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# HIV Vaccine FAILS!!! Volunteers infected. - Page 4

Well, here's my conspiracy theorist take on the matter.

I think there is probably some data that was collected but hadn't been officially entered for public review. It pushed the boundary so that statistical significance was, in fact, found that the vaccine contributed to the HIV infection rate.

So they abruptly pulled the plug on the entire operation.

You can quote me on that, but it won't get you very far.
Honestly, the math and science makes my head spin (the math a bit more than the science) :

but my husband and i just had the best discussion about the vaccine and the idea of an AIDS vaccine illustrates so clearly why we choose not to vaccinate. It just boils down to this:

vaccination for specific diseases or infections which without a doubt carries some risk vs maintainig good overall health practices to best combat any disease or infection wich carries no health risks
Quote:
 Originally Posted by blessed Here are the calculations for statistical signficance. Bolding is mine. Statistical signifcance was not reached. That means that there is a greater than 95% chance that these results would occur by sheer chance, and that no correlation exists. However, there is a trend toward significance, which is not scientifically meaningful in the traditional sense, but which I'm sure prompted Merck to completely shut down the trial.Chi-square test results P value and statistical significance: Chi squared equals 0.645 with 1 degrees of freedom. The two-tailed P value equals 0.4218By conventional criteria, this difference is considered to be not statistically significant. The P value answers this question: If the theory that generated the expected values were correct, what is the probability of observing such a large discrepancy (or larger) between observed and expected values? A small P value is evidence that the data are not sampled from the distribution you expected. http://www.graphpad.com/quickcalcs/chisquared2.cfm (In an earlier deleted thread, I explained the difference between categorical data and quantitative data, and that chi squared analysis is the test which must be used in this circumstance, not t test or ANOVA, which would require data to conform to a bell curve.) I'm no statistician, but there's the basic math for you (and god knows, somebody better check that). I'm happy to look at anything else that folks have to show. Specifically, Moya, I'm curious as to how you come to feel that statistical signficance is reached?
Real math. Yay! I knew there was no way it could be statistically significant, even though I didn't run the numbers.
Well, it wouldn't exactly be great for the future of HIV vaccines if the first big trial went really, really badly wrong.
That doesn't mean anything necessarily...but still...
Here's how it boils down for me:

The vaccine developers, distributors and policy makers have consistently demonstrated a lack of forthrightness, a tendency toward motivations of political or financial nature rather than altruistic healthcare.

And here is yet another example of that.

Each individual vaccine may be good, bad or indifferent. But I do know that I am unable to rely upon vaccine developers, vaccine policy makers, and the medical establishment to provide me with unbiased and accurate information.

I am therefore compelled to look at the proofs of efficacy and safety for each individual vaccine myself, and make my own decision about their utility.
Quote:
 Originally Posted by blessed Sorry, just one quick question: Moya, do you know what the term 'statistically significant' means?

: : : : : : : : :
Quote:
 Originally Posted by holly6737 Real math. Yay! I knew there was no way it could be statistically significant, even though I didn't run the numbers.
is the desperation to support a failed vaccine, dumped by the manufacturer so great that a system's failure to see that blessed later agreed with moya occured?
I always follow the truth (as I understand it, anyway).

I'm passionate about what I believe, but if you give me good reason to believe something else, then I'm right there with you.

Quote:
 Originally Posted by blessed Here's how it boils down for me: The vaccine developers, distributors and policy makers have consistently demonstrated a lack of forthrightness, a tendency toward motivations of political or financial nature rather than altruistic healthcare. And here is yet another example of that. Each individual vaccine may be good, bad or indifferent. But I do know that I am unable to rely upon vaccine developers, vaccine policy makers, and the medical establishment to provide me with unbiased and accurate information. I am therefore compelled to look at the proofs of efficacy and safety for each individual vaccine myself, and make my own decision about their utility.
I look at it like...sometimes vaccine manufacturers get lucky, and some scientist somewhere comes up with some really great idea that just works like a charm. I'm going to say the Hib conjugate vaccine is probably a pretty good example of this. It works, it works very well, doesn't probably have too many (or maybe any) crazy side effects, etc.
The data is consistent, clear, no weirdo anomalies, etc. Across the board.

Other times...something might go wrong...(I'll say bovine viruses popping up in the MMR and other adventitious agents in live vaccines is an example of this.)
That's when everything gets goofy. People who should, in theory, be trustworthy suddenly find themselves doing some strange moral juggling.
People like Philip Minor say things like "Now the regulatory authorities in the room will well be aware of a rather large number of other examples of this type that don't actually get published. I think that's not so good- I think this should be out there in the public literature. But these are ones that are well known, I think." And..."sooner or later this information will leak out."

WTF???

So...you never really know. It's hard to say...
Don't get too excited, Holly. Blessed's calculation is not accurate (and it's not her fault). That's not how the SD is (was) calculated for this data set. And unfortunately I must apologize to Blessed because there is not enough data from that article to do the actual SD. I was 'lucky' enough' to get hold of some primary data on the study. There are in fact t-tests involved and they have to do with the more primary data that goes into deciding who is HIV positive and who is not. There are also other statistical determinations involved regarding how many people are removed from each study. So you can't use the rate to determine the SD, you have to enter the specific data points and parameters into an algorithm. Regardless, by their own standards, the observed efficacy was determined to be real. There were subsets/parameters of data where the contrast was very marked.

Quote:
 Originally Posted by blessed I think there is probably some data that was collected but hadn't been officially entered for public review. It pushed the boundary so that statistical significance was, in fact, found that the vaccine contributed to the HIV infection rate. So they abruptly pulled the plug on the entire operation.
That is exactly what happened.
Quote:
 Originally Posted by blessed It ain't about being right. It's about being accurate.
Striving for accuracy makes being right a lot easier, as long as you're willing to go "Oh...I guess I was wrong" sometimes, too.
The South African one was just halted, too.

Quote:
 It's been a very bad day for us. We all feel terribly despondent at the news," Dr Glenda Gray, chief investigator in the South African trial of the Merck MRKAd5 vaccine based at Chris Hani Baragwanath Hospital in Soweto said in an interview. Seven hundred people had enrolled in the trial, code-named Phambili, that began at five sites across South Africa in February this year. The trial sought to test the efficacy of the vaccine in fighting the C subtype of the HI virus found in Africa after preliminary results from trials in other parts of the world had suggested it had some success in fighting the B subtype strain. But the trial was paused on Friday after interim results from a trial carried out in regions with the B subtype, including the US and Australia, showed it probably did not protect against HIV infection.The organisers of the South African trial will take a month to examine the data from the sister trial before deciding whether to continue with the Phambili trial in a modified form or suspend it, Gray said.The researcher stressed that the safety of the volunteers in the trial was never in jeopardy as the vaccine's safety had been borne out in earlier testing. "We do know it's safe and that it won't cause HIV, but we don't know if it protects against HIV infection," she said.
What phase was the RSV vaccine in before they figured out it caused enhancement?

ETA:

http://209.85.165.104/search?q=cache...lnk&cd=3&gl=us

Quote:
 Unexpected morbidity and mortality detected during efficacy trials. Trials should be examined carefully for unexpected events. Well-known examples include a phase III trial of formalin-inactivated RSV vaccine â€“ where increased incidence of severe RSV disease in vaccinees vs. controls was observed;phase IV immunogenicity trials of high-titre measles vaccine (= 105 pfu) in young African and Haitian infants â€“ increased long-term mortality in females.
Quote:
 Originally Posted by blessed I always follow the truth (as I understand it, anyway). I'm passionate about what I believe, but if you give me good reason to believe something else, then I'm right there with you.It ain't about being right. It's about being accurate.
sometimes there's no way to work out what is right or what is accurate

example.

your kid has a gardasil shot, and not only faints, but has excruciating body pain, and what anyone with half an old brain would see as landry's syndrome. it goes on for weeks. but because ole prof fraser (who wrote a medical article titled "god's gift to woman: the human papilomavirus" ) decrees the vaccine can't possible have those side effects, all us mums were told that our kiddos were hysterical and we are stupid.

for those silly enough to have the next shot, same things happen, same excuse from good ole fraser.

nowhere will you see any of that data in the safety specs, coz it didnt' happen, you know?

one day if your kid has a reaction and you go to the quack and he says "nope, nothing to do with it" you might need to review your ability to work out what is either right, or accurate, and then you might understand that the industry isnt about honesty or accountability. it's about selling a product to people by creating fear, then denying any consequences.
This thread has been very interesting.

Arguing over incomplete data=a sort of garbage in, garbage out situation, doesn't it?

And a lot of the data about vaccines is incomplete to say the least.
Quote:
 Originally Posted by anewmama Kind of ironic though. It's hard to have it both ways... wanting the vaccine to fail as yet more proof of the evil pharma, then people being victimized by HIV in and of itself but then what if the vaccine DID work and there was great promise, yes, with the possibility that it might eventually make it's way onto the schedule.

I don't want the vaccine to fail! And I certainly don't want it to fail just to prove the pharm companies are evil. AIDS is killing millions of people. If the vaccine can stop it, great. My problem with an AIDS vaccine is not that it might work (big 'might' in my opinion). My problem with an AIDS vaccine is that they will eventually mandate it for school entry in America, but like mamakay said on the first page, we're already going to be opting out anyway, so no big deal. Just annoying, that's all.
How sad. And when a vaccine is so desperately needed.

I hope the Russian vaccine does better, though since we are in new vaccine (retro-viral) territory, I think it's going to be a tough road.

I do feel sad for the sex workers. There are a lot of myths about sex workers, especially in the third world, but I don't think it's all black and white. Considering the infection rates and the fact that the weaker you are already, the less likely you are to get customers, the quality of condoms in a tropical, third-world country, etc. etc. it will be REALLY HARD to tease out causation linked to the vaccine, though, especially for a measly .5%. I doubt it.
Once again I have removed posts containing UAVs. Please remain on topic regarding the failure of this HIV vaccine trial and restrict any commentary regarding member behavior to PM.
Quote:
 Originally Posted by blessed I crunched the numbers given in the article cited. There were 21 out of 762 positives (infected with HIV) in the placebo arm, for an expected 0.028 infection rate. There were 24 out of 741 positives in the vax arm. Plug that into a chi square formula with 1 degree of freedom and that's what you get. Maybe Merck is factoring in some unpublished data? Or, there are modifications that professional statisticians sometimes apply to calculations to account for various factors which are beyond the basic formula. Maybe that is the case?
Hey blessed...what happens to the numbers when the 2-3 dose subgroup is added in? (or is that just a no-no to even try to do that?)

http://www.aidsmap.com/en/news/E5221...7E1C1CB477.asp

Quote:
 In the subgroup who had received at least two vaccinations and who were HIV negative for at least the first 12 weeks of the trial, 19 cases of HIV infection were observed in the 672 volunteers who received vaccine and 11 cases were observed in the 691 volunteers who received placebo.
I'm shamefully horrible at math...but that's about a 50% increase in the vaccine group, isn't it?

What are the chances that that was a coincidence???

ETA:

And the 17% difference was in the volunteers who only got ONE dose.

Quote:
 The vaccine did not prevent infection: in volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed in the 741 volunteers who received vaccine and 21 cases of HIV infection were observed in the 762 participants in the placebo group.
So...again, I'm not at all an expert on statistics and math or biology or anything...
But that looks like some kind of dose dependent response???? I mean, a bad kind???
Quote:
 Originally Posted by mamakay Hey blessed...what happens to the numbers when the 2-3 dose subgroup is added in? (or is that just a no-no to even try to do that?)http://www.aidsmap.com/en/news/E5221...7E1C1CB477.asp I'm shamefully horrible at math...but that's about a 50% increase in the vaccine group, isn't it? What are the chances that that was a coincidence???
Chi-square test results
P value and statistical significance:
Chi squared equals 6.542 with 1 degrees of freedom.
The two-tailed P value equals 0.0105
By conventional criteria, this difference is considered to be statistically significant.
There ya go.

There would have been around 10 expected infections in the vax group. Instead there were 19.
Quote:
 The vaccine did not prevent infection: in volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed in the 741 volunteers who received vaccine and 21 cases of HIV infection were observed in the 762 participants in the placebo group.
Quote:
 In the subgroup who had received at least two vaccinations and who were HIV negative for at least the first 12 weeks of the trial, 19 cases of HIV infection were observed in the 672 volunteers who received vaccine and 11 cases were observed in the 691 volunteers who received placebo.
The observed negative impact of the vaccine for both these sets of data is significant based on the methods that Merck uses to prove efficacy. Merck presents their statistical significance as confidence intervals so that they can cite data like this as relevant. Gardasil is the perfect example, it's efficacy in the general population is based on lower numbers than what is quoted above.
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