March 19, 2006
From the desk of Jane Galt:Should the FDA ban RU-486?
Jeffrey Alan Miron says no.
Obviously, if you don't think that the FDA should exist, the answer is no. But assuming, arguendo, the validity of the FDA, I might be willing to argue that the answer is "yes". Not because of some abortion thing, but because in the course of researching the question "Could RU-486 be used to undetectably induce abortion were it made illegal?" I realized, to my great surprise, that the evidence seems to indicate that RU-486 is a poor alternative to surgical abortion.
Women who have used RU-486 report much less satisfaction with the experience than women who have surgical abortions--particularly those who have had surgical abortions before. Over 10% of them have to have a surgical abortion anyway, and there's a substantial risk that the abortion won't work, at which point there is a high risk of birth defects (hence all the follow-up abortions). It's more painful, more bloody, lasts longer, and is apparently more psychologically traumatic. It takes more doctor's visits, and costs more.
There are only two potential benefits. One is that nurses can be used instead of doctors to monitor much of the proceedings (women have to sit in the doctor's office for hours waiting for the thing to take)--but the FDA is hardly supposed to be in the business of approving drugs because they're better for the prescribing physicians. And the other is the political aspect in the US. RU-486 doesn't need a special surgical clinic, meaning that individual doctors can prescribe the stuff, circumventing Operation Rescue's theatrics.
But in practice, apparently almost no one does . . . some because they don't want to be in the abortion business, some undoubtedly out of fear of reprisal, but most apparently just don't want to mess with it. It's tedious, requires somewhere to stash patients while you wait for the drugs to have their effects, and involves rather more emotional freight than most procedures performed by GPs. So while in theory, RU-486 may be a way to do an end run around the pro-life movement, in practice, it doesn't seem to be working very well.
Of course, the FDA's investigation of deaths may well be--even probably is--at least in part politically motivated. But that doesn't necessarily mean they're making the wrong decision.
Posted by Jane Galt at March 19, 2006 09:38 AM | TrackBack | Technorati inbound linksJane,
I agree that RU-486 is an inferior alternative to surgical abortion. However, I am surprised that you "might be willing to argue" that it should be banned. Even with the triple hedge, I have to disagree. Absent an unreasonable danger, I don't think the government should ban a product because there is a superior alternative.
RU-486 doesn't need a special surgical clinic, meaning that individual doctors can prescribe the stuff,
Until the state legislatures in South Dakota, Mississippi, Missouri, and other conservative states introduce laws requiring that RU-486 only be dispensed at special clinics that meet strict state requirements for medical personnel, insurance, BTU capacity of air conditioners, ceiling height, etc. The anti-abortion movement isn't stupid and won't ignore such a loophole.
Posted by: Brittain33 on March 19, 2006 01:26 PMI will bet you that RU-486 is more dangerous than Vioxx.
Posted by: Robert Schwartz on March 19, 2006 02:56 PMWere that the people who argue for keeping RU-486 legal applied the same metric of cost-benefit to all other drugs and procedures. Unfortunately, they will hold that it is a special case and demand ridiculous restrictions on all other medicines and attempt to eliminate medical profits through regulatory takings and illegitimate class action lawsuits.
It is unlikely that RU-486 should be banned, but further investigations into its effects and risks, and the dissemination of such, is appropriate. Too much medicine is defined through interest group pressure rather than good science. Of course this is true in all aspects of science, with all political groups using science and lawsuits as leverage to enact their prreferred agenda, without regard to its benefit or popularity.
It is too bad that we don't have a government controlled by a plain reading of the constitution.
Posted by: hey on March 19, 2006 05:43 PMRobert Schwartz wagers:
I will bet you that RU-486 is more dangerous than Vioxx.
Really?
Testimony of David J. Graham, MD, of the FDA, before the Senate:
... this report estimated that nearly
28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx. I emphasize to the
Committee that this is an extremely conservative estimate. FDA always claims that randomized clinical
trials provide the best data. If you apply the risk-levels seen in the 2 Merck trials, VIGOR and
APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died.
Source http://www.senate.gov/~finance/hearings/testimony/2004test/111804dgtest.pdf
30-40% of 88,000 to 139,000 gives a range of 26,400 to 55,600 deaths. Posted by: Michigander on March 19, 2006 06:55 PM
Comparing the risks of RU-486 to Vioxx can be misleading because a high percentage of the people who used the latter drug were elderly and often in suboptimal health to begin with. RU-486 is obviously not for use by the elderly, and it's a reasonable bet that the vast majority of the women who have used it are in good health.
Posted by: Peter on March 19, 2006 09:44 PMIf RU486 was used to treat any other health problem (with the exception of AIDS), it would have at least been pulled from the shelves by now.
Political correctness even affects drugs nowadays...
Posted by: Jay on March 19, 2006 10:38 PMMichigander:
"this report estimated that nearly
28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx. I emphasize to the
Committee that this is an extremely conservative estimate. FDA always claims that randomized clinical
trials provide the best data. If you apply the risk-levels seen in the 2 Merck trials, VIGOR and
APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died."
With all the waffle and weasel words (highlighted) this statement is nothing but a bunch of conjecture.
It is drivel and proves or refutes nothing.
thedaddy
Posted by: thedaddy on March 20, 2006 11:11 AMIf you look at the quote from the testimony above you will notice that there is NO DENOMINATOR. Millions of people took Vioxx, vastly more than those who have used RU-486. There is no doubt in my mind (after reading the Micromedex entry on RU-486/Mifeprestone) that the RELATIVE risk of RU-486 is much higher than that of Viox (e.g. "the use of RU-486 is commonly associated with vaginal bleeding" (duh, it's an abotifacent), "that at times can be severe and life-threatening.") -- and you only take one dose of RU-486. A drug's adverse effect profile is only useful when compared to other alternatives and the risk of NOT using the drug. For example if you had an antibiotic that killed 1/10000 people essentially instantly would you use it to treat pneumonia? Clearly not in the year 2006 because there are many, far safer, drugs with the same effect. In the 1950's however Chloramphenicol (CAM) was commonly prescribed even after it's 1/10000 risk of aplastic anemia was known because there were few alternatives. To look at this another way (i.e. to grind it into the ground) one might be willing to take a drug with a 1/100 risk of death to cure oneself of HIV or colon cancer but not for a head cold. The question then is RU-486 like CAM in 1955 or 2006 (i.e. are there better alternatives)-- or where on the common cold to fatal disease scale does an unwanted pregnancy lie?
Posted by: Blade Doc on March 20, 2006 04:18 PMVioxx is used to trean non-lethal pain, while RU-486 is used with pregnant women, so most of the above discussion is silly.
The overwhelming majority of Vioxx users were not in imminent peril. Morever, Vioxx does not address any lethal disease process. Thus, even slight rise in mortality is unacceptable.
Pregnancy, however, has mortality rate exceeding 10 per 100,000 cases. Left untreated, measurable number of pregnant women will be dead withing 12 months. By contrast, Surgical Abortion has a maternal mortality rate of about 1 per 100,000.
Assuming RU-486 has mortality rate between that of surgical abortion and pregnancy, approving RU-486 while pulling Vioxx from the market could be both rational and ethical.
Posted by: tylerh on March 20, 2006 04:54 PMMorever, Vioxx does not address any lethal disease process. Thus, even slight rise in mortality is unacceptable.
... which would mean that RU-486, which also raises mortality rates in treating a non-lethal medical issue, is also unacceptable. Particularly given that its per-capita mortality rate is twice that of surgical abortions.
It is also silly to talk about total number of deaths rather than deaths per user. More useful still would be talking about average years of life lost. A healthy 22-year-old who dies from a botched abortion loses 50-60 years of life; a sick 72-year-old who has a heart attack from Vioxx loses much less.
Posted by: Dan on March 20, 2006 07:51 PMBlade Doc wrote:
If you look at the quote from the testimony above you will notice that there is NO DENOMINATOR. Millions of people took Vioxx, vastly more than those who have used RU-486.
No argument with that. That does lead to the question of how to define dangerous? Is it relative risk? Give a definition and we can narrow it down.
Part of danger, I would contend, is prevalence.
But back to relative risk. I did a "back of the envelope" calculation based on the numbers in http://searchwarp.com/swa3121.htm and came up with an estimate of one death by sudden cardiac death due to vioxx for every 2,000 person-years of using Vioxx 25 mg/day or more. Versus the numbers in the Wash Post article, which mention seven deaths in 560,000 "medication abortions". One death per 80,000 uses.
How do you compare a medication intended to be used once to a medication intended to be used daily? In the unlikely event that someone used RU-486 monthly, their annual risk would be one death per 6,667 person years.
Posted by: Michigander on March 20, 2006 09:23 PM
Thus, even slight rise in mortality is unacceptable.
Unacceptable to whom?
Posted by: Cornelius van Vorst on March 20, 2006 10:39 PMYou mean as in "Lies, Damned Lies and Statistics"
No, but I am a compent reader of english and can with certainty state that the quote you provided is drivel, with no meaning, except what the author and you intended it to mean. Waffle words don't solidify meaning they only obfuscate.
Nice try Michagander, but you're a day late and a dollar short.
thedaddy
P.S.
2,000 'person-years' = One death per 80,000 uses is a case of Apples vs. Oranges.
What was that about studying statistics?
Posted by: thedaddy on March 21, 2006 10:13 AMobviously not a 'compent' speller s/b 'competent'
thedaddy
Posted by: thedaddy on March 21, 2006 10:17 AMThus, even slight rise in mortality is unacceptable.
You have never been or known someone who lives with chronic pain, have you? Severe cases can be debilitating and incredibly toxic to quality-of-life. A drug that can reduce the severity of that experience, especially in the case of someone who has already lived most of a normal lifespan, might be welcomed in exchange for a small risk of complications -- up to and including death.
Granted, once a risk is known, it is advisable to prescribe alternate treatments where possible; but your definition of "unacceptable" is very narrow.
Left untreated, measurable number of pregnant women will be dead withing 12 months.
Such language. Do you know who the Shakers were and why they no longer exist?
Posted by: anony-mouse on March 21, 2006 06:01 PMthedaddy
I am a compent reader of english and can with certainty state that the quote you provided is drivel, with no meaning, except what the author and you intended it to mean.That's a confession that you don't understand probabilities and statistical ranges. I'm guess that calculus would be complete drivel to you as well. The only thing you can do here is estimate. When someone who is taking Vioxx has a heart attack, there is no marker that says "Ha! This is Vioxx-induced AMI." The best tool to measure the effect of Vioxx (or any other drug) is a prospective randomized double-blind test. And that we have for Vioxx, starting with the VIGOR study. And you look at those studies and you can see the populations that took Vioxx had higher rates of cardiac events. And of death. With that information, you project it over the general population taking Vioxx.
Regarding Apples vs. Oranges; how does one compare a one-time event versus a daily event? I asked before Is it relative risk? Give a definition and we can narrow it down.
So, what is your definition of risk? How would you compare the two?
But rise above the tactic of just saying "No, you're wrong." Bring something to the table other than an angry voice and a lack of knowledge.
If you are an adult and someone wants to sell it to you and you want to put it in your body, go to it. If I want to accept the trade off to take RU-486 or vioxx or crack or meth, that's between me and my dealer. No government, no lawyers, just me and my supplier.
Let's put the FDA out of business.
Jimbo
Posted by: Jim Breed on March 23, 2006 09:58 PMNo government, no lawyers, just me and my supplier.
These are the kinds of rants that give the Badnarik-For-President! libertarians a bad name. While the proper role, scope, and implementation of the FDA are all potentially debateable, Having no regulatory disclosure and approval process whatsoever is a fast-track recipe for
(1) decimating the portion of the population that is dumb enough to ingest/insert whatever medical preparation they are given;
(2) denying many useful drugs to the portion of the population that is smart enough not to ingest/insert anything they don't have an excellent comprehension of (in terms of constituent components, side effects, potential drug/food/sunlight interactions etc.), which frankly, is most things.
Posted by: anony-mouse on March 25, 2006 04:44 AMComments are Closed.