March 8, 2020: On March 5, a nonprofit organization made public their court filing regarding the failure of the Centers for Disease Control and Prevention (CDC) to produce information relevant to their Freedom of Information Act (FOIA) Request. I’m very familiar with the topic, with people involved, and with FOIA (having used it myself many times over the last 20 years). Because I am not directly involved, but realizing the importance of the process and the outcomes; I wanted to give a Hawk’s views – that of the 3,000 feet up and zeroed in.
The Case itself: The Informed Consent Action Network (ICAN) made requests of the CDC through the FOIA process. In the press release, ICAN notes the CDC after many months failed to respond to FOIA requests to provide “All studies relied upon by CDC to claim that the DTaP vaccine does not cause autism.” ICAN also made the same request for HepB, Hib, PCV13 and IPV vaccines. They further asked that the CDC provide studies to support the claim that “cumulative exposure to these vaccines during the first six months of life do not cause autism.”
Why would ICAN do this? After all, its been 20 years of drama around this topic and the government says its ‘settled science’ that vaccines do not cause autism. Having become involved in this issue in 1999 while working for Congress, I realize exactly why and thought I would explain from my perspective. The data the CDC posts on their website, the studies they have conducted and funded, do not truthfully provide a scientific underpinning for their claim that ‘vaccines do not cause autism.’ Just because they say it does, does not make it so. If I look up at the sky and say it is lime green, just because I say it is, does not make it so. If I write on this page that President Trumps’ hair is his natural color and it not chemically enhanced, that does not make that a factually accurate statement.
Zeroing in on ground level: The facts are that the CDC has only investigated and published studies on MMR, thimerosal, and a couple of other ancillary topics (and in my personal view, done that poorly – but that would be a digression). The CDC and their colleagues – have not shown that all vaccines given in the first six months of life individually or as a group have no connection to the epidemic increase of autism rates or the dramatic increase of chronic health conditions in children born since 1988. They have not shown this, because they have not studied this. If CDC had, the document they submitted to the court in response to the court filing by ICAN would be very different. What did the CDC provide in response to the federal court’s stipulation order? They provided the same series of 20 papers and reports they always provide or post, none of which are actually responsive to the requests. To take a page out of former Congressman Trey Gowdy’s recent news interviews, related to political activities, I’ll draw a picture – after 21 years of funding, after 9 months of waiting for the FOIA response, after going to a federal court, the non-profit organization ICAN was handed a basket of stale, moldy apples when it had asked for a basket of fresh peaches.
In the2012, publication by the National Academy of Sciences, Ellen Wright Clayton, Chair Committee to Review Adverse Effects of Vaccines wrote, ” The Institute of Medicine (IOM) was charged by Congress when it enacted the National Childhood Vaccine Injury Act in 1986 with reviewing the literature regarding the adverse events associated with vaccines covered by the program, a charge which the IOM has addressed 11 times in the past 25 years. Following in this tradition, the task of this committee was to assess dispassionately the scientific evidence about whether eight different vaccines cause adverse events (AE), a total of 158 vaccine-AE pairs, the largest study undertaken to date, and the first comprehensive review since 1994.
The committee had a herculean task, requiring long and thoughtful discussions of our approach to analyzing the studies culled from more than 12,000 peer-reviewed articles in order to reach our conclusions, which are spelled out in the chapters that follow. In the process, we learned some lessons that may be of value for future efforts to evaluate vaccine safety. One is that some issues simply cannot be resolved with currently available epidemiologic data, excellent as some of the collections and studies are. ” They go on to provide more scientific guidance, ” Some adverse events caused by vaccines are also caused by the natural infection. These effects often cannot be detected by epidemiologic methods, which typically cannot distinguish between the adverse events that are caused by the vaccine itself and the decrease in adverse events due to the decreased rate of natural infection. In addition, even very large epidemiologic studies may not detect or rule out rare events. Subgroup analysis or more focused epidemiologic studies, informed by as yet incomplete knowledge of the biologic mechanisms of vaccine-induced injury, may be required. Examining mechanistic evidence to assess causation is also challenging. Many of the case reports the committee reviewed simply cited a temporal relation between vaccine administration and an adverse event. Association, however, does not equal causation. More is required. The proof can be relatively straightforward, as when vaccine-specific virus is recovered from the cerebrospinal fluid of a patient who develops viral meningitis a few weeks after receiving the vaccine. Alleged adverse effects that appear to be immune-mediated, as many of them are, are more challenging, in part because the biology is not completely understood.
One potentially useful line of inquiry as science advances is to assess whether the vaccine recipient who suffers harm had a preexisting susceptibility to that particular adverse event as such studies may provide insight into the mechanisms by which such events occur. The committee is aware of the work funded by the Centers for Disease Control and Prevention (CDC) to study such individuals and looks forward to their findings. Most individuals, for example, who develop invasive infection from live vaccine viruses have demonstrated immunodeficiencies. Our work was also complicated by the wide variation in the case reports regarding what other tests had been done to rule out other potential causes. To improve the utility of these reports, periodically convening a group of experts to suggest guidelines, based on the best available science, for providing mechanistic evidence that a particular adverse event was caused by a vaccine may be useful. These guidelines could be made available on the Web, and perhaps more important, shared with clinicians who report cases to the Vaccine Adverse Event Reporting System so their reports can be as complete and useful as possible. ”
The Committee published these findings:
The framework allows the committee to “favor rejection” of a causal relationship only in the face of epidemiologic evidence rated as high or moderate in the direction of no effect (the null) or of decreased risk and in the absence of strong or intermediate mechanistic evidence in support of a causal relationship. The committee concluded the evidence favors rejection of five vaccine–adverse event relationships. These include MMR vaccine and type 1 diabetes, diphtheria, tetanus, and pertussis (DTaP) vaccine and type 1 diabetes, MMR vaccine and autism, inactivated influenza vaccine and asthma exacerbation or reactive airway disease episodes, and inactivated influenza vaccine and Bell’s palsy. The evidence base for these conclusions consisted of epidemiologic studies reporting no increased risk; this evidence was not countered by mechanistic evidence.
The literature supporting several of the causality conclusions discussed
in the previous section indicates that individuals with certain characteristics
are more likely to suffer adverse effects from particular immunizations.
Individuals with an acquired or genetic immunodeficiency are clearly recognized as at increased risk for specific adverse reactions to live viral vaccines such as MMR and varicella vaccine. Age is also a risk factor; seizures after immunization, for example, are more likely to occur in young children.
The report is thorough and massive. The Cliff notes section, i.e. the chart of vaccines, suspected adverse events evaluated in the data and their findings is more than 600 pages into the report. On page 684, the National Academy of Sciences’ prestigious panel reported that in looking at autism as an adverse event from DTP, DTaP, or TT, the epidemiological assessment was “insufficient”, the mechanistic assessment was “lacking’ and the causality conclusion was “inadequate”.
As an aside, in the same table, the panel finds the mechanistic assessment for MMR and autism “Lacking’ but uses the epidemiological assessment to reject causation.
If you do nothing more than read the chart TABLE D-1 Causality Conclusions Organized by Chapter and Adverse Event which begins on page 674 of the report, your eyes will be opened. When you read how many suspected events have not been studied by the CDC (or anyone else) even with all of the billions of dollars since 1989 that have been directed towards this. The list of suspected events are not isolated incidences, but adverse events reported often enough to raise the red flag and warrant the committee investigate.
Having read this finding, the tenants of evidence-based reporting that the CDC is obligated to follow; the statements on their website AND their public information campaign should have changed in 2012 (and it did not). The CDC, Dr. Sanjy Gupta, and everyone in public health should not be able to say (since 2012) with a straight face that the question of autism and vaccines is settled science (which is a ridiculous unscientific statement anyway). To do so is simply a false statement when the preeminent committee within the scientific community published a report in 2012 which concluded that on one set of vaccines (Diptheria, pertussis, and tetanus) given multiple times to infants the question of causation remains unanswerable because the scientific evidence is lacking. Who will be held accountable? If Congress does not engage in oversight, these misdeeds will continue.
According to the law, if the CDC had data on the vaccines in question they were obligated to provide it. They did not, so, in short, but not providing any relevant studies, and providing the National Academies 2012 report they have shown themselves to be misrepresenting the facts of autism and vaccines to the public. They have by default admitted their data are insufficient to answer the question.
Why does this matter? Setting aside the parent bully technics that have taken place over the last 20 years by public health agencies and officials, as well as social media; setting aside, the miscarriage of justice in the Vaccine Injury Compensation Program, let’s pull the lens back out to 3,000 feet – if the CDC has intentionally or by neglect posted scientifically invalid information on their website about this topic, what else on their site is inaccurate?
If there is any take away from the current infectious disease drama playing out daily in the media, the information posted on the CDC website is the ‘trusted source’. It is where doctors, nurses, families, and policymakers and the world go for information about coronavirus, measles, autism, HIV, and the flu. They have a duty to the public to have only fact-based, scientifically substantiated information on their website. We are not Cuba or Russia, or Venezuela – the agency has a legal obligation not to get caught up in politics or propaganda and stick with the tenants of fact-based, scientifically substantiated information on all topics on their webpages.
Thank you to ICAN and the partnering organizations for staying focused on evidence gathering and being willing to take the agency to court when they do not comply with FOIA law. The families of the vaccine-injured need a “Judicial Watch” equivalent to keeping focused on seeking the truth; and not giving up even when the social media giants suspend free speech, bully the parents of injured children, and elected officials ignore their duty to conduct oversight.
At the end of the day, what this FOIA Case Really Says that after more than 20 years, the question of a link between acquired autism and vaccine injury remains an open question. That inconvenient evidence-based truth is not present on the CDC’s website.
Always,
Beth
Disclaimer: This opinion is purely my own personal view and does not represent the opinion or view of any organization, entity, or person that I am currently working with or have worked with in the past.