FDA's Role in Blocking 'Morning-After' Pill Cited

[brooklynite]

WASHINGTON — The last two appointees to head the FDA were closely involved in decisions to overrule the agency's medical reviewers and block the "morning-after" birth control pill from being sold without a prescription, according to court transcripts to be released today.

Last year, Lester M. Crawford personally took the decision away from his top subordinates, according to depositions of two senior Food and Drug Administration officials. And at an earlier stage in the process, his immediate predecessor as FDA commissioner, Mark B. McClellan, raised objections that formed the basis for overruling medical reviewers.

The transcripts provide the most detailed look yet at an internal review that some critics say has been tainted by politics. The dispute over the drug, marketed as Plan B, has pitted Christian conservatives against liberal women's groups and raised concerns in academic circles that the FDA had compromised its scientific principles.

The depositions were released by the Center for Reproductive Rights, a New York-based advocacy group that has filed suit against the FDA for delaying the decision on Plan B. It seeks to force the agency to approve over-the-counter sales. Similar lawsuits have been dismissed in the past, but a federal judge in New York has allowed this one to proceed.

http://www.latimes.com/news/nationworld/nation/la-na-fda25may25,1,1105211.story?coll=la-headlines-nation&track=crosspromo

[rodeodance]

1. good for the judge. This case is so blantant!-poliical appointees making

medical decisions!

..It seeks to force the agency to approve over-the-counter sales. Similar lawsuits have been dismissed in the past, but a federal judge in New York has allowed this one to proceed.

[rodeodance]

2. Kick and nominate.

[rodeodance]

3. and the FDA will soon rule on the cervical cancer vaccine.

.....http://www.nytimes.com/2006/05/23/health/23comm.html?_r...

"Someone please help me with my daughter!" the middle-aged woman announced in the waiting room of our clinic. "She's in the back of the car and I can't carry her."
Skip to next paragraph
Leigh Wells

I followed the woman to her car. Her daughter, in her late 20's, lay huddled under a blanket in the back seat. Her face was ashen and her body cadaveric, and when I picked her up, she stared at me with hollow, dull eyes as her bones rubbed against my arms. Her mother told me that she'd brought her daughter back on a plane from New York City, where she'd been a ballerina. I had never seen an adult patient so thin, so emaciated.

My patient said she had pain in her abdomen and pelvis, and when I did a pelvic exam, I did not know what I was feeling. I only knew it was very bad.

That was almost 30 years ago, and I was feeling the contours of a cauliflowerlike mass, a so-called fungating carcinoma of the cervix, a cancer every bit as bad as it sounds. It caused my young patient's death several weeks later.

[noonwitch]

4. I still don't think it should be sold over the counter

I'm not looking at this from a political standpoint about whether abortion should be legal or not. I really don't think a woman should take it without a doctor prescribing it. I know girls in college who took it after having unprotected sex. The Health Center would only give you one time-after one mistake, they expected you to use contraception or abstain. The girls who took it were sick for a few days-throwing up, laying in bed, like a bad case of the flu. A doctor needs to screen women for risk factors-it's probably not a good thing for someone who has problems with blood clotting to take it, for example.

[Doctor Venmkan]

5. Exactly!

[Lance_Boyle]

6. The safety profile of the drug

is considered *long* before anyone ever suggests making it available OTC. And they do actual clinical trials to establish that safety profile. Silly FDA - weighing clinical trial data over anecdotal evidence about the girls you knew in college!

[noonwitch]

8. Clinical data can be manipulated to produce the results someone wants

especially when profits are on the line. There is a huge profit potential from making this drug OTC.

I assume drug companies want to make profits far more than they care about women's health. I don't trust the FDA any more than I trust the drug companies.

[NorthernSpy]

34. ... which is why anecdotes are your preferred form of evidence, apparently

:eyes:

I assume drug companies want to make profits far more than they care about women's health. I don't trust the FDA any more than I trust the drug companies.

You don't trust the FDA -- but you want them to have the power to prevent me from obtaining emergency contraception -- which this same agency has already approved as safe and effective -- if I can't afford a doctor's visit?

Maybe I should assume that you and the FDA want to make RULES far more than you care about women's health...

[pooja]

9. i totally disagree

There are many doctors that won't prescribe it to rape victims... Think of rural areas and very sensitive communities. This pill is not about abortion. getthepill.com/faq.php Here is a web site that you can order this e.c. from. And actually every woman ought to have at least one dose in case of emergencies, etc. This is not abortion... this is preventing the conception all together... flushing out the mess...

[rodeodance]

11. With good screening this drug is safe. And, the clinic at our Univ. does

a follow up call.

[noonwitch]

12. That is exactly the point I was making-doctors need to make the decision

It can't be safe for everyone to use. Some women will ignore the risks. A doctor won't let them.

[pooja]

15. There are diff emergency contraceptive

The older contraceptive is marked by nausea and vomiting and is more disruptive. The newer model is the Plan B. It is less likely to induce any of these problems. In fact the FDA has approved this as safe over the counter medicine. The only reason it has not been put on the shelf is because of the Bush right-wing agenda. The audacity of 14 yr olds being able to buy this like vitamins... Believe it our not Glamour magazine keyed me into the controversies with this subject. The Dr. featured in the article explained how religion was playing into science. Also iteresting is the research regarding the HPV virus which causes cervical cancer. This innovation was sat on by the FDA, in her opinion, for much too long because if there was a way to stop HPV then children would start having sex (only virus that is not proven to be prevented by condoms--the only virus to stop education of children in sex). Like the Dr. says why would an agency sit on a break thru that could stop HPV from causing cervical cancer.... should sex be a death sentence for a young woman that is not married...wake up people... pesticides are more harmful than Plan B.

[noonwitch]

26. I personally don't believe them when they say the pill is safe

I don't think that it is good for a woman's body to mess around with her hormonal levels using artifical hormones. Isn't that what "emergency contraceptives" are?

I'm not a religious conservative, but if I was a parent, I would be concerned about a 14 year old using plan b without either a parent's or a doctor's knowledge.

I am a feminist, however, and all of this chemical birth control and emergency contraception really comes down to men's irresponsibility and unwillingness to use the safest, easiest to obtain method of contraception, which also prevents most disease transmission if used properly. If men didn't think using a condom was such a bad thing, we wouldn't need all this other crap. Does using condoms cause problems with blood clotting in either partner? Does using them contribute to a woman getting cancer later in life?

Of course, some women are no better. They let men talk them into either unprotected sex or using the pill instead of condoms because the women think having sex is more important than their own health and safety. They think they are sexually liberated, but they are not, or else they'd be able to walk away from sex if the risk was too high.

The HPV vaccine is a separate issue. It should be available, but it shouldn't be mandatory for school attendance, like a measles shot is. After all, you don't get HPV from breathing someone else's air. The vaccine can be discussed in health or biology class when discussing diseases and their effects.

Condoms can prevent HPV, too, for what it's worth, although it's a good thing that there is a vaccine.

[Mandate My Ass]

32. condoms are not effective against HPV

More disinformation. More prudish judgmentalism.

[pooja]

16. There are diff emergency contraceptive

The older contraceptive is marked by nausea and vomiting and is more disruptive. The newer model is the Plan B. It is less likely to induce any of these problems. In fact the FDA has approved this as safe over the counter medicine. The only reason it has not been put on the shelf is because of the Bush right-wing agenda. The audacity of 14 yr olds being able to buy this like vitamins... Believe it our not Glamour magazine keyed me into the controversies with this subject. The Dr. featured in the article explained how religion was playing into science. Also iteresting is the research regarding the HPV virus which causes cervical cancer. This innovation was sat on by the FDA, in her opinion, for much too long because if there was a way to stop HPV then children would start having sex (only virus that is not proven to be prevented by condoms--the only virus to stop education of children in sex). Like the Dr. says why would an agency sit on a break thru that could stop HPV from causing cervical cancer.... should sex be a death sentence for a young woman that is not married...wake up people... pesticides are more harmful than Plan B.

[Beaverhausen]

17. You must be aware of all the pharmacists who refuse to fill the scrips

Women getting pregnant and having to have an abortion - is that preferable to you?

Emergency contraception is just that - something that is needed in an emergency.

And the FDA medical team decided that it is indeed safe. That is the point here. It is the politicians who are deciding not to make it legal.

[Lisa0825]

18. Are you confusing Emergency Contraception with the abortion pill?

They are two totally different things. I have taken EC before, and had ZERO side effects, other than a slightly heavier than usual period that month. From what I know of it, I don't think the potential complications are any bigger than with normal birth control pills. The abortion pill RU486, on the other hand, can cause heavy cramping and has some potentially serious side effects. EC should have nothing to do with clotting. It does not cause anything to come out (like an abortion). The heavier period is just an effect of the higher hormone levels compared to standard pills.

I know several other women who have taken EC at some point, and NONE have ever had any side effects.

[ehrnst]

20. Much more dangerous drugs are on the shelves.

Diet pills, couch syrups, cold medications - all of which are available to kids in unlimited amounts and can harm them. Not that I'm supporting that - it just points out that EC has been besmirched so much by opponents, that reasonable folks like yourself don't even know that it has been.

And it is up to scientists to determine if the drug should be available - not off the shelf - but from the hands of a pharmacist who will advise them.

And they said that was acceptable. It was the politicos that said it wasn't.

And I think that the risks from abortion, surgical or medical, outweigh the risks of taking EC.

[nodehopper]

27. get your facts right, please

Plan B is a different kind of morning-after pill. It causes no nausea or vomiting because it has no estrogen. You are thinking of the earlier generation of emergency contraception. Blood clotting makes ESTROGEN risky (which is why women with high blood pressure are proscribed POPs, a.k.a. progesteron-only pills, which are not risky for blood pressure). Plan B has ONLY progesterone, it is very safe, hence the lobbying to approve it for over-the-counter sales. The only reason to prevent its sales is "moral" issues.

[Mandate My Ass]

30. I took it and I can't even tolerate regular BCPs

I had a few hours of mild nausea. This is not dangerous. Here we go again with the fearmongering and false information. :eyes:

[NorthernSpy]

33. Uninsured people CAN'T 'just go to the doctor for a prescription'!

I really don't think a woman should take it without a doctor prescribing it.

Do YOU plan to pay for all these doctor's vi$its that you want to force on other women who need emergency contraception? If not, maybe you should think twice before imposing such a burden (its being supposedly 'for our own good' notwithstanding).

A doctor needs to screen women for risk factors-it's probably not a good thing for someone who has problems with blood clotting to take it, for example.

If you see a benefit to seeking a doctor's advice, then please feel free to do just that. But some of us don't have that option. An uninsured person must pay the highest prices for things like doctor's visits -- and that's assuming that you can get time off from work for an appointment within the brief time period in which emergency contraception must be taken to be effective.

Insisting on prescription-only status for safe, beneficial medications has the effect of reserving these things for the affluent and the insured, while placing an unreasonable added burden on those less-affluent and uninsured who could benefit from them.

This is regulation that takes into account only the interests of medical 'haves', while ignoring the interests of medical have-nots.

[Doctor_J]

7. Welcome to Fundyland

every branch of the government is now run buy loonies imposing their version of morality on what used to be a nation where civil rights were sacrosanct

[rodeodance]

10. this De. Crawford is the one holding up things at the FDA

..Because of the controversy over Plan B, prominent Democratic senators are blocking confirmation of the FDA's current acting commissioner, Andrew C. von Eschenbach. The dispute also played a role in delaying Crawford's confirmation. He became acting commissioner in February 2004, after McClellan was named head of the Medicare program, but was not confirmed until July 2005. He resigned abruptly two months later.

According to the FDA officials' testimony in their depositions, Crawford took control of the Plan B review early in 2005, after it became evident that senior FDA staff members were going to recommend that women 17 and older be allowed to obtain the drug without a prescription. Crawford shut top managers out of the process and in August announced an indefinite postponement of the decision.

"Dr. Crawford … told me that he was concerned about where we were heading because he knew that I was heading toward this recommendation, and he told me that he was going to make the decision on what to do with the application," Dr. Steven Galson, head of the FDA division that reviews drugs, testified.

Galson testified that never before had such a decision been taken away from him.

[warrens]

13. Every federal agency is being overrun by fundies

Put there by the Bushies. EPA ran Whitman out because she actually wanted to protect the environment, USDA thinks science is something that comes and goes depending on if they can reward cattlemen with extra sales, and FDA might as well relocate to a southern baptist church.

[rodeodance]

23. and they make rule changes without Congress. over and over.

[CottonBear]

14. Lester Crawford is a political hack.

I know someone who was a colleague at the university where Crawford got his PhD. Crawford was allowed to skip certain advanced (biochemistry? I'll have to ask my friend which class it was.) courses and didn't have to do all of the research bench-lab work that the other graduate students had to do. He bounced back and forth from the university to Republican administration appointments.

Recent reports revealed that he owned (may still own) huge amounts of big pharmaceutical stocks in the companies that he was charged with regulating. He is married a wealthy Alabama woman and their net worth is huge.

Crawford is a unethical crook which is par for the course for Republicans.


Crawford received his DVM in Alabama and his graduate degrees at UGA.

[fshrink]

19. And the patent is (or was) French...

[Beaverhausen]

21. Are you thinking of RU 486? The "abortion" pill?

Not the same as emergency contraception- Plan B.

[fshrink]

24. RU 486 is the morning-after pill.

[Lars39]

25. No it is not.

[Beaverhausen]

28. RU486 is completely different than Plan B

Plan B
http://www.go2planb.com/section/about/

RU 486
http://www.ru486.com/topics/articles/article_73.asp

[fshrink]

29. OK. It's the 1 to 63 mornings-after pill.

[Mandate My Ass]

31. No it's not

RU-486 is an abortifacient and will result in the termination of a pregnancy.

The morning after pill prevents fertilization and cannot affect an already established pregnancy. It's merely a dose of hormones.

[HockeyMom]

22. This is probably close to the BC I took 30 years ago

before they lowered the dosage. I took the Progestin Only BC. When I missed a pill or two, I simply doubled up on the pills for a day or two. There is your "morning after" pill. I am sure on those days that I increased the pills, the dosage must have been equal to the Morning After Pill. I didn't even have to ask my doctor about this. You were instructed to do this on the package inserts.

What do people think we used to do years ago before they decided to MARKET what we women had been doing decades ago? I did not experience any side effects from doing this.

Personally, I think this Administration and people of a certain religious persuasion, not only want to confuse the public as to the difference between the Morning After Pill and RU-486, but would like nothing better than to ban ALL Birth Control.

Abstinence Only Before Marriage and Faithfulness In Marriage. Simple isn't it?:sarcasm:

[NorthernSpy]

35. Plan B is already available without prescription in my state...

And no, the bodies are not piling up.

:eyes:

In my state (Maine), any woman or girl can obtain EC directly from the pharmacy without the delay and expense of a trip to a doctor's office. A few other states also allow this.

Me, I think this is absolutely the way it should be. More medications ought to be made available through this process -- it would really help to lighten the burdens on the uninsured.

[pooja]

36. YOU CAN ORDER IT OFF THE INTERNET

Problem is if you are 14 and having sex (which I don't agree with), you can't exactly grab mom's credit card and order the shit.