Wednesday, 6 November 2013

Day 181: Failed attempts at a safer cigarette

The Executive Vice President in charge of science at RJR Tobacco,  Mr. Jeffery Gentry, returned this morning for his second day of testimony at the Montreal tobacco trials.

Throughout the morning, Mr. Guy Pratte (assisted by Mr. Patrick Plante) worked through a thick binder of documents and notes. Gone was the eye-glazing approach yesterday. Perhaps they made adjustments, or perhaps yesterday afternoon's questions had served their purpose. For whatever reason, the bumps and lulls were gone, and the morning passed in a smooth segue questions, objections, over-rulings and answers.

Mr. Gentry is a very skilled witness. No surprise, perhaps, given that he has testified in a dozen other tobacco trials and has been deposed in 20 others. His answers were succinct and smoothly, if somewhat quickly, delivered. His credibility was likely enhanced in the moments when he acknowledged that he didn't know a name or a document that his own lawyer clearly expected that he would have remembered. Even when his version of events was very different than my own understanding, I had to admit he made his answers sound plausible.

Everyone's skills were on display this morning. Guy Pratte efficiently and clearly put documents and answers on the court record. Philippe Trudel had short but eloquent objections and upped the pressure for the defendants to face the same constraints on relevance that had been imposed on the plaintiffs. Justice Riordan handily dismissed each of these objections, giving Mr. Pratte a large envelope to push but not creating new rules for the trial.

And so it was that the morning was spent hearing evidence about products that were developed in the United States, and about events that happened in a different country and often after the time period of this trial had ended.

A scrapheap of failed products

Mr. Gentry was asked to explain the number of ways that RJR had attempted to reduce the harms of its cigarettes, and the reasons that most of these failed. It soon became apparent that harmfulness in his eyes refers only to the toxic emissions from cigarettes. He clearly does not share the WHO view that harmfulness is also related to attractiveness and dependence potential.

High Nicotine to Tar:  Mr. Gentry said that RJR followed the advice of Gio Gori and Michael Russell (Exhibit 4036X) and made several attempts to reduce the proportion of tar to nicotine in conventional "burn down" cigarettes. "We explored a number of ways [to approach the problem] and always ended up with a product that was harsh."  These efforts began in the 1970s and continue today, he said, but not for conventional products. "Some of our newer technology products are based on this, but in a traditional burn-down cigarette it produces a harsh product that is not acceptable."

Tobacco substitutes:  Filling cigarettes with other nicotine-laced plant material was also tried -- even "lettuce leaf products," were attempted. These products were not found to be reliable safer, however. "The substitutes may produce as much or more of a problem as what you are substituting for."  Gio Gori agreed that there was little encouragement to continue this route. (Exhibit 20053.1)

(Gio Gori and Michael Russell have been cited so frequently in this trial as validators of the industry's actions that it is as though they are ghost witnesses, like Patrick O'Neil Dunne. Justice Riordan might be forgiven for thinking there were no other public health voices in the 1970s and 1980s, or that these men represented the mainstream view. He has been given no information about the controversies that surround Mr. Gori which might make questionable his appropriateness as a health validator.)

Heat-not-burn #1: Mr. Gentry explained the development and cost that was invested in development the Premier and Eclipse cigarettes. "Hundreds of millions of dollars" and the work of "300 or so" people were invested in these novel technologies. Work on Premier began around 1980, he said, but it did not reach the test market until late 1987 and 1988.

As Mr. Howie had done earlier this week, Mr. Gentry cited one of the reasons that Premier failed its market test was that it did not burn down - there was "no sensory cues that the product was progressing." This, and the taste, were why it was "not acceptable to consumers."

Nor was it acceptable to most in the public health community - with one notable exception. "It received a mixed reaction. There were a few who were commending it. There were many who thought the product should be withdrawn or regulated in such a way that it was banned."  Michael Russell not only liked the idea (Exhibit 40365), he liked it enough to write the man in charge of research at RJR to encourage him to not give up on the idea. (Exhibit 40366). Opposing views were not presented.

Heat-not-burn #2:  Mr. Gentry described the technological changes that were built into Eclipse, the successor to Premier. "Conceptually, it worked the same way... The hot air drawn across the heat source was pulled over the substrate to release the nicotine."

The Eclipse Cigarette 
Market testing for the Eclipse cigarette began in 1994, and it has not yet been fully pulled from the market. "It still does not taste like a traditional cigarette. It does not burn down. It suffers from low consumer acceptability" We keep it in the market place because we think it is the right thing to continue to offer, but it does not sell very well."

Mr. Gentry was not asked about the public health response to the Eclipse cigarette.

The carbon scrubber filter: Mr. Gentry described the development of a better carbon filter. (Carbon filters are more effective at reducing specific compounds, including those in the gas phase). The company launched a version of its popular Winston brand in a test market. It too was a market failure. "We watched that product for a good number of months. We had some fall off on franchise acceptability." 

(The elephant in the room?: Even though the barriers or time and geography were effectively lifted today, there was still no mention of the electronic cigarette. Mr. Gentry was not asked to explain whether or how it had overcome the consumer resistance described by him and Mr. Howie to a cigarette that did not burn down. Earlier this year, his company launched its own e-cigarette brand, VUSE.)

Back to the Canadian farm

Coal fired Kiln
Reduced nitrosamines: Mr. Gentry said that it was his company that had first discovered that nitrosamines could be reduced in flue-cured tobacco, but that this discovery had not been made until the late 1990s. For many years, he said, scientists thought that these resulted from chemical conversions caused by microbes living on the tobacco. Instead, it turned out that it was the exhaust from the heating system that was causing the problem.

"Combustion gases were passed directly into the curing barn, exposing the tobacco to exhaust gases. Oxides of nitrogen were reacting to form nitrosamines." The solution was to change the heating system with a heat exchange." 

Mr. Pratte provided his witness with the opportunity to rebut the suggestion made by the plaintiffs earlier this month that the problem with nitrosamine in flue-cured tobacco started when direct gas heating systems were installed in curing barns the 1960s and 1970s.

Mr. Gentry explained that it was because traditional fuels like coal, kerosene or diesel produced gases that spoiled the taste of tobacco that they were exhausted to the outside. (See photo- Exhibit 40367). The conversion to natural gas happened during the energy crisis, and curing was moved to bulk-barns. Because the exhaust from natural gas gave no bad taste to the tobacco, there were no concerns the exhaust gases being used to heat the tobacco.

There was no way that the company could have known that this process would increase nitrosamine levels, he said. Methods to measure these compounds was only developed around 1973 -- after the bulk barns were already in place. The research focus was elsewhere:  "People were still focused on microbial causes ... right up to the day we announced our finding." (Exhibit 40368).

He said that once their study was publicized within the industry that action was taken. In short order, Canadian farmers had also converted their curing barns to the less harmful method. (Exhibits 40369, 40370)

Additional comments on additives

The trial has already heard evidence that RJR-Macdonald (as it was then) used sugar, sorbitol and other additives in the cigarettes it manufactured, (Exhibit 630A) and that these were used up until the late 1980s.

Mr. Gentry was asked today by Mr. Patte to explain how it was that adding this material did not make the cigarettes any more harmful, even though the company's own toxicity sheets showed that one of these ingredients (d-sorbitol) produced benzopyrene when burned. (Exhibit 40350)

This was a rehearsed moment. Mr. Gentry had already calculated in micrograms how much benzopyrene would have resulted from the use of sorbitol, and his calculation had been circulated to all the lawyers. The hitch for Mr. Pratte was that such facts cannot normally be thrown into a trial by a fact witness -- he needed his witness to be liberated from such constraints. The plaintiffs lawyers were initially not willing to let this happen.

Jeffery Gentry calculates how much
benzopyrene is introduced
through the use of d-sorbitol
Exhibit 40373.1
Several entertaining minutes ticked by as lawyers and judge reached for their procedure books to sort this out.

Justice Riordan made it clear that he was willing to accommodate by recognizing Mr. Gentry as an expert witness for the purpose of presenting this finding. (Aha! I thought. No wonder the heavy emphasis on Mr. Gentry's academic record!)

And as for the legal requirement that expert witnesses provide written reports? Well, the one-page calculation he had prepared could be used for this purpose. After a face-saving lunch break, the plaintiffs withdrew their objection, and the spur-of-the moment upgrade to expert witness was avoided.

The way Mr. Gentry presented his mathematical conclusion was a more sophisticated version of Mr. Howie's exasperated claims of "harmless!" on Monday. He calculated that the 0.0035 micrograms of benzopyrene added to each cigarette through the use of sorbitol was a small fraction of the amount of this carcinogen that was naturally present in cigarette smoke.

In someways I thought Mr. Howie's approach might have been more helpful to the defence: Mr. Gentry not only confirmed that the sorbitol would add to the toxic burden, he also affirmed the high level of benzopyrene in every cigarette.

pH? It's the lungs that increase it, not ammonia

For more than a decade, scientific and popular literature has told the story of the "Secret of Marlboro" and the way that increasing the pH of tobacco by the addition of ammonia can create "free nicotine" that gives a faster nicotine hit. Evidence filed by the plaintiffs suggested that RJR-Macdonald was trying to figure out how to do this. (See, for example, exhibits 676A, 676B644, 647)

Surgeon General 1979 report, page 753
Mr. Gentry quietly pooh-poohed the idea of ammoniation. He said that the natural pH levels of cigarettes (from 5.5 to 6.5) only allowed for a very small amount of free nicotine. (Exhibit 601-1979) Moreover, he said, the lungs have a much higher pH value of 7.4 -- whatever the acidity or alkalinity of the nicotine that is inhaled, by the time it hits the lung wall it is "buffered" into the same level as the body. I wonder if Philip Morris was listening.

It was not even lunchtime before Mr. Pratte said he had no more questions for this witness. The cross examination, which began in the afternoon, will be reported in tomorrow's blog.

The Appeal Court opens the door to Imperial Tobacco

On Monday Justice Yves Marie Morissette of Quebec's Court of Appeal was asked to decide whether Imperial Tobacco could have permission to appeal Justice Riordan's September 13th decision that protected many personal details of individual class members from industry lawyer examination. (This issue was argued here last August 26.)

Marc Beauchemin arrived at the court this morning to tell his colleagues on the plaintiff team that Justice Morissette had decided to allow the appeal. It will be heard on the last day of February.

The cross-examination of Jeffery Gentry continues tomorrow. Next week a slight change of players: - a mystery motion filed by the plaintiffs against JTI-Macdonald will be heard before Justice Mongeon.