Tobacco On Trial

Today’s afternoon session saw the most interruptions yet by Judge Kessler, who requested some fairly detailed clarifications.

The material discussed during Dan Webb’s cross of Dr. Farone was somewhat technical, yes, but in addition, Farone was being very strict in his use of the term, “addiction.” Farone said he speaks of addiction as a chemist, and most emphatically not as an “addiction expert.”

The Defense seemed a bit looser in using “addiction” as both a chemical and a behavioral/psychological term, without differentiation.

You Say Tomato, I Say Tomato

Defense tried to draw Farone out on the human dimensions of addiction, but Farone steadfastly refused. At times it seemed as though Defense’s question was a physiological one, and Farone’s answer strictly chemical–yet it was unclear if anyone actually understood this at the time. It wasn’t until late in the day that Farone felt he had to spell out his position.

When Farone talked of the addictiveness of nicotine, he said, he spoke in the area of his own expertise–chemistry. He was speaking of the physical reaction of nicotine in the brain and body on a cellular level. For chemists, the basic process of nicotine as an addictive substance was known since the forties –a simple fact, Farone said, that he was taught in his 1960s Chem-class textbooks.

At the end of the day, Judge Kessler seemed to be satisfied her questions were answered. I, however, may yet be confused, so read the following with a dash of pH:

The Wizard of Os

Webb questioned Farone on his Direct Testimony about the routing and apparent destruction of documents from INBIFO, Philip Morris’ animal testing lab in Cologne, Germany. Farone’s DT cites this famous document in Osdene’s handwriting:

“(1) Ship all documents to Cologne by Tom

(2) Keep in Cologne.

(3) OK to phone & telex (these will be destroyed).

(4) Please make available file cabinet.

Jim will put into shape by end of August or beginning Sept.

(5) We will monitor in person every 2-3 months.

(6) If important letters have to be sent please send to home – I will act on them and destroy.

(7) Advise Rylander – when writing re INBIFO

(8) Can UH, RR + TSO meet in July in Cologne to discuss.”

Farone had indicated this way of handling INBIFO communications was official Philip Morris policy. Webb made much of the fact that handwritten memos don’t usually set official company policies. Farone said handwritten the whole point — to keep the policy undercover, for legal reasons.

How did Farone know this wasn’t just some personal quirk of Osdene’s? Farone said everyone in R&D–from his superiors to his coworkers–consistently operated just as if it were official policy.

Webb asked if telexes between INBIFO and Philip Morris were deleted. Farone said yes, certain ones, not all. Webb asked for documentation that said only _certain_ telexes should be deleted. Webb said out of hundreds of thousands of INBIFO documents on Philip Morris’ document site, you see a _lot_ of telexes–on biological research and testing, and even on mouse skin painting.

DeNoble’s Rats and the Nicotine Analog Program

There was a great deal of discussion on DeNoble’s work with animals, and what results he was allowed to present and what results he wasn’t.

Farone said DeNoble wasn’t working on addiction per se, but was working on a nicotine analog, a chemical that would have much the same effect as nicotine, but without its drawbacks.

Webb cited a number of studies DeNoble was allowed to make public. Farone said, yes, some– but not all.

Judge Kessler said, “I need to understand this better. What did Philip Morris preclude DeNoble from presenting?”

Farone said DeNoble had discovered that acetaldehyde, a carcinogen, reinforced the effects of nicotine. “Nicotine isn’t the only chemical you need to worry about,” Farone said.

Judge Kessler asked, “Am I correct that DeNoble never reached a conclusion because rat data doesn’t translate to humans?”

“Yes,” said Farone. “Animal models are usually used _after_ you’ve decided the mechanism you’re studying. You then choose the most appropriate animal model.”

Webb asked the reason for the Nicotine Analog Program–why was Philip Morris looking for an analog? Nicotine doesn’t cause cancer, does it?

No, said Farone. But there is an adverse affect on the cardiovascular system.

In fact, said Webb, there are established benefits to nicotine, aren’t there? Webb cited evidence that nicotine:

–May reduce schizophrenia

–May prevent Alzheimer’s

–May prevent Parkinson’s

In fact, said Webb, Dr. Neal Benowitz, a future DOJ witness, published a paper, “The Role of Nicotine in Smoking-Related Cardiovascular Disease,” wherein he said, “toxins other than nicotine are the most important causes of acute cardiovascular events.”

And, said Webb, Philip Morris did not keep its nicotine analog research hidden: it communicated with the government, published scientific items and publicly applied for patents.

Habituation vs. Addiction

Farone’s DT stated that everyone at Philip Morris worked on the assumption that nicotine was addicting. Farone told Webb, we knew the chemical behavior of nicotine–how it permeates membranes of cells, how free nicotine penetrates faster than the bound form, how it binds to a receptor, how the process triggers the release of dopamine in the brain–all the chemical aspects that indicate addiction.

Webb brought up the 1964 Surgeon General’s report’s finding that nicotine was “habituating,” not addicting. From page 351:

Drug Addiction

Drug addiction is a state of periodic or chronic intoxication produced by the repeated consumption of a drug (natural or synthetic). Its characteristics include:

1) An overpowering desire or need (compulsion) to continue taking the drug and to obtain it by any means;

2) A tendency to increase the dose;

3) A psychic (psychological) and generally a physical dependence on the effects of the drug;

4) Detrimental effect on the individual and on society.

Drug Habituation

Drug habituation (habit) is a condition resulting from the repeated consumption of a drug. Its characteristics include:

1) A desire (but not a compulsion) to continue taking the drug for the sense of improved well-being which it engenders;

2) Little or no tendency to increase the dose;

3) Some degree of psychic dependence on the effect of the drug, but absence of physical dependence and hence of an abstinence syndrome;

4) Detrimental effects, if any, primarily on the individual.

[A trial observer said to me, “How can you possibly judge if something’s physiologically addicting by its having a ‘ detrimental affect on society?’ Where they insane in those days??]

Farone said that the Surgeon General later changed his mind; the chemists never did. Farone said (paraphrasing): “We wouldn’t have been working on a nicotine analog in the first place if we didn’t recognize nicotine was addictive.”

Webb said (paraphrasing), “Are you telling me that Philip Morris would have been saying something wrong if it had based its opinion on the 1964 Surgeon General’s Report?”

Ammonia: the Secret to Marlboro’s Success?

Webb addressed this part of Farone’s DT:

As I heard at many Richmond meetings, speeches, and discussions when I was there, Philip Morris considered its blended leaf, or BL, to be a secret to Marlboro’s success, because of the ammonia added to the BL.

There was a great deal of discussion about exact ratios of pH to free nicotine, and how ammonia levels can raise the pH, or acidity level, of the smoke, and thus release free nicotine. Webb brought out contradicting opinions from Neal Benowitz and the 79 Surgeon General’s Report. (Farone: the 79 Surgeon General’s Report was wrong.)

Webb brought out a chart showing that the ammonia levels in Marlboro’s smoke have lowered over the 2 decades since Farone was at Philip Morris. (Farone: yes, but they’re still high–and look there at the bottom of the chart and see which brands are the highest–the ultra-lights!)

Judge Kessler asked a series of questions on how free nicotine is more addictive. Finally, she asked Farone, “So you’re focusing on the _speed_ of delivery?”

Yes, said Farone–how fast the nicotine travels across the cell’s permeable membrane. This is fundamental chemistry. It means free nicotine is potentially more addictive.

Webb then tried to accentuate a seeming difference between Farone’s position and Neal Benowitz’s testimony in the Ironworkers’ trial, but Judge Kessler interrupted him: “You’re trying to impeach this witness based on prior testimony of a witness who has yet to testify in this case. We don’t know his testimony at this time.”

She let Webb continue, but after a few more questions, Kessler had had enough.

“This is not useful,” she said, stopping the line of questioning.

Nicotine Manipulation: It’s a Good Thing

Webb began asking Farone about nicotine manipulation (”And you believe it’s a good thing Philip Morris worked to alter the ratio of tar and nicotine”), and asked if he’d heard the charges that Philip Morris had “spiked” cigarettes with extra nicotine (Farone: Not _sold_ ones.)

It had been a long day, worthy of a 4-day weekend. Court resumes Tuesday at 9:30 AM.

This entry was posted on Tuesday, October 12th, 2004 at 12:05 am 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.