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Journalism in the Public Interest

Drug Company Used Ghostwriters to Write Work Bylined by Academics, Documents Show

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GlaxoSmithKline offices in London (Maxwell Hamilton/Flickr)

According to newly released documents from GlaxoSmithKline, the pharmaceutical company often paid ghostwriters to pen medical studies, editorials and even a textbook that listed physicians as the authors.

The documents—some of which date back to late 1990s—were recently unsealed in litigation over a GlaxoSmithKline product. We saw them after they were attached to a letter released this week by a nonprofit watchdog group urging the National Institutes of Health to crack down on ghostwriting in medical academia. The documents and the letter by Project on Government Oversight together outline several examples of how a major drug company contributed to the funding, writing and approval of material published in medical journals and elsewhere.

The textbook, published in 1999, listed two physician co-authors who at the time were chairs of the psychiatry departments at the medical schools of Stanford University and Emory University, the New York Times reported this week in a piece that focused only on the textbook. According to the Times, it’s the first instance where a book has been criticized for the same issues with ghostwriting and drug industry influence that have plagued medical journals.

A GSK spokesman told the Times that the company’s role was described in the book’s preface, which thanked the UK drugmaker (then known as SmithKline Beecham) for an “unrestricted educational grant” to the ghostwriting company, Scientific Therapeutics Information. Correspondence between a Scientific Therapeutics Information employee and one of the co-authors, however, shows the employee informing the stated author that she had “begun development of the text.” The employee, Sally Laden, also described her co-worker as the “primary technical writer” and manager for the project.

According to the documents, that same ghostwriter, Sally Laden, wrote an editorial published in 2003 in a medical journal with authorship attributed to two more doctors. One, Dwight Evans, is chairman of the psychiatry department of the University of Pennsylvania School of Medicine. His co-author, Dennis Charney, was head of a research program for the National Institute of Mental Health. (We’ve asked both for comment but have not yet received a response.) While Laden was credited for “editorial support” in the published article, another document seems to suggest she played more than just a supporting role. In an e-mail to a GlaxoSmithKline employee, she inquired about the status of her payment “for writing Dwight Evans’ editorial.”

Laden also helped a number of authors write a 2001 study that was funded by GlaxoSmithKline and concluded that a GSK antidepressant, Paxil, is “generally well tolerated and effective for [treating] major depression in adolescents.” Within a few years, problems with the study became apparent, and both UK regulators and the Food and Drug administration issued warnings about Paxil. Glaxo, following the FDA’s warning, issued a letter in 2004 informing healthcare providers that Paxil is “not approved for use in the pediatric population, and clinical trials for PAXIL failed to demonstrate efficacy in pediatric depression.” [PDF]

Of course, just because a ghostwriter is involved doesn’t mean a study is flawed. An anonymous medical writer who has ghostwritten articles published in top medical journals gave an interview in October to the executive editor of a blog by the Society for Scholarly Publishing. In it, he argued that he provides “a service to those who need assistance presenting their findings to the scientific community”—in other words, to academics who “have a great study” but aren’t good writers.

The ghostwriter also acknowledged, however, that writing services are often solicited by a pharmaceutical company first, and a manuscript is sometimes written before an academic “author” is found:

In my experience, the pharmaceutical company would pay a communications/marketing company to write the manuscript, who would then go out and find academics who would be willing to become the “authors” of the manuscript and paid an honorarium. I’ve worked with some authors who do absolutely nothing on the manuscript, requiring an additional ghostwriter to be hired, and still demand an honorarium for their time. These academics are willing to enter into this relationship because of the importance of authorship to their careers. You can’t entirely blame the pharma company. Universities encourage academics to play this game.

Earlier this year, a study in a scientific journal analyzed how medical ghostwriting works. It found that simply acknowledging ghostwriters “does not accurately reflect their authorship role.” It also found that, of the top 50 medical schools, only 10 explicitly ban ghostwriting.

GlaxoSmithKline told the Times that in recent years, the company has tightened its internal guidelines for medical writers.

Inform our investigations: Do you have information or expertise relevant to this story? Help us and journalists around the country by sharing your stories and experiences.

When the process starts off with a marketing company writing a manuscript, followed by a technical writer who is often not even mentioned in the book, and finally paying a doctor to put his name on it for credibility, you end up with quite simply “fraud”.  To add to that, here’s the ghostwriters response when asked if his sponsor (pharma) ever wanted him to make conclusions that were not supported by the data…”Yes, I have. Every manuscript includes some marketing spin and controlling how much spin is the trick.”  The process should be banned, doctors participating should lose their license, and pharma prosecuted.

Robert W. Hall

Dec. 2, 2010, 5:34 p.m.

This stuff has been going on for years; maybe decades. Schools and journals claim to be cleaning it up, but it refuses to die. Can you do some more digging and learn why this deception is do hard to kill?

Which journals are responsible for this?

Robert, I plan to do some more digging this end (Australia)

Allan Gardner

Dec. 2, 2010, 6:25 p.m.

During a long career in advertising (from 1963 to 2005) I had occasion to interact with several advertising agencies that specialized in medical advertising for pharma companies. It was then standard operating procedure for agency technical writers to draft articles (that way the companies themselves had some only slighty credible deniability) and then seek appropriate scientists and/or physicians to put their names on it. The process was widespread and virtually transparent—indicating the distain and dishonesty that permeates the pharmaceutical industry and many of the publishers of medical journals.

Good article, once more confirming what we’ve always known or suspected.  Problem: I copied and transcribed it for personal reference files.  The text contained [12] attributions or cross-references which I expected to find as footnotes.  However no such notes show up in the on-line article - where can I find them, please?

Stephen Figler, Ph.D.

Dec. 3, 2010, 12:20 a.m.

As a Ph.D. graduate from Stanford and an author of academic books and articles, I am disgusted to learn of Dr. Schatzberg’s dishonesty in signing his name to a book apparently written by someone else.  His co-author, a Dr. Nemeroff, then attempts to excuse their actions by stating that he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”
This is a feeble and transparent excuse, at best, for plagiarism, i.e., the form in which one signs one’s name to work produced significantly by someone else.  What they are saying in effect is that we had the idea, approved the writing of someone else, then passed it off as our work.
If accepted, or poo-poohed as a minor transgression by Stanford, this taints Dr. Schatzberg’s voluminous work, as well as other works emanating from the Stanford School of Medicine.  At the very least, it raises the question of authorial independence and hidden benefits, especially when pharmaceutical firms and their employee/representatives are both the true authors and the subject of the work.
As an aside, I checked the 100+ journal articles attributed to Dr. Schatzberg.  A great many of them list him as the last author.  This is a convention in academic publication indicating that graduate or post-doctoral students did the bulk of the work and the “advisor”, who has greater academic standing, is listed to enhance the chance of publication.  While that has been SOP for many decades, it shows the path to the greater transgression of questionable book authorship in which those with an economic interest write texts to which others, who are supposedly independent, lend their names.
That is shameful and dangerous.

This story ties in relatedly with a recent article in MOTHER JONES magazine about the corrupt practice of TRIAL TESTING DRUGS (co-opted testimony, fake reports).

Toward the end of the article you make an excellent point that universities contribute to this problem by placing such a tremendous emphasis on “publish or perish.”  To rid the scientific publication system of the ghostwriting problems, both the Conflict of Interest policies and the tenure policies would need to be overhauled.  It would be such a gift to society if leading academic medical schools gave more credit to scientists for giving back to the communities whose health they seek to improve, rather than lining the pockets of publishing companies, pharma, and these editorial/marketing/writing service companies. People who voluntarily contribute to these studies that end up in the journals and sometimes make the headlines rarely hear anything more about the outcome of their participation.  The entire research enterprise is developing fissures that will become yawning cracks if we don’t do something soon.

This article terrified me, so I thank you for writing it!

If you care about this issue, you may want to visit the website of the National Legislative Association on Prescription Drug Prices, http://www.reducedrugprices.org.  We’re a nonpartisan public policy group dedicated to helping state legislators reduce drug prices and expand access to medicines, in part by reducing conflicts of interest.  You can sign up for our newsletter and facebook page, and register for our next meeting on January 21, 2011 in Washington, D.C.

It is more sinister than that. Many of these companies and groups use this so-called authoritative medical literature to justify dangerous medical practices beyond just drugs. In the most extreme cases the “study” or review is used after the fact to help shield the company and doctors from legal liability. In legal proceedings the ‘standard of care” by which the medical community is held accountable is often set by the very “science” that they are now being shown to manipulate. You can bet that Glaxo was using the Paxil “study” and its made-up conclusions to defend itself against critics and claimaints alike. It is absolutely sickening how they betray their own science.

Well, this first blew up in the early 2000s. The industry got its act together. While a decade ago, this sort of shenanigans did go on, for the best part of a decade this has been stamped out.

GPP—good publications practice guidelines are adhered to by all credible companies; failing to follow them ends careers. It keeps everyine honest and transparent.

It seems here that everyone (rightly) is complaining about old news. But sabre rattling and calling for something to be done is a bit late. It has been. Years ago.

Look at GPP2, the latest guidelines before you do anything else. A quick google search gets you up to date on the industry now.

Even if things are improving, which frankly I doubt, the presence of tainted articles in the existing literature that is used by current researchers and students is insidious.

Current medical trainees are being fed general approaches to medicine that are fundamentally flawed, but that continue to make the drug companies rich.

An example of this is prescribing drugs for even small variations from ‘normal’ physiological values. These days, nobody ever even thinks of questioning whether a patient with a blood pressure of 140/95 should be treated with drugs.

When such a patient, who, in the absence of other risk factors is fundamentally healthy and does not really need to be treated, experiences side effects—let’s say his LDL goes up in response to a diuretic, he is then given a lipid lowering drug which has it’s OWN side effects, which are then treated with yet another drug, etc. etc. etc.

This is all good news for drug companies. AND, like it or not, good news for doctors, who get to charge for multiple office visits with a patient who might have been better off not being treated at all.

It is the insidious influence of drug companies in journals, med schools, research institutes, and for that matter the FDA that has brought this situation into existence.

Here’s some more:

http://ksjtracker.mit.edu/2010/12/04/carlat-blog-ny-times-tough-coverage-of-a-tough-story/

and thanks to AuSMC (downunder) I was given the following:

http://www.crikey.com.au/register-of-influence/

Of particular concern are the last comments on that website by Brett Forge, Physician and Cardiologist at West Gippsland Hospital

Forge’s comments confirm what I, as a knowledgeable non-MD, have suspected for years.

Forge zeros in on the waste of MONEY—millions spent on unnecessary procedures, drugs, etc.

Much more important is the fact that these unnecessary interventions have drastic, in many cases fatal, results for patients, often over a long term period, and in such a way that nobody, not even the patient or doctor, will see the connection..

A middle aged patient with slightly elevated blood pressure is prescribed an antihypertensive. No noticeable side effects are detected at first, but the next year that patient has elevated LDL and has started to gain weight, because the drug he’s on is reducing his energy level in small ways that are hard to put your finger on.

His cardiologist now puts him on a statin, and on a ‘blood thinner’ to ward off internal blood clots.

A year later he has internal bleeding, perhaps a bleeding ulcer, that requires surgery.

Surgery is always a risk. His incision might become infected. If he does not die of sepsis int he hospital, the patient now emerges from the hospital looking ten years older than his true age, feeling and acting like a sick man, well past the point where he is very likely to improve his general health by changes in diet or increases in exercise.

And of course he is now genuinely dependent on all the pharmaceuticals he’s been put on, because suddenly stopping them might result in a rebound effect that could be life threatening.

Of course such a person is now depressed, and is prescribed Whoknowswhat to deal with that, resulting in further side effects, possibly behavioral, affecting his family relationships and possibly compromising his professional performance, if that hasn’t already happened.

Of course when such a patient walks into a new clinic, or sees a new doctor, or even the same doctor who started him on the anti-hypertensive 20 years previously, the medical people only see a man with serious problems that really do need intervention here and now.

Nobody blames the medical establishment for this kind of scenario, and it is very difficult to prove. But the patient’s life has effectively been ruined, and he will probably die well before his time.

uebernachtung guenstig in timmendorfer strand buch

Dec. 13, 2010, 9:17 p.m.

Labour Chance,earn lot there kill minute first instead building ago extent blow finally southern after afternoon withdraw similar hardly capital both affect test regional minute book foot extent always nor life fly begin when start flat seat high standard plastic talk device white travel raise attempt bedroom press next private report following hall charge terms one modern what head means generally end afternoon point objective fire soil boat war risk representative hardly software nothing that very idea brother nature head affair transfer last

I have seen examples where “checkbook science” (“studies” that are bought and paid for by a company whose product is being “studied”) flood the research literature.  The same few authors (whether the actual authors or not) write dozens if not hundreds of articles, quoting each other, and then concluding that “the research clearly shows that this drug is highly effective and very safe.”  It’s especially terrible when the authors are physicians in academia, because it is such a betrayal of the Hippocratic Oath.  But it is also effective when the authors are at research institutes whose research is primarily bought and paid for by industry, regardless of the topic.  Check out the hundreds of articles by authors from the International Epidemiology Institute for an example.  Several of their researchers are former NIH scientists or currently have an academic appointment, and that lends undeserved credibility, just like the authors in this NYT article.  And, like the NYT authors, the links to industry funding or employees are often listed in the very fine print.

nette leute in nordrhein westfalen

Feb. 10, 2011, 2:33 p.m.

Good Day
Good stuff i will try & get back to you thanks
Bye Bye

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