Stem cell pseudoscience in the courts?

Author: Ubaka Ogbogu, 02/26/13

Patients contemplating medical travel for the purpose of receiving scientifically unproven stem cell treatments may wish to consider one more potential side effect: the possibility of losing their eligibility for health status-related compensation and benefits.

In May 2012, a United States appeal court affirmed an earlier New York district court decision to deny disability and social insurance income and benefits to a patient who had received “non-embryonic stem cell treatments” for disabling Crohn’s disease, on the grounds that his condition “improved markedly in the year following his stem cell transplant,” to a point where he can no longer be considered to be disabled by the disease. The patient, Steven Mosinski, a floral designer, received stem cell transplants in August 2002 for chronic Crohn’s disease, a condition that caused him to have “recurring diarrhea, which he experienced five to ten times a day, rectal bleeding, abdominal pain with bloating, and an inability to eat.” He experienced dramatic recovery shortly after treatment (“virtually no abdominal pain and reduced diarrhea”), and although a colonoscopy in the following year showed that his condition had improved, he soon suffered a relapse that included “abdominal pain and diarrhea five to six times a day.” By 2006, he was able to work for up to six hours a day and “had nearly no physical limitations.” He applied for disability and social insurance benefits in December 2005 and was initially denied in July 2006.

It is not clear from the case reports whether Mr. Mosinski received the stem cell transplants in or outside the US, or whether the transplants were an experimental treatment or have been approved for therapeutic use. Published reviews of clinical applications of stem cells, including experimental treatments, indicate that clinical trials of stem cell treatments for Crohn’s diseases are underway, but there are currently no approved treatments. This, of course, is not to suggest that the treatments received by Mr. Mosinski and the improvements he experienced are not legitimate or real, but rather, highlights the uncertainties surrounding premature and unapproved therapeutic uses of stem cells. Indeed, the fact that Mr. Mosinski filed a disability claim after treatment suggests that he still considers himself disabled, which of course raises questions as to the nature and extent of the improvements he experienced, and about the medical opinions of four doctors–three treating and one non-treating–who concluded that improvements in his condition removed him from the zone of disability. Interestingly, the court did not mention or consider the lack of clinical evidence supporting these therapies. There was also no mention of studies and news reports which suggest that patients typically experience “placebo-like” dramatic recovery immediately following treatment only to suffer, like Mr. Mosinski did, sharp declines or a complete relapse in the short to medium term.

The case underscores the concerns associated with clinical uses of stem cells in advance of scientific evidence of safety and efficacy. In addition to reports of adverse medical consequences suffered by patients who have received such treatments, the financial implications of seeking and obtaining bogus stem cell therapies is emerging as a primary concern. In another recent US case, six patients from California sued a prominent South Korean stem cell clinic and its US subsidiary seeking to recover $75,000USD paid by them for stem cell treatments that turned out to be ineffective. Whether or not such challenges by patients will deter treatment providers remain to be seen. However, the court’s unquestioning acceptance of “pseudo-scientific” stem cell treatments and related improvements in the Mosinski case conveys to the general public the impression that these treatments “work”. This is a win for treatment providers, who typically employ anecdotal reports and testimonials in marketing their services.

While legal scholars may contend, rightly, that it is not the role of the courts to consider information that is not relevant to the disposition of a case or to serve as watchdogs for medical products, the fact remains that a court’s decision is an imprimatur of legality. One can imagine that a headline which reads, “Court denies Crohn’s patient disability claim due to stem cell treatment improvements” will surely go a long way to convince desperate patients that unproven stem cell treatments are worth a shot.

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Ubaka Ogbogu

Ubaka Ogbogu is an Assistant Professor and the Katz Group Research Fellow in Health Law at the Faculty of Law, University of Alberta. His teaching and research interests include health law, law and biotechnology, law and bioethics, science and regulation, and legal history. Ubaka is a former SCN trainee and a recipient of the SCN Canadian Alumni Award. He has done extensive research work on the ethical, legal and social issues associated with stem cell research, and continues to research and publish in this area. Ubaka holds law degrees at the bachelors and masters levels from the University of Benin in Nigeria and the University of Alberta, and is currently in the process of completing a doctorate in law at the University of Toronto. His doctoral work focuses on the legal history of early health care and biotechnology policies in Canada, particularly in relation to smallpox vaccination and infectious diseases.
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