Friday, June 24, 2016

California's Battle for Easing Regulation of Stem Cells Attracts Global Notice

CIRM CEO Mills mentioned
FDA regulation/Regrow co-mingled
A tale of dubious stem cell treatments

California's $3 billion, 11-year-old effort to produce a stem cell therapy -- largely ignored by the mainstream media -- broke into global cyberspace today in a reasonably significant way.

The agency was featured in a piece on Buzzfeed, an online news operation that has chalked up more than 173 million unique visitors worldwide in the last 30 days.

The article by Dan Vergano focused on the efforts by the California Institute for Regenerative Medicine or CIRM, as the agency is formally known, and others to persuade the FDA to ease up on regulations so that stem cell therapies can be more quickly developed.

Vergano wrote,
"Despite a decade of scientific hype, progress has been slow in proving that these new treatments actually work. Some scientists are particularly frustrated with the slow pace of FDA review. In a Fox News op-ed published last month, for example, C. Randal Mills, the head of the prestigious California Institute for Regenerative Medicine (CIRM), called for the federal government to loosen its safety rules, promising “medical breakthroughs” for arthritis, back pain, and diabetes."
Mills has focused his efforts since last year on FDA regulation. But his campaign is being co-mingled in the media with the Regrow Act, an industry effort that the agency has not taken a position on.

Paul Knoepfler, a UC Davis stem cell researcher, also recently brought FDA regulation and Regrow together in a piece in the San Francisco Chronicle recently. Vergano interviewed Knoepfler for the Buzzfeed article,
"'We have been telling people to cut down the stem cell hype, and then we turn around and have this talk about miracles and beautiful medicine....Wishful thinking here could have a whole slew of dangerous consequences.' Most worrisome, (Knoepfler) said, is that desperately ill patients looking cures might end up with tumors instead."
Jim Gass, NYTimes photo by Carlos Moreno
One such case was chronicled this week by New York Times reporter Gina Kolata. Her hair-raising story told the tale of patient Jim Gass, a 66-year-old lawyer from San Diego. The article began,
"The surgeon gasped when he opened up his patient and saw what was in his spine. It was a huge mass, filling the entire part of the man’s lower spinal column.
"'The entire thing was filled with bloody tissue, and as I started to take pieces, it started to bleed,' said Dr. John Chi, the director of Neurosurgical Spine Cancer at Brigham and Women’s Hospital in Boston. 'It was stuck to everything around it.'"
"He added, 'I had never seen anything like it.'"
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