It's almost like a bad Yakov Smirnoff joke, "In America you test therapies in animals before giving them to humans, in Russia..." All I can do is wonder, what were they thinking? Injecting stem cells into a kid's spinal fluid to correct a genetic disorder? Are they insane?
Stem cells, in particular embryonic and fetal stem cells, are useful because they represent cells that are less differentiated than the cells that are working at specific functions throughout your body. Another result of being stem cells is that they are able to divide and proliferate without differentiating or undergoing apoptosis and as cells differentiate towards their final fate they tend to divide less and ultimately commit cellular suicide if they are signaled to begin dividing again - a protection against cancerous growth. The downside of this is that stem cells act, in their normal state, a bit like cancerous cells. In fact one of the assays to demonstrate the pluripotency of a cell (the ability of a stem cell to make many kinds of other tissues) is to inject them into an animal where they will make tumors called teratomas which are (usually) benign growths of cells that represent endoderm, mesoderm, and ectoderm - the three germ layers than give rise to all tissues in the body during development.
As a scientist who works with stem cells, both in culture and in vivo I could have told you this therapy was a bad idea. A year ago Jake explained why this was a bad idea. If you had described this therapy to us, we would have told you exactly what would happen based on scientific knowledge of how these cells act in vivo. The therapies offered to stem cell tourists are frank quackery. They are unproven, untested, unstudied, and unmonitored. And to you anti-FDA libertarians out there, this is what you get when you don't have regulatory oversight of human therapies. You get stupid quackery. The fact that this kid's cancer was detected is probably just luck - there are likely many more people who have tried these therapies of desperation who suffered side effects, and possibly even death, but we just haven't heard about it yet.
Ethical human trials require many things. At the very least, the therapy should have been tested extensively for safety in animals and ideally for efficacy in animal models of the disease. The patients should be selected carefully, should have a reasonable expectation of therapeutic benefit, and after the treatment follow-up should be extensive. Further, in the case of such a novel therapy, the bar should have been set higher before attempts in humans were made. In this case we have a child with a rare genetic neurodegenerative disorder that was experimented on without proper oversight, or a reasonable expectation that this therapy should do anything. Ataxia Telangiectasia is an autosomal recessive disorder in which every cell in the child's body lacks the appropriate gene which is involved in cell cycle regulation and DNA repair. By what mechanism did they think neural stem cells would have an effect on such a disorder? Would the cells replace the child's entire central nervous system? Would they miraculously repair the genetic defect? Or manage to insert themselves in just the right places to fix symptoms caused by a universal defect in the the hosts genome? This is magical thinking, not scientific thinking, and further I believe it is grossly unethical and stupid.
It is of no surprise that the careless injection of fetal stem cells into a child would result in tumors. This was a mind-bogglingly stupid act. What's worse, as we hear more about the damaging quackery being offered in countries without proper regulation and oversight of human therapy we will likely hear more stories like this one.
In the rush to find some dramatic cure for a disease using stem cells it is likely efforts like these will damage the success of legitimate and careful studies in regenerative medicine and stem cell therapies. Injury and deaths from careless stupid quacks using these cells will create and association in people's minds between stem cell therapies and cancer. We know the obstacles to using these cells in humans. The major one - immune compatibility - may have been solved already. The major remaining obstacles towards implementation of some fairly crude stem cell therapies are going to be (1) differentiating the cells into the appropriate tissues, (2) purifying the cells so that undifferentiated cells aren't accidentally transplanted into humans, (3) preventing tumorous growth in the transplanted cells (possibly including a lethal gene to reverse the therapy if necessary), and (4) proper anatomic delivery of the cells so they perform a useful function and survive in the host. We know what the problems are. Careful study must include addressing each of these issues and ensuring they are resolved before shoving them into someone's spinal fluid.
This quackery is not only going to prove harmful to individual human patients, but will likely harm the burgeoning field of regenerative medicine as a whole. For the sake of the patients, and for all future patients that might benefit from well-studied therapies, this quackery must be stopped.
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It's obvious why these therapies failed: they did not include the proper numerological, astrological, or aromatherapy protocols. ;-)
I'm a total layman ... when I read about this procedure in Russia, I was stunned because even I know they were doing it wrong.
Stem cells can actually improve the quality of life of the patient, but it is not proven and certified to resolve the problem 100% is a bit hasty statement so they can think that the stem cells are going to solve any problem and is not asi.
As a longtime libertarian, I find a so-called "scientist's" mention of the FDA beyond laughable. You use ONE case of improper use of stem cells to "prove" that all stem cell therapies are quackery, yet you fail to mention your sacrosanct bought-and-paid-for FDA is responsible for thousands of deaths a year---or have you never heard of Vioxx and a dozen others? Have you also not heard of all the FDA scientists leaving because science doesnât count and politics does?
One case among ten thousand stem cell successes is "proof" enough to you? That is typical of American medical science: "Let them suffer and die by the millions, but don't break our sacred, useless rules!"
So you, âdoctor,â keep genuflecting to the FDA. May I suggest to others that they read some real science: Cook, D. M., Gurugubelli, R. K. and Bero, L. A. , 2008-04-03 "Risk Management Policy and FDA Black Box Warnings.
ââ¦A policy rooted in risk management seems to facilitate keeping drugs with questionable safety on the market. We suggest risk management policy favors corporate interests.â
Finally, here is the result of YOUR rules (from The Commonwealth Fundâs 2008 report):
: âThe U.S. now ranks last out of 19 (developed) countries on a measure of mortality amenable to medical care, falling from 15th (in 2006) as other countries raised the bar on performance.â
Keep up the good work, âdoctor.â
i totally agree with you don margolis. you did fail to mention that american drs just want patients to keep comming back for more useless treatment and drugs. its all about the money
the health care in this country is a joke.the drs are a joke. the fda is a joke. the drs in our country poo poo every time some other country makes another stride with stem cells. why. becouse they want us to believe the usa drs are the best in the world. well get your head out of the sand. your not the best any more. your being left in the dust by 3rd world countries. your way behind and you no it but you wont admit it. just look at how many people from the usa go to other countries for better health care.i no its between 500,000 and a million and growing fast.wake up you morons. by the way don i wish i had your email add.
Oh, yes. Take us back to the lazy, hazy days before the FDA. Cocaine in my sodas and heroin in my cough syrup. Tapeworm eggs sold as diet pills. Salmonella and other foodborne diseases killing hundreds every year, mostly the very young and the very old.
Yeah. Give me more of those days.
And I'm sorry, mark m, but the US does have the most advanced health care in the world. Unfortunately it has become very difficult to afford decent health care. There are a wide variety of reasons for this, but you probably aren't interested in all that nuance. Short form: Insurance companies.
Also, on either side of your keyboard is a cool key labeled 'Shift'. Capitalizing sentences, while it may appear to be elitist and arrogant, does make reading your comments much easier.
Thank you both for playing.
Don, your comment includes a great many logical oddities. For example, you refer (apparently) to Mr. Hoofnagle by putting his title in scare quotes. Are you saying that he is not actually a doctor? Have you any evidence that any of his degrees are fraudulent?
You do the same thing in referring to scientists. Are you saying some all scientists are not actually scientists, but are in fact non-scientists masquerading as scientists?
Should I refer to you as:
the so-called "Don Margolis"
After all, we don't really know that you actually are the real Don Margolis. You could be a fake Don Margolis. Do you have a birth certificate to demonstrate that you are in fact a genuine Don Margolis?
In case you haven't figured it out, this comment is a snark.
Mark---see donmargolis.com
LanceR: The CommonwealthFund has pages and pages of data and reasoning why the USA is at the very bottom of medical care in the developed world. Besides "We're #1" cheerleading, what data do you have to refute the work of dozens of scientists, doctors, and medical pros who worked for two years on this report?
Erasmussimo: You got me! But is a doctor who tells a patient "There is nothing I can do, so stay home and die rather than go somewhere else for a treatment I know nothing about," really a doctor? Is a scientist who quotes one non-death in 10,000 cases and then uses a corrupt FDA, responsible for tens of thousands of approved drug deaths, as the alternative, really a scientist?
I went to donmargolis.com and I read the article about that guy who got stem cell surgery to repair his spine ..etc, etc. But that patient and the other one mentioned in this blog are two different types.
It's like saying stem cells are a panacea .. but they are not. It just happens to work in one case and not the other. You gotta show us where it says that because it helped 1 thing that it will help another. This is the key that you are missing from your rants.
There is 1 thing I hate about what you do. Though you provide true events and true statements about the FDA, you too are falling into the same trap that you are accusing the FDA and others of doing!
Just because you give us 1 or 2 facts about the FDA failing us doesn't mean that everything the FDA has been doing is completely wrong.
Every institution has it's bad and good moments. True the FDA is losing credibility but so are you right now as people investigate your claims. Science and medicine is not at fault here.
Don, let's consider the problem of treatments that have not been verified. You're a doctor. A patient comes to you with a fatal ailment. You know of no treatment that has been scientifically demonstrated to help this patient. You know of several treatments for which claims have been made, but you also know that no scientific demonstration of the efficacy of these treatments have been made. Given these facts, what do you tell the patient? I would think that the only ethical course of action is to simply state the only fact of which you are certain: "I know of no treatment that has been scientifically shown to be of any value to you."
Now, there's the counterargument, "Why not try the weirdo treatment? I'm going to die anyway -- isn't a small chance of saving my life better than no chance of saving my life?" There are four flaws with this reasoning:
1. The treatment could actively shorten your life.
2. The treatment could interfere with those courses that would prolong your life.
3. The time expended on obtaining the treatment would be subtracted from what little time you have left.
4. The treatment rewards people who may well be charlatans.
Thus, the decision to proceed with the alternative treatment requires that the patient weight the likelihood of success against these four negative factors. Yet how is a patient to make an informed decision in these circumstances? No informed decision can be made, because the crucial information (the likelihood of success) does not exist.
In the past, doctors felt that the most ethical thing to do was to present a false front of certainty, telling patients that such treatments did not work. This is humane in the sense that a person facing imminent death is not fully rational, and uncertainty itself is painful. In effect, the doctor removed the uncertainty to help the patient. However, my understanding is that the medical profession is now shifting towards the position that the rationalism of the patient must be deferred to in all cases, and the best thing to do is to present the facts, not a false certitude. Perhaps the medical Mr. Hoofnagle can provide us with some information on this.
While I would understand the desire of some people to understand all the facts relating to their impending death, I can also understand that some people are not equipped to appreciate the subtleties and might not even want to know about them. Let's face it: death is the most intense personal experience, and the attitudes of people toward death range from the suicide bomber's to the narcissist's, from the cancer patient in pain to the child who is terrified and dependent upon adults who cannot help him. There are no simple answers here and I think we need to cut doctors some slack in responding to each case individually. "Cutting slack" is not the same thing as "giving license to"; there should be some means for dealing with egregious error on the part of doctors. But I suspect that you are too sure of yourself on a subject with very few certainties.
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thank you for your comments lance.sure there r a few things that u.s drs might be ahead but not much any more. and as far as your comments about my typing,capital letters and such.just for your info lance im a quadrapaligic and can barely use the one finger im using.so thank you for that.maybe u should take some of youe own advice lance....mark
hey don. cocaine in my soda and heroine in my cough syrup dosent sound half bad right about now. and doing something is better than doing nothing.drs. wont move on anything with potential in this country. except prescribe more drugs. more drugs and more kick backs for the dr.s. thats a known fact. the do nothing dr.s remind me of our do nothing congress. reminds me of thease investment professionals telling everybody to stay the course. right to the poor house..mark
Mark,
I apologize for my comment about the typing. I was unaware of your condition.
IMHO, whenever anyone says "that's a known fact", I know they are wrong. It's kind of like when someone says "To be honest...", I can be sure they are about to lie.
Doing something is better than doing nothing. Where to start? So drilling holes in your skull to relieve headaches is better than doing nothing while waiting for MRI results?
Put down the chip and learn how actual science works, 'mkay? kthxbai.
This is for Mark Hoofnagle... when you protest that all this "quackery must be stopped", who actually takes the first step to do this, how does one stop this and is it all falling on deaf ears?
Don:
I would never suggest all stem cell therapies are quackery. The longest use of stem cells is that of hematopoietic stem cells - in the form of bone marrow transplant - used for over 50 years. Stem cells can be used to treat human illnesses, this is a fact. The question is, can embryonic and fetal stem cells magically target a disease like a genetic defect and repair it? The answer is no. Based on the literature, not to mention even a passing familiarity with these cells, the only expected result of careless transfusion into an immunologically privileged space like the CNS would be teratoma formation. Defense of any procedure so stupid, so incredibly careless and ignorant, devoid of any scientific basis or safety testing, is a losing proposition.
As far as your comments about the FDA, you can't use its current troubles to argue against the usefulness of its existence. The FDA took control over drug regulation in this country at a time when one man said "if you took the pharmacopoeia of the US and dumped it in the ocean, it would be better for the man, worse for the fish". Almost all medicines were quack remedies - patent medications - that promised to cure everything from cancer to the flu, but lacked any quality control, testing, monitoring for safety, or proof of efficacy. When over a hundred children died because a flu remedy contained ethylene glycol, the public outcry became such that government had to step in and regulate. Their regulation was simple. If you advertised an indication you had to provide clinical proof of efficacy. Almost overnight, pharmaceutical science was born. Previously, the incentive was to advertise cures which were really just alcohol, narcotics, and other addictive substances that made people feel good but didn't do anything for the underlying disorder. Addition of drugs to the FDA's authority put the impetus on creating actual efficacious medications. Within decades the modern science of pharmacology came into existence, and all the life-saving modalities we have today are thanks to the fact the government basically said "no more fraud".
One basic rule is necessary before you can treat someone ethically. First, do no harm. This failed the first rule of medicine. There is no evidence of people dying by the millions because of the FDA. That is libertarian crankery. Provide some evidence. Further the rules are quite helpful, modern medical science owes almost everything in our arsenal to the simple requirement that fraud no longer be perpetrated as medical intervention.
Quite possible. Also read Marcia Angell, she's an interesting read too. However, these things argue for more regulation, or a different regulatory framework. Not the wild-west idiocy that would result without any regulatory agency to monitor the claims of companies that historically would defraud the consumer given the chance.
But it worked for Christopher Reeve on South Park - and he ate them!
lance....apology accepted..thank you.......now i the let me be honest with you crap too. like you mean you havent been and so on......thats a skeptical clintonspeak type of thing. butas far as what i said about and i quote thats a known fact, well i do my homework and if you dont believe what i said about dr.s getting kick backs from the drug companies go to www.freep.com which is the detroit free press go to page 2d artical is...drug firm accused of paying mds.....also google dr.kickback from drug companies ......by the way the artical in the free press just came out today.its a fact lance....have a good day
mark h.........so what your saying is our problems are a result of not having universal health coverage and access to primary care and thats why we rank in last place out of 19 developing countries.in mortality.shame on us. reaks a little like socialism to me.from what i no in can take up to a year to get a mri in canada.i do agree that we need a total over haul of the system. and if i had the power the first thing id do is stop the waste and overcharging. i mean come on a hospital charging 200 bucks for a bandade.that u can buy a box for at wall mart.i think its time for a major revolution. mark m
Things like Vioxx are why we desperately need the FDA. If pharmaceutical corporations demonstrate themselves to be heartless, souless profit-mongers, the appropriate solution is not to say "oh well, we tried," and then just let them do whatever they want. The appropriate solution is to increase oversight, since obviously they are getting away with violations.
In any case, the fact that big pharmaceutical corporations sometimes commit massive fraud does not excuse outright quackery. One group massively betraying the public does not mean it's okay for another group to do the same. This is what always baffles me about the "well, what about Vioxx!" people. They bring up Vioxx as a reason to stop regulating medicine, when regulation is the only thing that forced the Vioxx scandal into the light of day. Without the meager resources of the FDA, FTC, and other agencies, we'd be totally unprotected from corporate scam artists.
If anything, the Vioxx scandal (and the more recent peanut butter scandal) demonstrates the need for better funding of the FDA. It lacks the resources to properly carry out its mission, and so loopholes are being found and exploited by everyone from the quack peddlers of dubious supplements to the glitzy executives of "Big Pharma". Personally, I don't see why scandals like the Vioxx thing mean anybody of these companies should get a break.
But getting back to the original post....
It's no surprise to me that this is going on in Russia. Russia has long had a penchant for woo, conducting extensive experiments on dowsing, ESP, and so forth long after our own government had abandoned such things as absurd. Good science does happen there, but the academic climate seems to be different.
Hey mark m,
About your comment of things reaking "socialism" it's already all around you and you don't even know it. In fact America would fail .. badly if it didn't socialize certain things.
For example.. the poilice and fire department services. Those are socialized, there was a time in the states when they weren't and if you didn't pay money to a local private fire department service they will not rescue you or put out a fire on your house. Cruel right?
This whole socialism illusion was introduced during the regan days just to scare people with the whole soviet scare thing not to make health care for everyone.
For the record, I am not american or canadian, I did live in canada for 4 years only and left, and anytime I got sick for any reason at any time. I went to the local clinic (wherever I was) and I got treated by a doctor for free, and my prescription medication was discounted. I just get scared thinking what would happen if I got bronchitis or something in America and if I didn't have any health insurance from a private company that can reject your application if you are going to be a cost to them.
Remember.. the government is by the people for the people. Having global health care coverage is the people of the USA helping each other. Anytime any US citizen gets sick they can go to any hospital or clinic and get treated. No more having to pay out of your own pocket for medical treatment, just pay your taxes and the government (formed by the people for the people) will take care of you.
Unless you think this is too socialist.
george.....i did get a good laugh out of that,really. you say socialism is all around me and i dont even no it. that was really funny. i was born in a big city in the u.s.a....have you ever heard of well fare HELLOOOOOOOOOOO. your probley not aware that after we went to the moon that our space program went down hill and scraped almost everything.becouse of all the social programs and well fare sucked all the money.i think you dont know the difference between socialism,communism or capitalism.im a capitalist and thats why the u.s.a is the u.s.a. unlike european countries and japan or china,our automakers and so on arnt subsidized by the government. also in canada they tax the crap out of their citizens then send them a check every month to help raise their families. you didnt touch the mri issue i brought up george.and to say socialism was brought on by ronald reagan now that really was funny. its been around here alot longer than when he was in office. and by the way the republicans like reagan and john engler created a thing called work fare to get people off well fare..saying if you want well fare you must work x amount of hours a week.ill bet that really irks you. by the way george where r you from anyway. id guess england or france. or some where in europe.another thing we have thease white round rolls of paper we call paper towels. but in your country i believe they call them little white surrender flags..oh yea big government isnt the solution,big government is the problem. do you know who said that.it was rr.......i hope you learned somthing george..have a good evening....................mark m
good Effects
good infomation I agree with you
This "conversation" seems to have veered off course, but as co-founder of the Stem Cell Pioneers forum, I deal with people who are dying all the time. It is very sad because in many cases if stem cell therapy was readily available to them, I truly believe in many instances it may have saved their lives. I was fortunate to be able to get A-ASC outside the U.S. by a U.S. doctor. Otherwise, I would not be here writing this comment. We need to have the choice to select such treatment, especially when our own doctors have told us we are end stage. The Pioneer forum has many excellent physicians, researchers and PhD's as members and all of them disdain the scare tactics you use concerning the small child who received a strange concoction of who knows what cells in an experiment of the worst kind. There are thousands and thousands of people, however, that have had beneficial treatment with no medical side effects. The FDA has declared our own stem cells to be drugs. They will not allow doctors to enhance our own stem cells enough to make them clinically relevant. They want years of endless clinical trials for each and every application. If you are unlucky to have an "unpopular" disease, you can kiss hope goodbye for a long time in the U.S. Clinicals also tend to exclude the very ill who might most benefit from them. The exclusion criteria will eliminate a large group right off the bat. What about people like myself, who do not have the time to wait for all of this? There are close to 10,000 published articles already on A-ASC's. The FDA doesn't care if they don't regulate tobacco and it is a proven fact that it kills. Why such an interest in my own stem cells? They allow foods to be loaded with very questionable preservatives and additives which according to a recent article may contribute to almost 2 million preventable deaths each year. There is a physician founded group (ASCTA) www.safestemcells.org that has started a grassroots effort to legalize adult stem cell therapy here in the U.S. They have written strict physician and laboratory guidelines with the help of doctors and scientists. Fertility clinics manipulate cells. They have written their own guidelines. The FDA has gone along with this for years. I believe the FDA to be riddled with problems and only a shadow of the agency it was supposed to be. President Obama campaigned for change and transparency and I can think of no other regulatory agency in so dire a need of those as the FDA. The intertwining of large pharmaceutical companies and the FDA is not a healthy relationship. The FDA should not be allowed to decide whether people will live or die when it comes to having their own stem cells administered by competent U.S. doctors who adhere to the strict ASCTA guidelines. I also support embryonic stem cell research and therapeutic cloning. I do not think all diseases can benefit from stem cell treatment,but a person should be able to make the decision for treatment on his or her own. The FDA is literally pushing people to the point of desperation and these people, knowing they do not have the time to wait for years, will seek treatment outside the U.S. when they can. The U.S. loses economically as well as letting its own citizens take a chance that the clinic or doctor could well be bogus. The Stem Cell Pioneers forum (www.stemcellpioneers.com) tries to alert people to this, but not everyone reads our forum. ASCTA's guidelines would allow patients to be treated with ASCTA physician members who follow safe guidelines. It's a win-win situation in my opinion. I am glad that you do not have to walk in my shoes or in MarkM's, but if you did, even for one week, I don't think you would be so quick to post what you did. Shame on anyone for criticizing Mark's "etiquette". No, you didn't know he had a reason for typing as he did, but there was no reason to call him out on something so frivolous in the first place. There is no empathy from you for those of us that do have chronic disease and conditions. Please, don't add to that by trying to create fear out of one story that has been flying around cyberspace like a crazed whirlygig (whatever that is).
I agree with Stem Cell Pioneers. I do not believe that the FDA or anyone else has the right to regulate MY stem cells and label them as a DRUG. But I do believe that I have a right to choose the care needed for my condition. My body, my cells, my right.
@Stem Cell Pioneers - Can you confirm that neither the founders, the organization nor anyone else associated with stemcellpioneers.com has received any money or other compensation from the ICMS, Christopher Centeno or anyone else associated directly or indirectly with ICMS or Dr. Centeno?