Yes, Virginia there ARE Two Sides to Vaccines

PARTIAL TRANSCRIPT: "This is the time when we do have the opportunity to understand whether or not there are susceptible children, perhaps genetically, perhaps they have a metabolic issue, mitochondrial disorder, immunological issue that makes them more susceptible to vaccines, plural, or to one particular vaccine, or to one component of vaccines, like mercury. So we now, in these times have to take another look at that hypothesis; not deny it. I think we have the tools today that we didn’t have 10 years ago. That we didn’t have 20 years ago . . . to try and tease that out and find out if there is indeed that susceptible group. Why is that important? A susceptible group does not mean that vaccines aren’t good. What a susceptible group will tell us is that maybe there is a group of individuals or a group of children that shouldn’t have a particular vaccine or shouldn’t have vaccines on the same schedule. I do not believe that if we identified a susceptibility group, that if we identified a particular risk factor for vaccines; or if we found out that they should be spread out a little longer, I do not believe that the public would lose faith in vaccines . . . .

It is the job of the public health community and of physicians to be out there and to say, “Yes, we can make it safer because we are able to say, this is a subset and we’re going to deliver it in a way that we think is safer . . . .” I think the government or certain public health officials in the government have been too quick to dismiss the concerns of these families without studying the population that got sick . . . . The public health officials have been too quick to dismiss the hypothesis as irrational, without sufficient studies of causation. I think they have often been too quick to dismiss studies in the animal laboratory, either in mice, in primates, that do show some concerns with regard to certain vaccines and also to the mercury preservative in vaccines. The government has said in a report by the Institute of Medicine . . . in a report in 2004, it basically said, “Do not pursue susceptibility groups. Don’t look for those patients, those children who may be vulnerable.”

I really take issue with that conclusion. The reason they didn’t want to look for those susceptibility groups was because they were afraid that if they found them, however big or small they were, that that would scare the public away. First of all, I think the public’s smarter than that; I think the public values vaccines, but more importantly I don’t think you should ever turn your back on any scientific hypothesis because you’re afraid of what it might show . . . If you read the 2004 report and converse with a few of my colleagues who believe this still to be the case, there is a completely expressed concern that they don’t want to pursue a hypothesis because that hypothesis could be damaging to the public health community at large by scaring people. I don’t believe the truth ever scares people and if it does have a certain edge to it, then that’s the obligation of those who are delivering those facts to do it in a responsible way so you don’t terrify the public.

One never should shy away from science; one should never shy away from getting causality information in a setting in which you can test it. Populations do not test causality; they test associations. You have to go into the laboratory, and you have to do designed research studies, in animals. What we’re seeing is in the bulk of the population vaccines are safe. Vaccines are safe. But there may be the susceptible group. The fact that there is concern that you don’t want to know that susceptible group is a real disappointment to me. If you know that susceptible group, you can save those children. If you turn your back on the notion that there’s a susceptible group that means that you are . . . what can I say? (13)

"Mitochondria key

To understand Hannah's case, it is important to understand mitochondria, which act like batteries in our cells to produce energy critical for normal function. Because the government's concession hinged on the presence of Hannah's underlying medical condition, mitochondrial dysfunction, some claim the decision is relevant to very few other children with autism. As a neurologist, scientist and father, I disagree.

Emerging evidence suggests that mitochondrial dysfunction may not be rare at all among children with autism. In the only population-based study of its kind, Portuguese researchers confirmed that at least 7.2 percent, and perhaps as many as 20 percent, of autistic children exhibit mitochondrial dysfunction. While we do not yet know a precise U.S. rate, 7.2 percent to 20 percent of children does not qualify as "rare." In fact, mitochondrial dysfunction may be the most common medical condition associated with autism.

Biological markers

Although unlikely, if the Portuguese studies are incorrect and mitochondrial dysfunction were found to be a rarity occurring in less than 1 percent of all autism, it would still impact up to 10,000 children (250,000 worldwide), based on current estimates that 1 million people in the U.S. (25 million worldwide) have autism. If, on the other hand, the research showing that 7.2 percent to 20 percent of children with autism have mitochondrial dysfunction is correct, then the implications are both staggering and urgent.

Autism researchers do not currently understand whether mitochondrial dysfunction causes autism or is simply a secondary biological marker. Autism clearly has many different causes, and should really be separated into multiple autism(s). I propose that we clearly identify and research the subpopulation term of "mitochondrial autism," which is distinguished by its unique biological, but not genetic, markers.

Based on what we know now, it is time to follow the prestigious Institute of Medicine 2004 report regarding autism and vaccines:

"Determining a specific cause (for autism) in the individual is impossible unless the etiology is known and there is a biological marker. Determining causality with population-based methods requires either a well-defined at-risk population or a large effect in the general population."

A paradigm shift

When the IOM report was published, mitochondrial dysfunction defining an autistic subpopulation was not firmly established. Today there is no doubt that mitochondrial dysfunction represents a distinct autism subpopulation biological marker. I urge health officials and the IOM to embrace their own report and pursue this breakthrough in the science of autism. National public health leaders, including those at CDC, must now recognize the paradigm shift caused by this biological marker with regard to their current position of dispelling a vaccine-autism link.

In light of the Hannah Poling concession, science must determine more precisely how large the mitochondrial autism subpopulation is: 1 percent, 7.2 percent, 20 percent?

Based on the 2004 IOM analysis, if the mitochondrial autism subpopulation is found to be relatively uncommon, then all conclusions from prior epidemiological studies refuting an autism-vaccination link must be discarded. New studies then need to be performed exclusively with the mitochondrial subpopulation. If mitochondrial autism turns out to be common, then we could re-analyze the data from prior studies to determine if these studies were powered sufficiently based on a predicted effect size. If not powered appropriately, the conclusion refuting an autism-vaccine link would again have to be rejected. These statistical concepts are basic.

The current vaccine schedule, co-sponsored by the CDC and the American Academy of Pediatrics, injures a small but significant minority of children, my daughter unfortunately being one of those victims. Every day, more parents and some pediatricians reject the current vaccine schedule. In an abundance of caution, meaningful reform must be performed urgently to prevent the re-emergence of serious diseases like polio or measles.

Need for research

As a neurologist, I have cared for those afflicted with SSPE (a rare but dreaded neurological complication of measles), paralytic polio and tetanus. If these serious vaccine-preventable diseases again become commonplace, the fault will rest solely on the shoulders of public health leaders and policymakers who have failed to heed the writing on the wall (scribbled by my 9-year old daughter).

The mitochondrial autism scenario that my daughter has so eloquently painted has the CDC and public health experts logically cornered. Denial and fear tactics won't close Pandora's Box. Whether we find that mitochondrial autism is rare or common, there is urgent research left to be done to fully understand the interrelationship of vaccines, autism and mitochondria.

Reform of the vaccine schedule will be an important part of the solution, whether vaccines play a major or minor role in autism. Our public health agencies and programs need a reconstruction plan. Day one of the reconstruction hopefully starts at the Vaccine Safety Advisory Committee's Working Group, to be held at HHS headquarters today in Washington."