We recently stayed overnight at a friend's place in New Jersey.In the morning a neighbor joined us for a pancake breakfast (four regular servings + 1 SCD serving for me). In talking to the neighbor, Elizabeth¹, I learned of a new profession². She had earned a science Ph.D. from a prominent university and initially accepted a job as a researcher. She lived and worked in a stimulating city with plenty of green space, friends resided close by, and neighborhood shops provided a pleasant life. However, with the guarantee of a large salary, she picked up and moved to New Jersey--living in one of the most densely populated areas of the country, trading in friends for traffic jams.

She now spends her time writing. Her employer produces articles for medical journals. Pharmaceutical companies hire her firm to produce articles, doctors sign them, and the firm submits them to the journals.

Before talking with Elizabeth, I always thought that hard-working doctors wrote their own journal articles--women and men using their intellectual gifts to serve humanity. I envisioned researchers and clinical practitioners making hypotheses based on their observations, having these ideas tested and critiqued by peers, and this knowledge³ improving healthcare. I understand there's competition and politics among researchers, but I also expected a sense of camaraderie and "gentlemanly conduct". The people involved with the system have to maintain a certain level of integrity--or the system fails. A 1998 article⁴ in The Journal of the American Medical Association (JAMA) describes medical journal authoring as follows:

USED APPROPRIATELY, authorship establishes accountability, responsibility, and credit for scientific information reported in biomedical publications. However, misappropriation of authorship undermines the integrity of the authorship system . . . Ghost authorship is defined as failure to name, as an author, an individual who has made substantial contributions to the research or writing of the article.⁴

After college, one friend spent a summer working/interning at a state agricultural center. He described a conversation with a scientist who received corporate funding to test a new pesticide for use on specific types of grass. Regardless of the results, the scientist would not write a wholly negative report.

"The company would never use us again. They would stop funding. We need the money for basic equipment. Of course we wouldn't lie, or promote the use of a dangerous product, but we won't slam anything either."

If a respectable, hard-working scientist at an agricultural station felt compelled to skew his results, what hope does a firm have that writes medical journal articles and receives 100% of its funding from pharmaceutical companies? By its very nature, the results will be skewed. Bad results would mean withdrawal of funding and the demise of the firm.

The 1998 JAMA article referenced above⁴ surveyed authors contributing to six prestigious peer review journals and found that between 9% and 16% of articles had been ghost written. More recently, a 2003 Observer article⁵ reported that up to one half of all journal articles may be ghost written. Within the last twelve months, several publications, including JAMA, have issued new authorship guidelines. However, they may be hard to enforce. A June 2005 letter published in the British Journal of Medicine related the experience of an employee working at Norway's Medicines Agency:

As a regular peer reviewer for medical journals I am sometimes surprised to see doctors writing on themes that I know are outside their usual field of interest or knowledge. About two years ago I was reviewing such a paper submitted electronically when I made an amusing discovery: when I turned on the track changes function, commentaries made by the drug company popped up. Needless to say, I rejected the paper.

As we all know, the problem with ghosts is that it is very difficult to prove their existence. This was a rare example of ghost tracking.⁶

A prominent member of The World Association of Medical Editors has also weighed in:

"Ghost writing initiated by industry is a big concern," said Robert Fletcher, chairman of the association's editorial policy board and professor of ambulatory care and prevention at Harvard Medical School. "When it is undetected, it distorts the scientific record, substituting marketing and persuasion for the balanced exchange of views and the search for sound answers that characterise the contents of medical journals at their best."⁷

Medical ghost writing is often tied to pharmaceutical company sponsored drug studies. Two doctors, writing in the October 2005 issue of Academic Medicine, listed the biases that have occurred with this arrangement:

> comparing a new drug with a sub-therapeutic dose of a standard drug

> failing to publish negative studies with results unfavorable to company products

> selectively reporting favorable outcomes

> duplicating publication of positive results

> omitting adequate statistics for assessing clinical significance (e.g. confidence intervals)

> promoting interpretive spin that exaggerates benefits or minimizes risks of company products.⁸

The problems of ghost authorship and industry sponsored research of their own products have even confused insurance companies. Below is the excerpt from an August 2005 Wall Street Journal article. In it, a Kaiser doctor describes some of her experiences in attempting to evaluate new drugs:

When Dr. Kubota started her current job in 1997, she says she "would just read the abstract," the summary at the beginning of a study. "I guess I was naive," she says. "You kind of assume everything is there for you in the abstract." Today, she quickly homes in on details that aren't mentioned in the abstract and generates a 6-inch stack of papers studded with Post-it notes for each drug.

. . .

Dr. Kubota has also reviewed studies of Lyrica, a new Pfizer Inc. drug for epilepsy and pain that is similar to the company's blockbuster Neurontin. Pfizer is hoping to persuade insurers that they should cover Lyrica rather than steering patients toward Neurontin, which is now available in generic copies that cost less than a dollar per pill.

At least four articles in leading medical journals, authored by scientists at Pfizer and in academia, described Lyrica as effective in treating pain. One last year in the journal Neurology stated in the summary that Lyrica "demonstrated early and sustained improvement in pain" for patients with pain caused by diabetes.

But Dr. Kubota discovered that in a section with a smaller font size, the Neurology paper said the trial excluded patients who hadn't responded to Neurontin. A similar caveat appeared in the other articles. That meant the trials failed to include patients who were likely to pull down Lyrica's results. [italics added]⁹

In recent months, the editorial pages of medical journals initiated debates, called for ethics, and issued guidelines for authorship disclosure. As for Elizabeth, the ghost writer eating pancakes, she didn't seem to be aware of any controversy. She mentioned that some doctors edit the studies, many simply sign their names to the studies, and that work was quite exciting--she was even thinking of transferring to marketing. As for a way that medical journals can re-claim their integrity, the editor of one journal summed it up as follows:

The solution? There is no good one. Each must obey his own conscience at the least, editors and publishers should insist that, everyone that materially contributes to a paper be listed as an author, and that each author signs an affidavit to that effect.¹⁰

some additional reading:

At medical journals, paid writers play big role
source: Wall Street Journal, posted in the Pittsburgh Post Gazette

Researcher Sheds Light on Ghost Writing in Medical Journals
source: Georgetown University Medical Center

Inside the business of medical ghostwriting
source: Canadian Broadcasting Corporation

Ghostwriting (powerpoint)
source: Tufts University Lecture

Hype in Health Reporting: "Checkbook science" buys distortion of medical news
source: FAIR (fairness and accuracy in reporting)

¹ "Elizabeth" is a pseudonym. In addition, the name of her graduate school was purposefully left out.

² If I had been paying more attention to the news, I would have heard of the medical ghost writing issue

³ I have taken issue with what is being studied but not the process of how studies are written.

⁴ Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals
Annette Flanagin, RN, MA; Lisa A. Carey, PhD; Phil B. Fontanarosa, MD; Stephanie G. Phillips, MS, PhD; Brian P. Pace, MA; George D. Lundberg, MD; Drummond Rennie, MD
JAMA. 1998;280:222-224.
http://jama.ama-assn.org/cgi/content/full/280/3/222

⁵ Revealed: how drug firms 'hoodwink' medical journals
Pharmaceutical giants hire ghostwriters to produce articles - then put doctors' names on them
The Observer
December 7, 2003
source: http://observer.guardian.co.uk/uk_news/story/0,6903,1101680,00.html

⁶ Consumer advertising and doctors' prescribing: "Track changes" tracks ghost writers
British Medical Journal 2005;330:1332 (4 June), doi:10.1136/bmj.330.7503.1332-b
Steinar Madsen, chief consultant, Norwegian Medicines Agency, Sven Oftedalsvei 8, N-0950 Oslo, Norway steinar.madsen@noma.no

⁷ Medical editors issue guidance on ghost writing
British Medical Journal 2005;330:988 (30 April), doi:10.1136/bmj.330.7498.988-a
http://bmj.bmjjournals.com/cgi/content/full/330/7498/988-a

⁸ Viewpoint: Professional Integrity in Industry-Sponsored Clinical Trials
Franklin G. Miller, PhD, and Howard Brody, MD, PhD
Academic Medicine, Vol. 80, No. 10 / October 2005 903

⁹ Detective Work: Reading Fine Print, Insurers Question Studies of Drugs --- Kaiser's Veteran Sleuth Scours Medical-Journal Articles And Sees Marketing Spin --- Doctors Fear Loss of Choices
By Anna Wilde Mathews
24 August 2005
The Wall Street Journal

¹⁰ Editorial: Ghost Unwriting
Neurourology and Urodynamics 23:287 (2004)
Jerry G. Blaivas, Editor-in-Chief