Today was day one of the Houston Stem Cell Summit, at which Guv Rick Perry was a keynote speaker. I thank the organizer for inviting me to attend and I wish I could have, but I’ve spent a good chunk of the day today teaching medical students right here in Sacramento, CA so I could not go.
The meeting got off to an impactful beginning with Perry’s speech (see below).
There are many interests elements to Perry’s speech, but one added part in particular was notable and that was Perry’s first public defense of Texas stem cell clinic, Celltex, which has effectively been frozen at the clinical level by a recent FDA warning letter.
Perry said:
“I disagree with the FDA that the process of what’s going on here in Texas in some of our companies is creating a drug. No more so than bone marrow transplants are not regulated by the FDA or in vitro fertilization is not regulated by them. So my hope here with this conference is that there’s a very good intellectual, open conversation about the future of adult stem cells.”
I respectfully disagree with Perry on the issue of propagated stem cells being a drug and about the FDA.
Perry said a lot more interesting things in his speech that I’ll discuss further tomorrow.
Paul,
You were missed by this reader of your blog.
I was a front row attendee and BioLife was an exhibitor at the meeting.
There were some very compelling sessions and I want to pass this on and ask a nagging question.
Patients gave personal testimonies and it was moving. One woman with MS and a patient of CellTex talked of her 18 year struggle with incontinence and constipation, and that being treated with expanded stem cells helped her, Dr. Jim Lieninger of KCI fame and a medical doctor with “no reason to explain it” talked of lessening pain in his back and his ability to walk without aides after 1 treatment of CellTex cells.
I’m not here to debate your very valid reasoning for continued peer review and facted based science. That said I did hear that the FDA original mandate from Congress was in part to protect public health, and to “do no harm”.
So my question to you would be this!
If the FDA already monitors human tissue labs, and medical device companies and the state IRB’s, why not back off a bit and allow Medical Doctors to treat the patients they want to treat with the “drug or cells” of choice?
My reason is simple, today any licensed physician in the US can go to a compounding pharmacy and create a “drug” and administer it to a patient. No long studies, no tox tests, no control group, no anything. ( I hope I’m correct here).
If the MD makes a mistake and causes harm to the patient with a drug he designed, then there are checks in place to correct the problem.
He will possibly be sued, the state medical board will investigate him and the system may even deal with him criminally, like Michael Jackson’s Doctor.
So I ask you, what right does the FDA have to come between a patient and a doctor in the treatment of an illness?
And further to that question, what are your thoughts on compassionate care of patients with no other options and looking for a higher quality at like?
Obviously my business only deals with the storage of cells and adipose tissue, but the debate is not only interesting, but also compelling when you hear from the PATIENTS, and not the businessmen, lawyers politicians or researchers.
JC
It sounds like an interesting, even if apparently one-sided stem cell meeting.
Your question is an interesting one and there are several layers to the answer.
First, the FDA does not have so much a “right” as a legal obligation to regulate biological materials based on the Public Health Service (PHS) Act and the Federal Food, Drug, and Cosmetic (FD&C) Act.
Second, the FDA also draws legal authority to regulate biologics of this kind from C.F.R Title 21, Part 1271A.
Third, the FDA definition of propagated stem cells as a drug has been upheld by the recent US v RSI case.
Therefore, the current law of the land is clear on this issue. Of course RSI could win on appeal, but right now this is the law and I find it astonishing that some physicians are breaking it.
I’m not a lawyer so while I take all of that seriously, I also feel as a scientist that we need more information before using patients as human guinea pigs and charging them for it to boot.
Thanks Paul for the response.
It appears the smart money is on Regenexx (RSI) winning on appeal, because as it was explained to me, the FDA has no prior authority granted by Congress to dictate law to medical doctors in the treatment of patients.
On another note I am suprised to read your statement, that it appears likely Romney will win the election.
Most republicans have sat back for the last 4 years patiently waiting for this election, as dems did the previous 8 years. I hope everyone gets out to vote & respects the free election process!
If I were betting, I would bet on RSI losing on appeal, but not more than $5. It could go either way.
Regarding Romney vs Obama I think that could also go either way, but it appear Romney’s chances have improved.
I also encourage everyone to vote and I hope for the best for everyone who has been affected by Hurricane Sandy.