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Human Trials of H1N1/novel flu? ... waiting, anyone?

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In looking at many news sources tonight I learned some things about the H1N1/novel flu vaccine. I already knew that human trials had started in Australia in July, and here in the U.S. in August.

I am one who will not get the H1N1 vaccine until the human trials are done. Yes I know how vaccines work and I routinely get the seasonal vaccine. I am in at least two priority groups for the H1N1 vaccine. However, in 1976 the 'swine flu vaccine' resulted in deaths totaling far beyond what that 'swine flu virus' might have caused.

Many countries, including Taiwan and India, have not completed their human trials. Some have had trouble with the stability of the vaccine's virus material.

I find some people in the U.S. saying that this vaccine has "been tested" and "is the most tested" vaccine. Some of these apparently have M.D. after their names but seem to be more functioning as Public Information Officers than medical professionals. The human trials in Australia apparently went off without serious problems, but all I could find was vague generalities in the Australian press.

So, what I did was a lot of looking with Yahoo-news and Google-news along with searching the CDC's website. I would expect that if U.S. trials in humans were complete that our government leaders would make big PR out of that, advising us to build confidence in the current H1N1/novel flu vaccine. Well, mum's the word it seems.

Oh, by the way, Mrs. Gnome is very sick just today with a flu-like illness.

So, if somebody has information on the U.S. human trials' outcome, or details on the australian trials, please post it here. I'd sure like to see it.

Comments

bearded_gnome 4 years, 5 months ago

http://news.yahoo.com/s/ap/20091024/ap_on_go_pr_wh/us_obama_swine_flu

Mr. Obama declares health emergency, among other things, allows hopitals to move E.R.'s offsite for speed and to isolate flu patients.

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Paul Decelles 4 years, 5 months ago

Well lets put this in perspective....at least 1,000 deaths in the United States are known to be due to swine flu or complications from that. Making flu vaccine is pretty established technology so were I in a high risk group I would take the vaccine.

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Boston_Corbett 4 years, 5 months ago


Gnome: citing "http://content.nejm.org/cgi/content/f… one example of thousands of U.S. population-based studies of particular immunity."

@ gnome: irrelevant to my point. I said there is no requirement that clinical trials for vaccines for FDA determination of safety and efficacy to be conducted in the geographical US. Never has been. There is no reason for it.

You seem to believe there is a basis for discounting clinical trials that are not performed within the geographic US. I challenge you to show any article that would suggest that vaccine immunology or the effect of these vaccines is different between the populations of the US, Australia, Europe or India, or pick a country.

The article you cite makes no such suggestion.

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Boston_Corbett 4 years, 5 months ago

Q: Gnome: "so, if u.s. trials aren't necessary, thenwhy are they in process? "

A: once pharmaceutics have been approved for safety and efficacy, and sale and distribution to the public, the manufacturers can and do continue to monitor the use of their products. They they share that data with the CDC and FDA. In addition, there are systems for health providers and state and local public health departments to directly report information to the CDC. So in one sense, trials are never "over."

It is also entirely false to say OR imply that the US-required safety and efficacy studies on monovalent H1N1 vaccine has not occurred, or that testing on these H1N1 vaccines is any less rigorous than any other annual flu vaccine in the US. And this is what you said.


Q: When did the FDA approve of the vaccines for US distribution.

A: The FDA issues a press release on September 15 approving four products for distribution. That press release says in part:

" The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response . . ."


Gnome: "as I know NEJM may have been beyond you" __ @ Gnome: Actually the report you cite has nothing to do with the NEJM, but is an article out of the MMWR, a weekly publication of the CDC. If you check my previous posts on this topic, you will find I have cited the information contained in this article several times.


Gnome: "obviously you've not run research with human subjects. I have. it wasn't medical, but it did involve human subjects with the necessary oversight."

@ Gnome: No I have not run research, but I am pretty familiar with the human experimentation regime under which you conducted your research and Title 45 CFR Part 46 from which it comes. And it may be nice for us to both understand this, but it is not at all relevant to your misunderstanding of clinical testing requirements of by the FDA. _

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Boston_Corbett 4 years, 5 months ago

Gnome, the study you share does not in any way address my challenge to you. Polish up your scholarship. Your friends can pat you on your back, but your statements are still just as factually incorrect.

You accuse me of prejudice. I am just challenging your basic assertion, that the vaccines are not safe.

The vaccines have been found by the FDA to be both safe and effective, yet you say "Multi, you got it. the h1n1/novel is here, we don't have vaccines in time and they aren't tested for safety or efficacy."

So, did the FDA violate the law?

Can you provide any source to back up your underlying assertion, that the clinical trials here are to not be trusted....that there is any immunological difference between Australians and North Americans, for example.

And I am still waiting on why you think 25 deaths is a larger public health tragedy than 100,000.

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Multidisciplinary 4 years, 5 months ago

May I also note..I'm reminded of why I'm divorced. As a woman, it's damned hard to live with a man when he gets an opinion about these matters..and he feels she must 'submit' to his opinion on this and that she is an idiot if she doesn't feel the same way he does about it!

Doesn't matter that she might be in the medical field and he isn't...he knows better! Thanks guys, you've brought back some nightmares for me! Human and veterinary! http://i42.photobucket.com/albums/e338/determinedafterstorm/smileys/massmoon.gif LOL LOL LOL!

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Ronda Miller 4 years, 5 months ago

I am glad to see you are so well informed on this topic. Thanks for scaring the hell of us! ;) Just kidding, I used to be one of the first in line to get flu shots...I am waiting this out.

Good blog, gnome. I just posted one today that includes mention of our military - they are first in line as guinea pigs - or is that swine flu testers.

Illnesses that can be obtained by being first in line with experimental vaccines are not pleasant. I don't know enough first hand to attest to how safe or unsafe they are. I know as a rule vaccines save many lives…but the ones they do damage to are horrific examples.

Please give my love to Mrs. Gnome. I hope she has a speedy recovery.

My latest blog: And I hope the military personnel who have acquired these shots fare well.

http://www2.ljworld.com/weblogs/at-random/2009/oct/23/ft-benning-georgia-the-new-guantanamo-bay/

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bearded_gnome 4 years, 5 months ago

And here is a popular report of a study of flu-related immunity among americans over age 60: http://www.healthjockey.com/2009/05/22/elderly-may-have-pre-existing-immunity-against-swine-flu/

as I know NEJM may have been beyond you. this link describes a u.s. population study to address preexisting flu immunity.

sorry BC, in a handful of minutes and I had no trouble answering your challenge to find u.s. population immunity studies, including one on point regarding h1n1/novel flu immunity. read this, it will be obvious why they analyzed the blood/immunity of american seniors.

sorry, thanks for playing.

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Multidisciplinary 4 years, 5 months ago

Now now...don't think I'm taking sides here.

You two friends can taunt, bicker and try to one up each other on the playground all you want to. That is what you do best, you wicked boys you. That is why I cherish you both, and will protest when they draw and quarter each of you one day. I'll even wave at your heads when they are displayed on pikes over the Kaw near City Hall as I pass. I'll drive up, I promise. :)

I read through it all and felt like the sister in the back seat when too overly educated, too smart for their own good brother get into an argument, and there was probably not going to be any end to it as there isn't a proven answer at this time, just opinion based on lots of research and differing opinions based on that research.

Every little brainiac sister's nightmare on a road trip! Time for mom to intervene.

So..when you two gonna kiss and make up? Agree to disagree?

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bearded_gnome 4 years, 5 months ago

BC: http://content.nejm.org/cgi/content/full/332/12/761

one example of thousands of U.S. population-based studies of particular immunity. this one is Tetanus immunity in the U.S.

and, again BC, pills work different from vaccines. try to realize that. again, vaccines build on and train existing immunological abilities in a population. pills work differently.

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bearded_gnome 4 years, 5 months ago

BC, I will find the resources you as, and though you speak from prejudice, I am quite schooled in scientific issues.

so, if u.s. trials aren't necessary, thenwhy are they in process?

I did look at the sources you gave. none indicates that u.s. trials are done. none indicates that the efficacy of either protocol has been adequately tested in humans, or that safety has been evaluated in human trials yet.

obviously you've not run research with human subjects.

I have. it wasn't medical, but it did involve human subjects with the necessary oversight.


Multi, you got it. the h1n1/novel is here, we don't have vaccines in time and they aren't tested for safety or efficacy.

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bearded_gnome 4 years, 5 months ago

http://www.cdc.gov/FLU/about/qa/gbs.htm

the CDC itself says that the 1976 swine flu vaccine was "associated" with GBS (Guillean-barre syndrome) cases.

same page says that other flu vaccines since have had essentially no association with GBS. they'd know this from human trials and from active survailence.
so, JJRLMom, looks like even the CDC believes that GBS was tied to the '76 swine flu vaccine.

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hawks21 4 years, 5 months ago

This comment was removed by the site staff for violation of the usage agreement.

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Boston_Corbett 4 years, 5 months ago

Gnome, I gave you resources and you choose not to research. Which is fine.

Please provide me a single link to any reputable science based reporting source supporting your contention that US populations are biologically or immunologically different from other countries for purpose of conducting clinical trials on vaccines. Or any other pharmaceutics, for that matter.

You can't, because you obviously have not read science based publications, or you wouldn't have even posted your blog.

If you believe what you believe, you should never ever receive a seasonal flu shot again, and you should probably toss a lot of your medications.

And 25 deaths in a single incident which happened over 30 years ago can not be compared to current vaccine technology, and can hardly be compared to the possible tens of thousands, or even more than one hundred thousand deaths which could occur this year. Your suggestion that the nation should wait for additional US-based human tests on novel H1N1 does nothing but assure that the deaths will be higher than they should be.

My foot is not in my mouth. I think you were looking in the mirror, dear gnome. Best of health to you and your wife.

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bearded_gnome 4 years, 5 months ago

and finally, you split hairs about some of the trials in process.

however, you highlight with this another serious problem I had not covered: there are vaccine administrations going on right now, and we don't have human trials to judge the efficacy of them!
that is, we don't have gooddata to show that they actually work, achieve the desired outcome, because human trial data is not there yet. you are right to raise this issue an that is what some of the trials I ref are addressing ...
but they're not done yet!

and, since you've likely never led human subjects research, you wouldn't particularly know this: though the trials are for efficacy, I guarantee you the experimenters are monitoring for safety too! if they weren't, it would be deeply unethical. that's why your argument about the trials is merely splitting hairs. though they're focusing on efficacy and outcomes, they have to also monitor safety.

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bearded_gnome 4 years, 5 months ago

None of your material contradicts what I posted above: no human trials have been completed in the U.S. further, around the world, only just a few of these have been completed.

in trying to make this a republican or something-else issue, you're blurring or slurring my refs to foreign trials in process or not started.

I never said those were inferior, and shame on you for trying to make such an implication.

it would be preferable if a lot more human trials were done all over the world. and it would be quite informative.

however, your comparison of vaccine to pill is again just silly. if you don't know that the american population differs immunologically from other communities in the world, well there's another lace you should have kept silent.

the only real way to test a virus response for the american populus is to test it with american subjects.

do you not know that the method of action for vaccines differs dramatically frm pills? that method of action relies on existing immune-system strengths and titers. there are dozens of blood titers involved.

the Indian populus differs from the american populus because of: diet; past exposures; environmental exposures; lifestyle and habits; genetics; among probably a dozen other elements in the immunological puzzl for a population.

you say that we should trust the h1n1/novel vaccine because it has been produced the same way as other vaccines in the past.

yet in the next breath you discuss how the h1n1/novel flu has a very different pattern of who it afflicts. so, the virus behaves differently, we all admit that. but you want us to make the trust leap to say thatthough the vaccine i produced the same way, it'll work the same, though admittedly the flu it is treating is different.
hmmmm.

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bearded_gnome 4 years, 5 months ago

Boston, according to your logic, the officials shouldn't have yanked the 1976 swine flu vaccine because there was no problen, if their analysis followed your logic!

first, the two numbers you're comparing for deaths is just a silly comparison. the number of people exposed to the 1976 swine flu vaccine was far smaller than the number of americans exposed to the flu itself. so, your comparison is literally apples to oranges.
so why then was the 1976 vaccine pulled so suddenly? well it was because death resulted far more likely from exposure to the vaccine than from exposure to the virus.

I believe from what you've shared with me you've never operated human subjects research.

your zeal to promote the use of the h1n1/novel vaccine has put your foot in your mouth; you'd have been better to avoid commenting.

and, blur and slur is really beneath you, makes you look like one of the really crazy liberal posters on ljworld, or Marioni.

more follows.

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canyon_wren 4 years, 5 months ago

Hey, Boston--you real name isn't Merrill, is it? You seem to approach your posts in much the same fashion!

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Boston_Corbett 4 years, 5 months ago

Actuallly, I should have been comparing the number 25 to 90,000. (thanks veggiegal)

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Boston_Corbett 4 years, 5 months ago

Gnome writes: "However, in 1976 the 'swine flu vaccine' resulted in deaths totaling far beyond what that 'swine flu virus' might have caused."


Well, that simply is untrue Gnome.

The 1976 incident involved 500 deaths from GB. And as jjrlmom points out that some still question the causality of the 1976 vaccine to the GB issue.

But even assuming that there was a direct cause, you can not compare the normal 30,000 to 40,000 flu deaths a year to 500. And this year, we could be talking about a lot more, and these deaths will hit the young very hard.

90,000 seems to me to be a larger than 500. In kilocycles or fatalities.

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Boston_Corbett 4 years, 5 months ago

Gnome, FYI, the Australian trial you referenced, as well as at least a couple of the news articles you have linked to, involve studies where product safety is not even the primary reason for the clinical research.

Instead they are "dosage" studies where immunity to this particular strain is measured through hemaggultination-inhibition and microneutralization assays. Again, it is about the dose. Safety is monitored, but the basic method of manufacture is the same as every other year. There is lots of clinical data on the safety of this method.

http://www.virology.ws/2009/05/27/influenza-hemagglutination-inhibition-assay/ http://www.virology.ws/2009/05/28/influenza-microneutralization-assay/

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Boston_Corbett 4 years, 5 months ago

More than you would possibly want to know about this years flu vaccines, from the FDA website:

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm

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Boston_Corbett 4 years, 5 months ago

BG says: "no word of u.s. clinical trials of the vaccine"


Gnome, where is the Republican in you? Don't you recall that because of mass tort litigation that Flu manufacturers long ago fled the United States?

Many of the medications you take, and especially vaccines, have likely been manufactured in foreign countries. Likewise clincial trials of all sorts of medications occurs in non-US populations using US testing protocols and standards. Always has. Always will. For lots of reasons.

I'm not sure if your lung lining, blood cells or immune system are particularly that patriotic, so a clinical trial in Australia or Europe or even Africa probably shouldn't bother you. And if it does, you better throw away a lot of your meds right now.

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Boston_Corbett 4 years, 5 months ago

Gnome, this vaccine was produced in the same manner and tested in the same manner as every annual seasonal flu shot. FDA requires tests showing 1) safety, and 2) efficacy. FDA has approved these vaccines. Are you suggesting that the FDA violated federal law in the testing of these vaccines? It seems to me that you are.

For some full length science journal articles you must have subscriptions, but there are very good general sources for virology related news. I recommend you check out the blog and podcasts of a nationally respected virologist at: http://www.twiv.tv http://www.virology.ws

Veggiegal: the numbers I have read from several sources stand for the basic principal that fatalities from novel H1N1 are slightly higher, but essentially the same as recent seasonal flus. About .1%. This surprises some based on all the media hype. But as you point out, this flu does not follow the patterns of seasonality we normally call "flu season." Novel H1N1 is highly infectious. For this reason, people believe that up to 3 x the normal flu infection rate. This means that even at the same rate of death, that three times the normal deaths could occur.

In a normal year 30,000-40,000 deaths in the US are attributed to the flu. So in this year we could see 90,000 plus.

What will be different is who dies. In a normal year, it is our grandparents in the nursing home. This year it will be the young. These deaths will be more noticeable. As you pointed out, there are already more deaths among the young than are typically experienced in an entire year with seasonal flu.

Remember there are also a significant number of people who simply can not take a flu shot due to asthma or an immune compromised system. These peoples lives depend upon living in a world where the rest of us are vaccinated. They depend on our herd immunity. To them it is not about a .1% chance of death. Flu is a far far greater danger to them.

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bearded_gnome 4 years, 5 months ago

Well thanks Wren and nice to see you here.

it just seems wise to not put that into my body until the ordinary testing is done, and human trials is part of the ordinary process.

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bearded_gnome 4 years, 5 months ago

very good post Veggiegal! and contracting a G-B virus infection has lots of complications. last I knew, it was linked to Chronic Fatigue Syndrome, etc.

yes, h1n1 does seem to infect and injure/kill people in a different profile than the seasonal flu.
but again, no word of u.s. clinical trials of the vaccine, in any of its forms.

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canyon_wren 4 years, 5 months ago

Good blog, gnome--and good information, veggie gal. Sounds like jjrlmom is willing to swallow the PR that is floating around. That's not good enough for me--I'm waiting for results on the trials, as well.

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jjrlmom 4 years, 5 months ago

I actually heard that the 500 cases of Guillian-Barre syndrome were never scientifically linked to the vaccine. This many cases would occure normally. The chances of having complications from the flu is 1 in 1000, and the chances of developing Guillian-Barre syndrome after having a flu vaccine are 1 in 1,000,000.

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veggiegal 4 years, 5 months ago

I'd love to know the results of clinical trials as well. Here's some related stats for you. In 1976, approx. 40 million H1N1 immunizations in the US led to 500 cases of Guillain-Barre (most folks recover with treatment), of which 25 ended in death. This means 25deaths/40million immunizations--or 0.625 deaths per million immunizations. The WHO puts the latest world death total from H1N1 at 4735 (updated stats available soon), so with a world population of about 7 billion, this would mean 0.676 deaths per million (and climbing). This ratio varies dramatically by region; e.g., Canada's latest data shows 2.4 deaths per million (google FluWatch Canada); California's is about 6.13 per million (233 deaths; 38 million pop.), and Australia's (who have been thru their winter flu season) about 8.8 per million (185 deaths; pop. 21 million). To make a reasonable decision about H1N1 vaccination you also need to consider (a) other possible side effects from flu shots, (b) the fact that immunizations are not 100% effective (I've seen data suggesting anywhere from about 33% to 82% effective), and (c) what subgroup you belong to. H1N1 has a low death rate overall compared to seasonal flu, but for some groups, like under-18s in the US, the death rate is higher than usual (latest CDC stats have 86 pediatric deaths; in previous 3 flu seasons this number has ranged from 46-88; the CDC will update their numbers later today and this total will be above the 88. Keep in mind that the northern hemisphere is at the beginning of the usual flu season). Asthmatics and pregnant women also are being disproportionately affected. Note also that the 1976 flu season did not behave like the current one. The vast majority of deaths were from seasonal flu, and among the elderly (as is usual), not from H1N1. This year the situation is being reported as different in many countries (US, UK, Canada, etc.) as the majority of deaths are occurring in those under-65, whereas in a usual flu season over 90% of flu deaths are in the over-65 crowd. Hope that gives you food for thought, though it certainly doesn't give clear answers as to what do do, does it?

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