Respectful Insolence

There is no doubt that the infiltration of quackademic medicine into medical schools in this country represents a profound threat to science-based medicine. By mixing mysticism, non-science, and pseudoscience along with science-based medicine, medical schools are in essence endorsing quackery and elevating it to the same level as science-based and science-tested modalities. Worse, they’re running the risk of training a generation of medical students accepting of this “integrating” woo with science, who can’t recognize highly implausible treatments or recognize obvious quackery. By letting pseudoscience take root, they’re risking the very foundations of medicine, the science that brought us such enormous progress over the last century. Indeed, over the last two or three years, this problem has been a frequent topic right here on this very blog.

But the dubious therapies, some of which are outright quackery, that make up CAM are, unfortunately, not the only threat to science-based medicine. They may not even be the most dangerous threat. Science-based medicine requires, as its name implies, a strong evidence base rooted in basic science and clinical trials. Without that, science-based medicine is not truly science-based; consequently, anything that threatens the integrity of the scientific literature supporting various therapies represents a threat to science-based medicine every bit as profound as the infiltration of reflexologists at the world-renowned and august M.D. Anderson Cancer Center. For instance, when the marketing division of a pharmaceutical company designs a clinical trial, it’s a threat to science-based medicine. When there’s publication bias in the trials used to support applications for FDA approval of drugs, it’s a threat to science-based medicine. When a drug company pays a publisher to publish a fake journal (six, actually) reprinting articles favorable to its products, it’s a threat to science-based medicine.

And when a drug company ghostwrites articles to be submitted to peer-reviewed journals for publication, it’s a threat to science-based medicine:

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.

Hormone replacement therapy (HRT) is one of the better examples of both the success and failure of science-based medicine. It’s a failure in that HRT became widely used largely on the basis of retrospective and cohort studies that found cardiovascular benefits in addition to its obvious ability to relieve hot flashes and menopausal symptoms, something no other therapy does better. In retrospect, the evidence base supporting HRT did not justify such widespread use. Unfortunately for Wyeth (and patients), in 2002 an analysis of data from the Women’s Health Initiative showed that HRT with estrogen-progestin results in increased risk for stroke, myocardial infarction, and breast cancer among postmenopausal women. The triumph of science-based medicine is that this result showed that previous practice was subjecting women to a higher risk than had been thought and publication of these data resulted in a near-instantaneous change in practice in which routine recommendation of HRT for cardiovascular benefit as well as relief of menopausal symptoms. Again, as I’ve said time and time again, it may be messy and it may take more time than we like (not to mention encounter more resistance than is always desirable), but eventually science-based medicine, like science, is self-correcting. This is in marked contrast to “alternative” medicine, where, no matter how much evidence is accumulated against an “alternative” modality, its practitioners almost never abandon it.

Not that Wyeth apparently didn’t do its damnedest to prevent that correction and to promote its HRT product. It did it mainly by writing review articles surveying the state of the evidence on the topic of HRT and publishing them in journals such as The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. Most importantly, Wyeth did not disclose its role in writing the articles, as documents recently revealed in a product liability lawsuit against Wyeth by women who claim to have been injured by its HRT products show. Here’s what Wyeth did:

In 1997, for example, DesignWrite, a medical communications company in Princeton, N.J., proposed to Wyeth a two-year plan that would include the preparation of about 30 articles for publication in medical journals.

The development of an article on the treatment of menopausal hot flashes and night sweats illustrates DesignWrite’s methodology.

Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as “TBD” — to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Bachmann responded in an e-mail message to DesignWrite: “Outline is excellent as written.” In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that “excellent” and added, “I only had one correction which I highlighted in red.”

The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies.

The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

Here’s a graphical representation of how DesignWrite did it.

So, in essence, Dr. Bachman appears to have signed on to a previously drafted article, suggested some changes, and then submitted it for publication under her own name. This sort of thing disgusts me. Besides being wholly deceptive and quite dishonest, it provides ammunition to the quacks to dismiss SBM as being hopelessly corrupt. Not surprisingly, the anti-vaccine quack apologists over at Age of Autism have already jumped all over this as being somehow “vindication” and evidence that the studies failing to find a link behind vaccines and autism are similarly tainted. Never mind that the HRT papers were review articles and not primary studies.

Look, I can understand as much as any academic the pressure to publish. It truly is “publish or perish,” and I probably haven’t published as much as I should have by this point in my career, at least in terms of sheer numbers of publication. If a drug company came up to me with a mostly written review article, I can see how it would be highly tempting to say yes. Hopefully my sense of honor would prevent me from saying yes, but, admittedly, also helping me to stand tall would be the knowledge that review articles don’t really count for much when it comes to career advancement or tenure, at least not among those of us who do lab research.

I believe that treatments based on the best available science represent the best medicine. I really do. Anything that contaminates the best available science contaminates the evidentiary basis behind what I believe to be the best medicine. it’s like weakening the pillar of a structure. It may stand with the weakened support, but it takes a lot less stress for the whole edifice to come tumbling down. In this particular case, Wyeth firmly asserts that everything it published was correct and based on good science. Even if that is absolutely, positively, 100% true, it’s also absolutely, positively, 100% beside the point. Failure to disclose that Wyeth (or, more specifically, a company hired by Wyeth to promote its products in the medical literature) had a major hand in writing a review article, if it didn’t write it completely itself, deprives the reader of a critical piece of information necessary to judge the content of that article. Review articles are different from primary research articles in that there is no new data. What they do is to review the existing literature, synthesize it, and come to conclusions. Thus, decisions about what articles to include, which ones to emphasize, and how to synthesize the totality of the literature become very important. The “spin” put on the article is everything, and you can bet that Wyeth tried to spin the data in the most favorable possible manner to its interests. Moreover, if a reader (or a peer reviewer) doesn’t know who was really behind the article, he assumes that it represents the analysis, conclusion, and opinion of the professor whose name is on the article. The practice of ghostwriting review articles is thus, at its heart, completely corrupt.

I don’t know what’s worse, that Wyeth would pull such a stunt or that medical faculty would willingly sign on to this deception. As Dr. Roy Poses pointed out, as hard as it is for those of us in academia to believe, we hold trusted positions. Our opinions matter, both to patients and to community physicians who read what we write for guidance regarding what the latest science- and evidence-based practice is. Whoring one’s good name to a pharmaceutical company for an extra line on one’s CV or for a “consulting fee” destroys that trust and poisons the scientific literature. It deceives physicians and patients into thinking that a therapy is more efficacious and/or less risky than it really is. It would be different if it were disclosed that a drug company employee or hired gun co-authored the paper, because then at least the reader would be aware of the article’s source and could take that into account when analyzing its conclusions. As Adriane Fugh-Berman put it:

While ghostwriters for celebrity autobiographies may do readers a service by rendering a non-writer’s story readable, the ghostwriters who haunt medical journals represent the views of product manufacturers rather than the academic “authors” whose names decorate the articles.

Riffing on the baseball analogy in the NYT article, Dr. Daniel Carlat puts it well:

As with baseball players on steroids, when companies pour marketing money into ghostwriting campaigns, they change the rules of the academic game. The playing field is no longer level; the drug company’s version of the truth gains the upper hand. Sometimes, their truth really is the truth, but sometimes it’s a carefully crafted lie. Sorting it out is difficult even for physicians who specialize in the area being written about. It’s essentially impossible for the average generalist physician, to say nothing of patients who did not have the advantage of attending medical school.

Exactly, which is, of course, the whole reason why pharmaceutical companies do this.

I used to complain about the increasingly detailed reporting about which author did what demanded by journals to which I’ve submitted manuscripts over the last few years. Sometimes the requests for exactly which author did what in a manuscript, from designing and carrying out the experiments to analyzing the data to writing the manuscript seemed to be reaching ridiculous heights. (Or should I say depths?) Maybe it’s not so ridiculous. On the other hand, I’m not sure what journals can do. After all, as I pointed out before, even articles with ostensibly very strict disclosure rules for authors often don’t catch omissions when authors fail to disclose pharmaceutical company ties. Journal staffs aren’t large enough to investigate the veracity of every author when it comes to reporting conflicts of interest. What is really needed is to attack the problem at the most vulnerable point, namely the faculty who lend their names to ghostwritten papers. Universities need to make it very clear that such activity will have a major negative impact on the careers of its faculty and that ghostwritten articles absolutely, positively will not count towards tenure, promotion, or pay raises. In fact, they should impact negatively on these career milestones.

Actions must have consequences.

Comments

  1. #1 Todd W.
    August 6, 2009

    How easy is it to sneak this kind of thing by? It seems like the only real way for an academic researcher to be caught is well after the fact, when a court case brings it to the fore. They should definitely be held accountable, though, by not only not having those papers count toward tenure or promotion, but by also setting the service clock back, etc.

    The companies, too, should be heavily fined, IMO, when they do not disclose their role in the paper. Could this be something that the regulatory affairs staff of the companies could nip in the bud, as it were? Or would it be too difficult, since it’s more likely the marketing staff that would be involved?

  2. #2 Pablo
    August 6, 2009

    You know, I really don’t hold it too much against the drug company. They couldn’t get away with this crap if there weren’t people willing to sign on. It’s kind of like illegal immigration. Who’s to blame? Immigrants that sneak in to get jobs? Or the companies who illegally hire them? (I blame the companies, btw)

    Dr. Bachman should lose her medical license. That’s a serious breach of ethics there, allowing yourself to be an author for a work to which you had no contribution (seriously, “it looks good!” is not contributing).

    I’m curious who the other authors were. Bachman is listed as the “primary” author, but that’s a vague concept.

  3. #3 FreeSpeaker
    August 6, 2009

    I wonder if Whyeth approached DesignWrite of was it the other way around?

    I visited the DesignWrite site, and they purport to be a communications firm. Well, their site does not communicate what they do.

  4. #4 Danimal
    August 6, 2009

    Interesting that Dr. Gloria Bachmann, works Robert Wood Johnson Medical School. It almost sounds like the Robert Wood Johnson Foundation (RWJF) which sponsers most second hand smoke (SHS) studies, with the up front intent to fund only research that will show SHS is harmful. Thus, if I see anything about SHS funded by RWJF, I automatically consider researcher bias. So it is not surprizing the someone working for a Medical School with Robert Wood Johnson in its name is also not all in the up and up. Yes I know there is a logical fallacy in there, but WTF.

  5. #5 BB
    August 6, 2009

    Some ghostwriters work in-house for pharma companies. A few years ago I interviewed for a medical writer position at a different pharma compnay (thought I’d be writing labeling, docs for the FDA, conference presentations, and such). Turns out I was supposed to recruit the Dr. Bachmanns out there to put their names to articles I wrote. When I pointed out the ethical dilemma with that approach (journals that require listing the extent of contributions each co-author made) to the recruiter, the recruiter looked down and mumbled something about how it was really fine.
    Fortunately, the next day I got word my big grant would be funded.

  6. #6 Jane
    August 6, 2009

    I worked at a med-ed company as a science writer for a short time–my one sad foray into the private sector. I have a science background, but that was hardly universal and in any case I was hardly qualified to make treatment decisions.

    I remember watching in amazement as a colleague with a bachelor’s in English taught herself immunology as she wrote a review article ordered by a drug company. She began with the conclusions and was fed information upon which to base the article. While some wonderful science has been done by intelligent amateurs (astronomy benefits from the patience and persistence with which enthusiasts monitor the sky, for example), immunology is pretty damn complex.

    In other work I saw writers asked to weight a small study with positive results much more heavily than a large study with negative or neutral results. Confused writers sometimes had doctors to consult and sometimes didn’t.

    There is certainly a place for people like me who can write clearly in lay language about medicine and science. But that is not what businesses like DesignWrite are selling or what drug companies are buying.

  7. #7 Marcus Ranum
    August 6, 2009

    In most fields, marketing bullshit is everywhere. And the social response to it is to learn how to filter it out. Ultimately, it’s probably better that people learn to assume that everything is corrupted with marketing bullshit than not, because that way their skeptical shields will stay up.

  8. #8 HealthEd
    August 6, 2009

    It’s as bad as BB and Jane says it is, and worse.

    I worked for a firm that published a few health care journals. (Note: health care, not medical, although we did frequently publish clinical studies)

    Our major advertisers were largely the major pharma companies. So far, no harm, no foul, you do what you have to do to keep the printer paid.

    But another line of the business was doing project work (CME, materials for satellite symposia, etc.) for pharma companies.

    On top of that, we did consulting for pharma companies, helping them get a sense of how well their products would be received/covered (or not) by payers.

    Best boss I ever worked for and I learned so many new and valuable skills (plus the business trip to Hawaii was icing), but man the soul-sucking nature of it was awful. I have learned my lesson now and refuse to ever work for a pharma or pharma-affiliated company anymore, even in this dire economy.

  9. #9 IBY
    August 6, 2009

    I wonder how some people can live with themselves by selling themselves to such corrupt doings. But then again, I have never had the pressure of having a job which depends on publishing or dying.

  10. #10 Ramel
    August 6, 2009

    Sad trueth is that it’s not just pharma companies, this sort of thing happens in all industries.

  11. #11 Pablo
    August 6, 2009

    I wonder how some people can live with themselves by selling themselves to such corrupt doings. But then again, I have never had the pressure of having a job which depends on publishing or dying.

    Well I have (do) and I still wonder how people can live with themselves. Then again, I am one who wants to make it on MY merits.

    I’ve had my name on papers where I’ve done less than a major contribution, but even then, I insist on having a significant intellectual contribution to the effort, if not contributing to the actual work, resources, or writing.

  12. #12 Phoenix Woman
    August 6, 2009

    You know, I really don’t hold it too much against the drug company. They couldn’t get away with this crap if there weren’t people willing to sign on.

    Who pays for drug research nowadays? The people who “sign on” likely can’t afford to set up their own labs. Even university labs are often (if not usually) subsidized in part by drug companies, who find it cheaper to use the cut-rate labor of grad students than to pay researchers at full rates.

    So in the end it comes down to the drug companies. Hell, they just again rammed through a provision in the new health bill, courtesy of one of their bought congresscritters Billy Tauzin, that makes it impossible for the government to do what private industry does all the time: Negotiate to get the best drug rates.

  13. #13 Zuska
    August 6, 2009

    I have worked in pharma, and for contract research organizations (medical communication companies are one specialized form of CRO) as a medical writer, doing mostly regulatory writing, but also some med ed and publication work. I worked with people who had extremely high ethical standards, and who would not have participated as ghostwriters in producing a journal article. That’s not to say that pharma didn’t have any affect on the content of the med ed materials or the pub – you didn’t see our company sponsoring any materials that claimed our product didn’t work, for example. On the one hand, we believed our data showed that our product did work. On the other hand, we also clearly had a vested interest. We tried our very best to be as ethical and open as possible.

    But I know it’s not like that everywhere in the industry (as certainly the case described above illustrates) and there are some very shady practices going on – there’s just too much money to be made for it not to be so. This is some of the fallout of medicine and medical research as a for-profit industry.

    The American Medical Writers Association is extremely concerned about ghostwriting as a threat to the integrity of the profession and has been discussing it in meetings and in its journal over the past year or two. There are good people in the profession and they are trying to deal with this issue. Fortunately or unfortunately, medical writing is not a highly regulated profession and so it is up to the writers to police their own ranks.

    As a final note, just for the record, a few of the finest writers in the profession at large do, in fact, have backgrounds in English or other non-science areas, and have taught themselves truckloads worth of science in order to do their jobs effectively. I have seen some of them in action and they would put some bench scientists to shame for their ability to marry language and data analysis skills. It’s a bit of science snobbery to think that it can’t be done.

    However, most of these folks got into the profession quite some time ago. It is much, much harder these days to get into medical writing with a non-science background, simply because there are so many surplus scientists around these days looking for alternative careers, and because pharma has changed its standards for writers more or less across the board to now include some science background for even beginning writers.

  14. #14 Bronze Dog
    August 6, 2009

    Always nasty when you find some bad eggs turned rotten by monetary interests. I’d certainly rather not have some greedy people give alties more ammo. At least the fact that people are getting caught means responsible people are keeping their eyes open.

    Keep up the blogging on this sort of thing, Orac. Always good to know skeptics will police our own scientific efforts, unlike the typical Altie.

  15. #15 John
    August 6, 2009

    Ghostwriting is one reason FDA approval is no guarantee of safety. 75 FDA-approved drugs were recalled from 1969 to 2002 because of safety concerns. According to The New York Times Merck used ghostwriters for Vioxx studies:

    “The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.”

    According to the FDA Vioxx killed between 89,000 and 139,000 Americans between 1999 and 2004, before being pulled from the market by Merck.

    Thanks for drawing attention to this problem.

  16. #16 John
    August 6, 2009

    In my previous post the New York Times link was incorrect. Here’s the correct address:
    http://www.nytimes.com/2008/04/15/business/15cnd-vioxx.html

  17. #17 DrFrank
    August 7, 2009

    Dishonest crap like this needs to be stamped down on hard. I’m not sure if there’s any legal scope to fine pharma companies for this, but there definitely needs to be some way of discouraging these practices.

  18. #18 Good to know...
    August 7, 2009

    Ghostwriting is a huge problem in the vaccine industry as well. The medical shills come out in droves to discuss how safe vaccines are … Sure…

  19. #19 wilsontown
    August 7, 2009

    Surely Dr. Bachman is guilty of academic misconduct here. Putting your name to an article that you had no hand in writing is, I would say, akin to plagiarism. It ought to be treated as a serious academic offence.

    Also, perhaps the scientific community in general should be doing more to resist the pressure to publish no matter what. It ought to be obvious that the quality of someone’s scientific contribution cannot be evaluated simply by counting how many papers they have published.

  20. #20 BB
    August 7, 2009

    @Danimal, if you had looked up Robert Wood Johnson Medical School, you’d have noticed it’s one of 3 state medical school in New Jersey.

  21. #21 Kemist
    August 7, 2009

    You know, I really don’t hold it too much against the drug company. They couldn’t get away with this crap if there weren’t people willing to sign on. It’s kind of like illegal immigration. Who’s to blame? Immigrants that sneak in to get jobs? Or the companies who illegally hire them? (I blame the companies, btw)

    I don’t think the scientist willing to ghostwrite is the most akin to the companies employing illegal immigrant in this case.

    Science isn’t exactly a lucrative endeavor for most of us, ie those of us who aren’t engineers or MDs. You wouldn’t believe the ludicrous salaries and poor working conditions academic research assistants, those 98% of PhD-ed people who fail at becoming profs, have. I have made more money as a junior claim examinator for a travel insurance company than many of them do, doing about half the hours a week they do, taking nowhere near the same risks.

    I have seen a lot of the lucky 2%, those young profs, go before I left the lab because they couldn’t scrape together the funding to maintain what little they had. Those people can’t go back to practice if they lose their current position. They often have to go back to zero in another career entirely, with a major drop in salary.

    I wouldn’t be so quick to judge them the guiltiest of parties for working for pharmas. It’s amazing the stuff you can do when you receive first notice that the bank is coming for your house.

    For my part I couldn’t do it and just left, but I’m still young enough to change careers. For most of them… it’s quite a dire situation.

  22. #22 James Sweet
    August 7, 2009

    Ghostwriting is a huge problem in the vaccine industry as well. The medical shills come out in droves to discuss how safe vaccines are … Sure…

    Lucky for us, Science Works(TM), and as we’ve seen here, even big evil corporations can’t get away with distorting the science for very long. Even if Merck is employing armies of shills to go around downplaying the risks of vaccines, we can still see that the overwhelming preponderance of evidence is that the risks of vaccines are tiny compared to the benefits.

    (Now I’m just waiting for Merck to send me my goddamn check already…)

  23. #23 Kemist
    August 7, 2009

    (Now I’m just waiting for Merck to send me my goddamn check already…)

    Ah, you’re waiting for it too ?

    Damn them. Can’t even pay their shills properly.

  24. #24 Syriuslee Njured
    October 17, 2009

    In response to what Pablo said about Dr. Bachmann, AKA Dr. Baatchman, losing her license, well it ain’t gonna happen. Dr. Bachmann is a female version of Dr. Jekyll…a white coat criminal and Robert Wood Johnson is complicit with her unethical, criminal conduct to the point of conspiring and racketeering. She and her cohort Dr. Ronnie Z. Bochner AKA Dr. Botchner who looks like Hitler in a labcoat, almost killed me in a Tuskegee Study type, unapproved IRB research with an unapproved device. The NJ Medical Board stated it was standard care. After I had retained an attorney, mysteriously, Dr. Stuart Hochron who also practices as an attorney was hired by the law firm and my case went down the toilet.

  25. #25 jon
    May 31, 2010

    This is hilarious. A site known for pharma ghostwriting and marketing research fraud…writes an article about pharma ghostwriting? I guess all I can say is it’s pure genius.

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