1. Provide the title of your story or series and the names of the journalists involved.
"Making a Killing" by Carl Elliott.
2. List date(s) this work was published or aired.
Mother Jones, September/October 2010.
3. Provide a brief synopsis of the story or stories, including any significant findings.
When a mentally ill young man named Dan Markingson committed suicide in an AstraZeneca clinical trial at the University of Minnesota in 2004, critics charged that he had been coerced into the trial. Markingson was acutely psychotic; he was under an involuntary commitment order that required that he obey the orders of his psychiatrist; and his psychiatrist had recruited him into the study over the objections of his mother. Yet the ethical problems with the case were even larger. Last year, AstraZeneca paid $520 million to settle fraud litigation over its antipsychotic drug, Seroquel. Company documents unsealed in that trial revealed a number of instances where AstraZeneca employees openly discussed ways to spin or bury unfavorable trial results. And while those discussions mainly centered on other Seroquel studies, it is very likely that the study in which Markingson died was rigged to produce a favorable result for Seroquel. This raises a much larger question: when is it ethical to recruit subjects into studies whose primary aim is to market a product?
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The main documents I used for the story came either from litigation or from the medical literature. From the lawsuit filed by Mary Weiss against the University of Minnesota I obtained medical records, depositions, court orders, and other documents related to the care of Dan Markingson. From the fraud litigation against AstraZeneca I obtained internal company memoranda, emails, and PowerPoint presentations.
5. Explain types of human sources used.
For the story of Dan Markingson, I spoke extensively to his mother, Mary Weiss; her friend, Mike Howard; and their attorney, Gail Pearson. I also had email correspondence with the psychiatrists involved, Stephen Olson and Charles Schulz, and with regulators at the FDA. I also spoke about the case with administrators and faculty members at the University of Minnesota. For expert opinion on psychiatric clinical trial design and biostatistics I contacted a number of experts in psychiatry and psychology.
6. Results (if any).
The original story received a considerable amount of attention in local media outlets, including Minnesota Public Radio, MinnPost, City Pages and The Minnesota Daily. National blog coverage included posts by The New York Times, Psychology Today, The Hastings Center Bioethics Forum, and PLoS Medicine. I was also invited to speak about the article at the annual meeting of the American Society for Bioethics and Humanities in October 2010. In December, two faculty groups at the university sent public letters to the university's Board of Regents, asking them to appoint an independent body to investigate the Markingson suicide. These letters were covered by most of the local media outlets. So far, however, the Board of Regents has not responded.
7. Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
There have been no corrections or clarification, or any requests for corrections.
8. Advice to other journalists planning a similar story or project.
There is a tremendous amount of information about pharmaceutical industry deception in the documents that are being unsealed and posted on the web as a result of litigation. There are also many academic experts willing to help interpret those documents, if asked. My advice is to locate the experts and ask them for help.