VFW Post 9876 Surgeon

Barely 120 people in the entire world have even had it. Of course, of those, 50% died from it. Not a promising ratio! But the good news is that bird flu is still mainly a disease of birds. The bad news is that it might not stay that way.

Bird flu is spreading around the world as migratory wild birds make their annual rounds. These wild birds come in contact with chickens and ducks that are being farmed for meat and they spread the infection. Those people who have had the disease have for the most part had close and prolonged contact with chickens or ducks. So far there has been no clear case of it spreading efficiently from one person to another. This, however, is the big fear.

It is entirely possible that the H5N1 virus that is currently in the news will transform into a deadly virus that will kill millions. But it hasn’t happened yet. It is appropriate and imperative that governments around the world prepare for that possibility, but we as individuals need not be too concerned or to do anything, yet.

The problem for scientists and governments is that we are not yet in an epidemic or pandemic situation. So developing a vaccine is problematic at this time. A vaccine against what virus? The exact virus that may lead us there has yet to arise.

There is another interesting twist in this situation. Influenza vaccine is produced by initially growing the virus in eggs. Since the virus in question is a bird flu, it often kills the chicken embryos in the eggs used to try to make the vaccine. Therefore, the vaccine is harder to mass produce even if they had the correct virus. Entirely new methods might have to be found!

The disease that we commonly refer to as flu or influenza is not one disease with one cause, it is actually a set of symptoms: fever, body aches, cough, respiratory and/or GI upset. Each year a new virus is generally the cause of these symptoms. Another good feature about flu is the once you get over it you are generally immune to that particular virus and partially immune to closely related viruses. This, plus the fact that these viruses tend not to change too much, usually makes the flu a fairly benign, if uncomfortable, disease. The more times, the more strains of flu, that you are exposed to the greater the likelihood that you will be at least partially immune to the next one.

Flu viruses change easily. They can combine with other flu viruses to form new strains. Scientists use two terms to describe this tendency to change: drift and shift. Mostly, the viruses will drift = change just a little. When this happens the immunity that we have from pervious infections helps to make the symptoms milder. But a shift is more serious; the change is greater. That is what has happened with H5N1. It is very different from the “ordinary flu” viruses that we have seen over the past few decades.

This is the reason why 50% of those infected so far have died. Their bodies simply couldn’t handle it. In a normal year, flu kills a lot of people. But it kills at a very low rate – very, very few of those who get sick actually die – and those are most often the young and the old. The young because they have been exposed to very few similar viruses and have little or no immunity. The old because as we age our ability to react wears out. Also, they are more likely to have some other disease (lung or heart problems) that reduces their ability to survive a simple flu infection. The flu virus that spread around the world in 1918 killed a disproportionate number of young men and women, not just children and old people. In some places, as many as 20% of the ill died. Since H5N1 is similar to that virus, that is the great concern.

There are lots of flu viruses. Not all f them infect humans. Flu viruses almost always arise out of animals and most often in Asia, especially China. Birds are the likely source of most flu. It’s what happens next that is important in whether or not it becomes a problem for people. The life-style of the people in southern China has many of them raising chickens, ducks and pigs for food. These animals live in close proximity to the family, often under and around, if not in, the house. The virus often moves from the birds to the pigs. For purposes of disease and immunity, pigs and people are very similar. Also pigs are extremely good incubators of viruses. A few go in and a lot come out. They are known as amplifiers. So, the pig gets infected from the bird and then passes it on to its human keeper. Of course, the virus can go directly from the bird to humans as is happening in most cases of bird flu currently.

But there is one more factor that can intensify the effect of the virus. If in either the pig or the human, the new bird virus meets up with an older human virus (yes, pigs and humans sometimes share the same viruses) then the new bird virus can recombine with the old virus and change into one that more easily infects humans.

A true bird virus will infect pigs easier than humans, but a recombined virus might be able to infect humans more easily. That is the big concern. So far this H5N1 virus is generally unable to move from one human to another. So, if you don’t raise chickens or ducks or handle recently killed chickens or ducks, you don’t have anything to worry about at the moment.

But should one of these people who are raising or handling recently killed chickens or ducks get infected and already be infected with an older flu virus, their recombination could result in a virus which jumps much easier from human to human.

We think of flu as a respiratory disease. Indeed, it does infect the lungs but it is not spread only but breathing it! Flu is mainly spread by contact. The infected person sneezes or coughs while covering his mouth with his hand. Now the virus is on their hand. That virus is then transferred to anything he touches. Doorknobs, handles, objects on display in a store all can have the virus on them. Fresh foods and vegetables in open bins that people can touch are easily covered with the virus. So the infected person doesn’t have to sneeze on you. You never even have to see him. He can leave a trail of virus wherever he goes! Worse still, he does not even have to be openly ill to be capable of spreading the virus. The virus is coming out of his lungs before he has a fever or any other symptoms.

You unsuspectingly come along behind this infected person and touch the same object. Maybe you buy the item that he just deposited the virus on in the store and carry it home. You get infected.

If and when the H5N1 virus transforms into a major epidemic, you should consider other measures as well. For one, the more direct contact you have with people the greater will be your chance of getting infected. Places like bars and restaurants will need to be avoided. Because of the number of people who congregate there as well as the likelihood that the glass or plate or fork has been touched by multiple people, they could be a major source of infection.

Obviously, all human contact cannot be avoided. People will tend to try to isolate themselves from others. Many will hide behind masks. Those cloth or paper masks that folks tend to wear in these situations, especially in Asia, can’t do much harm but they don’t do much good either. They in no way act as a filter or gas mask! At worst they provide a false sense of security. Perhaps the single best reason to wear one would be to prevent you from touching your own mouth or nose. Even if you touch something that has the virus on it, it can’t penetrate your skin. It has to get into your lungs via your nose or mouth. Until you have a chance to wash your hands, you need to avoid touching your mouth or nose. This is very difficult for most of us to do, hence the ease that flu spreads. People everywhere will need to become more conscious of contact with the things that they encounter every day as being likely sources of infection. Fruits and vegetables will need to be washed before eating. Even those things that we’d normally peel and throw away the peeling can have the part we eat contaminated by the knife used to peel it. Of course, cooking will kill the virus. But items like fresh salads sold in store will need to be avoided.

If worse comes to worse, what we will find ourselves with ‘outdoor’ clothes. You’ll wear these to go shopping, for example, but change immediately after coming home and wash them before putting them on again. Masks and even gloves (plastic or otherwise) could become a common fashion accessory.

But the most important action will be to wash your face and hands often in an effort to avoid infection. I can’t emphasize that enough. The most effective preventive method is hand washing; washing with simple soap and water. Anti-bacterial soaps is ineffective since the agent is a virus not a bacteria. Some of the water-less, alcohol-based hand cleaners may be better than nothing if you cannot wash your hands with soap and water readily.

If things get really bad, going out in public will be limited as well. Any place where people gather in close proximity, e.g. theaters, will simply close for lack of patrons. Outdoor activities will be better than doing anything indoor, even outdoor restaurants will be better. Schools will likely have to be closed. One reason is that (as noted above) children are more easily infected, thereby carrying the infection back into the home.

Air travel, both because of the prolonged time in close proximity as well as the fear of spreading the infection from one point to another, will drop-off initially, but would likely pick-up again after the entire world is infected; not every person but every place.

One good piece of news for those of us who live in the tropics is that flu viruses tend not to do as well there. Flu is a winter disease in temperate climates. It simply doesn’t thrive as well in the tropics. The precise reasons for that aren’t known; just the basic fact. One good way to avoid infection might be to take a prolonged vacation on a tropical beach. Sunlight also tends to kill these viruses!

There are really only three ways to deal with viruses. The first and foremost is avoidance. Don’t put yourself in a position to contract the virus. Wash your hands or otherwise interrupt the spread of the virus.

Second is a vaccine. There is currently NO vaccine that directly protects anyone from the H5N1 avian flu. The vaccine that is given out for the flu season annually is the world’s scientists’ best guess as to which flu viruses will circulate and cause disease in that season. They watch the spread of the various viruses and try to anticipate which three will be a problem. Unfortunately, it takes so long to make the vaccine that they need to decide based as much on an educated guess and hard data.

Last, and least, are anti-viral drugs. Antibiotics treat bacterial infections. Penicillin, tetracycline, and doxycycline are common antibiotics used to cure common infections. They do nothing for viruses. That is why it is a bad idea to take antibiotics when you have a simple cold. They are completely useless against viruses.

Much has been learned in the past 20+ years about drugs to treat viral infections from the work with AIDS. Notice I used different words. Antibiotics can indeed cure bacterial infections. Anti-viral drugs only treat viral infections. The only way one gets rid of a virus is to have the body’s immune system control and destroy it. Anti-viral drugs generally just slow down the spread of the virus in the body while the body’s immune system kills it off.

Many common vaccines are directed at strengthening the body’s ability to fight viruses. But as noted there is still no vaccine for avian flu.

A couple of anti-viral drugs seem to be effective in helping the body fight off avian flu. All anti-viral drugs suffer from the same short-coming. They are most effective before you know you need them! By the time you are infected to the point that your body is reacting with symptoms like a fever or cough, the virus has spread in large numbers in your body. This is the reason you feel sick! To be most effective in controlling the amount of virus in your body, you should begin to take the anti-viral drugs immediately after you come in contact with the virus, while its numbers are still minimal. Unfortunately, you have no way of knowing that you just came in contact with a virus. It is only after the virus has invaded and established a beachhead and begun to reproduce in huge numbers that your body reacts with symptoms like runny nose or fever.

To be most effective, you should take the drug before you come in contact with the virus, so it is already on board, like a defensive line, when the virus invades. There is not enough anti-viral drug in the entire world to make this practical!

Plus there is the problem of resistance. The over use of anti-bacterial drugs has led to resistant bacteria. The same will happen with any virus. Anti-viral drugs are rarely used outside of the treatment of AIDS. They are often too expensive and too ineffective to use. But if more and more people try to use anti-viral drugs, surely the virus will adapt and be able to live even in the presence of the drugs. This is called resistance.

This is a major danger with these drugs. If someone has symptoms of flu and takes an antiviral drug for 2-3 days, he’ll likely feel considerably better as the drug suppresses the virus. He’ll be tempted to stop taking the drug before the recommended 5-day course. This behavior will contribute to the virus developing resistance. People catching the virus from him and all those down the road will benefit less, if at all, from these drugs.

Avoidance of contact with chickens, ducks, turkeys and other birds is a good idea.

If you are over 65 or have lung or heart disease or a chronic condition like diabetes, you should get the annual flu vaccine. For those living in the tropics this is less of a necessity unless you plan to travel to Europe, America or some other cold climate between November and March. There is likely to be a run on flu vaccine since some people will assume that it will protect them against avian flu – it won’t. But it will protect you from the common flu in circulation.

Consider that mask, but understand that it is not a barrier like a gas mask!

For those of you who don’t like the layman’s approach and feel you need something more authentic, I suggest that you explore the CDC and WHO web sites. To provide a URL here is likely to lead you to old information as they post updates.

There is an aspect of this situation that bears clarification. As of this writing, the H5N1 strain of flu remains a disease of birds. Those humans who have had the disease were incidental side-tracks. The “pandemic flu” that is receiving so much attention hasn’t happened yet! In order for this to happen, the avian flu virus will need to find a way to infect humans as easily as it infects birds. That has not happened yet!

Right now about 50% of all the people who have had this disease, all of whom have had direct contact with birds, have died. A death rate like that cannot happen in a pandemic. If it did, the human race would be doomed. As bad as the pandemic of 1918 was, its death rate was 1-2%. That is, less than 2% of every one who got sick died. Yet about 50 million people died world-wide; all in less than a year. If 80% of the current world’s population were infected and 2% died, that would mean the death of over 100 Million!

A normal flu kills less than 1% of its victims. But flu spreads rapidly and extensively. So while it might seem like a large number of people die, they are only 1% of those who are ill.

Planning models say that every infected person will infect 2-3 others and those people get sick in about 3 days. That means that if a person gets off a plane and introduces flu into a new city, within 30 days he has caused about 1000 people to become ill. The remarkable thing is that this true of each of those 1000. Each one will be the seed for a thousand more cases! On the bright side, less than 1% of those will die.

A normal, annual epidemic of flu burns itself out over the period of a few months (usually but not always over the winter season) when around 80% of the population is exposed and becomes immune (or dies). A pandemic strain could not sustain the death rate that the H5N1 virus shows now in humans. Very quickly there would be no humans alive in most places to get sick.

What the scientists are waiting for is that mutated virus that looks like bird flu but is able to easily infect humans. This will occur when the current H5N1 virus meets up with a different, but similar, virus and recombines its genes. The good news is that most human viruses are not killers – at least not at a rate more than about 1%. So it is almost certain that the mutated virus will adopt that aspect of the human virus at its core.

Viruses are parasites. They depend on the host to reproduce billions of copies of themselves and then send them off in search of new hosts to infect. Parasites that kill the host are not very effective. They need a living host to sustain their life. Luckily humans (and many animals) have developed immune systems which allow us to first control and then wipe out the attackers, but not before 1) we are sick and 2) billions of copies have been made.

So, in short, there is no reason to be rushing around trying to make millions of doses of a vaccine to make humans immune to the current H5N1 virus. Should a pandemic occur, it will be as a result of a similar – cousin – virus if you will, not THIS virus as we see it today.

Giving vaccines that protect against other known human viruses to people who have direct contact with any types of birds is not a BAD idea, but it is not the answer either. The flu vaccine protects against three different viruses; only two of which are similar enough to the H5N1 virus to recombine with it. These are not the only flu viruses circulating in the world. They are just the most common, at this time. So, this is not a good solution. All we can really do is wait and watch and see what happens. Then try to react as quickly as possible when the new, pandemic strain of the virus appears somewhere in the world. Since the bird flu is spreading rapidly to most parts of the world, the meeting with another human flu and the recombination could take place almost anywhere. It does not have to happen in Asia where the H5N1 virus was born.

As I said at the outset, there is nothing to do now. The world’s scientists can’t really do anything either except to plan for what to do when…

Top Ten Dumb Guy Tips for Avoiding the Bird Flu:

1. High fever
2. Congestion
3. Nausea
4. Fatigue
5. Aching in the joints
6. An irresistible urge to shit on someone's windshield.

Health authorities in Vietnam have reported that one of the cases of bird flu in that country has a mutation in the virus that makes it easier for it to infect mammals. The change is to one gene called PB2. It is not known if this has any direct affect on its ability to infect humans.

For the more technical-minded among you I include the attached graphic copied from The Nation newspaper. It shows clearly how the N-proteins (shown in red) and the H-proteins (shown in yellow) are on the outside of the virus shell. These affect the way the virus enters and exits the cells of the body. They are also what the body “sees” and makes antibodies to. They are responsible for the naming of the flu virus. In this case H5 & N1.

Viruses in general are little more than pre-programmed reproduction robots. All viruses of any kind really do is infect cells and turn them into virus factories. Those new viruses break out and infect new cells and make more viruses; all this until the immune system kills of the viruses. The most successful viruses do not do enough damage to the host to kill it. They need it to stay alive to keep making virus particles for as long as possible. Some of those then will find their way out of the body of the host to a new host and begin the process again. For the virus to survive, the host needs to stay alive at least long enough to transfer some viruses to another host.

As noted above, the mutation of the H5N1 bird virus to be truly transferred from person-to-person as a common flu is, will likely mean that it will lose some of its lethality. But the news out of Vietnam is NOT good. It means that, in at least one case, the virus has taken a step in that direction. By the way, Vietnam says the person who had this particular strain of the virus died.

There are some valuable lessons to be learned from the ‘SARS problem’ a couple of years back. The most valuable of these is that quarantine works! The ‘SARS problem’ was prevented from becoming a major world-wide event by swift and decisive actions.

One thing that made SARS quite different from the bird flu that we are currently looking at is that SARS emerged into public view as a full-blown human disease. SARS was named before the actual cause was known. SARS was a “problem” because it killed and killed fast. Within a matter of weeks after the first cases were noted, a reasonably effective treatment had been devised. The problem was that the disease progressed so quickly, that many people were too far along in the disease process before they sought medical care. They were beyond the point of help and died quickly. The death rate for SARS was just about 5%. Remember, the common flu only kills about 1% of those infected and the 1918 pandemic had a death rate of <2%! For a disease, 5% is a very high number.

It only took a matter of weeks (a couple of months) for the virologists to isolate the virus that caused SARS. It was in the same family of viruses that causes the common cold. It was completely un-related to the flu viruses. But the SARS virus was also a very different. No human had ever seen a virus quite like it. Hence the fact that it made people very sick very fast and killed many. No one had any immunity, even partial immunity, to it. So it spread easily and it acted quickly.

Luckily, the world’s medical authorities acted quickly as well. Although a fairly large number of countries had cases of SARS, the hardest hit were China (where it started), Hong Kong and Singapore. We know a whole lot more about what happened in Hong Kong and Singapore, than we do about China. Because the Public Health authorities acted quickly and decisively, SARS was quickly contained and simply died out – for the most part. Hong Kong killed every chicken and duck in every market on the island and banned imports from crossing from China. Singapore rapidly quarantined the family and close contacts of every new case. They closed all the schools and forbade large public gatherings. Luckily, too, both Hong Kong and Singapore had very sophisticated medical facilities that could effectively treat people if they were found early enough. China was not as lucky and likely a much larger problem and number of deaths than they admitted to.

There is no question that birds and some small mammals like pigs and civets played a role in the development of the SARS virus, but the animals played almost no role in the human cases. All the humans got it from other people, many of the infected cases were hospital workers who took care of the earliest cases, before the severity of the disease was recognized. Singapore eventually dedicated one entire hospital to treat all – and nothing but – SARS cases. By concentrating the medical treatment expertise and the equipment needed, they were successful in saving many infected people. Likewise the bold act of ‘shutting down’ Singapore had the desired effect and, after a few weeks, the virus died out.

It is quite likely (as was noted above) that drastic measures, like closing schools, theaters, bars and postponing all sporting events, will be needed (and fast) if the avian flu virus begins to circulate easily among humans.

Talk of vaccines and anti-viral drugs is fine. But things like that take time and money – too much of both! An order to close schools is cheap – except one has to accept the eventual cost to the country’s and the world’s economy that such an order brings.

A few simple measures have proven to be effective in decreasing transmission of illnesses such as SARS. These measures include:

• washing your hands often, especially if there are ill people around you
• touching your face less often (to decrease moving infectious particles on your hands to your mouth and nose)
• covering your mouth and nose if you cough or sneeze
• decreasing unnecessary time spent close to others who are sick

It goes on to say: While the medical community continues its aggressive research into this disease and possible preventative measures, if you take the precautions outlined above, you will decrease your chances of getting SARS (and many other common
illnesses).

No vaccine for SARS was ever developed. No better treatment was found. Essentially, SARS died a natural death and the world at large lost interest. Hopefully, the world’s medical planners have not forgotten the lessons of SARS and will use then should the Avian Flu become the next pandemic human flu!

AVIAN FLU #10 — 15 NOV 05

The Swiss drug-maker Roche has embarked on one of the best marketing scams of all time. And it is perfectly legal. In fact, it makes them look like saints. All the while they are really devils in disguise. They have mounted a major marketing effort to assure the world that they are making enough Tamiflu for the entire world. This makes them seem like they are the saviors of the world! High-paid consultants are urging major corporations to stockpile Tamiflu for use by their staffs during the coming pandemic. Roche is more than happy to sell it to them. In fact they expect to sell over a Billion dollars worth of Tamiflu, this year alone! Too bad it will all be worthless!

It is a bit akin to all of the generators, tinned foods, ammunition and the like that were sold by the harbingers of doom in preparation for the Y2K ‘disaster.’ It all turned out to be worthless!

Yes, is the correct answer. But like Bill Clinton, one has to define ‘is.’ It is being used – today – to treat the bird flu of today. But the pandemic flu of tomorrow will – by definition – be a different virus.

Unlike the dozens of kinds of antibiotics used to kill bacteria, there are only a handful of anti-viral drugs. Most of them serve no other purpose than to treat (never cure) HIV infections. There are perhaps a half-dozen others. Two of the more commonly used ones are ineffective against the bird flu. Hence the seeming popularity of Tamiflu. But even Tamiflu is proving to be ineffective against some strains of the bird flu virus. Since in order to become a pandemic strain of human flu the bird flu virus must change, there is no reason whatsoever for anyone to expect that the altered bird flu that infects humans will be controlled or killed by Tamiflu. So much for those high-paid consultants!

I predict that, like Y2K stockpiles, all the Tamiflu in the world during the coming pandemic will be about as effective as the water used to wash down the pills!

But ya gotta hand it to Roche. They are laughing at the world – all the way to the bank.

It’s gonna go down in the annals of marketing somewhere between “new coke” and the Edsel! They’ll be teaching it in MBA courses for decades to come: “How to sell a Billion dollars worth of a useless product. And look good doing it!”

Influenza is a febrile respiratory illness caused by influenza virus that can be prevented by vaccination. The table below differentiates influenza from a ‘cold’.

Just remember that flu vaccine does nothing what so ever to protect you from catching a common cold!

What else (besides vaccine) can one do to protect oneself and others from influenza illness?

· Cover your nose and mouth with a tissue when you cough or sneeze, and dispose of the tissue afterward.

· Clean your hands after you cough or sneeze with soap and warm water or an alcohol-based hand cleaner.

· If you get the flu, avoid exposing others. Stay home from work or school until your fever is gone, and you feel ready to resume normal activities.

· Get pneumococcal vaccine if you’re age 65 or older or have a chronic health condition.

Follow-up on Roche: it seems that they ONLY sold $76 Million worth of Tamiflu last year.

As bad as the pandemic of 1918 was, its death rate was 1-2%. That is, less than 2% of every one who got sick died. Yet about 50 million people died world-wide; all in less than a year. If 80% of the current world’s population were infected and 2% died, that would mean the death of over 100 Million!

In response, it announced that it was promptly going to vaccine all the chickens in China.

Therefore, it would take 1200+ people working at one bird a second for one year (no rest) to zap all the chicks.

OR 1.1 Million people if they could only sustain the once per second rate for ONE 10-day,

My sources tell me that Roche is in the process of saving the world from bird flu at a mere $10 per tablet!

The antiviral drug being hurriedly stockpiled by governments worldwide may not be reliable protection against bird flu, a U.S. preparedness official warned Tuesday.

Experts have long said that Tamiflu is not a cure for bird flu, but the drug could help slow the severity or spread of the disease in the event of a human pandemic. Governments have rushed to order stocks, prompting a worldwide run on the drug and criticism of its manufacturer for apparent refusal to share its patent with generic drugmakers.

But even that assessment may be overly optimistic, Michael Osterholm, MD, told reporters Tuesday. Osterholm is associate director of the National Center for Food Protection and Defense within the Department of Homeland Security.

Questions of Effectiveness

“I believe that antiviral drugs really represent a tool, a limited tool,” said Osterholm, who is also director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “What we don’t know is if Tamiflu will work.”

Tamiflu and drugs like it can mitigate flu severity and slow disease spread if taken within 48 hours of symptoms. The drug has been shown to have some effectiveness against H5N1, the virus strain that has sickened more than 120 people and killed more than 60 in Southeast Asia.

Once it enters the body, H5N1 replicates more rapidly and penetrates a wider range of lung cells than do other more common flu viruses. The aggressive infection sets off a rapid and massive release of chemicals that then turn on the immune system to destroy it.

Experts call the chemical release a “cytokine storm.” One key but unanswered question about the drug is whether it needs to be given earlier or in higher-than-usual doses to stave off the dangerous “storm.”

Limited animal studies have suggested that Tamiflu must be given before infection in order to be effective, he said. That could greatly reduce Tamiflu’s usefulness in an epidemic because the drug would have to be given long before any evidence of sickness.

The U.S. has announced plans to increase its Tamiflu stores from 2 million to more 20 million treatment courses. The drug is on back order from Swiss manufacturer Roche as dozens of other governments have requested the drug.

“It’s being sold right now as almost the Cipro of post-9/11,” said Osterholm, referring to mass purchases of the antibiotic ciprofloxacin after mailed anthrax attacks killed five people in the fall of 2001.

In a statement Tuesday, William M. Burns, CEO of Roche’s pharmaceuticals division, said Tamiflu was effective.

“Tamiflu is designed to be active against all clinically relevant influenza viruses, and key international research groups have demonstrated, using animal models of influenza, that Tamiflu is effective against the avian H5N1 strain circulating in the Far East.”

The company has fallen under criticism from lawmakers and some governments for refusing to suspend its patent so that generic drug makers could help fill stockpile orders.

One Indian company, Cipla, announced last week that it would go ahead with plans to manufacture a Tamiflu copy whether or not Roche gives it a license.

Meanwhile, one lawmaker increased pressure on Roche Tuesday by calling on the company to allow up to five U.S. generic manufacturers to make emergency supplies of the drug within the next 30 days. Sen. Charles Schumer (D-N.Y.) said he would ask the Bush administration to use emergency powers to suspend the company’s patent if it does not license the drug by that time.

Roche spokesman Terrence Hurley told WebMD in an email that the company has not refused any official requests to sublicense Tamiflu. “To date, we have been approached by just one country in the Far East and are having conversations with them right now,” he said.

“That is not near good enough. Roche has responsibilities to the world,” Schumer told reporters.

SOURCES: Michael Osterholm, MD, director, Center for Infectious Disease Research and Policy, University of Minnesota, associate director, National Center for Food Protection and Defense, U.S. Dept. of Homeland Security. Sen. Charles Schumer, (D-N.Y.). William M. Burns, CEO, Roche Pharmaceuticals Division. Terrence Hurley, spokesman, Roche.

WASHINGTON — Federal drug regulators said Friday there was insufficient evidence to tie the flu drug Tamiflu to the deaths of 12 Japanese children or to hallucinations, encephalitis and other symptoms suffered by some Japanese patients.

Food and Drug Administration staff said they don't think it's necessary to update the drug's labeling to reflect those deaths or possible adverse effects. But the staff is recommending adding information to the label about serious skin reactions to Tamiflu.

Unlike other ailments reported in patients who took Tamiflu, the skin reactions don't appear to be related to the influenza the patients were being treated for, officials said in papers prepared for a meeting Friday by an FDA advisory committee.

"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," said Dr. Murray Lumpkin, deputy commissioner of the U.S. Food and Drug Administration, said prior to the meeting.

The reports are being discussed as part of the annual pediatric safety review of Tamiflu and seven other drugs. The Japanese deaths were detailed in papers released before Friday's meeting. There are no reports of deaths in the United States or Europe associated with Tamiflu.

The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from health authorities in Japan, where use of Tamiflu is more common than in the United States.

The FDA has not yet issued any warnings or initiated any other action, spokeswoman Susan Bro said.

"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Lumpkin said.

An update by FDA staff also includes reports of 32 "neuropsychiatric events" associated with Tamiflu, all but one experienced by Japanese patients. Those cases included delirium, hallucinations, convulsions and encephalitis.

Roche said several studies in the United States and Canada had shown that the incidence of death in influenza patients who took Tamiflu was far lower than in those who did not.

The company also has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, Lumpkin said.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" he said.

The popularity of Tamiflu in Japan may explain in part the number of reports from that country: Of 32 million people treated with Tamiflu since its approval in 1999, 24 million were in Japan, according to Roche.

Japan's Health Ministry warned last week that Tamiflu may induce "strange behavior" after reporting that two teenage boys died shortly after taking the medicine.

The Japanese distributor of the Roche-patented drug told health officials it could not rule out a link between Tamiflu and the deaths.

However, Roche said earlier this week that it "carefully reviewed these events and has concluded that a causal link cannot be established."

The U.S. labeling for Tamiflu lists nausea and vomiting as its most serious side effects. Its labeling in Japan includes any adverse effects that have been reported – including impaired consciousness, abnormal behavior and hallucinations – regardless of whether they can be attributed to the drug, according to Roche.

Tamiflu is one of the few drugs believed effective in treating bird flu, which health officials fear could spark a pandemic should it mutate into a form easily passed from human to human.

WASHINGTON — Federal health advisers are looking into the deaths of 12 Japanese children who took Tamiflu, part of their annual safety review of the anti-flu medication and seven other drugs.

There are no reports of deaths in the United States or Europe associated with Tamiflu.

"Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death," Dr. Murray Lumpkin, the deputy commissioner of the U.S. Food and Drug Administration, said Thursday.

The Japanese deaths were detailed in papers released in advance of a Food and Drug Administration advisory committee meeting Friday.

"Clearly, any time you get a report of a death or a serious occurrence, you want to look into it," Lumpkin said.

He added, however, "Based on the information we have right now, we cannot say definitively there is a causal relation between the drug and the children's death."

The FDA sought and received more information from the Swiss pharmaceutical company Roche Holding AG, which makes Tamiflu, and from Japanese health authorities. It has not issued any warnings or initiated any other action, spokeswoman Susan Bro said.

Lumpkin said "millions and millions" of patients have safely used the drug to treat the flu.

Complicating the issue is that many of the Japanese death and adverse reaction reports list symptoms commonly associated with the flu, he said.

"It is very difficult, when the underlying disease causes what it is being reported, to figure out: Is it the underlying disease? Is it the drug?" said Lumpkin.

A Roche spokesman did not immediately return an e-mail message seeking comment. Roche has supplied the FDA with two additional studies it commissioned that evaluated the safety of Tamiflu in pediatric patients.

Japan's Health Ministry warned last week that Tamiflu may induce "strange behavior" after reporting that two teenage boys died shortly after taking the medicine.

"Roche has carefully reviewed these events and has concluded that a causal link cannot be established," the company said in a statement released on Monday.

However, the Japanese distributor of the Roche-patented drug told health officials it could not rule out a link between Tamiflu and the deaths. Tamiflu is extensively used to treat children in Japan, according to the FDA.

The U.S. labeling for Tamiflu lists nausea and vomiting as its most serious side effects. Its labeling in Japan includes any adverse effects that have been reported — including impaired consciousness, abnormal behavior and hallucinations — regardless of whether they can be attributed to the drug, according to Roche.

Tamiflu is one of the few drugs believed effective in treating bird flu, which health officials fear could spark a pandemic should it mutate into a form easily passed from human to human.

Let me reassure you that those articles I sent yesterday are nothing to be concerned about. They are a completely expected occurrence. This is simply what happens as a ‘new’ drug comes on the market or, as in this case, an older drug becomes more popular. As more and more people take a drug, stories of problems arise. It does not always mean that there is a problem; just that there are stories.

The articles about the FDA are short on medical facts but here’s what likely happened:

Because they were taking Tamiflu, there is a report that their deaths “were associated with” Tamiflu.

Their deaths were “caused” by the flu. Not bird flu, but common, ordinary flu. Some people always die of the flu.

Some of you will undoubtedly recall that a popular drug for arthritis was recently withdrawn from the market after deaths “were associated with” it. The situation was completely different from that of Tamiflu. VIOXX (and related drugs) were used to treat the symptoms of a chronic condition. Once someone started to take it, they usually didn’t stop, especially if it stopped their pain. What happened with VIOXX was that as more and more people took the drug for longer and longer periods, some of them died. Those deaths “were associated with” it. The manufacturer still denies that VIOXX “caused” the deaths and the courts are making those decisions now, not scientists.

Tamiflu is used to treat an infection. It is used for a short time; until the infection is over. But that leads us to the concern that Tamiflu might not be effective when it is needed the most.

One consequence of the wide-spread use of drugs used to control biological organisms – whether bacteria or viruses – is that the organism eventually develops a resistance to that drug. The more adaptable the organism, the faster this happens. The flu viruses are very adaptable. They change often and rapidly. Hence, the concern that the current bird flu virus will become a human flu some time soon and that when that happens, Tamiflu will no longer be useful in treating the infection. As Dr. Osterholm points out in part #14, that is a very real possibility. I said the same thing in part 5. We’ll have to wait and see. But at $10 a pill, I won’t put all my faith in it, by any means!

AVIAN FLU #17 — 25 NOV 05

Chula-flu

BIRD-FLU PREVENTION: Academic warns people not to store eggs in refrigerators

Chula academic says the virus lives longer when cool, recommends that eggs be washed. Eggs should not be stored in refrigerators because the cooler conditions might allow the bird-flu virus to live longer, increasing the chance of exposure to humans, a senior Chulalongkorn University researcher said yesterday.

Professor Yong Phuvoravan, who is part of a team examining patterns of genes in bird flu, said that while the virus can be caught only through direct contact with chickens, refrigerated conditions could allow the virus to live longer on the outside of eggshells.

Speaking at a bird-flu seminar at the Chula Academy Exhibition yesterday, he urged people to wash their eggs carefully, especially those smattered with chicken droppings and not to store them in their fridges.

He added that people should wash their hands well after touching the eggs and cook the eggs in 70-degree Celsius heat.

The virus has mutated by about 3 per cent from the first batch found in 2003, which was a natural process, he said. However, as yet there has been no evidence of a mutation to make the virus transmittable from human to human.

Yong did say, however, that over consumption of the Tamiflu vaccine could lead to the virus building up a resistance.

Chulalongkorn Univ (named after the 5^th king of this dynasty) was recently named one of the world’s finest academic establishments. I hate to throw a chicken into their pot, but this is just nonsense. Good thing Chula is renown for it ‘liberal arts’ programs and not it’s science. The good Prof is “full of it!”

By the time, the eggs you buy in the market get that far along the food chain there AIN’T no threat!

Dried, caked bird feces on your eggs might be disgusting, but they are NOT infectious.

Viruses are small and simply but not indestructible. Once they are exposed to sunlight, they die to say nothing of the basic effect of drying.

Sure, if you walk out to your chicken coop and snatch a few eggs hot out of mommy to go hot on to your griddle, you MIGHT have a slim chance of exposing yourself – but from those chickens NOT the eggs!

There is a vegan vigilante in Thailand who plasters the Letters to the Editor on a weekly basis about the benefits of eating only veggies. His solution to bird flu is to eradicate chickens from the face of the earth and eat the chicken feed that is thereby saved. Right now, that sounds better than worrying about your sunny-side-up eggs.

It’s always nice when someone agrees with you:

Re: “Academic warns people not to store eggs in refrigerators”, News, November 25. [See Avian Flu #17]

Perhaps this comment by Prof Yong Phuvoravan is the most important one in this article: “...the virus can be caught only through direct contact with chickens...” There is no data to indicate it can be caught by eating infected eggs.

On the other hand, not refrigerating eggs can cause Salmonella enteritis, otherwise known as food poisoning, an extremely common and extremely unpleasant disorder.

Perhaps this extract from the US Centres for Disease Control and Prevention best describes the problem:

“Eggs, like meat, poultry, milk and other foods, are safe when handled properly. Shell eggs are safest when stored in the refrigerator, individually and thoroughly cooked, and promptly consumed. The larger the number of Salmonella present in the egg, the more likely it is to cause illness. Keeping eggs adequately refrigerated prevents any Salmonella present in the eggs from growing to higher numbers, so eggs should be held refrigerated until they are needed. Cooking reduces the number of bacteria present in an egg; however, an egg with a runny yolk still poses a greater risk than a completely cooked egg. Undercooked egg whites and yolks have been associated with outbreaks of Salmonella enteritis infections.”

You gentlemen of the press have done just about everything possible to talk up an avian flu pandemic, and if the press could actually create a pandemic, we would have one now.

Fortunately, flu pandemics cannot be created by talk. Flu pandemics occur about once every generation, and the science to prevent, deter or cure them does not yet exist. Tamiflu is a palliative. It may help, but it cures nothing.

Vaccines to immunize against flu-virus infections take at least six to nine months to create, and they are often ineffectual for rapidly mutating viruses. SARS has been around for three or four years, and they are still working on an effective vaccine! So, when the time comes for a flu pandemic, perhaps a billion people will die.

That may happen next year, in five years or later. But it will arrive in its own time, without any help from the press.

Lack of food-service hygiene poses large yet hidden threat

Okay, I’m convinced. The handshake is out. When in Thailand, do as the Thais and make use of the wai. Now what to do about the food-service folks?

About half of all Thais admit to not washing their hands before touching or eating food, a recent survey has found. The results coincide with an annual increase in the incidence of diseases such as diarrhoea, dysentery and typhoid, which are often related to poor personal hygiene.

Although the hand-washing figure was lower than last year, it is still too high, Public Health Minister Pinij Charusombat said yesterday.

Last year, the ministry’s survey found that 65 per cent of people said they did not wash their hands before handling or eating food.

The ministry did not provide exact details of who was polled or where they lived. A press release announcing the results said only that respondents were aged from six years up.

The combined total number of cases of diarrhoea, dysentery or typhoid rose by more than 200,000 this year, said Pinij. The rise was an apparent consequence of the population’s poor hygiene standards, he said.

The survey also revealed that some four in 10 people said they did not wash their hands after using the toilet.

The Public Health Ministry is encouraging the public to pay more attention to personal hygiene, particularly those involved with food processing and cooking, said Dr Pratch Boonyawongwiroj, an acting public health secretary.

Cooks are also being strongly advised not to paint their fingernails, as the varnish could conceal dirt trapped under the fingernails, Pratch said.

The two latest confirmed cases of human bird flu in Thailand might be human-to-human transmissions, a senior health official said yesterday.

Dr Charoen Chuchottaworn, a bird-flu expert at the Public Health Ministry’s Department of Medical Services, said doctors concluded after reviewing the history of the past two cases that both victims presented very mild symptoms of avian influenza and neither had any physical contact with chickens or birds.

One of the victims was a boy in Bangkok and the other was an 18-year-old man from Nonthaburi province. This left doctors no clues as to where the patients became infected with the H5N1 virus and showed that the avian influenza had moved from causing severe human infection to milder cases. Charoen, who is also a member of the national committee issuing guidelines for the treatment of avian influenza, was speaking at the Joint International Tropical Medicine Meeting 2005 in Bangkok.

Dr Kamnuan Ungchusak, director of the Epidemiology Bureau, challenged Charoen’s assertion about human-to-human transmissions. He told The Nation that while neither of the patients had direct contact with chickens, they lived in an environment where the virus was prevalent.

“Chickens were dying near their homes and chicken droppings were everywhere around their neighbourhood,” he said. “They might have contracted the virus through contaminated soil.”

Dr Charoen said that the milder the symptoms, the harder it is for doctors to diagnose. This means that a lot more advanced laboratory facilities are needed with a testing technique called RT-PCR to confirm cases and decide if patients should be treated with antiviral Tamiflu (oseltamivir phosphate). He said this meant that avian influenza could become asymptomatic now.

The only tool available in Thailand to fight H5N1 infections at the moment is insufficient, he said. At present, Thailand has about a million capsules (for 100,000 treatments) of Tamiflu, but it is estimated that about 120 million capsules of the drug will be needed.

In the past, only severe cases of human bird flu have been detected in Thailand simply because patients went to hospital for treatment. But doctors believe that there have been many cases with mild symptoms of the disease. “We believe that this is the tip of the iceberg,” he said.

Signs of possible human-to-human transmission were closely observed in Vietnam, where 10 clusters of probable human transmissions were detected in which the victims had no contact with infected poultry, Charoen said. Thailand and Indonesia had one official cluster, he said, but the Indonesian cluster showed clear-cut evidence because a child contracted H5N1 without going to an infected area, as her father had.

In Part 7, I wrote: “What the scientists are waiting for is that mutated virus that looks like bird flu but is able to easily infect humans. This will occur when the current H5N1 virus meets up with a different, but similar, virus and recombines its genes. The good news is that most human viruses are not killers.”

The highlighted portions above are potentially good news. Assume that both of these victims did, indeed, get infected not by contact with any birds but from another human. Their symptoms were mild; they responded to treatment; they lived. All are good outcomes. Practical scientific knowledge and guesswork would suggest that a human-to-human virus is more likely to be less lethal than the 50% death rate from the bird-to-human infections.

It has been some time since I did an update. Simple fact is that little has changed. That, in itself, is good. I searched the internet and found this summary of the situation. The only real ‘progression’ is that more countries have found infected birds. A few more people have died but only in places that have had deaths in the past and only among people who have contact with birds. While I wouldn’t exactly say that things are better, they certainly aren’t any worse. The fact that this virus has been around for nearly a decade and has yet failed to mutate into a serious threat to the human race, bodes well for the future. While the dreaded mutation and human-to-human transmission may still yet occur, the virus has not shown a tendency to do so. In that respect, status quo is good.

May 5 2006 (Reuters)

FACTBOX — Bird flu's spread around the globe

The World Health Organization (WHO) confirmed on Friday that a 27-year-old Egyptian woman from Cairo has died from bird flu, the country's 5th death from the H5N1 strain.

Bird flu has spread rapidly since late 2003 from Asia to Europe, the Middle East and Africa.

Following are some facts about the H5N1 avian flu virus and its spread around the globe:

– Since the virus re-emerged in Asia in 2003, outbreaks have been confirmed in more than 48 countries and territories, according to data from the World Organization for Animal Health (OIE).

– Since the beginning of January, 2006, more than 30 countries have reported outbreaks, in most cases involving wild birds such as swans.

– The virus has killed 114 people since 2003 in nine countries and territories, according to the WHO. Countries with confirmed human cases are: Azerbaijan, Cambodia, China, Egypt, Indonesia, Iraq, Thailand, Turkey and Vietnam.

– In total, the virus is known to have infected 206 people since 2003, according to the WHO. Many of those who have died are children and young adults.

– Vietnam and Indonesia have the highest number of cases, accounting for 66 of the total deaths.

– The H5N1 virus is not new to science and was responsible for an outbreak of highly pathogenic avian influenza in Scotland in 1959. Britain confirmed a new case in Scotland on April 6.

– Nor is H5N1 the only bird flu virus. There are numerous strains. For example, an outbreak in 2003 of the H7N7 bird flu virus in the Netherlands led to the destruction of more than 30 million birds – around a third of the country's poultry stock. About 2.7 million were destroyed in Belgium, and around 400,000 in Germany. In the Netherlands, 89 people were infected with the H7N7 virus, of whom one (a veterinarian) died.

– The H5N1 virus made the first known jump into humans in Hong Kong in 1997, infecting 18 people and killing six of them. The government ordered the immediate culling of the territory's entire poultry flock, ending the outbreak.

(Sources: OIE, WHO, Centers for Disease Control and Prevention)

FACTBOX — Bird flu's spread around the globe

http://www.alertnet.org/thenews/newsdesk/L05789668.htm

AVIAN FLU #21 — 24 JUN 06

GOOD news and bad?

The dreaded event portending a flu pandemic seems to have occurred: The H5N1 bird flu virus was passed from human to human in Indonesia. Scientists have been watching for such an event. In order for H5N1 to truly become a threat to humanity, it must be passed from human to human just as the standard annual flu virus is. As long as it remains a disease of birds and animals and is only passed from them to humans, it is a concern but not a threat.

But remember that viruses, the flu type viruses in particular, tend to mutate easily. That is why there is a different ‘flu’ circulating annually. So flu watchers have been looking for these mutated bird flu viruses.

The bad news is that it seems that the virus did indeed mutate so that it was passed easily among the members of this family. The fact that all but one of the infected family members died also suggests that it also became more virulent in the process.

The good news is that the mutated virus was unable to sustain itself. Seemingly, it was able to infect humans but not able to survive for very long outside the human body. No one who had contact with these 8 family members became infected.

No real progress towards a pandemic, but a noteworthy occurrence.

Slight mutation found in bird flu virus
By MARGIE MASON, AP Medical Writer
From the YAHOO news website 23 JUN 06

JAKARTA, Indonesia - The World Health Organization has detailed the first evidence that a person likely caught the bird flu virus from a human, then passed a slightly mutated version to another person. But experts said Friday the genetic change does not increase the threat of a pandemic.

The investigation said the mutation of the H5N1 strain of the virus occurred in a 10-year-old Indonesian boy who was part of the largest cluster ever reported. The index case is believed to have been infected by poultry. She then likely passed it to the boy and five other blood relatives. The boy is then thought to have infected his father, whose samples showed the same mutation. Only one infected family member survived.

"It stopped. It was dead end at that point," said Tim Uyeki, an epidemiologist from the U.S. Centers for Disease Control and Prevention. "We were fortunate in that the change that took place did not result in sustained human-to-human transmission," he said by telephone Friday. "This is a vivid reminder of the need to keep a very close watch on what the virus is doing."

Experts fear the H5N1 virus could eventually mutate into a highly contagious form that spreads easily among people, potentially sparking a global pandemic. The current virus remains hard for people to catch, and most human cases have been traced to contact with sick birds. Scientists believe limited human-to-human transmission has occurred in a handful of other clusters, all of which involved very close contact. "What we're really looking for is the kind of human-to-human transmission which can cause large neighborhood outbreaks and big community outbreaks," he said. The virus in Sumatra island did not spread beyond the eight blood relatives — no spouses were infected.

William Schaffner, a bird flu expert at the Vanderbilt University, called the mutation "noteworthy but not worrisome." Schaffner said it is remarkable that scientists were able to discover a mutation that occurred in a remote village. That's the result of intense surveillance linked with "21st-century laboratory virology," he said.

The virus has killed at least 130 people worldwide since it began ravaging Asian poultry stocks in late 2003. Indonesia has counted 39 deaths and trails only Vietnam, where 42 people have died.

Update #22 — 25 June 06

Your Infection Potential

We don’t often think about the things that we do on a regular basis (daily, weekly, monthly) as placing us at risk. But should there be a flu pandemic, some of those activities might truly be life threatening. This might be a good time, before there is a true threat, to examine our infection potential and perhaps to plan alternative actions.

For example, traveling on the Skytrain or Subway is, at the moment, a perfectly acceptable means of transport. In the event of a flu pandemic, it could be a death trap. Packed into a sausage with dozens of strangers, all breathing the same air, is definitely not the place you want be to avoid the flu! Being transported on the back of a motorcycle might bring with it a whole different set of hazards, but it might be the best way to avoid the flu. A middle ground would be using a taxi or driving yourself. Each routine activity needs to be examined for its infection potential.

As a general rule, you will want to avoid all close contact with strangers. You’ll need to determine if that trip out of the house is worth the risk. Might it be reasonable to stay home and tele-commute, perhaps even 1-2 days per week? Do you really need to go to the market? Can you have those things delivered?

During the SARS outbreak in Hong Kong, people developed some innovative behaviors. Many had a set of “outdoor clothes” that were changed immediately and washed daily. Think of these as the coveralls one might wear to paint or do car repairs. It might be worth your life to have a something like a lab coat to wear over your work clothes in public. This outer shell could then be shed when you arrive at work. Worn again for the trip home, it would then be washed each night and before being used the next morning. Some people developed the habit of showering after every public exposure. A bit extreme perhaps, but hand washing would be a must! Wearing a pair of washable cotton (not latex) gloves during public outings might also be life saving.

All unnecessary public outings will need to be avoided. Restaurants, movies and bars will be verboten. Even larger stores and malls might be places to avoid. Shopping might become a task performed by the brave, receiving hazardous duty pay = your maid. At some point, however, going to mall might become a viable option, if 90% of people decide that it is a risky activity. The remaining 10% might find it an outing of acceptable risk – as long as the trip there is risk free.

Each of us, should examine the routine things that we do and places that we go and the means we get there in terms of what the infection potential is. Many of us might find that in the midst of a pandemic, some drastic changes will need to be made. All in all, the best place to be will be at home, in an environment that we control access to. Some of you will find it necessary to actually leave home to go to work. How you conduct your business might need to change considerably. Telephone calls might replace face-to-face meetings. Couriers and faxes might replace inter-office visits. Email might truly be a life-saver!

Now is the time, while there is no threat, to assess your infection potential and plan alternatives. Do you really need to go there and do that? Can you hire someone to do things for you that might put you at risk? Is there an alternative way to accomplish tasks without human-to-human contact?

Those of you with employees might consider writing out a Flu Plan that spells out how business might be accomplished safely if there is indeed an outbreak. If you can show your employees how to stay safe at work, they might not abandon you and your workplace. You should assume the worse. Many will simply not show up for work. Some will die! How will you run your business with fewer employees? Which aspects of your business are essential? Which might be eliminated or changed in some manner to make them safer? Who knows, a critical look at the way your business operates might lead to some streamlining that is good even if there is never a flu pandemic.

Above all, look for any and all places and opportunities to wash your hands!

Top Ten Dumb Guy Tips for Avoiding the Bird Flu:

AVIAN FLU #10 — 15 NOV 05

Fever

Questions of Effectiveness

It’s always nice when someone agrees with you:

Lack of food-service hygiene poses large yet hidden threat