"Remember way back when "second generation rexlemestrocel-L in late stage development for the treatment of chronic low back pain (CLBP)" was actually meant to repair the Degenerative Disc Disease (DDD) itself, not just treat the pain...."
FDA wanted it treated as an implant. All the more reprehensible considering the safety profile of MPCs and in light of patients saying devices such as spinal cord stimulators were being forced onto them. Even those who had them willingly (What on earth was the rationale for the pain relief anyway? It's literally insane - the pain is there for a reason), were assured they were
safe and effective. It's been reported in the MSM that spinal cord stimulators are the devices responsible for the most complaints to the FDA.
SI explained simply at the last AGM that the disc was too broken down to repair in many cases. That's because they enrolled a significant number of late-stage patients, reflective of those in the REAL world. All rexlemestrocel-L had to do was show it wasn't worse than steroids, which it did. It was a trial in pain and the product should have been assessed as an analgesic.
I no longer see pharma as inherently bad. They have some good and safe drugs I've used myself (had them prescribed off-label) and I have a somewhat different view of the opioid floggers. I'm grateful to my rheumatologist for prescribing opioid pain relief. He didn't care it was a Saturday. He wasn't going to let me spend another night like that. He was going to stay on the line until it was organised. I've mentioned before in the US, even rheumatologists' rooms had been raided.
I didn't want to take Methotrexate, so I researched and asked my GP to prescribe another drug, which has worked well for me. I've been able to come off it using a diet to target the microbiome. This same drug was tried by a young man who was a colleague of a close friend. He had back pain from a sporting injury. He was having anti-TNF IV therapy used in IBD, which was doing nothing. He was in agony. I mentioned via my friend that he should get the book and take it to his doctor and discuss it, refer the doctor to the clinical trials.
My friend told him about the book but I guess he was so desperate he went straight to his doctor and asked for a prescription for the drug (which has a very good safety profile) and his doctor prescribed it somewhat reluctantly. The young man ended up taking a double dose and spent the weekend in agony (Herxheimer effect). He came in Monday and he was delighted. The pain had completely gone, which was my experience (although I took the correct dose). It's a long-term therapy, however, but he only took it for FIVE days! The pain came back. He didn't go back on the drug, agony was as before and he stopped coming to work. His family came to his workplace looking for him but were told he hadn't been there for weeks. They were very upset.
The terrible suffering of human beings doesn't mean anything to a group of literal psychopaths (reflected in the hubris and ideology, which have led to so much abuse) who have been in control of the pharmaceutical industry. They do care about profits, however, which are threatened by the emergence of biosimilars and the growing distrust and competition from cheap off-label drugs (Top UK oncologist Angus Dalgleish recently mentioned one) and it's a reflection of just how bad the state of affairs is in IBD and GvHD if FMT is becoming popular among patients and physicians.
Patients KNOW stem cells work for CBP and those who can afford it are going private and reporting on their experience. No one buys the "placebo effect" when literal agony is stopped in its tracks or the "psychosocial aspect" mumbo jumbo
@DocMcstuffins has come out with. Medical gaslighting has really come into its own these past three years!
The delay over the next trial has been infuriating. One thing, though, with pain as the PE, it could be stopped early for overwhelming efficacy because patients do report immediate relief from pain.
ALL IMO GLTH
(20min delay)