U of M ‘carefully evaluating’ legal letter in bioethics controversy

This article contains corrections.

On Friday, University of Minnesota President Eric Kaler received a letter from a law firm representing Celltex Therapeutics Corp., a Texas stem cell company, which lately has been at the epicenter of a mounting, tangled controversy. It asked him, in essence, to muzzle Leigh Turner, PhD, a U of M professor of bioethics who raised questions about Celltex and its relationship to a prominent bioethicist.

To say that academics and ethicists throughout the country are awaiting Kaler’s response with bated breath is the mother of all understatements.

On Monday, in response to MinnPost’s inquiry, U of M General Counsel Mark Rotenberg said the university is “carefully evaluating the letters.”

“In the meanwhile,” said Rotenberg, “it is important to remember that our faculty is protected by the Regents Policy on Academic Freedom and Responsibility, which safeguards the freedom to write on matters of public concern without institutional discipline or restraint, with the responsibility to make it clear that when one is speaking on matters of public interest, one is not speaking for the institution.”

Yes, that would be the same Mark Rotenberg who made headlines last year for suggesting to the U of M’s Academic Freedom and Tenure Committee that a similar warning shot — this one fired at the university itself over a controversial drug trial — fired by Dr. Carl Elliott, another U of M bioethicist, would have a chilling effect on controversial research.

And just because truth is invariably stranger than fiction, that would be the same professor Carl Elliott whose Slate story on the Celltex controversy was retracted late last month in the wake of a letter threatening a lawsuit and a day before the journal Nature published its own account of the controversy.

Banking stem cells

According to Nature’s Feb. 29 story, Celltex was founded by David Eller and Stanley Jones, the orthopedic surgeon who treated Texas Gov. Rick Perry for back pain with unapproved adult stem cells. It operates the largest stem-cell bank in the United States, a Houston-area facility that opened in December. It “multiplies and banks” stem cells there.

Thanks to a bill Perry pushed, the company is the only state-approved bank of stem cells, which many researchers believe show promise for treating a range of ailments but which have not been approved for use outside of clinical trials by the U.S. Food and Drug Administration (FDA). The agency has cracked down on some companies that are marketing the therapies, citing potential safety risks and misleading advertising to consumers.

According to an explanation in Nature, physicians remove five grams of abdominal fat from a patient, which are cultured by Celltex until they generate about 800 million cells. Patients, including sufferers of multiple sclerosis and Parkinson’s, then receive three injections containing at least 200 million cells apiece. According to one doctor interviewed by Nature, patients pay Celltex $7,000 per injection while their doctors receive $500 per shot from the company.

(Wondering about the difference between adult stem cells and embryonic ones? There are big differences in both political and scientific arenas.)

The extracting, banking and re-injecting is hardly done in secret: Indeed, patient Debbie Bertrand has been blogging about the experience, including her attendance at Celltex’s grand opening in the suburb Sugar Land.

The heart of the dispute

Still, exactly what Celltex is doing — operating “a program of clinical research,” as it has said, running a clinical trial, selling an unproven treatment or providing a very high-tech lab service — is at the heart of the disputes.

The attorneys who penned the letter did not return MinnPost’s call yesterday seeking comment. The following chronology of events is taken from public, reputable and independent sources.

In last week’s letter, Celltex asked Kaler to “disclaim any sponsorship” by the university of a letter to the FDA written by Turner,  retract the letter, remove it from the Internet and take steps to “prevent recurrence of this type of activity” by Turner or any other member of the faculty. A firm representing Celltex also sent a letter [PDF] to the FDA in response to Turner’s letter.

Turner, the letter claimed, mischaracterized Celltex’s work in a Feb. 21 letter in which the professor asked the agency to investigate eight allegations against the company and its research partner, RNL Bio, involving the administration of “non-FDA-approved, clinically unproven stem cells” to customers.

“It appears that their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA approved adult stem cells into paying customers,” Turner wrote. “This plan conflicts with FDA regulations governing human stem cells.”

RNL Bio

The exact timing of the events in question is hotly disputed, but according to the online pharmaceutical industry publication Pharmalot, controversy first erupted around Celltex’s South Korean partner, RNL Bio, which two years ago made headlines after patients in China and Japan died.

After investigating the deaths, the International Cellular Medicine Society initiated an evaluation  of RNL’s ethical and clinical practices, conducted by bioethicist Glenn McGee. His evaluation and recommendations, summarized here, described changes that would be required in both practices and adherence to ethical standards at RNL.

About a month ago, Turner noticed that McGee, whom he knew to be the editor of the American Journal of Bioethics (AJOB), appeared to have taken a job as Celltex’s first president for ethics and strategic initiatives. On Feb. 14, Turner posted about his discovery at his blog, Health in the Global Village. Other ethicists followed his links and cried foul.

As Pharmalot put it together: “Why? McGee was still identifying himself as editor-in-chief at AJOB as of January 30, when he wrote a note on his LinkedIn page that he planned to step down as of March 1 (look here). And as of February 12, he was still listed on the masthead as editor-in-chief (see this).”

(One of the many sub-controversies: McGee’s wife, Summer Johnson McGee, has been appointed co-editor-in-chief.)

The Slate article

On Feb. 17, Elliot published a piece entitled “The Celltex Affair: An Ethics Scandal Strikes the World of Bioethics” on the online magazine Slate.

“It has come to my attention that Dr. Glenn McGee, the bioethicist who investigated ethical issues related to the reports of two deaths following receipt of stem cells prepared by RNL Bio is now President, Ethics Research Division, at Celltex,” Turner wrote to the FDA four days later.

“I have not seen the full ethics analysis prepared by Dr. Glenn McGee but I can report that it is atypical for a bioethicist to participate in an independent investigation of deaths of patients and then subsequently accept employment at a corporation tied to the business he once investigated.

“Independent of Dr. McGee’s journey from investigating RNL Bio to joining CellTex’s senior management team, it appears that the ethics review available on the ICMS website does not adequately address the many ethical issues that need to be confronted when individuals die after receiving clinically unproven interventions.”

McGee says he did not participate in any investigation of the deaths; he conducted, after the ICMS’ investigation, a separate bioethics review of RNL’s practices and ethics, as described above.

McGee resigns from Celltex

On Feb. 28, McGee resigned from Celltex. “Enough,” he tweeted. “I resigned from #Celltex Therapeutics on & effective 2/28/2012. I am preparing timely, lengthy, pointed comments on the whole matter.”

Slate publicly retracted Elliott’s piece. Slate Editor David Plotz published this brief explanation about why the article was pulled: “Because of shortcomings in the editorial process, the article did not meet Slate’s standards for verification and fairness and should not have been published. We withdraw the article and apologize to Dr. Glenn McGee.” The article is no longer posted online.

As MinnPost’s Susan Perry reported at the time, Elliott wrote a point-by-point rebuttal [PDF] to Celltex’s complaints about his article. “I disagreed strongly with Slate’s decision to withdraw the article. McGee had threatened them with a lawsuit, and their editorial decision seemed driven entirely by fear,” Elliott told Pharmalot. “For a journalistic organization to allow itself to be bullied in this way is shameful.” 

Reached yesterday, Turner offered a few more details about his actions. He did not post his eight-page, footnoted letter online immediately, he said, but waited until he had spoken to someone at the FDA who gave him “the impression it was being taken seriously.” The official told him he was free to post it online, he said.

“I still stand behind it and I still think the issues I identified are valid,” he said. “Since I wrote it, additional information has entered the public arena.” Much of it can be found via his blog.

Turner said he has received a number of supportive e-mails from stem cell researchers who were upset by the controversy. He has not heard anything from either Celltex or Kaler, who he is optimistic will see the letter as an attempt “to make these concerns disappear.”

“It’s an infringement of free speech and of academic freedom,” he said. “I’m hopeful that [U of M administrators] will see the letter to the FDA as something that falls within my responsibilities as a member of the bioethics faculty.”

Correction: This version corrects a description of Glenn McGee’s bioethics review of RNL’s practices, and provides McGee’s unambiguous statement that he did not participate in any investigation of deaths associated with RNL. It also more clearly states Slate’s reasons for retracting its story and clarifies McGee’s wife’s title at AJOB.