Smoked: Did Two Experts Improperly Boost Chantix?

In April, four experts on smoking cessation published a paper in the Annals of Internal Medicine promoting an unconventional plan for helping hard-core nicotine addicts quit,BusinessWeek writes. And they proposed treating smokers as if they have a chronic disease, such as diabetes, instead of an addiction such as alcholism. Why? Insurance coverage for long-term med use.

Moreover, the authors, Michael Steinberg (pictured left) and Jonathan Foulds (pictured to the right), are paid for speaking and consulting by drugmakers with smoking-cessation products, such as Pfizer, the mag notes. And the paper appeared around the same time that Pfizer, at the urging of the FDA, added warnings to its Chantix label, fueling charges that paid experts are trying to protect a big-selling drug.

The researchers deny that. They say they follow only their independent judgment when recommending Chantix and other drugs, and emphasize they don't necessarily urge lifetime use of any drug. But they don't routinely reveal their Pfizer pay to hundreds of patients they've steered to Chantix, which has thrust them into the middle of a debate about proselytizing by medical researchers and how corporate relationships should be disclosed to patients, BusinessWeek writes.

"When (Chantix) goes wrong, it can go terribly wrong," Daniel Seidman, director of the smoking cessation clinic at Columbia University, tells the mag. "These guys may think (industry money) doesn't affect their opinions about the drug, but it does. When someone pays you, there's a bias."

Pfizer's Cathryn Clary, vp for external medical affairs, says she fears too much transparency will create confusion. "The more information that's out there, the more difficult it will be for patients to process," she says. Pfizer instructs the researchers it pays to disclose their compensation when speaking at professional conferences, and recently began disclosing grants for medical education on its Web site. [Our thought: Wait a minute. Withholding info is better? That's rather arrogant.]

The clinic at the University of Medicine & Dentistry of New Jersey run by Steinberg, an internist, and Foulds, a psychologist, is one of eight such centers in that state originally funded by the tobacco litigation settlements of the late 1990s. More than 500 smokers come through the clinic each year and it boasts a 30 percent success rate helping patients to quit for six months or more, the mag writes.

"The goal is to get more people not smoking," Steinberg tells the mag. "The medication is just a tool to increase their chances of being successful." And he's adamant that his work for Pfizer and other drug companies poses no problem: "We look at the data, and we look at our own clinical experience." Both of them stress that it's not standard practice to tell patients about potential conflicts.

Not that they make it easy to find out. The magazine tried and notes: There is no clearly labeled list of companies that pay Foulds and Steinberg that is directly accessible from the UMDNJ smoking clinic home page. There are links to journal articles, some of which reveal industry ties. But getting the info takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix.

But back In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix, and also selected Foulds and Steinberg to be "key opinion leaders," sending them to talk to docs about Chantix over dinners and paying them each $900 per presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.

Here's the rest of the story...

64 Comments

Jun 26, 2008 - 6:35pm

Dear Ms. Clary VP External Medical Affairs

“The more information that’s out there, the more difficult it will be for patients to process.”

You, Ms Clary, are a perfect example of why the public has lost confidence in the Pharmaceutical industry.

Jun 26, 2008 - 8:21pm

Marusa - Beautifully said.

Jun 26, 2008 - 8:37pm

Ms Clary,

As I recall,.. Congress raked you over the coals on Zoloft, in the pediatric population in Sept. 2004. I take it, that you havent learned your lesson!!!

Jun 26, 2008 - 9:42pm

When it comes to disclosure of financial relationships, the mantra from PhARMA, (as expressed by Ms. Clary is: “The more information that’s out there, the more difficult it will be for patients to process.”

When i comes to DTC advertisements, the mantra from PhARMA is something along the lines of consumers need more information so that they know all the options for addressing their healthcare needs.

These seemingly contradictory positions confused me momentarily; then I realized that Ms. Clary's position on physician disclosure is no different than the PhARMA policy on disclosing side effects, other treatment options, actual success rates of its medications, etc. in DTC advertising.

As my momma used to say, "the devil always speaks half the truth."

Jun 26, 2008 - 9:58pm

Here we go again... Ed, maybe YOU have a conflict of interest: You are paid by a newspaper to find stories that generate readership! Maybe there isn't really a story here at all -- it's all bias due the fact that you need stories to write in order to get paid!

Conflicts are everywhere... I wish EVERYONE quoted in stories (not just pharma folks) would start giving a COMPLETE conflict of interest statement including full tax returns, health history, charitable donations, occupation of spouse and children, and investment summary. Maybe then you'd all be happy. Probably not. I'm sure you'd still find something to gripe about.

I'd list my complete conflict like previously, but I've been told not to be sarcastic.

Jun 26, 2008 - 10:03pm

Anonymous,

Provide me the facts,.. Im quite confident that I am able to make informed decisions on my own...

Jun 26, 2008 - 10:06pm

Nathan,

Last Name and Company, will do just fine. Would you like to provide your credentials?

Jun 26, 2008 - 10:32pm

""Ed, maybe YOU have a conflict of interest: You are paid by a newspaper to find stories that generate readership!"

This "kill the messenger" tactic is getting tedious. Do you really agree with the statement “The more information that’s out there, the more difficult it will be for patients to process.” as an excuse?

Jun 26, 2008 - 11:54pm

Nice story! I wonder how many "clocks" they will be getting?

Steinberg states that the only way he will go back to prescribing patches and/or gum is if Chantix gets a black box warning?

Wow!

Surely a qualified physician would want an informed and knowledge patient unless he/she had something to hide like a conflict of interest that they were had not disclosed.

Go ahead and tell us Nathan. Don't stop in the middle. That's like keepin someone hangin!

Hi Nathan,

First, I'm in charge of the content at Pharmalot. That's my only gig. I am paid by the company that publishes The Star-Ledger of New Jersey, but this is a separate editorial product. I thought we'd gone over this before.

The Pharmalot readership, or viewership, reflects whatever people find interesting, or at least what I think they may find interesting. And it's a fairly diversified audience, which I think we've discussed before.

By the way, you seem to react selectively to the subject matter. I have posted frequently about compulsory licensing in Thailand, which rarely generates any comments. That isn't the only or best measure of readership, but if that was a primary gauge and I cared only about readership numbers, I wouldn't bother writing about that topic. But I continue to do so because I think it's interesting and important. So I think your premise is off base.

And yes, we've gone around and around on the conflicts issue. It may be an imperfect situation, but that doesn't mean there isn't room for improvement. Perhaps if these docs were more forthcoming in the first place, this would have been less of an issue. Maybe not. That might have depended on whether their patients knew or cared. But we've been over that ground, too.

So let's get to the point raised by BusyWeek - do you think these two docs should have been more forthcoming? Would have it made a practical difference? And in any event, why would it have been wrong for them not to be more forthcoming?

You spent time attacking me, but failed to make a case to defend them. So go ahead....

Cheers ed

Jun 27, 2008 - 4:53am

Ed, I'm not in the habit of "attack the messenger" -- I just this this self righteous attitude that everyone "else" should disclose thier COIs is silly. EVERYONE has COIs that are RELEVANT to the matter at hand. (including the writer of this post, the writer of the Buisnessweek article, and the writer of this blog) Otherwise we would have no interest in writing!

As I've said many times before, if you are going to critisize undislosed COIs then you really need to DEFINE exactly what constitutes a COI. Otherwise it appears to simply be selective reporting of whatever tickles your fancy. I have yet to see you report on any COI issue for someone opposed to the pharma agenda. (maybe I'm wrong - do you know of any examples?)

Jun 27, 2008 - 5:26am

Sorry, it's too early in the morning: I should have said "I just THINK this self-righteous attitute...."

BTW, you also need to define "disclose". From what I read in the Buisnessweek article, these guys did fully disclose their relationship with Pfizer in all professional journals and on their website. The only criticism was that they didn't directly disclose the relationship to their patients.

Maybe next time you are at your doctor's office, you can ask your doctor to go over his previous year's pay, his spouses occupation, his investments, and his health history. I, for one, will just trust his judgment. BTW, by focusing on this one (pharma) issue we are missing the biggest COI of all: Doctors are PAID to treat sick people! If we are all well, they will be out of a job! It's all a conspiracy!!

At some point we have to say enough information is enough. While you guys might scoff at Ms. Clary's statement, there is such a thing as "information overload". Look at the AE warnings listed on a bottle of Sudafed and tell me whether or not you think we've gone a little haywire...

So in closing, Ed, I'll completely stop bashing this type of story when you decide to post PUBLICLY a statement where you define EXACTLY what constitutes a "conflict" and what constitutes "disclose". Seriously. I want to see it. You owe it to your readers and you owe it to the people you criticize.

Jun 27, 2008 - 5:59am

BTW, Ed -- please don't deny you have a COI. You do. Here's the COI's that I can gather just from this comment thread:

Nathan: Employed by the pharma industry Ed: Employed to REPORT about the pharma industry Lisa Van S: Daughter was hurt by the pharma industry Laurie: Employed by the healthcare industry

We are not uninterested parties! Let's stop kidding ourselves: We ALL have COIs that are relevant! So, that said, I'll reiterate: I’ll completely stop bashing this type of story when you decide to post PUBLICLY a statement where you define EXACTLY what constitutes a “conflict” and what constitutes “disclose”.

Jun 27, 2008 - 6:13am

Claiming that everyone has COIs is right up there with claiming too much information just makes things "confusing" for patients--a very broad statement designed to cover a potentially problematic personal/business perspective.

Jun 27, 2008 - 8:50am

War horse, you hit it on the head. Sadly, this is the attitude that pharma has towards those who buy their products. They think that the public is unable to make a coherent decision regarding their own health.

As for the COI's Nathan listed above, none of those listed have recieved money to specifically go out and promote the use of any substance using a pharmaceutical template for that presentation. None of them has been shown to have minimized side effects and enhanced benefit outcomes. None of them has had the influence to alter the outcome of a clinical trial. If someone makes public their financial stake in a situation from the get go, then there is no problem. I can then make an informed decision with that disclosure taken into account.But when one has to search and search to find that association, that's a red flag for me as to why that disclosure is well hidden. As for Lisa, Ed and myself, it is well known what our background is. Yes, I get paid to do my job but I'm not in the position to influence others for financial gain. Reporting on a situation that is news is adding information, not witholding it. Reporters believe that the public is intelligent enough to have all of the information, and not the cliff notes version.

Jun 27, 2008 - 8:59am

Patients who "don't know" can continue to be blamed for their own stupidity when drugs do harm. Patients must TRUST their doctors and pharma to look out for them. Patients who seek "to know more" are prone to confusion . . . and journalists who shine a bit of light are conflicted to the same degree as Pharma. And pharma and doctors scratch their heads in wonderment that cynicism and mistrust abound in the patient population?

Jun 27, 2008 - 9:00am

Nathan,

that is pure subterfuge. Doctors cherry pick journal disclosures but if you don't think patients want to know about whether a particular manufacture pays them to speak, research or write before taking a doctor recommended med from that manufacturer- you are wrong. It may be the best med out there - great but as a doctor if you are going to take a 5 to 6 figure honorarium from pharma and MANY OF THEM do -- you should be able to support to your patients why that drug is best for them.

You and pharma are operating in a pre-internet world when the U.S. public didn't see the big cash cow that KOLS and speaker training programs are and didn't see what pricing regulations have done to the price of prescription drugs around the world-- that genie is long since out of the bottle and isn't going back in ... pharma needs to come up with less dervisive marketing tactics that are a positive benefit to the patient care paradigm. AND REMEMBER THAT THE END CONSUMER OF YOUR DRUG IS JUST THAT- THE CONSUMER

Jun 27, 2008 - 9:02am

Nathan,

that is pure subterfuge. Doctors cherry pick journal disclosures but if you don't think patients want to know about whether a particular manufacture pays them to speak, research or write before taking a doctor recommended med from that manufacturer- you are wrong. It may be the best med out there - great but as a doctor if you are going to take a 5 to 6 figure honorarium from pharma and MANY OF THEM do -- you should be able to support to your patients why that drug is best for them. Besides trust me and expect that with the information readily available in the information age- someone will ask. J

You and pharma are operating in a pre-internet world when the U.S. public didn't see the big cash cow that KOLS and speaker training programs are and didn't see what pricing regulations have done to the price of prescription drugs around the world-- that genie is long since out of the bottle and isn't going back in ... pharma needs to come up with less dervisive marketing tactics that are a positive benefit to the patient care paradigm. AND REMEMBER THAT THE END CONSUMER OF YOUR DRUG IS JUST THAT- THE CONSUMER!

Jun 27, 2008 - 9:13am

In a former life as a copywriter, the creative director at the agency I worked for issued each of us writers exactly five exclamation points at the beginning of each year.

That was our allotment. If we used them all up before the year was out and wanted to use more in our copy, we had to buy them from him...at $5 apiece.

His advice to us was simple: make the logic of your argument and the expressiveness of your language forceful, not your punctuation.

"If you have to use exclamation points," he said, "maybe you don't really have a point."

I'm thinking perhaps the same principle could be applied to CAPITALIZATION.

Just a thought...

;>

Hi Nathan,

Here goes...

A conflict of interest is a situation that has the potential to undermine the impartiality of a person because of the possibility of a clash between the person's self-interest and professional-interest or public-interest. This is from the BusinessDictionary.com site, but could easily apply to various situations, such as someone who holds public office, not just an organization.

Here is another from Columbia University, as it pertains to researchers and, arguably, anyone else...

A conflict of interest involves the abuse - actual, apparent, or potential - of the trust that people have in professionals. The simplest working definition states: A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. An apparent conflict of interest is one in which a reasonable person would think that the professional's judgment is likely to be compromised. A potential conflict of interest involves a situation that may develop into an actual conflict of interest. It is important to note that a conflict of interest exists whether or not decisions are affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood.

Now, you have spent a great deal of time attacking me for running posts that involve alleged - real or perceived - conflicts. You have missed posts in which I have noted alleged conflicts involving others, so do a search for Steve Nissen, David Egilman, Harlan Krumholz, to name a recent few. Sorry you missed those. They were noted.

I'd like to add that I don't wish to appear self-righteous. But you either missed or ignored my last point about the posts I choose to place on this site being based solely on their potential for generating readership. Do a search on compulsory licensing on this site and see how many people comment. Are those posts widely read? Not nearly as those on many other topics, such as preemption, antipsychotics or drug development. But I post them because, as I wrote earlier, the topic is interesting and important.

Finally, you ignored my last request which is whether you are willing to defend, justify or explain (choose your verb) why you think it is appropriate or acceptable that these two docs did not disclose their ties to Pfizer and other drugmakers.

Now, I have work to do. I can't spend more time on this issue I'm afraid.

ed

Jun 27, 2008 - 9:40am

Thank you Ed. I've copied those definitions to my desktop and I'll try to hold you to them! I really think you should put a shortcut link on your page highlighting those. Then there won't be any questions about what exactly you mean in the future.

Here's one: "But you either missed or ignored my last point about the posts I choose to place on this site being based solely on their potential for generating readership."

I never wrote that you ACTUALLY put stories onto your website in order to increase readership. As per your definitions, I would consider it a potential conflict of interest. You get paid to write stories people will read. If people stop reading, you loose your job. That's a conflict. Does it influence your judgement? Probably not.

Now, back to these doctors. Yes, there's a potential conflict. Do they stand to make money by getting people to take Chantix? No! Physician kickbacks were made illegal long ago.

Jun 27, 2008 - 9:45am

These guys disclosed their ties in scientific journals. From what I could read in the BusinessWeek article, the only thing that they are "accused" of is not directly telling the patients that they treated that they received funding from Pfizer. Don't you guys realize that this happens all the time at research hospitals? Where do you think all the research funding comes from?

Maybe anyone who gets paid by pharma can where a big sign hung around their neck or tattooed on their forehead "I received money from a pharmaceutical company". Would that make you guys happy?

I think the only thing that would make some of you happy is if the top 10 pharma companies suddenly went bankrupt and stopped distributing money to anyone...

Jun 27, 2008 - 9:51am

Use scientific information wisely. Most folks are fine on chantix..that is a fact.. The the fact that a few aren't requires some level of caution but I don't think overselling the problems works any better than overselling the benefits.

If you have side effect issues on chantix..just start smoking again and stop taking the drug..once chantix clears your system, in about a day, you'll be fine. Chantix does not do anything other than sit on all the excess nicotine receptor you have in your diseased brain.

I think the only thing that would make some of you happy is if the top 10 pharma companies suddenly went bankrupt and stopped distributing money to anyone…

No Nathan..

I think a a lot of us would be happy if the pharmaceutical industry remembered human life, ethics and morality! ..

Maybe the industry should be government run, and not profit driven?.. Would that weed out the corruption, conflicts of interest and deaths and damage from defective and dangerous drugs?..

Possibly.. I don't know..

Jun 27, 2008 - 10:16am

Point taken Truthman 30-

Nathan it does happen at hospitals all the time. But that doesn't make it right or good for the healthcare system as a whole.

You are right that in small tablet or drugs there are not "kickbacks" but there are "rebates" in devices and some biologics administered in physicians office which pretty much function the same.

Most importantly, as you well know, most speakers are high prescribers before they begin speaking for a product and even higher after.

Whether that is due to their increased experience with the product and exposure in prescribing it or wanting to gain/keep favored status with pharma is up for interpretation. I personally believe it is more experience explanation than favored doctor status.

But as a consumer and patient, I think that is my judgment call to make after discussions with my doctor. And neither the doctor nor the industry can expect trust without disclosure because when it comes out later in the media or congressional investigations, it always seems nepharious and perception is everything.

Jun 27, 2008 - 10:19am

"once chantix clears your system, in about a day, you’ll be fine. "

A drug with a 24 hour half life(which is what Chantix has) does not clear in a day....more like 4-5 days and this doesn't account for the time needed for the alterations made to the brain chemistry to correct if exposure to the drug is of a longer duration.

Jun 27, 2008 - 11:20am

I think it is important to see how that Pfizer has made a new illness regarding smoking cessation and has rallied a whole community of physicians to back these statements.

It is always easier to prescribe a "miracle pill" when the AEs are hidden deep in the pockets of the researchers' pockets. Even with the trouble surrounding Chantix these two fine doctors have been working hard with researchers to ensure insurance covers this medicine, all while prescribing Chantix to their patients. Without proper disclosure.

Yes, this was/is a conflict of interest.

Jun 27, 2008 - 11:44am

John Q, if this was so clearly a conflict of interest, please tell me exactly how prescribing Chantix to their patients would benifit them financially? Maybe I'm slow -- but I see no alleged connection between their prescription patterns and thier pocketbooks.

Jun 27, 2008 - 11:59am

I have to admit I laughed out loud when I saw the connection to UMDNJ - what restraint you have, Ed, to not mention the history of the university. If you don't know what I'm talking about, go to the lovely Health Care Renewal blog and search - what the heck, I'll do it for you.

I'm still curious if anyone knows the recidivism rate for Chantix users once they've stopped the drug. Can you truly say you've cured someone if it's only while they're taking the drug? (Is a heroin addict on Methadone still a heroin addict? What about a diabetic on insulin? Could one argue that diabetes is a self-induced disease state like smoking or heroin addiction?) Does anyone have the numbers for Chantix recidivism? I've looked, but I can't find anything reliable.

Jun 27, 2008 - 12:14pm

Ok, for simplicity sake, let's back up one step. Let's say for the sake of argument that Chantix is perfectly safe and perfectly efficacious. Who IS supposed to promote the drug? Cardiac surgeons? Supermarket clerks? No! These two people are experts in their field (smoking cessation). Of course they are the ones that are going to be the ones out there speaking favorably of it! Does they mean we shouldn't listen to their opinion?

If we judiciously ignore opinions from people who have any apparent or potential conflicts of interest, sooner or later there is no one left to offer a qualified opinion about a product. We might as well just choose our drugs by saying “eni-mini-mini-mo”.

Jun 27, 2008 - 12:49pm

Nathan, here’s a scenario on how we might select our drugs, let me know what you think. 1. Doctor sees patient for a problem. 2. Drug/Device is prescribed. 3. Doctor then generates a history of the results of the product. 4. Periodically or spontaneously the patient fills out a required comprehensive questionnaire much like a JD Powers or Consumers Report form about the performance of the product. Doctor does also. 5. Numerous things can be reported on a 1-5 rating. a. Did the product do the job it was intended to do? b. Severity of side affects c. Unexpected side effects d. Overall evaluation of the product e. Etc. 6. A score is established for the product based on customer satisfaction. 7. A 3rd party compiles all scores of all products and publishes the results after a determined time period. Maybe after a 2 year period that coincides with the beginning of public marketing of the product. Then when another patient goes to the doctor and is prescribed the same product: 1. The doctor provides the patient with the customer satisfaction score. a. If the rating is not very good i.The patient and doctor investigate further for other options or reiterate the things to look out for with the product. b. The patient notices that the rating is very good i.The patient is confident that the product will be OK. Then when the published score is reviewed by the Manufacturer 1. The company initiates intense investigations on the lack of product performance 2. The company takes care of problems ASAP.

No FDA, no need for political intervention, no Supreme Court interference with due process of law, no long list of fraudulent practices, hidden reports, paid supporters, poor industry performance reports (maybe just a few specific companies), the list would go on. And yes some companies would go out of business because they should.

One more thing, Pharma, you can have your preemption then, but it won’t do you a bit of good.

Jun 27, 2008 - 1:19pm

Nathan, the physicians in this article were already paid by Pfizer to promote Chantix.

Physicians(like Dr Steinberg) will only prescribe one particular medication to their patients while other medications are readily available after they have been involved in the research department of said drug, and no full disclosure. Clearly yes, this is a conflict of interest.

There are plenty smoking cessation experts that have a different opinion and are not paid by Pfizer. The difference being, the money is not there to contradict the false information.

When an expert in any field is influenced by money as these two doctors have been, then of course the results will be tainted.

Jun 27, 2008 - 1:26pm

Laurie

Half life for chantix is 17 hrs and falls below efficacious levels within 34hrs. The drug is excreted unchanged by metabolism. Like I said in about a day all these folks should be back to normal once they continue smoking.. A smoker's brain chemistry will return to normal for a smoker, when they restart smoking. They are no longer "normal"in a gebneral sense if they are addicted to nicotine. Don’t make a mountain out of a mole hill. It is a small number of people who have trouble compared to 6 million that have taken the drug.. Not a bad ratio. Those who know little ask much!!!

Jun 27, 2008 - 2:38pm

Jaynesday, Actually, I like your idea. Maybe with a few tweaks. However, I don't think your system would eliminate COIs completely. There will still be sales forces, advertising, twisting of numbers (on BOTH sides of the issue), etc.

The system doesn't currently exist. There isn't a clear path from our current system to the one you describe. Moreover, there isn't enough public outcry against the current system in order to warrant such a radical overhaul. In spite of the comments on this page, I think most people generally trust doctors and trust the medicine they take.

Jun 27, 2008 - 2:43pm

John Q - you didn't answer the question. You keep saying that this is "clearly a conflict of interest". I'm asking you a simple question: How does prescribing Chantix to their patients would benifit them financially? What is the connection between their prescription patterns and thier pocketbooks?

You can't answer the question because there is no benifit! If there is no benifit, then there is no conflict.

Jun 27, 2008 - 3:00pm

Nathan writes: "In spite of the comments on this page, I think most people generally trust doctors and trust the medicine they take."

I agree with this. It relates back to the Harris poll thread. For some time, there has been a split between the public perception of the industry and the perception of its products, which are much better in polls. Docs are a different issue, but also do reasonably well.

The question I've had - more related to the "tipping point" notion on the other thread - is whether this division will persist.

On one level, we _have_ to trust the docs we see and meds we take - it would be almost impossible psychologically not to.

But docs tell me that more and more pts express reservations about meds, even while taking them and hoping for the best.

Jun 27, 2008 - 3:04pm

Didn't see the Jaynesday plan when I first went through thread. I think it's brilliant, and some version of it could save a lot of butts (and more).

With Jaynesday's OK (I'll credit his alias), I'd like to use it in my class and see what students think.

Jun 27, 2008 - 3:13pm

"Half life for chantix is 17 hrs and falls below efficacious levels within 34hrs"

Then Pfizer needs to change their drug insert.

From Chantix.com: "Metabolism/Elimination The elimination half-life of varenicline is approximately 24 hours. "

And levels needed for "effectiveness" and levels for adverse reactions are not one in the same.

Jun 27, 2008 - 4:12pm

Laurie Here is the link to the original paper on varenicline half life

.http://dmd.aspetjournals.org/cgi/content/abstract/34/1/121

Which adverse events have been proven or are they just reported w/o data? and at what C. efficacious? An adverse event must also have an efficacious concentration..right??? We are only talking about effects at the nicotinic receptor since that's all that varenicline hits!!! So you are saying varenicline operates at below its efficacious concentration to cause side effects thorough the same receptor it functionally effects?.. Are you out of your mind..Give me a break. A company spends years collecting data and you are guessing for free...

Jun 27, 2008 - 5:34pm

JiM, You are more than welcome to use the Jaynesday plan. Please let me know what your students think. dheis@msn.com

Jun 27, 2008 - 6:18pm

Nathan, I also agree with you about COI's etc. But I think if we protect the service of the 3rd party scoring system there would be an over-riding force for self correcting even self policing activities within each company. It would be best if this 3rd party was not connected to the government in any way. This is the downfall of the FDA. To survive as a manufacturer (no mater what goods or services) we have to serve the desires of the consumer. We have to seek out their opinion and desires if they are not evident. Companies that can do this first and best are the winners. They are rewarded by the emperor (customer) with long life and good fortune.

Direct and face to face - customer and manufacturer is the best way I think.

Manufacturer - Do you like my product and will you buy it again? Customer – No Manufacturer - Why not, what can I do to make it better?

Not

Manufacturer – My product is good Customer – No it’s not Manufacturer – Yes it is, check with the FDA

Jun 27, 2008 - 7:20pm

"To survive as a manufacturer (no mater what goods or services) we have to serve the desires of the consumer. We have to seek out their opinion and desires if they are not evident. Companies that can do this first and best are the winners. They are rewarded by the emperor (customer) with long life and good fortune. "

Exactly! If pharma would listen to their customers and take seriously the complaints maybe their reputation would be restored to what it once was. But customers hear "No, our drug isn't the problem, your experience wasn't done in a scientific manner, therefore it didn't happen".

This is my gripe. As is pointed out all the time ALL drugs have side effects, but acknowledging those side effects in a timely manner is critical to a consumer. Instead we get “The more information that’s out there, the more difficult it will be for patients to process,” as if consumers are idiots.

Honesty is all consumers want.

Oracle, that link says nothing about Chantix' specific half life, so I'll go with the Pfizer,FDA approved, drug insert information of 24 hours. Only time will tell what happens with Chantix and it's effect on the brain in a diverse population of users. And no, I'm not an idiot. Just one who heard the same argument about paxil being "selective" and couldn't possibly cause the reactions that were being reported...and we all know how that turned out.

But as I said in another post, Pfizer put up the warning quickly, and I'll give credit where credit is due.

Jun 27, 2008 - 11:57pm

Nathan, Dr Foulds had a nice chance to tell his patients/readers that he was due credit(and had been paid) from the studies that he was referencing about as he was "helping" his audience quit smoking on this day. Notice how he was quick to come to Pfizers aide the day they needed him.

http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html

Again notice how fast he is there for Pfizer.

http://blogs.wsj.com/health/2008/05/29/pfizer-counterattacks-on-smoking-cessation-drug-chantix/

But the worst part is that he was being paid from the start of the research and continued his research alongside his employment with UMDNJ-school all the while treating patients that were unaware.

http://www.centerwatch.com/patient/drugs/dru897.html

Unless I missed the reference to Pfizer, he left that one out while he gave credit to three other organizations. I guess he thought it ok to give his patients that much information.

http://www.healthline.com/blogs/smoking_cessation/2008/02/what-does-tobacco-treatment-clinic-do.html

Dr Foulds contradicts his own words in each of these links, and I only listed a few.

Most patients assume that their dr is only receiving pens, maybe a lunch or dinner. I don't believe patients expect thousands of dollars to be paid to their doctor by pharma and not know that he/she is "pushing" that certain drug. When a patients dr is involved in the research of that drug he "pushing" without disclosure, in my opinion, is a conflict of interest.

Hi John Q,

Just to clarify one tiny point, I don't believe Fould showed up to comment on the WSJ site. The same comment was left here on Pharmalot the same day by someone who was defending Pfizer and Chantix, but I'm pretty certain it wasn't actually Fould who posted the comments. Here is the link to the Pharmalot post on May 29 that contained reference to a report by Fould...

http://www.pharmalot.com/2008/05/pfizer-plans-chantix-ad-blitz-to-counter-scrutiny/

Thanks for stopping by and providing those links, though. They're interesting.

Regards ed

Jun 28, 2008 - 9:11am

ED, Ok I see who was the first to post that report on your site. He really retrieved it fast as it had only been posted on Dr Foulds site the day prior. Where I had referenced that particular report from the WSJ site, it was actually posted by someone else, not Dr Foulds.

Also, here is the report on Dr Foulds site along with a report following the release of the VA studies regarding Chantix. At the end of his report(and his assessment of the VA data)Dr Foulds leaves a comment as to how he is paid by Pfizer and others.(June 2,2008)

http://www.healthline.com/blogs/smoking_cessation/labels/safety.html

Jun 28, 2008 - 9:17am

Laurie,

You shouldn't comment out of ignorance. The paper I forwarded shows the half life at 17 hours and other important information like near complete recovery of varenicline in urine (Drug Metabolism and Disposition 34 121-130, 2006 see page 124). I would send you other papers which demonstrate complete receptor profile for varenicline but that might be too much for you. Both of these remove any doubt that varenicline causes any long lasting harm.. The next suspect is nicotine itself. I could send you papers from post-mortem examinations showing an upregulation of nicotine receptors in smoker’s brain. This is highly variable between patients and could lead to inter-patient variability during smoking cessation treatment...Sorry to take this more seriously than you but because your flippant comments come from ignorance you represent and shape the scientific unawareness that signals our decline.. It pains me to recall that you might be a nurse…

Jun 28, 2008 - 9:31am

John Q

What are you paid to do by the way.. Anything important? and are you unbiased and dispassionate enough to satisfy your customers?..Do we really have enough volunteer clinicians to comment on or run clinical trials of new drugs? Would they be trustworthy or would they be tobacco company plants (no pun intended)...Everyone is paid to do something..It would appear to me that anyone not paid by a drug's sponsor is lobbying for that very job..I can think of a few...This trail leads to a red herring

Jun 28, 2008 - 10:40am

Oracle, Really no need to be so nasty to Laurie! No, I don't think you would even be the least interested in what I "do".

No, there are not enough volunteer clinicians that are not sponsored by pharma. Ok now paranoia has over taken you when you assume "tobacco company plants" will have an outcome in clinical trials if the sponsored clinician is not pharma. Get real.

I am not being paid by pharma or tobacco. I am not lobbying for either.

Jun 28, 2008 - 11:37am

John Q writes: "no, there are not enough volunteer clinicians that are not sponsored by pharma."

That's exactly Oracle's point! No doctor in their right mind is going to volunteer to take time away from their family and their practice in order to test out products that pharmaceutical companies design. We HAVE to pay them in order for them to study our products. That's one problem with Jaynsday's proposal (another thread). Unless you propose a complete government takeover of healthcare and of pharmaceuticals, there is NO WAY to avoid the transfer of money between pharmaceutical companies and doctors. It's just a fact of life that you'll have to get used to...

By the way, you are just dancing around the question I asked: How does prescribing Chantix to their patients benefit these two doctors financially? If there is no financial benefit, then there is no financial conflict. Pfizer paid these guys because they are smoking cessation experts who are open to the idea of drug therapy. No one (no even you) has alleged any sort of "quid-pro-quo".

Jun 29, 2008 - 12:42am

Nathan, You keep stating that I am against financial gain from pharma to their expert research teams. Making that type of assumption is false.

I do however have a problem as to how Dr Foulds and Dr Steinberg in this reported story evaded acknowledgement from Pfizer as being their sponsor.

As I have shown, Dr Foulds(along with Dr Steinberg)have been involved in the research with Chantix. Most "expert physicians" don't 1) run the initial drug trials and 2) have a state funded(from tobacco)clinic, hold trials, and make more money from pharma while 3) conduct pharma funded dinners for physicians all the while 4) deceiving patients by non-disclosure.

Look at this site for an example of how these two doctors deceived their patients. Read on page 6.

http://www.tobaccoprogram.org/pdf/tnc/summer06/tncsummer06.pdf

What a perfect place to say "yes, we are smoking cessation experts and we are involved with the trials of Chantix and the drug looks promising?" Instead Dr Steinberg acts as if he knows little to nothing about this "new drug".

I wonder why?

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