Biotech Bits – Pluristem's science by press release?

Pluristem Therapeutics is taking heat for its failure to disclose the death of a child treated on a compassionate use basis with its experimental placental stem cell treatment.

Paul Knoepfler, a stem cell scientist and prolific stemblogger, bluntly criticizes Pluristem for what a bioethicist he interviewed called "science-by-press-release" in touting the apparent benefit of the treatment as life-saving, but failing to follow up.

In its defense, Israel-based Pluristem said it didn't know that the child had died until later, because the doctor and family didn't tell the company. Its statement also said Pluristem maintains a culture of transparency. And indications were that the treatment had improved the child's physical condition.

The bioethicist, associate professor Leigh Turner of the University of Minnesota Center for Bioethics, told Knoepfler that wasn't a good excuse:

"Transparency is important, but it appears that the company is being transparent about dramatic improvements in health of individuals receiving Pluristems PLX Cells while failing to issue press release disclosing case of a child who died after undergoing this experimental intervention."

In other words, if you're going to mention something favorable to your product, it's only ethical to mention the unfavorable. Once Pluristem had given favorable coverage to this compassionate-use case, the publicly traded company had an obligation to monitor the child's progress and tell the public of any future developments. Even if Pluristem was legally in the right (because the death apparently was not caused by the stem cell treatment), ethically it was wrong.

Knoepfler concluded by urging biotech companies working on stem cell treatments to keep this lesson in mind, and to be scrupulous in searching for and disclosing adverse events:

"Part of what is so disappointing about this case to me is that the PLX therapy might have real promise as a drug, promise that has been at least temporarily clouded by actions by the company. I hope the case does indeed provide lessons to all interested parties including other biotech companies working on stem cell treatments."

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Biotech Bits - Pluristem's science by press release?

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