So far, I have written two posts (Part One and Part Two) on the Warning Letter received by Ms. Kristin Comella, which the FDA issued on August 24th, followed by two more posts (Part Three and Part Four) on the questions Ms. Comella included in a breathtakingly blunt diatribe against the FDA that she issued on August 29th. I will finish my review of the Comella 12 questions in this post. The questions are copied from her rebuttal letter:
Comella Question Nine: “Why is the FDA viewing a patient’s own body tissue used in clinic as a drug – please show specific case law justifying this violation of human rights?”
My Response: Whoa, girl. Pretty judgmental Ms. Comella for someone who just received a Warning Letter from the FDA. However, along the same lines elsewhere in your rebuttal letter, you state the following:
“If the federal government were to interfere with a person’s ability to obtain and utilize their own cells in their body to heal themselves, this could be a gross violation of the constitution.”
I don’t claim to be a Constitutional scholar, but the closest amendment in the Constitution I could find that references a person’s anatomy is the 2nd amendment. You know, the one that says “…the right of the people to keep and bear Arms, tissues, fat tissue and SVF shall not be infringed.” Okay, so that’s a bit of a stretch, but I doubt that the FDA gives a fig about what tissues from patients are being accessed, since they focus on what a physician/manufacturer does to and with those tissues. For example, if the patient is dead, you might think that the FDA would let a manufacturer do whatever they want, but there are very strict rules governing what a manufacturer can and can’t do with dead peoples’ parts. Naturally, with that kind of concern for the dead, it isn’t surprising the FDA has some strong views about how tissues from the living are handled and used, including obtaining fat tissue-derived stem cells. Thus, the FDA in my opinion doesn’t specifically care what tissues in a patient’s body are being used, just that the collection, processing and return are done in a safe and FDA rule-compliant manner. Your approach to SVFing isn’t compliant, as the Warning Letter pointed out, so I don’t understand why this is a Constitutional crisis.
Comella Question Ten: “Why has the FDA visited similar clinics and not taken action?”
My Response: Finally, a question even I would ask the FDA! Since you don’t provide any examples, I will point out that the FDA visited a trio of clinics owned by Dr. Thomas Gionis, who had a previous affiliation with the Cell Surgical Network, and who was issued a Warning Letter on December 30, 2015 for many of the same sins USSCC has committed. Before that there was a Warning Letter issued to Dr. Thomas Young who was mechanically processing fat, or so it seemed. I am not sure who else has been visited and who didn’t get a letter. However, I would urge the FDA to take to heart your plaintive cry that you and your clinic are being singled out for action and start leafleting the countryside with Warning Letters directed at SVFing clinics. Or, since the FDA’s enforcement budget would be stretched thin, they might crank up the Internet Surveillance section’s efforts, skip the on-site audits altogether, and just go with Untitled Letters. And I would urge those highly vigilant medical boards you refer to here and there in your rebuttal letter to take notice of who is getting letters from the FDA and do something about it.
Comella Question Eleven: “Why is the FDA ignoring the requests of tens of thousands of citizens to keep these therapies available?”
My Response: The point is a fair one, since isn’t the FDA supposed to work for the American people? Kind of. The problem is the FDA doesn’t get a warm and fuzzy feeling from clinics like yours in view of the three patients who under your clinic’s care ended up blinded or with highly diminished eyesight after receiving SVF therapy for macular degeneration. I also don’t see eye to eye with you on using SVF to treat the myriad of other pathologies like ALS, Parkinson’s, etc. for which you believe SVF would be an effective therapy, with no justification provided anywhere. Since your clinic’s approach to offering SVF therapy has failed the “do no harm” ideal you mentioned, somewhat ironically, in your rebuttal letter, I don’t see why the FDA should give in to public sentiment, since the public doesn’t know what I suspect the FDA knows—medical clinics are less than ideal places to be manufacturing stuff like SVF with manual methods, and those clinics certainly shouldn’t be using it.
Comella Question Twelve: “After the FDA hearing in September 2016 where scientists, physicians and patients spoke out in favor of these therapies, why has the FDA not responded?”
My Response: I have discussed with ex-FDA folks the procedure the FDA follows to deal with public input on draft guidances. They tell me that the FDA takes the testimony offered by the public, both at meetings and from submitted written comments, very seriously. In order to fulfill their obligation to the public they need to analyze the comments, assess the validity of the points being made, and figure out if or how the existing language in the draft guidances should be modified. Once changes, if any, are made to the drafts, the revised drafts need to be reviewed and signed off at multiple levels within the Agency. I have heard they were inundated with written comments and you heard for yourself the public testimony at the two-day hearing. So, give them a break, since they need to get it right the first time, in contrast to those with access to the Internet who are not affiliated with the Federal Government.
Glad I could help you out Ms. Comella, while you wait for the FDA to get around to answering your questions.
Now, I will go back through the Warning Letter to highlight the sins your clinic committed that don’t involve cGMP standards—the standards needed if you are making a drug. I am not saying the SVF you make in your clinic isn’t a drug, just that there are some disturbing examples the FDA cited that have nothing to do with the fact that your clinic falls well short of the quality framework needed when making a biologic drug.