Few topics are more contentious than ghostwriting - the mysterious practice in which an article lands in a medical journal with the names of various authors who, as it turns out, had little or nothing to do with the substance of the publication. The issue has caused several scandals for several drugmakers and medical journals, causing embarrassment and turmoil.
However, keeping track can be difficult. So the Project On Government Oversight, a watchdog group that regularly probes the topic, has compiled a handy primer on recent episodes (read here, here, here, here and here), as well as the steps taken by various universities and government agencies to cope with the problem.
In case you were wondering, though, allegations have been reported for the following journals: The American Journal of Obstetrics and Gynecology; the Journal of Clinical Psychiatry; The Annals of Internal Medicine; The Lancet; Biological Psychiatry; Nature Medicine; Circulation; The New England Journal of Medicine; The International Journal of Cardiology; Neuropsychopharmacology; Journal of the Academy of Child & Adolescent Psychiatry; PLoS Medicine; Journal of the American Medical Association and Psychopharmacology Bulletin.
Meanwhile, evidence of ghostwriting has come to light during litigation involving the following companies: Abbott Laboratories, Johnson & Johnson; Cyberonics; Merck; Eli Lilly; Pfizer and its Wyeth unit, and GlaxoSmithKline. As for products: Avandia; Tylenol; Fen-Phen; Vioxx; Neurontin; Zoloft; Premarin and Prempro; Paxil and Zyprexa. You can read the entire primer here.
Why stop to look? As POGO argues, ghostwriting can "distort the medical literature, affecting what prescribers and consumers believe about drugs, devices and biologics. It also drives up healthcare costs because companies use ghostwritten studies to seek approval for pharmaceuticals and devices and payment from healthcare programs...Ghostwritten journal articles betray the moral responsibility to patients and the effort to produce a reliable body of medical knowledge essential to evidence-based medicine."
pic thx to mattwi1s0n on flickr
7 Comments
Understand that POGO is trying to make a point, but it's simply untrue that journal articles are used "to seek approval for pharmaceuticals." FDA approves products based on New Drug or Biologic License Applications (& amendments), not literature, ghostwritten or otherwise.
I believe there are two issues here. One is marketing or commercially driven ghostwriting with the intent to create a voluminous positive presence in the medical or scientific literature. But what about, significant clinical data produced by a researcher who can't or isn't willing to expend the effort to write or go through the rigors of protracted peer-review to the level of standards required by scientific journals? They shouldn't seek help to get their data published? www.PharmaReform.com
Mike, you ask ...<i>But what about, significant clinical data produced by a researcher who can’t or isn’t willing to expend the effort to write or go through the rigors of protracted peer-review to the level of standards required by scientific journals?</i> Why do you imply that this is a normative state of affairs in science? It isn\'t.
Bernard, Mike is correct. Long gone are the days when an academic medical researcher had the time to sit in his office weeks on end crafting grant proposals and peer reviewed papers. Today's doctors are expected to both do high level research AND carry a large patient load in order to bring sorely lacking revenues into the institution.
This is why God created the postdoctoral fellow. In my first year as a PDF I and others were expected to spend wrting grants and papers for faculty who were too busy seeing sick patients. Since they were actuallly making a contribution to society by seeing patients I considered my writing efforts to be justified. At the end of the process they reviewed the material thoroughly, made critical comments and the papers were revised accordingly.
A busy faculty member doesn't have time to know how many characters per line or margin width; that's not what they're getting paid to do.
Insider: well then, I'm a dinosaur! :-)
While I am the first to accept that some industry practices up to the late 90's were questionable at best, to condemn editorial support for all medical literature is naive and potentially harmful to the dissemination of important scientific information to physicians and patients.
If you took a survey of physicians about their scientific writing practices, I dare say that less than 10 % ever reach the printed page without varying levels of editorial support. (In fact you should do that research anyway before lashing our again about the "Ghostwriting Scandals".) The fact is that the brilliance of our physician population often does not include writing and further, busy researchers just simply don't have the time.
So what does "Ghostwriting" do for society. First, it get important information into the literature in a timely fashion. Secondly, it provides an easily digested professionally written paper that can be readily digested by readers. I believe those are important to society.
One last point, how long do you think that articles and papers with unapproved or erroneous information would survive FDA or HHS scrutiny in the competitive world we live in today?
Agree with IV. 20% of my business is medical writing, and I\'ve been doing it for 30 years. I know what the different journals require in terms of style and formatting. I also know how to dissect an editorial review and respond in a way that maximizes acceptance. I know how to separate the comments that need response from those that can be ignored.
Does anybody in their right mind believe that an actively practicing physician researcher can do this without major league experience in research writing?