When Regenerative Medicine Changes Everything (Forbes)

FORBES | Two weeks ago I led a panel discussion at the Bipartisan Policy Center (BPC) on medical innovation with my good friends Senator Lamar Alexander (R-TN), who chairs the Senate Health,Education, Labor and Pension (HELP) Committee, and former Congressman Bart Gordon (D-TN), who previously chaired the House Committee on Science and Technology.  We were joined by Nashville native Doug Oliver, who had a powerful story to share.

Senator Lamar Alexander (R-TN), Doug Oliver, former Congressman Bart Gordon (D-TN), and myself.

Senator Lamar Alexander (R-TN), Doug Oliver, former Congressman Bart Gordon (D-TN), and myself.

Doug inherited a rare condition called dry macular degeneration. His vision began rapidly deteriorating at age 32, and within a year he was legally blind–unable to recognize faces, read the paper, continue his IT job, or drive a car. His doctor told him told him there was no cure but encouraged him to monitor clinicaltrials.gov, the federal site we set up when I was in the Senate where NIH-approved clinical trials are listed, for any new experimental studies that specialized in his illness.  Doug was diligent and in time found a physician in Florida who was treating his condition with patients’ own stem cells.

Doug’s decision to participate in this clinical trial was life-changing. His own stem cells were isolated in a centrifuge from bone marrow drawn from his hip bone, and then injected into his retinas. Doug saw improvement overnight, and within months—after a decade of blindness—he passed the Tennessee driver’s test and got his license back.

Read more at Forbes.

The Most Helpful Illegal Medical Procedure (Fox News)

FOX NEWS | Last year 47,000 Americans had their blindness reversed through the transplantation of cells from a corneal donor’s final selfless act. It is safe, it is effective, and because it is curative, it is a relatively cost effective procedure. It is medicine at its most beautiful.

And according to FDA regulations, the distribution of this cell therapy is in violation of federal law.

That’s right. The regulation says that no matter how competent the surgeon, the FDA must first approve cells from donated corneas as if they were a drug—a process that takes over a decade and can costs billions of dollars — all for a practice that has been successfully restoring sight for more than 50 years.

The good news: the FDA doesn’t always adhere to its regulations and has not in this case.

The bad news: inconsistent enforcement creates uncertainty, deterring innovation for other unmet medical needs such as arthritis, back pain, and diabetic ulcers.

Read more at Fox News.