CBC Radio: Medical Ghostwriting
They write on behalf of celebrities, politicians, public figures. But is there a point where ghostwriting crosses an ethical line? Critics say absolutely. And that line is when doctors or scientists agree to have their names on published papers, where the research and ghostwriting was paid for by drug companies.
Critics say this kind of medical ghost-writing taints the integrity of the results and that a medication side-effects can end up being down-played or omitted altogether. It’s not known how often this practice happens, but one study run by the Journal of American Medical Association suggested that more than seven percent of the articles in its own journal had unacknowledged contributions.
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Transcript
Piya Chattopadhyay: If you look at a scientific research paper, you probably assume that the person who signed their name to it is in fact the person who wrote it. But it turns out, that’s not always the case. In some cases, the paper you’re looking at was actually written by someone paid by a drug company ... ghost-writer whose name is nowhere to be found on the final product.
Critics say this kind of medical ghost-writing taints the integrity of the results and that a medication side-effects can end up being down-played or omitted altogether. It’s not known how often this practice happens, but one study run by the Journal of American Medical Association suggested that more than seven percent of the articles in its own journal had unacknowledged contributions.
Now, two Canadian lawyers are preparing to fight back against the practice of medical ghost-writing by suing the authors for fraud. Simon Stern is one of the lawyers. He teaches in the Faculty of Law at the University of Toronto. He’s also the co-author of the article, “Legal Remedies for Medical Ghost Writing,” which was published in the Public Library of Science. Simon Stern was in Toronto. Good morning.
Simon Stern: Good morning. Thanks for having me.
Piya Chattopadhyay: First off Simon, I mean we’ve all heard about ghost writing for biographies and things like that but most of us aren’t familiar with the practice in medical journals. Describe how medical ghost writing works in that field.
Simon Stern: This is somewhat different practice from what you would be familiar with in the context of ghost writers for say literary books or biographies and this instance, pharmaceuticals working together with medical writing companies develop studies. They plan trials of drugs. They work together to decide where to publish the articles and how to develop the articles and relatively late in the process, they ask someone, typically relatively well established doctor at a prestigious academic university to be the author of the piece to review essentially the final draft of the piece and then sign their name to the published article just before submitted to a journal.
Piya Chattopadhyay: So this person, the doctor, the academic who puts her name to it as you say come into the process relatively late. Are they paid to have their name attached to these articles?
Simon Stern: Well, there are all sorts of compensations associated with the practice. Sometimes they are not paid directly, sometimes they are. Sometimes, they are invited on conference trinkets, and indeed, even in instances where they are not compensated at all, and typically they are in one way or the other, they are at least compensated in the coin of academic credibility because they get another piece to put on their CV and this can be a very valuable asset when they are applying for grants, when they are seeking merit pay increase, or if they are looking for another job.
Piya Chattopadhyay: Clearly this is problematic. You are not the first to raise this as an issue. But, what do you see as the biggest problem with medical ghost writing?
Simon Stern: I think the biggest problem is the failure of objectivity and the misimpression of disinterest which is created when someone who seems to be a well known credentialed disinterested academic signs a piece which in fact wasn’t developed according to the protocols we normally expect to see of such a study.
Piya Chattopadhyay: If the science is legit, that’s got all the way up to the point where the paper is published and the name is attached, is it still wrong to practice even if the science isn’t manipulated?
Simon Stern: Well, my college Trudo Lemmens claims it is wrong for several reasons. The most obvious of which I think is that when we get to be the judge on our own cause, despite our best efforts, there are good reasons to think that subtle biases will creep in that will make the science other than legitimate because we got a stake in the outcome. We will interpret various aspects of the studies in ways that makes it favourable to the outcome we seek, rather than being honest about what’s really going on. We think it is also fraudulent for another reason, namely that authors of articles and medical journals are required to certify to the journal that they satisfied the guideline requirements of international committee of medical journal editors and these include forms of participations such as having been involved in the design of the study from the onset and of course, someone who signs his or her name at the last moment can’t accurately assert that they were involved in the study all the way along.
Piya Chattopadhyay: You said the word, “fraudulent”, and I want you to explain what the solution you’re suggesting is.
Simon Stern:So the solution we proposed is the one that I think might be understood by analogy to the suit that was recently filed against Donald Trump. A number of condo buyers were involved in a contract related to Donald Trump Property what was represented as Donald Trump Property. It carried Donald Trump certificate and they alleged that late in the day, they were told Donald Trump actually didn’t have anything to do with this. His name was just there for marketing purposes. So, there was a full certification involved. So, the fraud we see here is a fraud in which readers of medical journal had paid for a subscription to the journal on the understanding that the journal will supply them with articles that need that journal’s own publication requirements. And so, our argument is that subscribers are defrauded because they were given something other than what they paid for when they bought a subscription.
Piya Chattopadhyay: But, why not go after the drug companies or the ghost writer who in some cases allegedly have done some manipulation instead of going after academic and the doctor who attached their name to the final product?
Simon Stern: So, I think there are excellent reasons to go after all of those parties. The reason why we urge that the guest authors, as they are called, be appropriate defendants in a lawsuits is that if you think about other actors involved in the practice, many of them have been involved in doing this together for a long time. There have been many lawsuits against pharmaceuticals, for example, for negligence whereas guest authors are practically never defendants in these lawsuits. So the rationale for our theory liability is that perhaps by targeting the guest authors, this device might actually have deterrent effect. It doesn’t seem to be having the case in suits against pharmaceuticals for example.
Piya Chattopadhyay: This is a solution that you’ve written as possible solution. Under Canadian environment, can this really happen? Can people really sue these authors for fraud right now?
Simon Stern: For logistical purposes, it’s more likely that class actions would generate more revenue for the plain of class as in the U.S. but for a lawyer or a public interest group that is simply interested in pursuing the theory, it is equally available in Canada and in the U.S.
Piya Chattopadhyay: Okay, Simon Stern. Thank you for your time this morning.
Simon Stern: Thank you.
Piya Chattopadhyay: Simon Stern is a co-author of an article on medical ghost writing and the law professor at the University of Toronto.
Well, cases of academic fraud may sound a little bit abstract but when ghost written articles influence medication doctors prescribe, it has a potential for very serious consequences. David Klein is a lawyer from Vancouver representing women who developed breast cancer while taking Hormone Replacement Therapy drugs. The class action suit is against the pharmaceutical company Wyeth, which has since been purchased by Pfizer. In the late 1990’s, the company hired a P.R. company called DesignWrite to design a campaign to get favourable comment on the drug Premarin and Prempro in medical journals while down playing negative perceptions associated with estrogen and cancer. Lawyer David Klein says this had a huge impact.
David Klein: This ledged to a climate in the United States where the drug became a blockbuster seller. It was only when truth came out about the link that the sales plummeted. There’s several principle aims for this case. One of them is, of course, compensation for thousands of women who contracted breast cancer, and there’s also accountability issue. The ghost-writing, the over promotion of these drugs, the underplaying of the risks, all created a climate where women’s health was put at risk. And they should be held accountable for that.
Piya Chattopadhyay: David Klein is a class action lawyer representing women who developed breast cancer while taking Hormone Replacement Therapy. So, to find out how this practice of ghost- writing is being tackled by medical journals themselves, we we’re joined by Dr. Paul Hebert. He’s the Editor-in-Chief of the Canadian Medical Association Journal and he joins us from Ottawa this morning. Hi there.
Paul Hebert: Hello, how are you?
Piya Chattopadhyay: I’m very well. As the editor of a major medical journal, what do you think about Simon Stern’s proposal that subscribers to journals should sue the authors of ghost written articles?
Paul Hebert: First, I have to say that ghost writing is a very serious breach of conduct amongst our scientists. I would suggest that first, it is not that common and when it occurs, it has huge ramifications on both the doctors and for patients taking medications. What do I think of this proposal? I think it’s one of many approaches that we need to take on to address this serious issue. From my end, we don’t see much of this, at least in our journal. We more often than not detected prior to publication. Dr. Stern’s or Mr. Stern’s approach and Dr. Lemmens’ approach is probably many things we ought to do. It’s along the lines of punishment deterrents. But in any good system, I think we need to start with education and training and that needs to be first with editors. In major medical journals, we have full time staff who spend a lot of time looking for this and can detect it. At smaller journals, it is all part time and training is of the essence. We fully understand that drugs are big part of practice, that pharmaceutical companies develop drugs and they play an important role in the system. They on the other hand also need to respond to shareholders in Western world. Their primary driver is to make money for their shareholders and our goal is to ensure that their signs, when they produce it, is reported accurately, fairly and without bias. And we have a lot of ways we try to do that.
Piya Chattopadhyay: Share with me some of those ways. You get a lot of articles that come across your desk, I’m sure. How do you really figure out if one of them might have been ghost written, therefore allegedly, possibly, have some of its science manipulated?
Paul Hebert: So, there are a lot of techniques we use. For example, first where it comes from. If you are talking about a major drug and is a new release, we know where it came from. Pharmaceutical industry had a role in it. They are high risk papers, if you will. Interestingly, how the paper is written is often a major clue.
Piya Chattopadhyay: What do you mean by that?
Paul Hebert: Well, most scientists aren’t writers. So, when you get an article that is amazingly well written, your first question is, how did this happen?
Piya Chattopadhyay: Maybe they hired a journalist.
Paul Hebert: Perhaps. In fact, many of them work for great communication companies, so the whole point is that when authors actually follow the criteria in your journal, you question... We go through whole series of steps in our review processes to try to best understand how this is done. Then we ask authors to sign number of clear statements. One is on their competing interest: were they paid by the drug companies as we have alluded to earlier. In the last decade, we’ve gone from simple authorship to what we call contributor statements. So we ask very specifically what did you do in this article. Of course, all of these steps are designed to tell the reader what happened.
Piya Chattopadhyay: And yet, the problem persists. I know you said that you don’t have many in your journal but even JAMA, one of the most prestigious journal says seven percent of its own articles had help. And, I guess you suggested lots of possible deterrents but I mean isn’t the problem is that there’s actually no punishment yet?
Paul Hebert: So, there’s two parts to the whole issue. One is finding it ahead of publishing it. So, if it doesn’t show up in print, we just send it back to the author. We ask for explanations and often times, the article never comes back.
Piya Chattopadhyay: What about to the point you might consider suing them for fraud? Have you thought about that solution?
Paul Hebert: In terms of medical journal suing for fraud, I mean unless we find that our reputation’s been tarnished and that’s possible, the harms are largely to patients and to academic institutions. Those are the people who should be suing. Frankly, it’s mostly not the journal that’s being harmed.
Piya Chattopadhyay: Dr. Hebert, thanks for your time this morning.
Paul Hebert:Thank you for having me.
Piya Chattopadhyay: Dr. Paul Hebert is Editor-in-Chief of the Canadian Medical Association Journal. He was in Ottawa. With all this talk of ghost-writers, you might be wondering who these people are and how they got these jobs. Dr. Linda Logdberg is a former ghost-writer, who worked for several medical writing companies. Linda Logdberg joins us from Atlanta, Georgia. Good morning.
Linda Logdberg: Good morning.
Piya Chattopadhyay: So, tell me how you first get into this profession of medical writing.
Linda Logdberg: I left academic research and basically answered an ad in New York Times looking for another career and that was the first of several medical writing jobs. I began in smaller, much more dated companies that were headed PhD’s or MD’s and eventually migrated more to the advertising world.
Piya Chattopadhyay: So you get into the business of medical writing. What did you think of the work, initially?
Linda Logdberg: At the beginning, it just seemed like an extension of academic work. I was paid to write, which I liked doing a lot in subjects that was close to my heart: oncology, neurology. It really not felt different from writing up a grant application or a paper. I had a lot of communication with the, quote, author, that would be the physician or the researcher and really felt I was kind of highly paid lab technician or assistant.
Piya Chattopadhyay: And as your career moves on, things changed though, didn’t they?
Linda Logdberg: Well, yes. A lot of those companies... now we’re talking here, say mid to late 90’s, lot of those companies didn’t continue, didn’t succeed. So, I got hired more and more by med-ed branches of advertising companies and that put a lot of middle people or middle women usually in between me and physician author.
Piya Chattopadhyay: And what changed in terms of the process of you writing. Where did you see the pitfalls of that approach?
Linda Logdberg: Well, the worst thing was, I didn’t have the opportunity to discuss my issues or my concerns with the researcher directly. There would be a product manager, perhaps a program manager, an account executive... several people between me and that researcher. So, my questions got filtered through many levels of non-scientifically trained people who just really didn’t get it a lot of the issues of some these drugs.
Piya Chattopadhyay: So, you couldn’t pick up the phone and call the researcher yourself?
Linda Logdberg: Oh, no. We were in many cases absolutely forbidden to speak to that person directly. We were explicitly told in many cases not to do that.
Piya Chattopadhyay: And why were you told not to do that?
Linda Logdberg: I guess, one example of something that happened was, I had written a paper, drafted a paper I should say, had gone to the physician and it came back to account executive and she looked at the discussion section and she said, “oh, you put all these references to other work.” She said this author doesn’t want to see other references. So, I tried to explain what the purpose of the discussion section is of a paper, which is to critically evaluate the findings with context and she took all of my references out and sent it back to that author. The result of that was that the author said, “I will never work with this company again if this is kind of stuff they will send me.” That was one of the pitfalls. These people just did not understand how a scientific paper is meant to be written.
Piya Chattopadhyay: I want you to give me an example about a time where you felt uncomfortable with an assignment that you were given.
Linda Logdberg: Well, yes. One of the assignments was to help promote a contraceptive drug. I was working as a contract employee for one of the medical education companies and my job was to draft a statement, a sort of a backgrounder that could be shown to physicians to fill them in on the basics on drug and to present its advantages and side effects. Well, the problem with this drug was that it caused sudden uncontrollable, heavy, vaginal bleeding and my job was to turn this into a benefit. That was not an easy sell to turn this into a benefit. But after a much discussion, we arrived at the realization that the positive aspect of this was that at least woman knew this was going to know that it was going to happen. We then stressed in the promotional material and I should say educational material as well that, that okay, there was this drawback but at least the woman was sudden by the way of completely unanticipated vaginal bleeding was going to occur, so they could carry with them the proper supplies.
Piya Chattopadhyay: So, what would you do then, was it your job to approach the academic doctor to have their name attached to the paper?
Linda Logdberg: Oh, no. This was all decided by several levels above me. Often, we would come to a meeting that would be a job creation meeting called and we would sit there with the, quote, “message,” a scientific “message” that would be transmitted in the paper in front of us and we would discuss key phrasing or concepts that should be brought out in the article. It’s kind of like a recipe. You take a recipe and you make a cake. You follow the directions. You might have a little variability on your own, but basically, it is a product that is supposed to come out of the oven a certain way.
Piya Chattopadhyay: Well, given that clearly felt uncomfortable doing what you were doing. Why did you do it? Why do medical writers agree to do this kind of work?
Linda Logdberg: Well, there are several incentives. It did kind-a creep upon me gradually that this type of work had changed from being, pretty much of an academic exercise to a commercial one. It allows a lot of flexibility. I had small children at the time. I could be home a lot while working.
Piya Chattopadhyay: What do you think the doctors whose name is attached these articles, these academics. What do you think the incentives... the reason they do it... what do you think those are?
Linda Logdberg: I have to agree with some of what was already said. I think certainly there is a financial incentive. I think there is prestige attached to being a thought leader or K.O.L as they are sometimes called. Stands for Key Opinion Leader. And it is a person who is respected in his or her community. So, there’s prestige, there’s money, the same kinds of incentives of nice dinners, plays, other kinds of performances, concerts and so on. Being kind of courted by the pharmaceutical companies.
Piya Chattopadhyay: Linda Logdberg. Thank you for your time this morning.
Linda Logdberg: Thank you very much.
Piya Chattopadhyay: Dr. Linda Logdberg is a former ghost-writer. She is in Atlanta, Georgia. Coming up, in our next half hour, we have a documentary about a unique friendship between two people whose ages are decades apart. I’m Piya Chattopadhyay, sitting in for Anna Maria Tremonti and you are listening to summer edition of the Current.
Original broadcast on CBC The Current
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