VA Sends Chantix Warnings To 32,000 Vets
61 CommentsBy Ed Silverman // June 20th, 2008 // 12:06 pm
The move comes after a recent report that the Veterans Administration waited three months to notify veterans in a VA clinical trial of the side effects, including suicidal behavior and thoughts, associated with the Pfizer smoking-cessation pill. The vets in the study had post-traumatic stress disorder and were trying to quit smoking.
VA Secretary James Peake said in a conference call that agency docs will continue to prescribe the drug because they are seeing no serious problems or trends with its use, the Associated Press reports. And he defended the VA’s use of the drug to treat some of the veterans with stress disorders who were participating in a study to stop smoking.
Of the 143 veterans with PTSD who took Chantix in the study, Peake said that three - or 2 percent - experienced suicidal thoughts and that of roughly 800 vets in the study who did not take Chantix, 35 had suicidal thoughts - or about 4.4 percent.
According to the VA, the PTSD and smoking cessation study was aimed at determining whether it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately.
The VA would not hesitate to stop the study if needed, as some in Congress have demanded, but Peake said there was no evidence to suggest the study should be stopped. However, he added the study is not enrolling new people, according to ABC News.
Oracle
No incidents of suicide were seen in clinical trials of chantix. These addicts may be subject to severe side effects during cessation attempts and many won’t be able to quit. A comparison of the number of suicides among the general population vs chantix users would show PTSD sufferers are already at a very high risk. Shall we send them a letter? They are at higher risk of death from tobacco. Send them another letter. I don’t trust many of the self reports from chantix patients as one could end side effects just by smoking again. Tobacco will killl more PTSD paitients than any other substance. You’ve quit a hundred times and always feel better when smoking! Big –tobacco is fueling the battle over chantix..Who’s side are you on?
Laurie
“I don’t trust many of the self reports from chantix patients as one could end side effects just by smoking again.”
Oh, give me a break! They’re taking a drug that BLOCKS nicotine’s effects and has caused suicidal and psychotic reactions.You can’t just smoke to take away that reaction if the receptors are not responding to nicotine. Chantix alters brain chemistry..anything can happen when you do that. People who take chantix to quit smoking(and have tried other methods without success) don’t expect to become suicidal and psychotic, especially if they have tried to quit before without having that reaction on previous non drug attempts.
Yeah, don’t listen to those smokers adverse reaction reports….we all know smokers are incapable of knowing how they feel. :eyeroll:
Who’s side am I on? The patients side!
truthman30
Lets cut the BS here…
Chantix is yet another shining example of Pharma exploiting the public for financial gain…
They know that there are millions of desperate smokers out there who would literally try anything to help them give up…
So along comes another “wonder drug” called Chantix…
Never mind about suicidal and psychotic side effects , smoking kills millions so surely it’s better to risk killing yourself or your family on chantix than to die of lung cancer? …
All Chantix does is distract the brain, it doesn’t cure the habit of smoking, its replacing one dangerous drug with another..
That much is obvious…
truthman30
Chantix reminds me of another anti-depressant - quit smoking drug called Zyban (a GSK drug) ….
And if memory serves me correctly it also was hugely controversial and has a black box warning now about suicide..
What is it with pharma’s obsession of creating drugs that make you suicidal?
Bizarre…
Jane
Because truthman, its so easy to blame the patients for becoming suicidal.
oracle said “No incidents of suicide were seen in clinical trials of chantix”—–Let us see the raw data!
Laurie
““No incidents of suicide were seen in clinical trials of chantix””
Same argument they used for paxil…and look where that ended up.
Nathan
“Same argument they used for paxil…and look where that ended up.”
Still on the market — that’s where. Fortunately classic risk-benifit analysis generally prevails over media-induced hysteria. For now…
Jane
Nathan don’t be so fast to blame the media for this one. Patients have been trying to get people to listen for years. The media is just now picking up on the story. Please, give the patients some credit here.
anonymous
http://www.fda.gov/cder/foi/nda/2006/021928_s000_Chantix_MedR.pdf
Cut and paste that link–it takes you to the FDA NME review of varenicline. Not raw data but pretty close. 3 deaths with varenicline, 1 with placebo, 1 with buproprion. Also lists incidence of SAEs over 12-week trials and 1 52-week trial. Earlier in document indicates that FDA actually contacted study participants to ensure they had participated and no fraud had occurred.
Laurie
“Still on the market — that’s where. Fortunately classic risk-benifit analysis generally prevails over media-induced hysteria. For now…”
With a black box warning(based on GSK’s own clinical trials), banned for under 18 in the UK, and now under investigation for fraud.
I hope GSK’s behavior makes you proud on this one.
I have said over and over I am not antipharma, but it’s comments like Nathans above that show the total disrespect for the public that some pharma reps show.
Nathan
Laurie -
This society (as reflected on this website) is way too risk-averse when it comes to drugs. Did you look at the numbers above? There were actually fewer suicidal ideations in the Chantix group than in the control group! Granted it’s a small population size. It seems (at first glance) to be a noble aspiration to say that you are “on the patient’s side” and that you want full disclosure of risk to everyone. It’s a great soundbite. But have you looked at the patient information sheets already available? Have a look at the FDA info sheet for Naproxen:
http://www.fda.gov/cder/foi/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf
Look at the adverse event table. Here’s a sample of the adverse events listed for this OVER THE COUNTER medication:
heartburn*, abdominal pain*, nausea*,constipation*, diarrhea, dyspepsia, stomatitis
headache*, dizziness*, drowsiness*, lightheadedness, vertigo, pruritus (itching) *, skin eruptions*, ecchymoses*, sweating, purpura, tinnitus*, visual disturbances, hearing disturbances, edema*, palpitations, dyspnea*, thirst, flatulence, gross bleeding/perforation, GI ulcers (gastric/duodenal), vomiting, abnormal renal function, anemia, elevated liver enzymes, increased bleeding, time, rashes
The list goes on and on.
Laurie, you are a nurse, right? Have you ever recommended Naproxen to anyone experiencing mild to moderate pain? If so, did you go through this entire list of side effects with them? I’m willing to bet that you didn’t.
Drugs have such laundry lists of side effects that the consumer (including myself) either a) doesn’t take the warnings seriously or b) doesn’t bother to read them. We’ve OVERPROTECTED ourselves by going crazy with reporting every possible drug side effect! Now the lists are so long that consumers (and sometimes doctors) can’t make heads or tails of what is an actual important side effect to be concerned about and what isn’t. Based on the above list I should be concerned about taking Naproxen if I get thirsty, have gas, or get poison ivy!
So back to Paxil and Chantix. The list for those two drugs is at least as long as the above list. Probably longer. Suicidal thoughts and tendencies have ALREADY been added as a potential side effect. What more do you want? Do you want it off the market?
Has GSK behaved badly in the past? YES! But that isn’t my point or my concern. I’m interested in looking at presently known data and making the simple yes or no question: Does Chantix (and Paxil) have an appropriate risk-benefit profile that supports continued approval and marketing? I think in spite of the media storm of late, the overwhelming answer is YES.
Dr. Sal Giorgianni
I do hope that all who review the VA story above understand and appreciate the underlying clinical complexity here. (Sorry if all of this has been brought up before, I did not note it but do not always see every posting). These brave and honored individuals all had a very complex underlying condition. The four little letters P. T. S. and D. hardly convey the magnitude and horrors that this terrible psychiatric condition embodies; including suicidal ideation. You all here are pretty Internet savvy so look it up…check out the condition and its manifestations. I hope that will help you understand a bit of why the folks at the VA might have wanted to do this bit of work.
Now please mull this over, the group that took Chantex had a lower (probably not statistically significant with the numbers involved) rate of suicidal ideation than the non-Chantex group. Yes, the VA should have been a bit more disclosure oriented (please note critics who espouse the netharious corruptive powers of corporations, that the VA constructed and ran the study, not PhARMA) but from a scientific standpoint the early data would support studying this a bit more (and the politics would suggest with a bit more attention to detail and disclosure).
One additional note, a bit off topic but it is Sunday; as an advisor to The Men’s Health Network, (and father of a deployed US Marine); we believe that our nation will soon be challenged with a very difficult mental health matter. As our solders begin to return from war zones the need to manage PTSD both from the perspective of the solider (active or veteran) and that of their families will increase in numbers and complexity very rapidly. Our veterans and their families would benefit if those of us who have a voice in the health care debate keep an eye on this and as may be warranted help advocate for their needs
truthman30
: Does Chantix (and Paxil) have an appropriate risk-benefit profile that supports continued approval and marketing? I think in spite of the media storm of late, the overwhelming answer is YES.
Oh Nathan..
Have you read the current consensus about Paxil lately? ..
Have you read the last three posts on this very blog about the Department of Justice investigation into GSk marketing practices of Paxil in the US?
It has been discovered that GSK hid the true risk profile of this drug!
It makes depressed people more suicidal!
How can you justify it?..
Laurie
Nathan, I think I could agree with you on drug risks IF we had seen the suicidal/agression potential on the initial drug information with Paxil. The signals were there in the clinical trials, the drug didn’t recieve FDA approval for children.
But yet when parents tried to get that KNOWN information listed on the drug insert it took years to accomplish. It took finding suppressed clinical trials, it took lobbying the FDA, Congress and anyone who would listen to get those risks made public. It took the deaths of children to get that change made.
Yes, that risk is now documented because we, as parents, fought and fought hard to get them listed. If GSK had put those risks there in the first place, had not marketed to child psychiatrists and actually stood by their “dear doctor” letter to NOT prescribe this to children I might be able to agree with you.
Yes, all drugs have risks(and yes, I do give those risks to my patients..that’s my job) but in the case of Paxil those risks were denied and even worse hidden for years. Parents were not given the information to make in INFORMED decision, nor given the information to properly monitor their children. THAT is criminal, when GSK knew all along that those risks were very real, as evidenced by the black box warnings being placed based on the GSK initial clinical trials.
You’re argument only works if the drug company fully discloses the risks and benefits. This was NOT the case with Paxil and I fear not with Chantix either.
Drugs can be lifesaving substances(without them my diabetic husband would be dead), but that doesn’t mean we don’t lay out the good with the bad for the patient to make an informed decision. And yes, I choose to be overprotective when it comes to my child, as I’m sure you would also.
It is never ethical to withold drug information for the sake of compliance!
Atlex
Laurie,
The Chantix label includes suicide ideation and neuropsychiatric adverse events in its label. I’m pretty sure there’s full disclosure. Certainly there’s no evidence of data being withheld.
Atlex.
Laurie
I just did some research and the “pre warning” went up in November 2007 with the “official” warning being added in May 2008.
So I’ll give credit for the quicker response with Chantix. Interesting side note, I work with alot of surgeons. One tried Chantix and told me about the bizarre thoughts that he had. He stopped taking it quickly when the warnings came out and he identified the cause of those thoughts.
Jane
Even if Paxil was taken off the market today and never to appear again the ramifications of what was allowed to occur will live on.
The Paxil studies played a hugh part in conviencing doctors suicidual and other severe reactions did not occur with anti-depressants. To this day, many people do not believe these medications can be deadly. Almost anyone can tell a story about how a friend or loved one got worse after starting the drug. Because of the Paxil research everyone beleives its the illness and not the medications causing the symptoms. As a result our hospitals and Psychiatrist’s offices are flooded with “treatment resistant” patients. Many of them reacting to the first medications they were given.
Paxil research also said there was no withdrawal side effects so when patients began suffering when withdrawing from the medications it was deamed a symptom of their illness and not the withdrawals.
So when some of us hear what is being said about Chantix not causing people to become suicidal and that they are mentally ill, well it sounds eeriely like Paxil marketing.
It’s pretty scarey stuff!
Laurie
“Even if Paxil was taken off the market today and never to appear again the ramifications of what was allowed to occur will live on. ”
If paxil was removed from the market it would be a public health crisis for withdrawal related problems.
Lisa Van S
Ed,
Did the VA disclose how many of the 800 participants were receiving antidepressants or antipsychotics for their treatment of PTSD. This might explain the suicidal ideation in the group not getting Chantix.
Atlex
Jane,
Actually Pfizer updated the labeling on January 18th. The following is from a press release on that date:
“Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today updated the CHANTIX label in the U.S. to include a warning that patients who are attempting to quit smoking with CHANTIX should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.”
Atlex
Laurie
Good for Pfizer. Now if only doctors would recognize this type of reaction and stop writing it off to “mental illness” we would have some progress.
Nathan
Laurie writes:
“and yes, I do give those risks to my patients..that’s my job”
You give patients the COMPLETE risk profile of given drugs? Read back over the Naproxen side effects. Is that really the list of side effects that you give patients? What if “suicide ideation” was listed as a side effect. Would you highlight that risk or lump it in with the others?
Maybe you are more diligent than 99.9% of other doctors, but I’ve never had a doctor list more than 1 to maybe 3 possible side effects. In reality there are DOZENS AND DOZENS of side effects documented for each and every approved drug. This hysteria over suicide has gone way overboard. Yes, companies should be honest. In exchange, consumers should agree to act rationally! A 0.0001% risk is really not a risk at all.
Nathan
Truthman writes:
“have you read…Department of Justice investigation into GSk marketing practices of Paxil in the US? It has been discovered that GSK hid the true risk profile of this drug!”
I’m no advocate for coverups and lying. That’s what the DoJ is investigating. So far I know of no effort at the FDA to restrict the use or sale of Paxil. If it is so dangerous, why hasn’t the FDA (or any other worldwide regulatory agency) yanked it off the market?
Lisa Van S
Nathan,
Im sure your tone on this issue would be different if your daughter/daughters attempted or committed suicide due to the effects of a medication. Think about it for awhile!!
“Risk is really not a risk at all”,… Really!!
I wouldnt make that statement in a crowded room of parents, would you? Is a statement like that being brave,.. or just stupid.
Justice in MI
The Glenmullen report highlighted and linked in another recent thread asserts that GSK intentionally covered up the risk of sucide associated with Paxil. One can agree or disagree with that finding. It is, indeed, what is being investigated for possible criminal charges (which, as I’ve posted, are extremely unlikely regardless of what the evidence suggests. This not because of some conspiracy; it is conventional in these sorts of cases for DOJ to go for settlement or some other “remedial agreement” whatever the evidence available).
Whether Paxil should or should not be withdrawn or otherwise titrated is an entirely separate question. There is no logical connnection between that question and whether
GSK committed fraud during the approval and post-marketing process.
laurie
Nathan, your thoughts on this subject mean nothing to me. When those statistics mean your 14 year old son is standing in your living room running a knife across his arms, screaming he was born to die,and spends the next year of his life in the hell of withdrawal, yes, that tiny number is extremely important.
You lack of insight into what those statistics mean is seen throughout your industry. Try talking to real people who have gone through this…then tell me it’s “insignificant”.
As for my education of patients…I do what every medical professional is expected to do. I don’t pick and choose what side effects I feel are important to a patient. EVERY side effects is something they have a right to know.
I can only hope that your children are never victims to a situation that you deem “media hysteria” as ours were.
John Q
Nathan, Atlex, Just as I told you on the “Round Table” post, this is an uncontrolled problem that the FDA or Pfizer will no longer be adapt to handle.
Never in history has a drug(like Chantix) been taken away from pilots or truck drivers without the right to a NIDA screen. Now we are seeing four parts of the government involved in the withholding of information. What a travesty this little Pfizer story is becoming.
Someone(Nathan or Atlex) argued the point of Chantix not being the only drug being banned without the use of a NIDA screen for DOT.(No Benadryl is not one!) I need an example.
As for Pfizer, too bad for we all know what congress can and will do with this “media hysteria”.
truthman30
Nathan…
I am not going to debate the merits and dangers of Paxil to someone who defends the industry like it’s his mothers milk.. (yes that’s you Nathan)
You know nothing about the subject, I was on the horrible drug for 4 years, I know what it feels like to crap my insides out my ass in withdrawal for months , I know what it feels like to have my brain raped and poisoned. Do me a favour type “Seroxat” or “paxil” into your google search bar and pick your jaw up off the floor when you see the endless pages of bad s*it reported about ths disgusting chemical.
You ask why it hasn’t been pulled Nathan, Well you know how powerful your industry is, and you know how they get away with suppressing negative data for years on end, and you know how long it takes for investigations don’t you? And you would also be aware of the incompetance and dismal failure of the FDA I am sure .. Well that kind of answers your question doesn’t it?
Paxil is off patent now, JP garnier is gone, I wouldn’t be surprsed if Paxil is gradually withdrawn, and actually I spoke with a consultant psychiatrist recently about my experience with Seroxat and he believed every word I said about the side effects, the long term effects and the dangers of SSRI drugs. He also said that Seroxat is rarely if ever prescribed to new patients because the side effects are too unpredictable… So there you go, Most doctors don’t want to prescribe it anymore. But believe me , if GSK were to release all the data they have on Paxil and if all the court documents were unsealed, Paxil would be banned , absolutely no doubt in my mind…
Nathan
Laurie,
You can say I don’t understand statistics if you’d like. (frankly, you are right — that’s never been a strong point of mine. I’m a chemist.) My point is that every drug has dozens upon dozens upon DOZENS of potential side effects listed. Suicide now is now frequently one of these side effects. Why do you guys single this one out? There are plenty of other life-threatening side effects on most medications that you never mention. I think your fixation with suicide is likely due to a tragic personal experience. That doesn’t invalidate your opinion, of course — but it does make me question how much logic you are really applying here. Why are you fixated with suicide??? Why didn’t I see you posting when Ed ran a story about a little girl who became blide from a rare side effect likely due to Motrin???? This is just as tragic!! Her blindness was likely caused by a rare allergic reaction to the drug (Stevens-Johnson Syndrome)
These rare side effects likely are real! The problem is that they are SO rare that we in pharma R&D just don’t have any tools in our repertoire to deal with them. The only real solution to these incredibly rare side effects would be to not use drugs at all — which would entail a much, much higher risk for society. I’ve never advocated the cover-ups and lies supposedly perpetrated by GSK. We need honesty and complete transparency. But we also need consumers to be rational people who understand that sometimes unforeseen things just happen in life and that sometimes there really is no one to blame and nothing that can be done or could have been done to prevent it. We can’t just take drugs off the market because 0.0001% of people on the drug will commit suicide, suffer Stevens-Johnson Syndrome, or have an idiosynchratic drug reaction.
Here’s some numbers:
There are typically 8 deaths annually due to baby bathtub seats or rings in the US.
There are typically 16 deaths annually due to baby cribs in the US.
There is typically 1 deaths annually due to baby changing tables in the US.
There are 28 people that die every year due to natural gas heating systems.
Large appliances electrocute approximately 80 people per year (in the US).
Now, what are we supposed to do about those events? These are NOT due to lifesaving devices! Should we ban cribs, heating systems, fridges, etc. because they kill people every year?? Should we require mandatory consumer education before the purchase of such dangerous items as cribs and changing tables? The risk is REAL!!! It’s exactly analogous to the suicide issue in question. The risk is REAL – but the answer of what to do about it is not apparent.
laurie
Nathan, you obviously just don’t get it, and I’m not going to explain my position over and over again for you to put up non sensical comparisons.
Atlex
John Q,
You are wrong and no more explanation is needed.
Atlex
Nathan
Laurie,
You are right. I just don’t get it. We’ve said over and over again that drugs have side effects. But you seem to want to look only at one side of the risk-benefit analysis. An example used over and over again on this site is the fact that seatbelts, airbags, and car seats KILL many people every year. Yet society accepts the small risk that the use of these products entails in order to receive the benefit from them.
You can’t look at just the risk and you can’t look at just the benefit. You have to look at both and decide whether the risk is WORTH the benefit. Sure, for an individual family who deals with a suicide – the risk is NOT worth the benefit. But the FDA doesn’t approve drugs for use in 1 family – they approve drugs for SOCIETY. Drugs can’t be evaluated based on an individual case-by-case analysis – they can AND ALWAYS WILL unexpectedly hurt some people.
John Q
OK! Lol Give me facts. I actually have the facts. Let me see them from Mr. Pharma.
Atlex, People who actually work on the inside of medicine laugh and laugh at the great lengths at which a rep will state about his/her drug(or any drug). When actual FACTS are shown like how serious the AEs from Chantix are affecting the consumer, then yes, the fact remains that NEVER in history has a drug had to be banned(as in stopping the employee from working that day if they have taken the drug) by the FAA or DOT because of AEs…..
Sorry, you are completely wrong and can not prove other wise! Trying to talk about other drugs does not change the facts of this blog and the lies from our Government and Pfizer
John Q
The FAA and the DOT are not of the skiddist type as to ban a drug without the use of a NIDA screen because now it will set itself up against a bigger problem from the workers union.
The AEs from Chantix are more reported than the public is aware of. Do you think parts of the Government would ban a drug that has the potential to actually help people because of a little bad publicity? Give me a break!
Atlex
John Q,
First of all, both organizations are skittish and they should be; theyt are safety organizations and should not take chances. But, once again you provided no reference or link for your “facts”. We know that Chantix has been placed on a banned list by the FAA, but as I previously stated there are dozens upon dozens of drugs on that list, including all antihistamines (except the nonsedating ones), antidepressants, antipsychotics. etc.
Atlex
John Q
http://www.omsmd.com/occupational_medical_FAQS.cfm
I think you are intelligent enough to look up info as I’m sure that you already have.
I provided you links on the other post that you chose to ignore. Yes the FAA and the DOT do have the safety of everyone in their hands. That is why the withholding of AEs during studies is criminal!
Normally, a drug will not pass the FAA until proven safe for its pilots even if it is being used by the public. Yes, pilots CAN take antihistamines, but their list of drugs are more cautious than DOTs.
As for the DOT, there is NO ban on any drug that can not be tested!
I hope that you don’t have doping regulations that pertain to sports confused with the FAA and the DOT drug regulations. Anti-doping regulations are much stronger! Go figure!
Atlex
John Q,
No mention of Chantix on that webpage. And, by the way, benzodiazepines are very commonly used, FDA approved drugs that are not only banned by the FDA and DOT, but are also tested for in occupational drug screens.
Atlex
Nathan
As of March, Chantix was still approved for use by commercial pilots. Here’s the lastest info I could find:
http://www.leftseat.com/medcat1.htm
Chantix is allowed on a case-by-case basis once a pilot has taken it with no adverse observed. Here’s some other prohibited drugs:
Cetirazine (Zyrtec), Dipenhydramine (Benadryl) and Astelin (Azelastine) Nasal Inhaler, Diphenoxylate (Lomotil)
Anticholinergics (Bentyl)
Levsin (L-hyoscyamine)
Librax (chlordiazepoxide and clidinium)
Opiates (Paregoric)
Almost all SSRIs
Lisa Van S
Nathan,
You said, ” Why are you so fixated w/suidide”,.. Because young man, the side effect is preventable.
You also said,..But we also need consumers to be rational people who understand sometimes unforseen things happen in life,, Tell that to a grieving parent.
Horrible scenario,… a Pilot takes down a loaded plane due to a suicidal side effect. Ever fly Nathan? Wife and Children fly?.. think about it,.. but than again you are a reasonable person,.. right?
Atlex
Nathan,
Since March, Chantix has been placed on a banned list by the FAA. It is not allowed on a case by case basis.
Atlex
John Q
The reason there was No mention of Chantix being banned is we know that it has been banned by the FAA and the DOT. I was showing you an example of the use of the DOT NIDA drug screening process with the possibilities to more links. But if you need it again….
http://blogs.wsj.com/health/2008/05/21/faa-bans-chantix-for-pilots-air-traffic-controllers/
As I have stated NO drug has been banned by the DOT without a the chance for a NIDA drug screen.
http://www.fmcsa.dot.gov/safety-security/safety-initiatives/drugs/drug-testing-guide.htm
Uh, Yes benzodiazepines (Xanax,Valium)are on the NIDA list for both the FAA and the DOT as they should be, but not antihistamines as you stated.
Too bad original studies from Pharma and then thereafter must be lied about to try and protect one drug that causes SO much harm.
One only has to look within the company to see that the apple doesn’t fall far from the tree. In comparison,shall I say the chemical doesn’t fall far from the company!
Read Wednesday June 18 on
http://peterrost.blogspot.com/
What a bunch of pervs……
Nathan
John Q writes: “Too bad original studies from Pharma and then thereafter must be lied about to try and protect one drug that causes SO much harm.”
You really seem to have some animosity for this particular drug. I’m not sure what lying and coverup you are talking about. So far, communication about this drug has been incredibly open from what I’ve seen. If you are accusing Pfizer et al of lying, please provide the evidence and media coverage of it. (please, no blog entries — genuine media coverage only)
John Q
Nathan, are you reading about the subject before you type or do you just start typing and hope it seems true?
If this is what you call communication then I hope you are never sent to serve and protect us on the front lines. LOL, I don’t think you ever will. God save the troops.
No, no animosity for this particular drug, other than the lying.
Nathan
That’s funny John Q. Other than a 3 month delay in notification of vets by our government, I don’t see evidence or even any accusations of wrongdoing. Certainly none by Pfizer. Maybe you are reading a different article than I am.
John Q
http://www.ismp.org/docs/vareniclineStudy.asp
Wow! Wonder why Pfizer could not/would not give that info?
http://www.worldofdtcmarketing.com/files/e339eca6b0de27cd56054ccb263b407d-331.html
No, this is not “reliable new”, but seen it and it is funny!
http://blogs.wsj.com/health/2008/05/30/as-bad-news-mounts-chantix-prescriptions-crumble/#comment-192920
That was a nice try.
Nathan, it goes on and on. Where do you want me to go with this?
Nathan
John Q:
Link #1: This was adverse events reported to the FDA. This is all POST-APPROVAL adverse event reports. All of this is new data to Pfizer and it’s unclear what to do with the data since it wasn’t a controled study. Certainly this is worth looking into, but this alleges no wrongdoing on anyone’s part.
Link #2: Just humor - nothing of relevance.
Link #3: This is just a WSJ report of falling scripts - no allegations or evidence of wrongdoing. In fact, a doctor quoted in the article asserts that “The current response to Chantix is fear-driven — not science-driven”.
Nice try. If you think that Pfizer did something wrong, please provide the evidence. There’s nothing so far.
Atlex
One more thing to add to Nathan’s respose. The ISMP report is simply a categorization of AEs reported to the FDA. Many (maybe most) of the AEs were gathered and reported by Pfizer to the FDA. As that report notes, these are nothing more than signs that should be investigated further.
As Nathan also notes, you still don’t provide any evidence.
John Q
Man, you just like to keep on beating a dead horse, huh?
I guess the FAA and the FMCSA knew what to do with the info from the ISMP. Lol! where do you see in #1 where this is “POST-APPROVAL”. These are AEs that should have been reported in conjunction with the release of Chantix almost 2 years prior. What a screw-up!
Well…I’ll be back. I really do WORK for a living.
While I’m away, you might need to “brush” up on FAA and DOT regulations. I’ll try to “brush” up on Pfizer.
Atlex
John Q,
Again you are wrong. The ISMP report concentrated on AEs reported in the latter part of 2007, not the period immediately post approval. If you examined all AEs reports since approval, you would notice a significant spike after the media began reporting on the subject in September 2007. Spontaneous reports of AEs are very sensitive to media stories. That doesn’t make them any less relevant, but its important factor in any analysis.
Atlex
Jack2
Nathan and Atlex,
I appreciate your effort. You can’t please some of the people any of the time.
Lisa Van S
Hmmm,… Im all for Pfizer turning over clinical trial data,(Raw Data that is).
Gee,..Industry folks want our Young Men and Women in the Military to defend their freedoms, yet, refuse to display decency and human compassion when it comes to the truth about the safety and efficacy of the Meds they ingest.
Atlex
Lisa,
You’ve missed part of the point. Pfizer, as has been discussed, has nothing to do with the VA study. The incident involves the VA and its effort to communicate risks to its own patient population. The VA acknowledges that it was aware of FDA and Pfizer communications regarding label changes and admits that it might have been able to do a better job of communicating. Other than that, it strongly defends the study.
Importantly, if you believe the press reports, the study’s focus is not Chantix, but smoking cessation in general in PTSD patients. Only a small portion of the study’s enrollees were using Chantix. The VA also reports that a smaller percentage of patients on Chantix experienced suicide ideation than of those patients using other forms of smoking cessation treatment (although the numbers don’t reach a level of significance).
Bottom line…while you are trying to blame the pharma industry on this one, there’s no evidence to support your case.
Atlex
Just A Thought
I don’t really get this study. If Chantix proves itself, smoking decreases, revenue from tobacco taxes decrease, and the VA get’s it’s cut from a smaller pie. Government health care lies in the balance as there is discussion on all levels to support it with tobacco taxes.
Chantix ANHC (anti-national health care) drug
sarcasm, of course… kinda.
laurie
“But you seem to want to look only at one side of the risk-benefit analysis”
No, I’m looking at both sides. No benefit in children, directly from GSK’s clinical trials,a dear doctor letter from GSK telling doctors NOT to prescribe to under 18 and increased risk of suicide in that age group.
This information is from the “gold standard” placebo controlled clinical trial.
Pretty cut and dried.
John Q
Atlex, No these are AEs that have been reported since the release of Chantix as of May 06 that the ISMP is reporting. Do you guys read the ALL of the detailed material or only the relevant info that you like?
I do agree with you on the point of the military conducting studies that are focused on our vets. Normally this goes on without much ado from the general public. One study comes to mind is that of the of the MiniPress TTS. It was being studied for hypertension of course, but a weird thing happened, it caused smoking cessation. The military loved this one.
Come to think of it, I believe the studies were far more comparative than Chantix for smoking cessation. This should be taken back to HQ!
Congress will never let this one go. The ball has already started rolling. Pfizer is looking bleak.
Atlex
John Q,
Go back and read my note. I didn’t say that the ISMP report did not contain a look at AEs since the drugs launch. I said that it concentrated on (or focused on) AEs since September 2007. The key, though, as the FDA and Pfizer says, these AEs were taken into account with the label changes that occurred 3 times (I think) since the Fall and 4 times (I think) overall since the launch of the drug. In this instance, it looks as though the FDA and the manufacturer are diligently monitoring the AEs and making relatively rapid changes to the label. It seems to me that this is what should happen as a new drug enters the market.
I agree that Congress won’t let this go because it makes good politics. Of course, it’s terrible public policy, but why should that matter. The Washington Times and ABC made it sound as though the VA is performing Tuskegee-like experiments, when in reality they are comparing the effects of FDA approved drugs that are being prescribed within labeled indications. Semantics are important here–this is a “study” and not an “experiment.”
Atlex
John Q
Atlex, Just so there is no mistaken as to the AEs, I will quote…
“Varenicline crossed a signal threshold in the 4th quarter of 2006 when it appeared for the first time among a small group of drugs for multiple types of events: more potential cases of angioedema, cardiac arrhythmia, diabetes and severe cutaneous injury. By the 4th quarter of 2007 varenicline accounted for more reports of serious drug adverse events in the United States than any other drug.”
http://www.ismp.org/docs/vareniclineStudy.asp
Thanks Pfizer for the early warning(s).Lol!
Atlex, you do realize that the military was giving Chantix to these vets 2 years earlier than the release date from the FDA? That would constitute an experiment, not a study.
Atlex
John Q,
Your quote does not contradict my statement.
Also, I think you have misread the news report on the VA. They said the study, whihc is on smoking cessation in PTSD patients, was started two years ago. They didn’t say that Chantix was part of the study from the beginning; Given that it was only used in a small percetage of patients in the study, it is entirely possible that Chantix was not used until it received FDA approval. If it was used prior to approval, Pfizer would have been involved; both the VA and Pfizer have indicated that the company was not involved in this study.
Atlex
John Q
Atlex, You are correct. I do believe that I read the data incorrectly as the study for smoking cessation began in 2004 and still remains active with the current Chantix users.
I have no other reason(s) to believe that Chantix was used before its launch date.
James
Ridiculous.
The VA screwed up the protocol, used an incomplete IC form, and showed no concern for the subjects in the trial–their own soldiers.
So let’s attack Pfizer!
These discussions are becoming borderline pointless.
Todd
Google chantix warnings and then click on pfizer beefs up warnings on the first page. Im there with my story and its not just hype or a story. Im not a vet nor do I have ptsd. I took it for roughly 16 days and quite after about eight.Im so sick of hearing about suicide when its the rage , aggression , hallusinations that come before suicide. My whole world is different due to this drug and ive tried to quiet 4 times before chantix and had no rage.Im 44 years old and and ive seen toys recalled because one little wheel fell off but this drug is making money and i mean big money and thats all that matters to the big new tobacco or pharm. So before you sit and write whatever come to your head, …. come to realization that there are victoms out here from this and i asked my doc about all side effects and read the clinical trails. My box said nothing about suicide , rage , aggression and my doctor had been given no warnings from drug reps or pfizer as of April 25, 2008. If anyone else out there has had or knows anyone who has had my symtoms , please post. Thank you