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August 18, 2005
RU-486 Addendum (UPDATED)

Posted by Bill

In response to my critique of her post, Michelle Malkin says that she's "not quite ready to start pumping RU-486 into the water supply." Ok, I'll agree with that. She indicates that she should have noted the relative risk and is "worried that these four women (who died) are just the tip of the iceberg." This is a reasonable point-of-view, if expressed reasonably.

She also states:

According to the Los Angeles Times, the FDA is continuing to investigate the drug's safety. Is the FDA "shoehorning science and medicine in order to fit an ideological agenda?" What about the Centers for Disease Control and Prevention, the California Department of Health Services, and the Los Angeles County Department of Health Services--all of which have launched their own investigations? Are they right-wing whackos too?

No, certainly not. Tabling the fact that I wouldn't and have never described Michelle as a "right-wing wacko," I'm sure that there will be significant differences between her condemnatory analysis and the dispassionate investigations of the cited organizations; starting with a bet that they won't title their reports "THE FORGOTTEN VICTIMS OF CHOICE," will utilize relevant perspective of relative mortality for common medical protocols, and come to a conclusion about whether the drug represents a statistically significant health risk that calls for corrective action. These organizations are fulfilling their mandate to look out for public safety, but the jury is still out on their conclusions. As it stands, based on the information we have now, RU-486 can't be depicted as a dangerous drug.

And of course I don't expect a blogger to conduct statistical analysis worthy of a professional epidemiologist for every post on a health issue (my own general analysis was flawed, superficial and exposed to various avenues of criticism), but I would caution Michelle, and anyone else that writes about science or medicine in the context of politics, to use a bit of perspective when working backwards from an ideological presumption. We're all prone to making these mistakes, especially in the context of a political issue that commands our passion.

UPDATE: Hyscience (a pro-life blog) features a must-read on the possible mechanisms of fatal infections from RU-486. He also reaches a conclusion in which ideology and dispassionate analysis are properly demarcated:

Does it look like the just the "tip of the iceberg?" From what we know as we speak, we don't know! Do I think it's the tip of the iceberg? From what I've read about the pharmacology and what I know about the immunoendocrinology, I don't believe that anyone at this time believes it to be the tip of the iceberg.

So far, the risk seems small - unless you become one of the chosen few!

However, I still believe that it's a murder pill, and now (no) one can say that taking RU-486 is without any risk.

I don't agree with his characterization of the drug, but I agree with the way that he presented his case.

UPDATE: Another analysis that I agree with from a pro-life blog, partially and in form, if not all of the political particulars:

Secondly, as much as I hate supporting the pro-choice movement, both the government and the medical community agree that the unborn children killed by RU-486 don’t count as human beings. Further, it’s the law in this country that women have the right to first-term elective abortion–thus whether or not you and I see a need for RU-486, so long as it’s deemed safe by the FDA (which is what this whole circus is over, I know), women have the right to it. Period.

Those of you who’ve been reading for a while might recall that I’m no big fan of abortion or the pro-choice movement (see here for a rant on the subject), but facts are facts, and the facts in this case land fairly solidly in favor of the drug. One can argue against it on moral grounds, but the medical case for it seems pretty air-tight to me.

The medical case may yet prove to be more equivocal than "air-tight" (anything is possible), but based on current information, it's certainly not very questionable. And therein lies the important message from that post, which was probably conveyed better than mine: arguing against the drug on moral grounds, including making the statement that accidental fatalities are less acceptable because of the drug's function, is a distinct argument from criticizing the substance as a pharmaceutical approved for use by the FDA. The benefit of drugs is not established in combative moral terms, despite Paul from Wizbang's otherwise not-unreasonable personal sentiment (that I almost totally disagree with); they have an intended function and value assigned by regulatory bodies and the law as a reflection of society's will. One can argue against the value of this benefit, but it's simply best to make this argument separately from something like assigning outsized, imprecise "moral weights" to pharmaceutical analysis, specifically when those "moral weights" aren't representative of anything remotely approaching societal consensus.

Short form: don't portray a common, legal drug as dangerous just because you don't like what it does.

Posted by Bill at August 18, 2005 10:38 AM | TrackBack (5)

Comments

Oooh, catfight between Bill and Michelle...(Of course, for this to work in my imagination "Bill" needs to be transformed into "Billy Jean", i.e. a young Hellen Slater fighting for a noble cause: "Fair is Fair")

Posted by: JFH at August 18, 2005 11:11 AM

Make it mudwrestling. Or jello wrestling. And make it between Michelle and Jessica Alba.

Oh, and hasn't the CDC tried making "gun violence" a public health issue, i.e. to further the political aims of the gun control lobby.

Posted by: rbj at August 18, 2005 12:41 PM

These organizations are fulfilling their mandate to look out for public safety, but the jury is still out on their conclusions.

Exactly. And that's why I don't think her latest post is expressed reasonably either:

Clearly these agencies are worried that these four women are just the tip of the iceberg. So am I.

Huh? How does the identification of a need for further investigation logically lead to her conclusion, especially when characterized as woory about "the tip of the iceberg"?

Posted by: Hubris at August 18, 2005 01:04 PM

I'm a big MM fan, but I tend to agree with you on this one, Bill.

Though, in her defense, Hubris, the quote "The Times says the crux of these inquiries is how and why the women who died after taking RU-486 got infections and "whether more women might have been harmed."" MIGHT lead logically to the "tip of the iceberg" conclusion, if you throw in a splash of sensationalism.

Posted by: OHNOES at August 18, 2005 02:02 PM

And this quote...

"The drug already carried a black box warning (the most extreme warning possible)."

also can point to the "tip of the iceberg" conclusion.

Posted by: OHNOES at August 18, 2005 02:03 PM

OHNOES,

I coulda let it slide if she had, as you did, used "might be" instead of "are."

Of course, a review of my earlier comment reveals that I spell "worry" w-o-o-r-y, so what do I know?

Posted by: Hubris at August 18, 2005 02:17 PM

Another point: is it possible that problems with the drug are under-reported for political reasons? Everyone issuing it would be pro-choice, and some would be very activist about it. It's at least possible they would not want to publicize problems with a drug that they have a significant political investment in.

Posted by: JohnAnnArbor at August 18, 2005 02:57 PM

I don't have an answer to that.

Posted by: Bill from INDC at August 18, 2005 03:06 PM

One has to remember that from Michelle's standpoint, every time RU-486 is used, someone dies. 4 times that have been reported the mother ALSO dies. Also, there were very few deaths from the arthritis drugs, Vioxx etc the Cox-2 inhibitors, but they were very quickly pulled.

Posted by: Brian at August 18, 2005 04:02 PM

Also, there were very few deaths from the arthritis drugs, Vioxx etc the Cox-2 inhibitors, but they were very quickly pulled.

Are you assuming that's from her perspective? From extrapolations of large long-term studies, 25-50,000 fatalities may have been associated with Vioxx.

Posted by: Bill from INDC at August 18, 2005 04:11 PM

consider Non-Steroidal Anti-Inflammatory
Drugs Such As Aspirin cause 10,000 deaths per annum in this country.

The elderly are especially susceptible to gastrointestinal bleeding and damage.

Outlaw Aspirin???

There's a reason why young women during their optimal child bearing years constitute an elevated acturial insurance risk; i.e., higher health insurance premiums.

RU-486 is used throughout Europe and the United States. There's no conspiracy to under-report.

Quite the contrary, do you think for even a second that our cover-your-ass doctors would even consider for a moment exposing their butts to massive civil lawsuits and criminal prosecution by knowingly prescribing dangerous medication and purposely covering up the dangers.

Let's see, when it comes to grinding political axes: the Social Right or our entire medical community?

Now, that's a tough one.

Posted by: kaligula at August 18, 2005 04:24 PM

Bill:

I wouldn't be surprised if Michelle's attitude is one part revulsion at the purpose for which the drug is prescribed, one part suspicion based on the shortcuts which seem to have been taken in giving it FDA approval and one part suspicion based on the strong incentives the abortion industry would have to minimize / marginalize reports of complications / deaths associated with its use.

But enough of all that - you gonna get to any Gator games this fall?

Posted by: BradDad at August 18, 2005 10:19 PM

I wouldn't be surprised if ...

Well, I have suspicions about a lot of things ...

you gonna get to any Gator games this fall?

No plans, no.

Posted by: Bill from INDC at August 18, 2005 10:29 PM

Bill, with all due respect your whole argument is a house of cards.

You want to compare the costs (in deaths) of 2 different products but you don't want to look at what each product does for society.

Let's pretend two drugs BOTH killed 1% of the people taking it. (just to make things fair)

If one drug cured cancer and the other cured dandruff, one would be banned and the other one would get its creator a Nobel prize.

You simply can not equate the worth of antibiotics vs RU-486 based on the cost. If you think about it honestly Bill you'd have to admit your argument is just as flawed as Malkin's. (Be honest. ;-)

NOTE: I'm not talking about RU-486 or abortion. I'm talking about the relative merits of each sides arguments. Well OK I didn't read Malkin. I talking about this argument.

Posted by: Paul at August 18, 2005 11:14 PM

But for 10 bucks I'll read Malkin and shoot her argument down too. ;-)

Posted by: Paul at August 18, 2005 11:16 PM

You want to compare the costs (in deaths) of 2 different products but you don't want to look at what each product does for society.

Not exactly - the problem with this specific drug (and the political issue), is that the benefit to society is vastly different to different people, and the ones that state that it has great benefit are dictating the law here. So my position might be better stated as "those that do not agree with the drug's utility cannot assume that they can add moral weight to epidimeological analysis, when those moral weights do not have consensus."

And presenting such analysis without even making those moral weights clear - like saying RU-486 is a particularly dangerous drug in general - is misleading.

Posted by: Bill from INDC at August 18, 2005 11:21 PM

As I pointed out on Wizbang, RU-486 provides a safer, cheaper, faster alternative to a legal abortion. That's why, if you want to talk about cost benefit analysis of RU-486, you must take into account the number of abortions it is preventing. Of course, making this simple observation caused the ever sensible Paul to threaten to ban me from the site and delete my posts. I guess some people are better than others at receiving opposing viewpoints.

Posted by: jYt at August 18, 2005 11:25 PM

Bill you sidestepped my point. I'm not bringing a moral component into this. -And frankly it is irrelevant to your earlier point.

Not exactly - the problem with this specific drug (and the political issue), is that the benefit to society is vastly different to different people

Oh come now Bill... Can anyone... Anyone say that RU-486 is the same value to society as penicillin? Let's not go into moonbat territory. How many (millions of) lives has penicillin saved?

If you can look me square in the eye... er square in the browser and tell me that the benefit to society of RU-486 and penicillin are the same, then I'll grant you that it is fair to compare them on cost.

The fact is, your analogy was fatally flawed. It was one of those arguments that sounded bullet-proof but turned out to be bullet-riddled.

There's no shame in admitting it Bill...

Posted by: Paul at August 18, 2005 11:45 PM

jYt No- I said I'd ban you for baiting people and being a troll. You don't have to take my word for it, go read it again for the very first time.

Posted by: Paul at August 18, 2005 11:47 PM

Can anyone... Anyone say that RU-486 is the same value to society as penicillin?

You are totally missing the point. When one analyzes the "safety profile" of a drug, one does not analyze it in the context of subjective subtle gradiations of its value to society. It's typically defined as legal and having approved medical application, or not (this is the fundamental threshold for "value," and the courts, legistlatures and FDA determine that, not random opinions of activists or arrogant bloggers, for example). One of the few examples I can immediately think of where your "moral weights" actually have practical application and flexibility is in the case of something like gene therapy experiments specially approved on people with mortal illness.

So stop misrepresenting my point.

The fact is, your analogy was fatally flawed. It was one of those arguments that sounded bullet-proof but turned out to be bullet-riddled.

After a fundamental threshold/benchmark, the safety profile of a drug is unrelated to the minority's moral weight/purpose that you decide to assign to it, in the eyes of the regulatory bodies. That is why the FDA places drugs into "schedules." "Paul from Wizbang" spouting off about how RU-486 is terribly dangerous, because he doesn't see value in it's intended use, for example, does not change the reality that, rationally analyzed, it's not a particularly dangerous drug. And that is the point.

Why did I even bother to think that you could engage in legitimate discussion? Truly you don't change.

Go away now, Paul.

Posted by: Bill from INDC at August 18, 2005 11:55 PM

>Why??? He was not being an idiot. (this time ;-)

Clearly, for you, "idiot" = "someone making an argument you can't answer" as your continued silence on this point shows.

So, did you threaten/ban mantis when he was being an idiot before? If not, why not?

>Guess that distinction is lost on you eh?

My perspective is that I raised a valid, non-idiotic point about CBA of RU-486. Of course, I can't stop you from calling it idiotic, saying I'm a troll, being a coward any more than I can force you to address it. Everyone has their own viewpoint I guess.

JSchuler and I managed to find a good point of agreement on this issue. You and I found agreement on the penicillin > RU-486 analogy point. I don't think I'm being that unreasonable to stand by my guns. Your initial threat of banning simply makes me more convinced that I'm right and you're wrong. Your continued evasions help, too.

Finally, let's say that I did try to "bait people into a debate over abortion" (which I clearly did not). Is that really a banning offense at WizBang. My lack of ability to post there seems to say so. Can't we digress in these comments and raise points that weren't in the initial post? Are we all operating under strict posting rules about what is "on topic" and what is verbotten? Seriously, take a chill pill, dude.

Posted by: jYt at August 19, 2005 12:07 AM

On the other hand, RU-486 essentailly replaces abortion, thus saving lives and certainly saving anguish, time, and money for the person taking the drug. (taken from jYt's comments at wizbang)

As a partial pro-choice kinda guy (restrictions on late term abortions), I take objection to what some pro-lifers say - case in point above.

As I pointed out on Wizbang, RU-486 provides a safer, cheaper, faster alternative to a legal abortion.

Better, but...

RU486 does not replace, nor is it an alternate to abortion. Yes it is safer, cheaper, faster, (and less traumatic I'd add), yet it is still abortion.

Posted by: bains at August 19, 2005 12:09 AM

>Go away now, Paul.

What, you're not going to simply label Paul a troll and ban him? Wow, you must actually have a functional brain.

Paul, I'm pity you. You're a coward who can't make or back up your points. Dissenting opinions must be silenced. Enjoy your echo chamber.

Posted by: jYt at August 19, 2005 12:10 AM

"Paul from Wizbang" spouting off about how RU-486 is terribly dangerous, because he doesn't see value in it's intended use, for example, does not change the reality that,

I never once said it was dangerous. Not once.

I spoke only to your analogy, sorry to disappoint you.

Why did I even bother to think that you could engage in legitimate discussion?

I've been asking myself the same question of you.... You make a flawed analogy then when I explain it to you you claim I "spout off" things I never said.

Guess you haven't changed huh Bull?

see ya

Posted by: Paul at August 19, 2005 12:14 AM

heh- That was supposed to say "Bill" not "Bull" but considering the truthfulness of his statement it was downright Freudian.

Posted by: Paul at August 19, 2005 12:16 AM

I never once said it was dangerous. Not once.

and

You make a flawed analogy then when I explain it to you you claim I "spout off" things I never said.

I meant it as a hypothetical. As indicated by the "quotation" "marks." Should have used "Joe Schmo."

Posted by: Bill from INDC at August 19, 2005 12:17 AM

Bill I was not going to post again because you requested I not but really...

>I meant it as a hypothetical, silly man. As indicated by the "quotation" "marks."

You put the quotation marks around "Paul from Wizbang" I put the quotes around "spout off."

Being intellectually dishonest is one thing but come on.. people can read!

Geeze... If people like you can't see my point I just take it as a compliment.

see ya

Posted by: Paul at August 19, 2005 12:59 AM

>Being intellectually dishonest is one thing but come on.. people can read!

That's why I hope people followed my postings at your blog. For anyone who missed them:
http://wizbangblog.com/archives/006811.php#088425

>Geeze... If people like you can't see my point I just take it as a compliment.

Now your just writing my posts for me. I guess not being able to see my point AND banning me for your inability is really a HUGE compliment. Thank you, Paul. I noticed that since I've been gone epador and JSchuler have posted some good, salient points on abortion (not the word "abortion", like you might think). I guess my responses will just have to wait for 3 days.

Bill, sorry to hijack this discussion, but it'd cost me $30 to continue posting at WizBang and I don't think I'd be getting my money's worth from that particular fund raising technique.

Posted by: jYt at August 19, 2005 01:11 AM

Hubris,

Thanks for not lumping me in as supporting Malkin's arguments word for word, though I did my best to distance myself from her wording.

Had I written that blog post, I would have at least used the word "MIGHT," but I have done NO research on the topic, and I only know general knowledge and the posts by Malkin and Bill, so that assessment is based SOLELY on the facts I have stated that I know. Methinks Malkin is letting her personal opinion shade the word choice.

But, again, 4 deaths from a drug, even I think that's nothing as far as drugs go. To me, I think Malkin sees, justifiably or not, a pro-choice agenda pushing the drug, which, if you read the first post regarding this between the lines, you can get that impression. So, I can understand WHY she wrote what she wrote, but I can also easily understand that what she wrote was just a bit sensationalist.

Posted by: OHNOES at August 19, 2005 01:49 AM

Note: I'm not trying to insinuate that there are facts out there that add credence to the "tip of the iceberg" assertion, rather than something with less sureness. I simply stated that "but.." clause to indicate that I have no business blogging on the topic.

Though I think Malkin's political statements regarding silent women's health activists and "pharmaceutical-bashers" deserve a lively debate of their own, simply so that we can hammer out if they are worthy of merit, but I am unsure if they fit in the scope of the current debate and I am unqualified to participate in such a debate on either side. I'd rather read the informed opinions of others on such a matter.

I ramble. Apologies.

Posted by: OHNOES at August 19, 2005 02:00 AM

I find it interesting that Malkin decided to spin Bill's response like this as being too quick to dismiss RU-486 (OU812?) because, essentially, other things kill people too, rather than acknowledging the relative risk argument.

There's a deeper problem here, and it runs through Malkin's work when she takes off her journalist hat and puts on her historian/scientist hat, and that is that she argues from rhetoric and anecdote, then plays "make believe" and pretends it's real science by avoiding meaningful peer review or and ignoring (or misrepresenting) competing arguments. Sort of like "Intelligent Design" for historians (See also: In Defense of Internment).

Posted by: moebius at August 19, 2005 02:34 PM

This is actually a very dodgy issue, largely because of trial lawyers.

Anyone remember the fen-phen scandal? I sure do, because my grandmother's main holding was AHP stock. Basically, the plaintiff trial lawyers claimed fen-phen caused heart-valve damaage, based on echocardiogram analysis. It seemed plausible at the time, and estimates of liability ended up around $14 billion.

Later, another study was done including people who had not taken fen-phen, and it found that not only were many of the plaintiffs misdiagnosed based on faulty echocardiogram interpretation, the incidence of valvular disease that did turn up was entirely representative of the population of those obese enough to be taking the drug (remember, this was available only by prescription).

But I'm betting trial laywers won't get behind something so anti-NARAL as an RU-486 suit anyway. Not sure why I would think that.

Posted by: TallDave at August 19, 2005 02:38 PM

Did you know that natural gas explosions in homes destroy an average of 252 homes per year? I can't find US stats on the deaths, but I'd bet it's a lot more than 5. Should we outlaw gas heat? My father worked in a PVC plant in 1979. There was an explosion (vinyl chloride is a dangerous chemical) that killed 12 people. Should we outlaw plastic?

I really dislike this demonization of a drug because a few people die from using it. A few people die every year from just about EVERYTHING! My grandmothers life was destroyed by rheumatoid arthritis. Celebrex gave her her life back. Now they are considering removing it from the market, effectively ending the enjoyable part of her life. Just because someone may have possibly died from using it. It is insane!

Her biggest fear now is not of dying, but that she may not be able to get Celebrex. She's stockpiling it like a drug addict now (and it's like $3 a pill).

My solution is that we should put a warning on every product used in America:

Warning, we believe that using this product increases your likelyhood of dying by 0.XXXXXXXX%

And let the end user decide. If new information comes up, revise the number. I despise the government protecting me from products (saccharine and cyclamates come to mind). Please stop assuming the American public is a bunch of idiots.

I apologize for the rant, but I love my grandmother, so it's important to me.

Posted by: Kevin at August 20, 2005 03:59 AM

I still think that she's attacking the drug not because it kills people but for largely political reasons, in that she sees a situation where mentioning those deaths would be NARAL smear ads or what not and thus feels that attacking it is her duty as a pro-lifer.

Posted by: OHNOES at August 22, 2005 01:09 AM

Which is to say I don't think MM would have the same venom to throw at Celebrex.

Duty as a pro-lifer isn't exactly fair, probably more "duty as a counter-voice to liberal-dominated media" or what not.

Posted by: OHNOES at August 22, 2005 01:11 AM