Q&A with Leigh Turner, Part 3: Celltex Tries to Intimidate a Whistleblower

This is the final part of my interview with University of Minnesota bioethicist Leigh Turner. The first part was posted Monday and the second on Friday. It has been edited for space and clarity.

Q: What sort of reaction did you anticipate from when you wrote your letter asking the FDA to investigate Celltex?

A: I didn't know what reaction to expect from the FDA. As for how the FDA reacted when I spoke with someone there, I can make a few observations. I was left with the impression that my letter is being taken seriously by FDA officials. I also have the sense that it reached appropriate people within the organization. And while the FDA does not disclose details about ongoing investigations, the person with whom I spoke appeared to understand why I had written to the FDA and was not dismissive of my request.

I should add that if the FDA is investigating Celltex or at some point discloses that it has investigated Celltex, it would be a mistake for anyone to assume that my letter was responsible for the FDA's investigation. It is possible that the FDA was looking into Celltex before I sent my letter.

As for Celltex's reaction, I wasn't expecting a thank-you card from company executives.  I couldn't anticipate exactly how the company would respond but I'm not entirely surprised that Celltex is using the threat of a lawsuit to silence and intimidate me. The letter that was sent to the President of the University of Minnesota arrived after Glenn McGee and David Eller wrote to Slate and threatened a defamation suit over my friend and colleague Carl Elliott's article.

It is worth mentioning that David Eller, the CEO and president of Celltex, once launched a defamation lawsuit against William Barrett, a journalist who writes for Forbes. Litigation proceeded for eleven years before the Texas Supreme Court ruled in favor of Barrett and Forbes.     

Q: The reaction you got didn't actually come to you but went to the president of the University of Minnesota, Eric Kaler, when attorneys for Celltex wrote him asking him to retract the letter. Did Celltex contact you about removing your letter from the internet or did the company go straight to Kaler?

A: Celltex never contacted me. Celltex's lawyer sent a letter to Dr. Kaler and it was cc'ed to the co-directors of the Center for Bioethics.

Q: How did you find out that they had written to Kaler?

A: The co-directors of the Center for Bioethics came into my office with photocopies of the letter Celltex's lawyer sent to President Kaler, the letter Celltex sent to the FDA, as well as the letter that I sent to the FDA.   

Q: What do you think will happen next?

A: Some events have already happened. The general counsel at the University of Minnesota has sent a response to Celltex's lawyer. I had a day-long blog post flame war with a Texas-based philosopher who is not wildly enthusiastic about the idea of bioethicists writing to the FDA. There has been some news media coverage.

The most astonishing development was an "I'm Spartacus" event in which numerous colleagues and friends wrote their own letters to the FDA and requested an investigation of Celltex and RNL Bio. I find that act as moving as it was unexpected and I appreciate their support.

I'm not sure what will happen next. Maybe Celltex will initiate a lawsuit. Maybe Celltex will realize that a lawsuit that challenges freedom of speech, assaults the concept of academic freedom, and suggests that faculty members and other concerned individuals cannot write to the FDA and request an investigation of a company engaged in what appear to be questionable activities is unlikely to go very far.     

Q: Very few members of the mainstream media were paying attention to Celltex a year ago. In fact, you wrote your letter to the FDA on February 21, but nobody wrote about. What changed to draw so much attention to this issue?

A: I should mention that it wasn't until March that I posted to the internet my letter to the FDA. I wanted to give people at the FDA time to read my letter. What ultimately attracted attention wasn't the letter itself-though as I recall it did get the attention of some writers-but Celltex's response to the letter.

By writing to the President of the University of Minnesota, asking whether anyone at the university authorized the letter, and asking what steps the university would take to retract the letter and remove it from circulation, Celltex created a news hook far more compelling than anything provided by Celltex's critics. I'm told that this phenomenon is known as the Streisand Effect.      

Q: I had anticipated that Slate's decision to retract the article by Dr. Carl Elliott about Celltex would actually have a chilling effect on reporters, but now we are seeing more coverage of the issue than ever. What sort of effect, if any, do you think that retraction had?

A: My impression is that the retraction angered many journalists because they rely upon editors and publishers to defend them from such threats. Reporters get upset when an editor capitulates to the threat of a lawsuit instead of supporting them. And the retraction surprised many academics because Elliott wrote a strong, well-researched article that, as I see it, should never have been retracted.

Some corrections might have been justified, and my understanding is that when errors are identified the usual response is to acknowledge and correct mistakes. To return to your question, the primary result of the retraction was an increase in news media coverage of Celltex. For a company that has a web page that is "under construction" and provides little useful information, Celltex is remarkably successful at drawing attention to itself.   

Q: What do you hope will be the end result of this controversy?

A: Lest anyone think that I've forgotten about The American Journal of Bioethics, I hope that the current editors of the journal resign or are dismissed from their positions. If this step is not taken, I hope scholars in bioethics and other fields boycott AJOB and find other journals for their research.

Having the editor of AJOB go to work for Celltex is a massive embarrassment for the field of bioethics. Replacing Glenn McGee with his spouse and having this move not result in the resignation of every member of the editorial board indicates that this journal suffers from a crisis of governance and legitimacy. Time will pass, but if the leadership of AJOB remains unchanged the stench of this debacle will remain.

I hope the FDA investigates both Celltex Therapeutics and RNL Bio in a timely and thorough manner. It appears that patients are receiving stem cell injections and infusions containing stem cells processed and banked by Celltex and there is no publicly accessible information about whether these interventions are safe and effective.

If there is a detailed investigation by the FDA, then I suspect that it will take time to complete. In the interim, I hope that no patients are harmed or die as a result of receiving clinically unproven stem cell infusions. I'm also concerned about financial harm to individuals purchasing stem cell interventions that have appear not to have gone through the usual process of regulatory review and approval.

Taking a broader perspective, I hope the FDA investigates the numerous U.S. clinics that market stem cell procedures and make what appear to be unfounded claims about "cures" and "treatments."  Two patients of a doctor in Florida are reported to have died after receiving stem cell injections. There are accounts of other patients who died or were harmed after receiving stem cells provided in clinics located outside the United States.

I hope there is a domestic and transnational effort to better regulate clinics and hospitals that market stem cell "treatments" and "cures" that are either useless or outright dangerous. And I very much hope that Texas, Arizona, California, and other states within the U.S. are not permitted to become safe havens for quacks and other purveyors of snake oil masquerading as stem cells.

Here we are in the 21st century and we continue to face a regulatory challenge that became apparent at the start of the 20th century. Not all physicians and businesses can be trusted to provide medical interventions proven to be safe and effective; some remedies marketed as "cures" and "treatments" pose unnecessary risks to patients. If the FDA didn't already exist, someone might look at the appearance of dubious stem cell clinics across the U.S. and argue for the need to create it.    

Related Posts:

Q&A with Leigh Turner, Part 2: Finding Ethical Quandaries Amid Academic Rivalries

Q&A with Leigh Turner, Part 1: Tracking Medical Tourism Consequences

Home page photo credit: Brain stem cells by Corey Seehus/GE Healthcare via Flickr