From Flu Wiki 2

Forum: Vaccine

a regulatory dilemma

26 July 2006

montana99 – at 08:47

From the Wall Street Journal:

Wednesday, July 26

4:15 a.m.: GlaxoSmithKline, which is developing a pandemic flu vaccine, will be in a position to manufacture “hundreds of millions” of doses in 2007, Chief Executive Jean-Pierre Garnier told the BBC’s Today radio program. In a separate release, Glaxo said initial data from clinical trials, which began in April, showed that the vaccine achieved a high immune response with a low dose of H5N1 antigen.

InfoLadyat 08:55

Did it say what strains they were basing this on?

Crazy American Lady in the Village – at 09:01

I heard something similar on the radio here in London. No mention as to the strain. I don’t really know how they can come up with a vaccine until we know what the mutation will look like. I think they are banking on giving “some” immunity as opposed to full immunity which could be dangerous and lead to people taking even less precausions.

Anyone else hear anything?

Luke – at 09:55

GSK to the rescue, will this race be a photo finish….?

“Glaxo says its vaccine is more akin to shotgun treatment than a “precision-rifle cure”, which means that it appears to be effective against small mutations in the virus strain.

However, it has yet to determine the effectiveness of the vaccine against big changes in the H5N1 strain. “

http://news.bbc.co.uk/2/hi/business/5214776.stm

anon_22 – at 10:54

I had a quick read. Possible. 3.8 mcg is great, exactly what Fedson has been saying.

Problem is this is a new proprietary adjuvant, so everything about passing any new pharmaceutical drug applies, probably more stringently IMO. So its going to take a while.

Don’t know how fast the EU’s mock-up file process can go if it involves a new adjuvant. Have to look that up.

For the US, it will take even longer, as the FDA has not accepted the principle that pandemic vaccines require a different set of criteria than seasonal vaccine, AND they have not yet approved ANY proprietary adjuvants, including MF59 which is used in Europe.

anon_22 – at 10:56

The question of strains: yes, we can’t make a vaccine without knowing the strain. But currently the EU has a process where manufacturers can work on a prototype with current strains, and pass all the regulatory hurdles, so that when a pandemic strain does appear, it will be a lot faster to get it out to market.

Plus they are also making this as pre-pandemic vaccine, as discussed here.

Dude – at 11:04

There also remains the capacity to produce the vaccine in sufficient quantities. There is a link somewhere here that is very sobering about our planet wide capacity. If it is indeed a broad spectrum immune stimulant AND the h5n1 in it’s pandemic form is “close enough” we can get some benefit. Any vaccine produced now will not be an exact match to a potential pandemic strain. I am pleased, but cautious.

Dude – at 11:19

Here is one link:

http://tinyurl.com/npczr

[snip]

According to Dr Fedson, who also worked for a number of years in the vaccine manufacturing industry, the vaccine produced from H5N1 was proving particularly difficult to grow up. It was also proving ineffective at stimulating an immune response that would give a person a good defence against bird flu. He told BBC News: “Right now, worldwide, we can produce 300 million doses of seasonal flu vaccine, but it turns out that the H5N1 vaccine is so poorly immunogenic and replicates so poorly that… we could immunise globally, with six months of production, about 100 million people. “From a public health point of view this is catastrophic,” the former professor of medicine at the University of Virginia School of Medicine, US, said. “We have had reverse genetics H5N1 viruses available to work with for three years and after three years this is all we can say: ‘We could produce enough vaccine worldwide, for 100 million people’. Is that good enough? I don’t think so.”

[snip]

What this shows is a much better ability to show an immune response at a lower dose. But even if it were twice as good, this looks like 200 million people worldwide. I am trying to be real here. Please (hopefully) tear me apart on this post…I would love it!

banshee – at 11:53

From the BBC article:

“The UK and US have both indicated a desire to “prime” their respective populations with an initial inoculation. Mr Garnier (Glaxco CEO) said he recently met US President George W Bush to discuss the vaccination programme.”

Looks like a pre-pandemic vaccine might be what TPTB are counting on with the hope being that although people may still get sick perhaps they won’t die in great numbers.

“If there were a pandemic outbreak in the early autumn, mass manufacture of Glaxo’s vaccine could probably be started quickly by collaborating with rival pharmaceutical companies.”

Clearly, if a pandemic were to occur sooner rather than later, there won’t be enough vaccine to go around. However, if you have something to give HCWs, first responders, utility workers, government officials etc, it may help mitigate some of the other conseqences of a pandemic.

Racter – at 11:53

Development of a better adjuvant is good news no matter what. Vaccinating a few hundred million people may not stop a pandemic in its tracks, but if we can keep enough of the most critical people on their feet, it might go a long way toward minimizing social disruption.

banshee – at 12:34

From Reuters:

“However, experts say it could “prime” a person’s immune system so they will get stronger effects from a later, better-matched vaccine.”

http://tinyurl.com/ntgls

Tom DVM – at 14:04

“The UK and US have both indicated a desire to “prime” their respective populations with an initial inoculation…”

I spend a good deal of time trying to interpret what authorities are not telling us from the comments they make (often slip-ups) or actions that they take.

I think the evidence of an imminent pandemic is irrefutable…actions like the above by authorities would leave me to believe that they have reached the same conclusion.

Patch – at 14:20

Tom DVM at 14:04

I think there are very few, (including the gov’t) that refute that a pandemic is certain. The questions are what, when and how bad. That’s where the opinions break off.

I hope our gov’t IS considering a way to “prime” the population as a matter of precaution.

Tom DVM – at 14:31

Patch I agree. However, from an interpretative point of view, that’s a lot of money to spend on a hypotheitical pandemic before the fact…so I think the ‘if’ question is answered…’if H5N1’ is answered and I believe the when is also answered at the point this plan is implemented.

The ‘how bad’also seems to be answered as a vaccination program like this would seemingly not be provided unless a significant mortality was predicted…unlike the WHO’s bull-**** prediction of 2–7 million mortalities that they clung to for months.

It takes alot of analysis over many months or years to come to a conclusion about an H5N1 pandemic that you are completely comfortable with. Having spent the time and come to the conclusion…you begin to wonder how regulatory authorities and governments can be so darn optimistic. As far as prepping goes this should be the indicator…I still think that news about N5N1 and pigs is the best predicter as to timing…but in the end I cling to the hope that I am wrong.

anonymous – at 14:31

AP version-not so hopeful near the end of article

LONDON - A British company reported Wednesday it had achieved the best results ever seen on an experimental human vaccine for bird flu and said mass production might be possible by 2007.

A global health official called GlaxoSmithKline’s early results “an exciting piece of science.” If future tests are as promising, it would be a major step in the frustrating campaign to protect people from a possible deadly flu pandemic.

The U.S. government’s chief infectious disease scientist also was very optimistic.

“The data are really very impressive,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “It changes the whole complexion of the issue that we have to face of getting enough vaccine for people who might need it in a pandemic.”

Glaxo’s results came from tests on 400 people in Belgium, most of whom developed strong immune responses from very low doses of the prototype vaccine. Success from wider tests of the vaccine could intensify competition with Sanofi-Aventis SA, whose vaccine unit, Sanofi Pasteur, reported disappointing results in March on its experimental product. It protected only about half of those who got two shots with a very high dose _ 90 micrograms of the key ingredient.

Glaxo said two shots of its vaccine provoked strong responses in more than 80 percent of people tested at lower doses than other experimental bird flu vaccines are using. Some received as little as 3.8 micrograms, said Fauci, who has seen the test results on the vaccine.

“It’s pretty strong,” he said.

The Glaxo vaccine includes an immune-system booster that allows it to use less of the main active ingredient, meaning that greater quantities could be produced if the H5N1 bird virus mutates into a form that spreads easily among people and causes a global epidemic. The vaccine uses an inactivated version of the newer strain of H5N1, which was isolated in Indonesia last year. “It’s a good and exciting piece of science,” said Dr. David Nabarro, the United Nations’ coordinator for avian and pandemic influenza. “But as with all new discoveries, quite a lot of work has now got to be done to establish its place in public health and pandemic preparedness.”

Sanofi and another vaccine maker, Chiron Corp., also have been experimenting with ingredients called adjuvants to boost effectiveness. Glaxo’s results, which were announced by the company but have not yet been published in a medical journal, are the best success reported so far with this approach.

“This is very significant,” said Dr. Albert Osterhaus, head of the virology department at Erasmus University in the Netherlands. “With this adjuvant added to the vaccine, provided the rest of the tests are OK, you could make 10 times as much vaccine.”

Glaxo’s chief executive officer, J.P. Garnier, said the preliminary findings validate this approach, and that the company expects to seek regulatory approval “in the coming months.” While cautioning that it’s still early in the testing, some pandemic flu experts are optimistic that this may ultimately lead to production of many more doses of pandemic vaccine.

However, Dr. Klaus Stohr, a World Health Organization flu vaccine adviser, said it would have been better if the adjuvant was a substance widely available to other companies rather than a Glaxo company product.

“Access for other companies to use it will most likely be limited,” he said.

More than 20 clinical trials involving potential H5N1 vaccines are being underaken by more than 30 companies.

Glaxo’s success also would not guarantee that all people and countries would be protected in the event of a flu pandemic. Flu viruses mutate so readily that it may ultimately be a different strain of the virus that threatens people.

“It’s a risk judgment for those potentially purchasing vaccine,” said Dr. Angus Nicoll, influenza coordinator at the European Center for Disease Prevention and Control. Because it is impossible to predict which influenza strain will spark the next pandemic, “it’s a very difficult decision for a country to decide whether to invest in pandemic vaccines,” he said.

In May, the U.S. government awarded more than $1 billion to five companies, including Glaxo, which are developing faster ways to mass produce vaccine in case of a pandemic. The government also has ordered millions of dollars worth of Aventis’ experimental vaccine to stockpile in case bird flu starts spreading more easily from person to person.

Ken

Juliet – at 14:40

This is good no matter what, and one of the articles I read noted that this pre-pandemic vaccine was based on a virus isolated in Indonesia in 2005. So that sounds as good a place to start as any.

This was apparently a very difficult vaccine to work with - the virus was resistant to anything but the highest doses beforehand. No matter what, this is good news - we are more prepared as a planet than we were yesterday for a possible pandemic.

Now if we can just get past all the drug copyright regulations and get the infrastructure in place for mass production, we’d have a fighting chance at a pre-pandemic semi-immunity once the virus hits.

Path Forward – at 14:43

The article quoted by Anonymous at 14:31 is by new AP medical reporter Maria Cheng — formerly WHO spokesperson in the communicable diseases section.

Link to entire article:

http://tinyurl.com/gxlvh

Tom DVM – at 14:53

Hi Path Forward. It is good to hear from you again…I always find your comments well-considered.

I’m not that good with computers but I did not see a reference to Dr. Maria Cheng or a bio that describes her as a former employee of the WHO.

Could it be that there are two or more Maria Chengs and these are two different people.

If it is true…it would be extremely unusual for spokespersons to resign and particularly to resign to become a reporter…maybe she should interview herself of come on flu wiki and tell us the real truth!!

Thanks again.

Hillbilly Bill – at 15:17

TomDVM:

With your background, do you really think much optimism should be generated by stories about potentially effective vaccines?

Path Forward – at 15:22

It is the same Maria Cheng (she is not a doctor or a technical expert), and she was a journalist before she went to WHO. Google-search “Maria Cheng” + “Asia Week”.

Maria works extremely hard to tell the truth all the time. That does not mean revealing information that is confidential. And it does not mean that she (or any other reporter or nontechnical spokesperson)can always tell when the technical briefings she is given are accurate.

I am hopeful that the small pantheon of excellent influenza reporters (Branswell, Zamiska, Gale, plus a couple others) just got larger by one.

Leo7 – at 15:24

Good news indeed. I’ve been watching GSK for some time, heres info on the adjuvant being used. It’s not alum, but taken from tree bark. Article from drug researcher here: http://tinyurl.com/kyts7. It’s a war out there between the drug giants and my money is on GSK.

Tom DVM – at 15:52

Hillbilly Bill. If I wanted to I could discuss H5N1 with only say veterinarians or farmers for that matter, the conversation would be extremely narrow.

The real benefit of flu wiki, in my opinion, is in the diversity of the posters. I get to compare my opinions with others from a variety of backgrounds. Under these conditions, an individual gets far more than they give.

My opinion of vaccines is based on my personal and professional experience with large animals. In my opinion, it is too late for vaccines for this pandemic, the vaccines are primitive and therefore will be limited in the number of doses avaliable as well as effectiveness.

I believe we will be in a similar but probably worse postion then they were in 1918 and although there is technology avaliable, no one will be able to access it…

…and if they don’t start making more antibiotics masks gloves ( the boring stuff) in a hurry, we won’t even have those avaliable to us.

The thing is that if we get away from the ‘magic pills’ that won’t work and concentrate on the things that worked in 1918 in addition to with antibiotics anti-fever drugs, oral electroyltes and prednisolone, we can either learn to live with the virus and avoid it or treat ourselves if we are infected. If not, we won’t even have solutions that will work and save lives.

Hillbilly Bill – at 16:01

Tom DVM – at 15:52

I agree completely. I think the solutions to a coming pandemic are not “sleek and sexy” but more along the lines of hygiene and social distancing. I especially like your idea of converting McDonalds restaurants to drive up dispensaries (sp?) for the distribution of essential medications.

IMO, we are in a lot of problems today because we have begun to rely on a scientific or technological fix for all of the problems that face us. Just like a sneaky horse, this is going to turn around and bite us in the a**.

Dennis in Colorado – at 16:26

Racter – at 11:53 Development of a better adjuvant is good news no matter what.

Juliet – at 14:40 This is good no matter what

Leo7 – at 15:24 Good news indeed.


Wouldn’t it be ironic if the ability to prevent the most disasterous version of a pandemic came from one of those capitalist institutions that spends its Christmas money on Wall Street and CEO salaries?

Hillbilly Bill – at 16:28

Dennis in Colorado – at 16:26

Any idea where your name is on the vaccination list?

Gary Near Death Valley – at 16:36

Moderator NOTE: On the main page of Fluwikie, the forum connection is missing, has anyone noticed that?

Dennis in Colorado – at 16:36

Bill, my name’s position on any hypothetical list is irrelevant.

Roman – at 16:58

Tom DVM, We could also concentrate on providing communities with the ability to create fresh water during a pandemic, store food, identify and stock emergency shelters, etc. Spending billions and billions of dollars on an experimental vaccine is a joke. Making us sign a waiver, just in case the vaccine kills us, just adds to the comedy.

Leo7 – at 17:04

Well a new adjuvant that sounds promising is still years away from approval. Anyone following my posts should know I don’t advocate going around the rigorous review process. My personal opinion is if the government grants a waiver, then the exclusivity of the adjuvant must be released to all drug companies as as a condition and verification. Profit shouldn’t come at the cost of basically a shot in the dark as far as true effectiveness goes.

It’s been discussed before how meager vaccines will be handed out and this does make one cringe. Each and every hospital has hundreds of workers—all workers including janitors, cooks, laundry workers, and secretaries if designated as critical will get the vaccine, not just doctors, nurses, respiratory, lab etc. Patients and workers have to eat, don’t they? I hope politics is taken out of this equation or the states with minimal electoral votes will get less vaccine per percentage of population.

My vote is this—if the government really cares they should opt out of vaccine first line doses to show leadership and esprit de corp with the people less likely to get a shot. If the national politicians don’t do this then the state and local politicos won’t either. By the time the vaccine filters through these groups there won’t be any left. Someone really needs to establish a definition of essential workers, but make the most descriptive definition for non-essential workers.

Anon_451 – at 23:46

bump

27 July 2006

Felicia – at 00:09

What about the dangers with adjuvants and the risk of inadvertently giving everyone vaccinated the equivalent of lupus - the suspected cause of Gulf War Syndrome when soldiers were given anthrax vaccinations with what many think was a dangerous adjuvant?

Woodstock – at 00:14

Considering the kill rate for the virus i think i’d take the risk personally

Leo7 – at 00:46

Felicia:

I will be watching for the report of the clinical trials which I understand has over 400 participants. They will list side effects for a certain time frame (few months). Long term side effects will have to be checked before it gets full approval, but that won’t be like five years. Closer to one year if that. But, far better than nothing, and at least it’s a niche in the otherwise smooth wall of weapons to use.

Ima-Prepper – at 05:53

Historically bad news is generally temepered but good news comes prematurely.

The vaccine sounds very promising but in light of that I wouldn’t surrender my prep plans as there are too many variables that remain unanswered. It is still good news to follow up on while having a prep plan too.

Im hopefull but not completly convinced.

Ima-Prepper – at 05:54

Also it is important to consider the source and the stakes they have in their print.

Roman – at 09:16

Felicia, You may find this interesting, http://tinyurl.com/ecxz9

Until we get some serious answers about the dangers of vaccines, my family will skip the continuing experiment and use other methods to survive.

anon_22 – at 09:31

Felicia – at 00:09 “What about the dangers with adjuvants and the risk of inadvertently giving everyone vaccinated the equivalent of lupus - the suspected cause of Gulf War Syndrome when soldiers were given anthrax vaccinations with what many think was a dangerous adjuvant?”

That was MF59, the adjuvant used by Novartis (formerly Chiron).

We don’t know the formulation of the GSK adjuvant. An adjuvant is a strongly immunogenic substance used in this case to boost the immune response. It is useful when someone’s immune response is inadequate for whatever reason eg old age, when they do not respond to a vaccine that adequate immunogenicity in normal people.

It is a different story when you use it in people whose immune responses are normal eg young adults and children, to compensate for a poorly immunogenic vaccine.

Poor host response + good immunogenic vaccine + adjuvant

is not necessarily the same as

normal host response + poor immunogenic vaccine + adjuvant

There is not enough safety data for even the single proprietary adjuvant (MF59) for young people and kids, even though it’s been used in the elderly for some years, let alone an entirely new one.


NB the above discussion excludes aluminium hydroxide, or ‘alum’ which is non-proprietary and has been used for a while.


Klaus Stohr also has a good point: anything proprietary adds huge hurdles towards saving anything more than a small number of lives in a few countries.

And Leo7 is also right about new proprietary adjuvant being years away from approval. That is the same timescale that I’ve heard from Stohr and some vaccine company employees.

anon_22 – at 09:34

I wrote the story about MF59 and possible association with Gulf War syndrome here

Jewel – at 09:52

Felicia - at 00:09 mentioned lupus in association with the flu vaccine. My mother developed lupus within 6 months after receiving the Swine Flu vaccine in 1976–77. A friend of mine developed Guillain-Barre syndrome after receiving the vaccine as well. Both of these women have suffered literally for years and years as a result. Is it worth it? From what I have read about the 1918 pandemic and the success the doctors had with homeopathic remedies I think I would rather go that route. Any thoughts?

anon_22 – at 09:56

Jewel,

Sorry to hear that about your mother. There is no indication that the swine flu vaccine was associated with an increased chance of lupus. The Guillain-Barre syndrome could be related.

I don’t know enough about the pathogenesis of lupus to say whether it could be triggered by vaccination.

The significance of lupus in Gulf War syndrome was finding it in men, which is extremely rare.

LauraBat 10:17

WSJ article on it today - “Glaxo uses an inactivated strain of the H5N1 virus to make the shots. It has made the vaccine in small batches but is uncertain how much of the inactivated virus will be needed to make the shots in industrial quantities. Glaxo also is uncertain of demand.”

Sounds like they still ahve a lot of hurdles to overcome before this thing is ready on a large scale, but “In the U.S. the Food and Drug Administration has pledged a speedy review process for pandemic flu vaccines.”

It takes two shots to acheive the 80% effectivenss. 80% against a strain that could change, and probably will. Despite my kids being immunized for chicken pox, one of them got it this year (because it’s only 70% effective) and passed it on to DH. So, I am less enthusiaiastic about vaccines in general - false sense of security. HOWEVER, I am waiting to see what happens with this one. Deaths from Chicken Pox are rare while H5N1 kills > 50%.

So, do you think (if available) you’d get it?

Jewel – at 10:21

Since lupus is an autoimmune disease and the use of adjuvants in flu vaccines has been associated with autoimmune and neuromuscular dysfunctions I strongly suspect a causal factor between the adjuvant used in the Swine Flu vaccine with the development of lupus in my mom’s case and in my friend developing Guillain-Barre. I suppose it could be a coincidence with both, but I also worked with an RN who developed encephalitis after receiving the vaccine and he believes it was directly related to receiving the Swine Flu vaccine as well. All three of these people were healthy before receiving this vaccine. (Of course, most people are healthy before they get sick! It almost sounds like I am making all of this up but I truly am not!) I am just glad I had no trouble. I was in college at the time and remember ALL of my classmates lining up to receive the vaccine. So I know of three people personally who developed serious problems possibly as a direct result of receiving a flu vaccine. Just something to think about as we line up to receive the BF vaccine that may not be very effective. Is it worth the potential risks?

anon_22 – at 10:29

Jewel,

FYI they didn’t use an adjuvant with the swine flu vaccine.

Jewel – at 10:38

anon_22:

Well, I guess that blows my whole theory! Just goes to show how much I know. If it wasn’t the adjuvant that caused the problems, it could have been something else in the vaccine itself. Just seems like too much of a coincidence to me, but then I am not an expert on vaccines by any means. Thanks for the info!

anon_22 – at 10:42

LauraB,

Its a hard call on a personal level.

It is even more difficult when you factor in the issue of insufficient vaccines for everyone. Consider the following slide from David Fedson, using the current standard of Ab level 1:40 as efficacy,

The dosage at which the most number of people (132) would be protected would be 15mcg, but for an individual, you will only get 22% chance of being part of that group. If you raise the dose, you have a higher chance of being protected, but the total number of people protected would be far less.

anon_22 – at 10:45

Jewel,

There’s still a lot we don’t know about the immune system, and how individuals respond to antigenic challenges. So connections to vaccination, if they exist, do not have to depend on the presence of adjuvant.

glennk – at 11:19

IMO this story with all it’s qualifiers and caveats changes little. The virus is going to mutate and like all flus making a vaccine that will be effective at that time is a crap shoot. The further complicate the issue there is absolutely no way of knowing that after it mutates it won’t quickly mutate again leaving all our vaccine efforts in the dust. This is just a story being blown way out of porportion because of it’s propaganda value. I believe the thinking here is simple. Calm the herd right now we have enough problems to deal with. Pandemic flu is just one of them and it’s a BIG if when and maybe, so let’s throw this bucket of water on the fire and let the herd think the fires been put out. By weeks end the way news travels in this country and the world in general most people will think problem solved let’s move along to the next thing to panic about. As for myself I’ll continue to prepare and ignore this story.

Tom DVM – at 11:23

annon 22. Thanks for the information.

I think it’s time to face facts…read the writing on the wall for vaccines and anti-virals and then move on to other preventatives etc.

It is crystal clear that for the next ten years we need other solutions…while continuing to do research on new anti-virals (modest program offered by many including Dr. Osterhaus last fall-canned by the WHO and the UN) and the present primitive (on many levels) vaccines.

The insurmountable issues on several levels with these two instruments is like the ‘family secret’ kept for years despite the fact that everyone in the community and their dogs knew about it…

…I don’t know how many times regulators and governments have to re-examine these thing before we fundamentally face the facts of the matter.

Bronco Bill – at 11:28

This comes from the August 2006 issue of Popular Science magazine:

PopSci Medicine

Click on the “View Photos” link, and pop-up window opens. Click on Next until you get to slide 4 of 6.

Kryptonite For Flu

A single-shot universal vaccine against any strain of influenza

The Prescription: Immunologists are aiming at a fresh target: M2, a protein on the surface of
viruses that appears almost unchanged in nearly every known strain of flu. An M2 vaccine,
scientists say, could fight forms of the virus that haven’t even appeared yet. But unlike other
vaccines, the M2 shot won’t actually stop infection. It works by kicking off a massive immune
response that weakens the effects of flu, making it easier to survive potentially lethal
symptoms like fever and dehydration. Immunologist Walter Gerhard of the Wistar Institute in
Philadelphia says that spiking a standard flu shot with M2 could dramatically broaden its
protective powers against epidemic influenza strains.
→ When?: Trials could begin next year.
anon_22 – at 12:26

Tom,

The insurmountable issues on several levels with these two instruments is like the ‘family secret’ kept for years despite the fact that everyone in the community and their dogs knew about it…

Just as an aside, I’m kinda stubborn. :-) I refuse to think of them as insurmountable, but neither do I go in for wishful thinking.

I think we need to take every little bit of success as something to be applauded, and maybe, just maybe, if we persist long enough and if we get lucky, we may have some really good solutions before TSHTF.

anon_22 – at 12:28

Like the M2 vaccine that BBB just posted about. Long shot, but worth the effort.

Another of my 2C’s - hope I don’t run out of them too soon…

Tom DVM – at 12:32

annon 22. I agree but you and I both know that none of this will happen for this pandemic and the only solutions this time are the old solutions.

Again, as you know, if they do not start stockpiling significant levels of broadspectrum antibiotics now, we won’t even have them.

What is the production lag period or response time to increase current world production of antibiotics a thousand or ten thousnand or a million fold.

How many people could be provided antibiotics, oral electrolytes and anti-fever medications for one billion dollars and have it avaliabe to use in a pandemic that by my measure…and I’ll bet you by your measure is imminent…less than two years and definitely less than 5 years?

ironic is overused – at 12:35

Dennis in Colorado – at 16:26

“Wouldn’t it be ironic if the ability to prevent the most disasterous version of a pandemic came from one of those capitalist institutions that spends its Christmas money on Wall Street and CEO salaries?”

Ironic? why? It would show that for all the bashing the pharm’l industry gets, the large companies got that way by being competent developers of needed products. I don’t know anyone in biotech, except the many many post-docs in academic labs slaving away for years on their advisors projects, who claims to be taken terrible advantage of by thier companies.

glennk – at 12:35

Such an M2 vaccine might possibly make the effects of H5N1 H2 H2 H2 even worse. Like H1N1 (the Spanish Flu) H5 attacks and kills the 15–40 age group or that segment of the pop. with the healthiest and most active immune systems. [Check the present CFR figures as statistical proof of this.] As we know it does this by causing an extreme immune response (Cytokline storm) that kills the individual. If this vaccine doesn’t stop infection but causes a similar response on top of the same already extreme response in this age group it might just kill these same people a lot faster and maybe others who wouldn’t normally die from an extreme immune response. Could be a tricky proposition against a pandemic variety of flu. Maybe, it would work against “normal” seasonal flu though?

Tom DVM – at 12:39

glennk Good point!!

anon_22 – at 12:41

Tom, you know I agree with you on all that. Do you have to keep me awake another night doing all the calculations about how much shortfall we are at?

Just kidding…

LOL

Tom DVM – at 12:45

/:0)

annon 22…this is a ‘smiley’ face although at the moment I am chuckling …but I don’t know how to do a ‘chuckling’ face.

anon_22 – at 12:45

ironic is overused,

Ironic? why? It would show that for all the bashing the pharm’l industry gets, the large companies got that way by being competent developers of needed products.

I’m with you on that one. It’s not a viewpoint that makes one popular, I’m afraid, but still, the best advances in many human endeavors are often at least partly motivated by big profit, IMHO.

Bronco Bill – at 12:53

glennk – at 12:35 --- I read that article exactly the same way you did. Increasing the immune response to H5N1 could very well cause a higher CFR…however, and since there aren’t any other details in the online OR the magazine article, perhaps M2 might increase some other immunilogical response. No way of knowing yet for sure what it’ll do…

Roman – at 13:08

“Ironic? why? It would show that for all the bashing the pharm’l industry gets”

Bashing? They are “bashed” because some of the public perceives them as being dishonest and creating products that are dangerous. This is a deadly combination.

 “There’s still a lot we don’t know about the immune system, and how individuals respond to antigenic challenges. So connections to vaccination, if they exist, do not have to depend on the presence of adjuvant.”

Perhaps big Pharma should answer this question before they recommend another vaccine.

anon_22 – at 13:32

Roman,

We would all like answers to a lot of these questions. And lots of people have a role in answering them, scientists, governments, physicians, pharmaceutical companies, veterinarians, etc etc.

Just because people get paid does not necessarily mean they carry the brunt of responsibility. Sometimes they do, sometimes others such as regulatory agencies are more ‘to blame’.

Using a one-size-fits-all bat for bashing hardly ever gets one anywhere… other than into the bin of irrelevance.

Dennis in Colorado – at 13:38

ironic is overused – at 12:35 Ironic? why?

I used the word ironic very carefully. Irony is incongruity between what might be expected and what actually occurs. Many of the nattering nabobs of negativity here in fluwiki believe that US businesses are not capable of doing anything good, as exemplified by Eccle’s post:

Many of the issues reported throughout the Fluwikie seem to be linked to the same problem. US business is like a kid without good parents. Instead of using his Christmas money for underwear and socks, he has decided to spend it solely on “fun” stuff like Magic cards and snacks. (Or in the case of business, Wall street and CEO salaries).

Therefore, for them, it will be ironic if the solution does end up coming from one of the capitalist pigs.

Roman – at 13:56

“Using a one-size-fits-all bat for bashing hardly ever gets one anywhere… other than into the bin of irrelevance.”

There’s that word again. Bashing. “Bin of irrelevance” millions of Americans are making the choice not to vaccinate their children or receive vaccinations themselves. Unfortunately, this may be a normal reaction to an industry that has not been honest OR had enough good scientists come forward and share harmful side effects, etc. Either way, this situation forces individuals to be general with their suspicions of Big Pharma. The silence from the worker bees is heard loud and clear. Just as obvious as the dangerous side-effects vaccines carry. Jewel is not alone. I suppose I would be less general if Big Pharma accepted responsibility for not answering your question before they recommended some of their products to the public. “There’s still a lot we don’t know about the immune system”

anon_22 – at 14:25

Roman,

If you have a specific question/complaint/opinion about the issue under discussion ie H5N1 vaccines, the GSK media report, adjuvants, production capacity, automimmune disease, etc etc, please feel free to comment.

General comments blaming (Capitalized) Big Pharma for their inability to answer “There’s still a lot we don’t know about the immune system”, which btw is echoed by scientists and physicians from many different fields, not just those working in the vaccine business, counts as one-size-fits-all bashing and off topic in my book.

Roman – at 14:51

anon_22, I was sharing some of Tom DVM concerns, had compassion for Jewel, found your attack amusing and typical. I blame Big Pharma and cowardly scientists for the massive distrust the public has for their product and research, talk about “bin of irrelevance” (was your comment a personal attack?). No one here can tell us whether these new vaccines will carry side-effects. I guess all we have to go on is the past history of vaccines. Of course, that’s not easy to uncover, since a great deal of it has been buried. “There’s still a lot we don’t know about the immune system” I guess you could say, life long side effects and death from vaccines is evidence of that. There are other ways to prepare for this pandemic. It would be shame if there was no money to pursue them.

Tom DVM – at 15:01

Roman Thanks

You make good points and I agree with most of them…but there is a fine balance that we have to maintain…and I fall over the line too.

You have to be a little less confrontational. You make far too many good points to be lost to us over some comment on North Korea (even though it has relevance also).

I don’t think annon 22 necessarily disagrees with you. She doesn’t like generalizations but I am with you…it is hard not to generalize with pharmaceutical companies that have had a less than stellar track record.

So let’s try to make our points in a non-confrontational manner and let annon 22 jump on us once in a while…she almost always does it with a ‘sly’ smile anyway!!

Thanks again. It is an important subject…probably the most important given the inevitability of H5N1 at this point.

Tom DVM – at 15:07

Roman. By the way, your post at 14:51 is a perfect example of the non-confrontational manner I was talking about.

Roman – at 15:12

Tom DVM, Like I said before, I would love to believe a safe vaccine is possible. However, I need answers concerning vaccines and possible side-effects, now. I’ve heard and seen too much to simply trust individual companies with my family’s safety. No answers, no support, certainly no trust. I think my concerns are logical and reasonable.

Tom DVM – at 15:30

Roman Yes they are. I have had a life-threatening reaction to rabies vaccine and a very serious reaction to whooping cough vaccine.

Like you, my family will not be recieving H5N1 vaccine or anti-virals because my firm belief at the moment, is that they won’t work…

…However, that does mean that we should be against all vaccines and my daughter had all her vaccinations, luckily without my type reactions.

The only way around H5N1 is avoidance (masks, gloves handwashing) and basic non-invasive drug therapies if we are unfortunate enough to catch it.

The ‘rest’ (vaccines: antivirals: a functioning healthcare system) is in a word ‘dreaming’.

I guess ironic isn’t overused – at 15:55

Dennis in Colorado- sorry, I didn’t get the gist of your sarcasm.

Roman- You cannot lay all the blame on big Pharma, an undereducated public shares much of the blame.

I am personally upset that the Lyme Disease vaccine was taken off the market. Even at partial efficacy, as someone who works and plays in the brush, it would have been a safety net for me. However, I waited too long and now I can’t get it. Was big pharma to blame for not educating people that it wasn’t a cure-all? I don’t think so, I found plenty of information out there when the vaccine was offered, stating that it was not complete protection, and even with the vaccine people should still take precautions against exposure. But too many people were tuning out the information that was all around(I do not believe doctors were failing to inform their patients about the effectiveness), getting the vaccine, and then not taking simple precautions. What happened then, lawsuits, and as a result, a vaccine that was better than non was removed from the market.

Racter – at 18:00

Roman:

I think my concerns are logical and reasonable.

Can we get a show of hands from all those who think their views are illogical and unreasonable?

Roman – at 18:38

“undereducated public” Pretty hard to get educated when the facts are hidden. I just love the “undereducated public” argument. Now that’s comedy.

NS1 – at 19:57

Roman,

You are onto something.

A22 at 14:25,

General comments blaming (Capitalized) Big Pharma for their inability to answer “There’s still a lot we don’t know about the immune system”, which btw is echoed by scientists and physicians from many different fields, not just those working in the vaccine business, counts as one-size-fits-all bashing and off topic in my book.

Let’s ask the government agency that oversees 25% of the US economy, the FDA . . . now, who are the thinkers in the FDA . . . the staff-level scientists, right?

FDA Scientists Claim Interference May require no-charge registration

Tom DVM – at 20:14

NS1. Thanks.

NS1 – at 20:22

Tom,

A few of those guys have written books on the topic and are now speaking regularly to packed rooms.

Here’s one that should hit home, Relenza.

GAO Report Highly Critical of FDA Is Anything But News to Most Observers

For example, Michael Elashoff, an FDA reviewer and biostatistician, was asked to review the flu drug Relenza back in 1995. Elashoff recommended against approval due to the lack of efficacy of the drug and the agency advisory committee agreed and voted 13 to 4 against approving Relenza.
Yet Relenza was ultimately approved by the FDA and Elashoff was told that he would no longer make presentations to the advisory committee. Rezulin and Vioxx were both approved and marketed for years despite the fact that strong evidence of their potentially dangerous side effects was well known while the drugs were still being tested.
NS1 – at 20:29

The next step for the FDA is to issue a press release noting the lack of safety of Relenza. After patients died while being treated with the anti-viral, the agency that approved the drug warns the public in a newspaper about potential safety issues?

NYtimes.com FDA Warns of Overuse Of 2 New Drugs Against Flu

Relenza may pose a risk for patients with severe asthma and other breathing disorders, such as chronic obstructive pulmonary disease. Clinical studies found that such patients may experience a bronchospasm, a shutting down of the airways, after taking the drug.
Tom DVM – at 20:31

NS1. Thanks again. The bottom line is that I am with both Racter and Roman.

I wish things could be different…but I did read the two reports in 2005 than unfortunately concluded that seasonal influenza vaccines don’t work…another report in 2006, a retrospective report on the province of Ontario that has had free influenza vaccines for more than five years at a significant cost, concluded again that the vaccine had a neglgible efficacy.

Just because Polio and Rabies vaccine work, does not mean that all vaccines work…I have seen more than one vaccine that caused the very disease it was supposed to be preventing.

A response to a vaccine does not mean the response is effective to a viral field challenge. They know it but that specific qualifier is never made to the public. Also, if the vaccine is an immunosuppressant then you can be in big trouble vaccinating in the face of an outbreak.

These are complicated issues…on top of this their attempts at vaccine for H5N1 so far have been consistently abysmal failures. They have to give several times the normal dose to get 5% response rates and there is no garauntee that the 5% have a protective response.

Yep, Boy due I wish that we could have an effective vaccine for 5 billion people…but it looks more and more like it will be an in-effective vaccine for less than 300 million people worldwide.

Roman – at 20:45

There’s a reason Big Pharma has headed overseas and wants liability waivers. It’s not simply lawsuits. It’s called “The Moment of Truth”. It seems their current strategy is to delay the inevitable. It’s really kind of sad. Do they expect the public to overlook reports like the one in NS1’s post? Does it really take a high level of education to suspect Big Pharma is not telling the whole story? Is it reasonable to support an industry that will not accept responsibility for its products? Is this mistrust and violation of the “herd immunity” philosophy the fault of the individuals who simply want the truth? Let’s answer these questions before we spend billions of dollars on a “vaccine”. If we can’t, then perhaps we should focus on other ways to survive the pandemic.

Tom DVM – at 20:50

“If we can’t, then perhaps we should focus on other ways to survive the pandemic.”

BINGO!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

NS1 – at 20:55

What other ways?

Perhaps take steps to cause our bodies and the extensive immune systems to operate properly

and

to isolate?

Roman – at 21:02

And, we could use funds to help educate the public about preps, first aid, etc. Some countries could stock pile food, water, fuel, first aid supplies, etc. The list goes on and on.

Anon_451 – at 21:14

Tom DVM – at 20:31

‘but it looks more and more like it will be an in-effective vaccine for less than 300 million people worldwide.’

And John Q Public will go on with their lives not knowing that simple truth, and when the commission on the Flu of 200_ convenes all of the Health Officials in the world will say “But we though we had a good vaccine to protect the people with” The Pharm industry will get richer and the politicans will have cover, but a lot of people will have died that did not need to die because they either starved to death, had no water or froze to death. In my Very Humble Opinion.

NS1 – at 22:02

Roman,

Are you in the US?

Roman – at 22:06

Mountains of NC.

Tom DVM – at 22:06

Anon 451. I can’t disagree with most of what you’ve said…but if we can concentrate on living with the virus (I don’t think SIP is a reasonable approach for all but a miniscule fraction of the population) and then the treatments that we know work that were not avaliable in 1918, at least we’ve got a change to save some of the millions that will die not from the disease but from dehydration or lack of insulin etc…..ie. totally needless and preventable deaths.

If we continue to concentrate on vaccines and antivirals and put all our resources there…we are collectively screwed in my opinion.

Racter – at 22:06

Roman:

Does it really take a high level of education to suspect Big Pharma is not telling the whole story?

No, it doesn’t, and that’s perhaps the most penetrating insight I’ve seen you make yet.

Tom DVM – at 22:08

Sorry, should have mentioned secondary bacterial infections, dehydration or lack of insulin etc…ie totally needless and preventable deaths.

Roman – at 22:27

Racter, You remind me of a Chihuahua. All bark and no bite. Yip, Yip, Yip. Guys like you reaffirmed my beliefs. Thank you. By the way, as annoying as a Chihuahua can be, I still think they are cute. In a rodent sort of way.

Racter – at 22:38

Big Pharma is controlled by 12 illuminati all selected in secret by the Blacks, The Jews and the Queen of England to control our entertainment industry and outlaw firearms while implanting microchips in our pets to give us cancer for which they are witholding the cure until they can fake the moon landings. You haven’t heard of any of this, of course; that’s why it’s called a conspiracy.

Tom DVM – at 22:44

OK you two…I am chuckling but this is not very ‘ghandian’ or us…

…we have other fish to fry without falling in our own fire.

anonymous – at 22:46

Racter, you forgot the Big Oil Companies and Global Warming.

Tom DVM – at 22:47

anonymous Welcome. Please sit by our fire and pick a name…if not I will sick Pogge on you.

Roman – at 22:55

Oh Tom, I just like to get him fired up. It’s my goal to make the tin foil hat, placed neatly on his head, fall off. I am a bit concerned with his “the public must never question the highly educated” fixation. It’s a little scary. I would also like to see the stained lab coat replaced. One can dream.

Leo7 – at 22:57

Listen, while all of us feel free to ding WHO, we should have collectively turned our laser beams on the FDA. It just keeps skating on thin ice and never falling in. Some of the best researchers have quit in protest, because of the mediocrity and politicos (also known as big party contributors) are placed without merit into the highest decision making positions. The FDA will soon be in a worse position than the CDC if leadership doesn’t get a transfusion or maybe I should say a transplant.

Roman – at 22:59

and those saints “The Tobacco Industry”. If the Marlboro man had not died of lung cancer, he would be here kicking some serious butt. The injustice is just too much!!!!

Tom DVM – at 23:02

Leo7. Point well taken!!

Dude – at 23:50

You are talking all around and about a very large topic that has a bearing on what the problems of our Democracy are at this point in time. I have been, like many here, thinking on this subject a long time (since I was 16). I do, however, also think that this subject intersects all of the governmental problems of facing a pandemic flu. It also is a subject that is too broad in scope where our focus must be more narrow to have purpose. If we take on all the issues of just the United States at this time, we will not get anything done on the focus of our site “education, preparation, what can be accomplished, scientific brainstorming, personal trauma before during and after etc. I am the most political opinionated person you would ever want to meet. All I am saying is that I don’t want to stray too far. My Dad once said to me, “Listen, without self discipline you die.” Let us focus. How can we effect the FDA to do a better job of doing their job? Simple, there is an election coming up. If you know the truth as you see it and are not happy, throw the bums out of office. There, is no other way to effect a large change as quickly as we need to do it. Now, if you think things are going just, “Ducky” then I wish you a good life…The other political rantings and details are not really important to me in this context.

28 July 2006

NS1 – at 02:20

FDA behaviour has been consistent thru various administrations.

Agnostic – at 09:39

Cause of concern?: If H5N1 is highly neurotropic and the killing strains are those that infect neural tissue most easily http://tinyurl.com/hrkol , http://tinyurl.com/gc2fx , then how big is the risk of a H5N1 vaccine provocating ADEM or other kind of myeitis : http://tinyurl.com/ztvo7 ?

Tom DVM – at 10:06

Agnostic. Good point. This does happen with rabies vaccines but I don’t believe with a high frequency.

pandemicflu – at 10:12

was the vaccine tested with real H5N1 in ferrets or cats ?

Thinlina – at 12:22

pandemicflu, intresting question!

Dennis in Colorado – at 12:30

Tom DVM – at 22:47 anonymous Welcome. Please sit by our fire and pick a name

Ah, that was me. My current job responsibilities allow me to participate from work as well as from home. My work system allows my author name to remain intact; my home system periodically deletes the author name between posts.

Tom DVM – at 12:35

/:0)

Thinlina – at 12:51

http://tinyurl.com/ztvo7 : “However, experts believe that in many cases infection causes a derangement of the immune system which leads to an indirect autoimmune attack on the spinal cord, rather than a direct attack by the organism. One theory to explain this abnormal activation of the immune system toward human tissue is termed “molecular mimicry.” This theory postulates that an infectious agent may share a molecule which resembles or “mimics” a molecule in the spinal cord. When the body mounts an immune response to the invading virus or bacterium, it also responds to the spinal cord molecule with which it shares structural characteristics. This leads to inflammation and injury within the spinal cord. Vaccination is well known to carry a risk of the development of acute disseminated encephalomyelitis (ADEM) which is an acute inflammation of the brain and spinal cord. This was particularly common with the older antirabies vaccine which was grown in animal spinal cord cultures; the use of the newer antirabies vaccine grown in human tissue culture has almost eradicated this complication. This is also thought to occur as an immune system response.”

Leo7 – at 14:52

NS1:

Consistent behavior maybe, but the resignations and outings of what goes on by those who quit is new. People quit in protest and walked away from govt pensions—that’s more than the military commanders have been willing to do, and it takes guts to walk away from that kind of retirement cushion.

I want some hero’s! People who shoot (information) from the hit and muck up the plans of those with scheduled golf games.

Leo7 – at 15:00

Agnostic:

When I pulled up your first thread I noticed in the right hand column-Hemorraghic pneumonia outbreak in Brazil. MMmmmm. I also wondered why I haven’t heard a lot about ADEM with autism and I wonder why pregnant women and young children are now recommended to get influenza vaccines annually. I need to mull that over with a cold one.

anon_22 – at 15:07

Dude – at 23:50 “If we take on all the issues of just the United States at this time, we will not get anything done on the focus of our site “education, preparation, what can be accomplished, scientific brainstorming, personal trauma before during and after etc. I am the most political opinionated person you would ever want to meet. All I am saying is that I don’t want to stray too far. My Dad once said to me, “Listen, without self discipline you die.” Let us focus. How can we effect the FDA to do a better job of doing their job? Simple, there is an election coming up. If you know the truth as you see it and are not happy, throw the bums out of office. There, is no other way to effect a large change as quickly as we need to do it. Now, if you think things are going just, “Ducky” then I wish you a good life…The other political rantings and details are not really important to me in this context.

Bravo!

and thank you…

Thinlina – at 15:12

Leo7 – at 15:00 That makes me wonder, too!

anon_22 – at 15:17

The safety of vaccines or any other product is always an important issue. As Dude said, a lot of issues get tangled up in there. If every thread about a specific vaccine end up being about every single complaint against vaccines, vaccination, vaccine companies, or the big Big Pharma, then we might as well close shop and never talk about pandemic vaccines.

If I didn’t believe vaccine safety is a critical issue, I would not have spent my time writing up the MF59 story. I myself have not made up my mind whether I would let my family take any pandemic vaccines.

However, if we step out of our personal space, and look at it from the public health point of view, it is very hard to argue a case against all vaccinations for all people. It is still one of the most effective ways to save most lives, if we have a pandemic.

So I would suggest that we acknowledge the need to be vigilant about side effects, that there are controversies, but we still need to work with whatever we’ve got, and based on these parameters, it is still possible to have a constructive discussion about individual vaccines.

We need to be able to evaluate each situation despite all the inadequacies. If TSHTF, all solutions will be imperfect.

Thinlina – at 15:18

But I think the main reason for recommending vaccine agaisnst seasonal influenza is preventing otitis media of children, and preventing dysmorfias/congwnital malformations etc. of unborn children.

Thinlina – at 15:22

I agree with anon_22 – at 15:17. I’ll most probably take and recommend a vaccine against a pandemic to my family although I know som of the risks. But it’s better to take anyway since it gives better changes to *stay alive* than not taking it.

ANON-YYZ – at 15:37

I would hope that we learn from the Swine Flu lesson, and won’t just rush a new vaccine to market without proper testing.

Thinlina – at 15:49

I agree also with ANON-YYZ– at 15:37 :)

Was the swine flu vaccine, btw, made of whole killed viruses?

anon_22 – at 16:02

ANON-YYZ – at 15:37 “I would hope that we learn from the Swine Flu lesson, and won’t just rush a new vaccine to market without proper testing

Actually, the swine flu incident is the perfect illustration of how hard it is to make those judgments. Suppose you are the policymaker, and you depend on scientists to tell you whether and when a pandemic is imminent, and what are the risks of a new vaccine. Let’s examine all the possibilities:

You can have

(1) do not vaccinate, no pandemic

(2) vaccinate, no pandemic

(3) do not vaccinate, pandemic

(4) vaccinate, pandemic

If you get (1), no one will know all the effort that’s been put in, or maybe you’ll get questioined eventually about spending all that money on a vaccine that was never used on a pandemic that never happened.

If you get (2), which was what happened, there is always going to be a number of people with adverse reactions, some fatal, and you are in deep s***trouble.

If you get (3), a pandemic happens, people die, then they find out that the government has been sitting on a supply of vaccine the whole time, well the s*** is probably so big you will not survive politically. In fact, chances are you will go down in history as having the blood of innocent children (and it will always be children) on your hands.

If you get (4), you think people will thank you? I’m betting there is more chance of people saying since you knew enough to make the vaccine, you should have made a lot more and vaccinated sooner or everyone should have gotten 2 doses instead of 1 and how come we were not told to prepare to SIP etc.

Such is the reality of mass vaccination decisions.

Roman – at 16:18

“If TSHTF, all solutions will be imperfect.”

 This thread covered a lot of ground. Some posters wondered if a vaccine would work. Some thought focusing on vaccines at this stage endangered other ways to prepare the public. Some thought funds could be spent more efficiently.  Some worried about side effects. I think those are normal and reasonable concerns. It seems the side effects concern is especially difficult to address. IMHO this thread reflects a balanced approach to vaccines.  

“It is still one of the most effective ways to save most lives, if we have a pandemic.”

That’s your opinion. I’m not willing to make that statement until I have ALL the facts. I feel that’s important before making a life/death decision. Vaccines may also be a big waste of time and money.

Roman – at 16:24

“Such is the reality of mass vaccination decisions”

You forgot what happens to the public trust when you lie about side effects. There is a price to pay when you get caught deceiving your market. All your hard work may be placed in the bin of irrelevance. I guess that’s just part of the game.

NS1 – at 16:38

Agnostic – at 09:39

Please review my NS1 post on 12 July at 17:19 at Four of Five Doctors Miss Flu Diagnosis for information on vaccine-related encephalitis.

anon_22 – at 16:38

Roman,

“That’s your opinion. I’m not willing to make that statement until I have ALL the facts”

Yes, of course it is my opinion. It is also an opinion shared by the majority of the medical community. I am sorry that, having been trained and worked in that profession for many years, it appears that that does not meet with your approval.

No, I don’t have ALL the facts. Does anyone have ALL the facts?

It is easy to make judgements sitting on the sideline, when you are not the one who is called to make decisions based on inadequate information, with people’s lives in your hands. I’ve been in that space too many times.

Many of you have talked about how hard it is to make the right decision for your family. My post at 16:02 is nothing more than an extension of that and my own experiences.

To say, gee, I know politicians sometimes do awful things, but I’m sure glad I don’t have their job.

NS1 – at 16:48

Roman,

Keep probing; its deeper than you can ever guess.

anon_22 – at 16:54

NS1,

Someone once said to me that what they REALLY want is for everyone else to take the (measles) vaccine so their kid won’t need to take it.

:-)

Roman – at 17:01

Anon_22,

“It is also an opinion shared by the majority of the medical community”

Thank god we are starting to here from the minority. They are true heroes. I’m a little tired of hearing the “damned if you do, damned if you don’t” whining from officials. Sure, some of the public may be ungrateful. However, a large portion is just sick of being deceived. That includes some folks in the medical community. They simply don’t want to hurt their families, humanity, etc. They need the truth. Not spin.

“No, I don’t have ALL the facts. Does anyone have ALL the facts?”

In the case of vaccines, you don’t have the facts, because many of them are not revealed. I think millions of Americans understand this. So every decision you make is suspect and based on partial truths. What’s really frightening is, people’s lives are at stake. You could join the minority and demand some accountability.

To be clear, side effects is just one of many issues. I believe there are many other ways to prepare for this pandemic that deserve more focus and money than vaccines.

Roman – at 17:04

“everyone else to take the (measles) vaccine so their kid won’t need to take it.”

That would be silly. The measles vaccine obviously failed in Iowa.

anon_22 – at 17:10

Roman,

“You could join the minority and demand some accountability.”

You don’t know what else I do.

The MF59 story is just one glimpse.

anon_22 – at 17:14

“I believe there are many other ways to prepare for this pandemic that deserve more focus and money than vaccines.”

There are many ways to save lives, it doesn’t have to be either or. Even if given ALL the facts, there will still be plenty of people who will choose differently than you.

None of us have the answer that is good for everyone. The best we can do, and it is entirely inadequate, is to put out as much information as possible to help people decide.

Roman – at 17:15

anon_22, I respect you. Good luck in the trenches. It’s not easy being a cheerleader, but I’ll do what I can. I pulled a hamstring last night

anon_22 – at 17:16

:-)

Roman – at 17:19

“There are many ways to save lives, it doesn’t have to be either or”

Tell that to an accountant. Cash is finite. Big Pharma has a knack for acquiring it. I would prefer my tax money go somewhere else. I thought this was clear.

anon_22 – at 17:23

True, cash is finite.

But as i said, there are still plenty of well-informed people who disagree with you and think spending money on vaccines is a good idea.

That’s the price of living in a democracy.

If only we can have everything we want. I just wrote about wanting to find my fairy godmother on a different thread.

Roman – at 18:04

I think wanting the truth about vaccines and there side effects is a little different then wanting a fairy godmother.

“Plenty of well-informed people who disagree with you” and as you know, there are many well-informed people in your field who disagree with you.

Roman – at 18:04

I think wanting the truth about vaccines and their side effects is a little different then wanting a fairy godmother.

“Plenty of well-informed people who disagree with you” and as you know, there are many well-informed people in your field who disagree with you.

Racter – at 18:20

NS1: “Please review my NS1 post on 12 July at 17:19 at Four of Five Doctors Miss Flu Diagnosis for information on vaccine-related encephalitis.

That wasn’t information, it was an appeal to emotion. To those who find that sort of thing compelling I would suggest trying “measles” on a Google image search. Tell me: just how many people do you believe experience severe adverse reactions to flu vaccines, and what are your sources of information?

Did you think I was being sarcastic about the peanut butter?

The National Institutes of Health reports that approximately 0.6 percent of Americans are allergic to peanuts, and nut allergies account for the majority of the roughly 100 deaths from food allergies in the United States each year. Of course, those with particularly penetrating insight recognize at once that these numbers have been spun. The peanut lobby exerts a powerful influence over those who collect and report these numbers, therefore no one can make an informed decision on peanut butter, because the real facts are not revealed. (Ok, so that last part was sarcastic).

Roman – at 18:34

Racter,

The Peanut Lobby hasn’t lied to me. I hope. My how you love to throw around the low rate of side effects caused by vaccines. Unfortunately, your data is provided by the drug companies. Thankfully, the public has observed the reactions in their friends and loved ones. Your “you can’t prove anything” argument is so 1995. It’s over, Racter. The truth is emerging and it’s taking you with it.

Racter – at 18:41

Roman:

The Peanut Lobby hasn’t lied to me.

How would you know?

My how you love to throw around the low rate of side effects caused by vaccines.

Whether or not I “love to” isn’t what’s important. What’s important is whether the numbers are accurate. Do you have anything to offer besides ad hominem arguments?

Unfortunately, your data is provided by the drug companies

And yours are provided by…?

And exactly what are your numbers again?

Roman – at 18:50

Racter, That’s right. Let’s regurgitate the last thread. You’re amusing. This reminds me of the “Wizard of OZ”. You can click your heels all night, Racter. It will not change a thing. Perhaps you should follow the lions lead. The public could use another champion.

Racter – at 19:01

Roman:

“‘’Let’s regurgitate the last thread’”“

Wasn’t my idea, you might note. I don’t really expect to see anything substantive from you, and I don’t currently feel a need for the sort of entertainment you appear eager to provide (I won’t deny being an occasional dabbler myself, but I’ve never regarded this as an appropriate place for it). My assumption is that the heart-wrenching case NS1 presented in that thread was due to Guillain-Barre syndrome, and my hope is that he is busy gathering data to support his case. While I’m waiting, I’ll offer some numbers myself, and the sources I used:

After the swine influenza campaign in 1976, the risk of Guillain-Barré syndrome following influenza vaccination that year increased slightly. This risk was about one per 100,000 persons vaccinated.

Reference: Centers for Disease Control and Prevention. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48(RR-4):1–28.

A study of the 1992–93 and 1993–94 seasons demonstrated a slight increase in risk following influenza vaccination, representing an excess risk of approximately one additional case of Guillain-Barré syndrome per million persons vaccinated.

Reference: Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992–1993 and 1993–1994 influenza vaccines. N Engl J Med 1998; 339:1797–1802.

Thinlina – at 19:37

Ok, wise-noses, stop quarreling… speaking of facts, one such is that the doctors don’t report more than a small scratch of all adverse effects of medicines/vaccines. I could wager that there are many who haven’t done any reports of those in their whole career. Partly because of the general medical community opinion, partly because of the hurry in the trenches.

- and partly because the “FDA’s” recommend not to report any other side effects than are already known! - So, no reports!

Besides, the general opinion in medical community seems to be that if vaccinated, what ever happens after that is very, very difficult to judge why happened, i.e. if the child gets a high fever and is exhausted and maybe a short cramp even, the first response is many times: “we don’t know if this has anything to do with the vaccine, perhaps only first fever cramp, so let’s not report”. If a child gets autistic and has taken measles vaccine a couple of years ago, the med community tends to claim it’s soo soo impossible to know after so long time if that has anything at all to do with the vaccine.

Melanie – at 19:45

I think that lots of posters here have a very romantic idea of what a practicing physician’s day is like. It is unbelievably hectic for most doctors.

You can get a little flavor of it here, the blog of a new doctor who is still adjusting to the difference between what he learned in school and what the real life of practice is like. He also writes like a god. I wish Dr. Charles could be my doc.

Leo7 – at 19:47

Anon 22:

Have you done any research on the role of Vitamin C to regulate histamine production after vaccination? The research is stronger with multiple vaccinations but I wondered if it’s been discussed at all in the conferences you’ve attended. Let me find my links. http://tinyurl.com/zvfev and http://tinyurl.com/fmsrh are two examples that speak some to mistakes in shaken baby syndrome brought about by vessel fragility due to vaccs. Any opinion?

Thinlina – at 20:41

NS1, Unfortunately I’ve got the same kind of experience. The person I know had got it from army vaccinations - three in the same time.

NS1: “* I stood a few months ago beside a friend who is 6 feet and 6 inches tall, a robust ex-football player for a major U.S. college. I am only 6 feet tall, but I towered over him.

          o You like riddles, racter. How could that be?
          o He was wheelchair bound, paralyzed.
          o Not paralyzed from a football impact or a car accident or being hit by a train
          o Paralyzed from CNS, in fact, brain damage due to the effects of a flu vaccine
          o He was certified healthy according to his science-based doctors prior to the vaccine.
          o He is not the only or primary sample that I have studied which led me to a deeper opinion on Influenza vaccines, just one that appeared in front of me in my daily life.
          o What are the odds of that?”

I’m waiting with interest and some fright what are the consequences of national decicsion to vaccinate all children with a polyvax in my country. Meaning many vaccinations at the same appointment. Hopefully no adverse effects! :/

HillBilly Bill – at 20:48

I’m just interjecting a report of how some of the general public reacts to the vaccine news reports. People in my wife’s office asked her Thursday what we were going to do with all the food we have stored now that there is a vaccine for the bird flu. Months of talking and convincing were blown away by a story they didn’t even read to the end.

anon_22 – at 21:05

Leo7,

Do you have any idea what a complicated question you just asked? :-)

Vitamin C, I haven’t read enough ‘formal’ research about this, but my general inclination is that it appears to be implicated in a lot of tissue processes, and in normal to slightly higher doses is generally harmless and may be useful. (I am tempted to say beneficial but since I don’t have any more evidence than some very unscientific observations from patients, I’d rather not use that word.)

Shaken baby syndrome - I don’t have a view about the pathology, I have a lot of views about the ethics of accusing mothers based on dubious medical evidence unsupported by any other evidence of abuse such as eyewitnesses.

Multiple vaccinations - the issue is very complicated, and I’m certainly not an authority. But my personal viewpoint is that our immune system is in a very delicate state of balance much of the time, and its response to combined challenges can be substantially different from a series of the same challenges spread over time. Therefore, even though there are clear benefits in preventing infectious diseases for an individual, multiple simultaneous challenges should always be avoided if at all possible. I need to repeat this is just my personal not professional opinion, so any decision that anyone makes should be based on consultation with your healthcare provider.

Now I have no idea how to answer the question that combines all three. Sorry.

But I can say this: all the above is just in the context of our everyday vaccinations, not a pandemic situation.

In a pandemic, several additional considerations arise:

1) the mortality could be a lot higher than normal

2) there will be far less access to healthcare

3) on a population level, creating herd immunity carries the best protection for everyone including those not vaccinated.

Therefore, the risk/benefit considerations would be substantially different in a pandemic IMHO.

Anon_451 – at 21:11

HillBilly Bill – at 20:48

Same thing here. Boss is convinced that the vaccine will work and save us all. As much as told me to file 13 “that bird flu stuff” Got an email from my brother who was just starting to come around. Saying that he was glad he waited and didn’t waste his money on all that junk. IMVHO GSK has done more damage in one day then any good they may ever do. Of course MSM blasting it everywhere, over and over again, undid everything HHS has done over the past year.

Leo7 – at 23:57

Anon 22:

Through as usual. I just thought it might be something helpful to consider for those choosing to take the Pan flu Vacc, but also the Pneunmo and seasonal flu vacc. Vitamin C won’t hurt and it just might help. I didn’t mean to drag in shaken baby syndrome but I was surprised to find most of the discussion on that topic. Thanks for the input.

Anon 451 at 21.11-People hear what they want to hear. If your life depended on something I would imagine you would check it out and not just depend on a news blurb, that’s not so for the others you know. Sadly, as grandpa used to say, you can lead a horse to water but you can’t make him drink. Cliche, but still appropriate.

29 July 2006

Anon_451 – at 00:03

Leo7 – at 23:57

My Grandfather told me that If you want to teach a mule anything you hit them between the eyes with a 2×4 and when you have there attention then you can teach.

However the 2×4 that we need will come in the form of a rapid outbreak and it will be too late then.

Closed and Continued - Bronco Bill – at 00:58

Closed for length, but we’ll continue to get the “point” across here

Anon_451′s last comment is copied on the new thread…

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