The Texas State Medical Board reportedly approved new rules for the use of adult stem cells.
The ruling was at least in part a result of Texas Governor and former GOP presidential hopeful, Rick Perry, strongly pushing the issue.
Perry himself received a controversial, non-FDA approved stem cell transplant in 2011 as part of a treatment for a spinal injury. Ever since Perry has been trying to push through new Texas medical rules that would make his treatment kosher. In other words, he’s been trying to close the barn door after the horse already left.
This week he finally got his way.
Serious stem cell researchers and ethicists have serious concerns about the new Texas rules.
The WSJ quotes Dr. Leigh Turner of the University of Minnesota about his concerns: “The guidelines are skewed to favor business interests instead of patient safety.”
I agree with Dr. Turner.
Perry’s surgeon, Dr. Stanley Jones of Houston, is also a big stem cell booster and co-owner of controversial Texas stem cell company, Celltex. Celltex has been at the center of a firestorm of controversy in part after Turner wrote a letter to the FDA, which I supported, asking them to look into Celltex’s operations.
I have been critical of a Celltex doctor who said that the worst-case scenario for their stem cell treatments was that they wouldn’t work. Of course in reality the worst case scenario of a stem cell transplant is injury or death of patients.
There has been some speculation that stem cells and Perry’s spine injury, possibly alone with pain meds may have ruined his chances at the presidency after a series of terrible debate performances. Perry seemed very naive about stem cells, particularly for someone who got a dubious stem cell treatment himself. I described this situation in a post called “Rick Perry’s first stem cell rodeo: it ain’t pretty“.
What do the new Texas stem cell rules mean and what are their consequences?
Not much.
As I pointed out in the rodeo piece, state regulations on such matters are of relatively little consequence because they always take a back seat to federal regulations:
One problem–the treatment is not legal in the U.S., no matter what state you are in and no matter what state politicians might say.
The FDA has not approved such treatments. The feds frown on giving unapproved drugs such as this.
Thus, at a federal level Perry’s treatments and any future treatments of the same kind in the state of Texas, no matter what their medical board might say, remain on shaky legal ground on a federal level, which is really what matters.
Bottom line: What is really going on here is Rick Perry spinning things to (A) try to retroactively legitimize his dubious stem cell treatment and (B) push forward adult stem cell treatments in Texas without regard to patient safety.
it’s clear from your comments that you’re not a lawyer. autologous stem cell therapy is perfectly legal until a court says it’s not. the centeno ruling and the subsequent appeals should provide much needed guidance. until then, hooray for texas. innovation is here. there is no going back.
I’m not a lawyer, but you are wrong. FDA regulations come before state laws, and FDA guidelines specify that adult stem cell treatments are by default definition not minimally manipulated unless proven that they are.
It is clear that the FDA is interfering with autologous stem cell treatments that have been used for years on the veterinarian side of things as well as the use of cord blood and transfer of adipose containing these cells. This needs more study, but I just don’t buy that with the preliminary results of safety at places like Stem Cell Institute and others in Asia without complications, that further objective study is warranted in our country. This smells like big Pharma and their brethren on the Technology side blocking things because they can’t get a patent.
At the federal level, State Medical Boards that try to make end runs like this around the FDA, or do not monitor their state where these nefarious clinics pop up (California, Arkansas ect..) should be sanctioned and specific federal funding withheld from the state until said clinics are closed down. That would drag it out into the open and get the point across.