Monday, May 14, 2007

Senator DeMint Lied, [Senate] People Authorized, Part I ½

Senator Jim DeMint (R-SC) went to Washington and lied. Here are his remarks in support of his amendment to S. 1082: Prescription Drug User Fee Amendments of 2007, exposed.

Because there are so many lies, I've divided the material into two posts. Fair warning: despite my efforts to liven things up, it's a long, dry read. There's just nothing entertaining about politicians who oppose women's healthcare and who'd resort to lying, cheating, and dereliction of duty just to insure that their ideology triumphs over reality.

The first part of Sen. DeMint's remarks:

Mr. President, my amendment calls for the Food and Drug Administration to conduct an assessment of the risk evaluation and mitigation strategy, which we refer to as REMS, for Mifeprex, commonly known as RU-486, within 7 months of the effective date of this legislation.

According to the legislation before us, any drug that is currently on the market with restrictions on its distribution or use, which includes RU-486, would be required to have a risk evaluation and mitigation strategy. This means that RU-486 would be subject to periodic assessment of how well the risk management plan, including its restrictions, is working. Unfortunately, the bill does not establish a deadline for the risk evaluation for RU-486.

As I mentioned here, I don't think the amendment does what the Senator thinks (or at least says) it does. [Don't miss the comments for an alternate interpretation.]

The current RU-486 abortion regimen was approved by the Food and Drug Administration in September of 2000. Since that time, the regimen has been linked to the deaths of seven women, including three Americans. The public has learned since November of 2004, through the release of documents by the FDA through a Freedom of Information Act request, that over 1,000 additional women have experienced adverse effects from the RU-486 regimen, including 9 life-threatening incidences, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. It should be noted this dangerous drug is attacking young, healthy women.

(emphasis mine)

Senator DeMint, the representative of the people of South Carolina is lying on the [Congressional] record.

First, the Senator makes up things, and lies about them.

The current RU-486 abortion regimen [600 mg RU-486 and 400 mcg misoprostol po], approved by the Food and Drug Administration in September of 2000, has NOT been linked with any of the deaths, ever. The women did not use this regimen, but rather a 200 mg RU-486 po and 800 mcg misoprostol pv one. That's 1/3 RU-486 and x2 misoprostol of the FDA-approved dose.

Next, the Senator lies about what actually happened.

The RU-486/misoprostol medical abortion regimen has NOT been linked to the deaths of seven women. The regimen has not been linked with any of the deaths (emphasis mine):

Recently, a total of five fatal cases of septicemia during medical abortion have been reported from North America out of an estimated 450,000 cases of medical abortion carried out since approval in 2000 [169], [170], [171]. In all four cases, as well as in a fifth death in Canada in 2002, a septicemia with the bacteria Clostridium sordellii was the cause of death [171]. No explanation for these fatal events has been found. So far, no causation between septic shock and mifepristone and misoprostol has been shown. Death with the same bacteria have been reported following spontaneous abortion as well as postpartum [172]. Clostridium sordellii is sensitive to common antibiotics such as metronidazole. No such case has been reported from Europe with an estimated number of patients treated with medical abortion of more than 1.5 million for more than 15 years.

Recently, another two death cases were reported in association with medical abortion [173]. However, one of these cases has later been confirmed to be unrelated to medical abortion and the one case is still under investigation at the time of submission of this paper [FDA, Mifeprex (mifepristone) Information April 10, 2006 Update.].

Bottom line: Seven total cases reported; one confirmed to be unrelated to medical abortion, one still under investigation. Of the remaining five, none has been linked to the use of the RU-486/misoprostol regimen. [For a more detailed discussion of the cases--the deaths were due to endometritis and toxic shock syndrome--and autopsy reports, read this.]

Then, the Senator tries to pass off propaganda as medical information. [Budding ideologues, take notes.] Over 1,000 women maimed specifically by this most dangerous drug regimen--life threatened, hospitalized, transfused, infected. Good thing that elective abortion, just like any other medical procedure, or, for that matter, spontaneous abortion, isn't associated with any risks whatsoever. And good thing we have Freedom of Information requests, the cornerstone of scientific study, to allow us access to data.

Seriously now, part of Sen. DeMint's propaganda cames from a Dr. Harrison, an Ob/Gyn associated with a group called American Association of "Prolife" Obstetricians and Gynecologists (my quotes). [In the spirit of my total bias in favor of Ob/Gyns--smartest, bestest, beautifulest, and all that--I'd like to point out that Ob/Gyns who put propaganda before patients are the rare exception.]

The propaganda effort in question looked at the 607 mifepristone adverse events (AERs)--obtained via a Freedom of Information Act--reported to the FDA for the period from September 2000, to September 2004. [There's no mention of the number of abortions performed during that period, or, for that matter, the regimen/s used.]

The most frequent AERs were hemorrhage (n = 237) [68 transfusion] and infection (66); there were also 17 ectopic pregnancies. Since the work is not a scientific paper, the discussion and conclusion are opinion editorials. [Briefly, it is not appropriate to calculate statistics with use of adverse event reporting. These data provide a method only to detect signals and have never been intended to assess the frequency of a specific event because the exact denominator is unknown.]

Now, let's leave propaganda behind and look at an actual study. A study of safety of mifepristone abortion in routine clinical use based on 95,163 mifepristone abortions over 3 years (2001 to first quarter of 2004) found that 206 women experienced a complication for which hospital treatment was sought, bleeding 171 (52 transfusion), infection 19 (1 death). The study concludes (emphasis mine):

The data reported here provide evidence, based on routine clinical use from 2001 to 2004, supporting mifepristone as a safe and effective method of early pregnancy termination. Abortions counted for this study are from a centralized reporting system that collects affiliates' reports of the number of medication abortions provided each quarter based on billing records and procedure logs. The ability to calculate safety estimates from an actual count of the number of mifepristone abortions provided rather than from an estimate is a major strength of this analysis.


Our study allows us to describe the occurrence of serious medical complications associated with mifepristone abortion in routine clinical use. The findings are consistent with reports in the literature. Reported rates of ongoing pregnancy have varied from 0.2% to 1% [3], [4], [9], [10], [11], and transfusion rates have been low from 0% to 0.2% [1], [6], [9], [11], [15]. In American studies, the rate of infection requiring antibiotic treatment has been well below 1% [3], [6], [9], [10], [11], [17], [18]. In the United States, two deaths attributed to mifepristone use have been documented, including the death reported in this study. The other death occurred outside the PPFA network and was due to a ruptured ectopic pregnancy [15]. An additional non-PPFA American death due to septic shock is currently being investigated. As previously reported, death from septic shock occurred during a clinical trial in Canada [19], [20]. While serious complications are exceedingly rare, clinicians should keep in mind that systemic infection is possible with medication abortion, as it is with other forms of abortion and in childbirth.

Bottom line: Rates of ongoing pregnancy have varied from 0.2% to 1%, transfusion rates have been low from 0% to 0.2%, rate of infection requiring antibiotic treatment has been well below 1%....The efficacy and safety of this treatment have been confirmed on the basis of more than 14 years of use with close adherence to the approved recommendations.

Last, but not least, the Senator notes that this dangerous drug is attacking young, healthy women [my link]. Um, which drug? Since the Senator's remarks up to this point have been (or, at least, have pretended to be) about the RU-486/misoprostol regimen, a two-drug regimen, which drug are we talking about, mifepristone or misoprostol? Also, calling a drug that has been proven to be safe dangerous is a lie.

Next, we analyze the rest of Sen. DeMint's remarks, and continue to expose his lies.

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