Thesis topic

How many abortions resulted from the delay in approving Plan B for over-the-counter sales?

How many unintended pregnancies resulted from the three-year delay between the time FDA scientists decided that Plan B should be approved for over-the-counter sale and yesterday, when FDA leadership finally stopped dragging its heels and approved an idiotic pseudo-compromise? Of those, how many ended in abortion?

Note that state-to-state variation allows cross-sectional as well as time-series studies; the questions may in fact be answerable. But there’s benefit in just asking them, long and loud.

Footnote Why do I say “idiotic pseudo-compromise”? Because yesterday’s decision will make Plan B available to anyone over 18, including men. So the only minors who will be deprived of access are those who don’t know any grown-up who will buy for them after the fact and lacked the good sense to acquire an emergency dose before the fact.

No doubt they’ll make exceptionally fit mothers.

A refrain from Groucho Marx

“And even when you’ve changed it or condensed it,
I’m against it!”
The Beloved Leader opposed embryonic stem cell research because it involved killing embryos. Now a new technique allows embryonic stem cell research that doesn’t involve embryos.
The Beloved Leader opposes it anyway.

As the college president in Horse Feathers:

And even when you’ve changed it or condensed it,

I’m against it!

The ethical case, such as it was, for opposing embryonic stem cell research just got substantially weaker. It’s possible to extract a single cell from a zygote without killing the zygote; IVF clinics already do that to test for genetic abnormalities, and the resulting children don’t seem to be any worse off than those who develop from untouched zygotes. Now it turns out that a stem cell line can be developed from such an extracted cell.

The Bush Administration, which opposed embryonic stem cell research because it destroys embryos (as opposed to routine IVF, which simply produces embryos and then disposes of them) turns out to be opposed to embryonic stem cell research that doesn’t destroy any embryos; now its objection is to the use of human embryos in research. Naturally, its allied yahoos also remain opposed, with Sam Brownback proudly parading his ignorance.

Update Okay, I take back “ignorant.” It’s possible that a single blastomere could develop into a fetus, though of course not without lots of fancy maniupulation that has never been done with a human blastomere; even the research to determine whether it might be possible would be grossly unethical. I still claim it’s pretty damned silly to call the single blastomere a “twin” of the seven-blastomere group we know can and does develop into a fetus, and then claim that the “twin” was destroyed.

Even putting aside the fact that the zygotes in question weren’t going to be implanted anyway, no harm of any sort has been done to the zygote. But I keep forgetting that in discussions of these issues the rule “no harm, no foul” simply doesn’t apply.

Deep in the (doughnut) hole

Under Medicaid Part D, a patient who can’t come up with $2850 to cover the “doughnut hole” in effect loses coverage entirely after the first $2200.

Like Matt Yglesias, I hope the “doughnut hole” coverage gap in Medicare Part D turns out to be a political disaster for its Republican designers this fall.

But reading this Washington Post story on the doughnut hole, I was struck by a blinding flash of the obvious. Because the coverage gap is defined by actual expenditure, not by prescription, a Medicare recipient with very big drug bills who can’t scrape up $2850 is out of luck for the rest of the year. It’s not as if he or she can just forgo $2850 worth of medicine, or get it in physician samples or under drug-company programs to assist low-income patients, and then start collecting again. There needs to be actual money on the table. So the program is well-designed for those to whom high drug prices are an annoyance, and badly designed for those to whom high drug prices are a catastrophe.

Good going, guys!

Non-punitive sanctions

… since the punitive kind would damage some of BushCo’s corporate sponsors, in this case the health insurers who provide Medicare Part D coverage.

Who says the Bush Administration isn’t creative?

Robert Pear in the New York Times has yet another excellent story about the misadventures of the Medicare Part D prescription drug insurance program.

The big insurers who (along with Big Pharma) bought and paid for Medicare Part D are massively cheating on their legal obligations. In particular, they’re not providing the customer service function they’re required to provide; instead, they merely refer customers who need immediate medication refills but have had their claims rejected to the government’s own 800 number.

The President, who has the Constitutional duty to “take care that the laws be faithfully executed,” has apparently allowed his subordinates to declare an “unofficial grace period” during which Part D insurance providers can violate the rules with impunity. The government has even failed to publish a schedule of penalties to be imposed for breaking the rules, on the somewhat bizarre ground that “sanction authority is not intended to be punitive.”

Now that they’ve invented non-punitive sanctions, how about chaste pornography? Merciful torture? Dry water? (Or how about compassionate conservatism?)

And of course the Administration that never stops yammering about “choice” has decided to deny to consumers the information about the performance of the competing plans that would allow them to choose intelligently rather than by eenie-meenie-miney-mo.

The plot

I think the Medicare prescription-drug plan was DESIGNED to fail; it would have been almost impossible to do such a poor job of policy design and implementation by accident.

I think I’ve got it figured out. The Bush Administration truly is compassionate, and the drug companies actually care about getting medicines to sick people. So they deliberately designed Medicare Part D (the prescription-drug benefit) to fail in order to generate public support for some sort of true national health coverage.

Yes, I know: any theory that attributes good motives to Bush or Big Pharma requires a lot of believing. But I can’t come up with an alternative explanation for how badly the damned thing was designed and implemented, and in particular for the “donut hole.”

What’s your theory?

    an epidemiological smoking gun?

Probably not. But I’d like to see a careful look at these data from a neutral expert.

Back when the possible thimerosal/autism link was a hot topic in blogland, I kept pounding the table demanding epidemiological evidence. Since thimerosal was removed from most infant vaccines in 1999 we ought to be seeing falling rates of autism if there were a real causal link from thimerosal to autism.

Ask, and ye shall receive. A reader sent me a link to a paper that claims to find exactly that: falling rates of autism starting in 2002.

If that’s what the data really show, I withdraw my skepticism. Some caveats, however:

1. The American Journal of Physicians and Surgeons is a fairly obscure publication. A result this clear-cut on an issue this important should have been able to muscle its way into Science or Nature or NEJM or JAMA or the Annals of Internal Medicine or The Lancet or the British Medical Journal, just to name the ones I can think of offhand.

2. The authors are a father-son team. The father, Mark Geier, is an MD/Ph.D. running something called the Genetic Centers of America. He was an assistant professor of OB/GYN at Hopkins, but has no current academic affiliation. He has been a frequent expert witness in vaccine cases, and has at least once attracted serious adverse comment from the bench. The son, David Geier, is a Ph.D. student. at GWU, who runs a “medical-legal consulting” enterprise called MedCon, Inc., on the side. This is not a reassuring profile.

3. The authors note their use of what they call “a novel rapid-sampling epidemiological technique.” Methodological novelty is inversely correlated with reliability.

4. The result might be a reporting artifact. One of the primary data sources is the Vaccine Adverse Event Reporting System (VAERS). If a child who had received thimerosal-bearing vaccines were diagnosed with autism, it would be natural to report that as a possible adverse result of vaccination. If a child who had never been exposed to thimerosal in vaccination were diagnosed with autism, there would be no particular reason to suspect that vaccination had caused the autism. So the rate of autism diagnoses with suspected links to vaccination might have fallen without any drop in the rate of autism diagnoses overall. Other studies suggest that autism diagnosis rates have continued to rise. (I owe this point to Alan B. Cohen. Sc.D., of Boston University.)

So color me unconvinced.

Still, even a blind chipmunk finds an acorn every once in a while, and the data are what they are. In particular, there’s no obvious reason why the California Department of Developmental Services data should be subject to the reporting-artifact problem that renders the VAERS data suspect. So I’d be interested in hearing from any reader who can tell me whether the Geiers have actually found something here.

Update: More here, courtesy of Kevin Drum. One of the commenters makes the obvious analytic point: it’s not raw case counts we want, it’s cohort-specific diagnosis rates by age. Of children born in, say, 2002, how many had been diagnosed by age 3, compared to children born in 1999? That shouldn’t be a hard analysis to do.

Second update A reader points out that the American Association of Physicans and Surgeons, the publisher of the Journal of American Physicians and Surgeons, is a fairly flaky group &#8212 opposing, for example, over-the-counter sales of emergency contraceptives to adults because their availability might increase sexual activity among minors &#8212 and that its journal has published quasi-medical “studies” attacking abortion (using the breast-cancer link), homosexuality, and illegal immigration. So caveat lector.

Third update An expert looks at the study and finds that the statistical analysis “isn’t even third rate.”