Field of Science

Another drug maker paying for scientific articles

About a week ago I saw the full-page ad in the Washington Post by Pfizer for its drug Chantix. The ad didn’t say what Chantix was for (it supposedly helps people quit smoking); instead, it was a statement by Pfizer reassuring patients who take Chantix that everything was okay. There was some verbiage about how careful Pfizer is to ensure the safety of its drugs and that no one need worry. Obviously something wasn’t okay.

A quick web search revealed that Chantix is causing some very bad side effects: heart problems, seizures, diabetes, and over 100 vehicle accidents linked to the drug. (See the Wall St. Journal article by Alicia Mundy and Avery Johnson, May 29, 2008.) After my recent blog on Merck and Vioxx, discussing how Merck paid for scientific articles about Vioxx and then got outside scientists to put their names on them (the Vioxx Wall of Shame) , I wondered if Pfizer had done something similar for Chantix.

Well, they did.

I jumped over to PubMed and searched for articles on varenicline, the generic name for Chantix. I found many articles, some of which were exactly what I suspected: articles promoting the use of Chantix as safe that were paid for by Pfizer, but whose authors were not Pfizer employees. Let’s look at a few:
Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, Anziano R, Reeves KR.
Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med. 2006 Aug 14-28;166(15):1561-8.
The lead author, Mitchell Nides, works for Los Angeles Clinical Trials, a company that runs trials for a fee. The article discloses at the end that Pfizer paid for the entire trial. Oncken is at the Univ. of Connecticut, Gonzales at the Univ of Oregon, and Rennard at the Univ. of Nebraska. The last 3 authors – Watsky, Anziano, Reeves – are Pfizer employees. All three of the university authors have been paid by Pfizer – as consultants, grantees, and/or speakers. Not surprisingly, this article concludes that “Varenicline was well tolerated and may provide a novel therapy to aid smoking cessation.”

The same issue of Arch Intern Med has another article by many of the same authors, concludes that “Varenicline tartrate is efficacious for smoking cessation.” On this one, Dr. Oncken is now first author, which means Pfizer can say that this study was led by the Univ. of Connecticut:
Cheryl Oncken, D Gonzales, M Nides, S Rennard, E Watsky, CB Billing, R Anziano, K Reeves; for the Varenicline Study Group. Efficacy and Safety of the Novel Selective Nicotinic Acetylcholine Receptor Partial Agonist, Varenicline, for Smoking Cessation. Arch Intern Med, Aug 14/28, 2006; 166: 1571 - 1577.
If you go to the end of the article, you learn that all the authors are in the pocket of Pfizer. Here’s what it says about just the first two authors: “Dr Oncken has received research grants, consulting fees, and honoraria from Pfizer; nicotine replacement and placebo products from GlaxoSmithKline at no cost for smoking cessation studies; and honoraria from Pri-Med. Dr Gonzales has received research contracts, consulting fees, and honoraria from Pfizer.”

Here are two more articles by LA Clinical Trials:
Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB, Williams KE.
Nides again, and LA Clinical trials. Varenicline Versus Bupropion SR or Placebo for Smoking Cessation: A Pooled Analysis. Am J Health Behav. 2008 Nov-Dec;32(6):664-75.

Mitchell Nides M. Update on pharmacologic options for smoking cessation treatment. Americal Journal of Medicine 2008 Apr;121(4 Suppl 1):S20-31.
They’ve been busy! (Guess how well Chantix/Varenicline fared?) But Pfizer can’t just use this unknown company – they also recruited much more prestigious institutes, such as the Mayo Clinic:
J. Taylor Hays, Jon O. Ebbert, and Amit Sood. Efficacy and Safety of Varenicline for Smoking Cessation. American Journal of Medicine 2008 Apr;121(4 Suppl 1):S32-42.
The lead author – Hays – is at the Mayo Clinic in Rochester, Minnesota. But if you go to the end of the article, you find that “J. Taylor Hays, MD, has served as an unpaid consultant on an advisory board for Pfizer Inc; and has received grant/research support from Pfizer Inc. But get this: “Editorial support was provided by Darlene Benson, BSPharm, of Medesta Publications Group, and funded by Pfizer Inc.” I strongly suspect that Ms. Benson may have written part of this article. Another example of doctors basically selling their names to a drug company for the financial benefit of both. The Mayo clinic should be ashamed.

There are many more, for example this article on Chantix:
D F Heitjan, D A Asch, Riju Ray, M Rukstalis, F Patterson, and C Lerman. Cost-effectiveness of pharmacogenetic testing to tailor smoking-cessation treatment. Pharmacogenomics J. 2008 Mar 18.
These authors are at the University of Pennsylvania, and the senior (last) author was paid by Pfizer: “Dr Lerman has served as a consultant to Glaxo Smith-Kline, who provided bupropion and placebo for the studies described. She has also served as a consultant for Pfizer and has received funding for a project unrelated to the data presented in this paper.”

Pfizer also paid a group at Lund University (Sweden) to show that their drug was better than their competitors:
Kristian Bolina, Ann-Christin Mörk, Stefan Willers, and Björn Lindgren. Varenicline as compared to bupropion in smoking-cessation therapy—Cost–utility results for Sweden 2003. Respiratory Medicine 102:5, May 2008, 699-710.
The paper reveals that “this research was sponsored by Pfizer AB, Sweden. Kristian Bolin, Stefan Willers, and Björn Lindgren [at Lund University], were funded by Pfizer AB, Sweden, in connection with the development of this manuscript. Ann-Christin Mörk is an employee of Pfizer AB, Sollentuna, Sweden.”

There are many more, but I hope this list more than makes my point. Even one bad article pollutes the literature – but the drug companies don’t take chances. They pay for multiple studies that show the results they want. When Pfizer doesn’t pay, you get articles like this one:
Kristensen PL, Pedersen-Bjergaard U, Thorsteinsson B. Varenicline may trigger severe hypoglycaemia in Type 1 diabetes. Diabet Med. 2008 May;25(5):625-6.
The title says enough here – Chantix can be deadly to diabetics.

These are only a small sample – there are many more articles, but my institution (U. Maryland) doesn’t have subscriptions to all these journals, so I’d have to pay to read them. Without paying, I can’t find out the author affiliations and I can’t look at the end of the article to see if they disclosed any financial relationships. But I saw enough: just like Merck’s behavior with Vioxx, Pfizer paid to have articles published in the peer-reviewed literature that demonstrated the results they wanted.

The scientists who put their names on these articles aren’t independent – they are tools of their sponsors, the drug companies. But many of these articles don’t hide the affiliation with Pfizer, so there is more blame to go around. The journals should be held accountable: for example, why is Archives of Internal Medicine publishing studies run by LA Clinical Trials, which apparently is happy to run studies that produce the results a sponsor wants? Archives is a highly reputable journal (or at least I thought so) run by the American Medical Association.

I’m beginning to think that we can’t trust anything we hear about a new drug unless we read the original literature, and scan the literature with a highly critical eye for conflicts of interest. This is truly unfortunate. Most people don’t have the training (or the time!) to read these original articles, and very few non-academics have subscriptions to these journals. Even the experts tend to rely on the short abstracts (which summarize the conclusions), especially in reputable journals, but it appears that we can’t trust those either.

Money seems to have corrupted the biomedical literature, more deeply than I had realized. We need to work to correct this situation, starting by pointing it out wherever we see it. And before taking any new medication, I plan to dig into the literature to find out if the benefits are real, and if there are harmful side effects that the drug manufacturers have attempted to hide. Meanwhile, shame on Pfizer and on all the so-called scientists listed above who took Pfizer’s money to write articles promoting its drug Chantix.

11 comments:

  1. Here's a relevant NYTimes article from today's edition about academic researchers who fail to fully disclose money received from drug companies:

    http://www.nytimes.com/2008/06/08/us/08conflict.html?hp

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  2. [I deleted a comment because it was primarily a personal attack. Thoughtful comments and debate are welcome here. Rants are not.]

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  3. Great article! I've had similar experiences digging through the medical literature. In researching a drug or condition on behalf of myself or a family member, I've often run across articles that seem to be the basis for commonly-held beliefs. But when I read them carefully, I realize the conclusions are suspect, either because the authors seem to have an agenda or the evidence just isn't there. I wouldn't want to spend all my time digging through the drug-lit, but I wonder: Could doing this type of research turn into a career? Are there people who make a living digging through the biomedical research on behalf of patients who need unbiased, critical conclusions about drugs and disease?

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  4. This is really bad thing. If some one is giving some information about some drug, he should give full information’s about it. Why it is use , how its work, what are the side effects of it etc,etc. A drug can cure a present and it also can harm that parent. So please use any drug with full information otherwise not. For more information about chantix please go to http://www.chantixhome.com

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  5. Well, I won't delete the comment above from "ricky", but his link goes to a site that is little more than an ad for Chantix, and for a service that he probably runs that sells Chantix (or maybe fake Chantix?). Either way I wouldn't touch the stuff.

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  6. How amusing that someone comes here talking up Chantix in a post about unethical behavior.

    http://www.washingtontimes.com/news/2008/jun/17/va-testing-drugs-on-war-veterans/?page=1


    From the article "The government is testing drugs with severe side effects like psychosis and suicidal behavior on hundreds of military veterans, using small cash payments to attract patients into medical experiments that often target distressed soldiers returning from Iraq and Afghanistan, a Washington Times/ABC News investigation has found."

    ReplyDelete
  7. Blah url is too long, here's the tinyurl version:

    http://tinyurl.com/5ctup7

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  8. Thanks for the link - the responses to that Wash. Times article include some sad tales, including this:

    "I know how dangerous Chantix is first hand.. My fiance is DEAD because he took chantix to try to quit smoking. And we were unaware of any side affects because none were public yet. If we would have known about the side effects he might be alive... why risk veterans lives?! why risk citizens lives??

    and all this is done under the "take this pill, you'll quit smoking and it'll save your life" guise. Well, if the love of my life had never taken the "magic" pill to try and "save" his life... He'd be alive!

    This is sickening … but it doesn't surprise me. It seems more and more evident that our govt is wrapped around big pharma’s finger [...]

    Why is this drug on the market? and why isn’t Pfizer being investigated for their negligence? [...]

    an apology would be nice… no one should have to go through the grief I’ve had to endure… especially not our veterans. shame on Pfizer, shame on the VA, shame on the FDA and shame on the White House."

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  9. Just wanted to post here about my experience with Chantix. It was everything I needed to finally quit smoking. I had no side effects at all (I swear) and its ability to alleviate almost all of my cravings for cigarettes was something I would consider amazing. While I don't deny that other people have had problems using the drug, I just wanted to let people know that it can be a life saver for those of us desperate to quit smoking.

    todd

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  10. Ur blog is very interesting with a lot of good article and information.

    I haven't appraised the literature yet.

    not all physicians are aware of this medical conspiracy and conflicts of interest in the RCT.

    FACT = Healthcare is business

    Doctors are only a healthcare provider.

    I learn EBM(evidence-based medicine) in med school.
    "What is the clinical question for this patient?
    Search for the relevant literature
    Is the paper valid? conflict of interest?
    How is the result?
    and the applicability to this patient."

    We use EBM to help in the medical practice.
    Each attending staffs are different in the way they practice even with the same clinical patient and clinical setting.

    The RCT/metaanalysis... are just ONE OF the process of clinical practice.

    clinical practice (SOAP)
    1. History taking + physical exam
    2. summary of pertinent findings
    3. make the clinical problem lists
    4. laboratory investigations

    5. assess each clinical problems
    here we use the clinical method/
    clinical thinking
    a. standard text book
    b. RCT/case report/meta analysis
    c. clinical expert opinions
    or d. his own clinical experience]

    6. plan of treatment

    nowadays, the Hippocratic oath has already become a hypocritical/hypocrite oath.

    HEALTHCARE IS BUSINESS AND BECOMING THE LARGEST INDUSTRY in the world.
    with the world market cap of maybe a couple of hundred billion$.

    MEdical practice is tiring and getting more complicated each day.

    Doctors around the world are quitting working in a public sector and going to work in a private healthcare sector instead.

    We just go with the flow in this subtle conspiracy.

    IT'S ALL ABOUT THE MONEY$$$.

    NOthing we can do about this.

    ReplyDelete
  11. The evidence used by the FDA to approve drugs is now known to be tainted. If this were a state or federal court, that evidence would be thrown out as being inadmissible. But at the FDA, there's no such thing as pro drug evidence that's too tainted to accept as fact. Based on what we now know, the FDA needs to retract its approval of numerous drugs that were approved based on ghostwritten papers. In other words, if the FDA's original approval of these drugs was based on scientific fraud, then the FDA needs to rectify the situation and withdraw the approval of those drugs until proper studies can be conducted.
    ---------------------
    Reeta


    washington drug rehab

    ReplyDelete

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