Regenerative Sciences, Inc. just announced in a press release (PR) that John C. Malone (pictured above in their PR), Ph.D. has “joined the Regenexx Team”. Malone has infused the restive stem cell company with millions in cash.
Regenerative Sciences is the adult stem cell company run by Dr. Chris Centeno of the Centeno/Schultz Clinic that is locked in a high-stakes lawsuit with the Federal Government over the degree to which the FDA can regulate autologous stem cell treatments. For more background on Centeno’s perspectives on stem cells and regulatory issues, you might want to read a recent post in which Centeno and Doug Sipp, a proponent of a high degree of stem cell regulation, engaged in a lively and fascinating debate of sorts via me email interviewing them. That post stimulated a debate in the more than 2-dozen comments on it.
Malone is a libertarian, billionaire (read more on Wikipedia) investor, known in part for reportedly being the single largest landholder in the entire U.S.
According to the PR, Malone has invested $2 million in Regenerative Sciences, which will not only support the Centeno Clinic, but also
“…. help support the national expansion of their Regenexx™ Physician Network.”
What’s the big deal about Malone investing in Regenerative Sciences?
From my perspective this events further supports my theory that a national effort to promote stem cell deregulation is underway, which has significant risks in my opinion.
In line with this notion the PR goes on to say (emphasis mine):
“This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use.”
Given Malone’s savvy as an investor, one might interpret his investment as a sign that he thinks that Centeno will win the federal lawsuit. One way or another it is certainly a pivotal case. I respect the fact that there are different opinions on balancing risk and innovation in the stem cell treatment arena through influencing regulatory mechanisms, but my feeling is that a high degree of regulation is important for patient safety.
I am close to retirement and was just told I will need a knee replacement. After spending a furious two weeks researching the subject, I just sent a letter to my senator to draw a line half way down the FDA org chart, and fire the upper half. I now also wonder why they are going after Rodger Clemens for trying to heal his shoulder as I want to heal my knee.
While I do think it would be at least desirable to try to get the treatments to the patients swifter (and think there are some ways to go about this), I don’t think a full deregulation is a good idea. How would we prevent clandestine clinics from selling their patients snake oil? Or, through negligence, use techniques that go beyond uneffective and are actually harmful?
If we let the FDA regulate stem cells like they do medicine, it will take 10 years and a billion dollars to get a stem cell procedure from inception to the patient. For those with existing conditions, stem cell treatment is the only hope they have. Please don’t let the FDA get involved in approving stem cell procedures.
Wow, that is quite the investment! I am on the same page as you; regulations need to be made to protect the patient.