The Mittleman Files, Part 2: Just another day on the ghostwriting assembly line

Putting together a scientific research paper should be a different process than building a Ford Taurus or making a Big Mac.

For the drug companies and their ghostwriting partners, it isn't.

While reading the deposition of Karen Mittleman, one of the lead ghostwriters hired by Wyeth to sell its products through the scientific literature, it becomes clear how much of what we are reading in medical and scientific journals has been built from a bunch of interchangeable parts moving along an assembly line. The end result is always an article that promotes a particular product or a condition for which a company has new drugs working their way through the FDA approval process. Antidote provided highlights from Mittleman's deposition last week. Here are more jumping off points for great stories.

1. The mechanics on the assembly line. There's a good list of names of DesignWrite writers here. Look for them in the acknowledgments section of the journal article to see if they have been thanked for "editorial assistance." That can be code for, "They wrote it." Ann Contijoch, Robert Doyle, Stella Elkabes, Robert Graham, Steven Gutkin, Andrea Gwosdow, Fina Herr, Ann Maliszewski, Tom McClellan, Kathleen Ohleth, Karen Pruitt, Trina Ricci, Barbara Rinehart, John Smith, Linda Stanley, Carol Tozzi and Edward Weselcouch.

2. The figureheads. One of the chief defenses from scientists who have been caught acting as puppets for drug companies is that the article, while written by someone else, reflected the scientists' opinions and research. The truth is, when DesignWrite and Wyeth are shopping for shopping for authors, they see the scientists as cogs. Here's a memo from DesignWrite to an author that Wyeth was hoping would "author" an article on a drug line, "selective estrogen receptor modulators" (SERMS), that was a threat to Wyeth's "hormone replacement therapy" (HRT) drugs:

Because the SERMs paper is a priority for us to get into press, we need to move forward with it. Although your comments would be extremely important to us, we could submit it to another author in an attempt to alleviate some of the burden on your already hectic plate.

3. The company mantra. When Mittleman tries to present herself as an objective scientist who was simply filling gaps in the medical literature but never pitching a specific marketing message, plaintiffs' attorney James Szaller quotes from a memo written by Wyeth's Gerald Burr:

DesignWrite has been involved in publication planning in support of the Premarin Family of Products since 1997. The ongoing plan includes 20 review articles that promote the global effects of the Premarin Family of Products for postmenopausal health, while questioning the use of selective estrogen receptor modulators (SERMs) as an alternative therapy.

4. New and improved! Szaller produces a memo from two Wyeth employees who made a series of suggestions about an HRT article. One of the editing messages says, "Add CNS (central nervous system), (use paper by Ron Schneider) and colon cancer data to HRT benefits." And they decided to hit those concerns that HRT causes breast cancer right between the eyes by saying that HRT was "beneficial with respect to the risk of breast cancer".

5. Same great taste! If an outline for a paper isn't fitting the marketing message for the drug company perfectly, the title of the article can be changed. One article titled "The Atherosclerotic Process and the Impact of Estrogens" became "The Impact of Timing of Initiation of Therapy on the Cardiovascular Effects of Postmenopausal Hormone Replacement Therapy." The "authors," Dr. Richard H. Karas, Vice Chairman of Medicine at Tufts University, and Thomas B. Clarkson, a veterinarian and professor at Wake Forest University, remained the same.

6. Beating Brand X. The idea of a review article should be to take in all the known science about a particular treatment and draw some conclusions. Or, if the review article is being written for one of the drug companies, its purpose can be to find subtle ways to slight the competition. The breast cancer treatment tamoxifen was shown to have serious side effects long after it had been on the market. Raloxifene, an osteoporosis treatment, is sold as Evista by Eli Lilly, one of Wyeth's biggest competitors. The Wyeth team involved with DesignWrite's outline for one paper suggested that the paper paint raloxifene with the scary tamoxifen brush.

Focus on tamoxifen and minimize sections on raloxifene but infer that raloxifene might be new tamoxifen in that problems weren't found until after it was accepted.

7. Keeping morale high. Not all researchers say "yes" when asked by a drug company to sign their name to a ghostwritten paper. Some of them worry about how that might be perceived. One DesignWrite memo notes:

Previous co-author declined to participate due to bad press on articles affiliated with pharmaceutical industry.

8. Trade secrets. Some "authors" find a way to at least mention that they received help writing the articles or that they have worked as consultants for drug companies in the past. Others go so far as to claim that they have absolutely no conflicts, despite the fact that the article they are presenting to the public as an objective piece of science was conceived and drafted for a drug company. The review paper "Estrogens and the skin," published in Climacteric in 2005, was signed by Mark Brincat, and two co-authors. Nowhere was DesignWrite or Wyeth mentioned. In fact, it says "there is no conflict of interest and no source of funding."

9. Productivity. At one point, DesignWrite had 41 different Wyeth-sponsored review articles in some stage of development. At $25,000 a pop, that was more than $1 million worth of business from Wyeth alone.

10. The subsidiary. Here's more evidence that associations with nice-sounding causes can be industry fronts. One of Wyeth's go-to authors willing to work with a ghostwriter, according to the documents presented during the deposition, was Lila Nachtigall, a New York University professor and the president of the North American Menopause Society.

You can read more about Mittleman's deposition and other documents in the Drug Industry Document Archive in future posts.