Posts Tagged embryonic stem cells

The stem cell hard sell

It's generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

It’s generally not a good indication that their treatments work when doctors use the same hard sell techniques as used car salesmen.

Stem cells are magical. Stem cells are all-powerful. Stem cells cure everything. Stroke? No problem! Paralysis? Stem cells’ll fix it. Autism? Yes, even autism.

That’s the narrative one frequently hears about stem cells in the press and courtesy of offshore stem cell clinics and direct-to-consumer marketing of stem cells in the US. Of course, stem cells aren’t mystical and magical, although they are very promising as a treatment for some degenerative conditions. As promising as they are, though, they don’t cure everything. In fact, we don’t even know for sure that they cure anything because for the vast majority of conditions for which stem cells are used in these clinics, they are still at best experimental and at worst completely unproven. In fact, at their worst, they can do great harm.

I learned about the unrelentingly positive spin the media tend to place on stem cell treatments when I first started blogging about Gordie Howe’s stroke and Dr. Maynard Howe (CEO) and Dave McGuigan (VP) of Stemedica Cell Technologies reached out to the Howe family to see if it could help him with its products. When Howe and McGuigan discovered that Howe was not eligible for any of their US clinical trials, they facilitated Howe’s receiving an unproven stem cell therapy through one of its partners in Mexico, Novastem, which uses Stemedica stem cell products to treat patients in its clinic, Clínica Santa Clarita. In the ultimate bit of privilege for a sports hero (or, as I saw it at the time and as it ultimately turned out, an excellent investment for marketing and advertising of Stemedica products) Gordie Howe even received the treatment for free, even though Clínica Santa Clarita charges everyone else around $30,000. Let’s just say that I didn’t find the explanations for waiving this rather massive fee in Gordie Howe’s case to be persuasive, and I was rather disturbed at the entitlement expressed by Howe’s son over it, who didn’t see the ethical problem at all. Nor did I find the excuses given by Stemedica and Novastem for why their clinical trial protocol in Mexico was so substandard.

It turns out that this new, poorly regulated industry operates a lot like the many quack cancer clinics that I’ve blogged about over the years and like a lot of other dubious businesses, such as multilevel marketing scams. This comes in the form of a recent paper in Stem Cells Translational Research by Paul Knoepfler, who describes attending a marketing seminar.

Posted in: Health Fraud, Science and the Media

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Forget stem cell tourism: Stem cell clinics in the US are plentiful

Snake Oil Salesman & Wagon
I had planned on writing about something else this week, but late last week another story caught my eye, because it served as a perfect follow-up to what I wrote about last week. To recap, I wrote about a man named Jim Gass, a former chief legal counsel for Sylvania, who had suffered a debilitating stroke in 2009 that left him without the use of his left arm, and weak left leg. He could still walk with a cane, but was understandably desperate to try anything to be able to function more normally in life. Mr. Gass was both driven enough, credulous enough, and wealthy enough to spend $300,000 pursuing stem cell tourism in China, Mexico, and Argentina over the course of four years. The result is that he now has a tumor growing in his spinal column, as reported in The New England Journal of Medicine (NEJM) and The New York Times (NYT). Genetic analysis has demonstrated that the cells in this tumor mass did not come from Jim Gass, and the mass has left him paralyzed from the neck down, except for his right arm, incontinent, and with severe chronic back pain. Worse, although radiation temporarily stopped the tumor from growing, apparently it’s growing again, and no one seems to know how to stop it. Given that the traits that make stem cells so desirable as a regenerative treatment, their plasticity and immortality (ability to divide indefinitely), are shared with cancer, scientists doing legitimate stem cell research have always tried to take precautions to stop just this sort of thing from happening in clinical trials. Clearly, “stem cell tourist” clinics, which intentionally operate in countries where the regulatory environment is—shall we say?—less than rigorous are nowhere near as cautious, as they charge tens of thousands of dollars a pop for stem cell treatments that might or might not actually have real stem cells in them.

At the time I wrote that article, I emphasized primarily clinics outside of the US, where shady operators locate in order to be able to operate largely unhindered by local governments. You’d think that such a thing couldn’t possibly be going on in the US. You’d be wrong. Last week, Paul Knoepfler, a stem cell scientist who has previously contributed to Science-Based Medicine, teamed up with Leigh Turner to publish a paper in Cell Stem Cell estimating the number of stem cell clinics in the US. The number they came up with astonished me. (more…)

Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the one that treated Gordie Howe, and, I’m happy to say, he accepted my invitation and agreed to write this post. I hope to persuade him to write more for us in the future, even though he has his own blog.

When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

Stem cell clinics should be better-regulated than a Starbucks

Stem cell clinics should be better-regulated than a Starbucks

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Science and the Media

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Undermining the regulation of stem cell therapies in Italy: A warning for the future?

Stem cells are magical.

At least, if you listen to what docs and “practitioners” who run stem cell clinics in various parts of the world, usually where regulation is lax and money from First World clientele is much sought after, that’s what you could easily come to believe. Unfortunately, it’s not just Third World countries in which “stem cell clinics” have proliferated. For instance, they are not nearly uncommon enough in Europe. The example that is most troubling right now is Italy, and the reason is that there is currently a law being considered that would greatly weaken the regulation of stem cell therapies, so much so that on Friday I saw something that’s fairly rare: a major scientific journal published a pointed editorial about this new law. Specifically EMBO Journal published a commentary by an international group of scientists warning about the path that the government of Italy is considering entitled Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

Stem cell quackery is a very popular form of quackery these days because, well, stem cells are so magical-seeming. You can now find stem cell treatments offered for autism (one of which, offered at a clinic in Costa Rica, I’ve discussed before and involves injecting “stem cells” into the cerebrospinal fluid of autistic children for a cool $15,000). Kent Heckenlively, the man who took his daughter to the aforementioned Costa Rica clinic for this treatment, is not alone in subjecting his autistic child to such unproven uses of stem cells. Just a couple of months ago, a broadcast journalist in the Philippines named Karen Davila took her autistic son to the Villa Medica Clinic in Germany, which offers variants of stem cell therapy. One is known as “fresh cell therapy” and involves harvesting cells from lamb fetuses and injecting them into the patient. The other is called fat stem cell repair therapy, which is claimed to involve harvesting fat from the patient’s abdomen or thigh and then isolating “stem cells” from them to be injected back into the patient’s body.

Posted in: Basic Science, Clinical Trials, Legal, Medical Ethics, Politics and Regulation

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