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Stem Cell Tourists Take Costa Rica Off the Agenda
An anonymous reader writes "Stem cell tourism is a booming and troubling industry, in which clinics in places like Mexico, China, and India offer rich tourists experimental stem-cell-based treatments, none of which have been approved by the FDA here in the US. (Check out some of these creepy sites that offer treatments for everything from autism to MS, and even the 'very common ailment called aging.') But in one positive development, Costa Rica just shut down its top stem cell clinic. Said the country's health minister, 'This isn't allowed in any serious country in the world.'"
In 1974, I released The Book Which Tells The Truth, which described my contact with the Elohim, the extra-terrestrials who created us scientifically in their laboratories, and who were mistaken for 'God' or 'gods' by our primitive ancestors, who were too ignorant to understand the truth. At the time, it was the public's enthusiasm for the 'UFO phenomenon' that made my books and the conferences I held around the world a success.
Nevertheless, when I explained that we would soon be able to do the same thing ourselves and live forever, thanks to cloning, many laughed. However, their laughter was tinged with the empty sound of those who have always been too shortsighted to see beyond their noses and foresee the fall of their own paradigms.
Which website will you pick to clone you? I think I'm going for the one that gave me some propaganda on a religion surrounding the Elohim. Sounds like they know what they're up to. Or maybe you've got advanced AIDS (one of the many treatable conditions which conveniently have no other cures) How does it work? Well, they just shoot you up with a bunch of stem cells. No, I'm serious:
Stem Cell Therapy, SCT, is a treatment that provides stem cells in the appropriate location to assist the body where it needs to heal and regenerate its existing cells.
Depending on the conditions, stem cells can be delivered through the blood stream or directly to the organ to treat. It isn’t understood yet how stem cell communicates with the body to determine and travel to sites of need but results have been observed showing stem cells located near the damage area and dividing there generating new differentiated healthy cells.
It's a process which many leading scientists suspect might be a miracle! And you know, if it doesn't work, you just didn't present the stem cells the right conditions and we just need you to pay for a trip back and more saline ... er therapy injections. Maybe you have a supressive person in your life who has been telling you that we are a scam and that's why the stem cell therapy didn't work? Anyone else reminded of Professor Farnsworth's trip to GeneWorks S.K.G. from Three Hundred Big Boys?
My work here is dung.
In other news, the health minister is no longer invited to any parties hosted by Costa Rica's total joke neighbours.
DRM: Terminator crops for your mind!
Human trials before approval on people who have the money to fund it... it might be incredibly dangerous and questionable ethically but these people who get these treatments pay themselves and take all the risks. Why not study them instead of stop them?
will always take advantage of the desperate. 60 Minutes did a piece on this same topic in April about a guy living in the US who scams people the same way, a real upstanding citizen. Kudos to Costa Rica for shutting their clinic down.
http://www.cbsnews.com/stories/2010/04/16/60minutes/main6402854.shtml
Did you ever wake up in the morning, with a Zombie Woof behind your eyes? -- FZ
How many of these various offshore stem-cell shops fall into the following categories?
1. Scientists/research MDs whose interpretation of risk/reward tradeoffs differs from that of the FDA. In this category I would put more or less orthodox researchers who are of the position that the risks of stem cell use(cancer, infection, immune responses, etc.) are either just not that serious compared to the potential benefits and/or are the individual's choice to make.
2. Sincere cranks. In this category would go the various flavors of nutter who have gone straight off the deep end in terms of actual research about what stem cells are capable of, and how to make them do it; but are fully sincere in their belief that stem cells are the magic bullet against autism or aging, or whatever they are selling them as.
3. Cynical hucksters: All the research seriousness of the above; but without the slightly wild-eyed sincerity. However, they know that lying to desperate sick people is both easy and lucrative.
Are there some charlatans out there? Of course. Are there also legitimate treatments that the U.S. FDA just doesn't recognize yet? Of course. Why is it a good thing to take away people's freedom to decide for themselves which is which? Experts are frequently wrong. If people have the money to pay for treatments -- even if some of us think they're bad ideas -- why do we have the right to tell them what they can do with their money? It's arrogant to make that decision for them.
This is not medicine. I'm a huge proponent of embryonic stem cell research - that is not what these places are. Even in the linked pages, they don't call themselves real medicine - more like 1950's utopian therapy centers, complete with watercolor art and messages of "the promise of eternal life." I've seen cryonics center websites that are far, far more ethical and honest about the product they provide. The second website even puts its own title in quotes ('"the clinic"') to avoid being as actionable about their claims.
These sites are all about offering dubiously vague claims about what folks are saying about stem cells, then offering even more dubious treatments while standing behind the mystique of being a persecuted 'forbidden' super-technique. That would be fine if they were specific about what they were attempting, and if they could point to legitimate and active partners they were involved with in order to advance the science - but they're just namedropping the science to get the flim-flam magic appeal.
There's an endless series of variants of this style of bullshit. Take a look at these sites for just the tip of the iceburg in terms of keeping an eye on it:
Science Based Medicine
The JREF Website ($1 million verifiable reward for any evidence of the paranormal.)
Ryan Fenton
Don't tell that to someone with Gastroparesis. The FDA being influenced by large drug companies (especially the manufacturer of Reglan, the approved drug in the US) won't approve the the drug that is used in EVERY other industrialized country to treat this condition, Domperidone. A big part of that reason is lobbing. And the side effects of reglan is just plan scary.
Admit-tingly, the FDA does it job in general. But it is also a poster child of political influences and represents why government intervention in health care can be bad.
While many of the current stem cell clinics overseas do fall into the snake oil category one should not cast out the baby with the bathwater. If one understands the following probable guidelines, then one may be able to navigate the field.
1) Non-autologous (non-self) stem cells are likely to be extremely problematic for therapeutic purposes because there have been a number of reports showing that the immune system will eliminate those cells over time (without immune system suppression). If you view them as "organ transplants" from other individuals which require drug protocols to suppress Natural Killer Cells and other arms of the immune system with significant probabilities of rejection then therapies which involve non-self embryonic stem cells or non-self iPSC cells might be useful. But they are never going to be a "good" solution. (This means that the debate over "embryonic stem cells" which blocked a significant amount of progress in stem cell research in the U.S. over 8 years was useless "noise".)
2) Autologous (self) stem cell therapies *are* useful. One already effectively uses them in cases of storing sperm, eggs, blood and skin for future use. There have been common uses for decades such as for blood storage before a major surgery, growing skin grafts for burn victims breast reconstruction surgery, etc. Common heart bypass operations are another example of transplanting tissue from one region of the body to another. There has been a "Holy Grail" search to obtain embryonic or totipotent stem cells over the last decade due to the press/hype that they can "grow into any tissue". While we have the knowledge to do this for some tissues we do not have it for many more. Indeed one doesn't need totipotent cells for most therapies. Partially differentiated stem cells which are very close to the target tissue types will work as well, perhaps even better, than totipotent undifferentiated cells.
3) While injecting stem cells into the blood and hoping that they end up in the right place and will do the right thing works in some cases (e.g. bone marrow transplants) it is *not* likely to work for most applications of stem cells. Each type of therapy where stem cells may be used is going to have to be a precise tissue specific (heart, brain, lung, hair follicle, joint, tendon, muscle, blood vessel, skin, etc.) therapeutic protocol. That is why one is likely to see dozens of companies with specific expertise and not "one size fits all" solutions. There isn't going to be a "magic bullet" -- therapies are largely going to have to replicate, typically through cell culture in a laboratory, many of the natural processes which occur during fetal development in order for therapies to be effective.
4) There are on the order of 2300+ clinical trials in stem cells going on around the world (according to the NIH clinical trials database). Some of them are likely to be useless. But some of them might be quite useful.
5) There are companies in the U.S. that are doing autologous stem cell therapies with a fair amount of success. Three that I'm aware of are VetStem, Regenexx and BioHeart.
6) There has not been a widespread understanding yet within the stem cell R&D and therapy communities that stem cells *do* age. Simply, stem cells accumulate mutations in their genetic code with age which will cause them to function less well if sourced from elderly individuals compared with young individuals. [Everyone should have cryopreserved pools of stem cells when they were 10-15 years old.] So a stem cell therapy that might work very well in a young individual (say 20-30) may not work as well (or at all) in an older individual (say 60-70). There are methods that may be used to address this problem (disclaimer: I am the author of a pending patent on one of these methods) but they have yet to be put into practice by *any* stem cell clinic to the best of my knowledge.
So one can "dis" current stem cell therapies as being snake oil, often with some basis for the feelings, but you should
There are real risks here. If you are talking something that is no risk then ok, more or less let people go to it provided they aren't misrepresenting it. However medical treatments carry risks. Even well tested, established ones carry risks. Wild, untested, nutball ones carry more risks and worse, unknown risks. With proper medicine the doctor can do two very important things:
1) Tell you what the risks are, so you can weigh them against the benefits. You can know what could happen and how likely it is to happen. You can then make an informed decision as to if it is worth it.
2) Monitor you for signs of the risks, and let you know what to look for. Many times the risks can be mitigated, so long as you are aware what to look for and deal with them.
As an example, when I was a kid I went on Acutane to treat my Acne. It is a heavy hitter medicine with rare, but serious side effects. Namely, it can shut your liver down. However, despite that, it is generally worth the risk. Reason is that the liver problems can be picked up early with a blood test, and medicine discontinued, treatment started, and you are generally fine. So while on it I had my blood taken every other week.
However, the reason they knew to do that was extensive testing and trials before it went on the market. They had a wealth of data that showed that this could result, and they had a remediation strategy ready. Still wasn't perfectly safe, but was pretty safe and I was aware of the risks. Had it been untested, well then maybe my liver would have just shut down and I'd have not known until I had frank symptoms, when it was far too late.
Medicine carries real risks at the best of times. You certainly don't want it done half-assed.
It's got stems cells, its what the body craves.
Libertarians are strongly anti-fraud. If there's one thing libaertarians agree on (fundamentalist or otherwise), it's the sanctity of the contract.
Community good, on the other hand, is often fraud itself. Politicians love to explain that even though this new law is bad for every individual person, it's good for "the people".
Altruism is a very silly thing indeed to base any system of government or economics on, but that's a different topic.
But then I don't know why I'm arguing with a post that looks like it was written by an 8 year old. I know your shift key works: it's not just for shouting! Start sentances with a capital letter and finish them with a period: it's for the community good.
Socialism: a lie told by totalitarians and believed by fools.
I have an excellent idea of how multistage clinical trials work, and why. I have family members who were strongly affected by well known drugs that failed to be safe in general practice.
The specific technique in question has worked in all the mammals it's been tried in. That doesn't mean you can just skip ahead to doing it in humans on large scale without trials, no. But it was having problems getting approval to get the trials started, in no small part because of the insane federal government stem cell regulations from the previous administration. T his was particularly offensive because it entirely uses the patient's own stem cells (you liposuction some body fat to extract the stem cells from), and had nothing to do with embryonic stem cells.
I wouldn't be complaining if it had been winding its way through approval. The FDA had threatened vets who were doing this and who had openly discussed doing a less rigorous Phase 0 study on themselves as human test subjects. Admittedly that's not nearly as rigorous as a fully rigorous Phase 0, but it will at least give you some bounds on serious side effects.
As an aside on the normal pharmaceutical testing protocol, there are cases where severe or uniformly fatal diseases exist and people will die anyways. It took a long time to get the FDA to approve shorter protocols and widening Phase III trials to allow a chance of saving some dying patients with the study phase drugs; some of the AIDS drugs were the catalytic agent for that change. There are some cases where even a worst case - the drug kills everyone who takes it - would not be necessarily a societal or individual moral disaster compared to the underlying diseases.
You should have enough risk mitigation from Phase 0 and Phase 1 that a wider Phase 2 in many acute or terminal conditions is entirely called for. A number of medical ethicists have commented that liability risks (someone will sue, even if their loved one would have died within a month anyways) and FDA inertia are holding back a number of treatments that fall into these categories.
Just to be clear - The joint repair stem cells aren't relevant to that question - joint injuries and damage are a quality of life not survival disease.
This is a matter of contract enforcement. These clinics are claiming things that are patently untrue. The only thing that injecting yourself with stem cells will give you is a teratoma, a particularly nasty form of cancer with hair and teeth inside it. Making false claims is not okay. Scamming people is not okay, nobody wants to be scammed, nobody wants to be lied to, and nobody wants hair and teeth growing out of their innards.
Joe Scammed does not want to be scammed, he wants a cure. These clinics are not selling cures, they are selling hairy, toothy cancer, labeled as a cure. Your argument is laughable. But at least it is novel. I don't think I've ever heard anyone seriously argue for the 'right' to be taken advantage of. Did anyone ask for that? Do YOU even want that?
- None can love freedom heartily, but good men; the rest love not freedom, but license. -- John Milton
I kid about ol' Rush... in reality, its nice to see a man that is so obsessed with the sanctity of marriage that he has successfully completed 3 of them, and is now starting on his 4th one!
I've abandoned my search for truth; now I'm just looking for some useful delusions.
Oh dude, you're not kidding about Reglan.
I was recently hospitalized for major surgery, and they put me on that drug when I went home to help "wake up" my bowels after all of the narcotics administered in the hospital.
I straight up lost my fucking mind, "fear and loathing" style. My living room was "bat country" for like three days, until we figured out (on our own, -- thanks google --) that the Reglan might causing it.
Scariest three days of my life, dude.
This is what happened with my little brother who has a related disease and had very nasty side effects from Reglan and is now on Domperidone. However, the background behind the issues with domperidone in the US are a bit more complicated than you describe. Domperidone was brought to the FDA as a lactation aid for nursing women. However, there were (and remain) serious concerns about the safety of that use (See for example URL:http://news.scotsman.com/childsaltpoisoningtrial/English-case-paves-way-for.2829892.jp). That matter has gotten domperidone tied up for approval for other things. So the real problem here is that the US system has trouble saying about a drug "This use is ok but this use is not." We have ways of doing that but they are slow and get tied up easily. So there are problems here but there's very little evidence that it has to do with lobbying. Indeed, note that Domperidone's primary manufacture is owned by Johnson & Johnson which is a very large company and which has lots of lobbyists. If this were just about lobbying, the would have won by now.