The CBS News website called HealthPop.com posted two very preliminary research stories on the same day that both needed stronger caveats if they were to be published at all. Both covered interesting research with important targets. But a few words of caution and a few words from an independent expert would have helped in each case.
One was headlined, “Stem cells restore feeling for paralyzed patients.” Excerpt:
“…promising new research from a phase 1 study conducted at the University of Zurich sponsored by StemCells, Inc. shows that six months after the implantation of neural stem cells, two out of three complete injury patients – meaning they had no neurological function below the point of injury – were able to gain some sensory function.”
Phase I studies are not designed to test efficacy. The primary purpose is to test safety. And the story didn’t interview any independent expert, quoting only a VP of a private company reporting the results. This is not the best form for reporting on paralysis research – or any research.
The other story began: “There may be hope for people who are unable to smell.” But the next line revealed, “Using gene therapy, scientists have successfully restored the sense of smell in mice that had a genetic mutation that took away their olfactory senses.”
Apparently no one was interviewed for the story – just two quotes pulled from two different news releases, one of which may have been the source for the “hope” line.
Stories about stem cells and gene therapy demand scrutiny. Better than what these two topics received in these two CBS attempts.
Comments (2)
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Lee Henderson
September 4, 2012 at 3:32 pmThere are Phase I trials performed in patients, like the one above, that are proof-of-concept human trials. These are typically trials that cannot be performed on nonpatient populations and do often provide indications of positive responses. In many rare and orphan diseases, a positive response is often critical to taking the drug forward. So while a phase I is a safety trial, there many, in some circumstances, be an efficacy readout, as long as one understands the limitations. The first article does reflect those limitations noting that there were only 3 total patients and two had regained ‘some’ sensory function. The second is totally bogus.
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