Last week I linked to an emerging story about a woman who has died while being involved in gene therapy for arthritis: Not a good day for research. While it is not yet confirmed whether the woman's death was due to the gene therapy it does appear that there were some irregularities in process of recruitment that lead her to be involved. The Washington Post has a very comprehensive article: Death Points to Risks in Research
Key points are:
B"It was presented to her like this is going to make her knee better," said Robb Mohr, an agronomist who lived with his wife of nine years in a modest vinyl-sided ranch home near Springfield, Ill. "It was supposed to be just a simple thing."
A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of "unknown side effects," including, "in rare circumstances, death."
Further in, after long descriptions of how the product may help, a single sentence states: "We do not expect you to receive any direct medical benefits from participation in this study."
Mohr was in an early-phase study, the prime goal of which was to see whether the treatment was safe, not to provide a therapeutic benefit. If the drug passed muster, other studies would determine whether it was an effective treatment.
So first things first, a 15 page consent document is worse than useless, few people will read this much material in detail. Especially if, as later emerges in the article, they are not given the document to take away and study. And while the disclaimers are there by the sounds of things, they are hidden by the context, it isn't appropriate to talk about the potential benefits of a treatment, at great length, in what is effectively a safety study.
It then gets worse, since her rheumatologist gets payments from the company involved for each person they recruit onto the study. So we have direct therapeutic recruitment, which is bound to cause therapeutic confusion coupled with a conflict of interest.
The sad thing is that it is unlikely that this is an isolated case of poor practice, instead this is likely to be only the tip of the iceberg, revealed by a tragic death.
Monday, August 06, 2007
Irregularities in Recruitment in Potential Gene Therapy Research Death
Monday, July 16, 2007
Medical Ethics 2.0?
A very interesting post is over at The Personal Genome focusing on some of the ethical implications of the engagement of Web 2.0 with medicine.
The post is focused on one example namely the possibility of a genealogy website allowing users to add medical information to the genealogical data. The use of this in medical terms is obvious imagine someone being able to say to their doctor "I think aunt betsy had cancer I can't remember what type I tell you what go look here at our family tree that will tell you"
Likewise this could present a goldmine of medical information for researchers and data miners.
But the public (and even shared private) availability of such information raises significant ethical issues both about consent, and whose information this is. In particular should you be able to update the records of your deceased relatives and of course what the implications this might have for insurance purposes.
