Sunday, March 19, 2006

Women's Health Matters

There's a story in the NY Times today about two new deaths associated with RU 486, inelegantly referred to as "the abortion pill."

These have not been the first deaths associated with RU 486; two of the prior deaths were determined to be caused by Clostridium sordellii, a gnarly bacteria. The cause of the newest deaths has not yet been determined.

RU 486 is actually a combination of two drugs taken in succession, Mifeprex with misoprostol. Although they are not sure this is the cause, Planned Parenthood has made a change in how they administer the misoprostal from vaginal to oral.

Any woman who has given birth via induction or accompanied a woman giving birth this way may recognize this name, misoprostol (brand name Cytotec) or by the shortened version used in hospitals, "miso," not to be confused with the salty broth you get at Japanese restaurants with chunks of tofu and seaweed floating in it. Miso is used to soften the cervix and to induce uterine contractions. It can be used alone or in conjunction with Pitocin. Yet it has also caused uterine rupture resulting in maternal death, particularly when used with women who have had a prior c-section. It has also caused amniotic fluid embolism (AFE) which can cause serious injury or death to mother and/or child.

Here's the other thing you may not have known about miso: misoprostol is not actually FDA approved for use in labor and delivery. Misoprostol is FDA approved as a gastric ulcer medication.

This is the FDA's alert about the use of miso in labor and delivery.

Yet off label prescribing is not so uncommon. After all, isn't that how they discovered Viagra? A heart medication gave their study participants wicked wood and voila, or rather cha-ching! a revolution was born. But, unlike in the case of Viagra, Searle (maker of Cytotec, a company of Pfizer) has not applied for any patent changes for misoprostol, is under no obligation to do so and has made it clear they have no intention of doing so.

In fact, in August of 2000 Searle issued a letter to medical providers stating their awareness of the off label use of their drug and a reminder of the associated dangers with labor and delivery usage. I assume they feel just fine about reaping whatever profit this drug makes with this off label use, however. By the way, everything that I read about miso as an ulcer drug is that it sucks. It sure would be interesting to know what percentage of their sales from Cytotec are from labor and delivery usage but I'll leave the investigative sleuthing to Erin Brockovich.

What I don't need Erin to tell me is that women being induced with miso are not being informed about the off label usage and the very serious problems that can result. This has prompted a California legislator to urge for informed consent. Here's the article from the SF Chronicle following a Bay Area woman's death as a result of AFE after Cytotec.

Here is an example of one of the many lawsuits filed as a result of mother and/or child injury or death associated with use of Cytotec:

If you have ever been trying to birth an overdue baby or have accompanied a woman trying to do so, you know perfectly well that is not going to be the time for your medical provider to have a discussion about the risks involved with off label use of cytotec. More than likely you or your loved one, having carried this bowling ball around for nine months, slept a total of five minutes in the past month, suffer from indigestion, hemorrhoids and compressed internal organs. More than likely if your ob/gyn handed you a palmful of mealie worms and told you this was the fastest way to start your labor, you'd chow down. Clearly any chat about risks would need happen before you were at that point, i.e. not at the hospital.

Before we throw out the miso with the bathwater, it's helpful to remember that not only is it safe, cheap and effective for many women in the U.S., the World Health Organization has listed misoprostol as an "Essential Drug" in reducing the shockingly high maternal death rates in Africa.

Misoprostol is a prostaglandin, stimulating uterine contraction, and this is what is needed in instances of incomplete miscarriage, intrauterine death and postpartum hemorrhage. As in the U.S., it is also used to induce abortion. Check out this article for details on the importance of misoprostal in international women's health.

Misoprostol leaves us in a dilemma. When it's good, it's really good and when it's bad it doesn't get any worse. Clearly it's a drug in need of further testing, but that's not going to happen. It's manufactured by a drug company that is aware of the problem but has taken steps to insulate itself from liability, restricting their involvement to profit. Lawsuits are primarily being aimed at doctors and hospitals, because they have prescribed the drug off label. This may result in hospitals pulling this drug entirely. The FDA maintains they are powerless to do anything other than issue alerts because the use is off label.

Women are not dying because of diseases we cannot treat. They are dying because societies have yet to make the decision that their lives are worth saving.
Prof. Mahmoud Fathalla,MD, PhD, 1997

Former President of the International Federation of Gynaecology and ObstetricsProfessor of Obstetrics and Gynaecology, Assiut University, Egypt.

Sorry to end this on such a downer but jeez. I think it's true.


Ajlouny and Associates said...

Why aren't women being warned about the risks of taking this pill. That is a bad mistake. My suggestion ask alot of question on risk before you agree to any types of medication.

Professional Critic said...

This is a good suggestion. Since your firm practices medical malpractice law perhaps you can tell us something about legal developments in this area.