Today DOJ lawyer Patrick Klein cross examined defense witness Dr. Donald Rubin, a Professor of statistics at Harvard and a consultant to the defense.
After a day of vague questioning and non-sequiturs by Klein, Judge Kessler summed up the overall thrust of Dr. Rubin’s testimony with the following question: Using the framework (assessing potential effectiveness of intervention) you described this morning you do not believe Dr. Fiore has put forth a convincing analytical case for the very expensive program he recommended? Dr. Rubin agreed with this summary.
For the bulk of the morning, Klein questioned Dr. Rubin on what measurements he believed should be used when assessing the potential effectiveness of a Cessation Program. The main components Dr. Rubin mentioned are Efficacy and Participation Rate. Dr. Rubin defined efficacy as the effect of the intervention on the subjects versus effectiveness which he defined as the effect or potential effect of the intervention on the general population.
Rubin focused on the importance of defining subpopulations when assessing the participation rates of a program. As he said in his Written Direct,
“You would, for each component in the national cessation plan, and for each demographic and smoking behavior subpopulation, estimate efficacy — the increase in the cessation rate for participants caused by the program.”
Rubin repeatedly labeled the participants in randomized cessation studies as a specific subpopulation. Dr. Rubin implied that people willing to participate in randomized studies differ from the general population.. In his testimony, Dr. Rubin also discussed racial and ethnic groups as subpopulations. He said in his Written Direct,
“[J]ust as Surgeon General Carmona testified in his written direct (at 16-17) that smoking cessation initiatives must be ‘culturally competent and targeted’ toward specific ‘racial/ethnic populations,’ so, too, it is reasonable to anticipate that any effect of the Defendants’ allegedly fraudulent statements could have been different in different subpopulations.”
“Subpopulations,” he said on the stand, “respond differently to the same intervention.”
Klein responded to this by presenting Dr. Rubin with a number of studies which found cessation interventions to be effective across all subgroups. In addition Klein presented a CDC document titled “Best Practices for Comprehensive Tobacco Control,” which did mention variables associated with lower cessation rates but the document concluded that the recommended Cessation treatment was still effective in all these subgroups. The document suggested that the delivery of Cessation program not be based on Specialized Assessments which would be used to target subpopulations.
Klein also made clear that the National Quitline suggested by Dr. Fiore was not some gigantic government behemoth. States would still have the freedom and power to modify their own quitlines to the needs of their residents.
Later a brief moment occurred in the courtroom when everyone present probably thought they were working in the wrong profession (except the defense). Dr. Rubin was asked if he was paid more than $2,000,000 by the tobacco industry in the last five years. Dr. Rubin answered, maybe… that sounds correct.
The witness was briefly re-examined by the defense. Dr. Rubin was asked if the methods or framework he discussed earlier are necessary to do valid reliable research. He replied yes, again suggesting that Dr. Fiore’s methods were incomplete due to his lack of focus on subpopulations.