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A difficult decision

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I am considering a choice for medical treatment. This is a self-driven choice; there is no one who can serve as a guide. I have written about this before, but will restate the basic facts here.

The ailment: I have degenerative joint disease and degenerative disc disease, in many joints and many intervertebral discs.

There is a novel type of treatment in existence called orthobiologics, which involves the use of the body's endogenous healing agents to treat orthopedic disorders. As they are currently considered "investigational," the procedures are cash-based. While some variants of this treatment are available in the United States, the FDA regulates the best kind of treatment, culture expanded mesenchymal stem cells, as a "drug," so there is currently no form of it that is legal here. But apparently, that doesn't stop some outfits from providing it.

Outfit "A"  is considered the world's foremost authority on orthobiologics. Though they are controversial, in my opinion, they are very conscientious about what they do, and go to great lengths to ensure the best possible outcomes and protect their reputation. In addition to their US operations, where they offer the legal kind of treatments, they operate a clinic in an offshore haven that permits them to sell their culture expanded stem cell procedure. Their process is very refined. Using precise image guidance, they deliver a small, concentrated volume of injectate to the exact locus of tissue damage in a joint, the rationale for which is that the cells adhere to the surface and to which they are injected. This is technically demanding and requires great skill, and all of their physicians are musculoskeletal experts.

But is impractical for me to get extensive treatment at this offshore facility for two reasons: 1) they use bone marrow as their cell source, which is limited in the number of stem cells that it can yield, and 2) it is extremely expensive. 

Outfit "B" operates in the United States and does culture expansion illegally. The FDA does not have the resources to go after everybody in the field who is breaking the law, so they have been able to get away with it, so far. They use fat as their cell source, which capable of yielding more cells than bone marrow, and are MUCH cheaper than outfit A, allowing me to treat a large number of joints at a relatively low cost. So in one sense, they overcome the limitations of outfit A's offshore facility.

The problem is that they have no reputation good or bad, and I know nothing of their skill level. In my estimation, they are significantly less conscientious and refined than outfit A. In contrast to outfit A's super-precise method, they simply ensure that the needle is inside the joint capsule and splash the fluid containing cells in. The fluid sloshes around in the joint, and while presumably some of the cells contact the aspect of the joint surface that needs them, other cells may not. Their doctors are not musculoskeletal experts, but treat many conditions, and call in a guy with a background in emergency medicine to do joint injections.

I don't know how much these technical differences influence the outcome; I only know that outfit B is much less particular about how they do things. 

In my conversation with outfit B, they disclosed that they use a fluid volume of 5 mL to inject a disc. This is about 5x higher than what outfit A uses, and the doctors at outfit A have told me that it is actually impossible to inject a disc with 5 mL of anything. There are only a few studies on intradiscal injection of orthobiologics,  and all of them use small fluid volumes (1-2cc). Someone doesn't know what they're talking about, and I trust outfit A's judgment. It is probably impossible to do much harm by injecting a synovial joint like a knee with more fluid than necessary, but intradiscal procedures are much riskier, as discs don't like to be injected with anything. The complications of an incompetently handled intradiscal procedure could be catastrophic. 

For this reason, I've already decided that I will not let outfit B inject my discs. But I might let them inject my synovial joints (knees, hips, fingers, etc.) because there is little potential for harm. The main risk is that it won't work, and I'll waste a significant amount, though not devastating amount of money.  

I am concerned about the implications of the fact that outfit B operates illegally. While I strongly believe that they have the right to sell this treatment, the fact that they risk losing their licenses, incurring huge fines, and possibly even imprisonment, concerns me. The likelihood of these things happening seems to be low—the FDA warns you before prosecuting you, giving you an opportunity to avoid prosecution, so there may in fact be no risk. But if there is a risk, and they are reckless and short-term with their own well-being, how can they be conscientious and long-term with mine?

I asked the doctor orchestrating the operation at outfit B a question that I won't state here, because I don't want to give information that could identify them. It was a question about the regulatory status of the procedure and the risk of the FDA shutting them down after I invest in the tissue harvest and cell expansion, but before reinjection. The man lied to me outright about something I already knew the answer to. There was a change in the tone of his voice when he did so, because he knew I knew he was lying. I can understand that I was asking him to admit to a crime on the phone, so maybe it was a stupid question, but it was still a question pertinent to my well-being, and he lied to me about it.

While it is exciting that outfit B could provide inexpensive culture-expanded cell therapy in the US, there is clearly a trade-off in terms of my confidence in them. I would be trusting the same mind that want to put 5 mL of fluid into a disc with my other joints, and all of the details of cell processing and handling.  

If I don't use outfit B for culture expanded stem cells, I will use outfit A for platelet rich plasma therapy, which is one of the forms orthobiologics that is legally available in the US. While not as powerful as culture-expanded stem cells, it is cheap and practical, and works (confirmed by both academic studies and personal experience). 

I would like to solicit opinions from objectivist life expert on the implications of the facts presented here:

1) outfit B is less conscientious than outfit A.

2) outfit B is operating illegally.

3) the proprietor of outfit B lied to me about the legal risk of proceeding.

4) outfit B claims to use and injectate volume that is impossible according to other sources, to inject high-risk structures.

Thank you for reading.

Edited by happiness
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