Ghostwriters in the sky

This seems to be one of those weeks when a lot of things come together, when patterns that were less clear before become more clear. TPM’s been all over the bogus “grassroots” letters and faxes, written by outfits like Bonner & Associates (which actually forges some of them) and FreedomWorks. And today the Times has a piece on an even more disturbing practice, utilized by drug companies:

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients.

I don’t know whether or not paying ghostwriters counts as R&D spending.






45 replies
  1. 1
    Matt says:

    Damn you big pharma. Now you got that song in my head.

  2. 2
    PeakVT says:

    Sometimes I think it would be better if the government contracted out for drug research directly, and then leased the manufacturing rights.

  3. 3
    pineview1997 says:

    Last summer I went to a wedding in DC and one of the guys I sat next to at dinner worked for a firm called Keybridge Communications. They seemed like your standard PR/communications firm but the guy I was talking to said his work focused mostly on writing newspaper OpEds for public figures, mostly wingnuts. Y’know stuff like global warming is hooey, smoking is good for you, etc. While this is probably pretty small bore stuff in the greater scheme of things, I did find it vaguely…creepy.

  4. 4
    Keith says:

    I don’t know whether or not paying ghostwriters counts as R&D spending.

    If it helps people cheat death, sure!

  5. 5

    I hope Ms McArdle gets seriously ill with a treatable disease–and has her claims denied by her insurance carrier.

    There, I said it. Sometimes, only personal experience can instruct the terminally obtuse.

  6. 6
    Kryptik says:

    Disgusting.

    And what’s sadder is someone’s eventually going to point to this to support their anti-vax crazy as well.

  7. 7
    Unabogie says:

    My neighbor is a global warming skeptic (not a denier, just a “there’s a controversy” kind of guy). When I point out that the articles he keeps finding are funded by oil companies, he doesn’t believe it. I know it won’t matter, but I sent him this article. Perhaps if he sees it happening in other industries, such as pharmaceuticals and tobacco, it will sink in.

  8. 8
    Wag says:

    R+D+ Refute anyone who points out the downside of high profit medications and Dilute said heratic’s message.

  9. 9
    DougJ says:

    And what’s sadder is someone’s eventually going to point to this to support their anti-vax crazy as well.

    Yeah, I know. I almost mentioned that in the post, but thought it might just attract the anti-vax crazies in the comments.

  10. 10
    Ash Can says:

    @pineview1997: I guess we’ve just figured out who wrote that Op-Ed for Sarah Palin.

  11. 11

    I seriously hope some of those wingnut PR types get to face the justice system for mail fraud with their forged letters. And these R&D types should likewise face the prospect of criminal prosecution.

    Send a few folks to jail and all of this stuff would end pretty quickly, imho. allowing companies to pay a slap-on-the-wrist fine is what keeps the system going.

  12. 12
    cervantes says:

    See my post on this. Click the home page. (I’m trying not to jam up the comments with a long essay.)

  13. 13
    Michael Keyes says:

    Um, this story is at least a year old and probably older as the New England Journal of Medicine has been writing about it for some time.

    Still, it is one of the reasons I don’t trust any scientific paper paid for by the drug companies.

  14. 14
    schrodinger's cat says:

    Who are the people that wrote these papers? Are they tenured faculty or researchers at national labs?

  15. 15
    dmsilev says:

    Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said.

    And if you believe that, I’ve got a vintage suspension bridge to sell you.

    I’ve written collaborative research papers before; indeed, most everything I write for publication is multi-author. And there’s always a long paper trail (OK, electronic trail) showing the evolution of the document and the contributions that various authors made. Not to mention extensive emails discussing this or that point which may not make it into an actual draft. The absence of that sort of trail is a glaring red flag, along with the “first author”‘s inability to actually identify any particular contributions she made.

    -dms

  16. 16
    cleek says:

    and let’s not forget about Elsevier’s line of entirely fake science journals!

    i’m happy to not work for those clowns anymore.

  17. 17

    Admit Doug, you got your check from George Soros this morning. Just come clean with us buddy.

  18. 18
    jcricket says:

    I don’t know whether or not paying ghostwriters counts as R&D spending.

    This is clearly the kind of medical innovation that government-funded healthcare will absolutely destroy (Megan McArdle and Andrew Sullivan are already writing about this as we speak).

    More seriously, I think stuff like this perfectly highlights why Libertarians (glib or otherwise) are fucking idiots. Corporations across all industries have so much money power now that there’s almost nothing to stop them from achieving their goals or their interests, except possibly a stronger regulatory framework and more enforcement by the government.

    There is no “free market” solution to crap like these companies are pulling. I may not have a lot of faith in government (esp. not currently), but I have negative infinity faith in corporations to police themselves. Or for consumers to have any ability (or the smarts, frankly) to resolve this situation through their purchasing habits.

  19. 19
    DougJ says:

    i’m happy to not work for those clowns anymore.

    You work for Elsevier?

  20. 20
    Zifnab says:

    @DougJ:

    Yeah, I know. I almost mentioned that in the post, but thought it might just attract the anti-vax crazies in the comments.

    Can you blame them? It’s really easy to start suggesting that vaccinations cause glaucoma or AIDS or whatever they want to blame next when you’ve got pharmaceutical companies pushing this bullshit. Hell, young earthers would have a bit more firm ground if we found out oil companies were fabricating geological data. You can argue these guys are wrong, but when shit like this crops up it’s hard to argue these guys are doubtful without reason.

    Besides, five years ago if I told you the government was taping everyone’s phone lines, how many crazy looks would I get?

  21. 21
    gypsy howell says:

    I’d like to think that ultimately, these kinds of practices will backfire on Big PhARMA, when people get to the point that they no longer trust that new medications won’t in fact kill them.

    But sadly, I guess Big PhARMA will just shovel more money into their bamboozlement schemes, and keep the PR bullshit flowing.

    I will say, though, that it is precisely my skepticism about the reliability of HRT research which has stopped me from asking my doctor to put me on an HRT regimen. I’d rather suffer with good old natural hot flashes and sleeplessness than trust my body to paid-shill medical research. Sad, huh?

  22. 22
    ksmiami says:

    The only reason these studies even got exposed were the increased side effects and the studies that came out about Asian women who never had HRT and yet experienced menopause without any correlating symptoms or bad cancerous outcomes. For years, I have been incredibly wary of American medicine cause the drive for profit has ceased the drive for making people well. And don’t even get me started on the milk product issue…

  23. 23
    RSA says:

    From the article:

    The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

    This pisses me off (as a human being) and makes me sad (as an academic researcher). Review articles are really useful, especially for people who don’t have the time (or in some cases expertise) to read the original source material. So lots of people are being misled. And basically I can’t think of any way to stop this sort of thing in general. Scientific research does rely heavily on good faith. If you have people who are willing to take money to promote a particular point of view and to lie about their motivation, that can be hard even to recognize.

  24. 24
    terraformer says:

    What happened to peer-review?

    People who falsify research results for publication should lose their ability to publish, period.

  25. 25
    Mpqrt says:

    My wife took Prempro on the advice of both her GP & OBGYN. She developed breast cancer – stage 4 at discovery.

    Her GP also advised her own mother to take Prempro; the GP’s mother developed breast cancer.

    My wife has done well in her battle, but will battle this cancer for the rest of her life.

    For Wyeth and the Wyeth people who are responsible for Prempro, criminal prosecution should have resulted from their actions.

  26. 26
    Balconesfault says:

    This is why we need tort reform … to protect Big Pharma from the inevitable class action lawsuits that various jackals are going to file on this issue.

  27. 27
    RSA says:

    People who falsify research results for publication should lose their ability to publish, period.

    Yeah, but apparently the problem isn’t falsification of results per se, at least not in an obvious sense. These are review articles, in which I imagine there’s a little bit of cherry picking for desirable results among the papers covered, a little bit of “this result [that I like] supersedes this other result [that I didn’t like]”, and so forth. Except for the case of the doctor in the article apparently not writing the artcle she she was lead author on, there’s little you can do. Blackball those authors? Fine—except that every journal has different standards, the drug companies will just find someone else, and for some authors the risk of being blackballed is presumably too low to bother considering.

  28. 28
    RSA says:

    A bit of serial posting: A solution just occurred to me, that failure to disclose a “significant” conflict of interest on a publication would open the authors up to having their medical licenses revoked. That wouldn’t cover everyone, but it would certainly make people a little bit more careful.

  29. 29

    Sigh. This shit is taking the piss and vinegar out of me. Anybody with anything remotely resembling good news in the world of politics? Oh, yeah. Clinton (Ex-prez, that is) freed the captured reporters in N. Korea. That’s good news for John McCain!

    Yeah. Um, so fuck Big Pharma. That’s the nicest thing I can say right now.

  30. 30
    Bootlegger says:

    @RSA:

    And basically I can’t think of any way to stop this sort of thing in general.

    Sure there is. Even review articles are suppose to undergo peer review (at least in my fields) and the reviewers have the responsibility to tell the journal editor if the review’s author is being honest or cherry picking the data. So either the journal isn’t have literature review submissions peer reviewed, or the reviewers are lazy. Neither is good.

  31. 31
    The Main Gauche of Mild Reason says:

    @RSA:

    Review articles are really useful, especially for people who don’t have the time (or in some cases expertise) to read the original source material. So lots of people are being misled. And basically I can’t think of any way to stop this sort of thing in general.

    I don’t know about this particular field, but I know that I personally have a list of authors that I have met at conferences/trust in my (relatively large) research field, and I just sort of ignore the others; I think most people in basic research do the same.

    It seems like this might be sort of a unique problem to the medical field–you have a lot of doctors who don’t do research themselves and haven’t learned that not all published research is the same. Of course, the fact that these reviews made it so uncritically through peer review is terrible, but maybe peer-review standards need to be higher for medical journals to prevent this?

  32. 32
    Bootlegger says:

    @The Main Gauche of Mild Reason: Good point. In my fields if someone mischaracterizes an article no one dies. In the medical literature physicians in the field rely on those reviews to tell them the current state of knowledge. If they are disingenuous its dangerous.

  33. 33
    Brachiator says:

    @jcricket:

    There is no “free market” solution to crap like these companies are pulling. I may not have a lot of faith in government (esp. not currently), but I have negative infinity faith in corporations to police themselves. Or for consumers to have any ability (or the smarts, frankly) to resolve this situation through their purchasing habits.

    Don’t you get it? Whatever a company does represents the free market working at its best. If a company stifles competition and becomes a monopoly, lies about the safety or effectiveness of drugs, poisons consumers, it’s allowable as long as it is free of government interference.

    And in the libertarian fantasy universe, there’s no such thing as fraud, since if you get misled or harmed by a company’s products, then its your fault for being stupid. And libertarians always imagine themselves as too smart to be fooled by venal industry practices, or so rich that they will always be able to buy the “good stuff,” leaving tainted or potentially harmful stuff for lower-wage suckers.

  34. 34
    RSA says:

    @Bootlegger:

    Even review articles are suppose to undergo peer review (at least in my fields) and the reviewers have the responsibility to tell the journal editor if the review’s author is being honest or cherry picking the data. So either the journal isn’t have literature review submissions peer reviewed, or the reviewers are lazy.

    Right; I think I was assuming (I wrote in the heat of the moment) that there’s not very much journals can do about lazy peer reviewers. Also I was thinking about some of the reviews I’ve done, in which I (like the other reviewers) have reasonable knowledge of some fraction of the area being covered, but not complete knowledge. The editor handling the submission has to put it all together; a tough job. But maybe I’m too pessimistic.

  35. 35
    Bootlegger says:

    @RSA: No, not too pessimistic, the editor absolutely must ensure that a review piece is accurate. I’d argue, in fact, that it is the only chore when reviewing a literature review article. I mean there are no methods to evaluate, or conclusions to deduce, or theory to derive, there is only whether or not the articles are correctly represented.

  36. 36
    Delia says:

    And this, I assume, is why the general public reads in the noospaper that one particular vitamin or food substance is vital for health and well-being, and the following week reads that same substance will kill you. Different study funded by different interest group.

    And then when real scientists come along with real warnings about global warming same general public is easily made to doubt because “science” is untrustworthy.

  37. 37

    @Brachiator:

    Don’t you get it? Whatever a company does represents the free market working at its best. If a company stifles competition and becomes a monopoly, lies about the safety or effectiveness of drugs, poisons consumers, it’s allowable as long as it is free of government interference.

    I was just re-reading some of the founding documents of this great country of ours, and I couldn’t come up with instance one of the founders looking out for corporations or business interests. It was very individual and community-centric. “the general welfare” doesn’t mean whatever suits the corporations best. We need to get back to the basics of what this country was founded on. Rule one would be repealing the concept of corporation as individual. Even with all their faults, I’d imagine Jefferson, Washington, Madison, Paine and their cohort are rolling over in their graves.

  38. 38

    I don’t know that we can assume that there was anything wrong with the peer review process, in that articles were incorrectly cited in an obviously fraudulent manner. As the NYT article states, there was a pretty strong consensus that hormone replacement therapy was a good(or at least not bad) thing until somewhere around 2002 when lots of negative results started coming out and studies got stopped.

    I would certainly wonder about the ghostwritten review articles published 2003-2005 though, but its not exactly uncommon for scientists to continue to support a theory or treatment after consensus has begun to erode. The contrary results could be poorly done, after all.

    There are lots of bad things going on here, but I’m not sure the peer review process is really designed to stop this. You have to expect people to be true to the concept of authorship and disclose possible conflicts of interest.

  39. 39
    JerseyJeffersonian says:

    My comment to accompany an email to my wife and female friend forwarding the link to this post:

    “So, if the hormone replacement therapies increase the likelihood of cancers, heart disease, and strokes in women who undergo those therapies, our friends in the
    Pharmico-Medico-Industrial Complex can make even more money medicating and treating the women so impacted? Score!

    Where is Upton Sinclair when we need him?”

    And as another poster observed, given this kind of skeevy behavior, why would the public not have good reason to entertain doubts about the value or safety of vaccines? The other day I submitted a post to another thread stating that as an asthmatic I would surely want to get the vaccine against the H1N1 strain of the flu. And then I found information linking the presence of adjuvants in vaccines – components designed to enhance the immune system response – to the onset of autoimmune diseases. This new flu vaccine will likely contain adjuvants. Specifically, the article advanced what appear to be non-trivial correlations between the presence of these agents in anthrax vaccines administered to troops deployed in the Gulf War and the spectrum of illnesses grouped under the general rubric of Gulf War Syndrome. This was provocative, and is something about which I will ask my doctor. Asthma can in some ways be considered like an autoimmune disorder; I don’t want to potentially add fuel to the fire. And the significant element is that the pharmaceutical firms were DENYING that adjuvants were ingredients in the vaccine. Here is a link to a post consisting of a precis of the original article (and a link to the original with all of the endnotes).

    http://cryptogon.com/?p=10257

    Does this mean I am guilty of wearing a tin-foil hat? I don’t think so. When pharmaceutical houses are shading the truth or actually lying about their products, I reserve the right to make my own decisions, hopefully informed decisions. People with “interests” have been known to blow smoke up your ass, you know, either by making shit up, or by depriving you of access to the truth. The libertarians are correct at least in this: Caveat Emptor. And those Romans had another pithy little aphorism upon which I reflect when confronted with some corporation’s claims: Cui Bono?

  40. 40
    The Main Gauche of Mild Reason says:

    I mean, again, I’ve felt that this is a problem with the medical field for awhile. Very few “lay” (non-researchers or not trained in the subject area) people read articles on cell motility or kinase signaling, but the audience for a lot of medical journals includes a very large “lay” audience in the form of general practicioners/specialists not directly involved with studies or based at research hospitals that aren’t familiar with the caveats of the research.

    A lot of the time, even people that PUBLISH in medical research journals don’t have the proper background to understand their results; I remember reading several pieces in the last few years talking about how medical schools need to include more statistics training as there were statistical errors/misapplications in a large number of studies on patients.

    Now, all of this argues to me that the current model where medical research journals function similarly to standard academic research journals is wrong. Maybe medical journals need to include a more rigorous screening by several editors before forwarding pieces to be peer-reviewed.

  41. 41
    Brachiator says:

    @arguingwithsignposts:

    I was just re-reading some of the founding documents of this great country of ours, and I couldn’t come up with instance one of the founders looking out for corporations or business interests. It was very individual and community-centric. “the general welfare” doesn’t mean whatever suits the corporations best. We need to get back to the basics of what this country was founded on. Rule one would be repealing the concept of corporation as individual. Even with all their faults, I’d imagine Jefferson, Washington, Madison, Paine and their cohort are rolling over in their graves.

    The founding documents deal primarily with dissolving government (Declaration of Independence) or founding government (The Constitution), and on the rights of individuals, not even so much the community. Pretty much silent on business interests. I got no problem with corporations except when corporate interests are assumed to be superior to the rights of citizens.

    Jefferson was pretty much useless with respect to his fantasy of the country being made up of yeomen farmers. Here, Alexander Hamilton was far more prescient, for good or ill. It’s hard to imagine much of the world’s progress, including the InterTubes, without corporations.

    But you got to have reasonable regulation. The libertarian wet-dream just won’t do.

  42. 42
    Barry says:

    “And basically I can’t think of any way to stop this sort of thing in general.”

    Hanging the boards of directors of Wyeth and Elsevier (see comment #16; it’s unlikely that Elsevier was an innocent victim) and Dr. Bachman would be a good start.

    Frankly, the biggest problem that the USA faces today is a paucity of crow-picked skeletons of corporate bigwigs hanged in chains as a warning to other. If I were in charge, there’d be a really, really long gallows running down Wall St right now, and there’d hardly be an empty noose when one is needed.

  43. 43
    Barry says:

    Following up on Elsevier: http://www.guardian.co.uk/comm.....-companies

    “Things have deteriorated since. It turns out that Elsevier put out six such journals, sponsored by industry. The Elsevier chief executive, Michael Hansen, has now admitted that they were made to look like journals, and lacked proper disclosure. “This was an unacceptable practice and we regret that it took place,” he said.”

    From http://science.slashdot.org/ar.....8;from=rss

    “Now, several librarians say that they have uncovered an entire imprint of ‘advertorial’ publications. Excerpta Medica, a ‘strategic medical communications agency,’ is an Elsevier division. Along with the now infamous Australasian Journal of Bone and Joint Medicine, it published a number of other ‘journals.’ Elsevier CEO Michael Hansen now admits that at least six fake journals were published for pharmaceutical companies.””

  44. 44
    jcricket says:

    But you got to have reasonable regulation. The libertarian wet-dream just won’t do.

    See, to me this highlights the fundamental bankruptcy of all modern Libertarians and “Big C” conservatives. Once you start saying “reasonable regulation” instead of “regulation bad” then you’re basically a Democrat, or at least a pragmatist.

    I just don’t get the fetishization of small or no government. It doesn’t work in practice, and even in thought exercises cannot be shown to be a useful framework for making decisions.

    So why again do we spend all our time arguing with people like Megan McArdle?

  45. 45

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