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IOM review find adverse events are rare and usually reversible - Page 2

post #21 of 31

well it looks like what you linked is the entirety... where is the rest? where would they explain that?

 

JAMA. 2011;306(13):1427-1428

 

appears it is one page long...

 

so I don't know how I can realistically take this statement:

 

They found less convincing evidence linking the vaccines to other events. For example, they found some evidence that the MMR vaccine can cause temporary joint pain in some women and children. 

 

 over that of Merck's, or to indicate Merck reported inflated reaction rate...

 

Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women,incidence rates for arthritis and arthralgia are generally higher than those seen in children (children: 0-3%; women: 12-26%),17,52,53

 and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years.
post #22 of 31
Thread Starter 
In the actual report which you can download from the first IOM link I posted.
post #23 of 31

ahh ok you said the 2nd would be better, so I didn't go to first

 

ETA $79.95...

 

yeah, I'll go with Merck's 12-26% rate...

 

which to me is a bit more than "some evidence" 

post #24 of 31
Thread Starter 
I clicked "read online for free" and it took me here.

http://books.nap.edu/openbook.php?record_id=13164
post #25 of 31

yeah i found where you can see it for free

post #26 of 31

Well I got to the relevant part of it... some interesting things... did you know the Mumps strand in the current vax is from a guy named Jeryl Lynn Hilleman, isolated from his throat in the 1960s?

 

and this is very interesing:

Quote:

Prior to the licensure of a measles vaccine, an average of 400,000 measles cases were reported each year, although the actual incidence was estimated to be 3.5 million based on the size of the annual birth cohort and, the fact that nearly 100 percent of the population was infected during childhood (CDC 1998).   [Pg. 104]  http://www.nap.edu/openbook.php?record_id=13164&page=104

 

So that pretty much plummets the fatality rate... 400,000 reported cases is consistent with this:

 

 http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/G/cases&deaths.pdf 

 

which puts the deaths at 300-600/year... (and it is commonly accepted around here that death would be the most likely of all outcomes to be reported, albeit usually that is pointed out when speaking of vax reactions)

 

anyway, IMO says this about arthritis from Rubella vax (no one actually says anything about MMR II)

 

Epidemiologic Evidence - 

5 studies, one with methodological limitations so not included... others had other issues, so the one they cared about the most was this:

 

http://www.ncbi.nlm.nih.gov/pubmed/9142061

 

Randomised double-blind placebo-controlled study on adverse effects of rubella immunisation in seronegative women.

 

Quote:

Results indicated a significantly higher incidence (p = 0.006; odds ratio = 1.73 [95% CI = 1.17-2.57]) of acute joint manifestations in rubella-vaccine recipients (30%) than in placebo recipients (20%). Frequency of chronic (recurrent) arthralgia or arthritis was only marginally significant (p = 0.042; 1.58 [1.01-2.45]).

INTERPRETATION:

RA27/3 rubella vaccine given to seronegative women during the postpartum period was significantly associated with development of acute arthralgia or arthritis. Although the numbers of women assessed and length of follow-up revealed only marginally significant differences in persistent or recurrent joint manifestations between rubella vaccine and placebo recipients, it is possible that susceptible women who are given rubella vaccination may experience this outcome.

 

Mechanistic Evidence - 

 

16 studies...(measles & rubella or just rubella vax)... 4 they gave the most consideration:

 

 

Quote:

http://books.nap.edu/openbook.php?record_id=13164&page=180

"The authors reported transient arthralgia in 9 of the 36 seronegative woman after vaccination and transient arthritis in 6 of the 36 women(who received RA 27/3)

 

 

Quote:
Logistic regression modelling of DR, treatment, age, time postpartum, and arthropathy revealed that the odds of developing arthropathy was 1.9 times greater (95% CI, 1.07-3.44) after rubella vaccine than placebo.
 Risk for arthropathy (regardless of rubella vaccination) was also influenced by DR interactions: odds were 8 times greater in individuals with both DR1 and DR4 (95% CI, 1.45-44.02) and 7.1 times greater with both DR4 and DR6 present (95% CI, 1.85-27.52), suggesting that coexpression of these specificities may predispose to postpartum arthropathy.
Quote:
Arthropathy following RA27/3 rubella vaccination may be higher in women who have very low prevaccine levels of antibody, particularly in assays measuring functional (neutralizing) antibodies.

 

Quote:
A prospective study was carried out to correlate the development of joint symptoms after rubella immunization with pre- and post-immunization rubella-specific immunological responses. Arthralgia or arthritis or both occurred in 10 of 37 adult female volunteers at a mean time of 17.0 days after immunization with the RA 27/3 rubella vaccine.
 

 

....So that doesn't differ too greatly from Merck's statement... sounds like "some evidence" is a great downplay, but I can understand why, technically they did find some (any amount is "some"), and found a bunch of other studies they considered to have problems too.

post #27 of 31
I wonder how long they followed the "transient" arthritis and arthralgia cases. Rheumatoid arthritis tends to come and go, and can have long periods of relief. (I doubt they were cases of osteoarthritis.). The implication is that the arthritis/arthralgia cleared up on its own--but for how long?

I also wonder why they think it's acceptable for 26% of women to end up with this side effect. You KNOW if it were 26% of MEN, it would have been considered unacceptable!
post #28 of 31

Taxi, it varied... they discounted some studies because they did not indicate duration or had reporting flaws...

 

One study (not listed) states it lasted for up to 8 days... Merck insert says can occur up to months/years, rarely.

 

ETA: the last study I listed, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC264812/?page=2

10 who had a problem, (27%  10/37) 6 had single transient episode of arthralgia, and 4 had overt arthritis (in various joints), and those 4 all had recurrent episodes involving same joints during the six months they were followed.

post #29 of 31
I don't suppose it says what the placebo was? Was it a true placebo or another vaccine?
post #30 of 31

Sorry, I edited, 

 

http://www.ncbi.nlm.nih.gov/pubmed/9142061

with 20% arthropathy placebo and 30% arthropathy vax, the placebo was saline. 276 and 270 for sample sizes, respectively, all postpartum.

post #31 of 31

Interesting, gonna read through it tonight.  Thanks

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