EFF Bags A Big Win On NSLs
Our good friends at EFF have a big announcement. They have bagged a big win against the Bush Government on the improper use of National Security Letters.
The FBI has withdrawn an unconstitutional national security letter (NSL) issued to the Internet Archive after a legal challenge from the American Civil Liberties Union (ACLU) and the Electronic Frontier Foundation (EFF). As the result of a settlement agreement, the FBI withdrew the NSL and agreed to the unsealing of the case, finally allowing the Archive’s founder to speak out for the first time about his battle against the record demand.
"The free flow of information is at the heart of every library’s work. That’s why Congress passed a law limiting the FBI’s power to issue NSLs to America’s libraries," said Brewster Kahle, founder and Digital Librarian of the Internet Archive. "While it’s never easy standing up to the government — particularly when I was barred from discussing it with anyone — I knew I had to challenge something that was clearly wrong. I’m grateful that I am able now to talk about what happened to me, so that other libraries can learn how they can fight back from these overreaching demands."
…
The NSL included a gag order, prohibiting Kahle from discussing the letter and the legal issues it presented with the rest of the Archive’s Board of Directors or anyone else except his attorneys, who were also gagged. The gag also prevented the ACLU and EFF from discussing the NSL with members of Congress, even though an ACLU lawyer who represents the Archive recently testified at a congressional hearing about the FBI’s misuse of NSLs."This is a great victory for the Archive and also the Constitution," said Melissa Goodman, staff attorney with the ACLU. "It appears that every time a national security letter recipient has challenged an NSL in court and forced the government to justify it, the government has ultimately withdrawn its demand for records. In the absence of much needed judicial oversight – and with recipients silenced and the public in the dark – there is nothing to stop the FBI from abusing its NSL power."
You can read the entire press release here. When they say "there is nothing to stop the FBI from abusing its NSL power" that is not quite right; there is something, and it is the invaluable work of the EFF and ACLU. Make no mistake though, this is a big deal both in terms of timing and substance. It is an excellent fact situation for discussion both as an example to hold up and the full ability to discuss all aspects of the case. That is huge. But also the timing coming right as we gear up for another FISA battle is crucial. Kudos to the EFF.
For all the outstanding work and efforts put forth every day, both here and around the blogosphere, we would be nowhere without organizations like the EFF and ACLU doing the hard work of challenging the wrongs of the government in court. When you get around to making your various charitable donations, please keep them in mind; if there is a better bang for your buck place to donate your hard earned cash, other than the hostess of this blog, I cannot imagine what it is.
Three Cheers for the good guys and gals at ACLU & EFF!!!
They’re our BFF!
Bob in HI
A legal precedent for constitutional rights. Hooray for the constitution.
Ooh, can I get a bang?
Sorry. I’ll behave now.
Yay, EFF!
Okay, after you put it that way, it did look like I was pimping out EW didn’t it? The language has been, um, amended.
Silly me, I missed the fun on first read.
I thought it was funnier, bmaz, when you wrote the other day about putting some air under EW’s kilt. I can’t remember the last time farts were discussed on FDL or here (heh.)
But seriously, ACLU has been doing the good work for a long time. There was a period, under previous leadership, where the ACLU was expending resources on causes that I thought less than noble, even if fitting their mission, but their work will stand the test of time better than most.
And I didn’t know about the EFF until I read about them here. Good to know that such folks are involved.
I look forward to the day when Mary and all the rest of us can look upon the DOJ with pride once again as stalwart defenders of Lady Justice, using honest scales of justice with blindfold on, rather than peeking with one eye and thumbing the scales. It is not nice to contemplate Lady Justice as a prostitute, but unfortunately, that is what the Bush & Cheney regime have made her into.
Bob in HI
Noooo, that wasn’t a fart reference; it was a take on the old line “Whatever blows your dress up” used, among others, by Sinatra.
Boooyah!
WooHoo! What LHP said ; ) Thanks for the good news bmaz!
Pach, hope your dad’s ok…
This just in from the ACLU:
Of course, there’s less here than meets the eye, but the game is on. We do have a role to play.
Bob in HI
You may have seen something that makes me smile every time I see it Bob, that Addington’s attorney says he doesn’t have to testify, but he will testify (as of now subject to of course “change of the Addington mind”) in the spirit of a word that quintissentially represents all that are Cheney and Bush–”comity.”
Addinton’s Attorney’s Letter to Conyers that he’ll testify out of his deep sense of comity
The Libby trial showed that Addington has loose lips. D’ya think Addington will be allowed to testify IF he can be fitted with an unobrusive cattle prod device under the control of his attorney, who can press a button every time Addington’s lips loosen up?
“Why yes, Senator, I remember that meeting well. The Vice President was explaining to me the importance of… [urp]…ah…what was that question again?”
Bob in HI
it all depends on what he gets asked. philippe sands stressed several times in the hjc hearing yesterday that, iho, they should NOT waste any time questioning him about the legal justifications – sands said that what would be most helpful would be to question him as to what happened, when it happened, who was there, etc.
that advice seemed to tie in well with marcy’s description of addington.
As you and other dedicated readers of this blog may remember, I have been advocating for quite some time now that Congress, and plaintiffs in the court cases on emails, should haul Addington in as a fact witness (which is basically what you are describing) in relation to all his activity in coordinating the OVP and WH email responses under the theory that he made himself a de facto custodian of records as to those responses.
oh, is that what “fact witness” means? d’oh.
it’s good to have some lawyers around. *g*
still thought it was interesting how insistent sands was, he repeated it as though it was his number 1 talking point.
Would this could happen. I don’t know when I’ve seen a more chutzpahesque 3 card monte than the WH “we ain’t saved our emails” scandle not to mention the allegations if I understand them correctly that there are no preserved records of the use of the RNC servers for emails (or that they allege that material on the RNC servers was “destroyed?”
I think he will be fitted with a device that allows what DOJ and Yoo perceive as a progression towards “organ failure.” If his lips get loose, perhaps they have a hot iron implanted in his kidneys bilaterally and begin to necrose his kidneys per the memos that Yoo wrote and a DOJ torture power couple who haven’t gotten much notice in the EW blogs–current US Attorney in the Northern District of Georgia David E. Nahmias, and his wife who both wrote torture memos while at Main Justice.
There was mention of subpoening Nahmias to testify before HJC and DOJ made noises that they would consider his testimony privileged and to leave him alone.
Check out the google hits on “David Nahmias torture”
“David Nahmias Torture” Google Hits
including Leahy’s Statement:
Leahy’s Statement on David Nahmias’ Torture Memos
I might add my experience with DOJsters (any attorney who is employed by DOJ) is that they know enough medicine to urinate and defecate daily–not a scintilla more.
The EFF and ACLU progress called several similar matters to mind, namely, the epoch of transition from one administration to the next, given nara’s declaration that it intends not to snapshot government websites; Archive is a key crawler with its wayback service given that formal continuity. There was an interesting ombWatch testimony this past week in that regard. The government has averred it plans to appeal its Archive loss, oxymoron unintended. I wonder if the appeal might be in the court which is addressing the prisonerList secrecy issue AssociatedPress has been progressing recently.
Three cheers for the EFF and ACLU, those rich, rapacious plaintiffs’ lawyers. They make what, about the same or less than Congressional staffers? Living in SFO and NYC? Trent Lott spends that in a year on limos and cocktails.
Congressional judiciary committees should notice several things about this case:
One, the plaintiffs won, hands down.
Two, that’s not unusual, further evidence that the FBI is abusing the unusual authority granted under NSL’s, possibly (and also improperly) for routine domestic law enforcement purposes. It’s just easier. That means there are a lot more abuses that weren’t caught by the FBI, the DOJ, the courts or Congress. They should have been, which means something fundamental is broken and needs prompt attention.
Three, the gag orders are themselves abuses. This administration treats them as it does many of its claims of state secrets and national security. Primarily as a weapon to prevent disclosure of government abuse, not to keep secret details of national security investigations.
Congress ought to limit the availability of these occasionally necessary tools to applications where they’re legitimate. That’s typically by statute and, you know, by having judges review the bloody things. If Congress doesn’t act to limit these abuses, they approve of them and want to them to continue and grow. They will.
And there you have it. Every time there is a substantial challenge, the Bushies fight it as long and hard as they can right up to the point to where they are going to get their ass handed to them and then they cave enough to make the case go away but still live to abuse again with impunity.
Exactly right. They avoid like the plague ever having a court publicly declare their acts wrong, misguided, illegal or abusive. Just as for them, it’s not a lie if you don’t get caught, it’s not torture if nobody makes you stop, it’s not abuse if you yank the case before a judge can call you on it.
That’s how these ueber-Christian, forthright, compassionate, political leaders teach our young men and women to behave and lead. Holy water boils, Scout badges spontaneously immolate, at the thought.
Huge applause for the folks at EFF.
Complete nonsequitor but it flitted on my mind when I looked at the draft from the POGO site in the last thread. One of the mentions on that thread is OSC working with Michael Scudder (although I think they spell it Scutter) who is representing the WH on some of their requests.
And that is the same Scudder, I think, that had been McNulty’s counsel in his position as DAG before Bush brought him in to be WH Counsel. So how weird/bizarre is that? DAG, who was involved in the discussions on hiring/firing and is questioned by Congress about them – and looks like he fibified some, at least if you believe Goodling, is represented by counsel. That counsel then goes on to work for the White House when the White House is kindasortanotreally being investigated by OSC for, among other things, the same matter and voila – there is Scudder again.
There’s a lot the Bush administration lawyers and the Texas polygamy group seem to have in common.
Would Scudder be some kind of “minder”, by any chance?
I wouldn’t put it past Cheney to put into place a whole series of “minders.”
Bob in HI
Do I have this straight? Somebody was using the Wayback Machine and the FBI wanted some information so they could figure out who it was? Hmmm. Is this terrorist related or politically related?
YAY!!!! This made my day
OT but I’ll toss this in here too.
Some of the GITMO lawyers say they are being tapped and surveilled, causing lawyers to have to turn down new clients and law firms to have to rework communications with existing clients.
http://www.nytimes.com/2008/05…..ref=slogin
I really think they just need to come out and give the real, true and ulitmate on their, ‘refuse to confirm or deny’ blurbs. “The United States Department of Justice refuses to confirm or deny that it is populated by criminals engaged in illegal, unconstitutional and criminal behaviour, because doing so would compromise the criminals.”
Well, I’m down with that interpretation; but let’s be honest. That position by the Bush Administration yields only two possibilities, and a denial, and factual basis therefore, of doing the exact tapping alleged, is NOT one of them. What it means is either 1) They are tapping the hell out of these lawyers just as alleged; or 2) They are not tapping, but want to leave the impression they are in order to intentionally harm said lawyers business. Total scum either way.
Oh my, this is typically precious:
Anybody got a light?
Yeah, you know you picked a bad week to quit smoking when the alternative is depression and suicide….
You trying to kick smoking? How are you doing it?
There are a number of expensive drugs for smoke ending out now with modest results reflected by most of the literature/studies.
And of course there are all kinds of programs that are expensive with disappointing results that involve a mix of behavioral therapy, etc. etc. some legit and some quack.
One of the best and inexpensive meds I ever saw work awfully well, was the off lable use of Boeringher’s Ingelheim’s Catapres (Clonodine) either as a patch (TTS patches) or .2mg pills TID (about 3 times a day).
Catapres was released in the late ’60’s early ’70’s as an antihypertensive. It blocks alpha receptors that stimulate nicotine appetite in the brain stem.
The first concern would be that if you had a sterotypical small person with weight at the lower end of the scale, that you might cause hypotension especially when they stood up (orthostatic hypotension) but this has proved not to be the case and it has worked pretty well over the years, not to mention that we have about 12-15% of the population in this country who are untreated/sometimes undetected hypertensives anyway.
It’s not a perfect magic wand–there has to be concommitant willpower–but it gets good results in a significant percentage of people without excessive cost. As with almost any drug, I see google hits of reports by patients “worst drug in the world” but you can find those kinds of reports on the web for just about anything, including H20.
I found it to be an inexpensive help to the vast majority of people I tried it with to stop smoking.
At the risk of hijacking my own thread (probably fair though, because I hijack so many of Marcy’s), my real beef is what the hell is the Federal government doing recommending, and by name, a specific drug in a situation like this? And to the very professionals in the field to start with, the doctors? Tack onto that the fact that the drug clearly shows an adverse risk profile that looks significant, and directly recommending it just appears beyond the pale. The US government ought not be in the business of shilling and hawking brand name drugs. And especially not the asswipe that, you know used to work for that drug maker.
I read the little MNBC story on Chantrix. Take any drug and there are tons of MSM stories you can find on any given day some better researched and done than others. From the MSNBC article we actually (and typically in my years of experience) know next to nothing about the adverse risk profile of Chantrix.
Drugs get approved by the FDA after making it through NDA’s which are a 4 stage process that start with controlled and rigorous hospital bed studies, or hospital based studies, and then three more stages, with the last being studies in outpatients in physician’s offices and clinics. Then there is an extensive post marketing adverse reaction reporting system via the drug company that released the drug for doctors and patients to access and the FDA has a parallel reporting system.
I don’t know what the medical backdrop is on this drug right now, since it got on the market two years ago or the actual number of adverse reactions, but I’ll check it out in the medical lit in a day or two and tell you what I think fwiw.
As to adverse risk profiles that are significant, all drug pack inserts (ayk required by law to submit to the FDA after the NDA’s the hoops that meds have to get through to get on the market–hardly a perfect process and more lacking during the Bush admin) have risks/side effects listed.
Other than Catapres the results of so many of these new meds for smoke ending have been disappointing to me and equivocal, (not to mention that all of them are relatively expensive) that none of them have excited me.
I’ll give you an old stat. NEJM has a classic protean study done back in the 1980’s that has been reproduced scores of times that I use to hit people over the head with.
I always tell them forget you have lungs or there are lungs because long term COPD and other diseases are well known to almost everyone as an incentive not to smoke. Then I trot out this study. The study shows that in men and women on a cigarette by cigarette addittive basis that men over 40 who smoke 2 packs per day have an 800% morbidity/mortality rate from MI/CVA (stroke) and women have a 400% M&M rate.
That stark figure ought to be enough to get most people to want to stop smoking.
Granted drugs get on the market, and there are post marketing studies that produce alarmss (the companies have a pretty thorough monitoring and reporting system–you can bet they don’t want product liability litigation to happen and especially not to snow ball and they do care profoundly about patients who use them as do MDs.
I haven’t used Chantrix Bmaz and I haven’t had to because as I said above Catapres works very well for me, and it has for years (for patients–I haven’t taken it). The MSNBC article doesn’t mean much to me though. Sidney Wofle is a fixture who has been around as long as Ralph Nadar some good work and some questionable. That’s a stock comment for him and can be said of every single pharmaceutical agent that was released in 2005,2006, 2007, 2008.
I have to spend the rest of the night working on a presentation on atrial fibrillation I have to give tomorrow, but later on I’ll hit the literature on Chantrix and fwiw give you one physician’s assessment of the lit and suicide risk, etc. I’m not saying that’s not a signifciant concern, but what I am saying is that the MSNBC article is pretty superficial, and having seen a few thousand like it over the years, I’d rather go to the real literature and then I’ll tell you what I see.
Chantrix isn’t making a big splash in the scores of medical journals we get a month, that much I know, but I’m sure there have been some articles I just haven’t seen. MSNBC provided a statement to scare you, but not a lot of substantive adverse reaction info to support what it said. It was a typical “Rich capitalist drug company releasing crap that may harm or kill patients to make profit and by inuendo and MDs don’t give a damn.”
With all respect due, the MSNBC article tells me little, but I’ll get back to you given a little time to check Chantrix out and I’d do it now if I didn’t have to work on my presentationH
I’m hardly a fan of some of the Bush administration’s boneheaded moves in policing some adverse events–formadahyde in trailers and an agent that can cause irreversible respiratory harm that finally got removed from microwave popcorn comes to mind, but over the years, as to drugs released onto the market there has been a pretty decent track record overall.
The Heparin death situation currently in play is very alarming, and I’ve been following it closely. Currently the makers are saying the Chinese companies were sabotaged. I think evidence is that the situation is hardly that simple, and it will point to a sloppy policing procedure of the early stages of heparin manufacture in China.
BTW, these drugs get to market after extensive research and presentations to an FDA Committee composed of specialists in the particular field as well as FDA clinician researchers. I’ve watched votes over the years that are by one vote with much controversy in the medical literature generated after the vote. Controversial votes are the exception rather than the rule.
There is also a Supreme Court that puts people in the White House by 5-4 votes, (in that case a swing vote by one Sandra Day O’Conner and a smug son of a bitch like Scalia pissing you off and me off saying “Get over it.” going all over the place this week trying to sell his book. I’m not saying your health should be in such a precarious situation at all.
Irrespective of all that, my thought is simply that the Federal government should not be hawking specific drugs brand name, and it sure as hell should not be done by the chump formerly associated with the maker of that drug. It is just unseemly, and would be so if the drug were perfectly safe. So don’t knock yourself out on the risk profile of Chantix, it won’t affect my opinion one iota.
I missed how the feds are hawking Chantrix. It got to market by the normal channels. As for MSNBC’s claim that
In the first place, I know that you’re calling Fiore a chump because you suspect some whoring of the drug by someone who had prior ties with Pfizer. Ties of clinicians who have an established legitimate and often distinguished track record of research in the field, and I haven’t done anything yet to research Dr. Fiore are very necessary or we wouldn’t have people researching at all.
Every teaching hospital and research institution including some excellent ones in Arizona has all kinds of grants from pharmaceutical companies like Pfizer to do research on their drugs. Have their been abusive and even illegal situations in the spectrum of these relationships? Yes but not often.
MSNBC has cast aspersions/inuendos on Dr. Fiore however rather carelessly with nothing substantive to back them up. He was probably ideally situated to write the guidelines for smoke ending which by the way don’t have a damn thing to do with favoring Chantrix or any other med currently available to us for achieving it.
So I think you were a little quick on the trigger finger to bemoan this from the MSNBC sentence you read–he hasn’t endorsed Chantrix or Pfizer for smoke ending–he simply wrote some rather generic general guidelines that frankly have little impact on the prescribing of any drug for smoke ending, and realistically little impact on the enormous risks taken by people who continue to smoke.
BMaz I promise to give you a straight up assessment of Chantrix after I hit the medical lit and some more comprehensive decent articles than the MSNBC one tomorrow evening, but I’m not aware that the federal gov is hawking it or any other drug. Chantrix went through an FDA approval process period. It’s one of hundreds of new drugs that get to market every year. The federal government as far as I know hasn’t done anything specific to hawk it though. Pfizer hawks it on their websites and in spashy ads in all the “throwaway lit” magazines we get as part of controlled circulation as ever drug is hawked by their maker adhearing to FDA guidelines during the advertising which has vintage the last 15 years included a hypermanic rapid fire recitation on TV ads of side effects (which to me is worthless and was part of a law passed by Congress some years ago). Are side effect discussions relevant and critical, of course, but presented in the way that legislation has caused them to be like some auctioneer at Southby’s on TV–I don’t see the benefit.
I don’t give a damn about Chantix itself, that seems to be your overriding concern, not mine. When the Federal government instructs doctors that they should be using it as the primary treatment modality, they are hawking it. I am done with the issue.
Forgive me. I was offering to help you get information on Chantrix beyond the very superficial MSNBC little blurb you seemed to be relying on. If you don’t give a damn about Chantrix, then I’ll drop it unless and until I consider using it in a patient. But you don’t know anything about Chantrix that’s clincially significant at this point Bmaz and you’re way to smart than to rely on that piece of crap MSNBC article as clinically substantive. At any rate I wouldn’t and I’ve been at medicine for some time now and I am a voracious reader of medical literature.
What I missed in these comments was where in the hell has the federal government started to hawk a particular drug? That seems to be the source of your anger. I haven’t had all night to devote to these threads, but I missed something here. What says where that the feds are hawking a particular drug–I don’t care whether it’s a generic or a brand–I’m just intrigued where you were piqued and I missed that the feds are hawking anything?
I didn’t see that. I just saw your link to the rather crappy MSNBC article. I’m not saying your concern is crappy but if I were to assess a drug, I wouldn’t be using that article to do it. I offered to spend my time later to pull the literature on Chantrix (and use pretty extensive resources at my fingertips to do it) but I’ll forget that.
My concern was to respond to you and out of respect to something you brought up here, to help you research it. Your impressions that the guy who wrote the guidelines has anything to gain from Pfizer at this point given that they are generic guidelines for smoke ending are simply wrong.
I missed exactly what prompted you to call Mike Fiore, M.D. “a chump.” He’s devoted his career to smoke ending research at the University of Wisconsin School of Medicine.
His CV and career as an internist doesn’t spell chump to me, nor do the guidelines he wrote favor Pfizer.
Pete, you sound like you trust the FDA.
Loo Hoo–
You know by now that I share your distrust on many fronts with the government in general and Bush government specifically.
As to the FDA I’ve had the vantage point of a practicing MD for years. It’s a large complicated bureaucracy with a lot of interaction with tertiary academic centers and superb places like NIH. I trust a lot of things they do, and have had issues with many others.
I’ll guarantee you one thing. While I have been an early adopter of a lot of medications early on throughout my years of practice, I have an excellent idea of what they will do for years before we get our hands on them because they are in the literature for the most part for several years before they are released and the advent of the internet has made scores of the best and brightest studies available to us at our fingertips in our inboxes–not to mention the scores of sites I have access to to spoonfeed me the best literature on them.
I basically have faith in the FDA as to most of the drugs that have gotten on the market over the years. I am aware of any of the glitches that happen from a variety of sources incluing the literature, meetings, and a controlled circulation of excellent journals that pile up every day of every week.
In addition to these I do my best to follow a lot of the media. The MSNBC article is one of tens of thousands I have seen over the years. I’m not discounting concern over Chantrix/depression/suicide which I have not researched at all (but will) but I hope I wouldn’t rely on that MSNBC article for much of anything if I were in high school or an MD with years of experience.
Many of the SSRI’s and newer drugs for depression also have a paradoxical small incidence of causing depression and other side effects, some less serious and other more serious.
Some of the newer neurileptic (antipsychotic drugs) have serious concerns as to long term renal effects, or long term precipitation of athersclerosis and cardiovascular effects and adverse effects on lipids.
We try to know the fisks benefits well, and then make intelligent safe decisions that help people.
Sometimes, depending on what you have to use in clinical practice (Heparin is a good example right now) serious lethal events slip through the safe guards in the system and surprise and alarm us all.
The dog food situation last year was another example of a serious and sad scenario.
You gotta hand it to ole Gary, Indiana and Lake County. They set up a lot of the “best political news organizations” in television including normally sensible former US Attorney Jeff Toobin a CNNster to started a hyperventilating, panicked witch hunt for corruption in Lake County, Indiana including Gary Mayor Rudy Clay and long enough for Jon Stewart to skewer all of them.
I thought Lake County did the networks who would have otherwise had hours of paint drying dynamics a favor.
Well New York Cityites may want to quit smoking before July 1, which is when a pack of smokes will average $9. (New city taxes.)
I quit around the time they cost $3. I couldn’t afford tobacco and crack.
bmaz@13 “…fight it as long and hard as they can right up to the point to where they are going to get their ass handed to them and then they cave enough to make the case go away but still live to abuse again with impunity.”
That was precisely part of Modus Operandi of John D. Rockefeller,Sr as flushed out in Ida Tarbell’s History of The Standard Oil Co. from court docs and accounts of interested parties. Very effective when used against decent and reasonable persons.
This from the AP wire:
[snipped]
That’s true but what’s also true is that if Barak gave Hillary Michigan’s delegates straight up (I’ll remind you that both of them are Ivy league graduates of Harvard and Yale law schools who had a course in Contracts and knew damn well what the contract read that they signed–both of them are literate)she still doesn’t get the nominationby delegates not Super.
Michigan didn’t have Obama on the ballot, and he’s not going to be penalized for that no matter what happens, and there was no legitimate primary in Florida by anyone’s stretch of the imagination except for Hillary and Camp Clinton and perhaps an emerging comedian attorney who is becoming pathetic named Jeralyn Merritt and some of her cronies at FDL.
So if very committed people like Marcy Wheeler feel better and Michigan gets seated and that helps her feel better, bully that. But Clinton is desperately seeking to break the contract she signed to try to claw her way to an election she has clearly lost now, and it amuses me in one sense and saddens me in another to see Clinton emerging in the posture she has assumed after last night.
I’d give Mily Cyrus a better chance at being on Obama’s ticket than Hillary. It’s not going to happen. She’s over. Let’s seat Michigan; fine by me. It’s not going to help her. It might make the people in Michigan feel less screwed by the very nasty people who screwed them.
Hum, hum, hum hum. Hum, hum, hum hum. Oh, yeah, alright.
Here are the pertinent recommendations for the primary treatment contained in the new guidelines:
All but two are generic modalities; but two, Bupropion SR (Wellbutrin) and, notably, Varenicline (yep, that would be Chantix) are patented single maker drugs.
Here is the background on this guy Fiore from a Wall Street Journal article. He sure looks in the bag to Pharma if you ask me. Now, is it possible he is truly some white knight only interested in the well being of the public? It is possible, but unlikely with the government we have; much more likely that they have put the industry fox in place to guard the public henhouse, and true or not, that is exactly how this appears. If this truly is the right way to do things, they should have taken steps so as to insure it did not look improper. If it looks like a duck, walks like a duck, and quacks like a duck; you probably got a duck. Fiore has the traits of a duck. Quack!
Bmaz–
Bmaz lol yeah, except that:
There aren’t any other approved medications in the US for smoke ending.
So where is the reason for your concern that this guy was pushing or the feds were pushing Chantrix when there are literally only those drugs available–5 are Nicotine in some form of delivery–the other is Wellbrutin that we’ve had around sinnce the 1970’s and has been packaged as Zyban for smoke ending (doesn’t work worth a damn. Where did they say Yo “Chantrix is head and shoulders more efficacious”?
So then what has Fiore or anyone else on that several member committee done to promote Pfizer’s drug? They just named all of ‘em on the market!
And ironically although I haven’t tried Chantix and don’t see much reason to, the one that isn’t formally indicated but terribly safe that I’ve had a lot of success with isn’t on that list because it’s not approved formally for that indication. It happens to work extremely well. The others aren’t worth didly in my opinion, and in the opinion of several people I know. But Bmaz that committee didn’t in any way I see single out and showcase Chantrix in any way at all. And just for the hell of it this week later when I have time, I’ll “run Chantrix” meaning I’ll dig into it if you like and give you my straight up opinion. And often you’ll find that an alarmist lay article like the MSNBC little blurb that breathlessly reports suicide doesn’t clinically hold water in the legitimate medical literature, where double blind studies have been done at good tertiary centers like the med schools you have in Arizona and statistical results are actually reported. You’re entitled to that level of literature–not an MSNBC article designed to get web site hits.
Again where in that list is use of any one of those recommended? And look at the list–5 of them are all nicotine delivered by various means. I wouldn’t touch nicotine to help someone stop smoking. It’s a pathetic failure. Catapres works terifically well, but again they have to exert the same will power you need to exert when you’re trying to quit anything cold turkey. I view it as a helpful and inexpensive and safe adjunct. Buproprion not worth a damn for smoke ending. So that only leaves Chantrix which those guys and girls haven’t singled out preferentially and right now I don’t have any sense of how good or bad, safe or efficacious Chantrix is. But I’ll take a stab finding out sometime in the next week–possibly.
One thing is important to realize. Of the “modalities” listed–those are all of the approved ones. I take pride in the fact I’ve never used any of the nicotine replacement therapies and by the time anyone has ever asked me for help, they’ve always tried them. They fail consistently and remarkably. That leaves two on the list–Zyban (Buproprion) which has been available to us for over 20 years as buproprion or Wellbrutin for depression and in my opinion and many of my collegues totally pathetic as to efficacy for smoke ending–it gets touted cyclically for weight loss, ADHD, and many other potential indications, and I’ve been profoundly underwhelmed that it offers much help for anything except for depression in a small subset of patients.
So the committee of which the guy was one member simply listed every single drug that’s on the market right now. I’m holding in my hand the book we get mailed every month that lists all current medications, all new meds released this quarter, and all meds in the pipeline for the next six months. I’m looking at the list of what can be used for smoke ending and it coincides with the list you just posted.
There are no other drugs “approved” They just listed the ones availabe and left out the one I believe works much better than all of them.
I haven’t had any particular interest in Chantrix to date until I saw you mention it. So to call me obsessed was out in left field.
Here’s how this went. I like you. You spend a lot of time with good reasearch and good legal insights mixed with a healthy dose of common sense, and I was happy to use the tools I have and an objective look–I had to go back to see what drug the fuss was about–because I thought it would help you.
This is in the same vein that you mentioned wondering about Ted Turner’s opinion of dropping out of AOL/Time Warner day before yesterday or so, and I happend to have a long interview in a local paper of Ted who lives in the same town I do and I made a mental note to email you a copy when I got the time.
I’m trying to give you a straight up representation after many years of every day practice. I mean we see these conflict situations all the time–they are written about rather extensively in most of our journals, and Marcia Angel who is a brilliant internist was the editor of the New England Journal of Medicine which is a very prestegious job and she was terrifically experienced and well suited for that job. Marcia resigned her job over an article that she perceived to be a conflict of interest in 2000 after doing a superlative job running the NEJM editorialwise and medicine wise for 20 years–I’d have to look up the details but they are coming back to me.
Marcia wrote a recent book researching conflicts between doctors doing research and their relationships with Big Pharm–and because I know Marcia’s work–it has to be one of the best out there.
In my experience there has not been one med including all current ones that works near as well to stop smoking and it’s not a panacea but damn effective as Catapres TID and you can titrate up a bit with no significant side effects, dizziness, dry mouth or hypotensive worries. When I saw that sentence in the MSNBC article that
It didn’t mean much to me. The guideline might impact some PPO/HMOs lists, but not all that much. They do nothing for me. I’ve had a terrific success rate with Catapres–and when people ask me to help them stop smoking, they’ve already tried every form of nicotine gum, patch, etc. and it hasn’t done squat for them. I never use those products because in my experience over years they are a waste of time and money. The people have also tried quitting “cold turkey” by the time they ask for something, and they’ve failed with “cold turkey”.
The WSJ article didn’t do much for me because none of the claims was backed up by a scintilla of any studies in the lit.
I prefer Catapres pills to the patches and so do most patients for a variety of reasons.
And seven or 8 hours later, the Washington Post has picked up on the story we totally scooped them on. Emptywheel, first in news, first in insight…..
first in the eyes of her countrymen!
And also just up at WaPo, an extended length general profile piece on our friends at the National Security Archive.
Now there are at least 3 archives, Nsa, nara, waybak. On the pharm issue one of the gitmoite prisiners had mentioned something like chantix in a complaint recently which described what may be hepatorenal syndrome, I forget the document but may find it and read it again. When the kind md looks in the pdr, consider multiorgan impairments as a background on which to introduce it. PharmaceuticalRegimens of various sorts, some routine and some ‘atypical’ have been a longtime baliwick of both regular prisins and intell, and is a zone included in the list of exemptions in congress’ permissive mca, if I recall.
John–
I read the pack insert and a good deal of the the research info on this drug.
Do you mind rephrasing this sentence so that I can understand it with all respect due? I’ve read the PDR on Chantix and Pfizer’s ancillary information gleaned in their NDAs on this nicotinic receptor agonist. I’ve posted the entire pack insert from the PDR here and the significant points that it isn’t even metabolized in any passes in the liver and even in patients on hemodyalsis there have been no adverse effects reported during years of testing at multiple medical centers.
.
The most common adverse reactions include nausea, sleep disturbance, constipation, flatulence, and vomiting. Nausea occurred in 30% of patients; 3% discontinued due to nausea.
Observe patients for serious neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal thoughts or behavior. These symptoms as well as worsening of pre-existing psychiatric illness have been reported in patients attempting to quit smoking with CHANTIX.
In the first place after years and years of following hundreds if not a couple thousand drugs in the literature and in patients, a legal allegation that something may have caused HRS doesn’t count for much. If we take the pack insert (they btw have to pay to get their drugs in the PDR so thousands of generics aren’t in the PDR
I can take a random bunch of pages out of the PDR and in every single drug I can find rare instances case reported of some of the worst side effects or diseases. That’s always going to be the case. Sometimes there are post marketing sequellae that didn’t show up in years of testing during NDAs pre-market.
The on point question though is what are the incidences of documented side effects/adverse reactions/significant serious clinical results in carefully controlled statistical couble blinded studies done by experienced, reputable people?
Considering local attorneys are filing suits against the government for wiretapping them at Gitmo according to the NYT yesterday, and from reports I’ve heard Gitmo runs a pretty minimalist opersation I’d be astounded that Gitmo hasChantix or anything for smoke ending other than abstenance on their formulary and they probably encourage smoking as a way to calm their prisoners down.
Gitmo doesn’t give a flying fuck about the health of their prisoners, and I can tell you DOJ/BOP stateside doesn’t and the medical personnel they deploy are among the dumbest/most incompetent on the planet.
I find it hard to believe that Chantrix ever found its way into a Gitmo prisoner’s mouth.
Documenting that a single drug caused hepatorenal syndrome when it hasn’t got a clinical history of doing so is a difficult proposition.
Paradoxically, in the brief update we get mailed once a month, there are dosages of Chantrix for patients with “severe renal impairment” and even for patients on dyalysis!!!!
Prescribing Info Chantix
There is no hepatic impairment mentioned in this document. In fact, “Due to the absense of significant hepatic metabolism (relatively rare for most drugs, verinicline pharmokinetics should be unaffected in patients with hepatic insufficiency.”
In patients on hemodialysis 3 times a week, renal clearance was comparable to normal subjects.
Nothing is very surprising or atyical here. The worstening of psychiatric side effects comment is standard for virtually every single psychotropic medication including all anti-depressants and anti-psychotic meds on the American market.
And Chantix is a nicotinic receptor agonist so of course it has the side effect profile that Bmaz made such a fanfare of. So does every other psychotropic and nicotinic receptor agonist known to man. You wouldn’t know it from the erratic superficial articles at MSNBC or in the WSJ though. How surprising that is. Superficial ignorant articles in the print media that are medically naive with no pharmacologic background whatsoever. Heavens to Besty! How shocking!
So says the WSJ. But in fact the guidelines don’t say anything remotely like this. They simply list the drugs.
HHSGuideline Links Smoking Cessation
2008 HHS Guidelines Update
1) Number on the Committee: 24 mostly MD’s with MPHs, a couple of PhDs, a nurse, and one pharmacist. That’s par for the course.
2) Six liasons from medical entities.
3)Seven staff members (several are PhD level).
4) Typical federal government method of killing tress and wasting a considerable amount of time. About 250 pages of junk my 10 month old puppie already knows as far as clinical efficacy goes.
With the exception of listing a lot of studies for the sake of listing them, there is next to no clinical help at all. For an MD in practice for years, this yields zilch/zilch/zip/nadda over not diddly squat of useful clinical information. It doesn’t enhance or change most people’s practice one scintilla nor help a patient one scintilla.
And one of the reasons is that when you get down to it, we havent’ had any corner turning break through smoke ending efficacious drug in 30 years. I still put Catapres head and shoulders above these, and it’s not even on the list because that’s an off label indication drug that works beautifully to aid in smoke ending.
I’m wondering except for conventional custom why this was really written. The studies listed may be useful since some of them are in one place for research purposes, or completeness’ sake, but other than that I fail to see anything helpful here.
That said:
I don’t find one sentence in this whole thing that recommends Chantrix whatsoever.
So where in the world is the beef over the hue and cry that someone who used to do studies with Pfizer is one of 24 members of this committee when the committee didn’t recommend any of the seven “modalities” on the market as particularly effective over the other? And ironically in years of practice, I and hundreds of other people haven’t seen six of them work worth diddly squat.
Lets just agree to disagree, I grow very weary of this. I never would have mentioned this crap if I had any idea the thread would be consumed by so many longwinded comments by you on this off hand mention.
You don’t have shit for a duck Bmaz. Nothing is quacking and I’m surprised with your legal experience you couldn’t site and didn’t read the recommendations of the committee. They didn’t favor Chantix so how the fuck does anything quack like a duck or make a sound? You don’t like being called on something do you–at least tonight you don’t! I’m sorry but I have the medical experience here. There was nothing in the recs that favored any drug. Geez Louise there are only seven on the fucking market. 5 Nicotine analogs, 25 year old buproprion that we’ve had forever. And this nicotinic agonist. And I drilled into all the adverse reactions.
The psych warning is standard in every single antidepressant and psychotropic drug and nicotinic agonist on the American market.
Have you perhaps had a bad medical experience that has you chronically pissed off and colored your rush to judgement before actually reading the guidelines as I just did? A doc was not a good expert witness for you in a case? I mean there is nothing favorable in that 250 page epistle for Pfizer whatsoever!!!!!!
A few bottom lines for you Bmaz. I don’t know how long you’ve practiced medicine.
1) Nothing in the recs favored any drug. There are only seven on the US market as I drove home. You implied that the guy was a jackleg because it did. Show me Exhibit “A” where it did. I spent time reading it. Nothing there.
2) I gave you considerable years of clinical perspective and you’ve pissed on it like you were insulted.
The feds and this committee wrote a pretty meaningless standard set of recs as they do hundreds of times a year. Welcome to the USA. I’ve been seeing them for years. But Fiore and no one else on that 24 member committee or anyone else in that agency recommended any one drug (of the 7 and 5 are nicotine derivatives and only 2 are on the market that aren’t for Chrissake). I can’t agree to disagree. The medical facts are what they are. There isn’t anything subjective open to other interpretations here.
I know that MSNBC had a nitwit with no medical experience write an article and so did WSJ.
WSJ’s approach to the entire Libby trial was not one single article on it, not even when the fucker was convicted. They did however give us two stupid editorials. One was from Dorothy Rabinowitz and one was from Victoria Toensig and they were imbecilic. Welcome to the USA, and welcome to the WSJ.
For medical info try Larry Altman, M.D. who writes for the New York Times.
I’m not going to distort info when I give it to you–sorry. Have a good one.
Correcting the spelling of the hononym cite.
OT: Blockbuster from McClatchy: Did Bloch block ethics investigation of Condi to help Bush’s re-
selection?Here’s more. Thirteen page pdf draft memo from Bloch’s task force investigating a number of issues, obtained by the Project on Government Oversight. Happy prospecting!
That is great news Jim. Thanks for finding that. Lets hope all the evidence ends up in the hands that work for the Rule of Law. Another ROL win would be nice. Especially with this evidence.