Bioethics Blogs

The Value of Oversight in a Century of Promise & ‘Cures’

This post, by CEC member Paul McLean, originally appeared on WBUR’s CommonHealth blog.
The blood-thinner heparin is not a 21st-century cure. It was discovered 100 years ago by a scientist looking for something else entirely, and is one of the oldest drugs still in regular use.
After my daughter was diagnosed with a potentially fatal blood disorder, heparin played a key daily role in her treatment. We’d wash our hands meticulously, lay out gloves and antiseptic wipes, saline flushes for the access lines to her fragile immune system, and finally the sealed heparin syringe.
For many months, we went through boxes of heparin and never questioned its safety. Never had reason to.
But in 2008, after my daughter was officially declared cured and we’d used heparin for the last time, contamination in the supply from China killed 19 Americans and harmed many others. Writing that sentence still gives me the chills. My daughter survived thanks to medicine, but it also could have killed her.
So you can understand why, as the 21st Century Cures Act sailed to passage, I experienced both excitement and dread.
That heparin contamination was in part due to lax oversight of the drug supply chain. It reminds me why I do not want to see the work of the Food and Drug Administration compromised by overeager drug companies taking advantage of the hopes of desperate patients, and taking shortcuts on safety.
The “giant piñata” of a bill, as science blogger Derek Lowe aptly described the 21st Century Cures Act, is destined to explode in unexpected ways.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.