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June 27, 2005

Why the FDA is in tatters

This is Matthew Holt from The Health Care Blog getting in a piece that I meant to publish while I was guesting last week:

It's time to dip into the murky waters of the FDA once more. This is a classic tale of politics intruding into an agency that should have science as its prime motivator. Here's the story summarized so far.

The FDA has barely had a full time official commissioner since the start of the Bush Administration. Mark McClellan was officially head for a brief while in 2003, but he barely had time to look embarrassed on 60 Minutes when asked why Canadian drugs weren't safe enough for Americans before he nipped off to the rather more rarefied atmosphere of CMS -- where he's much better suited.

Meanwhile before, after (and basically during) McClellan's time at FDA, the acting commissioner has been Lester Crawford. Some cynics have noticed that there are a few clouds over Crawford. He was involved in some pretty close to the wind activities when he was in charge of Food Safety (ironically this weekend, there's more suspicion about the Administration covering up a second case of Mad Cow).  But more recently there's been much fuss over both his personal affairs (i.e. was he or wasn't he abusing his power to forward the career of a female colleague with whom he was having a close relationship) and, much more importantly, about his being behind the non-approval of Barr Labs' Plan B emergency contraceptive.

Robert Steeves has written convincingly on Why Plan B went down.

liEssentially Crawford overruled a scientific committee which voted overwhelmingly that Plan B (an emergency morning-after contraceptive) was safe and effective.  So it won't go on the market. Of course, any time you hear anything to do with "safety" in reproductive health care in this country, your ears should prick up. There are allegations that information was withheld from the Senate Panel investigating this. Whether that's true or not, David Hager the physician who apparently has Crawford's ear and was a one of the few dissenters on the panel, appears to be a certifiable loon. Yup, he attributes all his research skills and influence to God and is not shy about telling the world about it.  However, his ex-wife is not shy about telling the rest of the world about Hager's at the least inhumane and at most criminal treatment of her -- including paying her (at first) and then forcing her into types of sex that many on the Christian right probably think of as against God's law and should be banned (although they all probably indulge in private...OK that's my last direct slam on the Fundamentalists in this piece).

At any rate, it's good to know that the future of contraception in this country is in such stable and rational hands. And overall of course the whole thing is a payback from Crawford to the Christian right for supporting his appointment. 

As a result, three Democrats on the panel are going to hold up Senate confirmation of his nomination even though it got out of committee -- even with Ted Kennedy supporting him. (Kennedy says that FDA needs a leader of some kind to remove uncertainty). The real joke is that one of those delaying his vote is an even more extreme member of the Christian right, Sen. Tom Coburn of Oklahoma (ironically like Hager another ObGYN obsessed with sex, although in his case it's rampant schoolgirl lesbianism) who thinks that the FDA should be printing warning labels on condoms because they aren't effective enough preventing disease (and of course Coburn probably thinks that people shouldn't be having sex anyway).

This might all be fun and games in an inside baseball kind of way if the issues at hand weren't so damn important. Since the Vioxx scandal there is no trust of anything the FDA says about drug safety, and it's fairly clear that the FDA leadership at least has basically been in PhRMA's pocket. We're now even getting whiff of a bigger scandal about the contentious link between mercury and autism. I won't even pretend to look at the science behind that, but it's safe to say that the Robert Kennedy article that has reignited this fuss wouldn't have had nearly so much press if the FDA commanded more respect, and if the allegations that it covered up studies on behalf of the pharma industry -- as essentially it did in the cases of Vioxx and Celebrex -- weren't so believable.

The final piece of the puzzle rest with now famed FDA whistleblower David Graham. With maverick Republican Sen. Chuck Grassley in his corner, he is taking aim at the newly appointed FDA safety panel. Essentially, instead of creating an external review board with the power to pull drugs from the market, the FDA has created an internal panel to which insiders like Crawford control all the appointments. FDA needs to be seen to be scientific and neutral, but that's not happening. For example, the advisory panel that voted to continue sales of Celebrex and narrowly voted to allow Vioxx to return to market was shown to be filled with scientists with drug company ties, and that when they were excluded the tallied votes would have been very different. This may be what big pharma thinks it wants, but it's not what is good for the country or for that matter for the future of big pharma. We need an FDA that is beyond reproach or politics.

Instead we have a series of government agencies, with the FDA being a prime example, where whistleblowers are needed to maintain standards of honesty and dignity; something our Dear Leader said he was going to bring back to the White House (ha, ha). And the whistleblowers are being treated pretty badly, even if they do have the protection of an influential Senator.  (If you want more look at this article and editorial from PLoS about the treatment of whistleblowers)

Given that there are other Presidential appointments in deep trouble, and that a Supreme Court fight is about to start that will get nasty very quickly, one cynic has suggested to me that Crawford will be confirmed without a vote as a recess appointment. In any event, the politicization of every government agency has now produced a situation where the politicians, the bureaucrats and the industry are conspiring against the public. This is bad for business, bad for health care, and bad for America.

-- Matthew Holt

June 27, 2005 in Health Care | Permalink

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Comments

Matthew--I wrote that piece on Hager in The Nation, and I just wrapped up a second one on Plan B yesterday. You've got your facts wrong on the Plan B decision and its implications for Crawford's appointment.

Yes, the advisory committee voted 23-4 to go over-the-counter with the morning-after pill, and yes, the politicos in the agency rejected Barr's application with the completely bogus (and fully unscientific) rationale that it hadn't been adequately tested on young girls. But that wasn't a matter of David Hager "having Galson's ear," as you wrote. Hager was asked by someone in the FDA to author a "minority opinion" (Hager's words) to further clarify his public comments prior to the dissent vote. He's not the power player here, just a pawn for the Bush administration. That fact has been continually lost on people.

Take a look at the transcript: Hager was the first to raise this issue about "young adolescents" perhaps increasing their risky sexual behavior as a result of easier access to the morning-after pill. No matter that the FDA had six studies showing that young girls didn't No matter that Barr set its retail price at $40 per single dose...little to $$$ for most 11 year olds. And no matter that the FDA had no fewer than 6 studies that proved that girls as young as 14 showed no increase in risky behavior when Plan B was made available to them. (Notice this "behavior" has nothing to do with the safety or efficacy, the only two requirements a drug must meet to be sold on the pharmacy shelves.) Strategically, this issue was a brilliant one for groups like the Concerned Women for America to latch on to: There is simply no way an experimental study can be done to assess the use of emergency contraception in 9, 10, or 11 year old girls. What's more, women under 15 only comprise less than 2% of all unintended pregnancies anyway! Conservatives like Hager believe that emergency contraception is abortifacient. But since that won't fly scientifically, they raise these bogeyman concerns that have no bearing on actual usage, safety, and efficacy--but that "sound" serious to the public.

That's a very long way of saying that you neglected to tell the full story about Plan B, and where things currently stand at the FDA. (You're not the the only one, by the way--John Cohn got all of this mixed up in a recent article he wrote for TNR...it's a pretty complicated story.)

Today, Lester Crawford's confirmation is held up over a SECOND application Barr submitted last July for Plan B. Though its the initial application/rejection and the 23-4 vote, etc. that raises our hackles, it has nothing to do with the present standoff at the FDA over emergency contraception. In a nutshell: After the FDA denied Barr over concerns about young women, the drug company resubmitted an application that would essentially result in a "dual-status" for Plan B--meaning that it would be available by prescription only for women under 16, and available "behind-the-[pharmacist's]counter" for older women. This is an unprecedented scheme; the US does not market products this way. The plan raises a host of legal and regulatory issues, and it has the FDA in a serious bind. (Not to mention the real barriers it creates for older women who want to purchase the drug. Though Cohn praised this compromise, it has almost zero support from physicians and reproductive health advocates. But that's another post.)

Now they're stuck. They promised Barr that if they cleared up the age issue, they'd go ahead and approve Plan B. But for many large pharmacy chains, this new regulatory scheme is a high-profile lawsuit waiting to happen--hence all of the secrecy around the status/outline of the decision. To top it all off--the CONCERNED WOMEN OF AMERICA oppose this "dual-status" for Plan B because they are afraid that rapists and molesters will purchase the drug and slip it to women to "hide" their crime. Talk about preposterous. (If FDA officials thought they'd appease the hard right with a compromise on Plan B, they really are incredibly stupid.)

The FDA was supposed to rule on this revised application by last January. They are currently stalled out: The agency's own staff scientists are outraged at the politics, and the lawyers are freaked out about the unprecedented new age-restriction. No one will sign on.

And that's why Hillary Clinton and Patty Murray will try to hold Crawford's nomination: Not because he was a player in the Plan B debacle--the blame for this falls squarely on Steven Galson. But because it's one of the only ways they can push the agency to fulfill its obligation to Barr (and to American women) and make a decision on Plan B. The senators don't care what that decision is, by the way. They just want the FDA to rule yes or no on Plan B.

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