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

What's the Deal with Northfield Laboratories?

Apparently, Northfield sponsored a clinical trial of a technology it would like to market - a blood substitute called PolyHeme. The hope is that PolyHeme might be useful in situations where a supply of blood is needed, but is not readily available, such as where a traumatic injury has resulted in a significant loss of blood requiring an immediate, on-site, massive transfusion. The battlefield would be another likely site for this product.

Nineteen clinical trial sites were involved in testing the safety and efficacy of PolyHeme in patients who needed blood as a result of having elective surgery. It was reasonable to assume that such patients would be relatively healthy and able to withstand adverse reactions to the blood substitute, should there be any.

Some of the clinician-investigators at the nineteen sites have complained - to Northfield and publicly - that Northfield has not published the results of the clinical trial, which concluded in 2000. By failing to make all data from the study available to the scientific and medical communities, Northfield is depriving everyone of the knowledge generated by this research. The public good is not well-served when scientific information is generated but not shared.


Next time: The politics of business and science involved here.

-Joe

Related Topics: Rare Reactions Reported With Macugen, Cancer Vaccine Works Long-Term

Technorati Tags: northfield laboratories, clinical studies

Clinical Trials In the Public Interest

Who benefits from clinical research?

Obviously, individual participants stand to benefit from any particular clinical trial of a novel diagnosis or treatment. The new compound or method may be found to work safely and effectively on certain individuals. For those individuals, this may be the drug that cures them, or the one that makes their symptoms bearable, or that warns them they might be in the early stages of a condition that is curable if caught early on. Clearly, the most direct benefits are personal in such cases.

Groups of individuals with a condition or meeting certain criteria (such as the elderly or having a particular genetic background) may benefit from clinical research in less direct, but very significant ways. For them, the results of a clinical trial are necessary to improving the general approach to their condition.

In many cases, however, the benefits are even further removed and more abstract. Whether or not the primary hypothesis of the research is supported, solid information from the data generated by the clinical trial may be useful to the medical and scientific communities. It may not be obvious how such information would be of immediate use, but the availability of the information in the literature improves the chances that future research will be designed as intelligently as possible.

That's why it's incredibly important for the companies that sponsor clinical trials to display the utmost responsibility in collecting and analyzing data and in making it available.

Next time: Why a company called Northfield Laboratories is being criticized in this regard.

-Joe

Related Topics: Clinical Trials: Fact or Fiction Quiz, New Clinical Trial Matching Service for Breast Cancer

Technorati Tags: clinicaltrials, clinicaltrialbenefits