Tuesday, November 15, 2005

GAO Nails FDA on Plan B! Wingnut Pressure trumped science

There is strange news from Washington today,  it's so shocking that  I want you to sit down. According to a New report from the Government Accountability Office: the FDA ignored scientific data and made a politically motivated decision on over-the-counter sales of Plan B Contraceptives.:




A congressional audit released Monday cited "unusual" steps in the FDA's initial rejection of over-the-counter emergency contraception, including conflicting accounts of whether top officials made the decision even before scientists finished reviewing the evidence...


[the Report raises]the most serious questions to date about agency credibility


Well I know this comes as a terrible surprise to you all.  It barely seems possible that political ideology was able to trump science, especially in this administration. Its not like There is Video of an FDA appointee bragging about killing Plan B on white House orders or anything; but the Report lends itself to no other conclusion

 First for those in the class who didn't do the assigned reading, a brief recap on why this issue has gotten so huge:



In December 2003, FDA's scientific advisers overwhelmingly backed over-the-counter sales of the Plan B brand for all ages. They cited assessments that easier access could halve the nation's 3 million annual unintended pregnancies.


And since ensuring the  safety of drugs and food is  FDA's only mandate, and everybody wants to reduce unwanted pregnancies, when FDA's scientists overwhelmingly  said it was safe,  it was approved of course.  Right?


Well no, actually:




Conservatives who consider the pill tantamount to abortion intensely lobbied the Bush administration to reject nonprescription sales, saying it would increase teen sex.

{ these being the same fine upstanding folk who also

oppose a cervical cancer vaccine for the same reason
}


In May 2004, FDA leaders rejected the nonprescription switch, saying there was no data proving anyone under 16 could safely use the pills without a doctor's guidance


Which the FDA always worries about when approving drugs like this...except of course that they never had before.:




The age rationale was novel; FDA never before required special teen evidence for birth control   [and] could have extrapolated data from older teens showing no effect on sexual behavior. ....the women's health chief resigned in protest


Now, faced with these concerns, the durg's maker opted to roll with the punches and tried diplomatic compromise.   "worried about younger kids?, Well fine" sez the maker of the Drug, "we'll just sell it to those over 16:"




Maker Barr Laboratories reapplied, seeking to sell Plan B with age limits similar to those required for cigarettes: Females 16 or older could buy it without a prescription but younger teens would continue to need a doctor's note. In August, FDA leaders postponed a decision indefinitely, saying it wasn't clear how to enforce an age limit.



Well THAT didn't fly.  After all, the FDA reasoned, it's one thing to let teen girls buy cancer causing addictive substances  that we know will hurt them,  but a perfectly safe, over the counter drug?  Why that's just crazy.  What if it fell into the wrong hands?.


The FDA for its part is not taking this lying down. following the release of this damning report the FDA immediately overhauled it proceedures to remove a hint of political influence, attacked the messenger.


In a stunning display of the new: "I know you are but What am I?" PR technique pioneered last week by the president.  An FDA Spokeswoman criticized the report and questioned the integrity of the investigative process  apparently while maintaining a straight face:



In a statement, the FDA stood by its rejection and said the audit "mischaracterizes facts."


"We question the integrity of the investigative process that results in such partial conclusions," the agency said.


Yes She really DID just go there.  But perhaps she has a point.  I don;t see how you can reach the conclusion that this decision was politicized based on such flimsy evidence as:



_Minutes of a Jan. 15, 2004, meeting show that Dr. Steven Galson, then acting drug chief, told employees that rejection was "recommended" because of the young-teen question even though they hadn't finished reviewing the science. Other FDA officials told investigators that they, too, were informed a decision had already been made.


Now to be fair, Galson claims, he hadn't completely Killed the Plan B before reviewing the science, it was only mostly dead:




Galson denied making a final ruling until he had reviewed his employees' evidence a few weeks prior to the May rejection, although GAO said he did acknowledge that he was "90 percent sure" as early as January.


Because if there is one thing that is the Hallmark of good science, its reaching a conclusion before reviewing data.  


And then of course, was the completely coincidental fact that the poltical appointees at the FDA somehow managed to override the chain of command on this particular decision:




There was unusual involvement from high-ranking officials. During a Feb. 18, 2004, meeting, reviewers told then-Commissioner Mark McClellan there was no evidence to back Galson's concerns about young teens. Minutes show McClellan questioned those conclusions.


_Three FDA directors who normally would have been responsible for signing off on the drug's fate did not do so. They weren't asked to, and Galson did instead, because they were known to disagree with the decision.


And THIS of Course simply can't be believed because there has NEVER been a pattern in this Administration of "fixing facts and data around the policy"  and We've NEVER heard of analysts being pressured by their bosses to change conclusions based on a desired political outcome.


Well they've been caught red-handed caving to pressure from the radical right on this issue.   The real question is will it make any difference?  Does this administration even have a blush reflex anymore?


And if Not, do the Dems have the intestinal fortitude to run on this in '06?  Yes, it will piss the wingnuts off, but since they'd tattoo 666 on their foreheads before they'd vote democratic, I hardly see how losing them will matter overmuch.  And its NOT really about a Woman's right to choose, though that's certain a huge part of it for our base.  The real traction on this issue will come from a vast scared American middle that relies on the FDA to have the technical knowledge and integrity to protect them against dangers they can't even begin to understand.  If we show them how much that integrity has been undermined by these political hacks, I think we'll get a VERY strong surge for our side.

1 Comments:

Anonymous Anonymous said...

I'm glad I'm a normal human being who isn't subject to these sick rules of the Evangelical...........
right wing nuts! My god. These people are beyond.

7:23 PM  

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