Start naming names in the pharma ghostwriting scandal

When historians write the history of ghostwriting in U.S. medicine, they will mark Sept. 17, 2009 as pivotal.

On that date, the Drug Industry Document Archive (DIDA) at the University of California, San Francisco, added 1,120 new documents, nearly doubling its collection, all from one major court victory. In August, a federal judge unsealed documents at the request of the scientific journal PLoS, which was represented by Public Justice, and The New York Times that detailed Wyeth Pharmaceutical's ghostwriting practices.

Over the past decade, Wyeth's Premarin brand of hormone replacement drugs faced mounting scientific evidence of dangerous side effects. To rebuild its brand, the company hired DesignWrite, a medical communications company, to write articles, find respected researchers to appear as authors and then use those authors' names to land the articles in medical journals.

DIDA, for those of you who have not had a chance to use it, is one of those resources that are so rich with information that you fear that once you shut off your computer it might disappear forever or turn into a subscription-only service.

The folks at UCSF have done the hard work of making 2,500 scanned documents fully searchable. This allows you to search for drug company names, drug names, and, most importantly, the names of scientists who worked with pharma-paid ghostwriters.

DIDA has been around for more than four years, building slowly with documents from lawsuits and federal investigations into companies such as Parke-Davis (now part of Pfizer), Merck and Abbott Laboratories. One of the many beautiful things about DIDA is the ability to click on one link for each case that has become a part of the archive and pull up all the related documents. The list of cases is on the page titled The Documents.

To see the new Wyeth records, you can go to DIDA's home page and enter either one of these codes: ddu:2009* or cs:prempro* For history's sake, though, Antidote tried out a few of the names that already have appeared in the press to see if the documents shed any new light on their stories.

Dr. Gloria Bachmann was outed as a particularly effusive ghostwriting participant. Bachmann's name appears in 134 documents. Going through them, you can tally the ones tainted by ghostwriting and see how the drug maker's influence is often so subtle that it is easy to understand how the ghostwriters and the authors-in-name-only have gotten away with it for so long.

One article, "The impact of hormones on menopausal sexuality: a literature review" appeared in the January/February 2004 issue of Menopause with no mention of Wyeth's participation. It does not overtly advertise Premarin, but it makes it clear that hormone replacement therapy drugs are a good option.

The sexual symptoms of hormone deficiency may be treated with either estrogen alone or estrogen combined with androgen. Some women also find non-hormonal vaginal lubricants and moisturizers useful; clinical studies have shown that these can be as effective as local estrogen therapy for alleviating vaginal dryness. The treatment of other clinical symptoms resulting from hormone depletion also can improve menopausal symptoms and quality of life for many women, which in turn translates into enhanced sexual function.

Elsewhere in the archive, you can find clues that one of Bachmann's co-authors on that paper, Dr. Sandra Leiblum, may have questioned some of the content in the article (or, possibly, doubted the wisdom of working with a ghostwriter). In a document titled "Strategic Publication Plan Tracking Report - 2002-2003 Papers," someone at DesignWrite wrote, "Revisions in progress. Leiblum to reconsider authorship." In another document, you can read an email from Leiblum to Karen Mittleman, one of the DesignWrite editors. Here, Leiblum is nearly as ebullient as Bachmann:

Greetings! Sorry I missed you on the phone but I wanted to get the revisions back to you ASAP. To make your life a little easier, I decided to do the editing on-line. At this time, I would like to be cited as second author since I now feel comfortable with the article! I support Gloria's changes as well as my own.

During a deposition in a lawsuit over Wyeth's hormone drugs, Mittleman was asked point blank about why Lieblum was hesitating on authorship. She provided a different answer, one that had nothing to do with Lieblum's comfort level.

Sandra was ­- sorry.Dr. Leiblum was doing a one-year sabbatical in - or, you know, one year, six months, three - but it was a sabbatical, so she would be away for an extended period of time. And so her concern, at least, again, to the best of my recollection, was her time away that she would not have time to devote to this.

Mittleman also provided some interesting details about how exactly the writing and editing was done for these ghostwritten articles. The plaintiff's attorney, James Szaller, takes Mittleman's testimony and stitches it together, taking her (and us) through the process, starting with the freelance ghostwriter, Andrea Gwosdow. He is interrupted briefly by Wyeth attorney Erica Kuhl:

So if I can summarize - tell me if I'm wrong - we have looked - with respect to the article by Dr. Bachmann and Dr. Leiblum, we have seen that it began with an assignment form to Miss Gwosdow to prepare an outline and a manuscript. The outline went through an internal review at Wyeth and DesignWrite, and changes were made. It then progressed to the - to the authors for their changes to the outline. It then became a manuscript that Miss Gwosdow, in fact, worked on again. It became published. And in the published article, there's no acknowledgment of the effort of Miss Gwosdow, Designwrite, or any payment by Wyeth or any effort by Wyeth employees to review the outline and manuscript; is that correct?

MR. KUHL: Object to the form.

THE WITNESS: And I would say again, the acknowledgment is up to the authors and the journal. How they interpret what the journal wants, that's -

BY MR. SZALLER: Q. Other than that fact, what I said is correct.

A. That's correct.

If you are a true devotee of the ghostwriting saga, you might remember Mittleman's name (and not only because, in the context of what she does for a living, it seems straight out of Dickens). She was one of the ghostwriting editors who worked with Dr. John Eden. Her name turned up in a letter written by Sen. Chuck Grassley, R-Iowa, in December 2008, demanding information from Wyeth about ghostwriting.

Eden told Antidote he regretted what he referred to as his one experiment with signing his name to a ghostwritten article. You can read more about him and other scientists who worked with ghostwriters in future posts.