Targeted Genetics Fires Back at Washington Post, but Evades Charges

Targeted Genetics, the company sponsoring a clinical trial of a gene therapy that may have killed 36-year-old Jolee Mohr, has accused the Washington Post's recent investigation into the trial design as "designed to agitate as opposed to inform."

"We shared a very detailed chronology of our analyses and reporting activities regarding this particular study patient with the reporter from the Washington Post, which demonstrated how we acted in strictest compliance with today's best clinical trial practices, and which was not included in the article," said [Targeted Genetics CEO H. Stewart] Parker.

The rebuttal emphasized that the company had acted quickly and responsibly to notify the FDA as soon as it became clear that Mohr's symptoms were possibly related to the trial. But in doing so, they evaded the article's real criticisms.

The quickness of Targeted Genetics' response wasn't the* Post*'s primary focus. If anything, the article suggested that the lack of uniform standards for associating adverse events with experimental therapies made a timely response difficult.

Mohr's doctor and the company didn't make the association until
July 19, two weeks after her first symptoms, when she was given an emergency transfer to a Chicago hospital. In the interim, her symptoms were classified as unrelated to the treatment. The trial was halted on July 20, and Mohr died four days later.

What the Post really criticized was the trial's design.

"It was presented to her like this is going to make her knee better,"
said Robb Mohr, an agronomist who lived with his wife of nine years in a modest vinyl-sided ranch home near Springfield, Ill. "It was supposed to be just a simple thing." [...]

A two-sentence paragraph halfway through a 15-page consent document that Jolee Mohr signed warns of the possibility of "unknown side effects," including, "in rare circumstances, death."

Further in, after long descriptions of how the product may help, a single sentence states: "We do not expect you to receive any direct medical benefits from participation in this study." [...]

Two fundamental rules of clinical research were violated that day, experts said. First, consent forms are to be taken home and considered, not signed on first sight. Second, when a patient's own doctor is a principal investigator in a study, someone else is supposed to make the proposal.

And to these charges, Targeted Genetics made no response.

Targeted Genetics Responds to Washington Post Article [press release]

Death Points to Risks in Research [Washington Post]