1. Provide the title of your story or series and the names of the journalists involved.
The problem of outsourcing clinical drug trials
2. List date(s) this work was published or aired.
16-Nov-10
3. Provide a brief synopsis of the story or stories, including any significant findings.
On http://thehcc.tv/, in our exclusive interview with FDA’s Director of drugs at CDER, Janet Woodcock, we discussed the problem of the growing trend for Big Pharma to outsource clinical drug trials overseas and enroll in countries with poor oversight. We also interviewed in July the author of the OIG report, Joyce Greenleaf, Regional Inspector General for the HHS. Subsequent to our coverage, Vanity Fair and other national sources issued their own stories.
4. Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
We used the report from the OIG of the HHS and the interview with CDER Director.
5. Explain types of human sources used.
Our personal video interview on http://thehcc.tv/
6. Results (if any).
Benlysta, a lupus drug pending approval, and one that used non-US clinical data to meet endpoints, was delayed in its PDUFA date after we raised concerns with CDER Director
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.
None
8. Advice to other journalists planning a similar story or project.
Listing specific drugs pending approval at the FDA that rely on non-US data, such as ticagrelor where there was no efficacy in the US and Canadian cohort and met endpoints only in non-US patients, is a great way to make this abstract problem more relevant to an actionable theme.