Vaccine Safety Government Sites Rely Each Other To A Fault (part 1)


As a very outspoken advocate of stricter vaccine safety requirements and an increase in vaccine liberty, I decided to go straight to the source (the CDC website) to find out what is being done to protect us from dangerous vaccine reactions.   Below is a chart I made up to help visualize the complexity of the cyclical reasoning I found.   You may find the need to refer back to it as you read.  Any item enclosed with a red slashed circle are sources that do not meet my personal satisfaction for reliability given the lack of parental choice that is often presented and the lack of legal liability for the manufacturers.  The two CDC sources that have “???” beneath them will have to be reserved for a later article due to the complex nature of this issue.

I started my search with the VAERS, the Vaccine Adverse Event Reporting System.

According to the VAERS website, it’s information is not entirely correct do to the following limitations:

  1. VAERS is a passive system.  Only if someone thinks there may be a connection to a vaccination is an event reported.  There is no automated data collection.
  2. Under reporting:  The VAERS website states that it only “receives reports for a small fraction of events.”  VAERS assumes that the most unreported events are for “soreness,” but gives no documentation to back this up (like perhaps a standardized vaccine followup procedure)
  3. VAERS accepts reports without proof of vaccine cause, and
  4. VAERS follows up after serious events by looking into scans, labs, autopsy’s etc. BUT they admit that:

“However, in general, coding terms in VAERS do not change based on the information received during the follow-up process. VAERS data should be used with caution as numbers and conditions do not show data collected during follow-up.

So, wait a minute.  There is no standardized followup process to check for adverse reactions to vaccines (Is there any doctor out there pushing vaccines who wants to step up?).  Many times events do not get reported unless someone thinks to report it to VAERS, and it is assumed most of the missing reports are not serious.  Then the site goes on to say that when they do follow-up on the serious reports, they do not update their records.

So what happens if someone (perhaps a child) has an adverse reaction and does report it, before something worse happens?  What if they die?  If the codes do not get changed in the event of long-term injury or death, and the report does not get removed in the event of a false alarm, then what is the follow-up for?  Sorry, what is VAERS for again?  Not updating the codes seems like a ridiculous blunder.  Why do a follow-up if not to update the records?

The CDC uses the VAERS website as a reference, along with three more organizations.  It cites:

1. The Vaccine Safety Datalink Project,

2. The Clinical Immunization Safety Assessment Network, and

3. The Brighton Collaboration.

It sounds like a lot of scientific studying is going on to ensure vaccine safety.  In this report I will look at the first two of these listed sources, VAERS, and the VSD.  I will discuss the other two in a later report.

The Vaccine Safety Datalink Project,  VSD, is according to the CDC page,

“a collaboration between CDC and 10 health care organizations which monitors and evaluates adverse events following vaccination.”

That sounds great doesn’t it?  It makes you feel all warm, fuzzy, and safe inside even though you aren’t allowed to sue for harm.  Upon further inspection of the VSD, (about two more clicks on the CDC site), a map pops up with a listing of these “10 health care organizations.”  They are spread around the US are actually “Managed Care Organizations,” sites.  What is a managed care organization and why are they helping the CDC?  According to this website, managed care plans are:

“Health insurance plans intended to reduce unnecessary health care costs through a variety of mechanisms, including:economic incentives for physicians and patients to select less costly forms of care; programs for reviewing the medical necessity of specific servicesincreased beneficiary cost sharing; controls on inpatient admissions and lengths of stay; the establishment of cost-sharing incentives for outpatient surgery; selective contracting with health care providers; and the intensive management of high-cost health care cases. The programs may be provided in a variety of settings, such as health management organizations and preferred provider organizations.”

These managed care organizations are better known as HMO’s and PPO’s.  The VSD gets millions of records from these “participating managed care organizations,” with no identifying information, which would admittedly be a wealth of knowledge to apply to the study of vaccine safety.   It includes who had vaccines, dates, medical outcomes (documented ones by VAERS of course), and who didn’t receive vaccines, and their records.

The VSD reports that it is using what is called RCA, or “Rapid Cycle Analysis,” to track and detect adverse events.  According to that site, RCA works like this:

“Each week, the rate of adverse events that occurs in people who have received a particular vaccine are compared to the rate of adverse events that occurs in a similar group of people who have not received that vaccine. If the rate of adverse events among vaccinated people is significantly higher than among the comparison group, the vaccine may be associated with an adverse event.”

Of course, that VAERS is not reliable according to its own website means that this process is unsatisfactory to me.   There is no standardized follow-up procedure to check for adverse events and VAERS does not update reports after follow ups, so any long-term or later injury after reporting was done would still not be included in the RCA.  The site does not list the VSD managed care information as a source for comparison with VAERS, but I assume this must be what they are referring to when mentioning the “similar group of people who have not received that vaccine.”

What the RCA page says is that its information comes from 3 sources: VAERS (where they get the rate of adverse events), vaccine study data from before licensing, and published scientific articles.  Let us review these sources.

1.  I have already made point clear on VAERS.

2.  As far as the study data from before licensing, you have to ask yourself who is paying for the study and studying the effects of this vaccine?  A majority of the time it is the company trying to get it approved, of course!  This study data would give RCA with a list of possible adverse reactions that are expected based on what has been published in relation to vaccine reactions.  This sounds like a good addition to amend the fact that VAERS is so inaccurate but the problem I have with that is the article from January 2008 coming out of the New England Journal of Medicine which stated: (emphasis added by the author)

Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

3.  Do those published scientific articles based on the published studies sound very reliable now?

So in my opinion, all three sources listed for the Rapid Cycle Analysis are unreliable.

As for the other part of Vaccine Safety Datalink, which once again relies on the reports of incidents from insurance companies is still inaccurate because there is no follow-up procedure for vaccine reactions, although these reports would possibly include later injury and reactions not included in VAERS.  Once again you have to ask yourself, if someone had a reaction, injury, prolonged condition, or death after a vaccine, and it was in their medical record but not connected up to the vaccine through VAERS, wouldn’t it be disregarded?  The only way that it may be included is if some part of the person’s record matched up with the published studies and articles.  Are you beginning to see the problem?

Let’s review:

What is VAERS again?

A reporting system that is inaccurate for a variety of reasons: the most disturbing of which is that they don’t update records after following up on serious reactions, meaning is someone dies or is severely injured after the first report there is no record of it.

Who is the VSD again?

The CDC, along with Managed Care Organizations, which are just for profit health insurance companies whose primary goals are to cut costs, reward doctors that cost them less money, and minimize care while maximizing the cost to the “beneficiary.”  These two use a process called Rapid Cycling Analysis which matches up records to VAERS.  The records themselves will be incomplete because there is no follow-up procedure for checking with patients after their inoculations, and what is reported in their medical records would be in VAERS anyway.

There are two more sources that the government says it uses to make sure vaccines are safe.  I don’t have the energy to keep going in circles to analyze them at this time.

From what I’ve seen so far, the government sets one organization up to cite another organization that deems itself a bad source, then recycles the information through the new organization while partnering with private insurance companies.   It seems logical that they would be sharing epidemiological information for the random cycling analysis, but the RCA page says it uses VAERS, and does not specify what the information from the insurance companies is for (only that it is anonymous).  I have decided to base this report on the assumption that is why the CDC is partnering with the insurance companies for that specific purpose.  They say they compare to records of unvaccinated and that they work with the insurance companies, but don’t directly state that the insurance companies are where they are getting their information.

If the US policy makers are really concerned with the growing numbers of people who do not vaccinate, they need to do more.  They need to carry out a standardized follow-up procedure, update the records in the VAERS after all the damage is said and done (ie death, acute, or chronic illness), and maximize information on possible reactions to the consumer before the inoculations by forcing drug manufacturers to publish all studies (positive and negative) so that we can get a realistic picture of how safe vaccines really are to be aware enough to report an event in the first place.

So far I am not convinced of real vaccine safety. The intertwining of government regulations and private organizations is staggering in this subject and the vaccine safety pages always seem to tie back into VAERS which is lacking in accountability.  Perhaps if vaccines were entirely voluntary and we had the right to hold manufacturers accountable through lawsuits, I would be satisfied with the half-baked approach at protecting us that I have uncovered so far.

Starting a new agency to cite old ones or using multiple agencies to do the same job isn’t cutting it for me; the vaccine skeptic.  This will have “to be continued,” so to speak.  I will continue this investigation and next cover the fallibility of the CISA and the Brighton Collaboration in the near future.  I can only hope it is not as confusing as this was.

SOURCES

http://gawker.com/5848150/california-has-new-laws-for-uvas-hpvs-and-duis

http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html#Serious

http://vaers.hhs.gov/data/index

http://www.cdc.gov/vaccinesafety/activities/vsd.html

http://www.cdc.gov/vaccinesafety/Activities/vsd/rca.html

http://www.cdc.gov/vaccinesafety/Activities/cisa.html

http://www.cdc.gov/vaccinesafety/Vaccine_Monitoring/Index.html

http://www.ncbi.nlm.nih.gov/mesh?term=managed%20care

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