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Stem Cells: Save the Hope and Lose the Hype

Fellows Forum
R. Alta Charo is a UW–Madison professor of law and longtime student of the regulation and ethics of biotechnology.
R. Alta Charo is a UW–Madison professor of law and longtime student of the regulation and ethics of biotechnology.

There are a number of horrible diseases that we face in our lives and in the lives of our friends. And with the diagnosis of these diseases comes a realization that we don’t have a cure for everything. Even when there is the promise of a cure for any one disease, there is often frustration expressed at the time it takes to develop that cure—at least in the United States, Europe, Australia, and other developed countries.

There is a widespread perception that development of cures is lagging because researchers, or the U.S. Food and Drug Administration, are overly cautious about assuring their effectiveness and safety. But there can be severe consequences for not proceeding with caution. Some people may remember the 1970s, when desperate patients sought Laetrile, a fad cure for cancer. Steve McQueen was probably the most celebrated person to die from forgoing the standard therapies at the time, and, instead, pursuing the apricot pit-derived remedy from Mexico called Laetrile.

The quest for a miracle cure is an old story, but it’s one that we’re again hearing today. But this time it’s stem cell therapy, a therapy that suffers from tremendous hype. 

It began when, in an effort to counter the political forces lined up against stem cells—embryonic, adult, et cetera—stem cell researchers, medical doctors, and bioethicists like me talked to a lot of patients, politicians, and journalists about the cells’ phenomenal potential for human cures. It seemed the only way to protect this field of research during years of attacks aimed at defunding all stem cell work. 

But, in pressing that “phenomenal potential” story upon journalists, politicians, and the general population, we created a monster. We’ve created an atmosphere of finality around stem cell research where much of the public thinks that it’s a done deal, that it’s ready for prime time: they can get a cure now; it’s the magic bullet for each and every disease out there. And unethical clinics are taking advantage of this public perception by selling phony cures—even though most stem cell work is still in the research phase.

And it is getting harder and harder for the public to distinguish between what is real and what is fake when we talk about stem cell therapies.

Part of this is because, interestingly, in the world of medicine generally and in the stem cell field to some extent, there is a kind of growing consumerist approach to medicine. This consumerist approach combines diminished deference to medical authority and less trust in experts with a heavy reliance on self-selected websites, blogs, and patient anecdotes. Authoritative statements coming out of the Food and Drug Administration, the Centers for Disease Control, the National Institutes of Health, and the Surgeon General seem to matter little to people who take this approach.

We see this in the area of vaccines all the time, where information that overwhelmingly confirms the safety of vaccines is ignored in favor of a single anecdote that somebody finds on the web. And we find it in the realm of stem cells, where there is now a kind of “I’m going to take care of myself; I’m going to take control of my therapy” attitude that leads some people to put more faith in what they’re reading online than on what responsible medical authorities say.

It’s hard, I realize. We’re saying things like, This needs to be developed slowly, step-by-step while we watch each step and determine what kinds of cells actually are safe and effective for what kinds of applications. Yet what people are seeing online is that stem cell therapy is available right now for a price, and that it works like a charm. 

Visit Google for a moment and type in “stem cell treatment.” Lots of results, right? The advertising alone on some of these “treatment” sites is mind-boggling. Scrolling down the left side of the screen are lists of the different diseases that can be cured at this or that clinic, and citations of all the “studies” on how stem cells cure things.

Here’s the problem: You’re seeing an unfiltered mix on your computer screen.

There’s the real stuff—clinics in the United States that are currently doing clinical trials under the supervision of the U.S. Food and Drug Administration to test stem cell-based therapies for things like macular degeneration, spinal cord injury, and Lou Gehrig’s disease. These clinical trials start with a test tube and slowly move through animal models. The researchers understand the biological mechanism; they have safeguards in place. And when they move into human adults, they start with just a couple of people, and then gradually scale it up. It’s all done very incrementally so you can find a problem and solve it before you move to the next stage. 

And then there are the fly-by-night clinics all over the world, many of which are presented online as reputable establishments, that sell phony cures by making them sound like real ones that have been tested and proven effective.

Researchers do have decades of experience in which one particular kind of stem cell has been used for the treatment of one particular disease: and that’s leukemia. So just about anyone can say, We have studies that show that stem cells can be used to treat cancer and it’s a technically true statement. But it’s profoundly misleading because it’s made in the context of a website that describes everything else besides leukemia with the implication that all of these diseases are amenable to treatment. 

Without expert guidance, how can patients know what they are looking at?  Indeed, how is somebody who’s willing to trust the experts even able to distinguish between what is real and what is fake on the Internet? 

When the International Society for Stem Cell Research tried to educate and empower patients by listing on its own website those clinics and services they thought were dicey, they were inundated with threatening letters from lawyers representing those clinics. The Society took down the list because they weren’t yet ready to defend against the potential onslaught of defamation litigation. And yet what the Society was doing was helpful and truthful. 

We now have documentation of hundreds of clinics around the world that are selling phony-baloney stem cell therapies. They are especially prevalent in China, Russia, the Ukraine, and Mexico. But we also have them in the United States. And because of technicalities in the law that governs how the FDA regulates biological products—like cells from our bodies—the FDA has been subjected to litigation challenging its authority over these clinics.

These phony clinics are using all kinds of cells for their therapies. Some of them may be stem cells, others we’re not even sure what kinds of cells they actually are. We certainly don’t know how these unknown cells function or how to control them properly or how to stop them growing once they’re started. 

Of course the number of therapy claims has been expanding so that now, basically, if you have AIDS or Alzheimer’s or Lou Gehrig’s disease or Parkinson’s or Type One Diabetes, you are being targeted by these clinics. You don’t need to worry anymore, they say, we’ve got you covered.

Beyond the damage this does to legitimate stem cell research, the misinformation and deception surrounding these fake therapies does real damage to patients.

Certainly the injuries are financial. People are paying these clinics from $3,000 to $40,000 per treatment, and patients are often told that they will need to return again for booster treatments—and again and again. And because of the desperate hope that there is some cure or at least some improvement, you will find patient reports on blogs saying, I think I feel better. I feel better. I definitely feel better. The placebo effect or just the need to find something that works leads many people to grossly overestimate what is the result of the therapy and to ignore what may be the result of other factors. 

Perhaps beyond the financial injury is the emotional injury when people discover that at the end of the day this stuff really isn’t working, that the responsible use of stem cells in therapy is still at a research stage and governed by very careful clinical trials, and that these clinics are in fact phony.

Of course, there’s also physical injury. But this is hard to document because nobody is collecting this information. So, stories—like an Israeli boy with a rare brain disease who suffered from tumors caused by the injection of fetal stem cells—are not that easy to find. But the stories are out there. In one case, a child got meningitis from an injection of bone marrow and there is at least one other story of a child in Germany who also developed a tumor and died after receiving stem cell injections. 

Stem cell treatments have also expanded beyond clinics and therapies and into a world that I was, frankly, shocked to find when I started looking into this for a project I’m doing with the National Academies.

Go on Amazon.com right now, type in “stem cell,” and see what comes up under the Health and Personal Care category. Out of thousands of “stem cell”-related products you will find at least a hundred products with labels that explicitly say, “This is a stem cell-based treatment” for your moisturizer, or your lip plumper, or for that lotion to fade the dark spots on your face. Seriously, you name a cosmetic and stem cell will be there because it has now become one of those special phrases. It’s got a magical quality, just like electricity or magnetism.

Another magical word is nano, for nanotechnology, and I was really amused to see there was at least one cosmetic that had “nano stem cells” (they covered all of their bases). Most of this stuff is benign—the prices don’t go beyond $150 for a little bottle. (We pay that for Clinique even when Consumer Reports has been telling us for years that Jergens will do just as well.)

However, sometimes things are not so benign.

For instance, there’s a surgeon in California who is in the business of doing injections to plump up those pouchy pockets under your eyes that develop when you get older. This is standard cosmetic stuff—especially out in Los Angeles—but this surgeon decided he was going to inject stem cells. We think he injected a type of cell called mesenchymal, which may or may not actually be a stem cell, that causes a bad reaction when you put it in contact with the typical dermal filler. 

You can guess what happened next. One of his patients began growing bone fragments all around the pouch of her eye and even into her eye. She couldn’t see, couldn’t open up her eyelids, and has had to go through many surgeries to repair the damage.  If that surgeon had done the kind of careful clinical trials under oversight that is required under U.S. law, we—and he—would have known about the dangers of the procedure. It’s just one more example of someone who should be subjected to FDA control, but, because of pending litigation against the FDA, was allowed to administer his “treatment” with impunity.

This incident in Los Angeles shows that the abuse of stem cell therapies is not restricted to things going on abroad, nor is it restricted to cases involving desperate measures for people desperate to treat their illnesses.  

I think that we are at a stage where we need to have a coordinated effort from our professional medical and scientific societies and our government authorities to control the flow of misleading and false information about stem cells reaching patients via the Internet. This is tricky business. We don’t want to censor, but we do need to deal in truthfulness and counter those so-called “professionals” who are offering treatments that have not been proven to be safe or effective.

In other words, I think we are at a point with stem cells where it’s really important for us to save the hope and lose the hype.

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R. Alta Charo is the Warren P.

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