Stem Cell Tourist Dies From Treatment In Thailand 451
An anonymous reader writes "Last week, news that Costa Rica was shutting down a large stem cell clinic sparked a debate here on Slashdot about whether patients should be allowed to take the risks that come with untested treatments. Now comes news of what can happen when patients go looking for a shortcut. A patient suffering from an autoimmune disease that was destroying her kidneys went to a Bangkok clinic, where doctors injected her own adult stem cells into her kidneys. Now she's dead, and a postmortem revealed that the sites of injection had weird growths — 'tangled mixtures of blood vessels and bone marrow cells.' Researchers say the treatment almost certainly killed her."
Re:This will be interesting.... (Score:4, Informative)
As long as an individual is adequately informed of the risks that individual has a right to take that risk. The Geneva convention is about the state using humans as test subjects. That is a whole different can of worms.
Re:What is needed is 2 levels of FDA (Score:5, Informative)
This system already exist. Perhaps you should read up on Phase I clinical trials.
Re:What is needed is 2 levels of FDA (Score:5, Informative)
First, you have FDA-approved drugs, treatments, and devices. Then, you have clinical trials of drugs, treatments, and devices hoping to join the first category; but not yet there.
This latter category recruits trial subjects from either the public at large(for the safety/tolerability portion of the studies) or from the patient pool for whatever the condition is(for the efficacy portion). This means that, in practice, a fair number of patients(weighted toward those for whom the FDA-approved stuff isn't cutting it) are taking experimental, unapproved, therapies, with effort being made to minimize the danger; but with the recognition that this isn't without its risks. Now, it is true that not everyone who wants to can necessarily get into a given trial. Some are just size-limited. In other cases, the group running the trial might be cherry-picking patients to try to get the results they want(ie. if you drug kills a bunch of people, or fails to cure, your odds of FDA approval go down. This creates an incentive to keep the hopeless cases away.)
There is also the intermediate category of off-label use. Once something is FDA-approved, doctors are not required to use it only for whatever it was originally approved for(the manufacturer can't market it for any unapproved use; but doctors are free to prescribe it for pretty much whatever they deem suitable, subject only to the risk of this being declared "malpractice").
Re:The risks aren't bad for some of us. (Score:3, Informative)
but somebody in end-stage kidney failure would likely choose some risky options, maybe even unscientific ones.
I actually left the tech industry in 2001 to work with kidney failure patients. Kidney failure is not the end of one's life. You can live plenty of decades with no kidney function. It is certainly a drastic change to go from someone with no medical issues to low kidney function, but it is quite manageable.
To go to the lengths of flying across the world for an experimental treatment that doesn't even do the treatment right (just jam stem cells into some body part? that sounds fishy to me) seems silly. If she's got the money to do this, why not just get a regular old-fashioned kidney transplant from one of these poorer countries? That procedure has at least 50 years of research behind it to be somewhat successful (with the caveat that any kidney treatment including transplants is just that, a treatment, not a cure).
Re:Aim for the real problem. (Score:1, Informative)
Bumrungrad [wikipedia.org] is actually internationally accredited and quite famous, not dodgy.
Re:What is needed is 2 levels of FDA (Score:3, Informative)
This system already exist. Perhaps you should read up on Phase I clinical trials.
Pharmaceutical companies test a lot of drugs in Europe or India/Asia before they ever get close to America's shores.
There are drugs that have been legal in Europe for years before the FDA even allowed trials.
Re:The risks aren't bad for some of us. (Score:2, Informative)
I'm sorry about your situation.
I'm going to do something a little distasteful, which is to bring political ideology into a thread where a man talks about his grim situation. But in your case, it is a matter of life and death, and it is for many people every year. It's not so often that we hear from them first hand.
You always hear politicans talk about shrinking the government in vague ways. If you listen long enough, you start to hear from libertarians that say _crazy_ sounding stuff.
One such occasion was when I started reading Milton Friedman, who is very middle of the road between "now" and the "utopian anarchy" of someone like Murray Rothbard.
Anyway, Milton Friedman (and a bunch of other people) says that the FDA should be abolished.
As I read I thought, "sure, it's not constitutionally authorized, and sure, it's more than is strictly required to run the country, but really, we'd be better off without it?"
And then I continued to read, and he made the case very eloquently: all of the testing that the FDA currently does could and would be done by non-governmental entities, or even perhaps government entities. There is certainly a useful function being done there.
But where the FDA does damage is what is affecting the OP. There are people out there, whom after consulting with their doctors, are ready to try a new and experimental treatment. They've considered the risks and they've decided to go for it.
And the FDA says, in effect, "NO. We don't trust you and your doctor to make decisiosn for yourself, and we would honestly rather that you died -- for sure, all the way -- than chance you _maybe_ getting better or _maybe_ getting sicker".
And so you have the weird outcome that the FDA is responsible for the deaths of many Americans every year -- people who are unwilling to break the law in this country [and unwilling or unable to get treatment elsewhere] die every year because the FDA doesn't allow them to try and live.
The insidious evil of government power is that there is always a downside. Government's only tool is coercion. In this case, an agency meant to protect Americans gives some of them a death sentence. Every year.
It's easy to say "oh sure, but they help more than they kill".
It's very easy to say if you aren't one of the ones getting killed.
The FDA shouldn't be able to ban medicines or procedures. It is killing Americans.
Re:Aim for the real problem. (Score:5, Informative)
New ASC therapies are in trials using manipulation techniques learned from ESC research, but simply nothing can match the pluripotency of ESCs. Induced Pluripotent Stem Cells (ipSCs) are fine for research but due to the induction methods and production efficiency issues are wholly unsuitable for therapies.
The "market for dead babies" line is just so much inflammatory ignorant bullshit. The lines are generated from surplus material which would otherwise be discarded.
Yes, you are flat out wrong.
Re:What is needed is 2 levels of FDA (Score:5, Informative)
She tried some wild crap in Thailand. Not exactly a place known for it's cutting edge science. There are a number of countries doing a lot of really good biology work. Thailand isn't one of them.
Meanwhile, back in the States, where the NIH spends $28+ Billion a year on research, on clinialtrials.gov [clinicaltrials.gov] you can look up her condition, lupus nephritis, and see that there are *19* different clinical trials recruiting patients right now for that disease.
She died of freedom of choice alright. Just not a very good choice.
Re:This will be interesting.... (Score:3, Informative)
Noted, thank you. I'll make sure to pay closer attention to the wording, as I'm only marginally familiar with the convention. Though I wouldn't be surprised if the doctors were somehow connected to the state.
For future reference, whenever somebody tells you that "the Geneva Convention says you can/can't do X", that should immediately set off your bullshit detector. The conventions have become a kind of layperson shorthand for "international regulations", so everybody and their dog has some pretty weird notions about what they cover. People see these references to the GCs, assume the person making the reference knows better than they do, and the cycle continues.
The Geneva Conventions cover the treatment, in wartime, of prisoners, wounded, civilians and medics. That is literally all there is to them.
Now, back on to the topic at hand, medical tourism is one of those intractable problems that nobody wants to admit can't be fixed, irrespective of whether they ought to be. The US cannot control where its citizens travel, or what they do in other countries - look for example at the number of American tourists in Cuba, most of whom stopped over somewhere else en route to circumvent the restrictions on traveling there. Actually, this isn't specific to the US; no first world democracy can effectively regulate the actions of their citizens going abroad.
Thus, the only party in this whole affair who have any say in what Americans visiting Thailand can and cannot do is the Thai government. Meaning the only way Americans will stop going to Thai hospitals for dodgy untried treatments is if said hospitals are no longer allowed to offer them (either due to Thailand adopting USFDA style regulations, or by it prosecuting the purveyors of said treatments under existing laws).
Re:Aim for the real problem. (Score:4, Informative)
In fact, whole new retinas are being created from ESCs [ocmetro.com], something impossible with ASCs. This isn't pie-in-the-sky. Regenerative medicine is real. i am very literally betting my life on it and I wish the ignorant and morally-hollow would get out of my way.
Re:Aim for the real problem. (Score:5, Informative)
You have a moral issue with embryonic stem cell research because you have not clue what it entails.
Embryonic Stem Cell Basics [nih.gov]
"Most embryonic stem cells are derived from embryos that develop from eggs that have been fertilized in vitro--in an in vitro fertilization clinic--and then donated for research purposes with informed consent of the donors. They are not derived from eggs fertilized in a woman's body. The embryos from which human embryonic stem cells are derived are typically four or five days old and are a hollow microscopic ball of cells called the blastocyst."
A blastocyst [wikipedia.org] is the embryonic clump of cells, approximately 70 to 100 cells, that would have the potential to turn into a baby if it were in a womb. As noted in the basics these blastocysts are not in a womb, they will never develop a placenta or form into a human.
Using political power and social pressure to hold back embryonic stem cell research does not mean it has no potential uses, it means there has been limited research, that's all.
I'm glad you admitted that you do not understand because that truly is the root of the entire debate.
Embryonic Stem Cell Basics [nih.gov]
- Embryonic stem cells can become all cell types of the body because they are pluripotent. Adult stem cells are thought to be limited to differentiating into different cell types of their tissue of origin.
- Embryonic stem cells can be grown relatively easily in culture. Adult stem cells are rare in mature tissues, so isolating these cells from an adult tissue is challenging, and methods to expand their numbers in cell culture have not yet been worked out. This is an important distinction, as large numbers of cells are needed for stem cell replacement therapies.
In conclusion, there is no sane reason to be morally opposed to embryonic stem cell research due to a need for dead babies as no babies ever die for embryonic stem cell research.
Or perhaps you believe that virtually every man and woman on the planet are baby killers because they do not ensure that every single spermatozoa [wikipedia.org] and ovam [wikipedia.org] is given a chance to become a baby.
Perhaps you think that manufacturers of sanitary napkins [wikipedia.org] and condoms [wikipedia.org] are the enablers of baby killing.
You do see how irrational one can be when the probability of cells becoming a human becomes the basis for a moral standard, don't you? If you ever experience a nocturnal emission [wikipedia.org] or go through a menstrual cycle [wikipedia.org] without producing offspring then you are the same type of baby killer as the embryonic stem cell researchers. Obviously you did not kill any babies and neither did the researchers.
Re:What is needed is 2 levels of FDA (Score:3, Informative)
Desperate people do desperate things. I have known a few in my condition resort to stem cell quacks and a couple have died from it. I am a big believer in stem cells, but only done the right way.
Re:FUD (Score:2, Informative)
Yeah, I guess you are right. The first anonymous coward claims to be a doc, then said 'unusual tumors localized to the kidneys don't kill people'.
A doc would/should know, you don't know what genetically altered cells might be up to, or what their effects might be.
He'd also (should) know that sometimes folks do seemingly die of localized tumors.
http://www.ncbi.nlm.nih.gov/pubmed/17592276 [nih.gov]
"Among the 33 patients who died from seemingly localized RCC (localized renal cell carcinoma )..."
Oh, BTW. I'm a medical researcher. I just didn't think it was necessary to state that in my previous post, because the lack of evidence in the grandparents post was so obvious, I thought you regular folks would get that.
Re:"almodlst certainly killed her"... (Score:2, Informative)
Heliocentrism is just a theory. So is plate tectonics. So is the idea that microorganisms cause illness.
Re:Aim for the real problem. (Score:2, Informative)
I do oppose embryonic stem cell research, because it creates a demand for dead babies, which I have a huge moral problem with.
You do realize that there's already a glut of "dead babies," don't you? Every time a couple goes to an in vitro clinic, approximately many (~10) eggs are fertilized. They are then frozen until implantation. When the couple is ready for pregnancy, a subset (~3) of these eggs are chosen for implantation. The others remain frozen. The reason why multiples zygotes are created is due to the high rate of failure. After the couple conceives and gives birth, the extra zygotes remain frozen until the couple says they no longer need them, or the clinic loses contact with couple for a specified amount of time. At that point, the "babies" are incinerated as medical waste.
The problem of creating a "demand for 'dead babies,'" but rather it's an affirmative choice to deny treatment and medical research to those that need it. Believing that somehow denying treatment is saving "babies" is simply wrong. They're frozen. They aren't alive, and at no point will ever be implanted. It's simply using them to potentially save a life, or consigning them to the dumpster.
The "pro-life" position you've chosen, means your choosing death for the born, and death to unborn.
Sad but true.
Re:This will be interesting.... (Score:3, Informative)
It has nothing to do with experimental.
When a drug is prescription, it costs a lot more. It's just a rule in the drug market.
Drug companies fight HARD to make sure that while the drug is patented (first 7 years) that it is prescription so they can sell it for a higher price while they have a monopoly on the product.
When the 7 years is running out and generics are about to come out, they fight HARD to make sure it is over-the-counter, because they have a better chance of beating out generics when they don't have informed pharmacists and doctors notifying patients that the generic is identical and cheaper.
It's all about the Benjamins.
Re:Convincingly stated. (Score:3, Informative)
*cough* *cough* [wikipedia.org]:
Re:Aim for the real problem. (Score:4, Informative)
None of this would be happening if working with stem cells and bioengineering proper was legalized at large.
I hate to break it to you, but stem cell research is alive and well in the US, and has never ever been made illegal.
What did happen was public funding of embryonic stem cell research was stopped. This is an ethics decision, based on that administration's political values. Funding for non-embryonic stem cell research was actually significantly increased by the same administration that halted funding for embryonic stem cell research. If your still not getting it, it was the Bush administration. It was the same administration responsible for the most significant increase in funding for the sciences in the last 20+ years. Anti-science indeed!
A few truths about the state of stem cell research:
1.)Scientists think adult stem cells are limited to reproducing the tissues they originated from, whereas they know embryonic stem cells are not. Obviously this is not the case, since these adult stem cells produced many different types of tissues in the patient's kidneys
2.)Adult stem cells are much more difficult to culture than embryonic stem cells. Large numbers of cells are needed for stem cell therapy, so this is definitely an issue.
3.)Embryonic stem cells are much more likely to be rejected by the host than adult stem cells. In other words, even though they are easier to reproduce, they work less reliably.
Quit listening to anti-religion bullshit and open your own damn eyes and ears. Most of what you hear is total bigotry against religions, as though believing one thing makes you incapable of understanding anything. The fact is, anybody who does not follow a standard religion has a "religion replacement" that they follow just as fervently and dogmatically. Atheists are the epitome of this, and are really some of the most dogmatic people you'll ever come across (some of them right up there with street-corner evangelists). I generally prefer agnostics, as they tend to have a more open and reasonable outlook on things.