Another report that is guaranteed to infuriate all but the religious reactionaries and the social cons (is that redundant?):
Top federal drug officials decided to reject an application to allow over-the-counter sales of the morning-after pill months before a government scientific review of the application was completed, according to accounts given to Congressional investigators.
The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration’s May 2004 rejection of the morning-after pill, or emergency contraceptive, application was unusual in several respects.
Top agency officials were deeply involved in the decision, which was “very, very rare,” a top F.D.A. review official told investigators. The officials’ decision to ignore the recommendation of an independent advisory committee as well as the agency’s own scientific review staff was unprecedented, the report found. And a top official’s “novel” rationale for rejecting the application contradicted past agency practices, it concluded.
…
In April 2003, Women’s Capital applied to make Plan B available over the counter. Barr bought the rights to the drug and continued to pursue the application. An advisory committed voted 23 to 4 in December 2003 to recommend approving the switch.
Within days of the committee’s vote, however, Dr. Janet Woodcock, the F.D.A.’s acting deputy commissioner of operations, and Dr. Steven Galson, acting director of its drug center, told four top staff members that the application would be rejected, even though the agency’s scientific review of the application had yet to be completed, the staff members told Congressional investigators. That review was completed in April.
Drs. Woodcock and Galson denied to investigators that they had made such statements.
Dr. Galson told them that “although he was ’90 percent sure’ as early as January 2004” that he would reject the application, he made his final decision only after reviewing the scientific evidence.
What can I say?
Lines
Don’t forget, she was just asking to be raped.
Krista
Un-fucking-believable. Those miserable, controlling, ignorant bastards…
Krista MAD! Krista SMASH!
Slide
Dobson’s Army at the FDA? When was Dobson elected President? No its George fuckin Bush’s Army at the FDA. Do you EVER hold dubya accountable? ooops… almost called you the “A” work there John, I’ll have to watch myself.
John Cole
Slide, you are so breathtakingly stupid and annoying I don’t know why I even bother replying to you, but by stating that I believe Dobson and religious reactionaries are running the show at the FDA, I am pretty clearly attacking George Bush.
Christ almighty, you are a pain in the ass.
Krista
Dobson’s the General of that particular army, but Bush has pretty much given him carte blanche when it comes to influencing policy.
KC
What can you say, John? Honestly, at this point, it’s par for the course. There really is nothing to say.
Steve
Plan B is a stupid, stupid hill for the right wing to die on. Meanwhile Hillary and Patty Murray have been racking up points fighting against the FDA’s ridiculous behavior.
jg
Funniest thing I’ve read in weeks.
DougJ
Why don’t we ever hear the *good news* about letting religious zealots control our medical policies?
jg
Its all Da Vici’s fault. If he hadn’t gone to morgues and stolen bodies and opened them up none of this would have happened. We would still be living the glory days and assuming if you were sick it was because you swallowed a gremlin. Ahhh good times.
JKC
Bloody amazing. Maybe I’m getting cranky in my old age, but I remember when the FDA actually made decisions about medications based on science, not fringe politics.
cd6
I can’t believe there have been 10 comments and nobody posted to laugh at “woodcock”
How could this even be worse? “Janet Schlongpenis”??
Back on topic, don’t they have to give an official reason why they are rejecting it? Or can they just reject it outright? If they did give a reason, what was it?
ppGaz
I can’t figure out why anyone is suprised by this. We pretty much knew that this is what these meddling sonsabitches were going to do. And they did.
And now, what? Handwringing? We’re shocked — shocked!
Sorry, I don’t get it.
Boombo
The Republic is dead. Long live the Republic.
DougJ
No one could have anticipated that Karl Rove would give James Dobson control over the FDA.
srv
Infuriate? I’m confused. Where have y’all been that you find any of this surprising? You thought the decision last year was based on sound reasoning? You thought Saddam was a threat? You think Iran is a threat to you?
Steve
There must surely be a lawsuit wending its way through the courts on this. After all, if the government isn’t allowed to take away your right to use birth control for moral reasons (Griswold v. Connecticut), I don’t think the FDA can do it, either. Sure, they’re allowed to restrict unsafe products, but as long as the evidence shows the health concerns are just a pretext, the government is left without a rational basis for restricting Plan B.
Slide
There will always be the Dobsons in the world on both sides, right and left, I’ll put all blame on the government officials that pander to them. Oh, pandering to a constituancy? hmmmm…. unpatriotic?
Bush will go down in history as the worst President ever in my estimation. According to an article Drudge is linking to, it sounds like he is cracking up too. I like this passage:
hmmmmm… only talking to women. Interesting from a psychological point of view. Wish Maureen Dowd wasn’t on her book tour, I would love to read her take on that.
demimondian
John Cole asks:
It seems to me that the obvious answer is “Throw the bums out! I’m voting Democrat until the Republicans regain their sanity.”
DougJ
Is it possible that we’re being unpatriotic here? I mean, what if the FDA had flawed intelligence about the drug?
SeesThroughIt
True, and yet I still feel like we should’ve seen it coming. Religious loons have always used sex–and all tangents related to sex–as a morality club. Preventing unwanted pregnancy before it can even take place is easy to recast as “abortion” to people stupid enough to listen to James Dobson. Voila.
demimondian
Please, DougJ. Opportunistic is not the same as unpatriotic. The FDA director was doing a heckuva job, and no one could anticipate that the science would be as well established as it already was.
So bring it on.
Slide
How anybody can believe anything this administration says is beyond me. Simply beyond me.
Slide
Or as John would say:
.
stickler
Our gracious host is outraged about yet another pandering, stupid choice by Team Bush.
Our gracious host is a year and a week too late. I mean, seriously, was any of this not forseeable from the first day of Bush’s first term?
We had an accountability moment last November. Think back on who you voted for at that moment. Everyone who voted for George W. Bush is complicit in our great national trainwreck.
metalgrid
Well, it’s rather obvious that Dobson wants you to have abortions instead of taking pills.
Besides, I wouldn’t be too surprised if the AMA had a bigger hand in holding this as prescription only and greasing the appropriate political palms for it and just used the Dobsonites as the scapegoats.
Gratefulcub
They still do, they have just removed the liberal ungodly bias from the science. Now they can call birth control what it really is: MURDER.
phil
When a problem arises over a drug like Vioxx liberals proclaim that the FDA is in the pocket of the evil drug companies and this causes drugs to be approved with insufficient testing.
Now you hypocrites want to take a drug that was approved for incidental use, under a doctors care, and let it be sold over the counter where potentially (let’s face it, likely) it will be used in a way no long term clinical trials have tested for. The only thing separating you from the religious right is the dogma you follow.
Rob
No one that voted for Bush should be too suprised about this. Isn’t this exactly what they wanted when the pulled the Bush lever?
Krista
I’m certainly not surprised by this, but one doesn’t have to be surprised in order to be infuriated.
Dobson and his ilk are trying to recast conception as being when the egg is fertilized, not when it is implanted in the uterus, so that the two most reliable forms of contraception (the Pill and the IUD) could be considered abortifacients, and could potentially be banned if Roe gets reversed. Despite what they say, this isn’t about protecting babies or families…they’re full of shit, and if they cared so much about babies, they’d be fighting for better health care and maternity leave. They’re puritan tightasses who want nothing more than to eliminate any form of sex that they deem to be inappropriate. (In other words, everything except procreative, missonary-position, biannual sex by upper-class white married Christian Republicans.)
Mr Furious
You got me! I planned on buying ’em and popping ’em like vitamins. And I’m a man!
WTF? This drug has been thoroughly tested, has been in use for years and was recommended 8 to 1 by the Commission of actual scientists. The FDA rejected this purely on ideology. Wake up, jackass.
Krista
Have you ever talked to anybody who had to take Emergency Contraception? It makes you sick as a dog…really, really sick. I highly doubt that having it available OTC will cause people to abuse it. On the contrary, I think it might have benefits, particularly in those cases where people have been careless with birth control. I think a large percentage of woman would double-and-triple check their contraception before ever again going through the double whammy of a pregnancy scare combined with what feels like the worst hangover of your life.
The Disenfranchised Voter
Oh god, please tell me that was sarcasm. I don’t know you well enough Gratefulcub to be sure.
And DougJ, you literally cracked me up. Some priceless comments in here. Keep up the good work.
Mike S
This country has a fundie problem. I only partly blame the Republican party because the fundies made a concerted effort to take over the party. Rank and file Republicans are somewhat to blame because they made a political calculation that they would always be able to keep the fundies on the back bench and just use them to get elected. They gambled and lost.
But in a sense, that is no longer the point. The point now is how will the non fundies take back their party?
Steve S
Next thing you know, they’ll probably mandate that condoms only be available with a doctor’s prescription.
Steve S
Mike S – You mean wackos. The Republicans call them wackos, not fundies.
Gratefulcub
Rest easy DisVoter, sarcasm it is.
Ancient Purple
Now we see the problem with kowtowing to a base like the Religious Right. They will continue to dangle the voter block carrot in front of this administration until they get everything they want.
Don’t appoint a very conservative justice? No votes for you.
Allow Plan B to be over the counter? No votes for you.
Don’t sign the bill to allow Shiavo’s parents to access the federal courts? No votes for you.
No constitutional amendment to ban gay marriage: No votes for you.
Dobson is clearly in control of this administration’s agenda.
cd6
I think they’re right to oppose this… its just the beginning of a slippery slope of immorality in pill form
Coming soon: Pills that make you homosexual, cough syrup that makes you believe in evolution, and a laxative that also causes divorce
ppGaz
Whew! Close one, I’m not a Republican!
But serially, Krista, you are absolutely right on.
DougJ
911 changed everything. We were attacked by religious fanatics. And to catch religious fanatics, you have to think like a religious fanatic. The best way to learn to think like a religious fanatic is to let religious fanatics control your government. It’s simple really. Bush is a visionary, bordering on genius, just like Hindrocket at Powerline says.
Krista
ppGaz – biannual? Oh dear. You need to get away from your computer and attend to your lovely wife. Just don’t get her pregnant, ’cause in your country, you’re shit out of luck.
Otherwise known as “Budweiser”
Cyrus
phil Says:
Hypocrites? You keep on using that word, I do not think it means what you think it means. One drug was released due to politics (as in, lobbyists) when medical reasons should have prevented it, another drug was not released due to politics (as in, pandering to theocons) when medical reasons should have allowed it. That doesn’t seem like a contradiction to me. Maybe I’m just thick.
And if “top agency officials [became] deeply involved in the decision” and decided to ignore “the recommendation of an independent advisory committee as well as the agency’s own scientific review staff,” forgive me if I don’t take your word for it alone that they made the choice purely out of a concern that “it will be used in a way no long term clinical trials have tested for”. On what, pray tell, are you basing this? No, Newsmax is an unconvincing source, sorry.
DougJ
Maybe the science about the drugs wasn’t sound. We need sound science before we make decisions.
Krista
I say, protected & consented wild jungle sex for everybody! Dobson can go piss up a stump.
Ancient Purple
Absolutely. I will be requesting top-notch, sound science from Kansas ASAP.
Ancient Purple
Dibs on the handcuffs!
SeesThroughIt
This wins the Best Zinger of the Thread award so far.
Also, for the protected & consented wild jungle sex, I got dibs on the chocolate sauce.
Walker
Sound scientific research, yes. Which, by this report, was did not happen as decisions were made before research was completed.
The phrase sound science is Orwellian double-talk invented by the conservative think tanks.
Vladi G
This means you, John.
That needs to be repeated.
Boombo
Amen. If I had a spouse that tried to serve me Bud, they’d be out on their ass ASAP.
DougJ
Harsh, but true. And being a Republican is no excuse. I know plenty of Republicans who voted for Kerry.
stickler
Not only am I one of them, I even had a “Republicans for Kerry” bumpersticker on my pickup. People reacted to it; the larger the SUV, the more likely that the digit being waved wasn’t the thumb.
Krista
AncientPurple – you know what they say. Kinky is when you use a feather. Perverted is when you use the whole duck.
The Disenfranchised Voter
George HW Bush was one of ’em.
Ancient Purple
That’s just fowl.
(Sorry… had to say it.)
Krista
That’s why I just don’t understand the attitude of these anti-sex religious zealots. Sex is fun, sex is funny, and if you’re responsible about it, sex is very unlikely to harm you. Why the hell can they not just let people make their own damn decisions about what they want for their bodies. If John C. wants to go get his taint pierced, or if Darrell wants to tattoo “Dems are LIARS” onto his forehead, or if I want to have unmarried, Pill-protected sex with my atheist, live-in boyfriend, what the hell business is it of theirs?
jcricket
The only good thing about this whole turn of events is that the religious right’s agenda is being daylighted, and hopefully the American public will realize the vast majority is in danger of losing their rights.
It’s not about banning “partial birth abortion”. It’s not about banning gay marriage.
It’s about banning contraception, for both married and unmarried couples. It’s about an outright 100% ban on abortion. It’s banning fertility treatments if embryos are left over (unless you guarantee those embryos are implanted into someone). It’s about making divorce impossible to obtain (oh, and making civil marriage illegal). It’s about imposing one religion’s opinons on everyone regarding end-of-life decisions. It’s about requiring one religion’s view-point get veto power over the FDA.
For the last 20 years Republicans have conducted a “wink and nod” campaign with these people, saying, “Vote for me and I’ll give you some of what you want.” Well, now those fundies who’ve been dutifully voting “R” all these years view Republican control of Congress as their time to “get their due”.
Anyone outside of the religious right (Libertarians, small government conservatives, etc.) who continues to vote “R” when the party’s national agenda is so closely aligned with these religious fanatics has no one but themselves to blame for this situation. Vote Democrat. Vote Libertarian. Vote Green. Vote write-in. But a vote for Republican control of Congress or the WH is a vote for Dobsonian rule over our lives.
Dance with the devil and the devil don’t change, he changes you. Or, lie down with dogs, get up with fleas.
Perry Como
These comments illustrate the kinds of hedonistic perversions that values voters hate. The DemocRATS will keep losing elections by large margins unless they accept the values of the majority of Americans.
Mr Furious
Sweet Jesus, Krista, did you have to go there?
Steve
DougJ has set the bar for satire pretty high, but this was a five-star post.
phil
Cyrus-
I know exactly what the word hypocrite means.
Vioxx went through years of clinical testing for efficacy and side effects as a pain killer, and was rightly approved. Only when Merck did testing for expanded usage in anti-cancer, involving much longer times taking the drug, did a much different side effect profile emerge and the drug was pulled
Plan B contraception had not been tested for over the counter use, which is normally a high bar to cross because you have to account for misuse.
If you can name one drug the FDA approved as a prescription drug, let alone as over the counter, without a series of clinical trials I will stop calling you a hypocrite.
jcricket
It’s all about projection Perry :)
How else do you explain the Senator Brownback’s 4th (or 5th) porn hearings this year?
Slide
biannual? does that mean twice a year or every two years? always get that mixed up.
jcricket
These would be reasonable arguments if they were both not already asked and answered many times over. See Planned Parenthood and Medscape. and this UPI article about the availability of EC not changing sexual habits.
Here is some info from WikiPedia
Real world and clinic trials have been done, and the issue of misuse/abuse has been dealt with (it’s not the problem you think). Remember that Plan B is not RU486.
In other words, the requirements for OTC avilability have been more than met. The religious right didn’t like that result, so they moved the goal posts. For example, they are requiring many more tests for EC than they do for drugs available OTC with just as much fatality/abuse potential.
ppGaz
Well, the problem with Jimmy D is that he thinks pissing up a stump IS wild jungle sex.
Not that there’s anything wrong with that ………
ppGaz
Oh hell, I thought “biannual” meant bisexual, once a year.
Mary
*raises hand*
I too, have taken emergency contraception — once. Once was plenty to let me know that I didn’t want to feel seasick for two days straight. Luckily, I had no other obvious birth control mishaps that made a round necessary.
Mary
Whoops — didn’t mean to shout. Didn’t know that using * to emphasize text bolded it.
ppGaz
Spit soup onto laptop again.
Best line of the day so far. Kudos.
demimondian
No, damn it, ppg. Biannual means using a thistle or other similar biennial plant as a toy during foreplay.
Derek Flint
I don’t think it’s about sex for these people Krista. I think it’s about controlling women by limiting their choices. For the most part it’s MEN trying to force this agenda. Their view is women have way too much power in this society right now. This is one way for these guys to change the status quo…
Steve
Derek, you obviously missed the part where Krista says she has a live-in boyfriend. Stop sucking up.
Krista
I think that’s one large aspect of it, but I don’t think that encompasses the whole picture. I think that Dobson and his brethren want to eliminate any sex that they consider to be deviant, which would include premarital sex and sex with contraception, two things that are prevalent amongst both genders.
To what are you referring? (Bats eyelashes innocently). Seriously, I’ve made a number of “interesting” comments on this thread, so I wonder which one got to you…was it perhaps the one about John getting his ‘taint pierced? Sorry if I made you feel a bit squeamish…’twasn’t my intention.
jcricket
Don’t forget oral sex. I’m sure porn and masturbation are also on their no-no list.
Krista
This is Dobson we’re talking about. Anything that’s remotely enjoyable is off his list, as it MUST be sinful.
Krista
demimondian…now that’s just sick.
Pre-born Again
Yes. It’s estimated that 30% to 50% of all fertilized eggs do not implant in the uterus. This means, of course, that God murders a third of your children, before you even get to acknowledge their precious life.
The Disenfranchised Voter
Thank you. Hope it didn’t screw your laptop up this time…
james richardson
damn. all the good lines are already taken.
DougJ
Surprisingly, Dobson is pro-porn and has an extensive library of the hard-core stuff.
BARRASSO
I work at a library and Dobson’s video interview with Ted Bundy just showed up on my desk today, I may take it home and see which of the two are creepier tonight.
I’m all in for the hot jungle sex, been a long time since I fucked a jungle.
ppGaz
Okay, it’s on our to-do list.
Pug
In best Butthead voice: “huuh..huuh…he said Dr. Janet Woodcock”.
Larry
It isn’t that the Christian Fundies are making medical decisions for us — it’s just the wrong sect!
With the Christian Scientists in charge, the delivery system is simplified and the costs go down to zero.
Let us Pray….
Brian
Several young women have dies from taking this pill. How come I don’t see those companies being taken to the woodshed like Vioxx.
Liberalism is a death cult. The obsession with abortion and euthenasia woulod be hilarious if it weren’t so pathetic.
Krista
Source, please. And I mean a scientific source, not jimmied-up “facts” from Dobson.
Oh, and if you’re wondering about the “obsession”? It’s because, strangely enough, we wacky liberals seem to think that we have the right to choose trivial things like when to start a family, and when to slip these earthly bonds. It’s called having control over our own bodies. But if you don’t mind ceding control of your body over to the government, then bully for you…
Sojourner
At least several young women have died from aspirin. Do you want to make that prescription only also?