The Mittleman Files, Part 1: Deposition provides treasure map for ghostwriting stories

Have you ever worked on a story where you knew that you were just one source away from a blockbuster? But you could never find that one great document that spelled out the connections or that one repentant insider willing to walk you through the corporate crime, government malfeasance or law enforcement deceit.

The Drug Industry Document Archive at the University of California-San Francisco has posted two depositions that could be the linchpins for dozens of investigative stories.

The subject is Karen Mittleman, who, as Antidote has noted, has the perfect Dickensian name for her job as the go-between finding researchers willing to sign their names to papers written by drug companies. Her employer, DesignWrite, was hired by Wyeth to sell its products by disguising marketing messages as scientific research. (I have a feeling that Dickens would have found this story too tragic for his tastes. For one, where are the heroes?)

In May 2006, Mittleman was deposed by attorneys in Philadelphia suing Wyeth over the side effects, some deadly, of its estrogen replacement therapy (ERT) and hormone replacement therapy (HRT) drugs, including Premarin and Prempro. DesignWrite was not named in the suit, but Mittleman had information that the plaintiffs' attorneys knew was valuable. The first deposition is 160 pages long. The second is even longer. To make things simple, Antidote is culling the highlights that could become building blocks for stories and will post them in the weeks to come:

1. Who is Karen Mittleman? James Szaller, the lead plaintiffs' attorney, gave her the courtesy of referring to her as doctor throughout the deposition, probably to soften her up. She's not a medical doctor. She has a Ph.D. in environmental physiology. She was hired by the owner Mitch Leon, and she worked at DesignWrite from June 1997 to August 2003. "They were looking for a scientist who had experience in reproductive hormones, and that was my research area of - after my PhD." Mittleman said, adding that she was a "good listener. I could write and I understood research, and I also think that my ability to communicate with researchers was important."

2. Who else is important in this story? On the Wyeth side, Jeff Solomon, senior product manager for ERT/HRT, marketing director for women's health; Dr. Howard Rofsky, senior director for clinical development; Alice Conti, another member of the Wyeth marketing group in women's health; Dr. Amy Marren, drug information specialist in women's health; Dr. Margaret Weber, the head of medical affairs for women's health; Dr. Pamela Cobb, another member of the medical group; and Jean Marie "Jamie" Durocher, the marketing director for "the Premarin Family" of drugs.

3. Wyeth was in charge from the start. Solomon told the plaintiffs' attorneys, according to Szaller, "that the objectives of a publication plan were Wyeth's objectives and not DesignWrite's objectives." He also said that "one of the rationales of a publication program was the recognition of high clinician reliance on medical articles or journal articles for credible product information [O]ne of the objectives of a publication plan was to establish a greater need for hormone therapy with the eventual goal to have more prescriptions written."

4. Mittleman wants to present her work as pure science. In response to Solomon telling her what Wyeth's own executives said about their relationship with DesignWrite, Mittleman said:    

I have no idea what was done from the sales side. Ours were purely scientific papers that were in the literature for – for disseminating information on research that was done.

5. The work paid. DesignWrite received $20,000 and later $25,000 for every review article it helped write, regardless of whether it was published.

6. The work was part of a larger war on other drug companies. On May 15, 1997, Wyeth submitted to DesignWrite a "Premarin Publication Program." Its objectives were:

One, increase physician awareness of the multitude of benefits that hormone replacement therapy provides for postmenopausal patients; two, diminish the negative perceptions associated with estrogens and cancer, and, three, blunt the competitive threat of raloxifene [Evista, made by Eli Lilly], a selective estrogen receptor modulator, expected to be approved early next year for osteoporosis.

7. Some Wyeth executives have better ethical guidelines than DesignWrite or the "authors." Weber, the head of medical affairs for women's health, told Szaller in a deposition that he paraphrased, "that the names of anyone who made a substantial contribution to a medical article should be disclosed somewhere in the article." Cobb, another member of the medical group, also, according to Szaller, said "the cost of an outline, the research, and the development of a manuscript for a review article paid by a drug company should be acknowledged in the article."

8. There is one thing that seems to spook ghostwriters: the federal government. Szaller points out a study where Mittleman's name appears that was funded by the Naval Medical Research Institute.

Q. Dr. Mittleman, why did you and your co-authors feel it necessary to make that acknowledgment in this paper?

A. Because this research was funded through the Naval Medical Research Institute. They provided the grant to do the actual physical study .And the publishing of that study. I don't know, because I did not see the grant. I was not the primary investigator. I don't know if cost of publishing was part of that grant.

9. Wyeth had high hopes for its hormone pills, well beyond any of the indications for which it had been approved by the FDA. It was using DesignWrite and its "authors" to push new indications that had nothing to do with menopause, including diabetes, Alzheimer's, colorectal cancer, macular degeneration, and immune system changes

Q. Doctor, are any of those indicated benefits approved by the FDA for use of hormone therapy at this time period to your knowledge?

A. Not to - not to my knowledge.

10. Why does this all matter? A flow chart that Wyeth put together illustrates why. The accompanying document says:

Targeting key messages for defined audiences is critical to the success of the publication program. Traditionally, the hierarchy of medical audiences has been defined as shown below. Data is disseminated via a 'trickle down' approach with each layer directly involved in educating the layer beneath.

Everything in the flow chart eventually trickles down to the patients.

Stay tuned: Keep reading Antidote for more on this and other treasures to be found in the Drug Industry Document Archive.