Tobacco On Trial

Real life gave the trial another strange jolt late this afternoon as word came that Frederick Gulson has taken ill in his hotel room. Mr. Gulson has complained of flu-like symptoms. Dr. David Burns, having just stepped down after a grueling 2-3 hours of cross-examination, will go directly from the witness stand to the sick room: as Sharon Eubanks explained to Judge Kessler, he has agreed to “pay a house call, if you will.”

Dr. Burns is a practising internist with a specialty in pulmonary medicine, and an editor and an author of Monograph 13: “Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.” (2001) As well, he is an incredibly smart and canny scientist and witness.

One has to admire RJR’s Peter Bierstecker’s gumption, as well-trained and scientifically well-fortified as he is, to even attempt to shake Dr. Burns’ testimony concerning the effects–or non-effects–of low-yield cigarettes on lung cancer rates.

There were periodic outbursts of prickliness. A typical answer of Dr. Burns’ was, “You are asking a question that is imprecise; I’d be glad to help you fix it if you like.” Mr. Bierstecker never took Dr. Burns up on his offer.

There is an apparent discrepancy in the fact that lung cancer rates did not decline as expected in the later years of the 20th century, when people began smoking, almost exclusively, lower yield cigarettes. This is very clear in the ACS CPS I and II data, which were cohort studies of about 1 million people taken 20 years apart. This data was the main subject of Mr. Bierstecker’s cross.

Monograph 13 concluded that this seeming discrepancy was due to compensation: cigarettes may have been lower yield by FTC measurement, but the smoker’s compensation ensured that he (CPS measured white males) was getting as much as ever.

Testimony today involved alternate explanations for the effect–mainly the skewing of the data by early-life smoking. The Defense tried to criticize Dr. Burns for not telling the court in his testimony that one explanation for the unexpected increase in of lung cancer mortality in the later cohort may be “early-life smoking,” ie, in the later ACS CPS-II cohort, white men born 1945-50 or later may have had an earlier age of initiation and/or experienced heavier smoking early in life. This may have led to a greater death rate among this particular group, thus skewing the data and obscuring any benefit from low-yield cigarettes.
Mr. Bierstecker offered supportive opinions from Sir. Richard Peto and Dr. Michael Thun. Dr. Burns said that this issue had been looked at, and fully addressed, in Monograph 13. In fact, a conference in Toronto had been convened to look at just this issue, and the consensus–save Sir Richard Peto–was that the data to support such a hypothesis simply wasn’t there.

Dr. Burns stated that when lung cancer rates did begin to go down, that the decline was not, as Mr. Bierstecker posited, due to changes in cigarette design and technology such as filter design,tobacco puffing, tobacco expansion, sheet reconstitution and tobacco blending. He said in his testimony — written and live — that “These lung cancer trends are adequately explained by changes in smoking prevalence due to cessation and reduced initiation without postulating reductions in disease risks due to changes in cigarette design.’

Dr. Burns said that Sir Richard Peto was the only person at the Toronto conference who felt that early-life smoking was the only possible explanation for the unexpectedly high lung cancer death rates in the UK in later years.

“Other people there [in Toronto] felt there were alternative explanations. . . It’s fair to say we don’t know the answer. What isn’t fair is that the only potential explanation for the decline [in lung cancer rates] in the UK was the type of cigarette smoked.”

In all, Dr. Burns’ cross-examination was thick with relatively new scientific jargon, data and charts, but the testimony was not as tedious as it could have been. When Dr. Burns began to explain to Judge Kessler what FTC machine-measured tar/nicotine levels meant, she stopped him short. “I know all about that,” she said.

Mr. Bierstecker said he has another 3-4 hours to go. This will probably occur late in the day Wednesday, or Thursday, depending on the length of Mr. Gulson’s testimony tomorrow.

MONOGRAPH 13 CONCLUSIONS:

1. Epidemiologic and other scientific evidence, including patterns of mortality from smoke-caused diseases, does not indicate a benefit to public health from changes in cigarette design and manufacturing over the last 50 years.

2. For spontaneous brand switchers, there appears to be a complete compensation for nicotine delivery, reflecting more intensive smoking of lower-yield cigarettes.

3. Widespread adoption of lower yield cigarettes in the United States has not prevented the sustained increase in lung cancer among older smokers.

4. Many smokers switch to lower yield cigarettes out of concern for their health, believing these cigarettes to be less risky and to be a step toward quitting.

[and]

Advertising and marketing of lower yield cigarettes may promote initiation and impede cessation, more important determinants of smoking-related diseases.

5. Measurements of tar and nicotine yields using the FTC Method do not offer smokers meaningful information on the amount of tar and nicotine they will receive from a cigarette. The measurements also do not offer meaningful information on the relative amounts of tar and nicotine exposure likely to be received from smoking different brands of cigarettes.

This entry was posted on Tuesday, February 15th, 2005 at 6:24 pm and is filed under Notes. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.