Caplan Article on Bogus Stem Cell Research: Some Different Views

When bioethicist Arthur Caplan talks about stem cells, people pay close attention and for good reason.

Art Caplan

Caplan has provided important perspectives on the stem cell field over the years. For example, you can see a guest post on this blog here about human cloning.

However, in my post today I respectfully discuss how I disagree with several parts of this week’s piece by Caplan on why there are allegedly so many ethical problems in the stem cell research field.

Caplan’s article (see screenshot from video at right) is focused on a question articulated by the title:

Why so much Fake, Unduplicable Stem Cell Research?

One might start off the bat by challenging the article’s title and intrinsic question above, since in reality that the vast majority of stem cell research is quite real and replicable.

David Jensen over at California Stem Cell Report, writing about Caplan’s article, pointed out that serious research issues are not unique to the stem cell field as, for example, there have been disastrous issues in the cancer field too:

There is no doubt some spectacular fraud has surfaced in stem cell research. But the problem of replication within stem cell research may not be entirely out of line with problems elsewhere in science. Los Angeles Times columnist Michael Hiltzik wrote last fall about a study by Amgen that examined 53 “landmark papers” in cancer research and blood biology. Only five could be proved valid, a shocking result, according to Amgen. Similar results were turned up byBayer in Germany, Hiltzik said.

On the other hand, there have been some truly terrible stem cell research fiascos of late so let’s focus on Caplan’s reasoning for why the stem cell field has had these problematic events.

Caplan begins by talking about the STAP cell fiasco in Japan involving allegedly faked research reported in Nature that powerful stem cells could be made by simple stressors such as low pH.

Caplan writes that the researcher in question, Haruko Obokata, “confessed that she had made it up.” In fact, quite the opposite is true. Dr. Obokata says that her study is correct overall and that she did not make it up. To my knowledge, she only admitted to careless errors arising innocently from lack of experience that she says do not affect the conclusions of her papers.

Getting back to the central question of why stem cell research sometimes runs into ethical problems Caplan argues that lack of funding is one reason for the problems. I wish there was indeed more stem cell research funding, but I do not believe this is a clear reason for ethical problems in the field. I don’t see this playing a significant role and funding woes certainly aren’t specific to the stem cell field.

A second reason given for trouble is what one might call the “stem cell hero temptation” effect. In other words, breakthroughs in stem cells might gain a researcher the world’s attention  (“being a hero to the world” is how Caplan describes the attraction ) so there may be perceived incentive to fudge or outright fake stuff. From some of the cases we’ve seen in recent years, this reason seems accurate.

An additional Caplan assertion for explaining the ethical issues facing the stem cell field can be boiled down to a lack of people to provide oversight. Caplan writes:

Another major problem in the stem cell field is that the number of people doing research in this area has shrunk…That may mean that there are fewer people to watch one another.

I’d be interested to see if he has any data to back up this claim. In fact, my sense is the opposite about the size of the stem cell field. If anything the number of people working on stem cells seems to continue to grow overall. I do not believe that the stem cell field lacks sufficient people power to adequately review itself.

So if I disagree with two out of three of Caplan’s reasons, why then do I think that there are sometimes ethical challenges in the stem cell field such as the STAP cell problem?

First, let me say again that he’s right about a few unwise research folks chasing international fame at any cost.

However, another issue here is that a heck of a lot more people around the globe are paying attention to the stem cell field. As a result, ethical problems that are also present in other fields of science (e.g. image manipulation, non-reproducible papers, etc) get noticed far more if they are in stem cell papers. To sum it up, there are more eyes on stem cell papers looking for troubles after publication.

As I blogged before, I also believe that in the specific STAP case, the reviewers and probably editors too were unduly positively biased by the addition of some stem cell big wigs to the authors list on the STAP Nature papers. This points to another contributing problem to broader problems in the field: a small number of stem cell bigwigs have way too much power as reviewers. In other words, journal editors rely on too few eyes to review the highest profile manuscripts. Big journals and their editors need to diversify their stem cell reviewer lists and the review process needs to be more about data and less about names.

In the end the stem cell field is likely to continue to run into a few bumps and even land mines as it proceeds. Addressing recurring problems in an open, expeditious manner would be wise. Training in ethics for researchers seems to be in need of a boost. The journal review process also is a logical place to focus. Is it naive to hope that Nature might take the lead on reform of the review process?

Stem cell field stumbles on cloning dialogue

circle the wagonsWe had the big news last week that for the first time ever, human embryo cloning (aka “therapeutic cloning”) worked to produce apparently normal embryonic stem cells.

I posted about it a few times here, here, and here.

I have tried my best to be factual, open minded, and realistic about the issues.

Frankly, the stem cell field as a whole has done mostly a lousy job handling the human cloning dialogue sparked by the publication of the therapeutic cloning paper last week.

It was one of those classic challenges that was also an opportunity. Unfortunately that window of opportunity is closing, while the challenges will remain or intensify even.

Instead of being part of a rational, fact-based discussion of the ethics and policy issues that were raised, there seems to be a lot of wagon circling and group think going on within the stem cell field.

Some have gone so far as to contact me to say, in effect, “Cut it out!” regarding my open discussion of the cloning issues on this blog. They are not happy with me for my bluntness.

I must not have gotten the memo about the memes that good, well-behaved stem cell researchers are supposed to be sticking to, huh?

Openness and transparency on cloning is crucial, but that’s not what the stem cell field has been advocating in the past week.

What went wrong?

First of all, with all due respect I believe the authors of the paper should have included in their discussion section an overview of the ethical and policy implications of their work. Why didn’t this happen? I don’t know. To be clear, I liked the paper and found it fascinating, but it desperately needed more big picture context.

Second, the journal Cell should have included an accompanying preview and editorial also placing this major finding in the appropriate historical context online. Instead, nothing. Maybe something is coming for the print edition?

Third, the stem cell field should as a whole have been open to discussing the very real issues surrounding this complicated topic of therapeutic cloning and by logical extension the issues surrounding reproductive cloning. The two are at least somewhat linked. That’s a fact that we cannot pretend away.

Yes, cloning is a complicated, ethically challenging issue, but the stem cell field needs to be more open and genuine about talking about it or the field will continue to get criticized  by people on the other side. As a field we also do not engender public trust by futzing around the real issues.

Ethics and policy issues related to cloning should be discussed openly by the field and the leaders of the field have a particular responsibility in this area. I hope to see some of them step up to the plate and show true leadership by talking openly about this stuff.

CIRM Ethics & Regulatory Steps: highly responsive to IOM

CIRM bioethicsCIRM has indicated that the Institute of Medicine (IOM) recommended that CIRM provide funding for training and research on ethics and regulatory issues.

In response to this recommendation and with the perspectives of various “CIRM funded researchers and other experts”, CIRM has responded with a new ethics & regulatory recommendation document.

I have read it and am a big fan of this step by CIRM.

The document outlines a number of key areas for consideration and important questions.

The overall response to the IOM in this area is summarize as follows:

Management would establish initiatives on ethical and regulatory issues that relate to human subjects research.

What does this mean practically speaking?

My impression is that CIRM will in the near future support initiatives in the area of ethics and regulatory issues related to stem cell treatments. I think this is a very important, responsive development by CIRM.

At the end of the document (shown at the top of this post) they have a neat graphic visually conveying how CIRM will promote activities related to bioethics.

Recruiter-patients: how common & corrupt is this practice at US stem cell clinics?

How do dubious stem cell clinics get patients in the door to make money?

In part they do this via the Internet via the clinics’ own websites.

There are also patient websites, some secret, which may serve ad recruitment tools for specific clinics.

A more general tactic may be the use of so-called “recruiter-patients”.

There is an interesting article from 2011 on this practice in India: Recruiter-patients as ambiguous symbols of health: bionetworking and stem cell therapy in India .

What is a recruiter-patient?

A recruiter-patient is a patient of a specific, for-profit stem cell clinic who is used by the clinic to recruit more patients.

In exchange the recruiter-patient (most often secretly) receives either cash or discounted future treatments for themselves or family members. Apparently, some recruiter-patients recruit for specific clinics, while others push for many clinics.

A similar category of stem cell trickster is the stem cell facilitator, who makes money by directing patients to specific clinics through hype, while not necessarily pretending to be a patient.

The article indicates that this practice is common in India amongst stem cell clinics.

How common is this practice in the US?

Of course it is difficult to know because clinics and recruiter-patients hide what they are doing. Why? It is a form of fraud, potentially something that even could be criminally prosecuted.

However, from talking with stem cell clinic patients who received treatments here in the US, it is clear that the practice does occur in the US.

In India, recruiter-patients work for both adult stem cell and embryonic stem cell clinics.

At other times, it is unclear whether a patient who advocates for a clinic is actually a recruiter-patient or simply a very enthusiastic customer who wants to “spread the word”.

In the article on India, they express serious concerns about this practice:

It is difficult to determine whether such testimonials genuinely portray patients’ experiences of improvement in their medical condition and gratitude towards service providers. But there is no doubt that such testimonials are compelling in nature and content. Stem cell providers, then, exploit the symbolism of “cured patients” to attract new patients. Although it is not clear if “the cured patient” is a grateful patient, or a person paid to act as one, the symbolism of “the cured patient” is crucial to the connection between all involved.”

I think patients have an ethical duty to each other and to potential future patients to not over-sell clinic treatments, especially not in return for secret kickbacks or some other compensation.