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December 22, 2002
MORE THIMEROSAL

My post below has drawn a lot of attention, and many good comments, all of which I appreciate. Most notably, Dwight Meredith has responded in both the comments section and in a post on his own blog. Mr. Meredith's posts are models of how to rigorously argue a viewpoint on an emotional topic without allowing (justifiable) emotion to usurp reason. I regret not having followed his blog earlier, and a place will be made for his site in my permalinks in their next reorganization (which will occur sometime prior to the second Bill Frist administration).
As a tribute to Mr. Meredith's skills, I will not allow my own reasoning to unjustifiably succumb to his. Specifically, I want to address a few of the points he made in his post.

Mr. Meredith argues that I am "quick to declare that no link between thimerosal and autism has been shown and that there is no such link." I don't agree, at least with the second part. I do not think that the current evidence shows a convincing link between thimerosal and autism, but that does not mean that no such link exists. It just means it hasn't been shown yet. I'm glad that several studies are currently being done to explore the issue further.
Mr. Meredith then reads my post as implying that "the entire issue is driven by greedy lawyers eager to bankrupt Eli Lilly." Not the entire issue, but part of it. More specifically, that is an excellent summary of why I think the recent amendment to the Homeland Security bill was substantively appropriate in its own right. I don't argue that the lawyers created the concerns regarding thimerosal, though I wouldn't be surprised if they try to fan the flames of such concerns even if convincing scientific evidence emerges against such a link.
Mr. Meredith also refers me to Wampum, another interesting read. She notes that, in apparent contradiction to the CDC's officially sanguine view of thimerosal, the Bush administration has agreed to release certain documents in connection with the issue, including internal CDC documents which purportedly state that "mercury in children's vaccines is a potential source of neurological damage in children including ADD/ADHD, speech and language delays and other neurological disorders including autism."
We should all look forward to the revelation of whatever evidence is found in those documents. We should note, though, that the CDC documents referred to in the release are apparently the ones obtained by Safe Minds, an autism activist group, via the Freedom of Information Act. The New York Times Magazine article about the thimerosal issue notes in an aside that those CDC documents were "far from conclusive evidence" of a link. (Again - it's not proof of no link; just not clear proof of a link (assuming the Times' report is accurate).)
Finally, Mr. Meredith concludes:
We have been fighting battles in the area of autism for some time now. So far, money and politics has always trumped science and kids. For once, we should forget about politics, blame, potential liabilities, campaign contributions and other factors. Put all that stuff aside. Forget which side wins and which side loses. Sides suck. We should simply provide the scientists with all available information and plenty of money so that they can save our children.
I couldn't agree more.
And I assume one of my correspondents agrees as well. He identifies himself as a "parent of an autistic child and an active fundraiser for biomedical research into autism." He e-mailed me to describe "how angry I was that this group of trial lawyers was so active at trying to suck resources away from the research and into their pockets in the name of a phony connection between thimerosal and autism. Frankly, I wish whoever added that provision to the Homeland Security bill would come forward so I could express my appreciation."
Unfortunately, resources are never infinite. We should certainly pursue whatever leads appear promising, but not be afraid to reallocate scarce resources if those leads fail to deliver on their promise.
P.S. A tax lawyer friend e-mailed me an interesting article about the amendment that appeared in Tax Notes. Unfortunately, the article is only available by subscription.
The author is openly hostile to the amendment on both procedural and substantive grounds. Nothing new there. But then he adds a kicker:

But a funny thing happened on the way to the forum. Our lawmakers forgot a lot of law. Without amending the Internal Revenue Code, it is not possible for the vaccine-injury amendments to tap revenues from the fund to serve their intended purposes. Internal Revenue Code section 9510 establishes and provides the rules for operation of the Vaccine Injury Compensation Trust Fund. Sections 4131 and 4132 describe the 75-cents-per-dose excise tax that feeds the fund.
Specifically, there appear to be at least three drafting problems. First, section 9510(c)(1)(A) requires that any money disbursed from the trust fund must be in accordance with the Public Health Service Act as in effect on October 18, 2000. Because the Homeland Security Act did not amend that section, no funds can be distributed for the thimerosal cases or any cases newly covered by the amendments made by the Homeland Security Act.
Second, under section 9510(b)(3) if any amounts in the trust fund are used for ineligible purposes, the Treasury Department must cease paying funds (from excise tax revenues) into the trust fund. That is a poison pill. If any funds were paid to thimerosal victims, transfers for all vaccine-injury cases would be cut off.
Third, the Homeland Security Act does not alter the definition of taxable vaccine in code section 4132(a). That does not affect the disbursement of funds under section 9510, but it does raise the question of linking trust fund costs with trust fund benefits. If the fund's purposes are expanded to include cases against manufacturers of vaccine components, should the trust fund tax base be expanded to include separate taxation of components? (If so, that could be problematic given that the current taxable unit for the excise tax is "per dose." How would a shipment of vaccine preservative be taxed?) Or could it be ! argued that components are already effectively taxed under the current law's levy on the final product?
If Congress gets around to making code changes to amend the VICP as intended by the Homeland Security Act, it will have to consider those issues.

Oops! As the author concludes: "[T]his is a great case study in how Washington works . . . and how it doesn't." (Ellipses in original.)

P.P.S. I hope to respond to Meredith's and Wampum's criticisms of the existing studies soon.


Posted by Dr. Manhattan at 1:03 AM |



Comments

Thimerasol taken in itself is one thing..see Dr.Spritzer,McGill....Grier and Dr.Baskin... Baylor....but put it in context with Lilly cheif Sydney Taurel a Morrocon native, barely a citizen 8 yrs or so getting appointed to the Homeland Advisory Board, ....this, after he incredibly sent Vote for Bush pleas in the company's annual report!...before the last Presidential election...Along with this on the Lilly board Kenny Lay and at one time George Bush senior sat!...Parlay that with the fact that Lilly's lobbiests couldn't get a bill through Kennedy's commitee forgiving vaccine makers of sins....The law mysteriously and dubiously explained was slipped through the Home Land Security Bill....Read Lilly's remarkable headlines on their drugs...a drug with a black box warning is tauted as the best thing since Kellogs cornflakes......take all this together and you have a pattern!

Frankly, you're conceding far too much to the anti-vaccine crowd. There is absolutely no reliable evidence that thimerosal or combination MMR or whatever the anti-vaccine target of choice is this month contributes to autism.

On the other hand, there are a number of opportunity costs of varying degree attendant with yet more calls to study this phantom. There are both real costs in performing such studies, and the bigger fear of seeing people abandon routine vaccination as we wait a decade or two for more studies that don't find a causal connection but also cannot definitively rule one out (you will never be able to construct a study that satisfies these people -- witness the groups still convinced that breast implants cause their diseases/conditions).

To Brian Carnell: if Thimerosol really IS harmless, then why don't we let the legal system decide the fact, rather than having the manufacturer try to hide behind Congress' skirts from the legal system? (Of course, that's a ridiculous question -- we all know that Congressmen who have received large campaign contributions from the potential defendant are more reliable in their judgement than any silly old jury.)

By the way, Glenn Reynolds has been responding to me on this subject by waving in my face the fact that Bendectin turned out to be harmless despite the testimony of eight scientific witnesses with "impressive credentials" (to quote the US Supreme Court) that it wasn't -- without his ever mentioning that the Court ruled that their testimony was inadmissible because it hadn't been peer-reviewed, and that this naturally means that any testimony a jury hears that Thimerosol is dangerous WILL have been peer-reviewed. So I repeat: why is its manufacturer trying to use Congress to hide from the legal system?

To Bruce Moomaw: The last place I or any thinking person would want to see this issue decided is in a court of law, where a jury of well-meaning but untrained peers would decide an issue of utmost importance to our society.

I, for one, would not want a panel of beauticians, retired mechanics, stockbrokers, journalists, advertising account executives, grocery store clerks, English professors, firefighters, welfare recipients, college students or clerics to determine any corporation's guilt (or innocence) on matters in which they have no expertise.

If the addition of mercury to vaccines caused evil results to our most innocent population, let scientists prove it first.

While I'm agnostic on this particular issue, I keep in mind that vaccines have provided safe and healthy lives to far more children than the doses are accused of harming.

As for settling scientific questions in court, need I say anything more than "breast implant"? Despite years of study and dozens of reports, implants have proven safe by researchers. Tell that to the companies bankrupted by lawsuits.

I don't want to see the world thrust back into the 18th century by the legal profession.

Just to give you some idea of how bad things are: I am a physician working in Dallas, and I've already been approached by 2 lawyers who want to pursue these bogus "thimerosal - autism" claims with class-action suits. Ten years ago , I was approached by another lawyer who wanted to be the "breast implant lawyer of Dallas" (believe me, that's quite a big project in our city). He was quite upset when I told him there's no evidence to support such a link.

The deal is - in a court of law, the plaintiff is supposed to show that there is a 51% likelihood that the defendant's actions were the "proximate cause" of the plaintiff's damages. There is simply no science to support such a link (just like there was none in the breast implant cases).
Unfortunately, juries frequently choose to ignore the law, and judges are reluctant to overthrow their verdicts. That is the problem, and there's no way (agreeable to the trial lawyers) to change that fact.

Evidently Mr. Mierzejewski overlooked my statement that any scientific expert witnesses in such trials must now have had their work peer-reviewed, by a 1993 order of the Supreme Court. That is, to be allowed to testify to juries at all, scientists must have significant evidence on the subject.

And the trouble with limiting examination of the safety of drugs (or anything else) entirely to regulatory boards is, of course, that the regulators are appointed by politicians whose campaign contributions have in turn been largely provided by the businesses that are supposed to be regulated. Which is precisely why that little codicil forbidding lawsuits against the makers of Thimerosol (but not of any other drug) was quietly slipped into a wholly unconnected bill. (In this connection, it's also interesting that -- as "60 Minutes" pointed out earlier this year -- Reagan's first head of the FDA, immediately after cutting corners left and right in standard procedure to get aspartame approved despite significant evidence that it causes brain damage, took a job with its manufacturer.) There's no way to change THAT brute political fact, either -- which is why it's disastrously unwise to deprive juries of the opportunity to consider issues of complex fact in this area, just as in possible economic crimes or in any other legal area.

Bruce,

Peer review publication is not a high hurdle to clear. For example: Andrew Wakefield has had his articles on an MMR/autism connection published in multiple peer reviewed journals, including the Lancet, thereby satisfying the Supreme Court's standard. Just because there are articles which refute his claims doesn't mean he couldn't get his opinion before the trier of fact.

To which the obvious retort is: in that case, why SHOULDN'T his views get a legal hearing? (At this point I'll hand over the debate, though, since Mark Kleiman has reiterated all my points with more corroborative detail. Our central point is simply that government regulatory boards cannot be anywhere near entirely trusted, for the reasons I've described.)

Unfortunately, juries frequently choose to ignore the law, and judges are reluctant to overthrow their verdicts. That is the problem, and there's no way (agreeable to the trial lawyers) to change that fact.

You do trust, however, congressman to make these decisions, and they're not any more qualified; if anything, less, as their chance of having scientific or statistical training is no doubt smaller than the public at large.

This isn't about whether there's a connection to autism; it's about a anti-democratic distrust of the legal system.

I'm a single dad of a autistic child who is seeking compensation due to the fact, he is mercury poisoned from vaccines.
The
PfeifferTreatmentCenter,http://www.hriptc.org/booklet.html
has a book called "Metallothionein and Autism".
This will answer many of your questions in regards to autism due to mercury.
I pull mercury from my sons body every other weekend. I have been doing this for a year and a half. He has never ate fish, and i have had him on purified water since he was born.
He is ten years old.
You watch Dr. Baskin's testimony and then do the math of where all of this mercury in my son's body came from.
Mercury inbeds its self deep into the bone, muscle and fatty tissue. My son's body was not able to handle the high mercury content during vaccinations and his body shut down Metallothionein production causing his body to retain mercury, it turn the mercury as placed into tissues and such, in order to rid of it in some way. Unfortunately, the brain is a good absorbent of toxins, especially mercury as it will cross the blood brain barrier.
There needs to be proof of autism and thimerosal? I have it.
All I need is my day in court!
I am a parent researcher and I keep my son alive through supplementation and therapies as he has almost died before I was able to begin therapy to remove mercury from his body.
1500 articles on Pubmed to reveal how bad thimerosal is to the human body.
We all know of the dangers of lead and lead paint. Kids eating lead paint peelings in the past.
Why is it so hard to grasp the same for mercury, which in clinical evaluations, is more toxic and more damaging to brain neurons than lead?
The parents of these damaged mercury poisoned children are not out to "get rich" with these law suits, they are trying to STOP this abuse in the medical community and get adequate compensation for their kids so their kids will not end up on the streets after the parents die.
Some of the parents are gonna fund projects with the money to help all of the kids, not only their own child, to find a way to heal these affected children due to mercury poisoning.
I am one of them.
We are not going to be mislead as the parents of Down Syndrome children were. We are not gonna allow our funding to be used to find a test to allow a mother to abort a autistic child if they desire not to have one. The Down Syndrome parents wanted research for a cure, they gave them a test instead.
It is heart breaking what goes on in this country to the disabled.
If you are born into a disability, no insurance company will cover you. You can go for government assistance, but it is limited, hard to get and does not pay for the things that you REALLY need.
Private funding help is limited.
Autistic children are not born, they are made. If I knew mercury was in the vaccines, I would have NEVER considered vaccinating my child, bottom line!
The vaccine program in this country needs to be gutted and re-established.
There are too many families out there that are loosing EVERYTHING to care for their child due to the government medical health agencies not having the knowledge to use a calculator in order to figure out that kids were receiving more mercury than the EPA deemed safe for a adult human body.
We, the parents of autistic children, are paying for their mistakes!
There's no reason to debate if mercury causes autism, it;s just a matter of gathering up the info. as Dr. Baskin did in his recent testimony.
It's always been there, the truth.
It's just am matter of people realizing that "the world is not flat, it is round" kind of thing.
Mercury is the 21st century's downfall in the health of humanity.

Gary

To all those who believe that vaccines are innocent in regards to our children. Fact number one: All vaccines to date have in there history caused the very diseases that they were ment to protect against. Not in all cases of course. Many wild strains seem to appear after vaccines have been given.
Perhaps you could offer another way that this rise in numbers could be explained? We all know that genes play some roll but we must remember that chemicals can cause abberations. Morris Kharasch himself said thimerosal was toxic. If it were bound, As Lilly claimed it would have been rendered harmless as a preservative.
When your child recieves the MMR you are given a paper from the CDC that says adverse reactions include change in behavior. And could you please tell me what other drug that the FDA has asked be removed that wasn't proven to be dangerous or have caused a problem? This whole problem hit quickly and due to the timelines of diagnoses it was 8 years before this hit it's highest rates.
A 1 in 10,000 ratio was the rule with vaccines. Now the injury rate is 1 in 250 for children. 1 in 1,000 for Smallpox in adults. There is a problem here and the only shared situations are the vaccines themselves. We have two years to wait to see if it was the thimerosal that led they way. Remember that only our military people have reported Gulf War Syndrome. We gave our people the most vaccines. All these darn coincidence as the pharmecutical companies claim are getting out of hand.

Why do I see many new studies that show that thimerosal is a player in the rise of Autism. So why does everyone keep bringing up the Danish study? The rates in Denmark are much less than other thimerosal using western countries.
Why did Denmark ban thimerosal in the first place in 1992? What concerns drove this action way before our government even began looking into this?
I still have a bottle of merthiolate that contains 50% thimerosal and it states in the warnings : May cause severe mercury poisoning. Let's see if I have this right. Mercury is toxic in any form. If I get to much on my skin it will cause mercury poisoning. If I inhale too much it can cause mercury poisoning, If I eat too much fish that contains mercury I can be mercury poisoned. But if it is injected directly into my blood stream it is not going to cause a thing???????
HELLO would others please add to the obvious.


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