I (Albert Salazar) attended the STEMSO conference on February 7th representing a patient’s point of view. The conference was for three days, however I was only able to attend that particular day which was a full day. Here is my synopsis on the conference that day. The number of people attending were mostly stem cell medical doctors, regulation lawyers, and a few researchers. I wrote some notes.
One particular lawyer without mentioning her name held to much faith on the FDA’s sensibility in changing their position, so knowing how unyielding and unreasonable the FDA’s position, I held a strong apposition to her position. This is why I thought having a patient's perspective is very important. If you culminate all the information from the speakers, you can only conclude that the FDA’s position is senseless and ridiculous, and at the end, you ultimately ask yourself "the elephant in room question," why pick on autologous stem cells??? I think we all know the answer to that. However, many speakers alluding to the fact that the FDA’s overnight editing to a regulation that states “…transplant, infusion to another human” to an overnight change of the word “another” to now the letter “a” which magically appears without warning to “…transplant, infusion to a human,” moved the FDA jurisdiction towards the autologous stem cell industry, and poof overnight, they increased their power. Here are some bullets below that were touched upon by various speakers mostly by Dr. Centeno, Ittleman Esq, Dr. Allan Wu, and Karl Nobert Esq:
1. Regulatory structure of the FDA is geared towards massively produced drugs and not for unique individualized SCT’s
2. FDA will require with the same identical processing of ASC’s that every various medical procedure has to be registered as a clinical trial
3. On premise 1 and 2 above, imposing drug regulations towards individualized medical treatments makes it unfeasible, unattractive, and unprofitable to the industry
4. Overnight, the FDA has converted medical doctors into the field of research which they are unfamiliar in every aspect
5. the one regulation deeming SCT as drug is defined as “minimal manipulation” – the major problem with that is that minimal manipulation threshold is ambiguous and poorly defined
6. if a medical procedure is defined as “homologous” it exempts the procedure from the minimal manipulation regulation – however, the FDA never responded to Centeno’s lawyers on a clear definition on homologous
7. FDA currently receives fees from pharmaceutical companies that influences their position
8. One lawyer said, when evidence was presented that Lasik procedures were successfully done overseas with proven efficacy, the FDA changed position – problem, there have been over 8000+ SCT’s done safely already overseas
I wrote all of these notes during the meeting. When the panel discussion took place, I decided to ask the question pointing out all of these bullets above, and corner the panel of lawyers with the ultimate question without sounding like a conspirator; ‘why pick on autologous stem cell treatments when thousands of more venturesome medical procedures have not been deemed as drug like fertility clinics, bone marrow transplants, etc?’ Unfortunately, the segment was over the time limit, and they took the microphone away. Oh well, maybe next time. I think that these conferences should have patient’s point of view and have one spokesperson allotted a segment. In conclusion, my personal opinion after all evidence presented, the FDA is protecting their power, and in the same time being influenced by pharma to protect their drug market. No doubt, the FDA is purposely stalling the progression of SCT’s, and I am sure that all speakers can conclude that SCT's will revolutionize medical practice. Sadly enough, Dr. Centeno and Dr. Wu have said that the U.S. is way behind compared to many foreign countries, and we may never catch up.
I want to thank Doug Hammond for inviting me, and also Barbara Hanson making it possible for me to go.
Sincerely,
Albert Salazar father of Lawrence Salazar (diagnosed with severe CP)
Please feel free to ask me any questions.
One particular lawyer without mentioning her name held to much faith on the FDA’s sensibility in changing their position, so knowing how unyielding and unreasonable the FDA’s position, I held a strong apposition to her position. This is why I thought having a patient's perspective is very important. If you culminate all the information from the speakers, you can only conclude that the FDA’s position is senseless and ridiculous, and at the end, you ultimately ask yourself "the elephant in room question," why pick on autologous stem cells??? I think we all know the answer to that. However, many speakers alluding to the fact that the FDA’s overnight editing to a regulation that states “…transplant, infusion to another human” to an overnight change of the word “another” to now the letter “a” which magically appears without warning to “…transplant, infusion to a human,” moved the FDA jurisdiction towards the autologous stem cell industry, and poof overnight, they increased their power. Here are some bullets below that were touched upon by various speakers mostly by Dr. Centeno, Ittleman Esq, Dr. Allan Wu, and Karl Nobert Esq:
1. Regulatory structure of the FDA is geared towards massively produced drugs and not for unique individualized SCT’s
2. FDA will require with the same identical processing of ASC’s that every various medical procedure has to be registered as a clinical trial
3. On premise 1 and 2 above, imposing drug regulations towards individualized medical treatments makes it unfeasible, unattractive, and unprofitable to the industry
4. Overnight, the FDA has converted medical doctors into the field of research which they are unfamiliar in every aspect
5. the one regulation deeming SCT as drug is defined as “minimal manipulation” – the major problem with that is that minimal manipulation threshold is ambiguous and poorly defined
6. if a medical procedure is defined as “homologous” it exempts the procedure from the minimal manipulation regulation – however, the FDA never responded to Centeno’s lawyers on a clear definition on homologous
7. FDA currently receives fees from pharmaceutical companies that influences their position
8. One lawyer said, when evidence was presented that Lasik procedures were successfully done overseas with proven efficacy, the FDA changed position – problem, there have been over 8000+ SCT’s done safely already overseas
I wrote all of these notes during the meeting. When the panel discussion took place, I decided to ask the question pointing out all of these bullets above, and corner the panel of lawyers with the ultimate question without sounding like a conspirator; ‘why pick on autologous stem cell treatments when thousands of more venturesome medical procedures have not been deemed as drug like fertility clinics, bone marrow transplants, etc?’ Unfortunately, the segment was over the time limit, and they took the microphone away. Oh well, maybe next time. I think that these conferences should have patient’s point of view and have one spokesperson allotted a segment. In conclusion, my personal opinion after all evidence presented, the FDA is protecting their power, and in the same time being influenced by pharma to protect their drug market. No doubt, the FDA is purposely stalling the progression of SCT’s, and I am sure that all speakers can conclude that SCT's will revolutionize medical practice. Sadly enough, Dr. Centeno and Dr. Wu have said that the U.S. is way behind compared to many foreign countries, and we may never catch up.
I want to thank Doug Hammond for inviting me, and also Barbara Hanson making it possible for me to go.
Sincerely,
Albert Salazar father of Lawrence Salazar (diagnosed with severe CP)
Please feel free to ask me any questions.