Q&A with Leigh Turner, Part 2: Finding Ethical Quandaries Amid Academic Rivalries
This is the second part of my e-mail interview with University of Minnesota bioethicist Leigh Turner. The first part was posted Monday. It has been edited for space and clarity.
Q: Is there any part of the Celltex controversy that stems from professional jealousy? Glenn McGee, after all, is one of the best-known bioethicists in the field while many of his colleagues toil in obscurity.
A: "Best known" isn't necessarily positive. Look at the most recent chapter in his employment history. He accepted a position at Celltex, a company that charges patients $20,000-$30,000 for processing and banking of stem cells. Celltex claims that it does not administer stem cells to patients, but at least one Celltex senior executive, Dr. Stanley Jones, has both extracted stem cells and administered stem cells to customers of Celltex. It seems that these stem cell interventions are not established, clinically proven medical treatments. It also appears that Celltex never filed an Investigational New Drug application with the FDA before stem cells expanded, processed, and banked by Celltex were administered to patients.
I cannot fathom why a bioethicist would accept employment at a company like this. And while working there, at least initially, McGee continued in his role as editor-in-chief of The American Journal of Bioethics, as if there were no conflict. Such conduct has rightly brought McGee considerable notoriety among his colleagues in bioethics. It is far better to toil in obscurity than to be "well known" for the wrong reasons. In short, I don't see the reaction to Glenn McGee's employment at Celltex as being driven by professional jealousy. Anger, yes. A widespread sense that someone claiming to be a bioethicist betrayed his field, yes. Those reactions seem appropriate given the circumstances.
Q: And how much of this ire against McGee comes from the shellacking some ethicists have taken in the pages of AJOB? One of the journal's main reasons for being is prosecuting ethical questions and ethicists with great vigor, and clearly that has bruised some egos, if not reputations, in the past.
A: There is an important distinction between the business-as-usual of argument and counter-argument in scholarly journals and using peer-reviewed academic journals as a platform to launch personal attacks on particular academics. In articles for peer-reviewed academic journals I have sometimes criticized arguments made by other scholars. In turn, sometimes my work has been the subject of critical commentary. Most of these exchanges involve some passion.
I'm probably like many of my colleagues when I acknowledge that I experience a connection to arguments I'm making and feel an urge to defend them when I disagree with how they are described and criticized. But these types of exchanges don't have the feel of taking a pipe to a colleague's knees or being the victim of an unprovoked assault. In contrast, I see AJOB as a journal that has published some good articles and some articles in which it appears that AJOB is being used as selective delivery system to attack particular academics. I happen to be friends with several of the individuals who have been targeted by articles in AJOB, and if they wonder how such articles survived credible peer-review then I understand their reaction. So sure, I suppose there are personal histories and longstanding animosities in addition to allegiances and friendships as different individuals respond to Glenn McGee's decision to work for Celltex.
Acknowledging this point, it is a mistake to assume that the strong reaction to McGee's employment at Celltex is nothing more than a product of past disagreements or personal conflicts. People are outraged because there is no place for a bioethicist at a company such as Celltex. I'm surprised that every member of AJOB's Editorial Board didn't resign when they learned that McGee was working at Celltex. I'm equally amazed that board members allowed Glenn McGee's wife, Summer Johnson McGee, to become the new co-editor. I take board members' acquiescence to these events as a signal that there is a total failure of governance and leadership at that journal.
Q: Prior to this Celltex controversy, had you ever been on the receiving end of criticism in the pages of AJOB or from McGee personally? If so, how did you respond?
A: I am unaware of ever being a target of any articles published in AJOB. I have no recollection of ever being publicly criticized by Glenn McGee before our conflict over his employment by Celltex. And before I became aware of his employment at Celltex I did not go out of my way to criticize him or his work.
Q: You decided that the way Celltex was doing business was problematic enough that you wrote a letter to the FDA asking it to investigate. At first glance, this may seem an unusual thing for an academic to do. How does it fit into your role as a professional ethicist?
A: In addition to being a university professor my professional experience includes working as a clinical ethicist at three hospitals in Canada. I regard trying to promote and protect patient safety as part of my job-and that statement holds true for my current position as a faculty member at a Center for Bioethics. At some point I realized that there were enough unanswered questions and grounds for concern that there were legitimate, urgent reasons for me to contact the FDA and request an investigation. And so that's what I did. Some people have a history of contacting the FDA and raising concerns about drugs and medical devices. I had no idea who to contact at the FDA, where to send my letter, or the exact form a request for an investigation by the FDA should take.
There were several developments that concerned me. First, Celltex licenses its stem cell technology from RNL Bio, and RNL Bio is a controversial company. Its history includes reports of patients who died after receiving stem cells as well as additional reports of patients injured as a result of receiving stem cell injections. Also, RNL Bio claims to have administered stem cells to over 8,000 individuals and yet articles published by RNL Bio employees are based on tiny sample sizes. It also has a history of sending stem cells to clinics in poorly regulated settings and promoting so-called "stem cell tourism."
RNL Bio's public record is worrisome, and that is why I asked the FDA to investigate both Celltex and RNL Bio. Second, if Celltex conducts clinical trials involving delivery of stem cells, these studies are not listed in the ClinicalTrials.gov database. If Celltex filed an Investigational New Drug application and FDA did not place a hold on the application there presumably should be mention of a Celltex-sponsored Phase I or II clinical study in that database.
And finally, I had seen a blog by a woman who was a client and patient of Celltex that contained photos of the Celltex processing facility and stem cell bank as well as pictures of the doctors and other health care providers involved in her care. The blog provided a detailed account of the stem cell infusions this patient received. Her account suggests that stem cells are being provided to patients outside the context of carefully designed clinical trials.
Let me hasten to add that Doug Sipp, David Cyranoski, Carl Elliott, and many other researchers and journalists all deserve credit for writing about Celltex and RNL Bio. If you look at the references in my letter it becomes clear that I did little more than organize information that was already in the public domain. That letter has some personal significance now that Celltex is threatening to sue me for it, but it should be viewed as one of many critical analyses raising troubling questions related to both Celltex and RNL Bio.
Q: You used University of Minnesota letterhead to write your inquiry to the FDA. Why not just write a personal letter or send an email from your private account?
A: I'm not sure that there has been much criticism of my decision to use University of Minnesota letterhead when writing to the FDA. What I have seen is a letter sent by Celltex Therapeutics' lawyer to the President of the University of Minnesota.
That document-which appears to have been written with the objective of getting the University of Minnesota to distance itself from me-questions whether I was "authorized" to use university letterhead and asks what steps the University of Minnesota will take to "retract" the letter and withdraw it from public circulation. These are the questions a lawyer asks to see whether I can be peeled away from the institutional and legal support of my employer. But to answer your question, I used my University of Minnesota letterhead and my university email account because my letter to the FDA falls within the scope of my work as a faculty member situated within a Center for Bioethics.
The issues identified in the letter are all related to my work as a bioethicist. They are connected to fundamental questions about patient safety. And I should mention that shortly after I sent my letter to the FDA a patient in Florida died reportedly while receiving an injection of adult stem cells administered by a physician whose medical license was restricted as a result of the previous death of a patient who had received stem cells.
When I see a company that is charging tens of thousands of dollars for processing, storing, and administering or permitting the administration of stem cells and there is evidence suggesting that this activity is occurring outside applicable rules and regulations then the responsible step to take is to contact the FDA and try to identify the relevant public concerns.
Next: What does a stem cell controversy have to do with Barbra Streisand?