blog.bioethics.net

A Well-Timed Step Forward

Today, the FDA announced its approval of the first stem cell clinical trial in human beings. Geron will perform the trial on 10 spinal cord injured patients. To call this trial, "medical treatment" is the biggest overstatement one could make--and fully illustrates one of the biggest ethical problems with stem cell clinical trials at this very early stage in the game: therapeutic misconception.

With all the hype and hope surrounding embryonic stem cell research, it will be nearly impossible to prevent using the language of "treatment" and "cure" and "therapy" when talking about the Geron study and others that are certainly soon to follow with FDA approval. However, somehow researchers, the FDA and the media MUST find a way to resist the temptation of over-promising what these studies are designed to do and what they can hope to achieve. To expect that we will learn anything more than about safety from these first 10 patients is unreasonable and almost cruel. To raise these patients' and their families' hopes would be wrong.

But one cannot ignore that the approval of Geron's 21,000 page application just 2 days after the inauguration of President Barack Obama is a well-timed step forward in the battle to get embryonic stem cell research reinstated at the federal level. Approval of this protocol by the FDA certainly will engender excitement for ESC research and grease the wheels for the legislative process at the federal level.

But that's politics. As for the ethics, many ethical issues, besides therapeutic misconception, still remain unaddressed and unresolved. I would not go so far as to argue that stem cell clinical trials represent a special category of research or are in some way exceptional, but as I said in Tech News World, questions of which diseases to study first, in which patient populations, how we inform patients about these studies, and how we ensure that these trials are transparent are critical questions that have as of yet have been resolved to many scholars satisfaction. Moreover, if gene therapy taught us anything, proceeding slowly and with caution would serve stem cell clinical trials well--for one media crisis, one major death, one scandal--could send the entire field of research into a frenzy from which it may not recover.

Ultimately, though, it is an important first step and an important milestone for embryonic stem cell research. Geron was the first, and many are certain to follow quickly on its heels in the race for stem cell cures. Let's just hope that none of these researchers are too quick to claim success or therapeutic goals at the expense of research participants' and patients' understanding, hopes or safety.

Summer Johnson, PhD