IOM review find adverse events are rare and usually reversible - Mothering Forums

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Old 05-22-2012, 12:59 PM - Thread Starter
 
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I came across this today, it's from 2011 so maybe it's been discussed here before.

http://jama.jamanetwork.com/article.aspx?articleid=201629
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Old 05-22-2012, 01:17 PM
 
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It is interesting that this is worded so:

 

 

Quote:

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. 

 

When the MMR II product insert states that 1/4 - 1/8 teen and adult women receiving vaccine will experience that side effect, 12 - 20something % if I am remembering correctly.

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Old 05-22-2012, 01:18 PM - Thread Starter
 
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Things are included in the packet information without very conclusive evidence at all, is my understanding. The IOM uses a different threshold and kind of evidence in their reviews.
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Old 05-22-2012, 01:39 PM
 
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I hope things included in vax product inserts do have satisfactory evidence, especially the clinical trial results.

 

Quote:

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.

footnotes:

17.  Unpublished data from the files of Merck Research Laboratories.

 

52.  Gershon, A.; et al: Live attenuated rubella virus vaccine: comparison of responses to HPV-77-DE5 and RA 27/3 strains, Am. J. Med. Sci. 279(2): 95-97, 1980. 
53.  Weibel, R.E.; et al: Clinical and laboratory studies of live attenuated RA 27/3 and HPV-77-DE rubella virus vaccines, Proc. Soc. Exp. Biol. Med. 165: 44-49, 1980.
 
respectively 52 and 53:
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Old 05-22-2012, 01:53 PM - Thread Starter
 
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The bar is much lower, on the theory that better to report it, and I don't think there has to be any evidence for causality, I think they just report everything that gets reported more than a certain number of times in the clinical study. It's been awhile since I read about it, though.

The iom uses a whole different kind of and criteria for evidence.
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Old 05-22-2012, 02:30 PM
 
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Quote:
Originally Posted by Rrrrrachel View Post

The bar is much lower, on the theory that better to report it, and I don't think there has to be any evidence for causality, I think they just report everything that gets reported more than a certain number of times in the clinical study. It's been awhile since I read about it, though.
The iom uses a whole different kind of and criteria for evidence.

 

I wonder where that information would be available? IOM's definition of arthritis and arthralgia (in multiple studies since this is a review of 1000+) vs. Merck's and the two studies ref'd in the Merck document.

 

Funny how Merck would exxagerate how bad their vaccine is. I mean, they can't get sued for it anyway!

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Old 05-22-2012, 02:41 PM - Thread Starter
 
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I will try to remember where I read about it. It may have been in the vaccine book but that doesn't sound right.
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Old 05-22-2012, 02:45 PM - Thread Starter
 
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Page 57 in the vaccine book talks about how irises of side effects are generated.
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Old 05-22-2012, 02:49 PM
 
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which vaccine book?

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Old 05-22-2012, 02:49 PM - Thread Starter
 
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Sorry, the book titled "the vaccine book" by bob sears.
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Old 05-22-2012, 03:08 PM
 
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Lent out my copy. He really discusses how IOM's criteria for arthritis and arthralgia differs from Merck's and that of the two studies ref'd by Merck?

 

That is the info I was inquiring about.

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Old 05-22-2012, 03:09 PM - Thread Starter
 
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No, he discusses how lists of possible side effects are generated that are used on packet inserts.

You asked about the discrepancy between the two statements. In my opinion it is easily explained by the fact that the two use different kinds and standards of evidence. Beyond that you are on your own.
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Old 05-22-2012, 03:17 PM
 
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ok. That explains no differences in criteria. I don't know what Sears discusses, probably why they use fever...crying...swelling... etc.? as the list of effects they look at in clinical trials?

 

Merck's own criteria and that of two different studies by different researchers they reference puts arthritis/arthralgia at 12-26% of teen and adult women.

 

I wonder what IOM's criteria lends to "some" 5% 12% 25%, 50%?

 

shrug.gif

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Old 05-22-2012, 03:22 PM - Thread Starter
 
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That's what they observed in their study. That doesn't mean it was caused by the vaccine, just that it occurred that often in those studies. You can read the IOM methodology for yourself, but usually they look at all the studies on a particular topic, their methodologies, their biases, etc and kind of compile all the evidence into one big statement. They also pay more attention to causation.
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Old 05-22-2012, 03:40 PM - Thread Starter
 
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I think (?) that this is the actual IOM study if you want to read more about it.

http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx
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Old 05-22-2012, 03:43 PM - Thread Starter
 
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Old 05-22-2012, 03:58 PM
 
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Well maybe I am not understanding that link correctly, can you explain?

 

 

It looks like the adverse effects reviewed were ones that people filed in VICP for. I doubt many adult women filed for arthritis from MMR in VICP?? How would we know that?
 
It just looks like they reviewed evidence and conducted no study of their own. I wonder how many and which studies they reviewed to conclude what they did about arthritis from MMRII
 
(I would copy and paste but it has dark highlight)
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Old 05-22-2012, 04:05 PM - Thread Starter
 
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Right, iom doesn't do studies, they examine the evidence that's already out there. It was over 100 studies. Apparently people do report joint pain since it was included.
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Old 05-22-2012, 04:08 PM
 
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So I wonder what studies they looked at that concluded arthrtitis and arthralgia occur less than what Merck states? 

 

Because without seeing that, I don't know how to quantify "some." 

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Old 05-22-2012, 04:13 PM - Thread Starter
 
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I don't know but I bet if you read the review you'll find out.
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Old 05-22-2012, 04:29 PM
 
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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.
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Old 05-22-2012, 04:35 PM - Thread Starter
 
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In the actual report which you can download from the first IOM link I posted.
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Old 05-22-2012, 04:39 PM
 
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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" 

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Old 05-22-2012, 04:44 PM - Thread Starter
 
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I clicked "read online for free" and it took me here.

http://books.nap.edu/openbook.php?record_id=13164
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Old 05-22-2012, 04:44 PM
 
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yeah i found where you can see it for free

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Old 05-22-2012, 06:29 PM
 
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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.

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Old 05-22-2012, 06:45 PM
 
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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!
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Old 05-22-2012, 07:02 PM
 
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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.

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Old 05-22-2012, 07:10 PM
 
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I don't suppose it says what the placebo was? Was it a true placebo or another vaccine?
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Old 05-22-2012, 07:16 PM
 
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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.

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