Nuggets and pyrite in Businessweek article on Celltex

Businessweek just published a very long, interesting article on Celltex by Susan Berfield yesterday.

I was happy to talk with Susan at length about the key issues and be quoted in the article.

David Eller

See image at left of two key Celltex leaders, David Eller, CEO of Celltex, and Stan Jones above (Photograph by Thomas Prior for Bloomberg Businessweek).

On the positive side, I think the article sheds significant light on Celltex and its former partner RNL Bio/Human Biostar. It also provides the perspectives of a number of Celltex patients, which I found valuable and interesting. I respect these patients greatly. More on these two areas below, which I view as the nuggets. But there were some not-so-golden parts too and the article didn’t seem balanced in my opinion overall. I wish more independent scientists were quoted. Thus, I am concerned the article may not be a net positive for the stem cell field and patients.

Some quotes from specific people in the article seemed extreme to me, but interesting in that they illuminate their thinking.

For example, Jeong Chan Ra DVM, who found RNL Bio a dozen years ago, is quoted via email a few times in the piece. I have to disagree with much of what he says. Ra, who it says in the article “has received 46 infusions of adult stem cells in the past four years” himself, admits experimenting on himself:

“In the grand tradition of many scientists like Sir Isaac Newton and Jonas Salk, I experimented upon myself first to confirm that adult stem cells cultured and expanded by RNL Bio are safe,” he says via e-mail.

I’m not sure there is a grand tradition of scientific self-experimentation and I was taught as a graduate student that self-experimentation was to be avoided.

Another striking quote was the following:

Arnold Caplan, a professor of biology at Case Western Reserve University and founder of two stem cell companies, says: “It sounds like stem cells could be the magic elixir for every malady. The answer is that, on a scientific basis, they could be.”

In my opinion this statement is potentially dangerous hype.

“Magic elixir for every malady”…really?

Caplan goes on to say:

“The FDA will shudder, but I say, if you want to pay $25,000 and get pain relief for four months as a placebo, go do it.”

First of all, in my opinion these two quotes from Caplan seem at odds.

Secondly, if it is all placebo, why should patients be charged $25,000?

Thirdly, what about safety?

The worst-case scenario is not that the therapy won’t work, but rather that it will kill or seriously injure the patient.

Eller, CEO of Celltex, is quoted as saying that data was collected on the 230 patients and will ultimately be published. I hope so and in a rigorous fashion in a peer-reviewed journal. The article says:

Eller expects the results to be published sometime next year. “It will be the largest and possibly most important study on adult stem cells that’s been produced anywhere,” he says. Adds Jones: “I can tell you it looks good.”

We’ll see.

Interestingly, the piece says that the stem cells of early Celltex patients were shipped out of the U.S. to Korea, amplified in Korea by RNL and then exported to Japan where they were injected into patients, potentially violating Korean law (see here).

A quote from ICMS President Ricardo Rodriguez (see my interview with him here) was also quite notable for its bluntness (which I appreciate), in my opinion, about Celltex:

 “It’s one thing for Celltex to take an ideological position [with regard to the FDA] and still do everything possible to guarantee patient safety. They were not doing everything possible.”

Overall I feel frustrated by the article.

I felt like I did learn a few new things, but not enough on balance. There was not enough analysis.

Certainly the piece is not helpful for the FDA and may to the contrary be helpful for the advocates of deregulation. Ultimately, my concern is primarily for what’s best for patients. While this article highlights patients’ stories and perspectives (a good thing), I believe that this article is a net negative for current and future patients, putting them at greater risk.

4 thoughts on “Nuggets and pyrite in Businessweek article on Celltex


  1. I actually do agree with the statement that there’s a grand and historic tradition of doctors and researchers experimenting on themselves; it’s tempting to say that this is the sort of thing that died out at the turn of the 19th/20th century, or before there were established ethical rules about human subjects research, but the reality is we do still hear about it all the time. Barry Marshall is probably the most well-known recent example of this (with the self-induced h. pylori infection/cure), but there are lots.

    This does not make it okay, though, and it’s a subject that doesn’t get a lot of conversation because we do typically only hear about it in the hero-scientist narrative (as with Marshall), rather than in the research that goes nowhere, or actually causes harm. And since schools teach their students that this is something one simply doesn’t do, there’s no real discussion of the reality of what goes on.

    (And this, of course, isn’t even stepping into the realm of DIYBio, where things can get really scary really fast.)


  2. I suppose it depends on how one defines “grand” and “tradition”, right? A specific ethical problem in this case that makes the claim of being part of a grand tradition is that here self-experimentation via injection of billions of stem cells whether it is at one company or another (it seems they all have gotten transplants of billions of cells) is being used as a tool to make specific claims of safety and efficacy outside the realm of a meaningful clinical trial.


  3. There are lots of grand old traditions that, by very virtue of, means they shouldn’t be followed any more. But most of the time, these self-experimentations are done because there’s no other avenue. We hear about the positive results because those results are used to advance a cause – get a clinical trial going, advance a paper or theory, etc. We don’t hear about the ones with neutral or bad results, because the research is either abandoned or the person dies (or whatever bad result you’d like to insert here).

    Is self-experimentation ethical? Mmm. Is it ethical to use as a recruiting tool as proof of safety and efficacy (beyond perhaps a limited appeal to a broader protocol)? Certainly not!

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