Scott McPherson's Web Presence

A few weeks ago, I had the absolute, unmitigated pleasure to attend and speak at the CIDRAP Summit in Minneapolis.  I had never been to Minnesota, and I was enchanted by the city and the adjacent countryside.  It quickly became one of my favorite states.

But I digress.  So there I was in the front row of the Marriott ballroom, on Day One, siting at the front table like a classroom nerd.  Joining me were (among others) fellow blogger Mike Coston, aka FLA_MEDIC, with his friend and lovely traveling companion, Blue from Flutrackers, aka Indigo Girl of allnurses.com, aka Camille. 

So there I sat, waiting for the keynote speaker, Dr. Juile Gerberding.  She, of course, is the immediate former head of the CDC.  I think we all have been fortunate enough to listen to and enjoy Dr. Gerberding's speeches over the years.  Despite the stress of watching her yard and garden fill with rising water as a result of the Atlanta-area flooding, she looked freed from the trappings of stress and headache which accompany anyone who wears the mantle of responsibility that she wore so capably during the Bush years.  In other words, despite the worry about her home and possessions, she looked great.

I think it was around the third or fourth slide that I suddenly sat up. 

For there, projected on the two giant screens, was a slide.

But not just any slide.

It was a slide of -- this blogsite!

My reactions were as follows.

1.  Well, I surely didn't expect to see that today!

2.  Don't call me Shirley.

3.  OhmyGod, what is she going to say about it?  Is she going to tear me apart in front of all these people?

4.  She said it was well-written!  She likes it! Thank you Jesus!

It really went that way.

So I wanted to give a heartfelt thanks to Dr. Julie Gerberding, who is an occasional reader of this blogsite.  Dr. Gerberding, you made my year!  Thank you for everything you have done, and continue to do, in the name of public health and preparedness. 

Between you and me, I also think that is one reason why I have not blogged in over five weeks.  I think it intimidated me that someone so important would be reading my blogs, that I want to make sure everything I write from this point on is of absolute quality.  I have always writen with quality in mind, but you know what I mean. 

Dr. Mike Osterholm told me afterward, "Scott, you really don't know how well-read your blog is, do you?"

No, Mike, I didn't know until that time. 

First off, let me apologize for my lack of blogs the past FIVE WEEKS.  As I always say, however, I will not blog if I do not have something to say.  There are others (Mike Coston, Crof, Revere) who get the job done day in and day out, and so I leave them to do their thing.

I have actually had plenty to say recently, but I flat out have not had the time to write.  So let me catch you all up on events in the McPherson household:

Wife is recovering from her chemo.  Daughter is fine and long-over The Swine.  However, son came down with H1N1 at his school in Long island, Stony Brook (Go Seawolves!).  I might add, they are 4-4 and are battling for the conference title, and my boy is contributing nicely as a D-lineman. 

Fortunately, I had delivered some Tamiflu for him (and his girlfriend) on our last visit.  Knocked it out of him within 36 hours.  Tamiflu is really amazing.  He also did the "double dose" on the first treatment, and I am more convinced than ever that this is an excellent way to go.  TomDVM agrees, as you might have read on a previous comment.

Work has also conspired to keep me occupied.  So now you are caught up.  However, within the past ten days there have been several news stories which I will attempt to take on with a sweeping (rambling?) monologue.

First, the issue of H1N1 vaccine shortages.  Why is everyone so worked up about these manufacturing delays?  Because someone(s) set the bar too high to begin with.  May I refer back to my previous blogs regarding the delays experienced by vaccine manufacturers in the late spring.  The seed stock was not efficient enough, and the virus was growing ever-so-slowly in eggs.  So the CDC, or the WHO, or whomever does these things, grew new seed stock and sent it out to the vaccine makers (all six of them, or however many there still be).

What is apparent from these delays is that the problem of slow-growing virus never truly went away.  And it would be very interesting to know exactly why the vaccine is moving so slowly down the pipeline.  Was the virus drifting during manufacture?  Was there just not enough yield?  Was the virus killing the eggs (which we have seen in H5N1 vaccine manufacturing)?  If the latter is true, then that is a cause for future concern.

Or were some policy-spinners in DC just too damn quick with promises of ample vaccine in the month of October?

One thing is for sure:  State and county health departments are having enormous difficulties in scheduling mass vaccination programs based on delivery assurances from Washington that are ringing hollow. 

Which leads us to the weekend declaration from President Obama that H1N1v has become a National Emergency.  Now before everyone gets too worked up about this, be assured that sometimes one has to move to this level in order to circumvent certain existing rules and policies that can combine to slow the treatment of patients. 

The declaration does several things.  First, it allows more flexibility in federal reimbursements for triage centers that may be set up hundreds of yards away from the hospital property, say in an elementary school cafetorium.  Second, it allows more rapid movement of people and stuff.  And third, it does re-focus attention on the existing problem of H1N1v.

So don't make too much, nor too little, about the presidential declaration. 

Now on to the BioCryst antiviral, peramivir.  Loyal readers of this Blogsite have followed my blogs about this Birmingham, Alabama-based company for years.  And it seems that, finally, it is positioned at the right place in the right time.  The FDA has given its approval for the emergency use of its injectable antiviral peramivir to very seriously ill H1N1 patients.  And none too soon, as both H1N1v cases and deaths continue to increase.  If they can keep enough medicine in the pipeline, we could have a very powerful weapon in the flu arsenal.

Now for my feeling of unease.  Here in sunny Tallahassee, we have seen a spike in the number of flu cases, followed by a lull, and then another recent spike.  In Florida, we are seeing an average of ten deaths per week directly attributable to "lab-confirmed" swine flu.  Who knows how many other deaths we have missed; that will be worked out by the statisticians later on.

But I just don't feel like we have seen everything this virus can deliver yet.  I am looking at the latest Florida statistics as I write this.  Leon County (Tallahassee) is currently not reporting widespread flu activity, a trend that seems to be repeated throughout the urban areas.  In the meantime, the virus is considered widespread in southwest Florida, a haven for retireds and winter residents.

What really distresses me are the Florida flu map's shaded areas that signify "no report."  There are about a dozen "serial non-reporters," county health departments who have not reported their status the last two weeks in a row.  Most of these are in the Panhandle and the "Big Bend" area that joins the Panhandle to the peninsula.  Don't they know there's a pandemic on?  If they are not reporting their status, how do we know if they have recorded any deaths attributable to flu? 

Rant over; now back to the issue at hand.  I am likening my feeling to the calm that precedes the storm.  This virus, I believe, is still far from having finished seeding itself across the globe.  Nor do I believe the virus has finished its first wave across Asia.  It moved so quickly across the industrialized world, then resumed its regular pace (or has seemed to me to do so) as it crossed those areas where transportation is basically unchanged from what it was fifty years ago. 

For much of the developing world, the first "seed" wave is still upon them, even as we move into what will certainly be known as the pandemic's second wave in the Americas.  Just how long it will take for this virus to emerge from Asia, and what form it will take once it does so, is the subject of much speculation.

And while schoolchildren are understandably getting a lot of attention as victims of this virus, here in Florida, look at the faces of death over the past three weeks:

A 20-year-old female in Alachua County, a 52-year-old female in Baker County, a 24-year-old-female in Citrus County, a  49-year-old female in Miami-Dade County, a 78-year-old male in Miami-Dade County, a 53-year-old female in Hernando County, and a 15-year-old male in Volusia County. A 49-year-old female in Broward County, a 49-year-old female in Miami-Dade County,  a 67-year-old female in Miami-Dade County, a 50-year-old female in Duval County, a 47-year-old male in Lake County, a 37-year-old female in Manatee County, a 35-year-old male in Pasco County, a 43-year-old female in Pinellas County,
a 50-year-old female in Pinellas County, a 56-year-old female in Polk County, a 58-year-old male in Volusia County, and a 10-month-old female in Sarasota County. a 51-year-old male in Brevard County, a 55-year-old female in Charlotte County, a 62-year old female in Desoto County, a 51-year-old female in Hillsborough County, a 30-year old female in Lee County, a 55-year-old male in Monroe County, a 33-year-old female in Okaloosa County, a 45-year-old male in Pasco County, a 64-year-old female in
Pinellas County, and a 45-year-old male in St. John’s County.

That is an average age at death of 46 years.  It will be interesting to see just how far upward the average age at death is trending nationwide.  But in Florida, where the average living age is older than most states, it appears as though the virus is taking a wider swath of victims -- and what that may portend for the coming months is unsettling. 

Recently, I was sitting in my dentist's chair when an assistant remarked she could not receive flu vaccine due to her allergy to eggs and egg products.

I listened intently and replied,

"Cauuuuuuggggggwwwwwllllllhhhhhh.  MMmmmugggggggwwwaaaaaawwwwaaahhh."

After the assistant removed all the stuff in my mouth, I then translated:  I would check this out and get back to her.

Well, I happened upon the insert to the monovalent H1N1v vaccine manufactured by Medimmune. Medimmune manufactures a live virus, intranasal vaccine principally for youth, and they are one of the four FDA-approved pandemic vaccines.

But I noticed this entry:

4 CONTRAINDICATIONS
4.1 Hypersensitivity
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions, to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.

Likewise, I also saw this factoid:

------------------------------DRUG INTERACTIONS-------------------------------
• Antiviral agents active against influenza A and/or B: Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal until 48 hours after antiviral cessation. Antiviral agents should not be administered until 2 weeks after Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal administration unless medically necessary.
(7.2)

So, you have to be off Tamiflu and Relenza for at least two days prior to accepting this vaccine into your schnozz.  Probably because FluMist is live virus, and the antivirals might kill the virus before it helps you.

Finally, immunocompromised persons should not receive the vaccine intranasally. 

5.4 Altered Immunocompetence
Administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, or FluMist live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

I had never realized that FluMist was not for persons with sensitivity to eggs.  So in the event others thought as I did (or did not), this is offered as a helpful; and potentially lifesaving reminder.

Buit wait, you say!  Wasn't there word Novartis was making a vaccine from cells, rather than eggs, and they had whipped up a whopping ten liters of vaccine?

That's what the media ballyhooed.  But again, directly from the Novartis package insert:

CONTRAINDICATIONS
•
History of systemic hypersensitivity reactions to egg proteins, or any other component of Influenza A (H1N1) 2009 Monovalent Vaccine, or life-threatening reactions to previous influenza vaccinations. (4, 11)

So there you go.  None of the four vaccines can be taken by persons sensitive to eggs.  I am unsure how much of the US population falls into that category, but I am betting it is a significant number.  Better save the antivirals for them!  Easpecially persons with egg allergies and under age 50.

Scott

PS.  I will try to blog from the CIDRAP Summit in Minneapolis.  Mostly, I hope FLA_MEDIC and I get around to some used book and comic stores! FLA_MEDIC should be quite the celebrity after this is all said and done!  He is appearing with Robert Bazell of NBC News, one of my favorite correspondents, and Katie Couric's producer.  The print editors are no slouches, either. 

I think I will tell Mike some Katie Couric stories when she was a cub reporter at Channel 4 in Miami and I ws running for office......

As I speculated last week, as a durect result of tests showing only one vaccination might be required to confer full immunity to H1N1/2009 "swine" flu, the WHO is asking the wealthier nations to donate vaccine to the poorer nations.

I had speculated that the United States should seriously consider this option, as long as we could also gain a functional amount of "herd immunity."  Go back two or three blogs and you will find the story, dated 9/11/09.

Here is the story from Bloomberg.  Remember you can always count on this blogsite to give you good, informed speculation.  Share it with your friends!

One-Shot Swine Flu Results May Spur Vaccine Sharing, WHO Says

By Michelle Fay Cortez

Sept. 16 (Bloomberg) -- The World Health Organization is in talks with the U.S. and other developed countries about using pandemic flu vaccine from their stockpiles for poorer nations after studies suggested only one shot is needed for protection.

Half a dozen trials released in the past week found a single injection of swine flu vaccine protected most healthy adults from the virus known formally as H1N1, with infection- fighting antibodies produced in as little as eight days. U.S. regulators approved shots from four manufacturers yesterday, clearing the way for immunizations to start within weeks.

“This is all contingent on these early reports” from the studies, said David Mercer, acting head of the communicable diseases unit of the WHO’s European region, which met in Copenhagen this week. “It may be possible that a single dose is protective, which would double the number of people that could be immunized.”

Public health officials expected it would take two doses to trigger immunity to the infection, a novel mix of swine, avian and human influenza. Countries including the U.S., U.K., France, Belgium, Finland, Sweden and Australia have already placed orders for the vaccine. Additional studies are needed to confirm the finding that only one shot is needed and can ensure protection for children and other high-risk groups.

“Some countries may have excessive stocks of vaccine and some won’t see the demand they have expected,” said Thomas Zeltner, director of Switzerland’s Federal Office of Public Health. “What is needed here is a good dialogue to ensure the reasonable use of vaccination.”

Active Discussions

The U.S. is in “very active discussions” about donating some of its supply to countries that need it, said Nancy Cox, director for the flu division of the U.S. Centers for Disease Control and Prevention. The U.S. has about 600 million doses in advance purchase agreements from GlaxoSmithKline Plc, Novartis AG, CSL Ltd., AstraZeneca Plc and Sanofi-Aventis SA.

In a best-case scenario, the U.S. may need only half that amount, said Rebecca Martin, medical officer at the United Nations health agency’s European communicable diseases unit. It’s too soon to know if that will be the case, she said.

“We welcome the initial findings of some clinical trials,” WHO Director-General Margaret Chan said in a statement. “We cannot conclude now how many doses would be required for different groups.”

The U.K., which has ordered 132 million doses, is still planning two shots for each person and is monitoring the clinical trials, according to a Department of Health spokeswoman who declined to be named in line with government policy.

Age Groups

More data from the studies will be coming in mid-October about how effective the vaccine is in different age groups, Martin said in an interview.

“This is not just in the European region,” Martin said. “We’re all dipping into the same pool of vaccine.”

CSL, based in Melbourne, said it plans to donate the vaccine to developing nations in Asia and the South Pacific and is discussing a pilot program with the WHO to start by providing as many as 100,000 doses. Paris-based Sanofi, London-based Glaxo, and Basel, Switzerland-based Novartis are among the other companies making the vaccine.

As many as 2 billion people, or 30 percent of the world’s population, may become infected by the new virus as it spreads globally, according to the Geneva-based WHO. While fewer than 0.5 percent of sufferers may need hospitalization, those who do may require critical care for up to three weeks, overwhelming intensive-care units.

Concern that vaccine bought by governments might not get used by their people may make countries more inclined to share supplies with poorer nations, said Marie-Paule Kieny, director of the WHO’s Initiative for Vaccine Research.

“Some countries may take a more altruistic view now,” she said. “We will see this fear of not being able to use all of it and concern of public money being spent unwisely, and you may now start to see generosity mushrooming.”

###

Deep lung infections are becoming more common as the virus spreads across America again.

Despite being nicknamed "swine flu," H1N1v, or H1N1/2009, is a triple-threat of influenza.  It is one-third avian, or bird, flu; one-third swine flu; and one-third human flu.

And to even call this new pandemic strain "swine" flu really is a misnomer, since we gave the pigs the virus to begin with.  As Shope and others proved many years ago, pigs caught H1N1 from humans back in 1918, probably in the Midwest, probably Iowa. Swine H1N1 is the closest antigenic match to the 1918 pandemic strain that there is, because it has not been subject to all the mutations that human H1 has.

The pigs should probably sue for defamation of character.

OK, that's out of the way.  As I just mentioned, this pandemic virus is 1/3 human flu, 1/3 bird flu and 1/3 swine flu with antigenic similarities to 1918's pandemic virus.  And I believe that, in some people, those last two parts of this strain occasionally flare up and cause severe lung infections.  And death.

There are myriad reports available now, all of which detail the (thankfully) infrequent deep lung infections experienced by victims of H1N1/2009.   

But first, my speculation:  I think that currently, and in the lion's share of cases, H1N1v is a mild, relatively harmless virus.  But once in a great while, it "runs home to Momma."  Momma, in this case, comprises the real origins of the virus:  The 1918 pandemic strain, plus bird flu.  In both cases, the flu virus penetrated/s deep into the lungs and did/does its damage there.  Without Tamiflu administered quickly and decisively, this virus can cause ARDS, or Acute Respiratory Distress Syndrome.  We have seen this phenomenon time and again in Vietnam, Indonesia, Egypt, China, and everywhere else that H5N1 has gained any foothold in the human population. 

It is precisely these exceptions that make me nervous.  As more and more people catch this disease, we will see more and more cases of ARDS in victims.  The more we see ARDS-related flu cases, the more that particular phenomenon could turn into a much more frequent occurrence.

Now let me shift gears and talk about the three confirmed species jumps this virus has made.  In Canada and Australia, the H1N1v virus has returned to its swine roots, infecting pigs on farms in those nations.  A small number of hogs became sick, but enough to provoke concern among hog farmers everywhere.

And in Chile, turkeys have been sickened by H1N1v.  In all these cases, the virus retained enough of its original genetic material and proclivities to infect multiple species.  This tells me, as a layman (but a well-informed layman, to be sure) that this virus is fully capable of vacuuming up whatever genetic material it wants from whatever source, without sacrificing its ability to infect humans.

This is one big reason why I listened carefully to the words of virology professor John Oxford of Britain's St Bartholomew's and the Royal London Hospital.  Dr. Oxford is one of the biggies in flu research; a man who bridges the span between Kilbourne and Webster and Kawaoka, who knows pretty much every researcher on the planet, and whose opinions deserve respect.  Dr. Oxford made headlines recently when he prognosticated that the spring, and not the fall, will mark a decided turn for the worse with H1N1v.

A link to that story is at:

http://www.straitstimes.com/Breaking%2BNews/World/Story/STIStory_422344.html

Here is a snippet from that story:

'For the moment, the virus is running around the world finding lots of young people and infecting them. It is doing very nicely, thank you, why should it change?", he said by phone.

'But once the virus has infected about a third of the world's population - which is what we expect - it will find less 'susceptibles'. That is when mutants will have a selective advantage.' It would be a serious mistake to think that once the impending flu season is over, the danger will have passed, he added.

Prof Oxford said he had just returned from Australia, where he met front-line doctors who were concerned about an emerging pattern in swine flu patients.

Whether they are people in high risk groups - the obese, pregnant women, asthmatics - or young adults with no underlying conditions, an alarming number of patients wind up in intensive care units. 'One minute they are okay in a hospital bed, the next minute they are in intensive care,' he said.

There have been more than 100 confirmed deaths from the pandemic H1N1 strain in Australia, which is just emerging from the southern hemisphere winter. Epidemiologists sifting through data from other countries have also found similar - and disquieting - patterns.

French epidemiologist Antoine Flahault reported a 100-fold increase, compared to seasonal flu, in the number of swine flu deaths in Mauritius and New Caledonia attributed directly to the virus itself rather than secondary bacterial infections or underlying conditions.

Many of those deaths were caused by acute respiratory disease syndrome (ARDS), which requires intensive-care treatment for an average of three weeks.

Only 50 per cent of ARDS patients survive. -- AFP

I intend to cover Dr. Oxford's theory more fully in a separate blog regarding pandemic waves.  But I do want to forward a theory of mine, which nests nicely with Professor Oxford's.

This virus has seen a dramatically accelerated pattern of movement in the industrialized world.  Dr. Chan of the WHO has said this is the fastest-moving pandemic in recorded history, which should surprise no one.  We are moving faster than at any other time in recorded history. 

However, when H1N1v hit Asia, it took on a more familiar pandemic timeframe.  This, in my opinion, has left the world watching what I would call two pandemic waves.  One is the accelerated and elongated wave which never, ever really subsided and which may or may not now be considered the second wave of the virus; and one is the traditional, plodding, months-long Asian/Indian/African/Middle Eastern wave. 

The following corrorborative data is from the WHO, and is current as of 6 September 2009.

Note that the total of the two Asian reporting regions is about half the cases from the Americas and Europe combined. 

Look at recent news reports to see how long it has taken this virus to seed India alone.  Admittedly, information is difficult to come by within Asia, especially China, on a good day, let alone during a pandemic.  But it feels like the virus is plodding along in the interior of those remote countries.  What the virus is doing in there, and what other flu virus it is coming into contact with, are anyone's guess.  But I am not optimistic about what may emerge from the other side.

Anyway, I see the intersection of these waves -- the Core's first wave (to use the definition of the industrialized world according to Thomas P.M. Barnett), and the developing world's second wave -- sometime in the spring of 2010.  It is at that juncture that the virus may change, having exhausted a significant source of carriers to the milder form of the virus.

Well, as Forrest Gump would say, that's all I have to say about that.  To say any more would deprive me of the opportunity to write that other blog. 

Another news story, this time from India, would tend to support my speculation.  Public health officials are claiming a viral mutation has been discovered in a district there.  There are other reports, awaiting confirmation, that a mutation in the PB2 gene segment has begun to appear that would make transmission even easier than it is today.  H1N1v still retains avian proclivities to infect at higher temperatures (birds have higher core temperatures than we humans do).  One reason why H5N1 has not "caught on" yet is that it refuses to shed that avian gene segment, known to researchers as E627K, on the PB2 strand. 

Some speculate that E627K may explain why H1N1v never went away in the summer.  It actually liked the warmer temperatures!  And sensing, somehow, that colder temps are on the way, its Darwinian mechanisms would logically prompt it to seek out a more reasonable thermometer -- a change in that genetic position, which it would probably seek to acquire from seasonal influenza.

If there is a shift in E627K toward human respiratory temperatures instead of a duck's intestinal temps, this virus could become quite perilous.    

So let me sum all this up.  I believe H1N1v, for reasons yet unknown, occasionally decides to return to its infectious origins and cause severe and occasionally lethal infections.  The virus retains enough of its original genetic material to have spawned species jumps to pigs and birds in the spring and summer, and there is no reason to believe it has not continued to do so.  And we have not seen abatement of the virus' first wave in the Asian and Indian regions, and so we should assume the virus' first wave continues to traverse those regions.

For these reasons, it is absolutely imperative that we remain vigilant and watch carefully for any sign that this virus has become more virulent and more severe.