Wednesday, May 10, 2006

Uninformed Opinions Are A Dime A Dozen

Reuters reports that U.S. health officials ... will hold an open meeting on Thursday to discuss rare bacterial infections in women who took [Mifeprex/RU-486].

We already knew that:

Six women who took the pill have died since the controversial drug was approved five years ago, although the Food and Drug Administration has not attributed their deaths to the drug.


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. Another death was not related, the FDA concluded, and the remaining case is under review.

Unfortunately, based on past performance, we also could've predicted that Reuters [as well as AP, for that matter--All four California women inserted the second drug into the vagina, a method of use not endorsed by the FDA, which urges that it be swallowed instead.] will report the RU-486 (Mifeprex)/misoprostol drug regimen wrong. The women were given BOTH an off-label dosage of both RU-486 [1/3 of the regular dose] and misoprostol [double the regular dose], and an off-label route of administration was used for one of the drugs (misoprostol, vaginally).

Also we're all aware that politicians are incompetent, often malevolent, morons [can you guess what I really think of our beloved leaders?]

Dozens of U.S. lawmakers, mostly Republican, back legislation calling for the withdrawal of the drug, also known as mifepristone or RU-486.

And here's some information we might not all be familiar with:

U.S. health officials will also ask a panel of mostly outside experts to review related infections in tissue graft patients and outbreaks of Clostridium difficile bacteria infections in several states.


Eight fatal cases of Clostridium sordellii infection in women who had just given birth have also been reported in medical literature. The CDC also said last month it had discovered reports of two fatal cases of the same infection in women who had miscarriages in their second trimester.

And, from AP:

The risk posed by C. sordellii remains murky. In studies and letters published in the New England Journal of Medicine in December and April, researchers detail eight other women who died of C. sordellii infection after giving birth, vaginally or by Caesarean section. Also counted are two additional deaths following miscarriages and a final death linked to infection during the woman's menstrual period.


The abortion pill might suppress the immune system, which would increase susceptibility to bacteria already present in the vaginal canal, according to a study published last year by Dr. Ralph Miech of Brown University.

However, pregnancy naturally suppresses the immune system, too. Dilation of the cervix, whether because of abortion, childbirth or miscarriage, also may let bacteria penetrate deeper into the body, Miech and others have proposed.

Various species of Clostridium bacteria are found naturally in the vaginas of an estimated 4 percent to 10 percent of all women. C. sordellii in particular accounts for perhaps just 1 percent of those bacteria, meaning that roughly one in 1,000 women may harbor the bug. [Dr. Beverly] Winikoff said some doctors speculate that the presence of placental or fetal tissue in the vagina following childbirth, miscarriage or abortion could provide the medium the bug requires to flourish.

"It's a vulnerability of the female genital tract. What unleashes it, we don't know. Who's at risk? We also don't know," Winikoff said.

But one thing that remains a mystery for all of us [well, possibly, mostly for me], is the insistence of reporters to get quotes from uninformed people.

The National Right to Life Committee said there is enough research to show Mifeprex is too risky. "The most responsible thing to do would be to pull this drug off the market," said Randall O'Bannon, education director of the group.

Either Mr. O'Bannon is not familiar with the available research, or he is, but he chooses to misrepresent it. Just because one holds an opinion and/or belief is not enough to merit a quote. At a minimum, one needs to be familiar with the topic in order to have something useful to add to the discussion. So the question remains: When it comes to health reporting, what is the value of uninformed opinion?


At 2:26 PM, Blogger David Toub said...

The fact is that this infection is also seen with vaginal delivery. Why it is seen in association with vaginal use of misoprostol remains a mystery. Vaginal misoprostol had also been used very successfully in conjunction with methotrexate for medical abortion before the approval of mifepristone, and I'm not aware of any increase in these infections with the methotrexate regimen. Yes, there is a possibility that mifepristone could be affecting the immune system. But methotrexate definitely affects the immune system, as a systemic chemotherapeutic agent.

At 2:57 PM, Anonymous Anonymous said...

And yet STILL no debate on whether to withdraw Viagra from the market, which has directly caused far more deaths in men.

128 Verified deaths in the first 7.5 months of Viagra's availability, according to the Annals of Pharmacotherapy, Vol. 35, no. 3, 2001. That was five years ago. How many more have been shown to have caused death in men, but not a peep about withdrawing it from the market.

At 8:48 AM, Anonymous Anonymous said...

And what about D & C performed under a general anaesthetic - if you're going to withdraw the mifepristone from the market, that will be the alternative - how many dies or are maimed by that procedure?

This whole discussion looks like politicians are wanting the FDA to do the dirty work the voters won't allow the politicians to do.

And that's disgusting.


Post a Comment

<< Home