NationStates Jolt Archive

COMMENTARY: As with any new drug, this one should have been handled with great care. It was not, and women died as a result. Now there's even a bill in Congress to force the FDA to withdraw approval of the drug.


After 2 More Deaths, Planned Parenthood Alters Method for Abortion Pill (http://www.nytimes.com/2006/03/18/national/18abort.html?th&emc=th)


By GARDINER HARRIS
Published: March 18, 2006
WASHINGTON, March 17 — After receiving reports that two more women died after taking abortion pills, Planned Parenthood, the nation's largest provider of abortion and contraceptive services, announced that it would immediately change the way it gives the medicines.

The change partly resolves a long-running dispute between Planned Parenthood and the Food and Drug Administration over the safest way to provide pill-based abortions.

The F.D.A. has now received reports that six women in the United States died after taking RU-486, or Mifeprex. A seventh died in Canada. The two most recent deaths and two of the previous four underwent their procedures at Planned Parenthood clinics, a spokeswoman said.

Federal officials do not yet know the cause of the latest two deaths. The previous four resulted from systemic infections with a virulent bacteria, Clostridium sordellii. Planned Parenthood announced in a statement that one of the two recent deaths occurred within days of the victim's undergoing a pill-based abortion, while the other woman died within five weeks.

Mifeprex has been used in more than 560,000 medical abortions in the United States and more than 1.5 million in Europe. The risks of death from infection after using the pill are similar to the risks after surgical abortions or childbirth, drug agency officials said.

When Mifeprex was first approved by the agency in 2000, the standard regimen was to give the drug in a doctor's office followed two days later by an oral dose of a different drug, misoprostol, also in a doctor's office. Women expelled the fetus over the following days or weeks in a process that mimicked a miscarriage. The procedure must begin within 49 days of conception.

Soon after Mifeprex's approval, most Planned Parenthood doctors switched to a different regimen, instructing women to insert misoprostol vaginally at home two to three days after taking Mifeprex. Studies of the new regimen showed that it was effective, and it allowed women to take lower doses of misoprostol. It also meant fewer office visits for Planned Parenthood.

But this regimen was not approved by the drug agency. It is not unusual for doctors to use drugs differently from how they are officially approved. But as reports of deaths among women undergoing the procedure trickled into the F.D.A., government officials issued stern warnings that doctors should stick to the approved regimen.

Until Friday, Planned Parenthood had rejected those warnings.

Dr. Vanessa Cullins, vice president of medical affairs for Planned Parenthood, said in an interview that effective immediately the group would ask patients to take misoprostol orally instead of vaginally. Although the F.D.A. has asked that this be done in doctors' offices, a Planned Parenthood spokeswoman said patients would still be asked to take the second drug at home.

"There is no single reason for the change" in policy by the group, Dr. Cullins said.

"We don't really know all the circumstances surrounding these women's deaths," she said.

Whether the method of drug administration has anything to do with the deaths is not known. The drug agency said it was "investigating all the circumstances associated with these cases." The agency has already added strong warnings to Mifeprex's label regarding the risks of infection.

On Friday, the agency repeated warnings that women who undergo pill-based abortions should be vigilant for signs of trouble. If they suffer from nausea, vomiting or diarrhea and weakness with or without abdominal pain more than a day after taking abortion medicines they should be given antibiotics.

Clostridium sordellii infections are rare and can be difficult to diagnose because they are not always accompanied by fever.

Since reporting drug side effects is voluntary in the United States, it is possible that more women have died and that their deaths have gone unreported because doctors, medical examiners and coroners are not obligated to forward such reports to the F.D.A. Doctors and local officials also may not associate a death with a pill-based abortion, especially if the death occurs weeks later.

The risk of infections could be lowered or eliminated if abortion patients were given antibiotics as a preventative. But antibiotic therapy has its own risks, and officials say that the risk of infection from Clostridium sordellii is so slight that it does not merit such a precaution.

The government has scheduled a scientific conference on May 11 at the Centers for Disease Control and Prevention to discuss Clostridium sordellii and a related bacteria, Clostridium difficile, that has caused outbreaks of diarrhea and colitis in hospitals and nursing homes.

Both bacteria generally live in the soil and human intestinal tracts. Both thrive in environments with limited oxygen. When these bacteria infect the bloodstream, they can produce a toxin that causes something akin to toxic shock syndrome.

Senators Jim DeMint, Republican of South Carolina, and Tom Coburn, Republican of Oklahoma, released a statement Friday calling for the withdrawal of Mifeprex. They have sponsored a bill that would force the F.D.A. to withdraw the drug.

Monty Patterson, whose 18-year-old daughter, Holly, died on Sept. 17, 2003, from a Clostridium sordellii infection after a medical abortion, has since argued that Mifeprex predisposes women to such infections by suppressing their immune systems.

"How many women have to die needlessly before this drug is removed from the market?" Mr. Patterson asked.

6 in 560,000.

This is only news because of the villainization of abortion. They are trying to get rid of it by starting at the bottom with a controversial pill and highlighting deaths caused by it, then work their way up.

6 in 560,000 ... about 1 in 100,000

If this was some standard drug, it'd be left alone.
Since it's an abortion drug, it gets targetted.
It'd help if people followed proper procedures in the first place.

6 in 560,000 ... about 1 in 100,000

If this was some standard drug, it'd be left alone.
Since it's an abortion drug, it gets targetted.

I'd like to see if there is any proof of that (IE how many people does a drug have to harm before it gets removed)

Mifeprex has been used in more than 560,000 medical abortions in the United States and more than 1.5 million in Europe. The risks of death from infection after using the pill are similar to the risks after surgical abortions or childbirth, drug agency officials said.

Hmm, I wonder when they'll ban childbirth.

I'd like to see if there is any proof of that (IE how many people does a drug have to harm before it gets removed)

640 deaths caused by Viagra since September 2001 (officially).
Not banned yet!

http://www.globalchange.com/viagranews2.htm

640 deaths caused by Viagra since September 2001 (officially).
Not banned yet!

http://www.globalchange.com/viagranews2.htm

Isn't the diffrence though here is that Viagra is not perscribed, but that the drug described here is.

Isn't the diffrence though here is that Viagra is not perscribed, but that the drug described here is.
viagra isnt over the counter.

viagra isnt over the counter.

You can get it over the counter if you take enough.

*leaves thread in shame*

Isn't the diffrence though here is that Viagra is not perscribed, but that the drug described here is.
Viagra is a prescribed drug. As the above posters noted, 1 in 100,000 isn't a tremendous death rate for a prescription drug. The reporter didn't note that--maybe it didn't occur to him--but I'm certainly not surprised that abortion foes are blowing it well out of proportion.

As well as the fact that Viagra is covered by most insurance, but not only is this pill not covered, no abortion is, nor is birth control usually. Screw this patriarchal crap. Screw the meddlers that think only a man's sxx life is sacred. Screw the anti-choice meddlers who think they have a right to interfere with a woman's medical decisions.

As well as the fact that Viagra is covered by most insurance, but not only is this pill not covered, no abortion is, nor is birth control usually. Screw this patriarchal crap. Screw the meddlers that think only a man's sxx life is sacred. Screw the anti-choice meddlers who think they have a right to interfere with a woman's medical decisions.

Don't know much about how insurance works in the USA (apart making lots of $$$ for those involved), but they sure have a lot of say about drugs and medical system.

640 deaths caused by Viagra since September 2001 (officially).
Not banned yet!

http://www.globalchange.com/viagranews2.htm
Viagra is a self-administered drug and is prescribed by many doctors as a matter of course. If a doctor isn't aware that a man is on blood-thinners such as treatments for high blood pressure, there is a greatly increased liklihood that taking Viagra will cause serious problems, up to and including death.

This drug in the article is not self-administered but must be given under a doctor's care. Big difference.

Don't know much about how insurance works in the USA (apart making lots of $$$ for those involved), but they sure have a lot of say about drugs and medical system.
So do drug companies and even moreso pharmacies.

As well as the fact that Viagra is covered by most insurance, but not only is this pill not covered, no abortion is, nor is birth control usually. Screw this patriarchal crap. Screw the meddlers that think only a man's sxx life is sacred. Screw the anti-choice meddlers who think they have a right to interfere with a woman's medical decisions.
Calm down, hon, before you break something.

Last time I checked, women were in the majority in America. Perhaps you're barking up the wrong tree.

Last time I checked, women were in the majority in America.

In government and positions of power? Are you really going to be this specious?

Viagra is a self-administered drug and is prescribed by many doctors as a matter of course. If a doctor isn't aware that a man is on blood-thinners such as treatments for high blood pressure, there is a greatly increased liklihood that taking Viagra will cause serious problems, up to and including death.

This drug in the article is not self-administered but must be given under a doctor's care. Big difference.

True, but given the nature of an abortions - the death rate is low.
In comparison, Viagra does have relatively high death rate for what it does.

I think in Australia, Viagra is by prescription only.

In government and positions of power? Are you really going to be this specious?
If I recall correctly, women still have the right to vote in America. What part of "a majority of the voting age population" do you not understand?

If I recall correctly, women still have the right to vote in America. What part of "a majority of the voting age population" do you not understand?
Which means squat really. I take it you know this isn't a direct democracy.

Which means squat really. I take it you know this isn't a direct democracy.
Why does it mean "squat?" Don't you believe that women having the right to vote is important?

True, but given the nature of an abortions - the death rate is low.
In comparison, Viagra does have relatively high death rate for what it does.

I think in Australia, Viagra is by prescription only.
As it is in the US, but unless the prescribing physician knows that the individual is, for example, on blood thinners, he will most likely prescribe Viagra if the patient requests it.

the religious right would LOVE to use this as an excuse to ban ru486.

if the planned parenthoods practice is faulty, they can be barred from using it or be fined or have the doctors censured or something. there is no need to ban a drug that it no more dangerous than the procedures it replaces.

but

the religious right HATES ru486. it lets a woman get an abortion without having to face people on the street screaming at her for being a baby killer. it can be done in the office of any ob-gyn without the prolife forces finding out and sending the doctors threatening letters. they just cant use their usual hateful tactics to pressure people out of getting or performing abortions.

Why does it mean "squat?" Don't you believe that women having the right to vote is important?

I believe you are missing the point of "patriachy" as a concept.

Eutrusca... nahh, forget it; you ain't worth it.