Wired Science Designed to Agitate, Not Inform, Says Targeted Genetics

I sent an email to Stacie Byars, the communications director of Targeted Genetics, asking for data from the two trials of tgA
AC94, the gene therapy that may have caused the death of trial participant Jolee Mohr.

Stacie replied:

We’ve read your Blog and believe it is designed to agitate as opposed to inform. The trial data that you have requested has been presented at numerous public scientific meetings and can be obtained by you from those sources.

The unfortunate death of the patient on the Targeted Genetics Phase I/II clinical trial is being assessed by the Company and the FDA. We believe that it is both premature and irresponsible to draw conclusions prior to the completion of that investigation and do not intend to engage in discussions with you on this issue.

"Designed to agitate rather than inform" is the same phrase used by the company to describe the coverage of the Washington Post, who raised a number of criticisms about the recently halted trial's conduct. The company has not addressed these criticisms.

I responded to Stacie:

I am sorry you feel that way, as I believe we've taken care to point out that the cause of Mrs. Mohr's death has not yet been firmly established, though the available evidence does suggest a very possible role for the therapy. I do not believe this position to be controversial from either my own standpoint or that of the company.

Furthermore, questions about the design of the trial itself, from the content of consent forms to the sensibility of participating in experimental trials for non-severe conditions, can and should be raised independently of conclusions about her death.

The trial data has, as you say, been presented at various public scientific meetings, and I'm doing my best to track it down.
Unfortunately, this does not mean accessible records of it have been kept. While I don't doubt that I will eventually be able to acquire it, the process is long and painstaking.

If indeed you wish coverage to inform rather than "agitate," the best way to do so would be to demonstrate, per your response to the
Washington Post's article, your commitment "to being as transparent as possible with respect to our activities prior to the patient's death"
by making available the trial data as well as consent forms. If these show that the trials were indeed designed and conducted with patient safety of paramount importance in practice as well as intention, I will make that as clear as possible in my coverage.

I hope that Targeted Genetics decides to provide the data, and to communicate rather than disengage as the reporting process continues and I -- and other journalists -- have more questions for them. Her charge that my coverage has been "designed to agitate rather than inform" is one I take seriously, and feel has been made disingenuously.

Last week, Paul Gelsinger, father of a young man who died during a clinical trial in 1999, observed that it was the investigative efforts of the *Washington Post that uncovered flaws in that trial's design and conduct and prompted the FDA to reform the trial system. A tragedy has occurred again, and it is the responsibility of journalists to find out what happened, whether it could have been prevented, and whether future tragedies could also be averted.
*
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