Missouri Politicians Abolish Professional Duties, Standards for Pharmacies

Missouri politicians just passed a law that strikes a serious blow to Communism on American soil.

The Missouri House on Tuesday voted 115-43 to approve HB 226, an amendment that [s]pecifies that no pharmacy can be required to perform, assist, recommend, refer to, or participate in any act or service resulting in an abortion and it will be immune from liability for refusing to do so.

By definition, when it comes to women of reproductive age, refusing to provide professional services to patients you deem undesirable is an inalienable right. As such, there's nothing special about politicians enacting laws to shield medical professionals from liability. These politicians are just doing [insert deity of choice]'s work. (Hear that malpractice lawyers!)

What is remarkable about Missouri's HB 226 is that it represents a quantum leap forward from the noble pursuit of playing games with your untouchable patients' trust, dignity, and health without any professional or legal liability.

This law HB 226 allows pharmacies and pharmacists to take advantage of all the benefits of having a monopoly on the sale of drugs without any requirements to abide by those pesky professional duties and standards that are usually a condition of being granted a State monopoly.

Like so:

No licensed pharmacy in this state shall be required to perform, assist, recommend, refer to, or participate in any act or service...

No duty to dispense drugs, talk to or advise patients, refer them to another pharmacist, or refrain from stealing taking a patient's prescription and refusing to return it to her.

...in connection with any drug or device that is an abortifacient, including but not limited to the RU486 drug and emergency contraception such as the Plan B drug...

No requirement to adhere to the professional standard of using science when dispensing drugs. (The medical definition of abortifacient is out, the personal definition is in.)

No duty to dispense drugs to *pregnant* patients, since most prescription medications are Category C. (Good luck with that asthma attack if you're a pregnant woman in Missouri!)

...not limited to the RU486 drug...

No requirement to stock or dispense a drug, RU-486, that cannot be legally stocked by pharmacies or dispensed by pharmacists to begin with.

No duty to provide pain meds or antibiotics to a patient who's been administered misoprostol and RU-486 by her physician, or, for that matter, to a patient who has an IUD, is already using birth control pills, or to men who are wearing tight underwear. (Hey, when you legislate science out of medicine, defining man panties as a device that is an abortifacient is perfectly valid.)

You tell me, what is more anti-communist than having the State grant a monopoly to an enterprise, remove duty and standard requirements, and then shield the entity from liability?

Here is the full text oh HB 226; read it and weep:

338.575. 1. No licensed pharmacy in this state shall be required to perform, assist, recommend, refer to, or participate in any act or service in connection with any drug or device that is an abortifacient, including but not limited to the RU486 drug and emergency contraception such as the Plan B drug.

2. No civil or criminal cause of action shall accrue against a pharmacy due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.

3. No board, commission, or other agency or instrumentality of this state shall deny, revoke, suspend, or otherwise discipline the license of a pharmacy, nor shall it impose any other condition of operation due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.

4. No pharmacy shall be denied or discriminated against in eligibility for or the receipt of any public benefit, assistance, or privilege of any kind due to a refusal to perform, assist, recommend, refer for, or participate in any act or service in accordance with subsection 1 of this section.

One last thing. I have a question for Rep. Ed Emery, Rep. Cynthia Davis, and all the other Missouri politicians who passed HB 226. Since you've removed the professional duty and standard requirements for the sale of drugs, can I haz street stand for the glorious, Capitalist selling of Plan B in your state?


(via)

Missouri Senators: RU-486 On Par With Morphine and Opium

Photo by pasotraspaso

RU-486 is the opium of the [female] people, according to Missouri politicians.

Missouri Senators in a vote of 34-0 approve a bill, designed to track the sale of controlled substances and cold medicines, that puts RU-486 in the same category as morphine, opium and pain pills.

Less than a half hour after the bill's passage, Sen. Norma Champion, who is anti-abortion rights and the bill's handler [is that like a bear handler?], asks the Senate to reconsider the bill minus any mention of mifepristone because:

Turns out [RU-486] wasn't supposed to be in the bill.

It was left in because of a clerical error. The House had originally tacked it on as amendment.

...

"There was a problem with the computer version, for one reason or another," Champion told her colleagues.

Why these Missouri politicians believe that we've all just recently fallen off a turnip truck is unclear.

First, just the fact that, at any point in crafting this bill, RU-486 was even considered for inclusion in a bill designed to track drug sales is indefensible.

Medically, there's no justification for singling out RU-486 for this degree of government intrusion. RU-486 is a safe and effective drug with no addictive potential.

Politically, the lackeys at the FDA have already taken care of regulating RU-486 based on ideology, not science.

Briefly, the FDA restricts the distribution of RU-486 because the Agency determined that post-marketing distribution restrictions on the product were necessary to ensure its safe use.

Yeah, right! To use just one example, associated deaths: Viagra 5/100,000 prescriptions; RU-486 1/100,000 prescriptions. And, unlike Viagra, RU-486 has not been shown to have contributed to any deaths.

The FDA has determined that post-marketing distribution restrictions on Viagra were not necessary to ensure its safe use.

Second, a bill with an inappropriate provision, as per the bill's handler, sails thorough and gets voted on and "oops, it was a clerical error" is deemed an acceptable excuse. Are there no controls in place to insure a bill's accuracy? What assurance do the people of Missouri have that previous bills don't contain a provision to legalize slavery, or make Satanism the official state religion? Or are we to believe that this was the one and only clerical error in the history of the Missouri Senate?

Third, and most worrisome for the people of Missouri, 34 Senators vote on a bill without bothering to read it. I don't understand how that's possible. If you're a constituent maybe you could ask each and everyone of these Senators for an explanation.

But wait, there's more!

In 'Morning after' pill restriction said to be error, an article on the debacle, Chad Livengood, reporter for the Springfield News-Leader, writes that:

RU-486, or mifepristone, is an emergency contraceptive ingested orally to prevent or delay ovulation.

Thunk, thunk goes my head as it hits the desk repeatedly.

That 34 elected officials voted to pass a bill that they hadn't even bothered to read is, perhaps, not scandalous. They are, after all, just politicians. That a reporter can't be bothered to get his facts straight is.

If your article is about the 'Morning after' pill you need to at least mention Plan B somewhere in the article. You need to also make it clear that "morning after" pill is the lay term for the post-coital emergency contraceptive Plan B. The very same Plan B that's a progestin (levonorgestrel), an emergency contraceptive ingested to prevent or delay ovulation, and, most relevant here, an OTC drug (with some politically based age restrictions).

Of course, Chad Livengood's article isn't about Plan B but rather about RU-486. The very same RU-486 that's an anti-progestin (mifepristone), an abortifacient (or an emergency contraceptive, depending on dosage and regimen) ingested to cause shedding of the uterine lining (or prevention of ovulation and endometrial shedding when used as birth control), and a drug with a federally mandated distribution restriction.

So, to recap. First, 34 Missouri Senators vote on a bill they haven't bothered to read. Then, the Senators get a do-over [you know, how you do when you're responsible for a major screw up at your job]. Finally, a Missouri newspaper can't be bothered to get the facts straight and avoid misinforming its readers.

Well done Missouri!

Vaginal vs. Oral Misoprostol

Interesting report on misoprostol regimens. I don't have access to the study on the computer I'm on, but according to the article:

In this study, Dr. Helena von Hertzen, of the Department of Reproductive Health and Research at the World Health Organization, and her colleagues studied 2,046 women who were divided into four groups that received misoprostol either vaginally at three- and 12-hour intervals, or under the tongue at three or 12-hour intervals.

Among women who took misoprostol at 12-hour intervals, pregnancy continued in 9 percent of those who took the drug orally and in 4 percent of those who took it vaginally. Among those who took the drug at three-hour intervals, pregnancy continued in 6 percent of those who took it orally and in 4 percent of those who took it vaginally.

Side effects such as nausea and vomiting were more common among women who took misoprostol under the tongue and vaginally at three-hour intervals than among those who took the drug at 12-hour intervals. Side effects such as pain, diarrhea, chills and shivering were slightly higher among women who took the drug orally.

"Administration interval can be chosen between three hours and 12 hours when misoprostol is given vaginally. If administration is [oral], the intervals between misoprostol doses need to be short, but side effects are then increased. With 12-hour intervals, vaginal route should be used, whereas with three-hour intervals either route could be chosen," the study authors concluded.

A couple of points.

1. You could use misoprostol (Cytotec) alone, but you shouldn't (for now, anyway. Once abortion is outlawed, we'll revisit the recommendation.). Adding mifepristone (RU-486, Mifeprex) to the regimen improves efficacy and reduces side effects.

Note: I'll have more on the misoprostol/mifepristone (RU-486) drug regimen in Part II of my post exposing Senator Jim DeMint (R-SC) lies in support of his amendment to regulate mifepristone (RU-486). [Part I, here.]

In the interim, and without looking it up, try to answer this question: Why do the two drugs work better together? What's more likely: A) the drugs have different actions, or B) the drugs have similar actions, and one potentiates the other?

2. Vaginal misoprostol is not part of the FDA-approved regimen. FDA approved 600 mg mifepristone (RU-486) and 400 mcg misoprostol, both administered orally.

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. http://www.fda.gov/cder/drug/infopage/mifepristone].

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.

Senator DeMint Lied, [Senate] People Authorized

Recently the Senate approved bill S. 1082: Prescription Drug User Fee Amendments of 2007, which deals mostly with post-marketing FDA drug regulation.

The bill is brimming with amendments, ranging from the sale of turtles, to the regulation of RU-486 (Mifeprex). Turtles are cute, but what interests me is the RU-486 (Mifeprex) amendment. [Quelle surprise, I know.]

The way I found out about the RU-486 (Mifeprex) amendment and its sponsor, Senator Jim DeMint (R-South Carolina), was via an email from the ACLU, which included a link to Sen. DeMint's press release announcement. I read it and realized it was full of lies.

Not understanding how lies can be the basis for legislation regulating the availability of drugs I called one of the bill's sponsors, Senator Mike Enzi, (R-Wyoming) to ask for an explanation.

Before we go on, can you spot my mistake?

I spoke with a staffer in Sen. Enzi's office. She was familiar with the bill, but not so much with Sen. DeMint's amendment. All she could tell me was that there was only one amendment with his name on it, 1018, and its title: To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies. No point in discussing the substance of a piece of legislation, when you're not even clear on what legislation it is you want to talk about. I thanked the staffer for her help, and went back to the drawing board. [Learn from my mistake: Always check your primary source/s.]

I located the full version of S. 1082: Prescription Drug User Fee Amendments of 2007. Here's the section affected by Sen. DeMint's amendment:

(3) NOTIFICATION- Not later than 30 days after the effective date of this subtitle, the Secretary shall notify the applicant for each drug described in paragraph (1)--

(A) that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; and (B) of the date, which, unless a safety issue with the drug arises, shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (7)(B) of such section 505(o).

From the Congressional Record for the Senate on May 2, 2007, Sen. Jim DeMint's amendment, S.Amdt. 1018: To amend the notification provision with respect to drugs deemed to have risk evaluation and mitigation strategies., offered May 2 2007 and agreed to in Senate by Unanimous Consent:

SA 1018. Mr. DeMINT (for himself, Mr. Inhofe, Mr. Brownback, Mr. Martinez, Mr. Vitter, and Mr. Coburn) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; as follows:

In section 214(b)(3)(B) of the bill, insert ", except with respect to the drug Mifeprex (mifepristone), such assessment shall be submitted 6 months after the applicant is so notified" before the period at the end.

According to Sen. DeMint's press release (emphasis mine):

May 2nd, 2007 - Washington, D.C. - Today, U.S. Senator Jim DeMint (R-South Carolina) applauded the unanimous approval of his amendment to 1082, the FDA Reauthorization Act, which would require the FDA to assess the Risk Evaluation and Mitigation Strategy (REMS) for RU-486 within seven months of the bill’s effective date. The amendment was accepted by voice vote, which mandates that RU-486 be subject to assessments of how well the risk management plan, including its restrictions, is working.

Sen. DeMit says his amendment would require the FDA to assess the Risk Evaluation and Mitigation Strategy (REMS) for RU-486 within seven months of the bill’s effective date.

Either I misunderstand what the original bill and the Senator's amendment say, or Sen. DeMint is, once again, lying.

Let's examine the first possibility, shall we?

The text of the original bill says that no latter than 1 month (note, 1 mo) after the bill takes effect, the FDA shall notify the drug's manufacturer of the date by which the pharma company shall submit to the FDA an assessment of the risk evaluation strategy [Risk Evaluation and Mitigation Strategy (REMS)]. This date shall be no earlier than 6 months (note, 6 mo) after the pharma company is notified that it has to submit the assessment.

1 month + 6 months = 7 months.

My understanding, made possible in great part by my most advanced mathematical skills, is that the original bill would have required the FDA to assess the REMS for a drug, like, for example, RU-486, within 7 months of the bill's effective date.

What about Sen. DeMint's amendment, the very one which causes him to burst into fits of self-congratulatory applause? Will my, by now mythical, familiarity with math help me understand the Senator's amendment? This is how the amendment changes section 214(b)(3)(B):

(3) NOTIFICATION- Not later than 30 days after the effective date of this subtitle, the Secretary shall notify the applicant for each drug described in paragraph (1)--

(A) that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; and (B) of the date, which, unless a safety issue with the drug arises, shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (7)(B) of such section 505(o), except with respect to the drug Mifeprex (mifepristone), such assessment shall be submitted 6 months after the applicant is so notified.

Applying the same analysis we did to the original bill, the text of the amended bill says that no latter than 1 month (note, 1 mo) after the bill takes effect, the FDA shall notify the drug's manufacturer of the date by which the pharma company shall submit to the FDA an assessment of the risk evaluation strategy [Risk Evaluation and Mitigation Strategy (REMS)]. With the exception of one drug, Mifeprex, the submission date shall be no earlier than 6 months/6 months (note, 6 mo) after the pharma company is notified that it has to submit the assessment.

For all drugs, except RU-486 (Mifeprex): 1 month + 6 months = 7 months.

For RU-486 (Mifeprex): 1 month + ?

As far as I can tell Sen. DeMint's amendment does the exact opposite of what the Senator claims it does. It removes the requirement that the FDA assess the REMS for RU-486 (Mifeprex) within 7 months of the bill's effective date. It's not clear how long the RU-486 (Mifeprex) manufacturer has to submit its assessment since the amendment doesn't specify. [Ah, vagueness, the very thing you want when it comes to drugs and your health.] It could be 30 minutes, or 8 days. Who knows? The drug's manufacturer, the patients, we all exist to serve at Sen. DeMint's pleasure and command.

Bottom line: Sen. DeMint lies about the need to single out RU-486 (Mifeprex) for separate, propaganda-based regulation, his amendment does the exact opposite of what he claims it does, and not a single one of his illustrious colleagues is professional enough to challenge Sen. DeMint's dereliction of duty (assuming, of course, lying has not yet become a job requirement for the hallowed halls of Congress denizens).

Next, we'll analyze Sen. DeMint's lies remarks in support of his amendment. [Here, and here.]

RU-486 Is Next

***UPDATED***and ***UPDATED AGAIN***

And so it begins...or rather, ends: An amendment to S. 1082, which would suspend FDA approval of RU-486, is being debated on the Senate floor right now.

I just came home and found the announcement in my Inbox (via ACLU). I'm too tired and cranky to watch the debate (assuming it's televised) and post something useful. Maybe later.

UPDATE: From Rachel Perrone (ACLU), a correction:

[I]t appears the amendment was narrower than I originally described. Sen. DeMint has in the past introduced amendments asking for suspension of FDA approval of RU-486, and I was hearing he was going to try it again. His introductory remarks seemed to indicate as much. But instead, he inserted language requiring the FDA to conduct a "risk evaluation and mitigation" study on RU-486. (No doubt laying the groundwork for another go at the drug down the road.) It passed by unanimous consent.

Sen. DeMint's press release is here.

Every single claim in the release is false. Once again, a piece of legislation without any basis in reality has been enacted.

Long.Live.Propaganda-Based.Medicine!

ETA:

Welcome Pharyngula readers. Here's the condensed version of the facts Sen. DeMint lied about:

-- 6 reported deaths in women using RU-486/misoprostol.

-- 1 case has been determined to be unrelated to abortion/meds, 1 case is still under investigation.

-- 4 cases where, according to the FDA, [w]e do not know whether using Mifeprex or misoprostol caused these deaths.

Of the six fatalities, three involved the rare bacterium Clostridium sordellii. In four cases, women were given part of the drug regimen vaginally, an unapproved method.

Contrast that to reported deaths involving C. sordellii infection unrelated to ETOPs: 8 cases after giving birth, 2 cases following miscarriages, and 1 death linked to infection during the woman's menstrual period.

But wait, there's more!

According to the FDA, the off label regimen used in the cases under discussion was 1 tablet of RU-486 (200 mg) orally, followed by 4 tablets of misoprostol (800 mcg) pv.

[The FDA-approved regimen is 3 tablets of RU-486 (600 mg) orally, followed by 2 tablets of misoprostol (400 mcg) orally.]

All these deaths occurred in patients who used only 1/3 of the FDA-approved RU-486 dose po, but double the misoprostol dose administered pv.

The Many Uses of Mifepristone (RU-486)

Reuters gets a mifepristone story right [almost]:

WASHINGTON (Reuters) - The chemical compound in the abortion pill RU-486 blocked formation in mice of breast tumors caused by a mutant gene blamed in many women's breast and ovarian cancers, researchers found.

The study, published on Thursday in the journal Science, suggests a potential new path to protect women genetically predisposed to these cancers by using drugs to interfere with a hormone called progesterone, the researchers said.

A team led by University of California at Irvine scientist Eva Lee found that the compound, mifepristone, prevented breast tumors by blocking progesterone in mouse breast tissue cells.

They said they found that progesterone, which is involved in the female reproductive cycle, stimulates the proliferation of breast cells carrying a gene linked to breast cancer, possibly feeding tumor growth.

Women with a mutated version of the gene, known as BRCA-1, face a much higher risk of breast and ovarian cancers. By age 70, more than half of them end up with one of the two types of cancer.

Some of these women opt to have their breasts or ovaries surgically removed to lower the risk. This study raises hope that they might have another option -- using drugs rather than surgery to guard against cancers linked to the mutated gene.

In its normal form, BRCA-1 protects against cancer, suppressing tumor formation by assisting cells to repair DNA damage that could lead to cancer-causing mutations.

In this study, the researchers focused on how mifepristone influences the way the mutated gene functions in tissue, using mice with the rodent version of the mutated gene.

TUMOR-FREE MICE

Mice given mifepristone were tumor-free by the time they were a year old, while the mice that did not get it all developed tumors by the time they were 8 months old, the researchers found.

Progesterone stimulates the development of tumors when the mutated gene is present because it accelerates cell division, but mifepristone interfered with a process needed for progesterone to spur the division of cells, the study found.

"By targeting the progesterone receptor, it's very possible that we can prevent the breast cancer, especially in the high risk BRCA-1 area," Lee said in a telephone interview.

The good news is that the article manages to (a) point out the difference between mifepristone (RU-486) and Plan B, and (b) correctly identifies Plan B as "emergency contraception" (not the "morning after pill").

The bad news is that Reuters misses a perfectly good opportunity to educate the public about mifepristone's many other uses. Identifying mifepristone as the "abortion pill" is detrimental because it masks one key fact about this drug. Mifepristone's mechanism of action differs--it can terminate a pregnancy, or it can prevent one; it can act on uterine cells, or on brain cells--based on dosage/regimen.

Some of mifepristone's uses you might be familiar with are abortion, birth control, emergency contraception, and the treatment of endometriosis and uterine myoma (fibroids). Also neuroprotection. And here are some more.