List date(s) this work was published or aired.
23-May-12
Provide a brief synopsis of the story or stories, including any significant findings.
Through the lens of a local wrongful death lawsuit, the story examines risks associated with a relatively new blood-thinner called Pradaxa. After the drug went to market, the FDA, and drug regulators in other countries, issued notices to clarify the fact that there is virtually no way to reverse a severe bleeding incident, which is something that patients who switched from the standard treatment (Coumadin) may not have realized.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The information came in part from medical journal studies on Pradaxa, FDA letters/notices, CDC statistics, study results published by the manufacturer, and critiques by advocacy groups, including the Institute for Safe Medication Practices. I also used news reports and regulatory notices from other countries dealing with their own Pradaxa concerns. No FOI or public records acts were required.
Explain types of human sources used.
I interviewed the plaintiffs in a local suit filed against the manufacturer — two daughters of an 80-year-old woman who died in 2011. I also interviewed two of the attorneys handling their case. Other interviewees included: Dr. Bryan Cotton, a local trauma surgeon whose letter to the New England Journal of Medicine helped bring awareness to the lack of a reversal agent; and the manufacturer’s spokesperson and senior vice president of clinical development and medical affairs.
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.
No follow-ups — the lawsuit is still pending. And no one challenges to its accuracy.
Advice to other journalists planning a similar story or project.
This was a pretty straightforward story. The only advice I’d have is to be wary of how statistics can be presented in studies in a way that makes a drug seem a lot more beneficial, or a risk a lot less severe, than it really is. I made sure to speak on a background basis with scientists about how to objectively interpret many of the statistics in the clinical findings.