Sunday, August 07, 2005

Thimerosal and autism -- initial reaction to Meet the Press with David Kirby and Dr. Harvey Fineberg

Posted by Craig Westover | 1:04 PM |  

I just finished watching and replaying the Meet the Press segment featuring “Evidence of Harm” author David Kirby and IOM President Dr. Harvey Fineberg. As readers of this blog know, my bias going in was (and coming out is) that there is a strong case for plausibility of a connection between thimerosal and autistic symptoms. I have personally met and have a great deal of respect and admiration for David Kirby and the work he has done on this issue. Having that background, I think Kirby made the most telling points in his debate with Dr. Fineberg, but equally clear to me is that the important audience -- parents with no skin in the game either by virtue of having an autistic-free child born in the 1990s or giving birth in the post 2003 “thimerosal-fee” era -- was won by Dr. Fineberg.

First, it is important to note that the case for a thimerosal connection to autistic symptoms has been raised to the prominence it has by parents with autistic children. The primary converts have been individuals with an autism connection. The message has targeted those individuals. Meet the Press was one of the first major opportunities to reach out to a broader audience that does not share the motivation of the original proponents, understanding of the problem, background on some of the issues -- they do not have a direct connection to autism.

For parents with children born in the 1990s without autistic symptoms, why should they care about this issue? Thimerosal has been removed from childhood vaccines in 1999. After 2002 vaccines are thimerosal free. Why should the parent of a newborn care? Dr. Fineberg, knowingly or not, played to that apathy.

Looking at the specifics of the Meet the Press segment, it started off well with Tim Russert citing two questions raised by Kirby’s book:

In your book, Mr. Kirby, you raise early on two questions. "Why did the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) allow mercury exposures from childhood vaccines to more than double between 1988 and 1992 without bothering to calculate cumulative totals and their potential risks? Why ... was there a corresponding spike in reported cases of autism spectrum disorders? Why did autism grow from a relatively rare incidence of 1 in every 10,000 births in the 1980s to 1 in 500 in the late 1990s? Why did it continue to increase 1 in 250 in 2000 and then 1 in 166 today?" Have you answered those questions?
Kirby responded by pointing out that those question have not been answered and he made the telling point that most of the evidence developed by the public health sector has been looking at the epidemiology, and biological research is what is needed in order to solve the controversy. However the significance of both Russert’s questions and Kirby’s observations were probably lost on a first-exposure audience and were not reemphasized. Opportunities to bring the audience back to those points were not exploited.

For example, Russert brought up the difference between the conclusions in a 2001 IOM and the controversial 2004 IOM report.

Let me go back and review two of the studies that the Institute of Medicine did because this has helped feed much of this controversy and discussion. Back in 2001, the headline on your press release was "Link Between Neurodevelopment Disorders And Thimerosal Remains Unclear. Current scientific evidence neither proves nor disproves a link between the mercury-containing preservative thimerosal and neurodevelopmental disorders in children, says a new report from the Institute of Medicine... While very few vaccines given to children in the United States today still contain thimerosal, prudence dictates that precautionary measures be taken to decrease thimerosal exposure even further. ... It is medically plausible that some children's risk of a neurodevelopmental disorder could rise in part through increased mercury exposure from thimerosal-containing vaccines."

Thimerosal being a preservative that is put into the vaccine. Then about three years later in May of 2004, the Institute of Medicine issued this headline: "MMR Vaccine And Thimerosal-Containing Vaccines Are Not Associated With Autism, IOM Report Says. Based on a thorough review of clinical and epidemiological studies"--I always destroy that word--"neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are associated with autism, says a new report from the Institute of Medicine..."

What changed in those three years?
Fineberg gave a concise and plausible explanation about the complexity of autism and new evidence surfacing.

When the 2001 report was written there was a lot of suggestive information about the toxic properties of mercury and the problem of autism incompletely understood. By 2004, the main change was that there were completed additional studies that were actually looking in the population at the relationship of receipt of vaccines containing thimerosal and the development of autism.
Let’s analyze that statement. First, what he is saying is that in 2001, two years after removing thimerosal from vaccines and conservatively more than a decade after first being made aware of the amount of mercury in the immunization schedule, the toxic properties of mercury and autism were incompletely understood. Yet, that incomplete understanding did not prompt action until 1999 and did not warrant a recall of vaccines containing thimerosal, which remained on shelves and in use until 2003. Is that how a government agency protects consumers? by assuming safety?

Second, although it was the toxic properties of mercury that were incompletely understood, the “definitive” evidence in 2004 was epidemiological, which added little if any new information about biological toxicity.

The response to Fineberg’s statement really ought to be -- Okay, you’re saying in 2004 you believe there is no connection between thimerosal and autism. But if that is the case, and no children have been damaged, isn’t that due to blind luck and not rigorous scientific testing prior to increasing the immunization schedule? Is that the way government agencies operate? Fineberg’s explanation doesn’t change the first question -- Why did the government allow the levels of mercury into vaccines that it did without proof of safety, which the 2001 report essentially admitted was the case? Given the 2001 report, isn’t there the less-than-subtle need to disprove a connection in order to avoid accountability for not adequately establishing the safety of an increased immunization schedule?

A lot of time was spent on the epidemiological studies used by the IOM. When asked to respond to Fineberg’s synopsis of the studies, Kirby declared the studies flawed.

Well, I think those flawed epidemiological studies range from severely flawed to seriously questionable. And I also think that you cannot rely solely on epidemiology to prove or disproof causation. . . . Virtually half of the evidence that was presented against the theory was epidemiological . . . The other half supporting the theory was largely biological. And yet the committee [the prepared the 2004 IOM report] gave a preponderance of evidence or emphasis to the epidemiological evidence and rather, I would say, gave short shrift to the biological evidence. . . .Dr. Fineberg has mentioned that there are 215 references in the report. I counted them up. By my count, it's roughly a 2:1 ratio, about 115 references for epidemiology, 60 references for biology, and of those, only seven were toxicological reports. Now, we're talking about a known neurotoxin, and there were no toxicologists on the committee, either. So I think even Dr. McCormick, the chairwoman of the committee, told me that there was definitely an emphasis on the epidemiology over the biological evidence.
Russert also cited a letter received from the National Autism Association --

The National Autism Associations, Dr. Fineberg, wrote a letter to us including this: "The five studies the Institute of Medicine based its conclusion upon are fatally flawed, have never been replicated and have ties to the CDC"--Center for Disease Control-- "(or foreign equivalent mandating vaccines in other countries) and/or the pharmaceutical industry. However, the Institute of Medicine chose to completely ignore the biological and clinical data supporting the link between thimerosal exposure and injuries to children conducted by independent, appropriately- credentialed researchers."
Kirby’s point was well documented and again, I believe there was an opportunity to point out that the government needs to rely on retrospective data because it has no primary safety data. Nonetheless, the difficulty is that the burden of proof in disputing the IOM report rests with Kirby, and in the timeframe of the interview, doing so was impossible. What made it more difficult was that Russert went right from Kirby’s response to the NAA letter before giving the floor to Fineberg. This allowed Fineberg to essentially address the conflict of interest/conspiracy tone of the NAA letter rather than the substantive issues raised by Kirby. For refutation, Fineberg, as he did, merely has to imply “Read the IOM study and judge for yourself,” knowing full well that 99 percent of the listening public will not read the study and of those that do, few have the ability to understand the statistical analysis even if they have the background to know what to look for. And within the Meet the Press segment, Kirby certainly couldn’t get into any detailed flaws. Thus, the comparison was left at “Whom do you trust about conflict of interest -- A dedicated scientist working for the government on behalf of the people or a writer plugging a book for profit?”

Here’s what I believe the key point is and how one brings the point back to the trust issue. Epidemiological studies are, by their nature, retrospective studies -- they look at the past. The reason the government relies primarily on such studies of thimerosal is that it has no primary safety data. In other words, if there is a connection between thimerosal and autistic symptoms, the only way the government can document it is the same way the parent have raised the issue -- by looking at a generation of damaged children. The government is, essentially relying on blind luck to absolve the National Immunization Program of responsibility for neurological damage of tens of thousands of children.

Another point that I think it would be wise to make is that “autism” is not an all or nothing “thimerosal” issue. Fineberg did a good job making the point about the autism spectrum and creating doubts about the thimerosal hypothesis by citing differences between types of autism. This is my understanding of the issue and, if I am correct, I think it is important to make the following points to avoid having to defend against an “all or nothing” argument.

“Autism,” as Dr. Fineberg described it, is not defined by a cause, but by a constellation of symptoms. (His vastly over-simplified definition does not even begin to touch on the severity of physical symptoms presented children whose parents point to mercury poisoning as the cause of the child’s distress.)

Autism is a severe neurodevelopmental disorder that is characterized by social withdrawal, by repetitive behaviors and by some kind of focal attention in its classic form. Basically, it's an inability to relate to others.
What the thimerosal hypothesis says, my understanding, is that “mercury poisoning” presents with very similar symptoms that are being misdiagnosed as “autism.” There may indeed be some as yet undiscovered genetic cause of autistic symptoms not related to mercury in any way. What needs to be researched, and what is being researched by independent scientists, is the ways in which mercury reacts in the body (Kirby made this point). However, working back to the main question, government is relying on epidemiology and retrospective studies to deny an increase in “autism.” The government is ignoring the basic assumption of an epidemiological study that there is a consistent genetic base in the population being studied, which apparently from new research, is not the case with at least a subset of children presenting autistic symptoms.

The thimerosal hypothesis is that a significant subset of the population has a genetic inability to excrete mercury. When such infants with non-fully developed immune systems and incomplete neurological development are exposed to bolus doses of mercury, they can present symptoms of mercury poisoning that are easily misdiagnosed as “autism.” This is not the same as saying “all” autism is caused by mercury or that there is no other cause of “autism” other than mercury or that mercury “always” causes autism. The case needs to be made that “autism” and “mercury poisoning” are not the same thing and the working hypothesis is that they can exist independently of each other. More importantly, while there may or may not be a biomedical treatment for "autism," biomedical treatments like chelation are demonstrating effectiveness in diagnosised cases of "mercury poisoning."

In this regard, I also believe it’s important to emphasize that the independent research on thimerosal and autistic symptoms is pushing the envelop of science in genetics, in toxicology, in neurology. In any one of such hard science studies, any piece of evidence that seriously contradicts the thimerosal hypothesis would be virtually conclusive evidence that there is no connection -- and no such piece of evidence has yet been found.

People interested in proving the hypothesis push forward in the interest of increasing their understanding of autism while the government concentrates on statistically disproving the hypothesis with little advancement of hard science. Which methodology would one want to see pursued on other issues affecting his children’s health?

Simpsonwood was brought up on Meet the Press by Russert but the discussion got side-tracked when Kirby, in my opinion, made the tactical error of essentially asking a question to which he did not know how Fineberg would answer.

MR. RUSSERT: Mr. Kirby, in your book, you talk about a conference on June 7 to 8 in 2000 in Simpsonwood, Georgia. We've gotten many e-mails and letters about a government conspiracy, that the CDC and the FDA and the Institute of Medicine and everyone has gotten together and really tried to deny information to the parents of children with autism. Do you believe that?

MR. KIRBY: Well, I think the word "conspiracy" and "cover-up," those are very loaded words and I never use them. I do think there has been a lack of transparency and I would think Dr. Fineberg would probably agree with that statement. In this entire process...
MR. RUSSERT: Do you agree with that?

DR. FINEBERG: I don't agree that the lack of transparency had had any bearing on conclusions, and I'm not sure what we mean by a lack of transparency.

MR. RUSSERT: Right now many parents are seeking information from studies from the CDC through the Freedom of Information Act, and they're being told that the HMOs now have that information and they cannot share it because of privacy. And the parents are saying that's outrageous. It could easily be obtained by the CDC and disburse that science, that data so people can look at it and make their own judgments. Should the CDC at least do that?

DR. FINEBERG: In fact, Tim, the Institute of Medicine looked separately in a different study at this system that was in place and did urge the CDC to make these records more available to qualified researchers. But that is not the same as a lack of transparency in the studies or in the reports. All anyone has to do in the case of the Institute of Medicine report is to read the report. All of the logic is laid out, all of the weighing of considerations. Not everyone may agree with each assessment, but they have all the relevant evidence right before them.

MR. RUSSERT: Mr. Kirby, you have said, "I am totally willing to accept there are other factors at play. It may turn out not to be thimerosal at all." What do you think should be done?

MR. KIRBY: Well, I think, first of all, we need clinical trials for treatments. We need to try to help these children as best we can. There is a clinical trial of chelation therapy under way right now at University of Arizona. Dr. Fineberg said we need these trials. I wish the government was funding them. We need to listen to these parents as well. And I think that they've gotten a lot of dismissal from the scientific community. Parents were telling scientists that their children were born normally and then regressed. A lot of people dismissed that and said that couldn't be the case. We now know from a brand- new study from the University of Washington using videotapes of one-year birthday and two-year birthday that is indeed the case. If the parents were right about regression, maybe they're right about chelation.

Just getting back to transparency for one second if I could and this whole safety data base that we're trying to get access to from the report that Dr. Fineberg cited, it says right here, "The lack of transparency of some of the processes also affects the trust relationship between the NIP, the National Immunization Program, and the general public." The lack of trust and the lack of transparency is what's threatening the vaccine program, not talk about mercury. So the doctor's own committee said that there was a lack of transparency again inside this process of analyzing this data that was presented at that conference in Georgia.
To those not familiar with Simpsonwood or the database issues, this who section of commentary was not very relevant. If any impression is left, it kind of imparts the conspiratorial flare that critics use to brand the parents as desperate and irrational.
If the Simpsonwood meeting is going to be brought up, it should not be brought up using out of context quotes to support sinister motives. Rather Simpsonwood should be -- accuraely -- characterized as an arrogant response by returning to the very first question Russert asked --

Why did the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) allow mercury exposures from childhood vaccines to more than double between 1988 and 1992 without bothering to calculate cumulative totals and their potential risks?
Simpsonwood was the first realization by government agencies that indeed, they had not taken the necessary precautions to guarantee safety of the immunization schedule (not individual vaccines). Given the position that failure put them in -- good intentions, great results, inadvertently damaging tens of thousands of children -- it’s natural, not sinister, that they would hope and pray but look for a way to show that despite lack of testing, thimerosal was safe. That’s what Simpsonwood was all about. It's also a motivation easier and more sympathetically applied than -- wrongly -- accusing all government scientists and phamaceutical employees of engaging in some wholesale conspiracy to poision children.

In short, as the thimerosal debate audience broadens, the initial arguments for the hypothesis lose none of their validity, but they are no longer the most persuasive when trying to reach an audience that has no direct stake in the issue or no immediate familiarity with autism. A focal issue is needed, and I think Russert confirmed that when his first question was "Why did the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) allow mercury exposures from childhood vaccines to more than double between 1988 and 1992 without bothering to calculate cumulative totals and their potential risks?

That, I believe is where the attention-grabbing argument lies that needs to be the underlying theme as the thimerosal debate gets wider play because it speaks to ongoing issues for new parents. Without an incentive for people not directly affected by autism to get involved, the thimerosal issue will not be resolved and equally important, proper reforms will not be implemented that reduce the likelihood of such a tragedy from happening again.

[Thanks to Unlocking Autism for a timely transcription of Meet the Press from which direct quotes were taken.

This is my initial take on the Meet the Press program. Please check back for updates and additional links.]

Update: A comment on the Evidence of Harm list took exception with my a statement in this post --

Westover wrote:Thimerosal has been removed from childhood vaccines in 1999. After 2002vaccines are thimerosal free. EGADS! IF he read the transcript properly then he would not have even published such a gross error. How do we write to him to let him know that it was not removed in 1999 and to please stop perpetuating that myth.

My statement was a characterization of the impression left by Dr. Fineberg. The actual situation is the FDA recommended in 1999 that thimerosal be removed. Companies complied at varying rates with unestimatable amounts of thimerosal-containing vaccines in use and on shelves. Government agencies use 2002 as the expiration date based on 1999. In fact, vaccines containing thimerosal could have been on shelves as late as 2004 and early 2005. Nonetheless, the point I was making was about perceptions of people not intimately connected to the autism issue and is still valid.