The Business and Politics of PolyHeme
Northfield Laboratories' web site says that the deaths observed in its elective surgery clinical trial were not due directly to PolyHeme. Apparently, Northfield also announced last month that one of the study's investigators, the principal investigator from Johns Hopkins, would be speaking at a conference on the data on PolyHeme. Northfield suggested that the Hopkins investigator would be commenting on the safety of PolyHeme and that the deaths observed in participants in the clinical trial were not caused by PolyHeme. The investigator and Johns Hopkins objected, saying on Hopkins' web site that the investigator would not be speaking on PolyHeme at the conference mentioned by Northfield.
Companies enlist experienced investigators at prestigious institutions such as Johns Hopkins for several reasons. They know how to conduct clinical trials and they have solid reputations for doing them. It is good for business to be able to say that the research data being used to back up a particular new compound were generated by researchers of the highest caliber.
Apparently, those participants enrolled by Johns Hopkins experienced no serious adverse events - like the deaths experienced at other of the clinical trial sites. How is it no one died at Hopkins? How does Northfield know that the deaths were not related to PolyHeme? And why does the Hopkins investigator not want to speak at the conference?
These are all important questions. But none of them can be answered without a thorough and transparent review of all data collected at all of the clinical trial sites. In the short term, even acknowledging the deaths will likely hurt business for PolyHeme and Northfield. But it will be difficult for Northfield to hold out for very long when well-respected investigators at premier research institutions are calling for release of the data.
-Joe
Related Topics: Clinical Trials: Take the Quiz, Newly-Approved Drugs (2006)
Technorati Tags: clinical trial, Northfield Laboratories, Johns Hopkins
Companies enlist experienced investigators at prestigious institutions such as Johns Hopkins for several reasons. They know how to conduct clinical trials and they have solid reputations for doing them. It is good for business to be able to say that the research data being used to back up a particular new compound were generated by researchers of the highest caliber.
Apparently, those participants enrolled by Johns Hopkins experienced no serious adverse events - like the deaths experienced at other of the clinical trial sites. How is it no one died at Hopkins? How does Northfield know that the deaths were not related to PolyHeme? And why does the Hopkins investigator not want to speak at the conference?
These are all important questions. But none of them can be answered without a thorough and transparent review of all data collected at all of the clinical trial sites. In the short term, even acknowledging the deaths will likely hurt business for PolyHeme and Northfield. But it will be difficult for Northfield to hold out for very long when well-respected investigators at premier research institutions are calling for release of the data.
-Joe
Related Topics: Clinical Trials: Take the Quiz, Newly-Approved Drugs (2006)
Technorati Tags: clinical trial, Northfield Laboratories, Johns Hopkins
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