Researcher upset by tobacco company’s actions

Findings from a University of Minnesota study on quitting smoking have turned up in a tobacco company’s press release before they were published, prompting an investigation by officials at the University’s Masonic Cancer Center.

In an Oct. 28 press release, 22nd Century Limited LLC, a biotechnology company which develops tobacco strains, cited information from University professor Dorothy Hatsukami’s research on the effectiveness of very low nicotine cigarettes (VLN) in smoking cessation.

Michael Moynihan , vice president of research and development at 22nd Century, said the company, which is developing a very low nicotine strain of tobacco, issued the press release in hopes of receiving funding for larger clinical studies needed for their product to be approved by the Food and Drug Association .

But Hatsukami, whose research is sponsored by the National Institutes of Health and is not financially affiliated with 22nd Century, said the company “jumped the gun” on their press release, and was upset by their use of her research without her knowledge.

Hatsukami also expressed concerns regarding the company’s interpretation of her findings.

“My study’s results are not as strong as the reporting [in the press release] indicated,” Hatsukami said. “22nd Century is misleading in their representation of my study. The results can be interpreted multiple ways.”

Moynihan specifically cited Hatsukami’s study in the press release as being of “particular interest,” stating that it “suggests that quitting efficacy using VLN cigarettes exclusively may exceed that of Nicotine Replacement Therapy.”

“The problem is, the public can’t distinguish between misleading wording, such as ‘may’ instead of ‘does,’” Hatsukami said.

Hatsukami’s study found using VLN cigarettes as a tool for quitting smoking could be as or more effective than using traditional cessation methods, like nicotine lozenges, in helping smokers quit.

However, she said, larger clinical trials are still needed to prove VLN cigarette’s effectiveness.

The press release cited Hatsukami’s study, stating that 47 percent of patients who exclusively used VLN cigarettes during the study were not smoking six weeks after the study concluded. Only 32 percent of the group using nicotine lozenges successfully abstained from smoking for the six-week period after the study.

Hatsukami and University Masonic Cancer Center spokeswoman Mary Lawson are investigating how the information was obtained by 22nd Century, and whether or not there was a breach in the study’s embargo.

“In my experience, you don’t release information on study findings until the study is published in an academic journal,” Lawson said. “Some journals won’t publish research if it has been leaked or made public before publication, but we are still trying to gather the facts.”

Hatsukami’s study has been accepted, but not yet published, by an academic journal. 22nd Century requested to see a manuscript of the report prior to the press release, but they did not mention a press release or ask for permission to print her results, Hatsukami said.

Moynihan said the statistics used in the press release are public information drawn from presentations of Hatsukami’s posted on the Internet.

“[Hatsukami’s] work is of very great interest to us, but we don’t want to claim any credit,” he said. “None of the information in the press release isn’t in the public.”

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