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Comment by loceng | Hacker News Reader

Citations would require the doctors that I have had multiple of both fat and bone marrow derived stem cell treatments from over the last 3 years including last month.

The FDA has considered your own stem cells as a medication to bring it under their control - honestly that claim alone is pretty disingenuous, stem cells and properties of your blood are your body's natural healing mechanisms; with these treatments they're not changing or manipulating the stem cells, which you could more reasonably argue should be classified as a medication.

Another claim big pharma is trying to use is that injecting bone marrow into joints shouldn't be allowed because it's non-homologous - meaning that bone marrow isn't naturally in the joints, so it shouldn't be allowed to be injected - the reason they want to prevent it is because injecting stem cells into joints will clear up the pain caused by osteoarthritis.

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So, no citations then? Just the say-so from the people selling you expensive treatments insurance won't cover?

https://www.nytimes.com/2019/05/13/health/stem-cells-fda.htm...

> There is almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets, which are regarded as low risk. While the Food and Drug Administration insists that it does have the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving companies a three-year grace period in which to describe their products or treatments so the agency can determine whether they meet the criteria of drugs that would require agency approval. So far, few companies have submitted any information.

> In the meantime, rogue clinics offering other kinds of procedures have flourished, accused of blinding people by injecting cells into their eyes, mixing stem cells with smallpox vaccine to treat cancer or causing severe infections by administering contaminated blood from umbilical cords into patients’ joints or spines. In some of the worst cases, patients had already been harmed before the agency took any action, and the patients took legal steps themselves, suing the clinics that injured them.

What's your point? Not having proper oversight is a different beast than big pharma trying to gain control.

I've spent nearly $100,000 over the last 3 years on stem cell treatments because they permanently heal injuries. I researched doctors and clinics first, felt them out along with their knowledge, and then have done plenty more than a single treatment with them because they proved to know what they were doing. Certainly that doesn't negate bad actors who will take advantage and don't have enough knowledge or proper protocol to maximize outcome, however once again, you shouldn't be so pessimistically dismissive nor confounding issues when trying to argue a point.

Who do you propose should do the oversight of stem cell treatments, if not the FDA?

One person's "proven" is an anecdote. Scientific clinical trials are how we actually demonstrate efficacy (versus the very real placebo effect), safety, etc. Plus, there's the bonus of actually proven procedures being easier to get insurance to cover, which should be appealing to someone who's shelled out six figures.

You're still confounding and not understanding what I'm saying.

Whatever organization has oversight of that doctors should have oversight - that doesn't negate the challenges of regulatory capture that is occurring.

That you're completely dismissing my own personal experience, that I'm willing to spend $100k of money I'd much rather spend elsewhere, shows just how dismissive you are. I didn't argue my own experience as part of the data that does exist relating to stem cell treatments either, like you're seeming to counter argue with.

You should probably dive into the existing research, and not depend on using whatever mainstream sources you've used to develop your narrative and arguments - seems you're falling into the narrative mainstream media wants you to follow.

> That you're completely dismissing my own personal experience, that I'm willing to spend $100k of money I'd much rather spend elsewhere, shows just how dismissive you are.

Look, people have "personal experience" that prayer cured their cancer, that essential oils fixed their bipolar disorder, that aliens anally probed them, etc.

Having invested large amounts of money can make one susceptible to sunk cost fallacies, too.

"I say it works" is worthless by itself. Sometimes, worse than worthless - actively harmful. The FDA approval process may not be perfect, but some sort of scientifically rigorous "does this work and is it safe?" is necessary.

I'm not arguing against proper research being done.

You realize that there are, and you can see, before and after imagery - whether ultrasound, x-ray, or MRI - that is used to see the physical trauma of the area being treated, treating it, and then seeing the healing that's occurred with imagery afterward, right? I'm guessing your limited sources don't actually share that information with you based on your lack of investigating any of this while being so dismissive, and counter arguing points I've not been making.

What I was warning of is regulatory capture that I've learned about directly from the legitimate doctors (not all are I'm sure) that are at the forefront of regenerative medicine, some who have been doing research on using stem cell for 18+ years now already.

I understand your skepticism - maybe dive in deeper into different sources and have just a little bit of curiosity as to the legitimacy of what I'm saying.

Lots of aggressive statements about me having "limited sources" and "dive in deeper into different sources" and... no sources.

I asked you for sources at the very top of this thread. Instead I got a bunch of defensiveness, which is itself illuminating.

Surely this sort of imagery you're talking about is available somewhere, with clear examples from both the experimental group and the control group, demonstrating better results in the experimental? These clinics should present that to the FDA, get the procedures approved, and rake in enormous amounts of cash from health insurance from their arthritis cures.

While I'm expecting it will turn out to be bunk, I'm glad you currently have the right to spend your own money on what you want. I'm sure that will soon go away though.

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