WED, DAY 106: The 16% Solution

May 18, 2005 11:48 pm by Gene Borio

updated May 19, 2005, 8:53 AM

For awhile there, it seemed Philip Morris USA attorney Ted Wells was out in the country happily duck-shooting. And he seemed to have them all in a row and was picking them off one by one.

Over the course of a nearly 8-hour cross, he seemed to establish that there was very little science-based evidence for many of the figures on which Dr. Michael Fiore based the utilization and cost of his National Action Plan for smoking cessation.

I think it made a great deal of sense for the 2002-03 Subcommittee on Cessation of the Interagency Committee on Smoking and Health (ICSH), charged by DHHS Secretary Tommy Thompson to develop a national cessation plan, to assemble leaders in the field of smoking cessation programs–local, private and statewide. I think it made sense to accept their avowed figures and their advice, and to extrapolate from their experiences to create a national model. And yet the figures on utilization rates and costs seemed to be plucked out of the air and accepted at face value, with little hard data to back them up, and with little concrete discussion of, say, how much weight the Subcommittee should give the various factors that may increase utilization rates.

Also, I think it made sense to leave the practical details of such a plan for others to develop as part of the actual construction of such a “National Tobacco Quitline Network.” And yet the lack of some practicalities seemed to paint the plan as somewhat pie-in-the-sky.

And I think it makes sense that you would have to go about developing something so unprecedented this way; I can understand how with limited science you could — and should–make certain assumptions based on the opinions of the most qualified and experienced people in the country.

But then, I’m biased. And then again, I’m not rule 702 under Daubert.

Mr. Wells’ main sticking-point was Dr. Fiore’s projected program utilization rate of 16%, ie, that with a “barrier-free” and well-promoted NTQN, 16% of smokers who want to quit would use the service.

The 16% rate posited in Dr. Fiore’s plan is based primarily on figures from the Group Health Cooperative of Puget Sound in Washington. (It has now spun off its smoking cessation arm to create “Free and Clear,” a cessation services company that provides smoking cessation quitlines for 8 states.) The figure is a doubling of Group Health’s 8% utilization rate from a 600,000-person study of their comprehensive (free counseling and free meds) program. The program had no promotion beyond “physician referral.” This 8% figure was doubled –by someone, somewhere, somehow–to achieve Dr. Fiore’s projected 16% utilization rate–if the program were promoted.

However, Mr. Wells emphasized that the GHC study participants were far from typical. GHC’s program dealt only with enrollees in GHC’s managed care group, and those enrollees had steady jobs, had health care, were educated and lived in a region that had relatively low smoking rates. Thus, that 8% figure could be seen as extemely unrepresentative of the U.S. population as a whole, which has a quitline usage rate of 1-2%. Even though there is evidence that aggressive media promotion increases the use of tobacco control programs, the Subcommittee’s rationale for doubling the 8% GHC rate simply didn’t exist. It apparently just seemed right to the experts.

Mr. Wells pointed out that if you have 16% of smokers using the program, the program will have a high cost–Dr. Fiore’s $3.2 billion/year. But at 8%, costs would go down to $1.6 billion, at 4%, only $800 million, etc.

In fact, Mr. Wells accused the subcommittee of ignoring GHC’s later experience running Washington’s own statewide quitline, where the rate was more consistent with the 1-2% national utilization rate.

Mr. Wells went through all 5 meetings of the Subcommittee, scouring the transcripts to see if there were any discussion of the appropriateness of using the 8% figure, or why it was doubled. There appeared to be no real record of any such discussions.

This became an extremely contentious issue, as Dr. Fiore seemed reluctant to cede any ground at all to the defense. His answers seemed oblique to the questions, and Mr. Wells even began crowding the witness stand, asking forcefully,

MR. WELLS: DID THEY (the Subcommittee members) HAVE DISCUSSIONS AMONG THEMSELVES?

DR. FIORE: I’m not sure what I can add.. .

MR. WELLS: WERE THERE DISCUSSIONS?

Mr. Brody objected, saying the question had been “asked and answered,” and wondering why Mr. Wells had to ask the question from so near the witness stand rather than back at the podium.

Mr. Wells apologized and scurried back while Judge Kessler asked Dr. Fiore, “It’s a simple question, yes or no, did the subcommittee discuss the issue?”

Dr. Fiore obviously had no recollection of such a discussion, but told how the Subcommittee had listened to the Free and Clear presentation, and had talked about it and ultimately had adopted its recommendations. Mr. Wells said this implied a discusion, so was there a discussion, “in any way, shape or form” about the appropriateness of using the 8% utilization rate? “How could they not consider it appropriate, by voting on it and endorsing it?” Dr. Fiore said. “I can’t give you specific words, on specific days.”

Judge Kessler came in again, and said, “That wasn’t the question. At some point, was the subject discussed? I’m not asking what the substance was.”

Dr. Fiore said, “We discussed the presentation of Free and Clear in detail. Others responded to it as well, in other testimony.”

Judge Kessler didn’t physically throw up her hands, but yes, she threw up her hands. “All right, Mr. Wells, please [go on].”

Dr. Fiore didn’t seem to be purposefully evasive, for the most part. I don’t know how he was coached for this session, but he seemed unreasonably unwilling to concede an inch, and there were definitely times when he should have. After this episode, there were several other similar instances, and, for the first time in the trial, the reporters in the gallery actually got a bit vociferous in their impatience with his answers, muttering lowly but intensely, “Just say, yes!” or “Just say, right!”

Altria litigation spokesman John Sorrells felt Dr. Fiore’s awkwardness was because of his inexperience. I had assumed otherwise, because of all the “you read that correctly”s, but yes, lack of previous live testimony might explain his unease on the stand.

But Dr. Fiore could do little about the dangerous record Mr. Wells was inexorably constructing, a record that could make a strong impact on an appeals court judge–or even Judge Kessler herself in a Daubert challenge: a record that could conceivably demonstrate a dire lack of “sufficient facts or data” to back up his expert opinion, as required by Federal Rules of Evidence #702.

Mr. Wells started to go through each transcript of the 5 subcommittee meetings–and these transcripts were filled with misspellings and even, at one critical point for this trial, stopped altogether while the tape was changed(!)–asking Dr. Fiore, “would you accept my representation that there was no discussion or evaluation of any subcommittee member in regards to the appropriateness of using the 16% figure for the purposes of costing out a national quitline?”

Judge Kessler stopped him at the second such question:

JUDGE KESSLER: Why do we have to go through this? I know the record you are trying to build. In making that argument, it is either in the record–or not–of the subcommittee’s proceedings. I don’t think any of it is necessary at this point.

**———————————————————

Mr. Wells similarly attacked Dr. Fiore’s other funding proposals–the $1 billion/year for a comprehensive media campaign for smoking cessation (this figure was extrapolated from the “Fairness Doctrine” years 1966-1970), the $500 million/year for research on cessation, and the $500 million/year for medical school cessation training.

Mr. Wells’ cross will not only provide fodder for an appeals court overturn, but, should anyone decide a National Quitline is an appropriate remedy, the cost to the Defendants may be considerably scaled down.

**———————————————————

Mr. Wells attacked Dr. Fiore’s acceptance of pharmaceutical company funds for research and consulting. He showed that the American Journal of Public Health article in which he described the National Action Plan did not include a disclosure of these funds. Judge Kessler asked, “Isn’t it general procedure or requirement for peer-reviewed journals that the authors disclose any financial connections whatsoever creating the appearance of a conflict?”

“Yes,” said Dr. Fiore, “and what I can’t recall is at the time, what if any discussion there was about copying the conflict of interest form to the actual article. This is an oversight and I don’t know why it was made.”

[Mr. Brody later introduced evidence that a disclosure letter had indeed been sent to AJPH.]

**———————————————————

Mr. Wells then attempted to highlight the legal obstacles to a court-ordered “barrier-free” national cessation program–that there would be no requirement that a smoker prove he or she smoked the defendants’ brands, or had relied in any way on misrepresentations of any of the defendants.

**———————————————————

DOJ attorney Stephen Brody delivered a fairly robust reclamation of Dr. Fiore, successfully dismissing at least one important Defense document with a dubious provenance, and providing Dr. Fiore with at least some semblance of “sufficient facts and data.” (I’m not sure why we were missing so much of it before Mr. Brody rode to the rescue.)

He established real-world cost estimates of daily patch use, and the legitimacy and necessity of extrapolating the experiences of other quitlines and promotions to a national level.

**———————————————————

Judge Kessler admitted Dr. Fiore as an expert–but the Daubert question still hangs over his testimony. Defense will file written papers, undoubtedly requesting the heart of his testimony be thrown out.

**———————————————————

On a deeper level, it is unclear to me how DOJ will justify this particular “remedy.”

Dr. Fiore does address February’s Appeals Court decision, but only in one short, cryptic sentence in his Expert Report:

It is my understanding that one of the goals of a cessation program will be to prevent and restrain future conduct by defendant tobacco manufacturers through the reduction or elimination of smoking within many groups.

If that makes little sense to you, you’re not alone. Presumably, the how of this restraint will be discussed in closing arguments.

Another odd aspect of Dr. Fiore’s filings is that the actual assigning of the cost of the program to the Defendants is never stated either in his Expert Report nor in his Written Direct. Everyone–including Defense and DOJ–just seems to assume the bill is to be laid at Defendants’ door, and Dr. Fiore verbally confirmed that on the stand Tuesday.

**———————————————————

The court was able to squeeze in about 30″ of testimony from Campaign for Tobacco-Free Kids CEO Matt Meyers. Mr. Myers’ written direct testimony has already been eviscerated, and is now down to maybe 20 pages, less than 1/3 what it was. He is not allowed to address the negotiations leading up to the June 20, 1997 Proposed Resolution. I believe this is because a) the PR was a package deal–all the elements were a part of a package, and can not be considered individually, and b) it was never enacted.

However, Mr. Myers may discuss the differences between the 1997 PR and the 1998 MSA.

**———————————————————

I must say I worried for Mr. Bernick as he began his cross of Mr. Myers. He stumbled badly when he began, “Your organization is called the Cen–Center- the Coalit –the–the—???.” He actually began to sputter! Finally, mercifully, he nonverbally asked Mr. Myers to remind him of the name, “Campaign for Tobacco-Free Kids.” Oh, I tell you it was a terrible sight to see.

I know it’s been a long trial, and yes, Mr. Bernick must be under a lot of strain–he has certainly been doing most of the heavy lifting here, laboring away while Mr. Wells and Mr. Webb “supervise.” But, even so, in all that vast trove of knowledge he has, for him to lose that one piece of information–his own witness’ organization . . . !

Ah, and it was once such a fine mind, too.

Leave a Reply

The primary purpose of this site is to provide information in a timely manner. Postings should be informative. The usual rules apply: No libel, no profanity, no personal abuse, keep it on topic, and short.

If you are scheduled as a court witness, CHECK with your lawyer before posting anything here!