RU-486: Unsafe Regardless of Ideology

Michelle Malkin and Bill of INDC Journal have been discussing the latest FDA investigation into RU-486.  This latest public health advisory by the FDA is the result of four deaths of California of women who took RU-486 for a medical abortion.  Bill doesn't think the risk of RU-486 is that great, and that those who point it out are doing so for merely ideological purposes:

Look: pro-choice, pro-life, Democrat, Republican, I don't care what your politics are, in this respect: when it comes to shoehorning science and medicine in order to fit an ideological agenda, misrepresenting risk and utilizing hyperbole, you're doing the public debate a serious disservice, doing your readers a disservice and emulating the worst flaws of the mainstream media: combining a distorted ideological narrative with superficial analysis of complex issues.

Frankly, a superficial analysis of a complex issue if exactly what Bill is doing here.   As one who prescribes medication every day, I am well aware that there risks to every medication.  However, the analysis of such risks are far more complex than simply comparing published mortality rates for the drugs.  In comparing the mortality rate for women taking RU-486 to those taking other medications, there are a number of factors which makes such comparison a poor way to determine the relative safety of the drugs.  The fact that "only" 4 women have died from the administration of this drug is no reason to believe it is safe:

1.  The adverse reaction of the drugs that Bill compares RU-486 to (antidepressants and antibiotics) occur due to an allergic reaction to those medications.  Allergic reactions are a well known risk to the administration of any medication.  Septic shock of unknown origin presenting with atypical clinical presentation is not something that any physician would expect from a prescription medication.  This is why the FDA has required Danco to inform physicians via letters here and here, as well as emergency room administrators here. 

2.  The best theories regarding the septic shock in these women are a direct result of the mifepristone on the immune response of the patient, as seen in this recent article here by Dr. Ralph Miech in the Annuls of Pharmacology.  Here is a bit from the abstract:

        DATA SYNTHESIS: The mechanisms of action of mifepristone were incorporated into the pathophysiology of septic shock due to C. sordellii. Mifepristone, by blocking both progesterone and glucocorticoid receptors, interferes with the controlled release and functioning of cortisol and cytokines. Failure of physiologically controlled cortisol and cytokine responses results in an impaired innate immune system that results in disintegration of the body's defense system necessary to prevent the endometrial spread of C. sordellii infection. The abnormal cortisol and cytokine responses due to mifepristone coupled to the release of potent exotoxins and an endotoxin from C. sordellii are the major contributors to the rapid development of lethal septic shock.

        CONCLUSIONS: Theoretically, it appears that the mechanisms of mifepristone action favor the development of infection that leads to septic shock and intensifies the actions of multiple inflammatory cytokines, resulting in fulminant, lethal septic shock.

      

3.  Antibiotics and antidepressants are used to treat pathological conditions.  In choosing to prescribe a medication, one always has to weigh the risks of prescribing vs the therapeutic effect in treating such pathology.

At last I checked, pregnancy is not a pathology.  A pregnant woman has no "disease" that needs to be treated. A medical abortion is always elective.  For that reason a drug which is used to facilitate an elective procure and one that is not necessary to save the life of a patient needs to have a higher level of safety than others.

4.  The patient population that RU-486 is given are healthy, young women.  They should be expected to have a lower rate of adverse effects than the typical patient who is given antibiotics or antidepressants.

5.  One thing that seems to have been missed is that these very complications were predicted almost two years ago by pro-life groups including the Christian Medical and Dental Association (of which I am a member).  This is from their response to Danco regarding the citizen's petition to have RU-486 removed from the market.  They accurately predict the presentation of these lethal infections:

The scenario presented in fn92 is similar to the presentation of the other women who have died from this infection:

The bottom line: RU 486 is a medication used for an elective procedure pushed through using an accelerated FDA protocol that has resulted in the deaths of at least five women.  The dangers have been pointed out by concerned pro-life groups and have been essentially ignored as ideological propaganda while Danco and the FDA continue to change the labaling and warn physicians of potential adverse effects.  Regardless of where you stand on the issue of abortion, this is very concerning. 

Update: Outside the Beltway adds a very naive comment regarding RU-486 safety:

That is fine and good, but right now there is zero evidence to suspect that this drug is any less safe than amoxicillin that Michelle Malkin has been giving to her children.¹

A naive and ridiculous comment.  RU-486 is never taken outside of a physicians office.  You can not get it at a pharmacy.  We don't place these heavy restrictions on drugs that are safer than amoxicillin.  Amoxicillin is in no way more "statistically risky" than RU-486.