As procedures prove save and efficacious and pass through the regulatory process, they will be FDA approved.
They are in the business of making money, full stop.
The rest of your comment is a rant (and a retread rant at that), to which no response is warranted.
Because if you smoke a joint, bong hit or what ever you prefer and you donât like it, get nauseous, or what ever, you just wait a while and it goes away.
No great liability. Back to the original application of âwell, if you think it helpsâŠâ.
You give someone the wrong medication and they could very well die in very short order with no recourse.
So thats a liability.
If you take a syring and shoot some magical pixie dust into someones eyeball and they go blind- Big fucking liability.
Have you looked very far into the medical liability laws of Panama or any of these other places that are administering these stem cells? I havenât, but just a guess that they arenât as stringent as in the US.
Like, what is the recourse if an MD in Panama does permanent and irreparable damage to somebody?
Have you even considered that?
Oh damn. That took less time than my kid running to the fridge-
Pertinent-
So yeah, thereâs that.
Many people outside this country, and the ones from this country, who go outside for help have already had some diseases reverse themselves.
This procedure or therapy is being stopped or slowed down considerably by Big Pharmaâs lackeys in the FDA. To quote Dr. Barth Green of Miami University âThe pharmaceutical companies all over the world are shaking in their boots.â Why? Because they know their time of having control over the healthcare system and making billions of dollars are coming to a close.
The difference here is that The Stem Cell Institute is not stopping a less expensive, more beneficial treatment from coming to the market so they could keep the spigot of profits running like Big Pharma. The way they tried to do with medicinal marijuana. Once the public becomes more familiar with stem cell therapy the same thing will happen. And I for one will be extremely happy when this happens to Big Pharma as their vice grip on the healthcare system will be coming to an end.
No I donât know the medical liability laws.
How many people are being helped vs. how many people are suffering? That is a legitimate question and it ought to be asked of the American healthcare system. Did you ever think of that? More people may be harmed because of this procedure not being legal in this country.
And how many people are being harmed by stem cells not being allowed to be administered in the U.S.?
As a side note Japan has the most friendly regulatory environment for regenerative therapyâs. This is why just about every stem cell company has a division located there.
Upon publication of the appropriate clinical trials demonstrating the safety and efficacy of a given stem-cell treatment (like limbal stem-cell transplantation), I will be happy to advocate for it right along with you.
And if medicinal marijuana is no big deal, as you imply, then why did Big Pharma fight it?
More info and published works from Medistem (An arm of The Stem Cell Institute)
Do you EVER get tired of repeating yourself and living in your echo chamber? At least try some new word choices. Or thinking. Thinking would be nice too. Problem with you is you canât accept the fact the world might be a bit more complicated than your 8-bit black and white picture of it. And you have no interest in actually learning anything.
Whatâs annoying is that you, me, and AG all have rather nuanced views on this subject that in a REAL conversation could criticize the FDAâs handling of any number of things as well as shed light on what we could do to improve the research-treatment pipeline efficiency. Except Zep wants to boil it down into either/or while citing biased, commercially vested sources and shoving his fingers in his ears.
The only truly interesting part of this thread has been the brief point where you, AG, and myself had an actual conversation going about problems with FDA and regulation.
Do I ever get tired of showing the emperor has no clothes? No. Problem with you is that you canât accept the fact that Big Pharmaâs primary objective is to increase profits at any cost. Even making the public suffer as long as they can cast some degree of plausible deniability. And they have lackeys in the FDA t help them. As they routinely have a revolving door between the two. An obvious conflict of interest. You have no interest in admitting what is right before your eyes. Why? To admit so is to admit your view of the world doesnât work and that is too painful for you.
Same thing, same words, ad-fucking-nauseum. If you had any damn brain cells at all you could hold a conversation. The three researchers here all hold much more nuanced views of this world than youâand that includes what we all disagree with the FDA. Problem is that you want everything black-and-white. Research is not all black-and-white, least of all new fields such as stem cells. Research, on the whole, is mostly gray, with small areas of black/white. Your failure to have any interest in a view not brainwashed by your predispositions prevents you from learning or growing. Iâd feel bad for you if you werenât so annoying.
Just because you work in the field does not make you immune to itâs brainwashing proclivity for profits above all else. Obviously. Like a lot of other industries. More evidence from way back in 08â http://www.marketwired.com/press-release/medistem-publishes-positive-preclinical-data-on-menstrual-derived-stem-cells-890937.htm
And the evidence keeps adding up. Cord blood in regenerative medicine: do we need immune suppression? | Journal of Translational Medicine | Full Text
Well what do you know. After this was being made fun of by a poster on this forum. http://onlinelibrary.wiley.com/doi/10.1111/j.1601-6343.2005.00331.x/full
Whatâs funny about this is you couldnât even be troubled to actually highlight a specific research publication here - you just copied a link to a PubMed search of the term âmedistemâ (which returns 20 results).
To the layperson: Impressive! There are published articles! Research! Science!
To the scientist: letâs take a look at these âstudiesâ and see what weâre working with.
The search for âMedistemâ returns 20 hits. A handful of them have literally nothing to do with stem-cell research (e.g. âA novel method of modifying immune responses by vaccination with lipiodol-siRNA mixturesâ). Another handful are not âoriginal researchâ studies but basically opinion pieces or proposals for ideas based on theoretical explanations (e.g. âTherapeutic use of Aldara in chronic myeloid leukemiaâ - if you actually click on that article, youâll notice that itâs not a study of results achieved with that therapy, but rather a proposition for âHey maybe we could try thisâ - the same is true of âStem cell therapy for autismâ and a few others). Several of these are case reports (i.e. âWe saw this interesting case, tried this thingy and hereâs what happenedâ) rather than outcomes research. One study was basically a âPhase 1â study (âFeasibility investigation of allogeneic endometrial regenerative cellsâ) where stem cells were given to 4 patients with multiple sclerosis and there were no reported adverse events in short-term treatment - this is the type of early-stage research that is used to justify performing a larger study.
Iâve stated several times in this thread that I have no specific axe to grind with stem cells, but I appreciate the necessity of following our present scientific process (Phase 1 trials for safety and dose-finding; Phase 2 trials for dose-finding and early-stage efficacy; Phase 3 trials for longer-term understanding of safety, adverse events, and clinical effectiveness) which you are either incapable of or unwilling to understand.
Cell therapy is not my area of expertise, but design and analysis of clinical trials is. I am happy to break down any studies on the subject. But most of what youâre posting has not advanced to the stage of clinical-outcomes research. There are a lot of studies that are basically âthis is how we grow stem cellsâ or âhereâs a population where stem cells might workâ and (from what youâve posted so far) little research demonstrating safety and efficacy of stem cell treatment. There are a few applications where it has proven effective; there are others where it was been insufficiently studied; and there are still others where it has been studied and, to date, has shown no benefit.
A few months ago, there was a Cochrane review that thoroughly reported on âStem cell therapy for chronic ischaemic heart disease and congestive heart failure.â
The Cochrane findings acknowledge that some of the results are promising but also criticize the studies for major methodological issues (such as a lack of blinding and/or randomization). Their conclusion is as follows:
âThis systematic review and meta-analysis found low-quality evidence that treatment with bone marrow-derived stem/progenitor cells reduces mortality and improves left ventricular ejection fraction over short- and long-term follow-up and may reduce the incidence of non-fatal myocardial infarction and improve New York Heart Association (NYHA) Functional Classification in people with chronic ischaemic heart disease and congestive heart failure. These findings should be interpreted with caution, as event rates were generally low, leading to a lack of precision.â
No, however it makes me infinitely more informed than you. Youâd probably be better off at least LISTENING (like, actually listening, not just pretending to listen) to people who work in research fields and what they are saying. Trying to actually understand positions is more trouble than just shoving your fingers in your ears and yelling though, so I understand why itâs not very attractive to you. It requires effort. So sad that youâre so lazy.
Your whole post is absolute gold, could not have possibly said it better myself. This part is absolutely key though.
Noâyouâll have to be much more specific if youâre going to say it was âmade fun ofâ in the first place, and in the second place did you even bloody read this thing? No, of course not.
And despite what you say it is already helping thousands of people. In fact people from this country have to leave to get help. But because of your inexorable and savant-like adherence to policies of the scientific community, you espouse rules that help people suffer. Bottom line. This treatment is not allowed in this country to protect markets for Big Pharma. Just like they fought medicinal marijuana. Why would they fight these two treatments? Because they are afraid people may choose other treatments which will net them less than their garbage drug sales.