Damned Heretics

Condemned by the established, but very often right

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Qualified outsiders and maverick insiders are often right about the need to replace received wisdom in science and society, as the history of the Nobel prize shows. This blog exists to back the best of them in their uphill assault on the massively entrenched edifice of resistance to and prejudice against reviewing, let alone revising, ruling ideas. In support of such qualified dissenters and courageous heretics we search for scientific paradigms and other established beliefs which may be maintained only by the power and politics of the status quo, comparing them with academic research and the published experimental and investigative record.

We especially defend and support the funding of honest, accomplished, independent minded and often heroic scientists, inventors and other original thinkers and their right to free speech and publication against the censorship, mudslinging, false arguments, ad hominem propaganda, overwhelming crowd prejudice and internal science politics of the paradigm wars of cancer, AIDS, evolution, global warming, cosmology, particle physics, macroeconomics, health and medicine, diet and nutrition.

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Many people would die rather than think – in fact, they do so. – Bertrand Russell.

Skepticism is dangerous. That’s exactly its function, in my view. It is the business of skepticism to be dangerous. And that’s why there is a great reluctance to teach it in schools. That’s why you don’t find a general fluency in skepticism in the media. On the other hand, how will we negotiate a very perilous future if we don’t have the elementary intellectual tools to ask searching questions of those nominally in charge, especially in a democracy? – Carl Sagan (The Burden of Skepticism, keynote address to CSICOP Annual Conference, Pasadena, April 3/4, 1982).

It is really important to underscore that everything we’re talking about tonight could be utter nonsense. – Brian Greene (NYU panel on Hidden Dimensions June 5 2010, World Science Festival)

I am Albert Einstein, and I heartily approve of this blog, insofar as it seems to believe both in science and the importance of intellectual imagination, uncompromised by out of date emotions such as the impulse toward conventional religious beliefs, national aggression as a part of patriotism, and so on.   As I once remarked, the further the spiritual evolution of mankind advances, the more certain it seems to me that the path to genuine religiosity does not lie through the fear of life, and the fear of death, and blind faith, but through striving after rational knowledge.   Certainly the application of the impulse toward blind faith in science whereby authority is treated as some kind of church is to be deplored.  As I have also said, the only thing ever interfered with my learning was my education. My name as you already perceive without a doubt is George Bernard Shaw, and I certainly approve of this blog, in that its guiding spirit appears to be blasphemous in regard to the High Church doctrines of science, and it flouts the censorship of the powers that be, and as I have famously remarked, all great truths begin as blasphemy, and the first duty of the truthteller is to fight censorship, and while I notice that its seriousness of purpose is often alleviated by a satirical irony which sometimes borders on the facetious, this is all to the good, for as I have also famously remarked, if you wish to be a dissenter, make certain that you frame your ideas in jest, otherwise they will seek to kill you.  My own method was always to take the utmost trouble to find the right thing to say, and then to say it with the utmost levity. (Photo by Alfred Eisenstaedt for Life magazine) One should as a rule respect public opinion in so far as is necessary to avoid starvation and to keep out of prison, but anything that goes beyond this is voluntary submission to an unnecessary tyranny, and is likely to interfere with happiness in all kinds of ways. – Bertrand Russell, Conquest of Happiness (1930) ch. 9

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Autism, vaccines and public trust in live debate on Meet The Press

Autism in children and whether it has been caused by the mercury laden preservative in vaccines since the 1930s, thimerosal, remains a hot enough media topic to appear this morning (Sunday Aug 7) on television’s Sunday front page, Tim Russert’s Meet The Press on NBC. The program did a splendid job covering all the points as Russert hosted a science establishment field general and a skeptical independent science writer.

Russert faced these two well chosen guests who are in fact currently the two key people in the vaccine-autism debate and asked all the tough questions. The exchange provided a case study in how authoritative science can come into conflict with anecdotal evidence from people who are sure the science is wrong.

If that proves to be the case, and science’s exculpation of vaccines in autism doesn’t hold up—and in a few years we will see the result of withdrawing thimerosal completely from vaccines— big epidemiological studies in human health will come under closer scrutiny than ever.

If not, it will show how misleading anecdotal and even lab evidence can be in finding the threads of cause and effect in the vast tapestry that is human health.

The skeptic featured was David Kirby, a friend of questioners in this field. He wrote the bible for the vaccine-skeptical among the parents of autistic children, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic, a sober analysis of the issue which raised questions as yet unanswered. He feels that the correspondence between mercury in vaccines (in the form of the preservative thimerosal) and the remarkable rise in autism needs to be explained. Nobody has yet answered the questions raised, he said. The doses received by children were far in excess of the federal safety guidelines.

The president of the Institute of Medicine, Dr. Harvey Fineberg, replied that we are not even sure that there has been such a huge rise in autism, because its vague definition and recognition has been expanding too. Asked to define it he came up with “basically, an inability to relate to others.”

All the evidence together at first did produce some suggestive data, he acknowledged, but by May 2004 (when the IOM report was issued) there were additional epidemiological studies covering hundreds of thousands of children compared systematically and uniformly, and the best of those studies (US, British, Danish and Swedish) all show no association between receiving vaccines with thimerosal and autism. That settled the issue as far as he was concerned.

(Special note: A recent study in Japan also found the diagnosis of autism continued to rise after the MMR triple vaccine was withdrawn (Journal of Child Psychology and Psychiatry, vol 46, p 572)).

Kirby responded by disparaging the epidemiology as inadequate. He said that the studies were flawed, some seriously, and that anyway epidemiology was not enough to inform us adequately. Indeed, he pointed out, it had been rejected as inadequate to prove a cause by the court system. The committee leaned entirely too much (2 to 1) on epidemiological studies, he said, rather than lab toxicology and anecdotal testimony. You need to look at the individual kids and the toxicology of cells in the lab and so forth. There were only seven toxicological reports and no toxicologists on the committee.

In line with this Russert noted that among the many emails the program had received since announcing the topic were some from the National Autism Associations saying that biological and clinical data had been ignored by the IOM and the studies the IOM relied upon were all tainted by association with the CDC or equivalent bodies in the other countries.

Weinberg responded that the committee had fairly evaluated all the evidence and all the studies for their strengths and weaknesses. They simply had found no association in the population. Yes, some studies more valid than others, and the committee had assessed them accordingly. You can read the entire report for yourself, he pointed out, by downloading it from their http://www.IOM.edu web site. In sum, they have a growing body of evidence which is imperfect but all taken together is convincing that there is no association between receipt of vaccines containing thimerosal and the development of autism.

So if it was harmless, Russert asked, why was it removed from vaccines? Well, there was no question that mercury is a neurotoxin and that it was prudent to remove it, and that had been done. But that was not because the studies were suspect, Fineberg insisted. That was simply an added measure of precaution that was sensible and correct. Any parent watching can now be confident that their child this year will receive vaccines without thimerosal, though some vaccines still had it prior to 2003 It is still in some flu vaccines, but there are flu vaccines for children available without it.

Russert then asks Fineberg the tough question, which is, So then should parents whose children were vaccinated before 2003 have some concerns? This is how he answers:

DR. FINEBERG: Prior to 2003, there were some that still had thimerosal, but the concern is not reaching the level of evidence related to the development of autism. The concern is a more general concern about mercury as a potential neurotoxin.

This little double think on the part of Dr. Fineberg was a little worrying. He seemed to be trying to have his cake and eat it ie reassure us that the danger had been removed, but at the same time deny the danger.

1) Vaccines have had thimerosal removed as a precautionary measure and parents can be reassured by that, and

2) the concern of parents whose children received thimerosal before that was done need not worry either, since the studies are showing no need to worry.

In other words, no one need worry. This was Dr. Fineberg’s reassuring message to the thousands of hysterical, paranoid and disenchanted parents out there watching this exchange.

Kirby for one was not going to stop worrying. He said that the report was issued 14 months ago and things have been moving rapidly since, with increasing evidence that some children have a genetic inability to process mercury very well. In the nineties, levels of exposure of two year olds reached 125 times the EPA limit. He talked of primate studies which show the ethyl mercury in vaccines converts to inorganic mercury in the brain very, very quickly and gets trapped, and in infant brains there is evidence you get hyper inflammation and the rapid nerve growth you see in autism.

All this biology is new since the IOM report so now he wondered if the IOM committee will meet again to consider the new evidence.

So will you meet again? Fineberg was asked by Tim Russert. Apparently not in the near future. Fineberg feels that the new evidence isn’t very important. David Kirby’s reading of the new evidence exceeded the facts, he said.

Russert said that many parents had written in and said that chelation treatment to remove the mercury had produced vast improvement in their autism-afflicted children. How about that?

Tim, said Dr Fineberg, autism is a complicated illness and many children show improvements over time. Keep in mind that the history of medicine is strewn with discarded treatments that people believed in at one time. The only way to decide if they work or not is to do systematic clinical trials.

Kirby was then asked by Russert if he credits parents’ complaints there is a government conspiracy between the CDC, the IOM and the FDA to withhold information from them and the public? He replied that he never uses such loaded words but he does think there has been a lack of transparency. Fineberg said he didn’t know what was meant by lack of transparency, exactly. Russert told him that parents want the information on children that HMOs have and won’t release for privacy reasons, and the CDC should get it for them and release it.

Fineberg didn’t agree that any problem of that kind if it exists had had any effect on the conclusions he and the others drew up. He said the IOM did urge the CDC to share the data with qualified researchers, and no one could complain that the IOM is not transparent since anyone can read the evidence it collected and the reasoning applied to it on the IOM site. .

Russert asked Kirby what he wanted to be done, since he has acknowledged that there is a possibility the cause could be something else entirely than thimerosal. We need clinical trials for treatments say Kirby, for example, chelation is being studied at University of Arizona, and the government should fund that kind of study. And we need to listen to the parents who are being dimissed by the scientists.

For example, parents said their children were born normal and then regressed, and they were scorned by scientists who said it was impossible. Yet now a video study at the University of Washington has proved them correct. We also need to release the data base the HMOs are hanging on to and make the system more transparent. The IOM’s own report acknowledges that there is a lack of trust and lack of transparency in the system.

“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.”

It is this lack of trust and transparency which is threatening the vaccine program, Kirby said, not the talk about mercury. Later in the exchange he mentioned leaked reports of pressure being put upon the IOM by the CDC, saying he had transcripts of internal private meetings which are not available through the Freedom of Information Act, but which the CDC should release.

But Fineberg emphatically denied there was any such pressure.

In fact, the whole reason why the Institute of Medicine, the National Academy of Sciences, the National Research Council exists is to be an independent voice outside of government to work on behalf of the needs of the American people. That’s what we do. Agencies do not always hear from us what they want to hear.

As he pointed out, the topics of stem cells, climate change and ways of fixing the Hubble Telescope have all yielded advice from these independent sources which government officials have found unwelcome.

Russert then asked Fineberg about the one page memo of instructions the CDC gave the IOM on how to conduct its thimerasol study, which is not being released, but didn’t get a straight answer as to why it could not be released. Instead, Fineberg simply emphasized that the experts convened by the IOM are not paid for their work and they assess the evidence on behalf of the American public whose taxes pay for the study.

Tim Russert then wound up the discussion by saying that surely we will know in a few years if there is a link between thimerosal and autism because thimerosal is now taken out of vaccines. Both his interviewees agreed with him, Kirby saying that even though the biology should be looked at more closely, any drop in case rates that shows up in the epidemiology will be “hugely significant.”

Fineberg having insisted that the work of the IOM is independent and not attuned to agency requirements, Russert asked him straight out if he is absolutely certain there is no link between thimerosal and autism? The best evidence indicates no association, Fineberg replied. These studies can never be absolutely certain in their findings but it is clear that other avenues are much more promising ways to spend our precious research dollars.

Kirby, on the other hand, said he believed “absolutely” that there is an association and that one day thimerosal will be shown to have caused cases of autism.

Conclusion: politics muddies science again

All in all, an excellent discussion which boiled down to this: plenty of charges and denials arising from the withholding of data from suspicious parents and others who believe often from their own experience there is a link, but in the final analysis, Dr Fineberg of the Institute of Medicine insisted his experts did an independent job and assessed the evidence thoroughly, and the impressively wide epidemiology just doesn’t yield up any visible link between thimerosal and autism.

Meanwhile, the well researched David Kirby continues to side with the parents in emphasizing that the biology of toxicity studied in the lab and in the children is recently even more suggestive than before that there is cause and effect, and that therefore it is possible that the field studies have not been done or reported properly.

Both agree that the epidemiology may soon be decisive. Since the possible culprit has been removed from vaccines given children since 2003, the link or lack of it should emerge fairly clearly in a few years.

If the link shows up, then it will be a powerful indictment of the design and quality of the very large epidemiological studies carried out so far in four countries on this question. If the link doesn’t show up, then it will confirm how misleading anecdotal and even lab evidence can be in determining cause and effect in human health.

Meanwhile parents are left uncertain whether to trust the estanlishment and its science because that science is partly curtained off by the arrogance and self-serving secrecy of the bureaucracy, and its spokesmen who insist on “reassuring the public” in such a blatantly one-sided way that the public is not reassured at all, especially a public consisting of parents frantic to protect their children in a state of mind confused and undermined by the withholding of information.

Here is the transcript from Meet The Press:

(show)

TRANSCRIPT SUN 7 AUG 2005

TIM RUSSERT: 500,000 American children have autism. The diagnosis rate has gone from one in 10,000 births in the ’80s to one in 166 births in 2003. Why the increase? What’s the cause? Why is there such controversy, with charges of a government conspiracy? With us: the president of the Institute of Medicine, Dr. Harvey Fineberg, and the author of “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic,” David Kirby.

Coming next, autism: what we know and what we don’t know. Dr. Harvey Fineberg of the Institute of Medicine and David Kirby, author of “Evidence of Harm: Mercury in Vaccines and the Autism Epidemic,” a medical controversy, next, right here on MEET THE PRESS.

(Announcements)

MR. RUSSERT: The controversy over childhood vaccines and autism, after this brief station break.

(Announcements)

MR. RUSSERT: And we are back.

Dr. Fineberg, Mr. Kirby, welcome both.

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?

MR. DAVID KIRBY: No, nobody’s answered those questions. And we have to answer those questions as soon as possible. We need to solve this mystery. We need to get this controversy behind us so we can go on to find ways to help these kids. Mercury is toxic. It’s a known neurotoxin. If it gets into the brain, it could stay there virtually forever. Children born in the ’90s received mercury far in excess of federal safety limits. That’s indisputable. And yet we’re looking at a neurotoxin. And yet most of the evidence developed by the public health sector has been looking at the epidemiology. And we really need to look at what this mercury is doing inside the bodies and brains of these children if we’re going to solve this mystery one way or the other.

MR. RUSSERT: Dr. Fineberg, in your 2004 report from the Institute of Medicine, you said this: “While some information suggests that autism rates may be rising, it is not clear whether the observed increase is real or due to factors such as heightened awareness of the disorder or the use of a broader diagnostic definition. …”

Do you think there’s an epidemic of autism or do you think it’s simply a change in defining it?

DR. HARVEY FINEBERG: There’s definitely a huge number of cases diagnosed with autism, Tim. What is clear is that number recognized has increased dramatically. It’s also clear that the definition was broadened markedly in the 1980s and 1990s, and there were increased incentives to recognize children from increased awareness and availability of services. No one knows with certainty what part of the increase is genuine, a genuine increase in numbers, and what part is from increased recognition of people who were already there but not previously recognized. Remember we’re talking about a spectrum of diagnoses here, autism spectrum diseases, which range in severity from relatively mild to relatively severe.

MR. RUSSERT: For a layman, in a few words, how would you explain autism?

DR. FINEBERG: 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.

MR. RUSSERT: 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?

DR. FINEBERG: When you’re dealing with a problem as complex as autism, Tim, you have to look at it from many different points of view and assemble evidence from many different vantage points. Biological evidence in humans and in animals, toxicologic evidence, how does the body deal with toxins, and evidence looking at the actual experience in populations. 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.

These studies were carried out in the United States, in Great Britain, in Denmark and Sweden. These studies covered hundreds of thousands of individuals, children, in these populations. They compared systematically in different ways whether you received vaccine with no thimerosal, with some thimerosal, with more thimerosal, and they looked at the relationship of those experiences with the development of autism. Uniformly, the best of those studies all show no association between receiving vaccine of different amounts with thimerosal or without and the development of autism. It was the absence of that association which was the main reason for reaching the conclusion that the evidence points to no association between vaccines and autism.

MR. RUSSERT: Mr. Kirby?

MR. KIRBY: 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. In fact, I have right here–this is from the federal court system, but they ruled that epidemiology is not acceptable to prove there is no causal link between an adverse event and a pharmaceutical.

MR. RUSSERT: Explain that in layman’s language.

MR. KIRBY: Well, it means that you really, like the doctor said, you can look at the kids as well as look at the large population studies. You need to look at the biology, the toxicology; you need to look at the cellular level. You need to look at immunology, and I would say that what the IOM did last year–I was at that meeting on February 9. Virtually half of the evidence that was presented against the theory was epidemiological–I have the same problem as you. The other half supporting the theory was largely biological. And yet the committee 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.

MR. RUSSERT: When we announced this program, as you might expect, we heard from both sides who are very emotional and passionate about this topic. 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.”

DR. FINEBERG: Tim, the Institute of Medicine panel that came together represented a spectrum of experts who were asked to look at all of the evidence, and they did. They assessed the evidence that bears on the question. Some of it is biological, as I mentioned; some of it has to depend on what you actually find when you go out and look in the population. Is there or is there not an association? Keep in mind that there are many neurotoxins in the world. Dozens of natural and industrial substances have neurotoxic properties. When you’re trying to assess a specific association, there are biological studies that are relevant, and there are epidemiological studies that are relevant. All of these studies are not equally valid. Some have more deficiencies and limitations than others.

The committee went through very carefully and assessed each of those studies representing its strengths and weaknesses. All of this is laid out in its report, which is available for download to anyone who wants it from the IOM Web site, www.iom.edu. And anyone can read for themselves how the committee evaluated critically and carefully all of this evidence.

When the letter you read states that these five studies were not replicated, I can’t help but think that each one of them has been replicated four times. We have now a growing body of evidence, while imperfect, altogether convincing and all reaching the same conclusion, even though they vary in their methods and in their approaches. And that conclusion was no association between the receipt of vaccines containing thimerosal and the development of autism.

MR. RUSSERT: Why was thimerosal then taken out of the vaccination?

DR. FINEBERG: There’s no question that mercury is a neurotoxin. And if there were ways, which there are, to protect vaccines without using mercury-containing substances, it was prudent to remove it, not because there was evidence that it caused autism or even definitive evidence that the amounts in those vaccines caused any neuro problems, but because it was an added measure of precaution that was sensible and correct. And I might add that the latest vaccines that contained any thimerosal as a preservative, with the exception of some flu vaccines, were completed in 2001 and outdated in 2003. So anyone watching this program, any parent can be confident that when they take their child to the pediatrician to be immunized this year, they will receive vaccines without thimerosal as a preservative.

MR. RUSSERT: But prior to this year, there may be some concern?

DR. FINEBERG: Prior to 2003, there were some that still had thimerosal, but the concern is not reaching the level of evidence related to the development of autism. The concern is a more general concern about mercury as a potential neurotoxin.

MR. RUSSERT: Mr. Kirby?

MR. KIRBY: Well, if I could get back to the IOM report, that meeting was held 14–or the report was actually issued 14 months ago. This story is moving very, very fast. In those last 14 months, there has been an equally growing body of evidence, again on the biological side, that would suggest that, in a small subset of children with a certain genetic predisposition, they are unable to properly process the mercury that they were exposed to. And, by the way, the rates of exposure were quite high in the 1990s. At two months of age, children got three shots for a total of 62.5 micrograms of mercury. For their body weight, that’s 125 times over the EPA level. For me to reach that level, that would be about 1,125 micrograms.

We know that certain children with autism, again, seem to have higher levels of mercury accumulating in their body. We know that when we give mercury to infant primates, the–there’s two types of organic mercury: ethyl mercury in vaccines, methyl mercury in fish. What they found was that the ethyl mercury, once it got into the brain, it converted to inorganic mercury very, very quickly. Inorganic mercury basically gets trapped in the brain, and there’s evidence to suggest that, in an infant brain, in the first six months to a year when the brain is still growing, when inorganic mercury gets trapped in that brain, you’re going to have this hyper neuro inflammation, or the rapid brain growth that we see in autistic children.

These are the types of things that I think need to be researched further. Yes, we need to look at the epidemiology. There’s a whole lot of new biology. This has all been published. None of the biology was published at the time of the IOM hearing. It has since been published, and I actually wonder if the IOM would consider reconvening a new committee or a new hearing to consider the evidence that’s come out in the year and a half since the last report.

MR. RUSSERT: Would you?

DR. FINEBERG: Tim, Mr. Kirby’s description about the certitude of this evidence, I think, exceeds the actual balance of evidence that is produced when you look at the totality. It’s true that mercury is handled differently in the body when it’s in the form of so-called ethyl mercury, which is in vaccines, and methyl mercury, which was actually the form which was–on which the standards of exposure were based. That’s the type found in fish, as has been mentioned. But when you look back at the studies of actual poisonings of children with large amounts of methyl mercury and ethyl mercury, most toxicologists believe that the ethyl form of the mercury is less toxic than the methyl form–less toxic to the nervous system. And that’s based on many experiences with poisoning by these different forms of mercury.

MR. RUSSERT: Many parents have written us over the last couple of days saying that they have put their child in the process of collation, which removes the mercury poisoning from the system, and they say they’ve seen vast improvement. Wouldn’t that suggest that there may be some relationship between the mercury from thimerosal and the removal from the child?

DR. FINEBERG: Tim, autism is a complicated illness, and children with a variety of treatments and non-treatments show improvement over time, which is all to the good. But when you have a single story and a repeated story of an experience that a parent has with a treatment like chelation, you have to keep in mind that the history of medicine is strewn with discarded treatments that people at one time believed in very, very strongly. When you have one case after another, it’s one anecdote after another, and the plural of anecdote in scientific terms is not evidence. The only way to know whether a treatment works or does not work compared to other things is to do the clinical trial, comparing those who are given the treatment in a systematic and balanced way with those who are not.

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.

MR. RUSSERT: Many of the National Autism Association and other groups, Doctor, point to Task Order 74.

DR. FINEBERG: Yes.

MR. RUSSERT: This is the arrangement between the CDC and the Institute of Medicine, a one-page memo which helps define the study and why it won’t be released. Is there a reason?

DR. FINEBERG: I don’t know what exactly that’s referring to, Tim, but when the Centers for Disease Control contracts with the Institute of Medicine to undertake a study, they do pay the actual costs of the study. But keep in mind that the panel of experts that are assembled by the Institute of Medicine receive no compensation whatsoever for their volunteer service. And when a government agency conveys money to the Institute of Medicine, it’s not the agency’s money. It’s the American people’s money. And our obligation is to do the best we can to assess the evidence on behalf of the American public.

MR. RUSSERT: Since thimerosal is now out of the vaccine, latest as of 2003, we will know in a few years whether or not there is a connection…

MR. KIRBY: That’s correct.

MR. RUSSERT: …definitively by the number of cases?

MR. KIRBY: I think so, but again I think we need to look at the biology, but the epidemiology is very important. If the case rates start to drop in the next couple years, I think that will be hugely significant. If I could also just get back to this commission by the CDC of the report, I’d like to do that as well.

MR. RUSSERT: Real fast.

MR. KIRBY: Well, there’s evidence that there was pressure put on the committee by the CDC, and we have internal transcripts. I think that’s what you were referring to. There are transcripts of private meetings. Some of them were leaked. They’re not obtainable through the Freedom of Information Act. Many people are trying to get copies of the other transcripts, and I do hope that the IOM will make those available in the name of transparency in this.

MR. RUSSERT: Was there pressure?

DR. FINEBERG: Absolutely not, Tim. In fact, the whole reason why the Institute of Medicine, the National Academy of Sciences, the National Research Council exists is to be an independent voice outside of government to work on behalf of the needs of the American people. That’s what we do. Agencies do not always hear from us what they want to hear. Sometimes the evidence does not point in a direction that is welcome. Stem cell guidelines or information about climate change or, for example, the ways to fix the Hubble Telescope which came out of the national academies–all of these are studies undertaken on behalf of the American public and the same was true for our assessment of vaccine safety.

MR. RUSSERT: You’re absolutely convinced there’s no connection between thimerosal and autism?

DR. FINEBERG: I’m convinced that the best evidence all points to the lack of an association. These studies can never prove to the point of absolute certainty an absence of an association. But I would say this, other avenues of research looking at other possible causes today are much more promising ways to spend our precious resources.

MR. RUSSERT: And our viewers should know that there is no thimerosal now in vaccinations, other than flu vaccinations, and so it’s safe for your children to do–have that done.

DR. FINEBERG: And even some flu vaccines for children are now available without thimerosal, as well.

MR. RUSSERT: You believe there is a possibility of a connection?

MR. KIRBY: Absolutely. And I think one day we’ll find out that there might have been–this has contributed to some of the cases in autism in this country.

MR. RUSSERT: Thank you for a very civil discussion. To be continued. We’ll be right back.

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