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One of the more bizarre things about the adult stem cell controversies playing out in the news (usually around the upcoming ISSCR annual meeting) has been that patients have been largely left out of the conversation. While every once in a while you’ll see a patient quoted, the vast majority of stories spend their word allotment quoting financially conflicted bench scientists or academic physicians. Well, hopefully, that changed over the weekend when the Texas adult stem cell bill came out of reconciliation committee intact and is headed for the governor’s desk for signature. In a very real way, patients found their voice in Texas, not through the media but through legislation.

The History of the Fight to Access Adults Stem Cells

Most physicians who have gotten involved in using adult stem cells over the past few years have no idea of the history of this battle. Since the ’90s, the FDA has tried to control more and more of the cells in our body as prescription drugs. While safety concerns are often cited, the bigger reason is that adult stem cells are competitive with prescription drugs and could threaten that FDA-regulated industry. Hence, what has been playing out is the agency giving pharma enough time to figure out how to successfully commercialize adult stem cells.

This Was Not a Good Weekend for Federal Control over Patients

While most of us were celebrating Memorial Day, the Texas legislature was hard at work trying to get an adult stem cell bill out of committee. At the same time, many interests were working hard to kill the bill. What left committee this weekend was a mostly intact adult stem cell bill that makes it clear that Texas physicians can use adult stem cells in chronically and terminally ill patients. The language is broad enough so that most patients who currently are being treated with adult stem cells will continue to have access to that treatment. A copy of the bill is here. 

The Bill Provisions

1. The treatment must have IRB approval from a hospital- or university-based IRB.
2. The results of the therapy must be reported back to that IRB.
3. As long as the standards of care and the bill’s provisions are followed, the Texas Medical Board is prohibited from going after any physician who offers this type of care.

The University Crowd Pursuing and Holding Stem Cell Patents Will Be Apoplectic over the Next Few Weeks

Most people don’t understand that their local university is a huge business. Gone are the days of threadbare academics toiling for the greater good in medicine. Instead, a trip to the ProPublica website Dollars for Docs will show you how many university physicians have been milking the corporate medical cow with the best of them. For bench scientists, the money is in university-based profit sharing agreements on cell biology patents licensed to pharma companies. Even if the bench biologist has no patents to vend, the mere thought of moving adult stem cells from the bench to the bedside means far fewer federal research dollars being allocated to basic science research in stem cells. This is why organized science groups like ISSCR have made sure to hire big Madison Avenue PR firms to ensure that the message we all hear is that adult stem cells aren’t ready to be used in patients. This is despite record amounts of basic science already published in the area.

Patients Finding Their Voice

The most amazing thing about the Texas bill is that while academia has done its best to squelch the voice of patients in the press, the patients found their voice through legislation. While every press story on the risks of physician adult stem cell use should have carried quotes from several patients that supported use, that often wasn’t the case. So in the end, academia fueled a groundswell of pissed-off patients who had had enough and used that anger to fuel this new bill. Having witnessed patients being muted for more than a decade, I couldn’t be prouder of adult stem cell groups like Patients For Stem Cells who organized enough e-mails and phone calls to take down the office staff of several Texas legislators.

Our New FDA Chief Used to Agree with Patients

While many physicians using adult stem cells don’t understand the significance of our new FDA chief, it wasn’t lost on me. Dr. Gottlieb is an adult stem cell advocate who wrote a 2012 Op-Ed in the Wall Street Journal criticizing the then FDA administration for trying to create drugs out of patient body parts. Hence, this Texas legislation may be the one-two punch that patients need to finally make it clear that giving chronically and terminally ill patients access to use their own cells in an attempt to cure them makes common sense.

The upshot? The Texas stem cell bill represents a turn in the tide from academia control over adult stem cells to patient control. It’s been a very long time coming. Patients have now found their voice on this matter, so I think academia needs to rethink its strategy lest it find itself nothing more than a forgotten footnote in this debate.

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile