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PHARMA/POLICY/POLITICS: The FDA remains in tatters

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.  Essentially 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.

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wendyLauraTerry BeernaertDanJAYNE GLENN Recent comment authors
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Kristina Zallinger
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Kristina Zallinger

Dear Wendy,
There are SO MANY problems with this drug that I have only heard a few! I am sorry about your Father. Is he still on Klonopin? I don’t know how to persuade a loved one to stop taking it. Does he know the difference in his personality? Sometimes we KNOW but deny that it’s a problem.
Please elaborate on your problem with your Dad and yourself.
Kristina

wendy
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wendy

this drug has ruined my whole family. my father was on this drug and it made him a mean person. i know this is what changed him and noone will believe me. He was a kind, loving father my whole life until this drug. i would like some help with this also

Kristina Zallinger
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Kristina Zallinger

Dear Laura, Having to go through withdrawal at all is disgusting! The FDA doesn’t care either! I have emailed them about the Benzos, sent my story. But to no avail! They don’t care (notice that the addictive meds, ie Klonopin, are the cheapest) so I don’t know what they’re getting out of it! Or the drug companies! The Doctor does sound like the typical Shrink. They don’t have to experience withdrawal and definitely have no idea what it feels like! Horror! Check out whether the Statute of Limitations has run out in your case. It is very hard to sue… Read more »

Kristina Zallinger
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Kristina Zallinger

Dear Terry, Your story is heart wrenching.! This shows you graphically the power of the Benzos! First off, I would sue the Doctor. He is truly at fault. Then send your letter to the FDA. The trouble with suing Doctors is that it is very difficult to get any satisfaction. Doctors have a lot of POWER. Get a Personal Injury lawyer and see what he/she thinks. The statute of limitations hasn’t run out (I don’t think, so call the lawyer as soon as possible. Get the records from the Hospital and anything about the autopsy, if she had one. But… Read more »

Laura
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Laura

I am happy I found this page to read. I am so sorry that I had to read the horror…you all have suffered so much. I have been addicted to klonopin for 14 years. Like you all, I had no idea that my body was addicted. In the end, I was taking up to 3-5mg daily, prescribed 3 mg daily. It’s been 8 months and I’m 1/2 way through withdrawal. my doctor now is an ass, (really!) and knows nothing of benzo withdrawal. I truly want to ge off of these for life and I know I will….i’m doing pretty… Read more »

Terry Beernaert
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Terry Beernaert

My daughter Tawny passed away on 04/27/08. Here’s her story. While in a rehabilitation center (successful completion) in March of 2008,in the presence of her therapist, she informed her physician that she was addicted to benzodiazepines. At which time she requested he not prescribe them to her any longer. On 4/22/08 said physician prescribed my daughter Ativan again. He was also prescribing her 2 other type CNS suppressents, Xanax and Roaxin(benzodiazepines). She passed away in the early morning hours of 04/26/08 after having an overdose amount of Ativan in her system and her body was discovered by a neighbor in… Read more »

Kristina Zallinger
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Kristina Zallinger

Dear Dan, I am on Atarax (Hydroxyzine) for anxiety. It is also an antihystamine (sp?). I don’t know the state of my anxiety right now, but it seems that when I do go off of Atarax, I become nervous, I can suggest trying this drug. It is non-addictive and perfectly harmless. If you wnat to get off of Klonopin, just wean yourself off of it very slowly. 6 months or so (or more), but ask your Doctor. You need to give your body enough so it’s not expecting more. Remember, Klonopin is addictive, so you need to watch any sign… Read more »

Dan
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Kristina, thanks for posting this info on your blog. While I might perhaps disagree with SOME of your descriptions — like describing 5.mg 4x a day as a “deadly” dose — but totally agree with 98% of what you’re saying. I have CFIDS — have had it for almost 10 years now. At first I was prescribed klonopin (or clonazepam) after an anxiety attack where I KNEW something was wrong and I couldn’t seem to control it. Went to the ER at almost midnight, and they prescribed it — for a short period. I was then put on an antidepressant… Read more »

Kristina Zallinger
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Kristina Zallinger

Dear Jayne, Your story is powerful! And frightening! It seems like you don’t know which way to turn! You had problems on Klonopin and had problems off! What a dangerous dilemna! 20 years is a long time to be hooked! Have you ever tried going off it very slowly to avoid withdrawel. Safely, it would probably take 6 or 8 months to get it out of your system. Have you talked to a GOOD doctor about your addiction? One you can trust? I will never be on Klonopin again. I take NO addictive medications now. Atarax (actually an antihystamine, but… Read more »

JAYNE GLENN
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JAYNE GLENN

I WAS TAKING EXAMS AT A UNIVERSITY, EARNING SOCIAL WORK DEGREE. I STARTED FEELING NERVOUS OVER THE UPCOMING EXAMS. I WAS ENCOURAGED BY A FELLOW COLLEGE CLASSMATE AT THE UNIVERSITY TO GO TO THE UNIVERSITY’S MEDICAL CLINIC AND JUST TELL THE UNIVERSITY’S PSYCYCHIATRIST I NEEDED PILLS TO HELP ME RELAX ABOUT MY COLLEGE COURSES. SHE, THE UNIVERSITY PSYCHIATRIST, WAS MY KLONOPIN, PILL PUSHER! AS SHE TOLD ME, TAKE THIS KLONOPIN AND YOU WILL FEEL SO MUCH BETTER! THAT IS WHEN I BEGAN KLONOPIN . THE SCHOOL PSYCHIATRIST WHO PUT ME ON THE KNONOPIN , GAVE ME NO INFORMATION SUCH AS… Read more »

Kristina Zallinger
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Kristina Zallinger

Dear Linda,
I would be glad to join you in a class-action suit against the makers of Klonopin!
Kristina Zallinger

Linda
Guest
Linda

I need help. Klonopin ruined my life. I was in such a fog, I lost 2 jobs, sold my condominium, and angered the hairdresser who gave me a short haircut, which emphasizes my sparse hair and gives me a male appearance. I want to sue the doctor and the makers of klonopin, if anyone will join me in a lawsuit. Please help-I am now destitute and have ruined my family.

Kristina Zallinger
Guest
Kristina Zallinger

Hello Wendy, Sorry I didn’t get back to you sooner. I was touched by your story. It made me cry. I understand what a lousy, insensitive Shrink is. I’ve seen them all. They want the bucks and don’t care about the patient. I’d find a new one if you can. How many have you been to? Are there enough choices in your Community? I don’t have a clue how to connect with a good one—–unfortunately you have to take your chances. Most of them should be turned into the AMA and whipped! I finally have a good one. She’s an… Read more »

Wendy Brown
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Wendy Brown

Your stories made me cry, I’m still crying. I’m so frightened. I don’t know what to do. I’ve been on Klonopin 4mgs for 1 1/2 years. I was so depressed coulnd’t function. Was put on 24 different medications for both depression and bipolar. None did me any good could not tollerate side effects made me more depressed. Went off all meds including Klonopin. I did not tell my Doctor, who I hated, bitch. I went crazy for 4 months. No sleep just was hysterical all the time for 4 months. Couldn’t take it any more. Went to a different Dr.… Read more »

John Whitmer
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John Whitmer

With another class action court case begun (June 2007) by parents of children with Autism Spectrum Disorders, I think the bigger scandal is that so little is being done by politicians and the media to investigate this issue. Since this blog was first started (June 2005) the number of children diagnosed with ASD has risen from 1 in 166 to 1 in 150. Why is this epidemic not constantly in political debates, media coverage, and the blogosphere?