Merck Ghostwrote Vioxx Studies For Doctors

Newly unearthed documents may reveal that Merck Pharmaceuticals ghostwrote dozens of Vioxx studies and then paid well-known doctors to put their name on them as if they wrote them, according to a new article to be published in The Journal of the American Medical Association (JAMA). In one instance, a draft version of an article to be published listed the lead author as “External author?” Dr. Steven H. Ferris, one of the doctors whose research was questioned, call the article “simply false”, its allegations “egregious.” Let’s see what the JAMA article has to say about the study Ferris supposedly worked on:

When publishing their own clinical trials (designed, conducted, and sponsored by
Merck), documents were found describing Merck scientists often working to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to collaborate on the manuscript as guest authors. For instance, rial 078 (a randomized, doubleblind study to investigate whether rofecoxib could delay the onset of Alzheimer disease in patients with mild cognitive impairment) was designed and conducted principally by scientists at Merck. FIGURE 2 shows the title and author list both from draft and published versions of the manuscript describing the trial. Both the title and the authorship were modified to attribute authorship to 3 academically affiliated investigators (first, second, and third authors) on the published article, in addition to the 8 Merck scientists who are attributed authorship on both the draft and published versions of the manuscript (1 Merck scientist is attributed authorship on the draft but not the final manuscript). Of note, only 1 of the 3 academically affiliated investigators who are attributed authorship on the published article was acknowledged in the draft version as a participating investigator in the rofecoxib 078 study group. In an internal e-mail discussing where to publish trial 078 as the draft is circulated, one of the Merck scientists states, “I think you should be the first author since you have done virtually all of the writing.” Although there are minor differences in language and organization between the draft and final versions of the manuscript (particularly in the abstract, as opposed to the text), the results presented are almost identical, reinforcing that the trial itself and the analyses were complete before the academically affiliated investigators were involved in the manuscript.

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib (PDF) [JAMA]
Merck Wrote Drug Studies for Doctors [NYT]

Comments

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  1. CaptainConsumer says:

    Are we REALLY surprised by this? Outraged, of course, surprised? Come on. The Bush Administration actually offered up SCIENTISTS 10K to put their names to ghostwritten reports on global warming claiming it didn’t exist to there seems to be a burgeoning market for said.

  2. Aphex242 says:

    Nah, not surprised, but man we’re in trouble if we elect a president that will allow this garbage to continue.

  3. chrisjames says:

    Well, this is pretty common practice in academic circles. People who were even close to a study, even to the smallest degree, but might not have even read the paper or known about it can get their name on it, in any particular order. It’s not always ghostwriting. Plus, take the fact that many parties can take part in one study, or provide bits and pieces of one study, so not everyone may know who is involved and this can happen.

    Of course, this needs investigation being from a pharmaceutical company, but it doesn’t immediately imply sneakiness to me.

  4. TheBigLewinski says:

    Yeah, we should close down these big-ass american companies cause we can get this stuff cheaper from China.

  5. BigElectricCat says:

    If this can be proven, then I think the doctors who permitted their names to be used should have their medical licenses pulled. They shouldn’t be permitted to practice or teach medicine, IMO.

  6. FLConsumer says:

    Let’s see… Pharma’s pushing for laws that take them off the hook once the FDA approves their drug. They use “evidence” such as this to convince the FDA to approve their drugs. No wonder they want immunity. ‘though I would imagine any immunity would be null and void if the evidence used to convince the FDA of the safety and efficacy of a drug was fabricated. At least I can hope.

  7. Raanne says:

    So, if a bunch of people are involved in a study, and the research and conclusions are given to a medical writer, is that ghost writing? just curious where the line is drawn.

  8. bohemian says:

    @TheBigLewinski: Drugs rushed to market based on cooked studies that are then produced in China with no oversight or product control, it is the new American way!

    @BigElectricCat: Totally agree. Any doctor who would help a drug company manipulate data should lose their license. Lawyers get disbarred for far less.

    I have lost a considerable amount of trust in both the medical community and most of the newer drugs. I recently changed GP doctors when the current one insisted I come in so she could inform me about all the great new drug options even though the cheap older medications I have been using are working fine.

  9. bohemian says:

    They need to just make Vioxx a class action and let anyone who ever took it collect against Merck.

  10. savvy9999 says:

    Somebody, somewhere, is going to take this very seriously.

  11. Mitch6 says:

    Sometimes, deceptions are perpetrated not only by what is said, but by what is withheld. Let’s face it, BigPharma isn’t primarily in business just for the health of it. Statin drugs, for example, have been the most profitable drug in history. Would BigPharma provide information about another, more effective, unprofitable drug that would compete with statins?

    Statin drugs are gaining popularity as a prescription method to lower CRP, a marker of inflammation and a risk factor for heart disease. It appears that the while majority of physicians appear to be aware of the effect of Lipitor and Pravachol on C-reactive protein they do not seem to be aware that niacin (1500 mg at night) lowered it by 20%, much more meaningful reductions than those seen with Pravachol and Lipitor.5,6

    There is much info about this at http://www.cholesterolscore.com

  12. thesilentnight says:

    Welllll at least they got REAL doctors to sign off on the studies they ACTUALLY conducted. I mean its not like they out and out made shit up completely.

    So where are they on the Worst Company in America bracket?

  13. bukz68 says:

    @chrisjames: I was an undergrad research assistant in the bio department and in my experience you can get your name on a paper ONLY if you have a concrete affiliation with the project. You don’t necessarily have to have a hand in writing the thing (usually left to the grad students/post docs). But if you’re a PI or even a lowly peon like myself you can get credited merely for generating and analyzing the data. As per your “in any particular order” comment, in my experience again, usually the PI is listed first, and then all other “authors” are listed by seniority or by contribution.

    In any event what Merck is doing is fucked up if these people have no affiliation with the study other than giving people a famous name to look at (or lend credibility).

  14. FLConsumer says:

    @thesilentnight: That’s kind of the problem. With no doctor overseeing the study, how can you be sure the study was indeed performed as described? There’s another NY Times article running this week which showed that positive articles about drugs get published far more often (I think it was 3:1) than negative studies about a drug.

  15. synergy says:

    I work with scientists who publish their work. You do NOT put as first author some random “guest” author. First author is always the person who has done most of the work!!!

  16. chrisjames says:

    @bukz68: But “concrete affiliation” covers a lot of ground. Like you said, you can get credit merely for generating and analyzing the data. You can get credit for developing the tools used to analyze the data, meaning you don’t even need to be aware of the project itself, though that’s really just a courtesy co-authorship. The paper I’m writing now has authors that were only running the associated project at the proposal end, which ended up using completely different results from what we’re including in the paper. I’m writing it myself, and I did much of the work, but I’m not first author and there is no principal. It’s just not so straightforward as people seem to think.

  17. utensil42 says:

    @chrisjames: This is not common practice in academia, and University ethics boards are very strict about this. If you were legitimately involved in the research OR the writing, you have earned authorship. It is not enough to fund research, or allow research to be done in your lab, etc. You must participate in the research to a significant degree to earn an authorship on a paper. Most academics are ethical enough that they won’t let the kind of thing you suggest fly.

    @Raanne: I’m not sure if it’s considered ghost writing, which is a fairly nebulous term. However, all involved researchers, as well as the medical writer should receive and authorship from the study.

  18. utensil42 says:

    @chrisjames: What the hell field are you in? Because that method of authorship is just bloody messed up.

  19. hill_policy_wonk says:

    Confluence of ironies. One of the few things that is actually taken very seriously is the order the authors’ names appear in academic papers.

    In medical or biological journals the first author is the one that did most of the work, the last author is usually the principal investigator (lab boss). The first and last places in the list are the most prestigious. There are often heated debates between which authors should be first and in the case of multilab collaboration, which PI should go last. The ones in the middle are considerably less prestigious and sometimes that’s where you might get author inflation where people who made marginal contibutions get added.

    First author publications are very important in an academic career. Get enough high profile ones and it will be the difference between getting tenure, a job at a better university, an endowed chair and not.

    Any scientists who signed on as a first author under these circumstances took a huge risk and gambled away all of their credibility if these accuasations bear out. They deserve what’s coming, hopefully they’ll be ostracized.

  20. synergy says:

    @utensil42: Ditto.

  21. dragonfire81 says:

    It’s all about money!

    Imagine getting paid $10 000 to allow your name to get put on something that’s ALREADY WRITTEN so you basically make bank for doing NOTHING whatsoever. You can’t tell me there’s many people who wouldn’t jump on that, regardless of the circumstances.

    Remember how America works folks. There are certain things that take priorities over others and it looks something like this:
    Morals ==> Ethics ========> MONEY

    I guarantee you there are people in corporate america who would kill their own mother it would get them an extra million dollars.

  22. FLConsumer says:

    @utensil42: Give me a break. I’ve seen far worse than this happen in the ivory tower. I’ve seen highly regarded PhD’s falsify data they didn’t have, rubber-stamp sources used by other papers (despite never reading the sources themselves) and plenty of misinterpretation of data because it fit their needs better than the actual results. Even Unis are big business now.

  23. FLConsumer says:

    @dragonfire81:

    I guarantee you there are people in corporate america who would kill their own mother it would get them an extra million dollars.

    I’ve been meaning to do this for some time anyway, which company will give me the extra million while I’m at it?

  24. TheBigLewinski says:

    @bohemian: Yup you are right, just open the floodgates for lawsuits against these bastards. Who needs this chemical “junk” anyway? Go to the witch doctor, get some plant and everything will be alright.

  25. utensil42 says:

    @FLConsumer: I wasn’t (and won’t) deny that this occurs on occasion. However, it is not particularly common and it pains me to see people write about academics like we’re all a bunch of money-grubbing demons.

  26. burgundyyears says:

    @aphex242: I agree. George W. Bush has indeed been a very disappointing editor and reviewer of medical journals during the past 8 years.

  27. chrisjames says:

    @utensil42: No, that’s just not right; or rather not relevant. And it’s not just anyone gets names on papers.

    It’s more like, not all projects are done by a small group of people with very narrow research. There’s a body of work that’s just spinoff from other things, whether that’s focused research or projects, and in those cases, a lot of people need to be credited and there’s rarely just one person that takes the cake as first author.

    You’re right about ethics being a concern and people needing to actually contribute, but what I’m saying is that sometimes a hell of a lot of people are contributing to the results being given in one paper, a paper that may cover more than just a simple case study.

    It’s much worse not to include the names of contributors, and if you don’t happen to know everyone involved with the work (not everyone is in the know), then you better damn well find out from someone who does, which may be the case here with Merck. It may not be, but they’ll need to investigate that.

  28. @burgundyyears: LOL, nice.

  29. azntg says:

    I just find it funny. The academic institutions practice one thing and the de facto practice is completely different. Quelle horreur!

  30. bobee says:

    @utensil42:

    Actually, it really is a fairly common practice in academia. Often one of the PI’s is on there for the name and attention/credibility it will generate. Don’t assume such things do not happen because you don’t see it in your microcosm. Yes, it seems obvious that one may be more inclined to confirm the validity of that study if their name and reputation are attached to it. However, you’d be surprised how often things are not challenged and “slip” through the cracks. Heck, alot of people put out studies just to puff up the list of publications they can list in their CV.

  31. arby says:

    @Mitch6: So, how do you like working as a Niaspan rep?