Smoked: Did Two Experts Improperly Boost Chantix?
64 CommentsBy Ed Silverman // June 26th, 2008 // 5:57 pm
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.
Marusa
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.
Justice in MI
Marusa - Beautifully said.
Lisa Van S
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!!!
Anonymous
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.”
Nathan
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.
Lisa Van S
Anonymous,
Provide me the facts,.. Im quite confident that I am able to make informed decisions on my own…
Lisa Van S
Nathan,
Last Name and Company, will do just fine. Would you like to provide your credentials?
laurie
“”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?
John Q
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!
Ed Silverman
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
Nathan
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?)
Nathan
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.
Nathan
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”.
war horse
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.
Laurie
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.
Melody
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?
pharma PR hack
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
pharma PR hack
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!
Bruce Grant
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…
;>
Ed Silverman
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
Nathan
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.
Nathan
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…
Oracle
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.
truthman30
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..
pharma PR hack
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.
Laurie
“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.
John Q
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.
Nathan
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.
harpy
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.
Nathan
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”.
Jaynesday
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.
John Q
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.
Oracle
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!!!
Nathan
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.
Nathan
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.
Justice in MI
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.
Justice in MI
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.
Laurie
“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.
Oracle
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…
Jaynesday
JiM,
You are more than welcome to use the Jaynesday plan. Please let me know what your students think.
dheis@msn.com
Jaynesday
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
Laurie
“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.
John Q
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.
Ed Silverman
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
John Q
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
Oracle
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…
Oracle
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
John Q
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.
Nathan
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”.
John Q
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?
Oracle
John Q
Again I ask you ..who would promote anything without being paid?…and you can’t deny that chantix is one of the better products sold in the American market for all but a few that need it..like anything
On the other hand your commentary is apparently provided free and there is no substance
Jonathan Foulds
Get the real story.
If you would like to read the real story, and if the links provided below don’t work,
You can get it by googling keywords: healthline Foulds influence
http://www.healthline.com/blogs/smoking_cessation/2008/06/doctors-under-influence-real-story.html
And if you would like to read the original article in Annals of Internal Medicine, that stimulated the BusinessWeek article, google keywords:
Annals Schmelzer tobacco
http://www.annals.org/cgi/content/abstract/148/7/554
Note the full disclosure at the end of that article…no secret at all. Note also that the patient described in the article wasn’t treated with Chantix at all. The connection is only in the mind of the journalist.
As far as BusinessWeek is concerned……
doctors who have ever done work for a pharma company, then providing the most effective treatment to help smokers quit – unethical,
but multinational tobacco companies winning litigation and selling more cigarettes around the world – priceless
Ed Silverman
Hi Jonathan Foulds,
A belated thanks for your reply. As you obviously noticed, the BusyWeek piece gained quite a bit of traction here these past few days. So I appreciate that you joined in.
So let me ask you a question - beyond the toing and froing, what do you think you can or might do differently to avoid the appearance of a conflict, given that this is of increasing concern, at least to some people?
Regards
ed
John Q
I too left the posted link for anyone with any interest to read this article over on the Koren story blog. I do take exception with the problem of the article being in the “mind of the journalist”.
Dr Foulds, one problem that I do have with your assessment of the tobacco companies..
You have gone from taking money from one giant to taking money from another. If you slam Chantix in the face of everyone in lieu of the facts, I must suspect money as an objective.
You must take a step back and ask yourself is it worth all the trouble that IT is going to cause, as I thought that your position was one in helping the smoker to quit and not one of guilt and shame to the smoker who is looking for assistant in their quit. Tobacco smoking is a problem of great addiction that we as a nation face and must conquer together.
We must take steps not to praise a drug that harms as bad/above the disease that the drug is trying control/abolish.
There are products on the market that are proven safe and effective(per your own standards)that can be afforded to the patient with better results without the side effects. You should not praise Chantix as you do. The reasons are all to clear.
John Q
Here is the press release about the article where Dr Foulds states smokeless tobacco”Snus” is better to use than cigarettes. Notice that this news release is written for New Brunswick. Can a dr actually promote Chantix and smokeless tobacco(for which he promotes Chantix ) at the same time.
Priceless…..
http://www.umdnj.edu/about/news_events/releases/07/r050907_Expert_Questions_Widsom.htm
Oracle
John Q
You are distorting the facts when you say “not to praise a drug that harms as bad/above the disease that the drug is trying control/abolish”..THAT is clearly not true for chantix, or zyban when compared with smoking..Give me a break..
There are not that many confirmed issues with chantix compared with the total chantix patient population..Time for a responsible debate among the scientifically illiterate..
John Q
Funny! did you read the rapid response on the site, Annals of Internal Medicine referenced by Dr Foulds.
http://www.annals.org/cgi/eletters/148/7/554
I must admit that my response was one of laughter as Pfizer was not only mentioned as being referenced to in this article, but actually seeing it disclosed on a physician’s journal. Of course Pfizer was a disclosure on a medical journal.
The article was a last ditch effort for funding from pharma and insurance. This is evident as to reading the table of comparison.
http://www.annals.org/content/vol148/issue7/images/large/12TT1.jpeg
Responsible? I hardly think so…..
kytra
Hi all,
Sorry for intruding but I think I can give you a valuable insight since I am a MD who worked as a MD, Pharma Sales Rep, Clinical Research Associate, and Product Manager and now I am a senior sales staff member.
I will try to put out very concisely some of my thoughts.
The fact: money move the world. Wherever there are money to be gained or lost by anyone there will be COIs, the bigger the amounts involved.
The fact: humans cannot be totally impartial whatever they declare. Otherwise we’ll be robots. That is applicable to all involved, on the both sides (companies/doctors vs governments/consumers)
I would agree on total transparency if that would be possible, but as it is very easy to finger someone for receiving a payment, it is very difficult to diclose more intricate interests and personal reasoning which could make people say things for the wrong reasons.
Everybody’s wish is to create the perfect drug, the one with zero side effects and 100% efficacy. That is impossible.
It would be perfectly ok to ask that each product to have a long term assesment (>10-15 yrs) of the potential harmfull effects but that will dramatically cut the patent protection time leading companies to ask much higher prices in order to deliver on their financials. One solution could be to prolong patent time and negotiate lower prices with the companies (but oh I can hear all generics makers screaming at this)
Nowadays it is more and more difficult (and costly) to discover new drugs. If governments think they can do it, then let them deliver - but I do not think so. Maybe there are no more needs for new drugs - than some therapeutic areas should be officially “closed” and we work with what we have currently - I really think that that wouldn’t be an option because we, as humans, allways strived for knowledge and discovery (thanks God!)
In the meantime the life expectancy of humans continues to grow and that is partially due to the newly discovered therapies and technologies.
So, to conclude:
I fully agree that sometimes companies made wrong decisions in informing the public/professionals about drugs AE/efficacy profile.
On the other hand I can tell you from experience that too much information for patients could undermine the efficacv/compliance rate of a therapy.
People should trust their doctors. The medical education system is responsible to generate honest and trustworthy doctors.
All this fuss about docs getting paid is decreasing the trust in the doctors in a vicious circle.
Really, in my informed opinions over 90% of the doctors will not be influenced by in their therapeutic decisions by anything else that by their own clinical experience. Maybe at the beginning they will try a drug because a KOL is advising that but if the drug does not deliver they will not use it.
I will stop here because this post could go on and on…
Jonathan Foulds
Ed Silverman…who i believe is the blogger, asked me a question on what I think is the solution to this. So here is a brief thought.
The current accepted practice is that when you publish a paper or do certain types of training you disclose your sources of funding. We did precisely that. Clearly no good deed goes unpunished. If you read our article you will notice its not about Chantix at all, so lets get back to the solution.
One suggestion is that MDs (and note, I’m not an MD and don’t prescribe medicines, period) should routinely tell patients where their funding comes from. I see this as completely impractical if we me mean do it verbally at every consultation. If it means post it on the wall of the clinic, on our website etc, I have no problem with that at all. In many clinical practices it will be a very long list (as it should include all funding, not just pharma) but I’m all for transparency. I think we might just go ahead and do it here…we may as well be ahead of the curve since we’ve taken heat on this issue.
I do find it weird, however, that we have been targeted, when we work on one of the few disorder’s (tobacco dependence) where the bigger financial interests are opposing us. I don’t believe its a coincidence that this appeared 3 weeks before I’m testifying in law suits against the tobacco industry. Its a funny old world.
John Q
Jonathan Foulds ponders that “no good deed goes unpunished”. Disclosure on an article for physicians that already know there is a sponsor is not to be compared with disclosure to all the patients that are being forced false information about Chantix.
It would be laughable if not true, to read from the blog of Dr Foulds. Only after a reading a paragraph do you get the “feel” of pharma. I did not see Pfizer listed after each article here.
http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html
http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html
http://www.healthline.com/blogs/smoking_cessation/2008/02/new-study-compares-chantix-to-nicotine.html
This “new” information of blaming the smoker for all the Chantix woes is unbelievable. If this information was just coming from Pfizer, I think drs(MDs) in the real world have been saying,”give me a break”. Instead, Dr Foulds is paid by Pfizer to do the dirty deed(s) for Pfizer. The information seemed more believable coming from a smoking expert, until the problems with Chantix continued and the lies and false studies continued. News agencies had to notice.
I do find it to be a problem with academics (PhDs) suggesting certain medications. MDs just have a little more training and skills to recognize problems that can arise with medications. Especially one(MD) that is working in a practice environment and not a sponsor ran clinic.
Lol! Being targeted. That is the funniest information I have heard all week. I feel the reason that this is being used as “news” at this time is because of the problems with Chantix(side effects ,false studies to VAs).
I find it weird that on every blog about Chantix there is “someone” there to post the lies of pharma. Why such a large campaign if the drug can stand alone?
It is a wonderful “funny old world”. One where one person sees lies from pharma and another feels threats from tobacco. Weird…..
Jonathan Foulds
Dear John Q,
Firstly, why not just sign on with your real name? Your rantings sound remarkably like those of the obsessed John Polito. He, like you, assumes that every piece of work done for a pharma company is actually a bribe to spread lies about a drug. Sorry, but some of us actually get paid to do work…advise on clinical trial design, review grant applications etc etc. These things have absolutely nothing whatsoever to do with what I write on my blog (under health experts at healthline.com ).
He, like you, also assumes that any clinical trial that finds that a medicine helps smokers to quit smoking must be faulty and also part of the massive plot to trick the public…nomatter who carried out or funded the study.
He, like you, also makes up stuff, and implies things that are simply not true. For example, up above you talk about clinicians not “working in a sponsor ran clinic.” If by “sponsor-ran” you mean pharma, you are rather confused about the funding of our smokers clinic, which has been exclusively funded by New Jersey State Department of Health and Senior Services since its inception in January 2001.
As explained in numerous publications in peer-reviewed journals, we treat our patients with the methods that are best supported by scientific and medical research..particularly as summarized by the US Pubic Health Service Clinical Practice Guideline on the Treatment of Tobacco Use and Dependence (new one published just last month).That evidece-based guideline, like virtually every other published over the past decade, concludes that FDA-approved smoking cessation medicines significantly increase smokers chances of successfully quitting. So I make no apologies for advocating that patients get the most effective treatments available (including counseling). Rather the onus is on you to explain why you oppose all the scientific evidence. I guess you believe that all the researchers were bought off by pharma companies in some massive conspiracy (including those that have never accepted a cent of pharma funding). Do you believe that about all medicines, or just those that help smokers quit? I’m afraid you are just wrong, but I don’t imagine for a second that any rational argument will convince you. Finally, you failed to mention that the majority of my blog posts cover aspects of tobacco use not related to pharmacological treatments. I’ve written about Chantix because those posts received many comments both from people who had success with the drug and from people who had suffered terrible experiences while using the drug (includng suicide). I advised those people to report their experiences to the FDA and provided a link to facilitate that on numerous occasions. I remain open minded about the cause of these events. I’m really not sure why you have such a problem with all this..other than via some mistaken belief that its all part of some pharma funded plot. I’m sorry, but thats simply not the case.
John Q
Jonathan Foulds, after reading your post, I am trying to collect myself from a great laugh. Let me assure you that I am John Q! I googled your John Polito and came up with a few results. I got an actor, an attorney and a smoking cessation educator. As I am unaware of your little battles, my non-legal opinion is that he is an attorney(or the other expert). Whatever your problem is with this person, you can leave me out of it. As you can read from my post above, I have never said ever article for or about pharma was a bribe. Lol. I am so misunderstood.
As I have stated within this blog, I believe there was improper handling of Chantix by yourself and Dr. Steinberg from non-disclosure to patients. I have debated back and forth with Nathan about this subject. In doing so, I have also been accused of being a red herring by someone going by the name of Oracle. I am so shocked that s/he hasn’t spoke to you here as they are one of your biggest fans. I know this because of the way they cited information from your blog the day after you had posted it. I assume this person knows you well. Now it appears if you are calling me names as well.
What I mean by sponsor ran clinic is because YOU are being paid to promote Chantix. I said it above and I’ll say it again, I feel there was/is a conflict of interest. Sorry if this offends you, but it is simply the truth. Not illegal, just improper.
Of course you only treat patients with methods that have been scientifically proven. I am not attacking your clinic or your work. I am stating that my view differs on Chantix as the trials were not sufficient enough to give rise to scientific proof for AEs than those of other methods. Also, there is that little fact that you are being paid by Pfizer. Furthermore, I didn’t mention the rest of your blog as I figured anyone could go read it if they were interested.
Sorry I don’t fit your profile as I never said this is some “pharma funded plot”. I am only stating the paid experts are doing more harm by not disclosing their ties to pharma.
In closing, I see where you want my opinion as to why I feel the scientific evidence to Chantix is not there. At this point I would ask you where is the proof pointing to the effectiveness of Chantix?(especially for long term use)
Jonathan Foulds
John Q,
The idea that clinicians should disclose to patients all their funding sources is truly a new one to me. I’ve never had this information provided by my own doctors, nor have I ever asked. Our funding sources are, however, fully disclosed in our publications (where the particlular journal chooses to print such info).
But now that Ive heard of this idea, Im trying to think of how best to implement this. The most obvious way would be to create a list of funding sources for all the clinicians in the clinic and to post it in the patient waiting area, and to also post it on our website. Is this the kind of disclosure some people are looking for? (in terms of patients being informed).
Would that satisfy you, or are you really wanting no clinicians to ever do any work for pharma, or accept any research funding from pharma either? (regardless of whether or not it is disclosed)
On Chantix efficacy, there are now about 9 published trials, all with clear evidence that Chantix helps smokers quit. Some of that evidence has been described and linked on my blog at healthline.com . In my latest posting I also summarize some of the evidence for longer term safety and efficacy (which in smoking cessation means longer than 12 weeks).
Also remember that the original paper in Annals of Internal Medicine that stimulated all the fuss was not about Chantix at all, and that we fully disclosed our funding in it. I’m still puzzled how a line gets drawn from that paper, with its disclosures of funding, to us as evil doctors pushing a specific drug to patients. In the coming months we will also post a new clinic annual report on our website which will summarize the meds used by our patients. It will show very clearly that only a minority choose to use Chantix, and some choose to use no medicines. We have already published data showing that patients in our clinic who choose to not use any medicines have lower quit rates. This is of course entirely consistent with almost all the placebo-controlled clinical trials.
John Q
Jonathan Foulds, It is quite a nice idea to disclose funding information to patients. I do believe the future of medicine and pharma are moving in ways that may bring dr/patient relationship back together. One must have this belief to have confidence in medicine as it has made an ugly turn to pharma ran medicine, and it is only a matter of time for an explosion of ideas.
As I have stated earlier, most patients expect their doctors to receive pens, mugs and maybe an occasional dinner. What most patients don’t expect are for their doctors to receive hundreds and thousands of dollars. Give me a break! I never would think that my dr has been doing research and giving speeches for pharma unless he told me. I would think this would be something of great pride for the dr(s) and would want to share this information if it was on the up-and-up. I certainly would be more concerned if that dr gave me the medicine without disclosure. Of course, that is just me.
I have concerns for the published trials of Chantix and still await the release of more data. Even the FDA had questioned the data before the release of Chantix and Pfizer gave the FDA names of participants so the FDA could call upon some who were in the trials.(per the FDA web site)
Once you have worked for pharma, it becomes norm to think all clinicians have work for them also. You clearly can’t see through all the smoke. Chantix has more AEs than you and other Pfizer working officials are willing to admit. The VA mess has proven that fact. The government is split over the use(ban) of Chantix because of the conflicting information from Pfizer paid experts.