A couple of years ago, the International Society for Stem Cell Research (ISSCR) launched a project to protect patients. According to Nature, fraudulent stem-cell clinics were offering bogus treatment to desperately ill patients, often at enormous fees, and the ISSCR wanted to help. So the society had set up a Web site instructing patients how to evaluate the claims that many stem cell clinics were making. The Web site, called “A Closer Look at Stem Cell Treatments,” explained that “Just because stem cells came from your body doesn’t mean they are safe,” and “An experimental treatment offered for sale is not the same as a clinical trial.” One section of the Web site, called “Submit a Clinic,” encouraged users to send ISSCR the names of companies offering stem-cell treatment. The ISSCR planned to find out whether the clinics were overseen by a regulatory agency such as the FDA, and whether they had an ethics committee to protect the rights of patients.
Unfortunately, when ISSCR began making inquiries to clinics, the answers often came back from an attorney. Simply asking questions about stem-cell clinics was enough to trigger a legal threat. Even though attorneys consulted by ISSCR believed there was little likelihood that a lawsuit would be successful, the ISSCR had a dilemma. Was the “Submit a clinic” service worth an expensive legal fight? Eventually the ISSCR decided to shut the project down. Today, the Web site reads, “Thank you for your interest. We regret that clinic submissions are not currently being accepted.”
On March 9, 2012, attorneys representing Celltex, the controversial stem cell company in Texas, sent a similar letter to the president of the University of Minnesota about my colleague at the Center for Bioethics, Leigh Turner. The reason? Turner had sent a letter to the FDA on February 21 asking the agency to investigate Celltex. Later, he posted the letter on the Web. Turner’s letter – a careful, referenced, eight-page document that draws on publicly available information – expressed his worry that Celltex and its partner organization, RNL Bio, plan to administer stem cells to patients without an adequate scientific rationale. Celltex was not pleased. According to its attorneys, Turner’s letter contained “numerous material and false allegations” and had created “real and permanent harm to Celltex’s reputation.” The attorneys went on to ask “what steps the University will take to disclaim sponsorship of the Turner letter, retract the letter, remove the letter from the Internet, prevent further distribution of the letter, and prevent recurrence of this type of action by Associate Professor Turner (or any other university faculty).”
Turner may have been the first person to contact the FDA, but he is hardly alone in his concerns. When Dr. Stanley Jones, a founder of Celltex, treated Gov. Rick Perry with stem-cell injections and intravenous infusions last summer, stem-cell researchers were among his most outspoken critics. “A major part of my concern is that he is legitimizing a process which is unfortunately highly suspicious,” Dr. George Daley, a professor at Harvard Medical School and a past president of the ISSCR, told NBC News. “That is bizarre, quite frankly ... and I would be concerned about his safety.” And when the Texas Medical Board began to review its stem-cell therapy policy last fall, many scientists pressed for rules that would protect the safety of patients. According to Nature, Bettie Sue Masters, a biochemist at the University of Texas Health Science Center in San Antonio, wrote, “As a biomedical researcher, I feel the extremes of regulatory burden every day, but I also feel that we must protect patients from risky treatments advanced by overzealous, even greedy, entrepreneurs.”
So far, the critics appear to have done little to deter Celltex. Nature reports that Celltex has been paying a physician to administer non-FDA-approved stem cell treatments to severely ill patients at prices up to $25,000. The physician himself admitted to Nature that there is no scientific evidence that the treatments are effective. According to The Houston Chronicle, the CEO of Celltex says the company has stored the stem cells of about 100 people so far, and doctors have re-injected cells in 40 to 50 of them.
It is difficult to see the Celltex letter to the University of Minnesota as anything other than an intimidation tactic designed to shut down a critic. These tactics have worked for Celltex in the past. But if an academic can be punished simply for asking a public agency to investigate a matter concerning the safety of patients, the consequences could be alarming. Pediatricians would hesitate to notify child-protection services when they suspect child abuse; patient advocates would hesitate to notify the medical licensing board when they suspect that a physician is incompetent; bioethicists would hesitate to notify the Office of Human Research Protection when they believe a clinical trial is dangerous. Fortunately, bioethicists and stem cell researchers have rallied to support Turner. The University of Minnesota administration has not yet responded to his letter in detail, but it has released a statement affirming its support for academic freedom and says it is carefully evaluating the Celltex letter.
Celltex attorneys have also disputed Turner’s complaints in a letter to the FDA. They explain that “Celltex is not in the business of administering stem cells directly to patients” and state that “prospective clinical studies” are being coordinated with Texas Applied Biomedical Services (TABS), a for-profit Institutional Review Board (or research ethics committee) managed by Joyce Heinrich in Houston. This defense is unlikely to satisfy critics. In 2000, Heinrich was issued a warning letter from the FDA about “serious deviations” from federal regulations by her similarly named IRB, the Texas Applied Biotechnology Research Review Committee. In 2007, Heinrich received another letter, this time from the U.S. House of Representatives Committee on Energy and Commerce, for the role of her IRB in approving studies of a dangerous electromagnetic device called the PAP-IMI. According to the Seattle Times, the inventor of the device claimed the PAP-IMI could “cure cancer and AIDS.” Although the use of the PAP-IMI had been prohibited by the FDA in 2005, the makers were able to market it anyway by claiming it was being tested in clinical studies.
(Hat tip to Elizabeth Woeckner of Circare.)