Guest Blog - On the Need to Get Ethical

Guest blog by Dr William Tierney -

This is old news. I'm the Co-Editor-in-Chief of the Journal of General Internal Medicine, and in our June 2005 issues we reported in detail a case of medical ghostwriting that had the particular target of showing the hazards of the oral anticoagulant drug warfarin, supporting a drug company's new oral anticoagulant. This article was accompanied by an editorial by me any my Co-Editor and a position statement by the World Association of Medical Editors decrying such practices.

I am a practicing general internist who prescribes drugs regularly that help my patients. I want and need new drugs to be developed, and I believe that users of those drugs should pay for the necessary research and development through both drug pricing and funding of NIH. I am also a patient and similarly want there to be effective drugs to prolong my life and healthy living. But they should be described in an evidence-based manner, and the evidence must be unbiased. The drugs should be priced so the drug company recoups its costs and makes a profit. I have no problems with any of that. But when they try to enhance their profits through illegitimate means -- by essentially lying through advertisements masquerading as scientific articles sneaked into peer-reviewed journals -- then these drug companies are behaving unethically and need to be punished.

I also am a clinical epidemiologist, and as such I do research investigating the positive and adverse outcomes of drugs. I have worked with and been funded by drug companies to do this work, collaborating with company scientists. To a person, I have found them to be honest, careful, and caring people who truly want to positively impact people's lives. It is the marketing divisions of these drug companies that operate in an atmosphere of "anything goes that helps the bottom line."

My father was a purchasing agent for a factory that made automobile parts. We used to get "presents" every Christmas, tickets to Broadway, etc. from suppliers, blatant attempts to influence his decision-making. I can't say whether it ever did, but in the end he had to live with his decisions and so did the company for which he worked. But as a physician, I don't receive the benefits of the drugs I prescribe for my patients, nor do I pay the costs. I act as an agent of my patients, and as such I need to balance benefits, adverse effects, and costs of everything I order. If I have bad information, or if I succumb to company bribes in the form of honoraria, meals, or gifts, my patients pay the price both directly (through my ordering an expensive drug they might not need) and indirectly (through inflated drug prices in general).

It is time for the drug companies to get ethical. Cut out the ghostwriting. Cut out the bribes. Cut out the marketing to patients that inflate drug benefits and minimize their costs and risks. Charge prices that recoup their drug development costs and stop paying billions to "push" drugs on physicians and patients, adding those costs to their drug prices. And we physicians likewise need to get ethical, stop taking bribes, stop reading propaganda or listening to drug detailmen, and base our decisions solely on what is best for our patients, without ignoring costs. (Nobody benefits if we bankrupt our system -- but that's another story...)

We are seeing changes. Eli Lilly now lists all payments they make to physicians (honoraria for speaking, meals, trips, etc.). Many medical schools and large practice organizations have outlawed meals and gifts by drug companies. Journals are more vigilant for ghostwriting and other conflicts of interest among authors. We are seeing a change, and hopefully the abuses by Wyeth, DesignWrite, and other companies involved in ghostwriting will become a thing of our (sordid) past. We can only hope and maintain our diligence as caring health care providers.

Dr Tierney is Co-Editor-in-Chief, the Journal of General Internal Medicine, and Professor of Medicine, Indiana University School of Medicine. This was also posted as a comment here on the NY Times article about Wyeth's sponsoring of ghost-writing of articles on hormone replacement therapy. See our most recent post on this topic here.

Wyeth's Industrial Scale Ghost-Writing

MedInformaticsMD noted the impending release of documents about how Wyeth engineered ghost-writing of articles about hormone replacement therapy (HRT) here. Now the NY Times has had a chance to review the documents, with fascinating results.

The scope of the ghost-writing campaign was on an impressively industrial scale: 26 articles published over 7 years in 18 medical journals.

The details were ably covered by at least three other blogs. Dr Adriane Fugh-Berman, guest- (not ghost-) blogging on PharmaGossip discussed how the documents reached the public domain. Dr Daniel Carlat on the Carlat Psychiatry Blog, Prof Margaret Soltan on the University Diaries offered some choice comments -

By Dr Carlat

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.

By Prof Soltan

This filthy practice incorporates just about everything people rightly revile about some precincts of academia: Plagiarism. Fakery. Arrogance. Laziness. Cynicism (Wyeth was promoting drugs that turned out to be dangerous.).

People make fun of postmodernists by talking about the Postmodern Generator, a program that automatically generates articles full of obscurantist rhetoric. But that’s only generating words. Ghosting whores among our medical faculties are generating real sickness.

These are hard acts to follow, so my comment is: ghost writing is also corrupt. Transparency International defines corruption as abuse of entrusted power for private gain. Medical academics are entrusted to discover and disseminate the truth. Practicing physicians, patients and the public entrust medical academics to provide honest, informed, unbiased information and opinions.

When academics allow marketing hacks to write supposed scholarly articles in their name, they abuse this entrusted power (and privately gain by padding their CV, and often by direct payment as "consultants.") Of course, as noted above, this sort of corruption deceives the public, patients, and physicians into thinking that drugs and devices are better and more valuable than they actually are, denying patients preferable treatments, increasing the risk of needless adverse effects, and driving up the costs of health care.

Those who are pushing for meaningful health care reform ought to put fighting health care corruption at the top of their agendas, starting with the blatant corruption of academic medicine and medical research of which ghost-writing is but one species.

The Haunting of Hormone Replacement Therapy

US Senator Charles Grassley (R-Iowa) is digging into what appears to be another ghost-writing case. As reported by the New York Times,

Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed role of Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

The documents show company executives came up with ideas for medical journal articles, titled them, drafted outlines, paid writers to draft the manuscripts, recruited academic authors and identified publications to run the articles — all without disclosing the companies’ roles to journal editors or readers.

The issue of ghostwriting for medical journals has been raised in the past, involving various companies and drugs, including the Merck painkiller Vioxx, which was withdrawn in 2004 after it was linked to heart problems, and Wyeth’s diet pills, Redux and Pondimin, withdrawn in 1997 after being linked to heart and lung problems.

But the documents Mr. Grassley released Friday provide a detailed look at the practice — from the conception of ideas for journal articles through the distribution of reprints.

The documents released Friday include a 'publication plan tracking report' by Wyeth showing 10 articles in which manuscripts were completed by the company before they were sent to the putative author for review. Any revisions were subject to final approval from the company, according to the tracking report.

A companion article tracked the process of creating a single article. It included the strategy meeting in which the article was conceived by Wyeth staff:

Agenda item II for a Sept. 19, 1997, meeting by company staff members involved the “SHBG Outline.” It is an apparent reference to the working outline of an academic article about the protein SHBG — sex hormone-binding globulin — in breast cancer. The planned steps included initiating contact with Dr. Lila E. Nachtigall, of the New York University Medical School, who would be asked to serve as the article’s author.

Then the ghost-writers were chosen:

A fax from Karen Mittleman, a DesignWrite writer, to Ann Contijoch, a professional medical writer with a Ph.D. in animal science, about developing and improving an outline and reference list for the article. (The document appears to be dated 2005, but that was the date it was obtained in a lawsuit; it was actually dated 1998.)

In the Times interview, Dr. Nachtigall said that Ms. Mittleman had helped her prepare slides for talks but that she had never heard of Ms. Contijoch.

Reached by telephone Friday, Ms. Contijoch said she did not remember whether she had drafted the outline or the manuscript but that she had provided 'editorial assistance,' like copy editing, while Dr. Nachtigall 'drove the content.'

Then the article outline was revised:

DesignWrite prepared a revised outline. Some of the outline’s language appeared verbatim in the final journal article.

Dr. Nachtigall told The Times that the outline might have been based on her previous work and that she must have prepared the references list herself.

Then the draft was sent to the supposed academic first author:

A subsequent letter, written sometime in 1998, to Dr. Nachtigall from Ms. Mittleman of DesignWrite told the doctor that the draft manuscript of the article was on its way to her.

The article finally appeared:

When the article was published in 1999 in the journal Primary Care Update for OB/GYNs, it listed Dr. Nachtigall as the author, but did not mention Wyeth or DesignWrite. The end of the article acknowledges 'editorial assistance' from Ms. Contijoch but does not further identify her.

In the Times interview, Dr. Nachtigall said, 'Ann Contijoch – I’ve never heard of that person.'

The article is Nachtigall LE. Sex hormone-binding globulin and breast cancer risk. Primary Care Update Ob/Gyns 1999; 6: 39-45.

By the way, at the end of the first NY Times article, Dr Nachtigall responded to Senator Grassley's inquiries thus:

It kind of makes me laugh that with what goes on in the Senate, the senator’s worried that something’s ghostwritten. I mean, give me a break.

So as long as people are robbing banks, the police should not care about petty theft? In fact, we should care about this sort of ghost-writing, since it is a difficult to detect deception which disguises marketing as scholarship. This latest case adds to the evidence that ghost-writing is a prevalent problem.

As we and others have said before, ghost-writing is dangerous to health, as it deludes physicians and patients into thinking health care products are more beneficial and less risky than they really are. Ghost-writing also undermines science by shifting the agenda away from interesting and important questions to questions whose answers may mainly benefit vested interests. Finally, on a personal note, ghost-writing demoralizes honest academics who must run their own studies, write their own papers, and manage the logistics of paper submission in competition with fake authors backed by corporate money and corporate staff. So, Dr Nachtigall deserves no break.