As of July 18, 2016, the FDA has approved 46 breakthrough therapy designated products. According to the Friends of Cancer Research, nearly 75% (34) of these are for the treatment of cancer. One of these drugs -- Bristol-Myers Squibb's PD-1 inhibitor Opdivo -- has been extensively covered in the media.
A recent NYT
OpEd piece, for example, called the TV ads for Opdivo "utterly misleading and exploitive" and said that if BMS really wishes to thank
patients who participated in the Opdivo drug trials, it should pull the ads because the drug "doesn't work" (see below).
This article explores the trend in direct-to-consumer (DTC) ads for "breakthrough" cancer therapies.
Topics (partial list)
Download the full article (PDF file) here:
- What FDA Means by "Breakthrough Therapy"
- Chart: Strong Opdivo Sales, For Now
- Big, Bold DTC Ad
- BMS' View
- Majority of Physicians Do Not Understand What Level of Evidence Supports FDA's "Breakthrough" Therapy Designation
- Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients
- Impact on Sales
- The Media's Role