The number of children with autism seemingly has increased dramatically in recent years. Many people have speculated that vaccinations - specifically the MMR vaccine - are causing the increase, but that allegation has not held up to scrutiny.
Recently, there has been much publicity given to allegations of a more specific link between vaccines and autism - specifically, the preservative thimerosal, which contained mercury in excess of the EPA standards for exposure and was included in vaccines given to children until 1999.
In the recently-passed Homeland Security bill, someone (Bill Frist, speculates Hesiod) inserted a provision at the last minute insulating makers of thimerosal from most of the lawsuits.
This last-minute insertion into the law has drawn much ire. Aside from general good-government concerns, the caricature of evil Republicans protecting big corporations such as Eli Lilly from the consequences of causing autism in children is far too tempting to pass up.
TAPPED has a short post on the subject which perfectly encapsulates that view, noting as an aside that the subject involves "medicines that apparently gave children autism."
There's only one problem: the caricature is probably wrong.
1) I would never want to be in the position of Dwight Meredith, father of an autistic child who wonders if sheer idiocy on the part of vaccine manufacturers and the medical establishment is responsible for his son's autism. I could certainly never deal with the topic with the level head that Mr. Meredith displays. But even Mr. Meredith is careful to note:
It is important, however, to stay focused on what is actually known about the relationship, if any, between mercury in vaccines and autism. There have been no studies of which we are aware that demonstrate that thimerosal in vaccines causes autism. Thus, it would be wrong, or at least premature, to conclude that vaccines have caused autism in any child.
Some, however, have suggested that there is no evidence of a link between thimerasol and autism. That is also not true. The increase in the incidence of autism in California coincides with the increased exposure of children to mercury in the form of thimerasol in vaccines. Mercury is known to cause brain damage to some kids at some level of exposure. That is evidence of a link but it is in no way conclusive evidence of causation.
I'm no expert, but it seems that Mr. Meredith may be too generous to the evidence of a link between thimerosal and autism. The CDC hasn't heard about it yet, and an unnamed friend of Mark Kleiman cites other evidence. Chemist Derek Lowe argues against the plausibility of a link between thimerosal and autism (click here and scroll up for more). Here's a study from The Lancet (free registration required) which reaches the following conclusions:
Overall, the results of this study show that amounts of mercury in the blood of infants receiving vaccines formulated with thiomersal are well below concentrations potentially associated with toxic effects. Coupled with 60 years of experience with administration of thiomersal-containing vaccines, we conclude that the thiomersal in routine vaccines poses very little risk to full-term infants, but that thiomersal-containing vaccines should not be administered at birth to very low birthweight premature infants.
At the very least, TAPPED's offhand statement that the thimerosal-preserved vaccines in question "apparently gave children autism" is a massive overstatement, which doesn't stand up to even a cursory reading of the evidence. A stronger link may be proven (especially since, as Meredith notes, a test will occur naturally based on the fact that thimerosal was eliminated from vaccines after 1999), but the current evidence doesn't seem to provide anything close to a reliable link.
2) As Mark Kleiman's friend notes:
When Congress established the Vaccine Injury Compensation Program in 1986, it was a rare legislative acknowledgment that the tort system is incapable of serving the public interest. At the time, you may recall, vaccine manufacturers were leaving the industry, vaccine prices were skyrocketing, and vaccination rates were falling sharply. VICP created a no-fault system for vaccine-related injuries. The system is inevitably imperfect, but it's clearly served the public interest. Vaccine prices and availability improved; the number of lawsuits plummeted; program costs have been modest ($110 million a year for pre-1988 injuries; an excise tax of 75 cents per dose for post-1988 injuries); and compensation to genuine victims has been non-trivial (VICP has paid over 1500 claims averaging just under $1 million per).
But of course the trial lawyers despise no-fault systems, and in thimerosal they see an opportunity to bypass and undermine VICP. They claim that thimerosal-related injuries (if there are such things) should not be covered under VICP because the injuries don't stem from the vaccine proper but from a "contaminant." They're suing the thimerosal manufacturers, who are not covered under VICP. They're aggregating millions of claims of $1000 or less because VICP precludes suits for > $1000. And so on.
Undermining VICP can't possibly serve the public interest. Thimerosal has already been phased out of childhood vaccines. There's an effective system in place for dealing with vaccine injuries; if there is credible evidence of thimerosal-related damage, then victims should fight to have the relevant adverse events added to the VICP vaccine injury table.
There's no reason to be believe that courts can deal with this. Juries routinely accept junk science when faced with heart-rending individual cases. (E.g., epidemiological evidence does not support a link between silicone breast implants and autoimmune disease. Some solace to the bankrupt manufacturers.) The threat of huge awards and litigation costs leads to settlement of meritless cases. (Last year, the vast majority of asbestos settlements were paid to unimpaired claimants.) Plaintiffs shop for judges that have been elected by the trial lawyers and for jurisdictions (in, e.g., WV, MS, and TX) that have absurdly pro-plaintiff rules. The record shows that in mass tort situations, legal costs typically absorb 50% - 80% of judgment and settlement dollars. And the 20% - 50% that trickles down to victims and "victims" is distributed in arbitrary and unequal fashion.
I have little to add to this. Even Kleiman admits: " That the tort system does a miserable job of handling medical injuries is too clear to be worth arguing about."
Even if you believe that pharmaceutical companies are profiteering, heartless entities which deserve to be humbled - and worse, heavily regulated (I think that's a fair summation of the editorial line at The American Prospect ), wouldn't it be proper to have evidence of truly harmful malfeasance before subjecting the companies to "bet-the-company" litigation? (No one remotely familiar with the history of mass torts can deny that lawsuits such as the thimerosal-vaccine claims have the potential to destroy any company, regardless of size. Ask Dow Corning, W.R. Grace, etc.) "Due process" and all that stuff.
I agree that it was sleazy to amend the law in the last-minute, anonymous fashion at issue. But the ideas behind the amendment were perfectly defensible - and its sponsors should not have been afraid to defend those ideas. That fear was the true scandal.
UPDATE: Thanks to TAPPED for the kind words. And they do paraphrase the issue correctly, though they should say that thimerosal "was" often added to vaccines, as it has been mostly removed due to the concerns raised about potential mercury poisoning (which formed the basis for the lawsuits at issue).
A couple of notes, as long as I'm revisiting the topic. First, I was struck by the following observation in the New York Times piece about the controversy:
On July 7, 1999, at Halsey's urging, the American Academy of Pediatrics and the Public Health Service released a statement urging vaccine manufacturers to remove thimerosal as quickly as possible and advising pediatricians to postpone giving most newborns the birth dose of the hepatitis B vaccine. The decision, which helped to create vaccine shortages and led some babies to become infected with hepatitis B... (Emphasis added)
That consequence helps show that the removal of thimerosal was not a costless decision. I do not know if there have been any good studies done to estimate the number of babies who contracted hepatitis B but would not have done so if thimerosal-preserved vaccine had been administered. But in theory, if further studies show no link between thimerosal and mental incapacitation, the costs of removing thiremosal from vaccines may be shown to have outweighed the benefits.
Second, TAPPED reiterates:
The real scandal here, such as it is, is that that someone friendly to Eli Lilly stuck a provision in the homeland security bill to exempt Lilly from tort lawsuits just in case there turns out to be such a link.
If that was indeed the expected progression of events - i.e., if lawsuits would follow evidence of a link - I'd agree. But in reality, the lawsuits have been filed by the dozen long before any such link had been established (check out this search result for an indication). This is not atypical for the mass-tort context, either. With that in mind, it's harder to see the amendment as illegitimately depriving legitimate claimants of recourse; I'd even argue it's closer to an attempt to maintain neutrality while studies are performed to establish whether or not the link exists. (I'd argue that if studies show such a link, Congress may well repeal the amendment. But that's a different argument.)
Comments
Thank you for your link to our writings and your kind words. We should all be very careful not to misstate the evidence concerning a possible link between thimerosal and autism.
No causal connection has yet to be established. No study of which we are aware (and we are aware of many) has yet been designed to try to answer the question. The Lancet study is flawed in a large number of ways. The Danish study of the MMR simply does not address the issue as that study was testing an alternate theory of causation of autism. It would be an error to conclude that thimerosal causes autism. It would also be an error to conclude that it does not.
The circumstantial evidence of a link between Thimerosal and autism, while not conclusive, is quite substantial. The increase in the incidence in autism, which you characterize as "seemingly" is not a myth but a fact. See the California study referred to at PLA.
That nearly 300% increase occured at the same time that the exposure to mercury was incresed through use of additonal vaccines containing the preservative thimerosal.
Many autistic kids who received those vaccines have wildly elevated levels of mercury in their brain. Mercury exposure at some levels is known to cause brain damage.
The symptoms of autism often appear shortly after the vaccinations.
The assumption that the absence of proof is proof of absence is a diservice to the 30,000,000 kids who were esposed to mercury in vaccines at levels greater that EPA guidelines, a diservice to autistic kids and their families who live with the consequences of autism every day and a diservice to science.
Neither you nor I know if autism is caused by mercury exposure. Neither did Congress when it slipped the Lilly Protection Act through as part of the Homeland Securty Bill in the dead of night with no hearings, no evidence and, we suspect, with fewer than 10% of the Congress having heard the word "Thimerosal" before the issue arose.
The process by which Lilly got it's swag stinks and while you may put perfume on a pig, it is still a pig.
The trial lawyers have one point that you dismiss far too quickly. Thimerosal is not a vaccine. It prevents no disease whatsoever. It is a preservative.
No thimerosal has ever been included in single dose containers of infant vaccines.
To have the VICP cover injuries caused by substances that are not vaccines would be to break new ground. The purpose of the VICP to to provide compensation for people who suffer from vaccinations.
It is inevitable that some harm will be caused by vaccinations. The benefits of vaccinations, however, far outweigh the damage.
If thimerosal causes autism, however, those injuries were not the inevitable result of vaccinations. The vaccine could just as easily, but at a slightly higher cost, have been provided in single dose containers for which no thimerosal is needed.
We support the VICP. We think a no fault basis for compensation for the inevitable damage caused by the greater good of vaccinations is an admirable program with very good social and public health benefits.
If thimerosal litigation remains confine to the VICP, however, the issue of causation will not disappear. The VICP does not pay compensation without proof that the injury was caused by a vaccination. If thimerosal does not cause autism, there will be no recovery from the VICP just as there would be no recovery from a state court suit.
If thimerosal does cause autism, the consequences of that autism have already been incurred. Those damages (exclusive of any pain and suffering or lost economic earnings) are between $2,000,000 and $3,000,000 per child. Those costs will have to be paid by someone or the autistic kids will have to be simply abondoned by society.
The costs in human terms to the children and their families will be borne by the children and their families in any event.
Ultimately, if thimerosal caused autism, the question is whether or not a combination of the taxpayers and the families will bear all of the burden or whether the maker of the mercury compound that was injected into our children should have to pay some of the costs.
Different views on that subject may be held in good faith.
The answer to that question is political in nature. The process by which the Lilly Protection Act was passed prevented an infomed political debate on that subject.
For that reason, the inclusion of the limitation of liability into the Homeland Security Bill was simply wrong.
Posted by: dwight meredith | December 19, 2002 2:39 PM
Mr. Meredith
Your situation is agonizing, and I salute your civility. I have an 8 month old daughter, and I dare not contemplate such a fate for her.
That said, the point about class-actions and trial lawyers is still quite valid. As Dr. Manhattan pointed out above, proof is not required - indeed, despite lack of proof, several suits have already been filed.
Class-actions are often filed by lawyers for their own gain - the targets are those most vulnerable, which unfortunately does not correlate well with fault, negligence, damage caused, or any other attribute for which honest people would seek compensation.
That is the point here. If proof is found, I certainly expect Congress would repeal the amendment in question cue to public outcry. Until that time, multitudes of law-suits do nothing but unjustly enrich lawyers - an unjust enrichment for which they will never be held accountable.
If there is proof, wouldn't you like to receive compensation? Without appropriate protections for the company, there is a very large chance that you (or others like you who don't happen to catch the very first wave of lawsuits) will have no companies left to recieve compensation from, as they will have all been obliterated by damages - the majority of which will have gone to the lawyers, not the victims.
Posted by: Deoxy | December 19, 2002 3:46 PM
Proof of a causal relationship between thimerosal and autism will be required, as a matter of law, before any recovery may be had either in the VICP or in a civil suit filed in any state or federal court. Proof of a causal relationship is not required to file the suit in either forum but is required to prevail in either forum.
The argument against the civil actions is that a jury is more likely to ignore the requirement of proof of a causal connection than is the VICP.
That may be true in some cases but Judges have a great deal of power over the process including the power to bifurcate the trial so that the jury focuses on liability before presentation of any evidence of damages, the power to direct a verdict, the power to grant summary judgment, the power to require generaly accepted scientific evidence under the Daubert decision of the Supreme Court and other powers.
In our experience, it is quite difficult to win a lawsuit without evidence of an essential element of the claim. Others may disagree. That is part of the debate that should be had by the political bodies before slipping such legislation through under the cloak of night.
Regardless of the ultimate answers to many of those questions, the proceduures used to insulate Lilly from liability are just plain wrong.
My concern is with 1)the processes of the medical establishment that saw fit to inject our children with mercury in quantities that were not determined to be safe and 2) with the subversion of the Democratic process to protect interests that contribute heavily to the Republican party.
It should be noted that although a lawyer and the parent of an autistic child, I have not sought recovery of any amount from any person or entity and have stated publicly that I have no intention of doing so.
Posted by: Dwight Meredith | December 19, 2002 5:31 PM
Companies were driven into bankruptcy after juries rendered judgments against them for the manufacture or sale of silicone breast implants. There never has been any scientific evidence presented that the product causes any harm to the recipient. The same could be true if lawyers were allowed unfettered access to the courts regarding vaccines.
Posted by: Paul Engel | December 19, 2002 6:03 PM
I know little about autism, other than what has been discussed in these postings. I do know a little bit more about the law, but I do not feel equipped to discuss what goes on during a product trial.
But as an American citizen, it bothers me that a company is able to seemingly buy itself protection. It's the equivalent of a millionaire saying: I'm being accused of murder, I didn't do it, but I don't want to be bothered with a trial, and the legislature passing a law to protect him.
Posted by: Emma | December 20, 2002 9:29 AM
I appreciate all the comments - especially the ones that defend my positions. Seriously, I appreciate that Mr. Meredith has taken the time to respond.
Here are a few thoughts in addition to a new post I'll do soon:
1) If it was unclear, I'll stipulate more clearly that I do not believe that the existing studies provide 100% proof that there is no link between thimerosal and autism. But, as you say, they do not provide convincing proof of such a link either. Absence of proof may not be proof of absence, but it is certainly not proof.
2) Regarding your (Mr. Meredith, that is) statements that:
"Proof of a causal relationship between thimerosal and autism will be required, as a matter of law, before any recovery may be had either in the VICP or in a civil suit filed in any state or federal court. Proof of a causal relationship is not required to file the suit in either forum but is required to prevail in either forum."
"The argument against the civil actions is that a jury is more likely to ignore the requirement of proof of a causal connection than is the VICP."
"That may be true in some cases but Judges have a great deal of power over the process including the power to bifurcate the trial so that the jury focuses on liability before presentation of any evidence of damages, the power to direct a verdict, the power to grant summary judgment, the power to require generaly accepted scientific evidence under the Daubert decision of the Supreme Court and other powers."
As Thomas Friedman would say, "Yes, but..."
Not all courts are created equal. As Mark Kleiman's unnamed friend quoted in my post summarizes, mass tort litigations are now characterized by sophisticated forum-shopping, aided by a track record of plaintiff-friendly verdicts in certain jurisdictions (especially certain state courts in Mississipi and other Southern states). I don't think too many of the thimerosal lawsuits are being filed in federal court in NY, for example (though I admit I don't yet have a detailed breakdown of the locales). It is not likely that, practically speaking, establishing proof of causation means the same thing when the determining party is a Mississippi state court jury rather than the VIPC.
For example, I believe that the breast implant manufacturers lost at least a couple of jury verdicts in state courts, despite the continuing lack of any reliable scientific link to any health problems. (Also note Kleiman's friend's point re: the current state of asbestos litigation.)
The breast-inplant example illustrates that the absence of clear scientific proof will not necessarily deter the incurrence of heavy costs in a mass-tort context. Much can be criticized about the amendment, but it at least faces that reality.
3) Lest I sound too critical about my Republican paymasters and face expulsion from the Vast Right-Wing Conspiracy...
Seriously, I agree that the issues at stake in the amendment should've been debated at length by our elected representatives. But offenses against that norm occur constantly, and I strongly doubt that the partisan balance of such offenses is disproportionately tipped to either side. To be uniquely offended about this amendment, I believe, requires taking strong offense at the substance of the amendment, not just the process. Nothing wrong with that - but I don't really agree with that sentiment.
4) Finally, from a purely logical standpoint, the idea that a substance only introduced into the human body in the context of a vaccination should be covered by the VIPC is one that strikes me as something short of outrageous.
Thanks again.
Posted by: Dr. Manhattan | December 22, 2002 12:12 AM
I'm just curios to know more about Thimerasol, I'm very worried about my 8 month old daughter. IF anyone can email me anything on this please feel free
Posted by: clint | March 29, 2003 9:10 PM
is thimerasol used in current flu vaccine
Posted by: elaine savlo | December 7, 2003 10:58 AM
I live in Croatia.What I can do with my son. He is 7,5. He has an autism, but we have not an educatinal system for such children.
Posted by: stipe | February 26, 2004 6:14 PM