Sunday, July 30, 2017

An open letter to Dr. Brenda Fitzgerald

Dear Dr. Fitzgerald - 

Congratulations on your recent appointment as Director of the Centers for Disease Control. 

As part of your orientation to your new position I am sure you were made aware of the many issues facing the agency you now head. 

One of those challenges is conducting valid research to provide clinicians and the public with "gold standard" evidence-based information on which to base their health decisions.
Sadly, it seems the CDC's committment to this in regards to vaccines is sorely lacking. I have come to that conclusion based on learning of the allegations put forth by Dr. William Thompson (aka: "#CDCwhistleblower") and by learning of a group within the CDC by the name of "SPIDER" (Scientists Preserving Integrity, Diligence, and Ethics in Research). Here is a link to the letter they sent. 

The #CDCwhistleblower alleges that he and his colleagues altered study protocol when the agreed upon protocol yielded disturbing results (namely a significantly increased risk of autism when MMR was given earlier than 3 years of age, especially for black boys). Equally alarming he also alleges that data revealing these conclusions were literally thrown away - they were destroyed (I believe this is a federal crime). It appears he was the only one of his peers involved in this study who did not get rid of the data - though he did keep silent about it for ten years. Here is a link to the 2004 study

But aside from the concerns he raises about one study it is alarming that those charged with vaccine research refuse to do the types of studies that are considered gold-standard - namely, using true placebos (a biologically inert substance like normal saline) rather than the biologically active vaccine excipient (minus the antigen). 

Another problem in vaccine research is the lack of vaccine-free control groups. Currently it is common in vaccine research for control groups to have people who receive other vaccines rather than no vaccines. The control group still receives vaccines - just not the vaccine in question. This makes it far more difficult to tease out the effects of the vaccine in question and does not meet the criteria for gold-standard research - this would be a control group who does not receive the intervention in question, nor any other intervention! 

There is also the issue of whether vaccine research is sufficiently powered to reveal if the conclusions reached are legitimate or genuine.  It is not ethical to use post-marketing research (where numbers are much larger) as defacto clinical research if/when pre-marketing "safety" studies are designed in a way that necessary safety data cannot be generated even if the study design is strong. Have we learned nothing from Vioxx (among many, many others?!) 

Since vaccines are a commonly used product administered to ostensibly healthy people it is all the more important to have confidence that we know their true safety profile. Given the issues I have outlined there is reason to doubt we have accurate information about vaccine safety. A high volume of incorrect data does not change into a solid foundation upon which to base decisions for this medical intervention just because it is high volume. 

However, the significant volume of reports from parents and others ("anecdata") stating they were harmed in various ways subsequent to vaccination (including miscarriage or death) more than suggest we need to do vaccine safety studies differently as their experience contradicts the published research. There is reason to doubt the published vaccine safety research since it does not meet the benchmarks for "gold standard" research. Besides, products that are "safe and effective" do not need laws that shield from liability all who are involved with manufacturing or administering them. 

The experience of those who report adverse events following vaccination underscores the weakness of our current system for capturing safety data (or lack thereof) for vaccination. The VAERS system is passive and widely acknowledged to be severely underused - therefore any use of its data likely inflate any appearance of safety while minimizing or reducing significant risks - in short, it is just as unreliable as is the vaccine safety research that does not meet the gold standard of medical studies. 

I would like to know if you will be requiring Merck to provide updated results (now 50 years old?!) regarding the efficacy of the mumps component of the MMR? Since they have an exclusive contract to provide this vaccine it seems reasonable to ask them to provide an update for this information. Please do not wait until the #MerckWhistleblower lawsuit is concluded to do this. I hope you are aware of the allegations of two Merck scientists who allege tests to prove the efficacy of the mumps portion of the vaccine were spiked with rabbit antibodies. In other words, the basis of Merck's exclusive contract may well be fraudulent. Perhaps that is why there are reports of outbreaks of mumps in fully vaccinated populations. If you do ask for updated results it might be prudent to have them verified through an independent third party - just sayin'! 

As an aside - is it a good idea to mandate vaccination in childhood for diseases that are generally mild and self-limited (and rarely result in long-term adverse sequelae) when doing so simply shifts the period of vulnerability to adulthood? Especially when the immunity aquired through exposure and recovery is generally life-long while any risk reduction through vaccination is time-limited (and the time period of risk-reduction shrinks with each dose of vaccination). 

You would go a long way toward building trust by mandating more transparency in vaccine safety research. 

               - Require sharing of data so studies can be replicated by others 
                 (outside the CDC) to determine if they get the same results. 

               - Communicate with members of CDC SPIDER publicly (for 
                 obvious reasons they will need to remain anonymous) and 
                 address their concerns. The #CDCwhistleblower is not the only 
                 scientist on staff with the CDC who has seen dodgy science   
                 done within the agency's walls. 

               - Invite members of the Vaccine Risk Aware community to 
                 participate in ACIP committee meetings. 

               - Purge from ACIP those who have conflicts of interests 
                 (Dr. Paul Offitt comes to mind but I suspect there are many others). 
                 Disclosing conflict of interest does not eliminate it. 

               - Release the #CDCwhistleblower (Dr. Bill Thompson) to testify 
                 to Congress without fear of retribution. Give him the legal immunity 
                 currently enjoyed by vaccine manufacturers. 

               - If you have not done so already, watch the documentary Vaxxed. 
                 Since I am local to the Atlanta area I would be happy to have you 
                 in my home for a private screening. 

               - Meet with members of the Vaccine Risk Aware community. 
                 Many will be right outside the door of your office on August 24th.  
                   I am hoping you will be more gracious in your response to their
                   concerns than at least one of your employees was last October

I am praying The Lord will bless you with wisdom and discernment for the challenges you will face during your tenure as director.  

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