Thimerosal update

The final version of the Homeland Security bill still has the provision to protect Eli Lilly from suits about the use of thimerosal in infant vaccines. A Democratic amendment to remove it (along with a couple of other howlers) failed 51-48.

McCain was the only Republican who voted for the amendment, saying of the bill “I’m too old to vote for this kind of crap.” Ben Nelson, Zell Miller, and Mary Landrieu (she’s facing a runoff in a couple of weeks) crossed over to provide Bush with the margin of victory. Nelson, along with Republicans Susan Collins and Olympia Snowe of Maine and Lincoln Chafee of Rhode Island, extracted some sort of promise from the Republican leadership to undo the liability provision as part of the appropriations process for the new agency; that was their price for voting against the amendment.

As soon as I heard that, I guessed that it was part of a standard Capitol Hill shuck and jive: someone pretends to make a promise, someone else pretends to believe it, and then pretends to be outraged when it’s not delivered on. (For one thing, an unrelated legislative provision in an appropriations bill faces a point of order in the House.) Wampum quotes from and links to CNN and UPI stories suggesting that my guess was right.

Just in case the whole business wasn’t quite perfect, pressure for the provision reportedly came from “the White House,” though no one at the White House seems to be claiming responsibility. But it turns out that Mitch Daniels, the OMB director, used to be the head of North American operations for Eli Lilly. Is that raw enough for you?

Of course, the policy embraced by the bill might still be good policy, even if the process was horrible. “Whoever loves law or sausage shouldn’t watch them being made,” said Bismarck. My earlier post on the subject drew two separate howls of well-informed outrage from a friend who is a health policy expert, arguing both that thimerosal might well be unrelated to the rise in autism and that the courts were lousy places to sort the matter out. Here are some paragraphs from those emails:

1. As Dan Simon suggests, the evidence linking thimerosal to autism is not much more than speculative. An IOM committee released a report last year reaching the same conclusion as the CDC.

2. Thimerosal contains ethylmercury. EPA standards, as well as almost all research linking mercury to nervous system damage, concern methylmercury. Thimerosal opponents assume that ethylmercury and methylmercury are equally damaging, but that is not clear. The aforementioned IOM report notes, among other evidence, that a) ethylmercury is thought to have a shorter whole-body half-life than methylmercury; and b) studies with mice indicate that ethylmercury is less likely than methylmercury to cross the blood-brain barrier. (Mice administered ethylmercury end up with more mercury in their blood and kidneys, and less in their brains, than mice given methylmercury.)

3. The EPA exposure limit is strict by comparison to other standards. EPA’s threshold is 0.1 micrograms/kg/day. HHS’s Agency for Toxic Substance and Disease Registry (ATSDR) has a threshold of 0.3 micrograms/kg/day. FDA’s limit is 0.4 micrograms/kg/day. The World Health Organization’s exposure limit is 3.3 micrograms/kg/week, which by definition is greater than or equal to 0.47 micrograms/kg/day. The European Agency for the Evaluation of Medicinal Products (EMEA) uses the WHO standard.

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.

There’s another side to the scientific question, which Wampum (again) provides. As I said before, the sudden withdrawal of thimeorsal from the market three years ago ought to provide a natural experiment that should tell us whether it was really the culprit.

That the tort system does a miserable job of handling medical injuries is too clear to be worth arguing about. Why should the provision of adequate care for a profoundly autistic child depend on finding some entity with deep pockets and a theory connecting that entity to the injury? (Note that even the VICP depends on showing a causal link between the damaged child and something in the vaccine.) The problem is that the very folks who are most vocal about reining in the tort bar are also the most firmly opposed to adequate measures of social insurance for profound disability and health care.

As a matter of law, the VICP may already cover thimerosal and other vaccine additives. If not, that was arguably a drafting error, and if Congress decided now that, from now on, anything in a vaccine would count as a “vaccine” for the purposes of coverage by VICP, why that’s exactly the sort of decisions legislatures are supposed to make. But (and here I differ from my expert friend) it’s not appropriate for Congress to monkey retrospectively with claims for injuries (or alleged injuries) already incurred, on behalf of a well-heeled defendant with a former executive in high place.

Still there’s a case to be made on the other side. Perhaps the thimerosal cases are exploiting a loophole in an otherwise satisfactory statutory scheme, and Congress is right to close that loophole, even retroactively. But (and here my friend and I agree) to do so by stealth, without hearings, by tying the change to a piece of (allegedly) “must-pass” legislation, is simply a disgrace, with nothing at all to be said for it.

I keep hoping this sort of shamelessness will eventually catch up with its perpetrators. But I’m not holding my breath.

Author: Mark Kleiman

Professor of Public Policy at the NYU Marron Institute for Urban Management and editor of the Journal of Drug Policy Analysis. Teaches about the methods of policy analysis about drug abuse control and crime control policy, working out the implications of two principles: that swift and certain sanctions don't have to be severe to be effective, and that well-designed threats usually don't have to be carried out. Books: Drugs and Drug Policy: What Everyone Needs to Know (with Jonathan Caulkins and Angela Hawken) When Brute Force Fails: How to Have Less Crime and Less Punishment (Princeton, 2009; named one of the "books of the year" by The Economist Against Excess: Drug Policy for Results (Basic, 1993) Marijuana: Costs of Abuse, Costs of Control (Greenwood, 1989) UCLA Homepage Curriculum Vitae Contact: