Stem cell company demands U of M bioethicist take back FDA investigation request


Late last week, a letter from a Washington D.C. law firm arrived in U of M President Eric Kaler's inbox. In it, attorneys representing an adult-stem cell company named Celltex demanded to know who authorized a bioethicist named Leigh Turner to request an official investigation of Celltex by the Federal Drug Administration.

"Associate Professor Turner's letter contains numerous material false and defamatory allegations," it read.

"I helped raise some concerns," says Turner. "Turns out Celltex isn't so excited about that idea."

Celltex is a Texas-based company, whose most famous client was Governor Rick Perry. Perry underwent an experimental procedure for back pain and had his own stem cells injected into his spine. But the company has been accused in an investigative piece by the science journal Nature of performing those experimental treatments on U.S. soil, which is still illegal.

Turner's letter points this out and also raises the issue of Celltex's relationship with a Korean company called RNL Bio, which licenses Celltex's technology. According to Korean news reports, two patients died after receiving RNL Bio stem cell treatments.

"It is unclear how CellTex and RNL Bio intend to address fundamental ethical issues related to protecting patients from risk of harm caused by clinically unproven interventions," wrote Turner. "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. This plan conflicts with FDA regulations governing human stem cells."

Read the entire letter here.

Attorneys for Celltex responded to Kaler, as opposed to Turner, demanding to know whether the U sanctioned Turner's request for the investigation.

If it was not authorized, please inform us of what steps the University will take to disclaim any sponsorship of the Turner letter, retract the letter, remove the letter from the internet, prevent further distribution of the letter, and prevent further recurrence of this type of action by Associate Professor Turner (or any other University faculty).

"I think the letter is just to intimidate and threaten," says Turner.

Read the whole Celltex letter here. The company also sent a letter to the FDA saying Turner's allegations are false, and offering an inspection of Celltex's facilities.

Turner says he hopes the U will back him up, though he says it would be near impossible in any case to make his letter disappear from the internet. Director of University Public Relations Chuck Tombarge issued the following statement in reply to Celltex:

The University is carefully evaluating the letters it has received involving allegations related to Celltex, the FDA, and Prof. Leigh Turner. In the meanwhile, 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.

This is not the first time a U of M bioethicist has butted heads with Celltex. Last week, Carl Elliott received a threatening letter from one of its former executives, whom Elliott called out, along with Celltex and RNL Bio for questionable ethics in an article for Slate. Slate responded by scrubbing Elliott's piece from the internet.

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