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Update: How to Tell When A Drug Company Fibs About Clinical Trial Results

Written by: Adam Feuerstein 07/06/12 - 11:38 AM EDT
Tickers in this article: OSIR

Update: Investigators in the Prochymal heart-attack study accuse Osiris Therapeutics(OSIR) of announced preliminary results without their input or consultation, according to Larry Husten of the CardioBrief news blog.

Husten reports:

"I have heard from several investigators in the trial that the Osiris press release was issued without any input or consultation from the site investigators. In fact, the site investigators, including several who are extremely experienced clinical trialists, have expressed frustration and disappointment because their input has not been sought at any point during the trial."

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Husten's reporting adds weight to the allegations first raised earlier this week that Osiris misled investors when it announced results from a mid-stage study of its stem cell therapy Prochymal in heart attack patients. Osiris claimed heart attack patients benefitted from Prochymal but the company failed to disclose key primary and secondary endpoints of the study.

Investigators from hospitals who enrolled the largest number of patients in the Prochymal study told CardioBrief's Husten that Osiris has kept them in the dark about the design and conduct of the study. Furthermore, the study's steering committee, which is supposed to oversee the study, has not seen the Prochymal data.

Husten:

"In fact, steering committee members were not even aware that Mark Vesely, an assistant professor at the University of Maryland, was the principal investigator of the study. One steering committee member said he’d never heard of him before reading the press release."

Officials with the University of Maryland have not returned a phone call seeking comment.

The full story on Osiris and its Prochymal heart-attack study, as published July 3, is below:

COLUMBIA, Md. (TheStreet) -- Osiris Therapeutics(OSIR) "disappeared" important data when the company announced results Monday from a mid-stage study of its stem cell therapy Prochymal in heart attack patients.