click here for the CDC’s recommendations.

8.) Who should receive treatment with anti-viral medication such as Tamiflu and Relenza?

Last week the CDC said that most people who come down with the 2009 H1N1 flu should just ride it out and not take antiviral medications such as Tamiflu and Relenza. Dr. Anne Schuchat of the CDC said the majority of adolescents, adults and children “can be cared for with mom’s chicken soup at home, rest, and lots of fluids.” But she stressed the importance of early treatment with antiviral medications – within 48 hours if possible – for certain patients at increased risk of complications, especially those hospitalized, under age 5, over age 65, or with chronic medical conditions.

A key change in advice from the CDC involves patients at high risk who may have been exposed to the H1N1 virus. Before last week, doctors were advised to give them medication to prevent infection; now doctors are being given the option of “watchful waiting” – observing the patient closely and only starting antiviral treatment if evidence of flu develops.

9) What warning signs should prompt immediate medical evaluation and treatment?

In adults, warning signs include: trouble breathing, pain or discomfort in the chest or abdomen, dizziness, confusion, severe or persistent vomiting, and symptoms that improve but then return with fever and worse cough. In children, warning signs include: trouble breathing, bluish or gray skin color, inability to drink enough fluids, severe or persistent vomiting, change in mental status (e.g., not waking up, not interacting, or being unusually irritable), and symptoms that improve but then return with fever and worse cough.

10) Should I get the 2009 H1N1 vaccine if I think I’ve already had the H1N1 flu?

The CDC told me “yes” – because the vast majority of patients diagnosed with 2009 H1N1 were not specifically tested for the virus. It may have been some other virus that made you ill. And even patients who had positive “quick tests” in the office for influenza A cannot be absolutely certain they had the 2009 H1N1 virus because the kits are sometimes wrong and because there’s a small chance that the strain of influenza A detected was NOT the 2009 H1N1. So the CDC recommends playing it safe and getting the both the regular seasonal vaccine and the 2009 H1N1 vaccine if you are in a group for which immunization is suggested.

For this week’s CBS Doc Dot Com, I discuss very practical advice – especially for parents – about H1N1 with Dr. Thomas Farley, who was appointed New York City Health Commissioner in May 2009 and immediately found himself smack in the middle of the 2009 H1N1 outbreak.
here to watch the interview.

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Influenza, Terrorism, and Pediatrics

animal20farm20graphic20-20big20pig20close20mouth-713368Before you get too “conspiracy theory” on me, let me assure you that I am not going to talk about how the influenza virus pandemic is the work of terrorists (unless the Napoleon and Snowball are trying to take over our farm).   I am also not suggesting that children are terrorists (although some do raise my suspicion).

The virus that brought such worry and even panic seems now to be “fizzling out” and people are now questioning if the authorities and the press overreacted to the threat.  Will this be a replay of the “boy who cried wolf” and have us complacent when a real threat comes?  One writer questioned if the flu “overreaction” was “more costly than the virus itself.“  Another article cites an Australian professor (of what, the article did not say) who stated that “the country would be better off declaring a pandemic of some of the real health problems it has, like diabetes and obesity.”

The real din, however is in the countless letters to the editor and calls to radio talk-show hosts mocking the “alarmism” put forth by the WHO and others about this flu.  This does appear to be in the minority, as one poll said that 83% of Americans were satisfied with the management of the outbreak by public authorities.  Still, I suspect the volume of the dissent and sniping at the non-serious nature of the pandemic so far will only increase over time.  The number of people who know better than public health officials will multiply.

This pandemic is a catch-22 for public health officials, as an excellent article on the subject states:

The irony is that the overreaction backlash will be more severe the more successful the public health measures are. If, for example, the virus peters out this spring because transmission was interrupted long enough for environmental conditions (whatever they are) to tip the balance against viral spread, CDC and local health officials will be accused of over reacting.

Which brings me to the connection to terrorism.  If public authorities somehow thought there was a 10% chance that New York City would be hit with another major terrorist attack, how big should their reaction be?  If they suspected that there was a reasonable probability, say 5%, that the subways would be flooded with sarin gas, should they shut them down?  I would certainly hope they wouldn’t leave that many people open to the chance of death.

And what is the best outcome?  The best outcome is that this is an overreaction.  The best outcome is that the terrorists, in fact, have reformed and are instead joining the Professional Bowling tour.  I would welcome this outcome (not to mention the exciting infusion of young talent to the tour).  The problem is, the officials have no idea how it will play itself out.  Truth be told, since 9/11, there have not been any major terrorist attacks in the US.  Does this mean that the money spent on the department of homeland security has been wasted?


As a pediatrician, I am very accustomed to overreaction.  If you bring in your 20 day-old child to my office with a fever of 102, I will do the following:

  1. Admit them immediately to the hospital
  2. Draw blood tests looking for serious infection
  3. Check a urinalysis to make sure there isn’t an infection (using a catheter to get the sample)
  4. Start IV antibiotics as soon as possible
  5. Perform a spinal tap to rule out meningitis.

This seems a little over-the-top, doesn’t it?  The child just has a fever!  The problem is that children this age with a fever caused by a virus look identical to those who have meningitis.  By the time their appearance differentiates, it is too late.  This forces me to do the full work-up on every infant with fever and treat each one as if they have meningitis or some other serious infection.  I do this despite the fact that the cases of meningitis are far outnumbered by that of less serious problems.

If this is your child, don’t you want me to do that?

Knowing what we know about pandemics, the same caution was, in my opinion, absolutely the right thing to do.  If the virus turns out to be nothing serious, hallelujah.  I don’t want my patients (or family members) dying at the rate that some of the previous H1N1 viruses caused.  I want this to be a lot of worry for “nothing.”  Please let it be so.

But I still don’t think it is time to relax.  As one commenter on an earlier post I wrote about this pandemic stated:

It’s still a bit early to relax. The 1918 flu went around first in the spring and was very mild – kinda like this. Then it came back in the fall after incubating and mutating and was a killer.

I think the CDC and WHO probably will be concerned about this until next year, at least. Just to be on the safe side.

Remember that that flu, which was mild in the spring, went on to kill 20-100 million people.

For this reason, I hope the voices of reason win out over the armchair quarterbacks that don’t have to make these decisions that could mean the life or death of millions.  Will you tell me that evacuating the NY subways wouldn’t be a good thing on the threat of Sarin gas?  Would you criticize me for “overreacting” if your infant with a fever turned out to just have an upper respiratory infection?  I hope not.

If you would, then that gives us ample reason to ignore your opinions on how this flu was handled.

*This blog post was originally published at Musings of a Distractible Mind*

What’s On The Horizon For A Swine Flu Vaccine

Swine Flu has brought an awareness of the catastrophic potential inherent in pandemic influenza to the public consciousness and led many to panic.  Industry has long played a major role in protecting us against epidemic influenza, providing doctors and patients with vaccinations and medications to help protect and treat the weakest individuals in our society:  the young and old.  However, pandemic flu frequently kills the healthiest in society; a hallmark of the 1918 Swine Flu Pandemic that left 500,000 dead in the U.S., far more that the average of 36,000 dead in a typical year.

This week, I had a discussion with Bill Enright, President and CEO of Vaxin Inc., about their efforts to create a vaccine for pandemic Flu.  Our daughters are kindergarten classmates and over the last two years I have enjoyed the opportunity our friendship has afforded me to learn about the vaccine industry.  As “Swine Flu” began to dominate the headlines I asked him to participate in a dialogue with me believing that a discussion between a clinical physician and a vaccine scientist would be interesting and informative for a reader without giving in to hysteria.  He was kind enough to give of his own time and a part of the discussion follows:

STEVE:  What is Vaxin, Inc.?

BILL:.  Vaxin is a vaccine development company focused on needle-free vaccines to protect against influenza (both seasonal and avian influenza) and anthrax.  Using technology developed at the University of Alabama at Birmingham, by our scientific founder Dr. De-chu Tang, we have been able to show proof of principle with our platform, intranasal seasonal influenza vaccine, and have just completed enrollment in a Phase I clinical study with an intranasal pre-pandemic influenza vaccine.  We are also investigating patch-based vaccines.

STEVE:  What is the difference between the vaccine you are developing for Pandemic Influenza and the vaccine given yearly for Epidemic Influenza?

BILL: Epidemic, or seasonal, vaccines are trivalent vaccines composed of three influenza strains (two A and one B) anticipated to be circulating.  The CDC and the WHO spend considerable effort in monitoring the circulating strains around the world before making a decision on which strains should be included in that year’s vaccine.  However, several changes could occur which result in the vaccine not being a good match for a particular year:  mutations could change a strain, new strains could evolve or different strains than anticipated could predominate.

Pandemic vaccines will be made to the circulating influenza virus causing the pandemic.  Vaccines made in advance of a pandemic are really “pre-pandemic” vaccines as they are attempting to estimate which influenza strain may make the jump to a pandemic and enable stockpiling and/or vaccination of at-risk individuals with the belief that the vaccine will mitigate symptoms and decrease mortality through cross-strain protection while a true pandemic vaccine is being developed/manufactured.

STEVE:  How long does it take to produce an epidemic trivalent vaccine and is it feasible to have the current H1N1 strain or “swine flu,” included in the standard flu shot this fall?

BILL:  That is a complex question. Do you include it as a 4th component? Replace one of the other A strains? Provide it as a separate vaccine? Manufacturers are currently trying to assess how much and of which type of vaccine they would be able to provide given a limited egg supply (since vaccine components require incubation in chicken eggs).  Chicken populations take a significant amount of time to increase to add egg capacity.  Seasonal vaccine antigen doses are typically 15µg and it takes approximately 1 egg for one, 15µg dose.  To date it has taken 90µg of antigen to show similar levelsof efficacy for pandemic vaccines.  Therefore, whether or not there is a sufficient egg supply and how that may impact the traditional epidemic vaccine is being discussed and calculated as we speak.

The length of time it takes to manufacture the epidemic trivalent vaccine depends a lot on the specific strains and how different the vaccine is from the previous year.  For instance, the 09/10 vaccine will contain 2 of the same strains as the 08/09 version, only the B strain is different.  The CDC put forward this years policy document on February 25th, identifying which exact strains were to be included in this year’s vaccine.  Many manufacturers had already started the production efforts on the seed strains guessing that these would be the strains based on available surveillance of circulating strains.  Typically the total process begins in December or January for most manufacturers.  Usually the first vaccines are ready to ship to distributors in August or September.  In certain years the process can take longer than usual because not all strains of influenza grow well in chicken eggs, including the recent H1N1 virus.  New “reverse genetic” techniques are helping to alleviate this problem but the rate of growth and yield of virus continues to be a concern to manufacturers.

STEVE:  Do you have any ongoing clinical trials for the H5 pre-pandemic flu?

BILL: Vaxin is currently completing a Phase I clinical trial for an intranasally delivered vaccine against the H5N1 influenza virus.  This is the first step in getting a vaccine approved for use by the FDA.  Typically Phase I trials involve a small number of otherwise healthy volunteers that agree to be vaccinated to allow us to test and ensure that our vaccine does not cause any serious unwanted safety concerns.  Vaxin’s study involved 48 people that were divided into 3 groups of 16.  Each group of 16 received a different dose of the vaccine on the first day and then received a second administration of a second dose 28 days later.  Within each group of 16, only 12 people actually receive the vaccine and 4 people receive a placebo.  Until the end of the study, no one knows who received the vaccine and who received the placebo.

STEVE:  The mortality rates for H5 influenza have been between 30% and 70%. Did this lead you to choose H5 as a focus for your pre-pandemic vaccine?

BILL: The focus on H5 as a target for pre-pandemic vaccines is a result of the high degree of mortality seen in those that have been infected with the virus.  While the 1918 flu had a catastrophic impact on the world and a large loss of life, it is estimated that the mortality rate was about 2%.  However, it was able to spread very rapidly. Similarly, other pandemics from H2 and H3 outbreaks had relatively low mortality rates (estimated to be between 0.1%-0.5% for both the 1957 and 1968 pandemics).

STEVE:  Can you speak about the delivery system you are using to deliver this vaccine?

BILL: Vaxin’s technology includes the use of another virus called adenovirus.  This is a virus commonly found in nature which typically causes mild respiratory illnesses or cold like symptoms.  It has a natural ability to infect humans at a very high rate.  We have modified this virus so that it can no longer reproduce and we have incorporated a very small piece of the flu virus into the adenovirus.  The adenovirus then infects people like normal but instead of making more adenovirus, it makes a piece of the flu virus.  The body sees this in the same way it sees the flu…as a bad foreign protein and jump starts the immune system to get rid of it.  In addition, our vaccine is given intranasally, the same way that the body normally sees both adenovirus and the flu.  We believe the body responds in a very similar fashion in identifying and clearing the potential threat.

STEVE:  Too many suffered complications to the H1N1 Swine Flu vaccine rushed through production in 1976; this leads me to ask if any corners would need to be cut, in terms of patient safety, to get a swine flu vaccine ready in time this year?

BILL: I am not familiar enough with the issues associated with moving the 1976 swine flu vaccine through the process to know about shortcuts taken, but the issues identified may still be issues.  The result however was a significantly higher incidence of Guillain-Barre Syndrome (GBS) in those vaccinated vs those unvaccinated; 13.3 vs 2.6 per millions of people contracting Guillain-Barre, respectively.  Note, significantly larger safety studies than are typically done for influenza vaccines would have been required to detect this event.

The current H1N1 swine flu vaccine would be against a very similar antigen and made with similar technologies for the most part and therefore the risk of GBS may still be prevalent.  This will be weighed as a risk/benefit calculation when deciding how to proceed.  It will depend in large part on the true mortality rate of the H1N1 swine flu vaccine.  This was originally estimated at about 10%, but as identified cases of H1N1 and associated deaths are “confirmed” as opposed to being “probable” cases and the reporting becomes more accurate, it is now about 1% and falling.  At 10% it is likely worth the calculated risk of GBS but at what point does the risk of death have a higher impact than the potential risk of GBS

STEVE:  What percentage of health care workers, in our country, typically receive a flu shot?”

BILL: Only 36% of health care workers in the U.S. on average receive an influenza vaccine annually.  (Source: CDC. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2003; 52 (RR8): 1-44.)  Therefore, with a disease that can be spread two or more days before a person is symptomatic, an individual healthcare worker has a tremendous opportunity to spread the disease, without knowing it, to a population that is likely very susceptible, those that are sick and immune compromised to begin with.

STEVE:  Do you have any suggestions for my colleagues and friends who tell me they get the flu from a flu shot?

BILL: It is scientifically not feasible to get the flu from a flu shot unless the vaccine has not been made appropriately and tested adequately.  The licensed influenza vaccines on the market today are primarily inactivated whole virus or split subunit vaccines.  Essentially the flu virus is grown in chicken eggs, purified and inactivated by heat or chemicals.  The virus is unable to replicate and therefore cannot cause the flu.  Usual side effects from any vaccination, because of the stimulation of a robust immune response from the body, include symptoms that some people associate with the flu, e.g., fever, body aches, sniffles etc.  These symptoms are typical of many vaccinations including flu.  Similarly in the new live virus vaccine (FluMist ®), the virus has been adapted to grow only in a cold environment.  Once in the body its ability to replicate is severely limited and again not feasible to cause the flu.

All in all vaccines are the most cost effective medical procedure invented.  Their use over the past century has saved millions of lives and untold expense with several previously common diseases now relatively under control or near complete eradication.  Many people do not realize the annual cost, in lives lost, hospitalizations and subsequent economic costs, that influenza outbreaks inflict. Our ability to track and monitor influenza outbreaks and continual improvements in technologies and manufacturing processes are allowing us to attack influenza with the same vigor.  While the world is more prepared than ever before to deal with potential pandemic influenza outbreaks, we still have room for improvement to ensure adequate, rapid access in all parts of the world.  Vaxin is hopeful that our technologies and products will continue to advance this effort for rapidly available, safe, effective, easy to administer vaccines.

Physicians And The H1N1 Flu

Yesterday I visited the Centers for Disease Control in Atlanta and was taken inside the command center, where almost 100 staffers have been working around the clock to monitor and stem the current outbreak of flu.

I first spoke to Toby Crafton, the manager of the command center, who oversees the day-to-day operations. He and his team have been preparing for a possible pandemic of flu or another infectious illness for years. I also spoke to Michael Shaw, PhD, who heads up the virology labs that are studying the H1N1 virus causing the current outbreak. He’s spent a career learning the laboratory techniques that are so urgently needed right now. The third person I spoke to was Dr. Richard Besser, Acting Director of the CDC, who has been working at the agency for 13 years and is an extensively published expert in infectious diseases.

I mentioned that last week I had received an email notification from the New York City Department of Health (NYCDOH) about how I should be managing my patients with flu-like symptoms. The advice was actually not intuitively obvious to me. For example, the Department of Health said that for patients with mild illness, treatment with anti-viral meds like Tamiflu and Relenza was only recommended for patients who also had underlying conditions that increased their risk for complications due to influenza. Dr. Besser pointed out that it was especially important right now for physicians to stay up to date with the recommendations being made by public health officials. Doctors can contact their local department of health and sign up for the same type of email notification that I received.

This brings us to the main point of today’s blog post. Many of us – patients and physicians alike – have been thinking about the influenza virus for about a week. Public health officials like the teams at the CDC and the NYCDOH have been thinking about it for years. Physicians, me included, are used to practicing medicine based on “clinical judgment.” We understand that medicine is an art and not a science, that there are many different ways to approach a problem, that there’s often no clear “right” or “wrong.” We are also used to doing things “our way”, whatever that way is. But this is not a time for doing things “our way” if it’s at significant odds with strong recommendations being made by public health officials. There are recommendations that may seem logical – like prescribing medication for somebody with mild flu symptoms “just in case” that nevertheless go against the judgment of people who have trained for years to think about how to deal with an epidemic.

What if you’re a physician who strongly disagrees with a suggestion of public officials? Then challenge that recommendation publicly. Bring the discussion to light; maybe you’re right. While this is no time to go rogue, doctors have an obligation to think carefully and independently and to challenge recommendations that seem illogical. But don’t silently do things your own way.

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