Ghostwriting, RICO And Fraud On The Court?
18 CommentsBy Ed Silverman // August 3rd, 2011 // 8:56 am
The contentious debate over ghostwriting shows no sign of abating. Even the definition of ghostwriting - the mysterious practice in which an article lands in a medical journal with the name of an author who, as it turns out, had little or nothing to do with the substance of the publication - prompts argument. Meanwhile, the issue has caused several scandals for several drugmakers and medical journals, causing embarrassment and turmoil.
So what to do? A pair of University of Toronto academics suggests two legal remedies - pursuing class action lawsuits based on the Racketeer Influenced and Corrupt Organizations Act, or RICO, and filing claims of ‘fraud on the court’ against a drugmaker that uses ghostwritten articles in litigation. They make their case in an article that was published in PLoS Medicine (here is the article).
As they explain, peer-reviewed articles are cited as credible sources of evidence in lawsuits to support claims about safety and effectiveness, and for determining liability. And they note that industry-controlled studies prepared by ghostwriters or guest authors - someone who is invited to have their name placed on a study - may distort perceptions about safety and effectiveness.
“By facilitating publication in peer-reviewed journals, guest authorship creates the impression that standards of academic independence and integrity have been satisfied even when they have not, and makes it more likely that the research will be treated as legally admissible even when this is inappropriate,” they write.
“Publications on which academics appear as guest authors also give credibility to these authors in the legal setting. These articles are sometimes used to establish an expert witness’s authority, even when the validity of the research in the article is the very issue under dispute. As a result, the treatment of the guest author as a legal expert may prevent scrutiny of the practice that is being challenged for contributing to serious harm.”
The problem, as they see it, is that other methods that might curtail the practice do not seem to be working. These would include bans on future submissions by authors who act as guests, formal retraction if unacknowledged ghostwriting is discovered after publication, reporting author misconduct to institutions and academic sanction. Why? Their may be reluctance if the precise role of the guest author is unclear or universities may believe unjust accusations are being made.
As a result, they believe that asserting RICO violations in a class action lawsuit would act as a deterrent. In their view, a false claim made by a guest author, which is “asserted in the authorship warranty,” would prompt a journal to publish an article, but mislead readers about the “scholarly care and scrutiny lavished on the research.”
Meanwhile, they argue the journal gives the guest author credit for an article that “may serve as a valuable credential, by impressing academic merit committees, grant agencies, conference organizers, and others including judges and juries if the guest later acts as an expert witness,” they write, adding that “such recognition may carry reputational and financial value.”
“Arguably, each repetition of the false warranty (implicitly asserted on a CV presented to any of these audiences) is an independent fraud. The journal loses the opportunity to publish an article that would legitimately have satisfied the authorship requirements. The subscribers lose the opportunity to read a legitimate article, and may be led to believe, rely on, and use data from a fraudulent article.”
From here, their theory gets still more interesting. As they see it, drugmakers and medical communication firm are “well aware” of publication requirements. And so “soliciting and facilitating fraud may amount to conspiracy, and may incur liability on the same grounds as the fraud itself.” And so they argue this may constitute fraud under RICO. If a guest author lends their name to two or more articles for the same product, this may satisfy the RICO criteria. Plaintiffs can seek treble damages.
But what is the harm? The researchers says this can be measured by reducing the subscription price in proportion to the space devoted to the ghostwritten article. They offer this example - if a subscription costs $100, and the journal publishes 100 articles per year, each subscriber would suffer a $1 loss from a fraudulent article. “The individual loss is small, but the aggregate loss to all subscribers may be significant, particularly if the cost is trebled under RICO,” they argue.
Of course, a court would have to be convinced that individual plaintiffs relied on fraudulent claims in such an article. But they note that the US Supreme Court ruled three years ago that, when plaintiffs allege fraud under RICO, “they are not required to show that they relied on the defendant’s assertions, so long as they were harmed because someone else relied on the fraud (such as the journal editors).” In other words, they continue, “once a plaintiff establishes that the article was ghostwritten, and shows that he or she paid for a subscription or a download, he (or she) has sufficiently established fraud, reliance, and harm for the whole class of RICO plaintiffs.”
“The combination of monetary sanctions and reputational harm might deter academics, and might also deter the medical communications agencies that design these studies and seek impressive names for the byline. Here is a case where the threat of liability - and the uncertainties and distractions that it brings - may be sufficient to discourage those who are not normally sued for harmful drugs, but who help to legitimate the studies that publicize these products.”
As for fraud on the court, the researchers note that lawyers who cite ghostwritten articles in court have a duty to disclose the truth about the articles, otherwise a fraud occurs. When this happens, they write, “the courts are among the institutions wronged by such practices, which may lead judges to treat the ghostwritten publications as evidence that is legally admissible.”
The researchers acknowledge that ghostwritten articles are generally not created for legal purposes, but restricting the legal use of such articles “could significantly diminish their overall value,” since they are often used in court to support arguments about safety and effectiveness, establish a scientific record or lend credence to an expert witness. “Each of those uses, if attempted by a party that had helped to create the article, could risk sanction,” they conclude. “The articles could still be used to promote drugs, but if litigation should arise, the defendant’s arsenal of responses would be limited.”
A provocative argument, yes? Are these theories feasible? Would they have a practical impact on the issue? What do you think?
Should RICO & Fraud On The Court Claims Be Pursued To Thwart Ghostwriting?
- Yes (68%, 88 Votes)
- No (32%, 41 Votes)
Total Voters: 129
Loading ...pic thx to mattwi1s0n on flickr
Observer
My first reaction was that I didn’t realize that the RICO statute applied in Candada - or is it just a suggestion for those of us “in the lower 48?”
Then again, i don’t have time this AM to read the learned paper. More later, perhaps …
John Nardo MD
While I know nothing of the legalities of RICO, it is a law designed to prosecute racketeers - and ghostwriting is an unquestioned racket. It’s a trick design to fool the consumer and reap profit by fraudulent means. Brilliant plan!
original industry insider
Hey if RICO was good enough for Salvatore Gravano, why not some hard working PhD science writer with no ill intent who’s trying to scratch out a living on $50,000/year less expenses. Yes, those science writers are indeed heavy hitters, and their racketeering ways must be stopped in their tracks for the salvation of society.
Michael S. Altus, PhD, ELS
Original industry insider (Aug 3, 2011; 12:17 pm), medical writers who are complicit in unethical activities such as ghostauthoring have ill intent and ought to be subject to sanctions.
The American Medical Writers Association (AMWA; http://www.amwa.org) regards the issue of ghostwriting as so important that membership applications state AMWA’s Code of Ethics and have applicants sign a pledge as follows: “I have read the AMWA Code of Ethics and agree to conduct myself accordingly in my professional interactions.”
For an awesome primer on the subject, read “Frequently Asked Questions about Medical Ghostwriting”, June 28, 2011, at POGO’s website (www.pogo.org/pogo-files/alerts/public-health/ph-iis-20110620.html).
I wrote a primer on the subject for AMWA. See AMWA Ethics FAQs (www.amwa.org/default.asp?id=466).
Justice in Michigan
I should do my homework and read the paper, but I assume that the fraud charge would be based on misrepresentation of authorship rather than fraudu within a published study itself, yes? (although both could certainly be the case)
The issue is interesting, but given how many other ways*, besides ghosts, there are to generate publications that are promotional, I don’t have a good sense of the scale of this issue.
Certainly it’s less about those poor PhD’s about whom OII is concerned than the large ad agencies for which journal planting is just a part of the show. Great examples from the HRT litigation. As I recall, agency was promising Wyeth 30 or so well-placed papers in a few months time.
original industry insider
Actually, the AMWA, of which I am a former member does not take a position at all on ghostwriting; it simply states that persons contributing to the writing of a paper should be appropriately recognized. As far as I’m concerned, that could even mean a mention in the “Acknowledgements” section at the end of a manuscript, and does not necessarily merit mention on the list of authors. I see it as the equivalent of mention of the company biostatistician in the Acknowledements section.
Here is the actual state from the AMWA website:
“AMWA Position Statement on the Contribution of Medical Writers to Scientific Publications The American Medical Writers Association (AMWA) recognizes the valuable contributions of medical communicators to the publication team. Medical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships. In all aspects of the publication process, medical communicators should adhere to the AMWA Code of Ethics.”
company insider
I tt the article was an excellent presentation on the facts and problems with Ghost writing. I have seen jual articles approved for distribution where the FDA had already negated the conclusions, the facts were changed as the article progressed and they misquoted other ares in the dicussion and provided false conclusions in the conclusions sections. When we asked questions about this, the trainers said it was ok to now declare superior efficicy. THis was Pfizer marketing Relpax against Imitrex. THe studes were all pure junk designed to disprove their own package insert. It was amazing they would go that far to disporve the statements they put in the package insert.
David Colquhoun
What’s contentious?
Ghost writing is always fraud. Anyone caught doing it should be fired. Period.
It puzzles me why clinical medicine is so corrupt compared with science.
company insider
Dear Dave,
It is all about easy money and lots of it. REgular science, the scientists are committed to findng the truth and you are trained that way from the very beginning of your career. Somehow Pharma got lost in their need for moeny.
Barry Turner
Without doubt ghostwriting is fraud. In the UK we used to have a quaint criminal charge of obtaining pecuniary advantage by deception (Now incorporated as striaght fraud) Ghostwriting is deception and it is always for pecuniary advantage.
Indict them under RICO and Qui Tam anyone who uses ghostwritten articles to get US taxpayers money.
original industry insider
Barry, please inform Scotland Yard to come after me. I confess to have written a research grant that was submitted under a faculty member’s name when I was a Post-Doctoral Fellow 30 years ago. Just give me some time to get my affairs in order. I hope that they still don’t practice hanging, drawing and quartering on your side of the pond. Quite messy, mate, I’m sure you’ll agree.
John
Yikes! I hope they don’t extradite. My entire PhD class will have to be hauled off for the countless reviews and grants that we wrote under the names of our dissertation advisors.
And god forbid, if they go after those who solicited these ghost-written manuscripts, we’ll see the faculty of American universities decimated.
GhostOne
The authors of the papers and most of the comments have no understanding about research, technical writing, RICO or fraud statues (note: I am scientist, lawyer, and drug developer that has authored papers both under my name and as a ghost).
1. The names of listed as authors should be understood as nothing more than representing support for the contents. In some cases the names may have had some direct or indirect involvement in the research or writing. By putting their name on the paper, they are publically stating their support for the paper and the research that supports the paper. It is pretty common (even in pure academic science) that not all of the “authors” all have material involvement in the work and writing (especially when there are a lot of names) and persons who have such involvement are not listed. There is a lot of ego and “lets include the big name” on the paper.
2. Many scientists, especially busy doctors, are terrible technical writers, and not too good with facts and details of the methods, analysis and data. I have often found my self pressed into writing, especially ghosting, because the authors cannot get the technical details right, or intelligibly communicate them.
3. The golden rule for all papers should be: ignore the names of the authors or sponsors– evaluate the research (and its reporting) on its own basis. It is also best to ignore the conclusions and take the analysis/review sections with skepticism. Challenge the study design and its execution, review the presented data and what analysis can be drawn from it.
original industry insider
John, now you know why they haven’t closed down Guantanamo Prison yet. There simply aren’t enough prisons in the continental US to hold all of the PhD students and post-docs who wrote grants for their supervisors. Actually there might be some familiarity wioh Gitmo since parts of the grad school experience were reminiscent of waterboarding.
badbonehealing (bones)
I broke my femur after 5 years of Fosamax….. and it did not heal because of Vioxx….. I have my own pro se Vioxx case still going…. and soon to submit a Fosamax case. Need attorney for Fosamax case. Would like to do a RICO … both drugs gave me harm and the pattern needed in RICO is thus established. If one has thoughts or is interested in pursuing with me my email is badbonehealing@gmail.com. Harm done in NY.
Thank You
Dennis Harrison
original industry insider
Badbone, it is because of people like you that serious tort reform is needed in the area of pharmaceutical product liability so that drug prices don’t go even higher than they already are.
badbonehealing
Original
You certainly have that wrong…. what I have learned from my Vioxx litigation has been chilling…. and understand that I have been what one may call an activist who really has penetrated through a lot of stuff I wish I never knew… what a sad state of affairs knowing the absolute depth of corruption…. I won’t share it on this Blog…. at the current time but Google me and you can piece it together…. I am both too busy on Vioxx yet too sick to do another pro se…. Vioxx litigation representation was blocked by Merck’s corruptive, collusive ways deep into the system… I could do Fosamax pro se but don’t have the steam…. there is in total so much and such gravity I don’t think you…. not trying to be mean here…. have a clue..
Sony Roy
In my view, RICO is th best method to cure the ills of racketeering. WE should avoid corruption by all means and we applaud every effort by the U.S. Government to do so. My name is Sony Roy and after seven years of intense suffering, I sympathize with those who suffer injustice regardless of social or financial ranks, gender, political orientation, biological age, nationality and race. To all who suffer due to frauds and more specifically Frauds Upon The Court, I pray God would grant them courage to hold on until justice is done. I feel the pain I share your grief after seven years of undue hardship and unprecedented suffering. God is listening to your cry.